Category Archives: Immunology

Merck to buy Prometheus Biosciences for US$10.8b – theSundaily

Merck will pay US$200 per share for the California-based biotechnology company that specialises in treatments for autoimmune diseases. That represents a 75% premium to the US$114.01 closing price for Prometheus shares on Friday.

This is allowing us to move into immunology in a strong way and will allow us sustainable growth, we think, well into the 2030s given the long patent life, Merck chief executive Robert Davis said in an interview.

Davis said the Prometheus drug, PRA023, being developed to treat ulcerative colitis, Crohns disease, and other autoimmune conditions, could be a multibillion-dollar seller for Merck. He said the recent release of encouraging Phase II clinical trial results drove Merck to pounce.

Weve been watching their clinical development programme for a while, Davis said.

If the deal closes in the third quarter of this year as hoped, Merck could launch a late-stage ulcerative colitis study of the drug in the fourth quarter or first quarter of 2024, Davis said.

Merck has been looking for deals to protect itself from eventual revenue loss as patents on its blockbuster cancer immunotherapy Keytruda begin to expire toward the end of the decade. The company reported nearly US$21 billion in Keytruda sales last year.

Davis said revenue from the Prometheus acquisition could start to roll in around the time Keytruda patents could potentially expire.

Davis compared the deal to one he struck in 2021 for Acceleron, which allowed Merck to quickly build out its pipeline of cardiovascular drugs.

I believe now we have a very strong portfolio in the cardiometabolic space. We see this acquisition of Prometheus building out a similar portfolio in the immunology space, Davis said, adding that Merck brings scale, global reach and significant capital to deploy.

Last summer, Merck was reportedly in talks to buy cancer focused biotech Seagen Inc, but rival Pfizer Inc ended up striking a US$43 billion deal for Seagen last month.

Davis said Merck would continue to be opportunistic on acquisitions, but is agnostic about size.

We look where we see the most compelling science, and where that science aligns with value we move, he said, noting that the company is not interested in large transformative or cost-synergy driven deals.

Mercks talks with Prometheus were first reported by The Wall Street Journal.

The company in February forecast 2023 earnings below Wall Street estimates and a steep decline in sales of its Covid-19 antiviral treatment. - Reuters

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Merck to buy Prometheus Biosciences for US$10.8b - theSundaily

Nektar Therapeutics Announces Strategic Reprioritization and Cost Restructuring Plan – Yahoo Finance

-- Pipeline focus will prioritize programs in immunology, including REZPEG and several immunology research programs --

-- Development of NKTR-255 in diffuse large B-cell lymphoma and bladder cancer to continue as strategic partnering options are pursued --

-- Cost restructuring plan reduces San Francisco-based workforce by approximately 60% and extends cash runway into the middle of 2026 --

-- Company to announce financial results for the first quarter of 2023 after close of U.S.-based financial markets on May 9, 2023 --

SAN FRANCISCO, April 17, 2023 /PRNewswire/ --Nektar Therapeutics (Nasdaq: NKTR) today announced a strategic reprioritization and cost restructuring plan that includes a new pipeline focus on immunology, as well as several cost reduction initiatives, which the company expects will significantly reduce future operating expenses and extend its cash runway into the middle of 2026.

(PRNewsfoto/Nektar Therapeutics)

Key elements of the new plan include:

Prioritize REZPEG development: Nektar intends to work with Eli Lilly to ensure the continuation of REZPEG development whether it is under the existing Eli Lilly agreement or Nektar regains the rights to REZPEG. The Phase 1b data for REZPEG in atopic dermatitis previously presented at the EADV meeting in September 2022 showed that a dose-dependent improvement was observed in key efficacy measures of mean change in EASI, EASI-75, vIGA-AD scores, and Itch NRS 4-point improvement ratesover placebo with 12 weeks of treatment. These improvements were observed for an additional 36 weeks following the 12-week treatment period. These proof-of-concept data show REZPEG's ability to stimulate Tregs to target an immune system imbalance resulting in an improvement of disease activity in patients. The Phase 1b data were recently highlighted in a talk by Eric Lawrence Simpson, MD, FAAD at the 2023 American Academy of Dermatology (AAD) Annual Meeting on March 17, 2023 in the scientific session covering atopic dermatitis, as a potential future remittive therapy.

Continue development of lead oncology asset, NKTR-255, while seeking a strategic development partner: As part of the strategic reprioritization, Nektar will continue its Phase 2 study of NKTR-255 in combination with cell therapies and the Phase 2 JAVELIN Bladder Medley Study with partner Merck KGaA while it explores strategic partnership options for NKTR-255. NKTR-255 is an investigational IL-15 receptor agonist designed to boost antitumor immunity by increasing the proliferation and survival of natural killer and memory CD8+ T cells and may have broad potential applicability across oncology indications.

Continue core research programs in immunology: Nektar will continue to advance two preclinical pipeline candidates in auto-immune diseases including a new PEG-Colony Stimulating Factor (CSF1) program and a separate TNFR2 agonist antibody being developed in collaboration with Biolojic Design. The company plans to file an IND for at least one of these programs in 2024.

Implement a cost restructuring plan: As part of the strategic reprioritization, Nektar also plans to reduce its San Francisco-based workforce by approximately 60%. Once the cost restructuring plan has been fully completed, the company is expected to have approximately 55 employees based in San Francisco. The company anticipates that its Huntsville manufacturing facility, which supports several large pharmaceutical partners, will continue to operate with its current staff. The restructuring also includes actions to reduce additional operating costs and is expected to be substantially completed by June 2023.

Story continues

"Following a comprehensive review of our portfolio, we have made the decision to prioritize the advancement of our immunology programs," said Howard W. Robin, President and CEO of Nektar. "We intend to work with Eli Lilly either to continue REZPEG's development in the clinic under our existing agreement or to regain the rights to REZPEG for Nektar. We believe the strong data generated for this asset demonstrates its potential as a remittive therapy in atopic dermatitis and sets the stage to move quickly into a Phase 2b study. REZPEG would be positioned as a novel potential therapeutic in a significant, growing biologic treatment landscape."

"The strategic initiative we announced today is intended to further streamline our operations and to extend considerably our cash runway into the middle of 2026," continued Robin. "Although the actions we are taking today are difficult, we are incredibly grateful for the contributions of the employees departing Nektar."

Nektar had cash, cash equivalents, and marketable securities of approximately $456 million as of March 31, 2023. These significant reductions in the company's operating expenses, including personnel-related costs and external expenses, are expected to extend the company's cash runway into the middle of 2026. Projected annual savings from the headcount reduction will be fully realized in 2024 and represent an annual savings of approximately $30 million. Nektar expects non-recurring cash payments of approximately $8 million, primarily in the second quarter of 2023 associated principally with the workforce reduction.

Executive Management Changes

As part of this initiative, Nektar also announced several changes to its executive team:

Dr.Brian Kotzin, Nektar's Chief Medical Officer, will be stepping down from his full-time role but will continue to serve in an ongoing role as a strategic advisor to the company. Dr. Mary Tagliaferri, current Chief Development Officer, will assume the role of Chief Medical Officer.

Jillian Thomsen will be stepping down from her role as Chief Financial Officer (CFO) and will depart the company in June following a transition period. The company has appointed Sandra Gardiner to the role of acting CFO. Sandra is a skilled business and finance executive with over 30 years of financial and accounting experience. She is a partner at FLG Partners, a leading CFO services firm in Silicon Valley.

Kevin Brodbeck, Nektar's SVP of Technical Operations, will depart the company in June following a transition period. Ken Franke, current VP of Biologics Development & Manufacturing will assume Kevin's responsibilities.

The company thanks its departing executives for their contributions to Nektar.

Conference Call Details to Announce First Quarter 2023 Financial Results:

Nektar will announce its financial results for the first quarter 2023 on Tuesday, May 9, 2023, after the close of U.S.-based financial markets. Howard W. Robin, President and Chief Executive Officer, will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time.

The press release and live audio-only webcast of the conference call can be accessed through a link that is posted on the Home Page and Investors section of the Nektar website: http://ir.nektar.com/. The web broadcast of the conference call will be available for replay through June 4, 2023.

To access the conference call, please pre-register at Nektar Earnings Call Registration. All registrants will receive dial-in information and a PIN allowing them to access the live call.

About Nektar Therapeutics

Nektar Therapeutics is a biopharmaceutical company with a robust, wholly owned R&D pipeline of investigational medicines in immunology and oncology as well as a portfolio of approved partnered medicines. Nektar is headquartered in San Francisco, California, with additional manufacturing operations in Huntsville, Alabama. Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com.

About Rezpegaldesleukin (REZPEG)

Autoimmune and inflammatory diseases cause the immune system to mistakenly attack and damage healthy cells in a person's body. A failure of the body's self-tolerance mechanisms enables the formation of the pathogenic T lymphocytes that conduct this attack. REZPEG is an investigational, potential first-in-class T regulatory cell stimulator that may address this underlying immune system imbalance in people with many autoimmune and inflammatory conditions. It is designed to target the interleukin-2 receptor complex in the body in order to stimulate proliferation of powerful inhibitory immune cells known as regulatory T cells. By activating these cells, REZPEG may act to bring the immune system back into balance. REZPEG is being developed as a self-administered injection for a number of autoimmune and inflammatory diseases.

About NKTR-255

NKTR-255 is a biologic that targets the IL-15 pathway in order to activate the body's innate and adaptive immunity. Through optimal engagement of the IL-15 receptor complex, NKTR-255 is designed to enhance functional NK cell populations and formation of long-term immunological memory, which may lead to sustained and durable anti-tumor immune response.

Preclinical findings suggest NKTR-255 has the potential to synergistically combine with antibody-dependent cellular cytotoxicity molecules as well as to enhance CAR-T therapies. A Phase 2/3 study is underway that combines NKTR-255 with approved CAR-T cell therapies in patients with diffuse large B-cell lymphoma, which is currently recruiting (NCT05664217).

There are two ongoing investigator sponsored trials (ISTs) evaluating NKTR-255 following treatment with a CAR-T cell therapy. Fred Hutchinson Cancer Center is conducting a Phase 1 study evaluating NKTR-255 in combination with CD19 CAR-T cell therapy in patients with relapsed or refractory large B-cell lymphoma (NCT05359211), and Stanford University is conducting a Phase 1 study evaluating NKTR-255 in combination with CD19/22 CAR-T cell therapy in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (NCT03233854).

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements which can be identified by words such as: "will," "may," "advance," "support," "develop," "provide," "expect," "aim," "potential" and similar references to future periods. Examples of forward-looking statements include, among others, statements regarding the therapeutic potential of, and future development plans for rezpegaldesleukin, NKTR-255 and our other drug candidates in research programs, the prospects and plans for our collaborations with other companies, the timing of the initiation of clinical studies and the data readouts for our drug candidates, our expectations regarding our 2023 cost restructuring plan and reduction in our San Francisco-based workforce, including the anticipated cost savings and non-recurringcash payment related to, and the timing for completion of, the cost restructuring plan, and our expected working capital and cash runway. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others: (i) our statements regarding the therapeutic potential of rezpegaldesleukin, NKTR-255 and our other drug candidates are based on preclinical and clinical findings and observations and are subject to change as research and development continue; (ii) rezpegaldesleukin, NKTR-255 and our other drug candidates are investigational agents and continued research and development for these drug candidates is subject to substantial risks, including negative safety and efficacy findings in ongoing clinical studies (notwithstanding positive findings in earlier preclinical and clinical studies); (iii) rezpegaldesleukin, NKTR-255 and our other drug candidates are in various stages of clinical development and the risk of failure is high and can unexpectedly occur at any stage prior to regulatory approval; (iv) the timing of the commencement or end of clinical trials and the availability of clinical data may be delayed or unsuccessful due to challenges caused by the COVID-19 pandemic, regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, changing standards of care, evolving regulatory requirements, clinical trial design, clinical outcomes, competitive factors, or delay or failure in ultimately obtaining regulatory approval in one or more important markets; (v) we may not achieve the expected cost savings we expect from our 2022 corporate restructuring and reorganization plan or our 2023 cost restructuring plan and we may undertake additional restructuring and cost-saving activities in the future, (vi) patents may not issue from our patent applications for our drug candidates, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (vii) certain other important risks and uncertainties set forth in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2023. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Contact:

For Investors:Vivian Wu of Nektar Therapeutics628-895-0661

For Media:David Rosen of Argot Partners(212) 600-1902david.rosen@argotpartners.com

Cision

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Nektar Therapeutics Announces Strategic Reprioritization and Cost Restructuring Plan - Yahoo Finance

Merck Strengthens Immunology Pipeline with Acquisition of … – Merck

April 16, 2023 6:00 am ET

PRA023 is a novel, late-stage candidate for ulcerative colitis and Crohns disease and other autoimmune conditions

Prometheus Biosciences comprehensive data set enables target discovery and precision medicine approach in inflammation and immunology

RAHWAY, N.J. & SAN DIEGO--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Prometheus Biosciences, Inc. (Prometheus) (Nasdaq: RXDX) today announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, has agreed to acquire Prometheus for $200.00 per share in cash for a total equity value of approximately $10.8 billion.

At Merck, we are committed to delivering on our purpose to save and improve lives and continue to identify and secure opportunities where compelling science and value creation align, said Robert M. Davis, chairman and chief executive officer, Merck. The agreement with Prometheus will accelerate our growing presence in immunology where there remains substantial unmet patient need. This transaction adds diversity to our overall portfolio and is an important building block as we strengthen the sustainable innovation engine that will drive our growth well into the next decade.

Prometheus is a clinical-stage biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases. The companys lead candidate, PRA023, is a humanized monoclonal antibody (mAb) directed to tumor necrosis factor (TNF)-like ligand 1A (TL1A), a target associated with both intestinal inflammation and fibrosis.

Prometheus was established to revolutionize the treatment of immune-mediated diseases through the application of a powerful precision medicine approach, said Mark McKenna, chairman and chief executive officer of Prometheus Biosciences. This agreement with Merck, a leader in biopharmaceutical research and development, allows Prometheus to maximize the potential for PRA023, while continuing to apply our technology and expertise to fuel further discoveries to address the needs of patients with immune disorders.

Prometheus is developing PRA023 for the treatment of immune-mediated diseases including ulcerative colitis (UC), Crohns disease (CD), and other autoimmune conditions. In December 2022, the company announced positive results for PRA023 from ARTEMIS-UC, a Phase 2, placebo controlled, study evaluating safety and efficacy in patients with moderate to severely active UC and APOLLO-CD a Phase 2A, open-label, study evaluating safety and efficacy in patients with moderate to severe CD. The findings were recently presented at the 18th Congress of European Crohns and Colitis Organisation (ECCO).

By applying a portfolio of powerful analytic tools to a comprehensive collection of IBD samples, Prometheus identified important disease insights that have now yielded a promising late-stage candidate, said Dr. Dean Y. Li, president, Merck Research Laboratories. I look forward to working with the talented Prometheus team to establish a new paradigm of precision treatment for immune diseases.

Under the terms of the acquisition agreement, Merck, through a subsidiary, will acquire all of the outstanding shares of Prometheus. The acquisition is subject to Prometheus Biosciences shareholder approval. The closing of the proposed transaction will be subject to certain conditions, including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The transaction is expected to close in the third quarter of 2023.

A copy of the merger agreement pursuant to the transaction will be filed with the Securities and Exchange Commission (SEC) and will be publicly available. In addition, Merck and Prometheus will file annual, quarterly and current reports and other information with the SEC, which are available to the public from commercial document-retrieval services and at the SECs website at http://www.sec.gov. Copies of the documents filed with the SEC by Merck may be obtained at no charge on Mercks internet website at http://www.merck.com or by contacting Merck at 126 East Lincoln Avenue P.O. Box 2000, Rahway, NJ 07065 USA, or (908) 740-4000. Copies of the documents filed with the SEC by Prometheus may be obtained at no charge on Prometheus internet website at https://www.prometheusbiosciences.com or by contacting Prometheus at 3050 Science Park Road, San Diego, CA 92121 or (646) 241-4400.

Advisors

Morgan Stanley & Co. LLC acted as financial advisor to Merck in this transaction and Paul, Weiss, Rifkind, Wharton & Garrison LLP as its legal advisors. Centerview Partners LLC and Goldman Sachs & Co. LLC acted as financial advisors to Prometheus and Latham & Watkins LLP as the companys legal advisor.

About inflammatory Bowel Disease

Inflammatory bowel disease (IBD) is a term used to collectively describe Crohns disease and ulcerative colitis. These conditions are characterized by chronic inflammation of the gastrointestinal (GI) tract. Prolonged inflammation results in damage to the tissues lining the GI tract.Both ulcerative colitis and Crohn's disease usually are characterized by diarrhea, rectal bleeding, abdominal pain, fatigue and weight loss.

About PRA023

PRA023 is a humanized monoclonal antibody directed to tumor necrosis factor (TNF)-like ligand 1A (TL1A). PRA023 binds both soluble and membrane associated human TL1A with high affinity and specificity. Prometheus is developing PRA023 for the treatment of immune-mediated diseases including UC, CD, and other autoimmune conditions.

About Prometheus Biosciences

Prometheus Biosciences, Inc. is a clinical-stage biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases. The companys precision medicine platform, Prometheus360, combines proprietary machine learning-based analytical approaches with one of the worlds largest gastrointestinal bioinformatics databases to identify novel therapeutic targets and develop therapeutic candidates to engage those targets.

Investor Call

Merck will hold an investor call on Monday, April 17, at 8:00 a.m. EDT to discuss this proposed acquisition. Journalists who wish to ask questions are requested to contact a member of Mercks Media Relations team at the conclusion of the call. To listen to the call, please visit https://www.merck.com/investor-relations/events-and-presentations/.

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world - and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit http://www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA includes statements that are not statements of historical fact, or forward-looking statements, including with respect to Mercks proposed acquisition of Prometheus. Such forward-looking statements include, but are not limited to, the ability of Merck and Prometheus to complete the transactions contemplated by the merger agreement, including the parties ability to satisfy the conditions to the consummation of the merger contemplated thereby and the other conditions set forth in the merger agreement, statements about the expected timetable for completing the transaction, Mercks and Prometheuss beliefs and expectations and statements about the benefits sought to be achieved in Mercks proposed acquisition of Prometheus, the potential effects of the acquisition on both Merck and Prometheus, the possibility of any termination of the merger agreement, as well as the expected benefits and success of Prometheuss product candidates. These statements are based upon the current beliefs and expectations of Mercks management and are subject to significant risks and uncertainties. There can be no guarantees that the conditions to the closing of the proposed transaction will be satisfied on the expected timetable or at all, with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include, but are not limited to, uncertainties as to the timing of the merger; the risk that competing offers or acquisition proposals will be made; the possibility that various conditions to the consummation of the merger contemplated thereby may not be satisfied or waived (including the failure to obtain the requisite vote by Prometheuss stockholders); the effects of disruption from the transactions contemplated by the merger agreement and the impact of the announcement and pendency of the transactions on Prometheuss business; the risk that stockholder litigation in connection with the merger may result in significant costs of defense, indemnification and liability; general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Mercks ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Mercks patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Mercks 2022 Annual Report on Form 10-K and Mercks other filings with the Securities and Exchange Commission (SEC) available at the SECs Internet site (www.sec.gov).

Forward-Looking Statements of Prometheus Biosciences

Prometheus cautions readers that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on Prometheus current beliefs and expectations. Such forward-looking statements include but are not limited to statements regarding the companys plans to advance PRA023 into Phase 3 trials in UC and CD, including the timing thereof. The inclusion of forward-looking statements should not be regarded as a representation by Prometheus that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: topline results Prometheus reports are based on preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial; interim results of a clinical trial do not predict final results and the clinical outcomes may materially change following more comprehensive reviews of the data, as follow-up on the outcome of any particular patient continues and as more patient data become available, including from Cohort 2 of the ARTEMIS-UC trial; potential delays in the commencement, enrollment and completion of clinical trials and preclinical studies; the results of clinical trials are not necessarily predictive of future results; Prometheus dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; Prometheus ability to develop diagnostics for its therapeutic product candidates; unexpected adverse side effects or inadequate efficacy of its product candidates that may limit their development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; planned future trials of PRA023 may not support regulatory registration; regulatory developments in the United States and foreign countries; Prometheus ability to maintain undisrupted business operations due to the COVID-19 pandemic, including delaying or otherwise disrupting its preclinical studies, clinical trials, manufacturing and supply chain; and other risks described in the companys prior press releases and filings with the Securities and Exchange Commission (SEC), including under the heading Risk Factors in Prometheus most recent annual report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Prometheus undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

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Merck Strengthens Immunology Pipeline with Acquisition of ... - Merck

Day of Immunology 2023 Discovery Tour at the Doherty Institute – The Peter Doherty Institute for Infection and Immunity

17 Apr 2023

Add to my calendar28/04/2023 4:00 pm28/04/2023 5:30 pmAustralia/MelbourneDay of Immunology 2023 Discovery Tour at the Doherty InstituteDoherty Institute, 792 Elizabeth StreetDD/MM/YYYY

WHEN28 Apr 20234.00 - 5.30pm

WHEREDoherty Institute, 792 Elizabeth Street

As part of the Day of Immunology Victoria & Tasmania, organised by the Australia and New Zealand Society for Immunology (ASI), the Doherty Instituteis opening its doors to the public. Discovery tours provide a unique opportunity for the community to find out more about medical research, see our state-of-the-art facilities, learn about our exciting discoveries and talk to passionate scientists about their research.

Thetour runs for approximately 75 minutes.

This is a free event however registration is essential. If you or someone you know are interested in attending the tour, please register using the link below before Wednesday, 26 April 2023.

https://www.immunology.org.au/events/-ASI-Public-Event-DoI-Discovery-Tour-at-the-Doherty-Institute-2023/

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Day of Immunology 2023 Discovery Tour at the Doherty Institute - The Peter Doherty Institute for Infection and Immunity

How I found a broader impact as a PhD student through podcasting – Nature.com

A professional studio is a luxury not every aspiring producer has or needs.Credit: Kjetil Kolbjrnsrud/Alamy

I remember, during my first year as an immunology PhD student, struggling with the broader impacts outreach section of my US National Science Foundation (NSF) graduate fellowship application one morning before heading into the laboratory.

Before graduate school at the University of California, San Diego, I spent several years as a research associate, studying allergic disease. In this role, I mentored many undergraduate and masters students and attended patient-advocacy group meetings to share our laboratorys work. Still, I felt that my outreach was neither broad nor impactful enough for the grant proposal.

Eventually, it was time to go to the lab; I put in my headphones, started an episode of my favourite podcast at the time, The Tim Ferriss Show, and walked to campus. When I arrived, the idea hit me: I would make a science podcast.

To get started, I used my phone to record simple audio versions of journal club presentations that Id given in the past year. I had put so much time into these talks, but only a handful of people had seen them which seemed inefficient. With a podcast, I could share fascinating immunology work and my perspective on it in an accessible, scalable and enduring format.

Collection: Science and social media

I love listening to podcasts because I can tune into them any time, anywhere: sitting in traffic, working out at the gym or doing cell culture work. Although I started the podcast with my colleagues in mind, I made sure that the content was accessible to lay listeners by adding more detail and background information. Aware of the importance of branding, I thought long and hard about a clever name for the show.

After recording the first episode, I edited it with the free audio-editing software Audacity and hosted the cleaned-up tracks on SoundCloud, which I then uploaded to major podcast platforms, including Apple Podcasts and Spotify. The first episode went live in 2019. I shared episode links with my connections on Twitter and LinkedIn and with my lab and graduate-programme colleagues, and plugged the podcast in nearly every conversation I had at conferences. The entire process took a few weeks for each episode, and cost nothing. And just like that, the immunology podcast Inflammatory Content was born.

Kellen Cavagnero records an episode of Inflammatory Content.Credit: Consuelo Sauceda

After about six months, I had recorded ten episodes with a few hours of content. Fans started reaching out to me on Twitter, telling me they enjoyed the show and requesting episodes on certain topics. The positive feedback inspired me to keep going and improve the quality of the podcast. I learnt that a programme at my university had US National Institutes of Health funds available for outreach, so I applied and was awarded US$1,000 to buy professional recording equipment, including two Audio-Technica microphones.

To further increase the production value of the show, I added a musical intro and outro using free public-domain tracks from Googles Audio Library. I also experimented with a new episode format. My favourite podcasts are interview-based, so I asked Alan ONeill, a postdoctoral researcher in my lab who had just published an exciting paper, to be my guinea pig. We spoke about his article, career trajectory and philosophies on science and mentorship. I next had my thesis adviser on, then committee members, and then other professors at my university. I am now three years into podcasting and have released seven long-form interviews and a dozen solo episodes that have received tens of thousands of listens.

Going forward, I would like to interview more scientists outside my university. Now that the podcast is relatively established, my unsolicited interview requests have a higher success rate, making this possible. I would also like to scale up the amount of content I release. The current bottleneck for me is the time-consuming editing process. To address this, I am recruiting an intern and working to improve my interview skills, so my episodes will require less editing.

This podcast has had a broader impact than I could have imagined. I now have the privilege of having deep conversations with scientists I admire and sharing these conversations with the world. Some of my favourites are the episodes with infectious-disease physician Victor Nizet, dermatologist Richard Gallo and immunologist Mitchell Kronenberg: these senior investigators have launched numerous trainees into independent careers and are chock-full of wisdom.

Not only has Inflammatory Content had a positive impact on the listeners, but by forcing me to listen carefully and communicate clearly and concisely, it has made me a better scientist and educator. Moreover, through the podcast, Ive made strong connections with professors with whom I might pursue postdoctoral research in the future. I was even awarded the NSF fellowship, and I feel that including details about the podcast in my application played a big part.

I hope my story inspires others to pursue outreach through podcasting. This is a burgeoning medium, and it is important that scientists at all career stages use podcasts to share their work and their stories, for the benefit of the scientific community and society at large. I encourage anyone interested in getting started to take the leap. Start something, learn along the way and see where it goes.

This is an article from the Nature Careers Community, a place for Nature readers to share their professional experiences and advice. Guest posts are encouraged.

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How I found a broader impact as a PhD student through podcasting - Nature.com

Researchers discover the molecule responsible for guiding T cells toward tumors – News-Medical.Net

Immunotherapy, particularly CAR T-Cell treatment for cancer, is extending the lives of many patients. But sometimes the therapy randomly migrates to places it shouldn't go, tucking into the lungs or other noncancerous tissue and causing toxic side effects. A University of Rochester/Wilmot Cancer Institute team discovered the molecule responsible for guiding T cells toward tumors, setting the stage for scientists to improve upon the groundbreaking treatment.

The next step is to find a drug that can manipulate the key T-cell protein, ST3GAL1, said Minsoo Kim, Ph.D., corresponding author of an article in Nature Immunology that describes the research. If the investigation evolves as planned, such a drug could be added to the CAR T-cell regimen to ensure that T cells hit their targets, Kim said.

His lab is collaborating with other Wilmot investigators to screen for drugs that will accomplish that feat, while also minimizing the risk of life-threatening side effects.

You can create very powerful treatments, but if they can't get to their targets or they go to the wrong place, it does not provide the outcome you intended."

Minsoo Kim, Ph.D., corresponding author, co-leader of Wilmot's Cancer Microenvironment research program at the UR

Enlisting a patient's own immune system to wipe out cancer has emerged as one of the most promising advances in cancer care.

CAR T-cell therapy involves extracting a patient's own T cells, a type of white blood cell, and re-engineering them outside of the body to recognize cancer. Once the reprogrammed cells are infused back into the patient, they act as a "living drug," searching for proteins on cancer cells for assault. In 2016, Wilmot was selected as one of the few national sites to begin clinical trials for this procedure, and later, upon FDA approval, became one of the first cancer centers in the U.S. to offer CAR T-cell treatment for eligible patients.

CAR T-cell therapy is only approved to treat blood cancers, including some forms of lymphoma, leukemia, and multiple myeloma, according to the National Cancer Institute. It's easier for the altered T cells to drift toward cancer hot spots in the bloodstream, Kim explained -; but finding their way to solid tumors such as breast, lung, brain cancer, or melanoma is a completely different story. The T cells have to work harder to migrate through tissues and organs and identify a solid tumor.

In fact, clinical trials testing this treatment in solid tumors have not been as favorable, Kim said.

Wilmot research suggests that something occurs during the re-engineering of T cells that blunts their homing properties.

In 2019, Kim and Wilmot colleagues Patrick Reagan, M.D., and Richard Waugh, Ph.D., received a $2.8 million National Institutes of Health grant to investigate the downside of CAR T-cell treatment, specifically what takes place when T cells sequester in noncancerous tissues.

Their discovery of the crucial migration-control gene that expresses ST3GAL1 came about through "unbiased genomic screening," a more effective way to study the problem, Kim said. Investigators used a cutting-edge CRISPR technique to edit thousands of genes expressed in T cells, and then tested the migration-control abilities of those genes, one-by-one over the course of nearly four years, in mouse models.

Kim credited Yeonsun Hong, Ph.D., a staff scientist in his lab and first author of the Nature Immunology report, for leading the work, as well as assistance from faculty and staff at Wilmot's highly rated Shared Resource facilities, led by John Ashton, Ph.D., M.B.A., director of the UR Genomics Research Center. Advanced imaging and use of microscope technologies with V. Kaye Thomas, Ph.D., allowed researchers to study the nuances of T-cell migration patterns, for example.

Kim is a Dean's professor of Microbiology and Immunology, and professor of Pharmacology and Physiology at the UR Medical Center. Co-author Reagan, an associate professor of Hematology/Oncology, specializes in CAR T-cell patient care at Wilmot and has been involved in CAR T-cell research since the earliest clinical studies took place locally and nationally. Waugh, professor of Biomedical Engineering and Vice Provost of Research at the University of Rochester, collaborates with Kim by studying the mechanical properties of T cells. Funding was primarily provided by the NIH, in addition to Wilmot support.

Source:

Journal reference:

Hong, Y., et al. (2023). ST3GAL1 and II-spectrin pathways control CAR T cell migration to target tumors. Nature Immunology. doi.org/10.1038/s41590-023-01498-x.

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Researchers discover the molecule responsible for guiding T cells toward tumors - News-Medical.Net

X4 Pharmaceuticals Announces Late-Breaking Abstract of WHIM Phase 3 Clinical Data Accepted for Oral Presentation at the 2023 Annual Meeting of the…

X4 Pharmaceuticals

X4 to host virtual investor event on Tuesday, May 16

CIS oral presentation to take place on Sunday, May 21

BOSTON, April 12, 2023 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a leader in the discovery and development of novel small molecule therapeutics to benefit patients with diseases of the immune system, today announced that its submitted late-breaker abstract entitled "Results of a Phase 3 Trial of an Oral CXCR4 Antagonist, Mavorixafor, for Treatment of Patients With WHIM Syndrome" has been accepted for oral presentation at the Annual Meeting of the Clinical Immunology Society (CIS), which is taking place May 18-21, 2023, in St. Louis, MO. New data related to clinical secondary endpoints, among other assessments, are to be presented.

In addition, X4 announced that the company will host a virtual event to present and discuss new data from the 4WHIM Phase 3 clinical trial at 4:00 pm ET on Tuesday, May 16, following expected publication of conference abstracts. In November 2022, X4 announced that the 4WHIM trial had met its primary endpoint and a key secondary endpoint, and that mavorixafor was generally well tolerated in the trial, with no treatment-related serious adverse events reported and no discontinuations for safety events. New data to be presented during the event will focus on additional secondary endpoints, including the impact of oral, once-daily mavorixafor on the rate, severity, and duration of infections, among other outcomes metrics, as measured during the 52-week trial period.

Additionally, the company expects to provide an update on its U.S. regulatory activities in support of its potential New Drug Application-submission for mavorixafor for the treatment of WHIM syndrome, which is expected early in the second half of 2023.

The X4 live-event webcast will be accessible on the investor relations section of the X4 website at http://www.x4pharma.com. Following the completion of the event, a replay will be available on the website.

Story continues

At the CIS Conference, Dr. Raffaele Badolato, Professor of Pediatrics at the University of Brescia (Italy) and an investigator in the 4WHIM clinical trial, will present at 11:30 am CT on Sunday, May 21. Although the session will only be accessible live to conference attendees, X4 will post the slides on its website concurrent with the presentation.

About Mavorixafor and WHIM SyndromeWHIM (warts, hypogammaglobulinemia, infections, and myelokathexis) syndrome is a rare, inherited, combined immunodeficiency disease caused by reduced mobilization and trafficking of white blood cells from the bone marrow due to over-signaling of the CXCR4/CXCL12 pathway. People with WHIM syndrome characteristically have very low blood levels of neutrophils (neutropenia) and lymphocytes (lymphopenia), and as a result, experience frequent, recurrent infections with a high risk of lung disease, refractory warts from underlying human papillomavirus (HPV) infection, limited antibody production due to low levels of immunoglobulin, and an increased risk of developing certain types of cancer. Mavorixafor is an investigational small-molecule antagonist of CXCR4 being developed as a once-daily oral therapy to correct the dysfunction resulting from the underlying causes of WHIM. For the WHIM indication, mavorixafor has been granted Breakthrough Therapy Designation, Fast Track Designation, and Rare Pediatric Designation in the U.S., and Orphan Drug Status in both the U.S. and European Union.

About the 4WHIM Phase 3 Clinical TrialThe 4WHIM Phase 3 clinical trial was a global, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy and safety of oral, once-daily mavorixafor in people with genetically confirmed WHIM syndrome. Originally designed to enroll 18-28 patients, the trial enrolled 31 patients aged 12 and older who received either 400 mg mavorixafor (n=14) or placebo (n=17) orally once daily for 52 weeks.

About X4 Pharmaceuticals X4 Pharmaceuticals is a late-stage clinical biopharmaceutical company focused on the discovery and development of novel therapies for people with diseases of the immune system. Our lead clinical candidate is mavorixafor, a small molecule antagonist of chemokine receptor CXCR4 that is being developed as an oral, once-daily therapy. Due to its ability to increase the mobilization of mature, functional white blood cells from the bone marrow into the bloodstream, we believe that mavorixafor has the potential to provide therapeutic benefit across a variety of chronic neutropenic disorders, including WHIM (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis) syndrome, a rare, primary immunodeficiency. Following announcement of positive top-line data from our global, pivotal, 4WHIM Phase 3 clinical trial, we are currently preparing a U.S. regulatory submission seeking approval of oral, once-daily mavorixafor in the treatment of people aged 12 years and older with WHIM syndrome. We are also currently evaluating mavorixafor in a Phase 2 clinical trial in people with certain chronic neutropenic disorders following positive results from a Phase 1b clinical trial of mavorixafor in people with congenital, idiopathic, or cyclic neutropenia. We continue to leverage our insights into CXCR4 and immune system biology at our corporate headquarters in Boston, Massachusetts and at our research center of excellence in Vienna, Austria. For more information, please visit our website at http://www.x4pharma.com.

Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by the words may, will, could, would, should, expect, plan, anticipate, intend, believe, estimate, predict, project, potential, continue, target, or other similar terms or expressions that concern X4's expectations, strategy, plans, or intentions. Forward-looking statements include, without limitation, statements regarding the clinical progress of X4s pipeline development programs, including the anticipated New Drug Application submission for mavorixafor for the treatment of WHIM syndrome and the timing thereof. Any forward-looking statements in this press release are based on management's current expectations and beliefs. Actual events or results may differ materially from those expressed or implied by any forward-looking statements contained herein, including, without limitation, on account of uncertainties inherent in the initiation and completion of clinical trials and clinical development; the risk that trials and studies may not have satisfactory outcomes; the risk that the outcomes of preclinical studies or earlier clinical trials will not be predictive of later clinical trial results; the risk that initial or interim results from a clinical trial may not be predictive of the final results of the trial or the results of future trials; the potential adverse effects arising from the testing or use of mavorixafor or other product candidates; the risk that the Food and Drug Administration (FDA) may not support and accept a regulatory submission for mavorixafor, and that X4s interactions with the FDA may not have satisfactory outcomes; the risks related to X4s ability to raise additional capital; the impacts of macroeconomic conditions, including the COVID-19 pandemic, the conflict in Ukraine, rising inflation, and uncertain credit and financial markets on X4s business, clinical trials and financial position; and other risks and uncertainties, including those described in the section entitled Risk Factors in X4s Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 21, 2023, and in other filings X4 makes with the SEC from time to time. X4 undertakes no obligation to update the information contained in this press release to reflect new events or circumstances, except as required by law.

Contacts:Daniel Ferry (investors)Managing Director, LifeSci Advisorsdaniel@lifesciadvisors.com (617) 430-7576

Cherilyn Cecchini, M.D. (media)LifeSci Communicationsccecchini@lifescicomms.com

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X4 Pharmaceuticals Announces Late-Breaking Abstract of WHIM Phase 3 Clinical Data Accepted for Oral Presentation at the 2023 Annual Meeting of the...

argenx Demonstrates Commitment to Redefining Treatment Goals … – GlobeNewswire

Amsterdam, the Netherlands [04/18/2023] argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that it will present six abstracts further demonstrating its long-term commitment to the generalized myasthenia gravis (gMG) community during the 75th American Academy of Neurology (AAN) Annual Meeting, which is taking place from April 22-27, 2023 in Boston, MA. The presentations include clinical and real-world efgartigimod data that demonstrate the potential of neonatal Fc receptor (FcRn) blockade in transforming treatment for gMG and other IgG-mediated autoimmune diseases.

Our presentations at AAN will showcase the depth of evidence we are generating in support of the clinical and real-world profile of efgartigimod to address the often-underappreciated needs of people living with gMG, said Luc Truyen, M.D. Ph.D., Chief Medical Officer, argenx. We have a unique opportunity to recalibrate expectations for patients and their supporters by setting a new standard for what well-controlled means in gMG and across autoimmunity more broadly.

Power of Individualized Dosing from Long-term Extension StudiesThe presentations include results from the open-label extension studies of VYVGART (efgartigimod alfa-fcab) and subcutaneous (SC) efgartigimod following long-term treatment in ADAPT+ (217.5 patient-years follow-up) and ADAPT-SC+ (72 patient-years follow-up). Long-term treatment, administered in individualized dosing cycles, led to consistent and repeatable reductions in IgG antibody levels and improved clinical outcomes.

A cross-indication review of the safety profile of efgartigimod will also be presented across multiple IgG-mediated autoimmune diseases, reinforcing the consistent safety profile observed with efgartigimod.

Potential in Patients Early in gMG Disease CourseA new exploratory analysis will be presented from the ADAPT Phase 3 trial showing that a greater percentage of gMG patients with fewer than three years disease duration were responders and achieved minimum symptom expression (MSE) compared with placebo.

New Opportunities with Patient Support ProgramsAs part of its commitment to address access for gMG patients impacted by social determinants of health challenges, argenx will present quantitative and qualitative research that identified potential opportunities to expand patient support program offerings, including the establishment of an information hotline and symptom tracking app, a patient mentoring program, an innovative giving strategy and broadened awareness campaigns of nurse case manager services.

Details for the poster presentations are as follows:

Title: Long-Term Safety, Tolerability, And Efficacy of Efgartigimod in Patients with Generalized Myasthenia Gravis: Concluding Analyses from the ADAPT+Session Date & Time: Oral Presentation - Sunday, April 23 at 2:00pm ETPresenter: Dr. Mamatha PasnoorAbstract Number: S5.006

Title: Long-Term Safety, Tolerability, and Efficacy of Subcutaneous Efgartigimod PH20 in Patients with Generalized Myasthenia Gravis: Interim Results of the ADAPT-SC+ StudySession Date & Time: Poster Session 1, Sunday, April 23, 8-9 am ETPresenter: Dr. James F. HowardAbstract Number: P1.5-014

Title: Dose Selection and Clinical Development of Efgartigimod Ph20 Subcutaneous Inpatients With Generalized Myasthenia GravisSession Date & Time: Poster Session 1, Sunday, April 23, 8-9 am ETPresenter: Dr. George LiAbstract Number: P1.5-017

Title: Overview of the Safety Profile from Efgartigimod Clinical Trials in Participants with Diverse IgG-Mediated Autoimmune DiseasesSession Date & Time: Poster Session 1, Sunday, April 23, 8-9 am ETPresenter: Dr. Kelly GwathmeyAbstract Number: P1.5-001

Title: Efgartigimod Demonstrates Consistent Improvements in Generalized Myasthenia Gravis Patients of Shorter Disease DurationSession Date & Time: Poster Session 1, Sunday, April 23, 8-9 am ETPresenter: Dr. Vera BrilAbstract Number: P1.5-015

Title: Patient Support Program Enhancements In Patients Diagnosed With Generalized Myasthenia Gravis Facing Social Determinants of Health ChallengesSession Date & Time: Poster Session 4, Monday, April 24, 8-9 am ETPresenter: Dr. Tom HughesAbstract Number: P4.9-006

See the full Prescribing Information for VYVGART in the U.S., which includes the below Important Safety Information. For more information related to VYVGART in Japan, visit argenx.jp.

Important Safety Information for VYVGART (efgartigimod alfa-fcab) intravenous (IV) formulation (U.S. prescribing information)

What is VYVGART (efgartigimod alfa-fcab)?VYVGART is a prescription medicine used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive).

What is the most important information I should know about VYVGART?VYVGART may cause serious side effects, including:

Before taking VYVGART, tell your health care provider about all of your medical conditions, including if you:

Tell your health care provider about all the medicines you take, including prescription and over- the-counter medicines, vitamins, and herbal supplements.

What are the common side effects of VYVGART?

The most common side effects of VYVGART are respiratory tract infection, headache, and urinary tract infection.

These are not all the possible side effects of VYVGART. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1- 800-FDA-1088.

Please see the full Prescribing Information for VYVGART and talk to your doctor.

About Generalized Myasthenia GravisGeneralized myasthenia gravis (gMG) is a rare and chronic autoimmune disease where IgG autoantibodies disrupt communication between nerves and muscles, causing debilitating and potentially life-threatening muscle weakness. Approximately 85% of people with MG progress to gMG within 24 months, where muscles throughout the body may be affected. Patients with confirmed AChR antibodies account for approximately 85% of the total gMG population.

About VYVGART (efgartigimod alfa-fcab)VYVGART is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating immunoglobulin G (IgG) autoantibodies. It is the first and only approved FcRn blocker. VYVGART is approved in the United States and Europe for the treatment of adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and in Japan for the treatment of adults with gMG who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs). VYVGART is being studied in adults with primary immune thrombocytopenia (ITP) and other IgG autoantibody-mediated diseases.

About argenxargenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first-and-only approved neonatal Fc receptor (FcRn) blocker in the U.S., the EU and UK, and Japan. The Company is evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit http://www.argenx.com and follow us on LinkedIn, Twitter, and Instagram.

For further information, please contact:

Media:Erin Murphyemurphy@argenx.com

Investors:Beth DelGiaccobdelgiacco@argenx.com

Forward Looking StatementsThe contents of this announcement include statements that are, or may be deemed to be, forward-looking statements. These forward-looking statements can be identified by the use of forward-looking terminology, including the terms believes, hope, estimates, anticipates, expects, intends, may, will, or should and include statements argenx makes concerning argenxs long-term commitment to the generalized myasthenia gravis (gMG) community, the potential of neonatal Fc receptor (FcRn) blockade in transforming treatment for gMG and other IgG-mediated autoimmune diseases, the expected long-term safety, tolerability and efficacy of VYVGART (efgartigimod alfa-fcab) in adult patients with gMG; and potential opportunities to expand patient support program offerings. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenxs actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors. A further list and description of these risks, uncertainties and other risks can be found in argenxs U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenxs most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.

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argenx Demonstrates Commitment to Redefining Treatment Goals ... - GlobeNewswire

WVU Today | WVU research team steers students through murky … – WVU Today

West Virginia University researchers are studying how high school seniors and college students can utilize ChatGPT to learn how to code, while recognizing the potential shortcomings of the AI-powered chatbot. (WVU Photo/Alyssa Reeves)

West Virginia University researchers are preparing high school seniors and college students to harness the power of ChatGPT, the popular artificial intelligence chatbot, through coding while addressing the platforms potential shortcomings.

In a paper published in Quantitative Biology, a team led by Gangqing Michael Hu, assistant professor in the WVU School of Medicine Department of Microbiology, Immunology and Cell Biology, explored how they could help students overcome the fear of learning code and enhance their critical thinking skills.

This is like kids wading in the muddy shoreline seeking beautiful seashells, Hu said. The kids are the beginning students and the muddy shoreline is ChatGPT. The beautiful seashells represent all the attractive opportunities which beginners cannot resist. But the ChatGPT shoreline is muddy with challenges such as the uncertainty from the chatbots response including misleading artifacts and students overreliance on AI for coding.

ChatGPT produces human-like responses to text-based conversations and is being used by multiple companies to respond to customer inquiries and provide general information. Anyone can use it to seek information on a plethora of subjects.

One of the responses from ChatGPT can be code, and in this case the platform becomes a coding tool through prompting.

This is a new tool of learning coding and there are some misconceptions, Hu said. Students may think coding is not important because of prompting or they may have a fear in trying to learn it. We need to educate them on the purpose of this chatbot-assisted learning. Because some of the code from the chatbot can be wrong, students need to use critical thinking to be able to tell if the answer is correct and, if it is not, how to find a solution.

One of the biggest drawbacks to ChatGPT is that generated responses to questions can be either correct, incorrect or incomplete. In fact, it takes a human to provide carefully crafted prompts to fully harness the tool in providing valid and robust results.

Inspired by adaptive learning in educational literature, the team used the OPTIMAL model to facilitate chatbot-aided scientific data analysis. OPTIMAL, which stands for Optimization of Prompts Through Iterative Mentoring and Assessment, involves a series of steps to improve communication with a chatbot. In this case, it was geared toward bioinformatics, the science of collecting and analyzing large amounts of biological, medical and health information. Researchers say the model can be used for other purposes as well, such as finance and economics.

The OPTIMAL model is like rubber boots for the children to wear at the muddy shoreline, Hu said. The boots protect the kids from getting dirty much like the model is a protective mechanism to prevent the students from being misled by inaccurate information from the chatbot. The model aims to improve both coding skills and prompting skills through an iterative communication with a chatbot guided by critical thinking and assessment.

Following the OPTIMAL model, students review all the information needed for input and receive guidance on how to create a set of draft prompts. Once they input the prompt, the chatbot produces code and students are ready to give it a test.

If error messages result after running the code, students must evaluate the error and determine the best way to proceed, such as instructing the chatbot to revise the code or debugging the code manually.

The process continues until the code no longer issues errors and outputs a result for critical assessment. At the end of the session, students reflect on the entire communication process and review the code to identify any missing details to finalize the prompts.

The research team found that merely using the chatbot as a code-generating tool may limit creative thinking and that reviewing the code at the end of each session is just as important as optimizing the prompts.

The work brought together researchers from a spectrum of disciplines: Evelyn Shue, student volunteer in the Department of Microbiology, Immunology and Cell Biology; Bingxin Li, WVU John Chambers College of Business and Economics; Xin Li, WVU Benjamin M. Statler College of Engineering and Mineral Resources; Zifeng Feng, University of Texas at El Paso; and Li Liu, Arizona State University.

The team plans to evaluate the OPTIMAL models effectiveness in enhancing traditional bioinformatics education for beginners in the classroom.

This assessment should encompass improvements in coding skills, prompting skills, problem-solving abilities, and critical thinking during interactions with a chatbot, Hu said.

Future research will delve into more profound insights and strategies on applying ChatGPT to precision education.

There are certainly other sorts of rubber boots, Hu said.

-WVU-

ls/04/13/23

MEDIA CONTACT: Jake StumpDirectorWVU Research Communications304-293-5507; jake.stump@mail.wvu.edu

Call 1-855-WVU-NEWS for the latest West Virginia University news and information from WVUToday.

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WVU Today | WVU research team steers students through murky ... - WVU Today