Biohealth Innovation - 491st Edition, January 18, 2022

Biohealth Innovation

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January 19, 2022

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BHI Client Avidea Merger with Vaccitech Provides New Opportunities for SNAPvax Platform · BioBuzz

One month after being acquired in a $40 million deal by U.K.-based Vaccitech plc, the team that was formerly part of Avidea Technologies continues to advance its SNAPvax platform into the crucible of clinical trials in about one year.

Privately-held Avidea is developing next-generation T cell immunotherapies for the treatment of cancer and autoimmune diseases. The company’s immunotherapies are driven by its polymer-drug conjugate technology platform, SNAPvax, which is designed to co-deliver multiple antigens and immunomodulators in nanoparticles of precise, programmable size and composition.

Image: https://biobuzz.io/

First pig-to-human heart transplant: what can scientists learn?

The first person to receive a transplanted heart from a genetically modified pig is doing well after the procedure last week in Baltimore, Maryland. Transplant surgeons hope the advance will enable them to give more people animal organs, but many ethical and technical hurdles remain.

“It’s been a long road to get to this point, and it’s very exciting we are at a point where a group was ready to try this,” says Megan Sykes, a surgeon and immunologist at Columbia University in New York City. “I think there’s going to be a lot of interesting things to be learned.”

Image: Surgeons at the University of Maryland Medical Center transplanted a genetically altered pig heart into David Bennett.Credit: University of Maryland School of Medicine

One Of America’s Richest Self-Made Women, Martine Rothblatt, Played Key Role In Week’s Historic Heart Transplant

When the University of Maryland Medical Center announced the first successful transplant of a heart that was grown in a genetically altered pig earlier this week, it notched a big win for one of America’s wealthiest self-made women.

Revivicor, a subsidiary of United Therapeutics–founded and led by Martine Rothblatt – supplied the heart that made the surgery possible. A former communications satellite lawyer who went on to cofound Sirius Satellite Radio, Rothblatt, 67, has been on a long journey to biotechnology success.

Image: https://en.wikipedia.org/wiki/Martine_Rothblatt

Founder and Executive Chairman of Emergent BioSolutions Announces Retirement

GAITHERSBURG, Md., Jan. 14, 2022 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced that Fuad El-Hibri, founder and executive chairman, has decided to retire effective April 1, 2022.

“Creating and leading Emergent has been the honor of my life, and it would not have been possible without the help of our incredible team,” said El-Hibri. “I want to thank everyone at Emergent, past and present, for helping advance our inspiring mission over the past two decades. I could never have imagined the number of lives we would impact, and I will forever be proud of our accomplishments. Emergent is on track to achieving its 2024 strategic plan goals and I have utmost confidence in the executive team under the leadership of Bob Kramer and the oversight of our highly experienced and capable board. While I have been looking forward to retirement after 23 years of service, I will be rooting from the sidelines as a fan, friend, and shareholder.”

Institute for Bioscience and Biotechnology Research Receives $16.8M Investment from the National Institute of Standards and Technolog

Fri, Jan 14, 2022

New Cooperative Agreement to Aid in the Development of Therapeutics and Vaccines, Improve Access to Medication

The Institute for Bioscience and Biotechnology Research (IBBR) announces a newly funded five-year cooperative agreement with the National Institute of Standards and Technology (NIST) headed by the Co-Directors of IBBR, Dr. David J. Weber (PI) and Dr. John Marino (NIST). This award provides more than $3.3 million each year to support groundbreaking research, including technology and standards development that will impact vaccine and therapeutic discovery and development, and to improve access to life-saving treatments for addressing other crucial health challenges.

IBBR is a joint research enterprise of the University of Maryland, College Park, the University of Maryland, Baltimore and NIST. Research born out of this new cooperative agreement will be applied to accelerating the development and manufacturing of new pharmaceutical and vaccine approaches including cell and gene therapies and mRNA vaccines. This type of bioscience and bioengineering research will enable robust and rapid responses to pandemics and help remove obstacles to care and treatment related to rare childhood diseases and complex cancers.

BioSpace: Cartesian Aims to Propel RNA Cell Therapy with Combinations

Cartesian Therapeutics is developing non-permanent cell therapies that can be used soon after diagnosis and address a wide range of diseases beyond cancer. The biotech’s approach to cell engineering relies upon RNA rather than DNA to effect changes within the cells.

The benefit, Cartesian President and CEO Murat Kalayoglu, M.D., Ph.D. told BioSpace, is that “our RNA approach, compared to a traditional DNA modification, offers an order of magnitude greater control over the therapeutic product and what happens when those cells are in the body.” A high level of control is important if cell therapy is to be used in the treatment of either front-line cancer or in indications where the choice isn’t between life and death.

“RNA has a measurable half-life,” Kalayoglu explained, so cell therapies driven by RNA aren’t permanent. “The cells can’t proliferate out of control.” Consequently, Cartesian can develop cell therapy for newly diagnosed populations and for autoimmune, respiratory and inflammatory diseases, for example.

Click here to read more via BioSpace.

South Korea Ministry of Food and Drug Safety Approves Novavax COVID-19 Vaccine - Jan 12, 2022

-- Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) is the first protein-based COVID-19 vaccine granted approval in South Korea

GAITHERSBURG, Md., Jan. 12, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and SK bioscience, Co. Limited, a vaccine business subsidiary of Korea-based SK Group, today announced that South Korea's Ministry of Food and Drug Safety (MFDS) has approved a Biologics License Application (BLA) from SK bioscience for Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) for active immunization in individuals 18 years of age and older for the prevention of COVID-19 caused by SARS-CoV-2. Nuvaxovid™, Novavax' COVID-19 vaccine also known as NVX-CoV2373, is the first protein-based COVID-19 vaccine to be approved for commercial use in South Korea and will be manufactured and marketed in the country by SK bioscience.

"Novavax is proud to bring our COVID-19 vaccine to South Korea at a critical time in the pandemic as both the Delta and Omicron variants have taken hold," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We thank our partners at SK bioscience for their commitment to this public health challenge and the MFDS for its thorough assessment of our data as we look forward to helping address major obstacles to controlling the pandemic through the additional option of our protein-based vaccine."

Orgenesis and Johns Hopkins University expand POCare in Maryland through creation of the Maryland Center for Cell Therapy Manufacturing

Center will expand Orgenesis’ Point of Care (POCare) Platform Capabilities in Maryland GERMANTOWN, Md., Jan. 18, 2022 (GLOBE NEWSWIRE) -- Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies, and The Johns Hopkins University, today announce the next phase of their collaboration. This new phase involves construction of a cell and gene therapy processing facility for point of care treatment of patients at Johns Hopkins which is planned to start in Q2 2022 and is expected to be operational in Q2 of 2023.

Construction of the new POCare Center, also known as the Maryland Center for Cell Therapy Manufacturing, has been funded in part by a $5 million grant from the State of Maryland. The new state-of-the-art 7,000-square-foot facility has been designed to meet U.S. Food and Drug Administration standards and provides Johns Hopkins clinicians and researchers with a more streamlined path to treat patients and take promising and novel treatments from the lab to patient trials. This path will enable local capacity for processing of clinical therapeutics at the point of care, rather than having to outsource clinical trial cell and gene therapy manufacturing to third parties.

Chain Drug Review Pharmacy Outlook: Ronald Piervincenzi, USP

January 10, 2022 by Ronald Piervincenzi

The COVID-19 pandemic made the last year both an extraordinary and challenging time to work in health care. Development, distribution and administration of new vaccines, treatments and preventatives moved at a pace never before experienced. Pharmacists and other health care practitioners were called to the front lines of a mass vaccination effort, working to balance safety, speed and a plethora of daily demands in caring for patients and working to save countless lives. Manufacturers, regulators, pharmacists and other care providers demonstrated how cross-sector collaboration could rapidly transform cutting-edge innovation into the new standard of care, including an expanding scope of practice for many pharmacists.

Stem Cell Therapy for NEC - Dr. David Hackam | Maryland Stem Cell Research Fund - YouTube

Dr. David Hackam and his lab are utilizing human stem cell technologies to tackle the leading cause of death and disability in premature infants, necrotizing enterocolitis (NEC), as well as other chronic intestinal conditions that affect children and adults. As the Chief of Pediatric Surgery at Johns Hopkins University and Surgeon-in-Chief of Johns Hopkins Children's Center, Dr. Hackam knows firsthand the complicated neonatal surgery and the devastating long-term effects that result from NEC.

https://www.youtube.com/watch?v=c5jVLDWrV4g

NIH Technology Accelerator Challenge (NTAC) | National Institute of Biomedical Imaging and Bioengineering

Prize Competition for Maternal Health

NIBIB launched the NIH Technology Accelerator Challenge (NTAC) series of prize competitions to stimulate the design of new diagnostic technologies to transform public and global health and to accelerate the full development of those products for use in low-resource settings. This iteration of NTAC intends to award cash prizes for innovative diagnostic technologies to help improve maternal health by diagnosing conditions related to maternal morbidity and mortality. Pregnancy and childbirth complications are a major global health problem resulting in the deaths of more than 800 women and 7,000 newborns each day. Contributing to the high rates of maternal morbidity and mortality in low-resource settings is the lack of low-cost diagnostics that operate at the point-of-care and are capable of detecting and differentiating common conditions during antenatal and intrapartum periods of pregnancy. Therefore, the intended purpose of NTAC: Maternal Health is to spur and reward the development of low-cost, point-of-care molecular, cellular, and/or metabolic sensing and diagnostic technologies integrated with a digital platform to guide rapid clinical decision-making, improve patient outcomes, and ultimately prevent maternal morbidity and mortality.

JHU revises COVID-19 safety protocols ahead of spring semester | Hub

ohns Hopkins University is revising its safety protocols ahead of the start of the spring semester as it prepares to resume a broad range of in-person academic, research, and other activities as safely as possible amid the surge in COVID-19 cases caused by the omicron variant, university leaders said Friday.

The most noticeable change is to the university's masking requirement: JHU will now require the use of N95s, KN95s, or a combination of a cloth mask with a surgical mask. In other words, a cloth mask alone or a surgical mask alone will no longer meet the university's mask requirement, wrote Stephen Gange, professor and executive vice provost for academic affairs; Jon Links, professor, vice provost, and chief risk officer; and Kevin Shollenberger, vice provost for student health and well-being and interim vice provost for student affairs in a message to the JHU community on Jan. 14.

Decentralized Clinical Trials Raise Concerns About Informed Consent

Under pressure of the COVID-19 pandemic, multitudes of clinical trials of new medications and treatments have moved to a decentralized model, bringing them to the patients rather than having patients come to a central trial site such as an urban medical center.(1) At the same time, recent research shows a worrying lack of patients’ informed consent to the treatment they are undergoing.(2) “This,” says Dr. Harsha Rajasimha, founder and CEO of Jeeva Informatics, “is not an acceptable situation. The extent to which patients comprehend the consent they grant is essential to the ethical conduct of medical research.”

Image: http://www.prweb.com

Detection of SARS-CoV-2 and other RNA Virus Using a Novel Improved RT-qPCR Method that Increases Sensitivity & Improves Safety

DNA or RNA-based diagnostic tests for infectious diseases are critical in modern medicine. The current gold standard for COVID-19 detection is testing SARS-CoV-2 viral RNA by quantitative reverse transcription Polymerase Chain Reaction (RT-qPCR). This method involves patient sample collection with a nasopharyngeal swab, storage of the swab in a universal transport medium during transport to a testing site, RNA extraction, and analysis of the extracted RNA sample. Collected patient samples, in addition to the possible presence of SARS-CoV-2, also contain inhibitors for downstream enzymatic reactions, RNA degrading enzymes (e.g., RNase), and magnesium and calcium ions that are required for RNase activity. Active RNase in the patient sample can reduce the amount of SARS-CoV-2 RNA in the sample; so, the RNA needs to be extracted for analysis.

Structural Biology Illuminates Molecular Determinants of Broad Ebolavirus Neutralization by Human Antibodies for Pan-Ebolavirus Therapeutic Development | Immunology | Frontiers

Monoclonal antibodies (mAbs) have proven effective for the treatment of ebolavirus infection in humans, with two mAb-based drugs Inmazeb™ and Ebanga™ receiving FDA approval in 2020. While these drugs represent a major advance in the field of filoviral therapeutics, they are composed of antibodies with single-species specificity for Zaire ebolavirus. The Ebolavirus genus includes five additional species, two of which, Bundibugyo ebolavirus and Sudan ebolavirus, have caused severe disease and significant outbreaks in the past. There are several recently identified broadly neutralizing ebolavirus antibodies, including some in the clinical development pipeline, that have demonstrated broad protection in preclinical studies.

Image: https://www.frontiersin.org

Unblock research bottlenecks with non-profit start-ups

It takes more than a great idea to accomplish a great project. Our research and experience have convinced us that many worthy projects wither or are never launched because neither academic laboratories, start-up firms nor government facilities can support them.

This applies particularly to projects that would produce public goods, such as data sets or tools, that could make research faster and easier. Few research-enabling projects will be commercially viable enough to attract venture capital.

Image: Mouse neurons imaged using a method similar to one being developed as a high-throughput tool by a focused research organization. Credit: P. W. Tillberg et al./Nature Biotechnol.

MEDA Education Session: "Primer on selling to hospitals"

Wednesday, February 02, 2022, 12:00pm - 01:30pm

Winning over a hospital Value Analysis Committee or “VAC” is a must for companies targeting hospital customers.

What does it take?

Who makes up VACs?

Case studies, lecture format + Q/A time.

Wednesday, February 2, 2022 12pm – 1:30pm EST

via webinar

To learn more click here.

Let’s Discuss the "still" Soaring Healthcare Investments in 2021 and beyond

Jonny’s back! Despite the continuation of COVID -19 through 2021, 2021 was a spectacular year for venture fundraising. Investment in every healthcare sector set records, and most experienced record IPO activity as well.

With pullback in both investments and public market performance in late 2021, what will 2022 have in store? Jon will provide his unique insights into 2021s market performance and his crystal ball predictions for 2022,

Age-Tech & Digital Health Solutions: Fundamentals of Longevity Economy Market (Audio Descriptions) - YouTube

The Developing and Accelerating Age-Tech and Digital Health Solutions webinar series, hosted by NIA’s Small Business Program, offers research entrepreneurs and biotech small business owners insights and best practices for digital health and age-tech solutions. The Understanding the Fundamentals of the Longevity Economy Market session provides guidance on developing and positioning your solutions, defining customer market segments, understanding reimbursement pathways, and creating a profitable and impactful business model.

https://www.youtube.com/watch?v=IcbPXa0_NOY