Category Archives: Cell Biology

Pluristem and Abu Dhabi Stem Cells Center Sign MOU to Collaborate in the Development of Cell Therapies and Regenerative Medicines for the Treatment of…

August 17, 2020 medical

Agreement comes as United Arab Emirates (UAE) and Israel Reach Historic Agreement to Fully Normalize Diplomatic Relations

HAIFA, Israel, Aug. 17, 2020 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PSTI), a leading regenerative medicine company developing a platform of novel biological therapeutic products, announced today its subsidiary, Pluristem Ltd., has signed a non-binding Memorandum of Understanding (MOU) with the United Arab Emirates-based Abu Dhabi Stem Cells Center (ADSCC), a specialist healthcare center focused on cell therapy and regenerative medicine. Executives from both companies took part in a signing ceremony held via video conference between Israel and the UAE. The aim of the collaboration is to capitalize on each companys respective areas of expertise in cell therapies to deliver regenerative medicine for the benefit not only of the citizens of the UAE and Israel, but for humanity as a whole. The collaboration between the parties was initiated by the Better Alternatives advisory firm.

The parties have agreed to exchange research results, share samples, join usage of equipment and testing, and other essential activities related to advancing the treatment and research of cell therapies for a broad range of medical conditions, including COVID-19.

ADSCC has been treating COVID-19 patients with stem cells sourced from the patients blood, by returning the cells back into the patients lungs as a fine mist through a nebulizer, a machine that helps a patient breathe in medicine through a mask or mouthpiece. Pluristem has treated patients with its placental PLX-PAD allogenic product via compassionate use programs in Israel and the U.S. and is currently conducting phase II studies in the U.S. and EU.

We are extremely proud to partner with our colleagues at the ADSCC by sharing knowledge and expertise that we believe will advance healthcare within and across our borders. We see life science and regenerative medicine as a bridge for building peace, prosperity, and well-being in our region and for the entire world. I believe it is our obligation and privilege as business and scientific leaders to lead the way forward to strengthen collaborations, and promote innovation and education. We are honored to be on the front line of this historical moment, stated Pluristem CEO and President Yaky Yanay.

Dr Yendry Ventura, General Manager of the ADSCC commented, Pluristem is a major player in the cell therapy field with years of experience, a unique platform and a robust clinical pipeline. We are excited to join forces and to promote the research and development of cell therapies for the best of the patients and the human society as a whole.

About Abu Dhabi Stem Cells CenterAbu Dhabi Stem Cells Center (ADSCC) is an Abu Dhabi-based specialist healthcare center focused on cell therapy and regenerative medicine, as well as delivering cutting-edge research on stem cells in the region. The Center was founded in March 2019 to meet growing domestic and regional demand for highly specialized medical services and treatments. Equipped with the latest technologies, medical devices which are unique to the region, and a team of internationally recognized doctors working hand in hand with researchers, ADSCC is the first of its kind in the UAE. ADSCC specialties include immunology, hematology, clinical stem cell therapy, molecular biology, immunotherapy, orthopedics, and urology amongst others.

About Pluristem TherapeuticsPluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates. The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications. PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage. The cells are grown using the Company's proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.

Safe Harbor Statement

This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluristem is using forward-looking statements when it discusses the aim of the collaboration with the ADSCC is to capitalize on each companys respective areas of expertise in cell therapies to deliver regenerative medicine for the benefit not only of the citizens of the UAE and Israel, but for humanity as a whole and the belief that it is its obligation and privilege as business and scientific leaders to lead the way forward to strengthen collaborations, and promote innovation and education. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristems products may not be approved by regulatory agencies, Pluristems technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristems process; Pluristems products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristems patents may not be sufficient; Pluristems products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

Contact:

Dana RubinDirector of Investor Relations972-74-7107194danar@pluristem.com

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Pluristem and Abu Dhabi Stem Cells Center Sign MOU to Collaborate in the Development of Cell Therapies and Regenerative Medicines for the Treatment of...

Cell Biology

Live-Cell Imaging Market Size and Growth By Leading Vendors, By Types and Application, By End Users and Forecast to 2027 – Bulletin Line

August 17, 2020 medical

New Jersey, United States,- This detailed market research covers the growth potential of the Live-Cell Imaging Market, which can help stakeholders understand the key trends and prospects of the Live-Cell Imaging market and identify growth opportunities and competitive scenarios. The report also focuses on data from other primary and secondary sources and is analyzed using a variety of tools. This will help investors better understand the growth potential of the market and help investors identify scope and opportunities. This analysis also provides details for each segment of the global Live-Cell Imaging market.

The report was touted as the most recent event hitting the market due to the COVID-19 outbreak. This outbreak brought about a dynamic change in the industry and the overall economic scenario. This report covers the analysis of the impact of the COVID-19 pandemic on market growth and revenue. The report also provides an in-depth analysis of the current and future impacts of the pandemic and post-COVID-19 scenario analysis.

The report covers extensive analysis of the key market players in the market, along with their business overview, expansion plans, and strategies. The key players studied in the report include:

The market is further segmented on the basis of types and end-user applications. The report also provides an estimation of the segment expected to lead the market in the forecast years. Detailed segmentation of the market based on types and applications along with historical data and forecast estimation is offered in the report.

Furthermore, the report provides an extensive analysis of the regional segmentation of the market. The regional analysis covers product development, sales, consumption trends, regional market share, and size in each region. The market analysis segment covers forecast estimation of the market share and size in the key geographical regions.

The report further studies the segmentation of the market based on product types offered in the market and their end-use/applications.

Global Live-Cell Imaging Market, By Product

Instruments Consumables Software

Global Live-Cell Imaging Market, By Application

Drug Discovery Developmental Biology Cell Biology Stem Cell Biology

Global Live-Cell Imaging Market, By End User

Academic & Research Institutes Pharmaceutical & Biotechnology Companies Academic & Research Institutes

On the basis of regional segmentation, the market is bifurcated into major regions ofNorth America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa.The regional analysis further covers country-wise bifurcation of the market and key players.

The research report offered by Verified Market Research provides an updated insight into the global Live-Cell Imaging market. The report covers an in-depth analysis of the key trends and emerging drivers of the market likely to influence industry growth. Additionally, the report covers market characteristics, competitive landscape, market size and growth, regional breakdown, and strategies for this market.

Highlights of the TOC of the Live-Cell Imaging Report:

Overview of the Global Live-Cell Imaging Market

Market competition by Players and Manufacturers

Competitive landscape

Production, revenue estimation by types and applications

Regional analysis

Industry chain analysis

Global Live-Cell Imaging market forecast estimation

This Live-Cell Imaging report umbrellas vital elements such as market trends, share, size, and aspects that facilitate the growth of the companies operating in the market to help readers implement profitable strategies to boost the growth of their business. This report also analyses the expansion, market size, key segments, market share, application, key drivers, and restraints.

Key Questions Addressed in the Report:

What are the key driving and restraining factors of the global Live-Cell Imaging market?

What is the concentration of the market, and is it fragmented or highly concentrated?

What are the major challenges and risks the companies will have to face in the market?

Which segment and region are expected to dominate the market in the forecast period?

What are the latest and emerging trends of the Live-Cell Imaging market?

What is the expected growth rate of the Live-Cell Imaging market in the forecast period?

What are the strategic business plans and steps were taken by key competitors?

Which product type or application segment is expected to grow at a significant rate during the forecast period?

What are the factors restraining the growth of the Live-Cell Imaging market?

Thank you for reading our report. The report is available for customization based on chapters or regions. Please get in touch with us to know more about customization options, and our team will ensure you get the report tailored according to your requirements.

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Verified Market Research is a leading Global Research and Consulting firm servicing over 5000+ customers. Verified Market Research provides advanced analytical research solutions while offering information enriched research studies. We offer insight into strategic and growth analyses, Data necessary to achieve corporate goals, and critical revenue decisions.

Our 250 Analysts and SMEs offer a high level of expertise in data collection and governance use industrial techniques to collect and analyze data on more than 15,000 high impact and niche markets. Our analysts are trained to combine modern data collection techniques, superior research methodology, expertise, and years of collective experience to produce informative and accurate research.

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Live-Cell Imaging Market Size and Growth By Leading Vendors, By Types and Application, By End Users and Forecast to 2027 - Bulletin Line

Cell Biology

Cell Imagers Market Size and Growth By Leading Vendors, By Types and Application, By End Users and Forecast to 2027 – Bulletin Line

August 17, 2020 medical

New Jersey, United States,- This detailed market research covers the growth potential of the Cell Imagers Market, which can help stakeholders understand the key trends and prospects of the Cell Imagers market and identify growth opportunities and competitive scenarios. The report also focuses on data from other primary and secondary sources and is analyzed using a variety of tools. This will help investors better understand the growth potential of the market and help investors identify scope and opportunities. This analysis also provides details for each segment of the global Cell Imagers market.

The report covers extensive analysis of the key market players in the market, along with their business overview, expansion plans, and strategies. The key players studied in the report include:

The report further studies the segmentation of the market based on product types offered in the market and their end-use/applications.

Global Cell Imagers Market, By Product

Equipment Consumables Software

Global Cell Imagers Market, By Application

Drug Discovery Developmental Biology Cell Biology Stem Cell Biology

Global Cell Imagers Market, By End User

Academic & Research Institutes Pharmaceutical & Biotechnology Companies Academic & Research Institutes

The research report offered by Verified Market Research provides an updated insight into the global Cell Imagers market. The report covers an in-depth analysis of the key trends and emerging drivers of the market likely to influence industry growth. Additionally, the report covers market characteristics, competitive landscape, market size and growth, regional breakdown, and strategies for this market.

Highlights of the TOC of the Cell Imagers Report:

Overview of the Global Cell Imagers Market

Market competition by Players and Manufacturers

Competitive landscape

Production, revenue estimation by types and applications

Regional analysis

Industry chain analysis

Global Cell Imagers market forecast estimation

This Cell Imagers report umbrellas vital elements such as market trends, share, size, and aspects that facilitate the growth of the companies operating in the market to help readers implement profitable strategies to boost the growth of their business. This report also analyses the expansion, market size, key segments, market share, application, key drivers, and restraints.

Key Questions Addressed in the Report:

What are the key driving and restraining factors of the global Cell Imagers market?

What is the concentration of the market, and is it fragmented or highly concentrated?

What are the major challenges and risks the companies will have to face in the market?

Which segment and region are expected to dominate the market in the forecast period?

What are the latest and emerging trends of the Cell Imagers market?

What is the expected growth rate of the Cell Imagers market in the forecast period?

What are the strategic business plans and steps were taken by key competitors?

Which product type or application segment is expected to grow at a significant rate during the forecast period?

What are the factors restraining the growth of the Cell Imagers market?

About us:

Mr. Edwyne Fernandes

US: +1 (650)-781-4080UK: +44 (203)-411-9686APAC: +91 (902)-863-5784US Toll-Free: +1 (800)-7821768

Email: [emailprotected]

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Cell Imagers Market Size and Growth By Leading Vendors, By Types and Application, By End Users and Forecast to 2027 - Bulletin Line

Cell Biology

Precigen Announces First Patient Dosed in Phase I/II Study of First-in-Class PRGN-2009 AdenoVerse Immunotherapy to Treat HPV-associated Cancers -…

August 17, 2020 medical

GERMANTOWN, Md., Aug. 17, 2020 /PRNewswire/ -- Precigen, Inc.(Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cellular therapies to improve the lives of patients, today announced that the first patient has been dosed with Precigen's PRGN-2009, a first-in-class,off-the-shelf (OTS) investigational immunotherapy utilizing the AdenoVerse platform designed to activate the immune system to recognize and target HPV+ solid tumors (clinical trial identifier: NCT04432597). HPV-associatedcancers represent a significant health burden in indications such as head and neck, cervical, vaginal and anal cancer.

ThePhase I portion of the study will use 3+3 dose escalation to evaluate the safety of PRGN-2009 administered as a monotherapy and to determine the recommended Phase II dose (R2PD) followed by an evaluation of the safety of the combination of PRGN-2009 at the R2PD and bintrafusp alfa (M7824), an investigational bifunctional fusion protein, in patients with recurrent or metastatic HPV-associated cancers. The Phase II portion of the study will evaluate PRGN-2009 as a monotherapy or in combination with bintrafusp alfa as a neoadjuvant or induction therapy in patients with newly-diagnosed stage II/III HPV16-positive oropharyngeal cancer.

PRGN-2009 leverages Precigen's proprietary UltraVector and AdenoVerse platforms to optimize HPV antigen design. Such design is differentiated from other therapies due to the gorilla adenovector's large payload capacity and potential for repeat administration due to very low to no seroprevalence in the human population.

PRGN-2009 is under development through a Cooperative Research and Development Agreement, or CRADA, with the laboratory of Dr. Jeffrey Schlom, Chief oftheLaboratory of Tumor Immunology and Biology (LTIB), Center for Cancer Research (CCR),National Cancer Institute (NCI). This CRADA has allowed Precigen to rapidly and cost-effectively advance PRGN-2009.The Phase I/II clinical trial of PRGN-2009 is being conducted at the NIH Clinical Center and will be led by Dr. Julius Strauss, Co-Director of the LTIB's Clinical Trials Group, and Dr. James Gulley, Chief of the Genitourinary Malignancies Branch, CCR, NCI. For patients interested in enrolling in this clinical study, please call NCI's toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615), email NCIMO_Referrals@mail.nih.gov,and/or visit the website:https://trials.cancer.gov.

"We appreciate working in collaboration with such renowned partners at the NCI to achieve this important milestone in our efforts to develop a new off-the-shelf immunotherapy treatment option for patients with HPV-associated cancers," said Helen Sabzevari, PhD, President and CEO of Precigen. "We are excited to investigate Precigen's proprietary gorilla adenovector platform for the first time in a clinical setting and achieve this milestone during the COVID-19 global pandemic."

About HPV-associated CancersHPV infects the squamous cells that line the inner surfaces of certain organs and, consequently, most HPV-related cancers are a type of cancer called squamous cell carcinoma. Some cervical cancers come from HPV infection of gland cells in the cervix and are referred to as adenocarcinomas.1 HPV-related cancers include cervical, oropharyngeal, anal, penile, vaginal, and vulvar.1 Nearly 44,000 HPV-associated cancers occur in the United States each year. Of these, approximately 25,000 occur in women and 19,000 occur in men.2HPV is considered responsible for more than 90% of analand cervicalcancers, about 70% of vaginal and vulvar cancers, and more than 60% of penile cancers.2 Recent studies indicate that about 70% of cancers of the oropharynxalso may be related to HPV.2

Precigen: Advancing Medicine with PrecisionPrecigen (Nasdaq: PGEN) is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases. Our technologies enable us to find innovative solutions for affordable biotherapeutics in a controlled manner. Precigen operates as an innovation engine progressing a preclinical and clinical pipeline of well-differentiated unique therapies toward clinical proof-of-concept and commercialization.

For more information about Precigen, visit http://www.precigen.com or follow us on Twitter @Precigen and LinkedIn.

References1HPV and Cancer, National Institutes of Health. Accessed in July 20202 HPV-Associated Cancer Statistics, Centers for Disease Control and Prevention. Accessed in July 2020

TrademarksPrecigen, AdenoVerse, UltraVector, and Advancing Medicine with Precision are trademarks of Precigen and/or its affiliates. Other names may be trademarks of their respective owners.

Safe Harbor StatementSome of the statements made in this press release are forward-looking statements. These forward-looking statements are based upon the Company's current expectations and projections about future events and generally relate to plans, objectives, and expectations for the development of the Company's business, including the timing and progress of preclinical and clinical trials and discovery programs, the promise of the Company's portfolio of therapies, the Company's refocus to a healthcare-oriented business, and its continuing evaluation of options for the Company's non-healthcare businesses. Although management believes that the plans and objectives reflected in or suggested by these forward-looking statements are reasonable, all forward-looking statements involve risks and uncertainties, including the possibility that the timeline for the Company's clinical trial might be impacted by the COVID-19 pandemic, and actual future results may be materially different from the plans, objectives and expectations expressed in this press release. The Company has no obligation to provide any updates to these forward-looking statements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. For further information on potential risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in the Company's most recent Annual Report on Form 10-K and subsequent reports filed with the Securities and Exchange Commission.

Investor Contact:

Steven Harasym

Vice President, Investor Relations

Tel: +1 (301) 556-9850

investors@precigen.com

Media Contact:

Marie Rossi, PhD

Vice President, Communications

Tel: +1 (301) 556-9850

press@precigen.com

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Cell Biology

What are the Differences Between Small Cell and Non-Small Cell Lung Cancer? – News-Medical.net

August 17, 2020 medical

Throughout the world, lung cancer is the main cause of cancer-related deaths. Whereas small cell lung cancer (SCLC) accounts for up to 15% of all lung cancer diagnoses, the remaining 85% of lung cancer cases are of the non-small cell lung cancer (NSCLC) subtype.

Image Credit: David A Litman/Shutterstock.com

Non-small cell lung cancer (NSCLC) can be further categorized into several different types, the most common of which include adenocarcinoma, squamous cell carcinoma (SCC), and large cell carcinoma. Other less common types of NSCLC include adenosquamous, pleomorphic, spindle cell, and giant cell carcinomas, as well as pulmonary blastoma, neuroendocrine tumors, and several others.

Recent advancements in molecular biology, particularly due to the discovery of epidermal growth factor (EGFR) mutations and anaplastic lymphoma kinase (ALK) rearrangements, have drastically changed how these NSCLC subtypes are treated. These discoveries have led to the development of EGFR tyrosine kinase inhibitors and ALK inhibitors, both of which are highly effective treatment options for patients with these specific histologic types of lung cancer.

It is estimated that adenocarcinomas comprise approximately 40% of all lung cancers. By definition, adenocarcinoma in the lung is a malignant epithelial neoplasm that can be accompanied by either glandular differentiation or the production of mucin. Typically, an adenocarcinoma will form a peripherally located mass that exhibits both central fibrosis and pleural puckering.

Other gross appearances that can be associated with an adenocarcinoma diagnosis include a centrally located mass, diffuse lobar consolidation, multiple lobes distributed bilaterally, and pleural thickening.

Following a biopsy or tumor resection, an adenocarcinoma can be further characterized as a lepidic, acinar, papillar, micropapillary, solid, invasive mucinous, colloid, fetal, enteric, or minimally invasive carcinoma.

Approximately 20% of all lung cancers are SCC, which can be present in various places throughout the lungs, the most common of which include the central portion, along major airways and in the form of cavities when present in larger sizes.

Some of the notable pathological characteristics of SCC include keratinization and intracellular bridges, as well as a solid nested growth pattern. The possible subtypes of SCCs include keratinizing, nonkeratinizing, and basaloid SCC.

The establishment of an SCC diagnosis plays a determining role in which chemotherapeutic agents are not only ideal in reducing the cancer burden but can also avoid certain life-threatening complications. The use of a vascular endothelial growth factor inhibitor in the treatment of SCC, for example, can increase the likelihood of a pulmonary hemorrhage, thereby indicating the need to avoid this type of drug.

Notably, patients with SCC often have a better survival rate as compared to those diagnosed with adenocarcinoma.

The establishment of a large cell carcinoma diagnosis can only be achieved after the tumor has been resected; therefore, this type of NSCLC should not be applied to small biopsies or cytology results. There are several different subtypes of large cell carcinoma including large cell neuroendocrine carcinoma (LCNEC), basaloid carcinoma, lymphoepithelioma-like carcinoma, clear cell carcinoma, and large cell carcinoma with rhabdoid phenotype.

Recent reports by the World Health Organization (WHO) have found that large cell carcinomas are a heterogeneous group of tumors that can be made up of adenocarcinoma, squamous cell differentiation, or a null immunophenotype and genotype.

Image Credit: Scio21/Shutterstock.com

Over the past twenty years, the incidence of SCLC has decreased, which is most likely related to the global reduction in tobacco use. It is estimated that at least 95% of patients diagnosed with SCLC have a positive smoking history; however, individuals who quit smoking not only have a reduced incidence of the disease but also have a 50% chance of reduced mortality when this type of lung cancer is diagnosed in its early stages.

In addition to a history of smoking, other environmental and occupational hazards that have been associated with causing SCLC to include exposure to chloromethyl ether, which is a chemical that can be used in various industrial settings, as well as high radon levels, which is particularly a concern for uranium miners.

Although SCLC only comprises about 15% of all lung cancer diagnoses, this form of lung cancer is highly aggressive. In addition, since many patients with SCLC also have multiple comorbidities due to previous tobacco use, which can include chronic obstructive pulmonary disease (COPD), ischemic cardiopathy, and hypertension, treatment for this type of lung cancer can be highly complicated.

Whereas patients with limited disease (LD) type of SCLC is often treated with concomitant chemoradiation, those with the extensive disease (ED) type are instead treated with palliative chemotherapy. Many patients with SCLC will respond well to initial treatment; however, it is common for patients with the resistant disease to relapse.

In the event that the cancer relapses, the median survival is typically in the range of 4 to 5 months when second- or third-line chemotherapy is used.

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What are the Differences Between Small Cell and Non-Small Cell Lung Cancer? - News-Medical.net

Cell Biology

HiFiBiO Therapeutics Collaborates with Coronavirus Immunotherapy Consortium in the Fight Against COVID-19 – BioSpace

August 17, 2020 medical

Aug. 17, 2020 12:05 UTC

Company leverages its unprecedented antibody drug discovery and development engine empowered by proprietary single-cell profiling technology to identify, engineer, and evaluate multiple neutralizing antibodies against SARS-CoV-2

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- HiFiBiO, a multinational biotherapeutics company focused on the development of novel antibodies for immunomodulation, today announced a collaboration with the Coronavirus Immunotherapy Consortium (CoVIC), a global, academic-industry, non-profit research alliance headquartered at the La Jolla Institute for Immunology (LJI). CoVIC was established to accelerate discovery, optimization, and delivery of life-saving antibody-based therapeutics against SARS-CoV-2. It has received support from the COVID-19 Therapeutics Accelerator, which was launched in March 2020 by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard with additional funding from a range of donors.

Using a combination of its proteomics and proprietary single-cell profiling technology, HiFiBiO has developed multiple SARS-CoV-2 neutralizing antibodies with the potential for both therapeutic and prophylactic applications. With an aligned commitment to deliver accessible therapies to vulnerable individuals globally, the company has submitted 10 distinct antibodies in the format of mono- or bispecific antibodies to CoVIC for in vitro and in vivo testing. HiFiBiO will gain a first look into the performance of its antibodies compared to dozens of other submitted antibodies and synergies among them for combinational therapies.

CoVIC is committed to accelerating the product development pipeline to provide immunotherapeutics that protect vulnerable individuals from severe COVID-19 across the globe, especially in regions where health care resources are severely limited, said Erica Ollmann Saphire, PhD, Professor at LJIs Center for Infectious Diseases and Vaccine Research and Director of CoVIC. We are excited to partner with HiFiBiO to include its antibodies against SARS-CoV-2 in the CoVIC panel that will be analyzed side-by-side in multiple tests to identify optimal immunotherapeutics for COVID-19 patients.

We look forward to working with CoVIC to further assess the potential of our neutralizing antibodies against SARS-CoV-2, said Liang Schweizer, PhD, President and CEO of HiFiBiO Therapeutics. This collaboration is another strong validation of our Drug Intelligent Science platform and our ongoing commitment to working with leading research and academic institutions, as well as pharmaceutical and biotech companies to identify and engineer highly potent and durable antibodies that can address unmet medical needs of patients around the world.

Additionally, HiFiBiO Therapeutics is preparing an Investigational New Drug (IND) application with the US Food and Drug Administration for HFB30132A, a novel SARS-CoV-2 neutralizing antibody for the treatment of COVID-19 patients. The highly differentiated antibody has been rapidly identified, engineered, and evaluated in all key preclinical studies, where it has demonstrated outstanding efficacy, exposure, and safety profile. A planned Phase I single-IV administration ascending dose study will assess the safety and tolerability of HFB30132A in healthy volunteers later this summer.

About HiFiBiO Therapeutics

HiFiBiO Therapeutics is transforming the field of immunotherapy by combining proprietary single-cell profiling technologies with advanced data intelligence and deep knowledge of immune system biology. This approach enables the development of novel antibody therapies that are paired with biomarkers to predict patient response. HiFiBiO Therapeutics is working actively to address unmet medical needs around the world through its own innovative pipeline programs and open-innovation partnerships with world-renowned industry and academic researchers. The companys strong global footprint features cutting-edge laboratories on three continents, in Cambridge, Mass., Paris, Shanghai, and Hong Kong. To learn more, please visit http://www.hifibio.com.

HiFiBiO Therapeutics and the HiFiBiO Therapeutics logo are trademarks of HiFiBiO and its affiliates.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200817005087/en/

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HiFiBiO Therapeutics Collaborates with Coronavirus Immunotherapy Consortium in the Fight Against COVID-19 - BioSpace

Cell Biology

To understand the machinery of life, this scientist breaks it on purpose – Newswise

August 14, 2020 medical

Newswise "I'm fascinated with life, and that's why I want to break it."

This is how Betl Kaar, an assistant professor at the University of Arizona with appointments in the Department of Molecular and Cellular Biology, Department of Astronomy and the Lunar and Planetary Laboratory, describes her research. What may sound callous is a legitimate scientific approach in astrobiology. Known as ancestral sequencing, the idea is to "resurrect" genetic sequences from the dawn of life, put them to work in the cellular pathways of modern microbes - think Jurassic Park but with extinct genes in place of dinosaurs, and study how the organism copes.

In a recent paper published in theProceedings of the National Academy of Sciences, Kaar's research team reports an unexpected discovery: Evolution, it seems, is not very good at multitasking.

Kaar uses ancestral sequencing to find out what makes life tick and how organisms are shaped by evolutionary selection pressure. The insights gained may, in turn, offer clues as to what it takes for organic precursor molecules to give rise to life - be it on Earth or faraway worlds. In her lab, Kaar specializes in designing molecules that act like tiny invisible wrenches, wreaking havoc with the delicate cellular machinery that allows organisms to eat, move and multiply - in short, to live.

Kaar has focused her attention on the translation machinery, a labyrinthine molecular clockwork that translates the information encoded in the bacteria's DNA into proteins. All organisms - from microbes to algae to trees to humans - possess this piece of machinery in their cells.

"We approximate everything about the past based on what we have today," Kaar said. "All life needs a coding system - something that takes information and turns it into molecules that can perform tasks - and the translational machinery does just that. It creates life's alphabet. That's why we think of it as a fossil that has remained largely unchanged, at least at its core. If we ever find life elsewhere, you bet that the first thing we'll look at is its information processing systems, and the translational machinery is just that."

So critical is the translational machinery to life on Earth that even over the course of more than 3.5 billion years of evolution, its parts have undergone little substantial change. Scientists have referred to it as "an evolutionary accident frozen in time."

"I guess I tend to mess with things I'm not supposed to," Kaar said. "Locked in time? Let's unlock it. Breaking it would lead the cell to destruction? Let's break it."

The researchers took six different strains of Escherichia coli bacteria and genetically engineered the cells with mutated components of their translational machinery. They targeted the step that feeds the unit with genetic information by swapping the shuttle protein with evolutionary cousins taken from other microbes, including a reconstructed ancestor from about 700 million years ago.

"We get into the heart of the heart of what we think is one of the earliest machineries of life," Kaar said. "We purposely break it a little, and a lot, to see how the cells deal with this problem. In doing this, we think we create an urgent problem for the cell, and it will fix that."

Next, the team mimicked evolution by having the manipulated bacterial strains compete with each other - like a microbial version of "The Hunger Games." A thousand generations later, some strains fared better than others, as was expected. But when Kaar's team analyzed exactly how the bacteria responded to perturbations in their translational components, they discovered something unexpected: Initially, natural selection improved the compromised translational machinery, but its focus shifted away to other cellular modules before the machinery's performance was fully restored.

To find out why, Kaar enlisted Sandeep Venkataram, a population genetics expert at the University of California, San Diego.

Venkataram likens the process to a game of whack-a-mole, with each mole representing a cellular module. Whenever a module experiences a mutation, it pops up. The hammer smashing it back down is the action of natural selection. Mutations are randomly spread across all modules, so that all moles pop up randomly.

"We expected that the hammer of natural selection also comes down randomly, but that is not what we found," he said. "Rather, it does not act randomly but has a strong bias, favoring those mutations that provide the largest fitness advantage while it smashes down other less beneficial mutations, even though they also provide a benefit to the organism."

In other words, evolution is not a multitasker when it comes to fixing problems.

"It seems that evolution is myopic," Venkataram said. "It focuses on the most immediate problem, puts a Band-Aid on and then it moves on to the next problem, without thoroughly finishing the problem it was working on before."

"It turns out the cells do fix their problems but not in the way we might fix them," Kaar added. "In a way, it's a bit like organizing a delivery truck as it drives down a bumpy road. You can stack and organize only so many boxes at a time before they inevitably get jumbled around. You never really get the chance to make any large, orderly arrangement."

Why natural selection acts in this way remains to be studied, but what the research showed is that, overall, the process results in what the authors call "evolutionary stalling" - while evolution is busy fixing one problem, it does at the expense of all other issues that need fixing. They conclude that at least in rapidly evolving populations, such as bacteria, adaptation in some modules would stall despite the availability of beneficial mutations. This results in a situation in which organisms can never reach a fully optimized state.

"The system has to be capable of being less than optimal so that evolution has something to act on in the face of disturbance - in other words, there needs to be room for improvement," Kaar said.

Kaar believes this feature of evolution may be a signature of any self-organizing system, and she suspects that this principle has counterparts at all levels of biological hierarchy, going back to life's beginnings, possibly even to prebiotic times when life had not yet materialized.

With continued funding from the John Templeton Foundation and NASA, the research group is now working on using ancestral sequencing to go back even further in time, Kaar said.

"We want to strip things down even more and create systems that start out as what we would consider pre-life and then transition into what we consider life."

###

The paper is online athttps://www.pnas.org/content/117/31/18582.

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To understand the machinery of life, this scientist breaks it on purpose - Newswise

Cell Biology

New tools catch and release molecules at the flip of a light switch – Science Codex

August 14, 2020 medical

A Princeton team has developed a class of light-switchable, highly adaptable molecular tools with new capabilities to control cellular activities. The antibody-like proteins, called OptoBinders, allow researchers to rapidly control processes inside and outside of cells by directing their localization, with potential applications including protein purification, the improved production of biofuels, and new types of targeted cancer therapies.

In a pair of papers published Aug. 13 in Nature Communications, the researchers describe the creation of OptoBinders that can specifically latch onto a variety of proteins both inside and outside of cells. OptoBinders can bind or release their targets in response to blue light. The team reported that one type of OptoBinder changed its affinity for its target molecules up to 330-fold when shifted from dark to blue light conditions, while others showed a five-fold difference in binding affinity -- all of which could be useful to researchers seeking to understand and engineer the behaviors of cells.

Crucially, OptoBinders can target proteins that are naturally present in cells, and their binding is easily reversible by changing light conditions -- "a new capability that is not available to normal antibodies," said co-author Jos Avalos, an assistant professor of chemical and biological engineering and the Andlinger Center for Energy and the Environment. "The ability to let go [of a target protein] is actually very valuable for many applications," said Avalos, including engineering cells' metabolisms, purifying proteins or potentially making biotherapeutics.

The new technique is the latest in a collaboration between Avalos and Jared Toettcher, an assistant professor of molecular biology. Both joined the Princeton faculty in 2015, and soon began working together on new ways to apply optogenetics -- a set of techniques that introduce genes encoding light-responsive proteins to control cells' behaviors.

"We hope that this is going to be the beginning of the next era of optogenetics, opening the door to light-sensitive proteins that can interface with virtually any protein in biology, either inside or outside of cells," said Toettcher, the James A. Elkins, Jr. '41 Preceptor in Molecular Biology.

Avalos and his team hope to use OptoBinders to control the metabolisms of yeast and bacteria to improve the production of biofuels and other renewable chemicals, while Toettcher's lab is interested in the molecules' potential to control signaling pathways involved in cancer.

The two papers describe different types of light-switchable binders: opto-nanobodies and opto-monobodies. Nanobodies are derived from the antibodies of camelids, the family of animals that includes camels, llamas and alpacas, which produce some antibodies that are smaller (hence the name nanobody) and simpler in structure than those of humans or other animals.

Nanobodies' small size makes them more adaptable and easier to work with than traditional antibodies; they recently received attention for their potential as a COVID-19 therapy. Monobodies, on the other hand, are engineered pieces of human fibronectin, a large protein that forms part of the matrix between cells.

"These papers go hand in hand," said Avalos. "The opto-nanobodies take advantage of the immune systems of these animals, and the monobodies have the advantage of being synthetic, which gives us opportunities to further engineer them in different ways."

The two types of OptoBinders both incorporate a light-sensitive domain from a protein found in oat plants.

"When you turn the light on and off, these tools bind and release their target almost immediately, so that brings another level of control" that was not previously possible, said co-author Csar Carrasco-Lpez, an associate research scholar in Avalos' lab. "Whenever you are analyzing things as complex as metabolism, you need tools that allow you to control these processes in a complex way in order to understand what is happening."

In principle, OptoBinders could be engineered to target any protein found in a cell. With most existing optogenetic systems, "you always had to genetically manipulate your target protein in a cell for each particular application," said co-author Agnieszka Gil, a postdoctoral research fellow in Toettcher's lab. "We wanted to develop an optogenetic binder that did not depend on additional genetic manipulation of the target protein."

In a proof of principle, the researchers created an opto-nanobody that binds to actin, a major component of the cytoskeleton that allows cells to move, divide and respond to their environment. The opto-nanobody strongly bound to actin in the dark, but released its hold within two minutes in the presence of blue light. Actin proteins normally join together to form filaments just inside the cell membrane and networks of stress fibers that traverse the cell. In the dark, the opto-nanobody against actin binds to these fibers; in the light, these binding interactions are disrupted, causing the opto-nanobody to scatter throughout the cell. The researchers could even manipulate binding interactions on just one side of a cell -- a level of localized control that opens new possibilities for cell biology research.

OptoBinders stand to unlock scores of innovative, previously inaccessible uses in cell biology and biotechnology, said Andreas Mglich, a professor of biochemistry at the University of Bayreuth in Germany who was not involved in the studies. But, Mglich said, "there is much more to the research" because the design strategy can be readily translated to other molecules, paving the way to an even wider repertoire of customized, light-sensitive binders.

"The impressive results mark a significant advance," he said.

"Future applications will depend on being able to generate more OptoBinders" against a variety of target proteins, said Carrasco-Lpez. "We are going to try to generate a platform so we can select OptoBinders against different targets" using a standardized, high-throughput protocol, he said, adding that this is among the first priorities for the team as they resume their experiments after lab research was halted this spring due to COVID-19.

Beyond applications that involve manipulating cell metabolism for microbial chemical production, Avalos said, OptoBinders could someday be used to design biomaterials whose properties can be changed by light.

The technology also holds promise as way to reduce side effects of drugs by focusing their action to a specific site in the body or adjusting dosages in real time, said Toettcher, who noted that applying light inside the body would require a device such as an implant. "There aren't many ways to do spatial targeting with normal pharmacology or other techniques, so having that kind of capability for antibodies and therapeutic binders would be a really cool thing," he said. "We think of this as a sea change in what sorts of processes can be placed under optogenetic control."

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New tools catch and release molecules at the flip of a light switch - Science Codex

Cell Biology

Research Roundup: How the COVID-19 Virus Infects Other Cells and More – BioSpace

August 14, 2020 medical

Every week there are numerous scientific studies published. Heres a look at some of the more interesting ones.

The Unusual Way the COVID-19 Virus Infects Other Cells

Researchers with the University of California, San Francisco found that when the SARS-CoV-2 virus infects a human cells, the infected cell grows multi-pronged tentacles that are studded with viral particles. These filaments, called filopodia, reach out to still-healthy neighboring cells, which then bore into the cells bodies and infect the healthy cells with virus. The research was published in the journal Cell.

Scientists previously believed the SARS-CoV-2 virus infected cells in a typical way, which is by finding receptors on the surface of cells in a persons mouth, nose, respiratory tract, lungs or blood vessels, and replicating and invading larger cells. Other viruses, such as smallpox, HIV and some influenza viruses also used filopodia to improve their ability to infect cells.

By conducting a systematic analysis of the changes in phosphorylation when SARS-CoV-2 infects a cell, we identified several key factors that will inform not only the next areas of biological study, but also treatments that may be repurposed to treat patients with COVID-19, said one of the studys authors, Nevan Krogan, professor, Department of Cellular Molecular Pharmacology at the UCSF School of Medicine.

They also tested 87 drugs and molecules by mapping global phosphorylation profiles to dysregulated kinases and pathways that have the potential for treating COVID-19. They then narrowed the list down to kinase inhibitors.

We narrowed in on about a dozen, Krogan told ABC News, and we highlighted about six or seven that look particularly potent in a laboratory setting. And were very excited now to try and take these into clinical trials.

Three of those drugs include Senhwa Biosciences silmitasertib, which is in clinical trials for bile duct cancer and other malignancies; Eli Lillys ralimetinib, a cancer drug being evaluated for ovarian cancer; and Astellas gilteritinib, which is used to treat acute myeloid leukemia and marketed under the brand name Xospata.

Predicting Which Babies Will Develop Type 1 Diabetes

Researchers at the University of Exeter with colleagues at seven international locations followed 7,798 children at high risk of developing type 1 diabetes from birth, over nine years. The TEDDY Study data was then used to develop an algorithm by combining multiple factors to determine if a child is likely to develop type 1 diabetes. The combined risk score melds genetics, family history, and islet autoantibody counts. It appeared to double current programs to screen newborns to prevent ketoacidosis, a potentially deadly consequence of type 1 diabetes.

COVID-19 Does Not Directly Damage Taste Buds

A common early symptom of COVID-19 is the loss of taste and smell. It was generally believed that the SARS-CoV-2 virus damaged the cells involved in taste and smell, which was the reason for this loss. Recent research suggests 20-25% of patients report a loss of taste. New research from the Regenerative Bioscience Center at the University of Georgia, however, suggests the damage is not caused directly by the virus, but indirectly by events induced during COVID-19 inflammation. The research found that taste bud cells are not vulnerable to the viral infection, because most do not express ACE2, the cell receptor that the virus uses to enter cells.

New Treatment for Osteoarthritis Shows Promise in Regrowing Cartilage

Researchers at NYU Langone Health/NYU School of Medicine conducted a study where they injected adenosine into the joints of rodents whose limbs had been damaged by inflammation caused by either traumatic injury or massive weight gain. The biological damage was similar to that seen in human osteoarthritis. Adenosine is typically used to store energy and plays a central role in metabolism. In the rodents, the eight weekly injections stimulated regrowth rates of cartilage tissue between 35% and 50%.

Llama-Inspired Nanobodies to Treat COVID-19

Researchers at the University of California, San Francisco (UCSF) have synthesized a molecule inspired by llama antibodies called nanobodies against SARS-CoV-2. They are approximately 25% of the size of human antibodies and from other animals, and they appear to be the most potent anti-coronavirus compound that has been tested in the laboratory so far. In addition, the nanobodies are extremely stable, which means they can be turned into a dry powder and aerosolized, which would make them much easier to administer than the human monoclonal antibodies being developed by companies such as Sorrento Therapeutics, Regeneron Pharmaceuticals and Eli Lilly.

Why People Have Different Responses to COVID-19

Researchers at McMaster University and the University of Waterloo discovered that ACE2 receptors exist in very low levels in human lung tissue. This challenges the generally accepted belief that the SARS-CoV-2 virus enters cells via ACE2, at least in the lungs. They published their research in the European Respiratory Journal and their findings were independently confirmed by other researchers and published in Molecular Systems Biology.

Our finding is somewhat controversial, as it suggests that there must be other ways, other receptors for the virus, that regulate its infection of the lungs, said Jeremy Hirota, co-lead scientist from the Research Institute of St. Joes Hamilton and an assistant professor of Medicine at McMaster. We were surprised that the fundamental characterization of the candidate receptors in human lung tissue had not yet been done in a systematic way with modern technologies.

Finding such low levels of ACE2 in lung tissue has important implications for how we think about this virus, said co-lead Andrew Doxey, professor of Biology at the University of Waterloo. ACE2 is not the full story and may be more relevant in other tissues such as the vascular system.

They are now exploring alternate additional infection pathways and why there are different patient responses to infection. To do so, they are using nasal swabs that were collected during COVID-19 diagnoses, which lets them analyze the genes expressed by the patients cells. They will correlate positive and negative COVID-19 cases with clinical outcomes and hope to develop predictive algorithms associated with morbidity and mortality.

It is clear that some individuals respond better than others to the same SARS-CoV-2 virus, said Hirota. The differential response to the same virus suggests that each individual patient, with their unique characteristics, heavily influences COVID-19 disease severity. We think it is the lung immune system that differs between COVID-19 patients, and by understanding which patients lung immune systems are helpful and which are harmful, we may be able to help physicians proactively manage the most at-risk patients.

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Research Roundup: How the COVID-19 Virus Infects Other Cells and More - BioSpace

Cell Biology

Dr. Suvas earns second R01 to explore cornea-based complication of herpes simplex virus-1 – The South End

August 14, 2020 medical

Susmit Suvas, Ph.D.

A faculty member in the Wayne State University School of Medicines Department of Ophthalmology, Vision and Anatomical Sciences will use a new five-year, $1.88 million grant from the National Eye Institute to study how better to fight a chronic inflammation of the cornea that often leads to vision loss.

Associate Professor Susmit Suvas, Ph.D., is the principal investigator of Role of insulin-like growth factor binding proteins in the pathogenesis of herpes stromal keratitis.

Herpes simplex virus-1, or HSV-1, is an infection of the cornea that can cause the development of herpes stromal keratitis, a chronic inflammatory condition. HSK is a major cause of infection-induced vision loss in the United States, said Dr. Suvas, who also serves as the graduate officer of the Anatomy and Cell Biology Graduate Program.

Clinical signs of HSK include the development of new leaky blood vessels in a once-clear and transparent cornea. Newly formed leaky blood vessels bring a massive influx of immune cell types, such as neutrophils. These immune cells persist in the inflamed cornea and cause damage to corneal tissue. As a result, the cornea becomes opaque and thick.

The long-term goal of our research is to understand the pathogenesis of herpes stromal keratitis so that novel therapeutic approaches can be developed to better manage the condition of HSK and reduce the loss of vision, Dr. Suvas said.

The focus of our current grant application is to understand the role of insulin-like growth factor binding protein-3 (IGFBP-3) in inhibiting the survival of immune cells and development of new blood vessels (angiogenesis) in HSV-1 infected corneas," he added.

The National Eye Institute of the National Institutes of Health has continuously funded Dr. Suvass research on herpes stromal keratitis since 2009.

It is a great feeling to have simultaneously two five-year R01s supporting our research to understand the pathogenesis of HSK, he said. We anticipate that at the end of our study we will have a clear understanding of how IGFBP-3 protein reduces viral load, hemangiogenesis, and the survival and effector function of neutrophils in HSK developing corneas.

The grant number for this award is EY030129.