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BHI Weekly News Archives

494th Edition, February 8, 2022

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February 08, 2022

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Geoffrey Lynn, co-founder Avedia, SVP, Synthetic Immunotherapies, Vaccitech, joins BioTalk

Geoffrey Lynn, SVP, Synthetic Immunotherapies, Vaccitech, visits Rich Bendis to discuss his career from NIH, to CEO of Avidea, to their merger with Vaccitech.

Listen now via Apple https://apple.co/3GztBZg, Google https://bit.ly/3gAfHvn, Spotify https://spoti.fi/3GBiaAm, and TuneIn https://bit.ly/3B54Y5V.

Dr. Geoffrey Lynn is leveraging his background in synthetic chemistry and cellular immunology to lead Avidea’s efforts to develop precision immunotherapies for treating cancer and autoimmune diseases. Dr. Lynn has expertise in designing, GMP manufacturing and assessing safety, efficacy & MOA of polymer-drug conjugate / nanoparticle technologies for immunotherapeutic applications. Previously, Dr. Lynn was a visiting scientist in the laboratory of Professor Christopher Jewell at the Fischell Department of Engineering at UMD and trained as a post-doctoral fellow with Dr. Robert Seder at the Vaccine Research Center of the National Institutes of Health (NIH). Dr. Lynn attended medical school at Johns Hopkins University; obtained a Ph.D. in Biomedical Engineering from the University of Oxford as an NIH-Oxford and National Science Foundation Graduate Research Fellow; and received his B.S. in chemistry from Elon University, where he was a Goldwater Scholar.

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Immediate Job Opportunity: Entrepreneur-In-Residence Role with BioHealth Innovation, Inc. and NIH

POSITION DESCRIPTION – Entrepreneur-In-Residence

EIRs will work in collaboration with SEED to mentor innovators and provide guidance to help them de-risk the technical and business elements of their product development projects. EIRs will also help NIH and individual innovators ensure the long-term success of their projects by facilitating connections with investors and strategic partners who can help achieve commercial success and healthcare consumer access. To be successful in this role, entrepreneurial, commercial or product development experience in areas of social impact including wellness & prevention, healthcare access/community health and a wide network in social impact ventures is required.

This position is currently remote (with opportunity for future in-person activities) and part time (20 hrs/week with potential for expansion); occasional travel may be required (when conditions permit).

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How can your BioHealth business benefit from a review by BHI industry experts? Please register for our next Entrepreneur-In-Residence (EIR) day on Feb. 16th and find out.

These free 1:1 virtual sessions are an opportunity to discuss your company with experts in diagnostics, therapeutics, digital health and medical devices. If you’re a growth-stage biohealth company looking for unbiased advice on your pitch deck, commercialization strategy, evidence development or entrepreneurial challenges, our EIRs can help.

To sign-up for any of the EIR dates in 2022, please follow this link.

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NEXT GENERATION TB TEST DEVELOPED WITH ELLUME TECHNOLOGY RECEIVES APPROVAL FROM KEY GLOBAL REVIEW PANEL FOR USE IN MORE THAN 100 LOW-RESOURCE, HIGH BURDEN COUNTRIES

FREDERICK, Md. and BRISBANE, Australia, Jan. 10, 2022 /PRNewswire/ — Digital diagnostics company Ellume today announced that the QIAreach QuantiFERON-TB test (QIAreach QFT), developed with Ellume technology, and designed to advance the control of tuberculosis (TB) in areas with limited infrastructure, has been approved by the Global Fund’s Expert Review Panel for Diagnostics.  Approval of QIAGEN N.V.’s battery-operated QIAreach QFT means the product will now be available to public health programs and institutions in more than 100 countries that qualify for Global Fund and/or UNITAID resources, as well as through the Stop TB Partnership’s Global Drug Facility (GDF). This development comes after the QIAreach QFT product was launched in October 2021, following CE marking.

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Emmes Supports New Collaboration to Accelerate COVID-19 Research for Children

Emmes, a global, full-service Clinical Research Organization dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced its role as a Data Coordinating Center on a team whose work has accelerated pediatric COVID-19 research through the Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children per Standard of Care (POP02).  The team, led by the Pediatric Trials Network at Duke University, also includes the Gabriella Miller Kids First Data Resource Center (DRC) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

POP02 is one of several cohort studies within the Collaboration to Assess Risk and Identify LoNG-term outcomes for Children with COVID, known as CARING for Children with COVID.  The National Institutes of Health (NIH) initiated the CARING for Children with COVID program to collect clinical data and samples that would advance the understanding of SARS-CoV-2 infections in children.  The program seeks to provide information to help healthcare providers and parents make informed decisions when caring for children infected with either COVID-19 (acute coronavirus disease) or who have MIS-C (multisystem inflammatory syndrome).  

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Arcellx Announces Pricing of Initial Public Offering – Arcellx

GAITHERSBURG, Md., Feb. 04, 2022 (GLOBE NEWSWIRE) — Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, today announced the pricing of its initial public offering of 8,250,000 shares of common stock at a public offering price of $15.00 per share. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Arcellx, are expected to be approximately $123.8 million. In addition, Arcellx has granted the underwriters a 30-day option to purchase up to an additional 1,237,500 shares of common stock at the initial public offering price, less underwriting discounts and commissions. All of the shares of common stock are being offered by Arcellx. Arcellx’s common stock is expected to begin trading on the Nasdaq Global Select Market on February 4, 2022, under the ticker symbol “ACLX.” The offering is expected to close on February 8, 2022, subject to the satisfaction of customary closing conditions.

BofA Securities, SVB Leerink, Barclays and William Blair are acting as joint book-running managers for the offering.

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USP and WHO Renew Official Relations to Continue Strengthening the Global Medicines Supply Chain | LinkedIn

On Saturday, January 29, the World Health Organization (WHO) Executive Board approved the renewal of official relations with the United States Pharmacopeial Convention (USP) through 2023. As an independent, scientific nonprofit organization focused on building trust in the supply of safe, quality medicines, USP is honored to continue our longstanding partnership with the WHO and contribute our expertise to shape and advance policies and strategies to improve the health and wellbeing of people around the world.

Image: https://www.linkedin.com/

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Baltimore Fishbowl | University of Maryland, Baltimore County reaches nation’s highest level as research university –

The University of Maryland, Baltimore County has received a Carnegie Classification, the nation’s highest designation for research universities.

Two other universities in Maryland – Johns Hopkins University and the University of Maryland – share the classification.

The Carnegie Classification of Institutions of Higher Education ranked UMBC in the R1 category, which signifies “very high research activity.”

UMBC is one of only 146 R1 institutes nationally, including 107 public universities and 39 private universities.

“This is an amazing accomplishment by faculty, staff, and administrative leaders who have built a research culture that nurtures undergraduate and graduate students,” said UMBC president Freeman Hrabowski in a news release.

Image: Photo via the University of Maryland, Baltimore County

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Gain Therapeutics Announces Additional Details on its February 4th Virtual R&D Day

BETHESDA, Md., Jan. 31, 2022 (GLOBE NEWSWIRE) — Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”), a biotechnology company transforming the drug discovery paradigm with structurally targeted allosteric regulators identified with its proprietary computational discovery platform, today announced additional details on its R&D Day being held virtually on Friday, February 4, 2022 from 10:00 am – 12:00 pm Eastern Time.

The R&D Day Event, entitled “Neuroscience and Beyond: Harnessing Computational Technology and Allosteric Modulators to Drug the Undruggable” will feature presentations from several Key Opinion Leaders (KOLs):

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Altimmune Announces FDA Clearance Of Pemvidutide (ALT-801) IND For Obesity

January 31, 2022 at 7:00 AM EST

Enrollment in 48-week Phase 2 clinical trial expected to begin in Q1 2022

GAITHERSBURG, Md., Jan. 31, 2022 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for its Phase 2 clinical trial of pemvidutide for obesity. Pemvidutide is an investigational GLP-1/glucagon dual receptor agonist under development for the treatment of obesity and non-alcoholic steatohepatitis (NASH). Altimmune expects to initiate the Phase 2 trial in obesity in the first quarter of 2022. The Company previously received IND clearance for pemvidutide in NASH and is currently enrolling subjects with nonalcoholic fatty liver disease (NAFLD) in a Phase 1b trial.

“This Phase 2 trial in obesity represents an important milestone toward developing a safe and effective treatment option for people with obesity,” said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. “Results from a recently completed Phase 1 study of pemvidutide in Australia showed that 12 weekly subcutaneous doses of pemvidutide at the 1.8 mg dose level resulted in an average weight loss of 10.3% in overweight and obese subjects. Importantly, there were no study discontinuations due to adverse events. We believe these results rank among the best in terms of the rate and magnitude of weight loss and tolerability among drugs in development for obesity.”

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MaxCyte Signs Strategic Platform License with Intima Bioscience to Advance Tumor Infiltrating Lymphocytes Programs

Intima Bioscience to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to accelerate the development of its solid tumor cell-therapy candidates NEW YORK and GAITHERSBURG, Md., Jan. 31, 2022 (GLOBE NEWSWIRE) — MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT, MXCN), a leading provider of enabling platform technologies for ex-vivo cell engineering, today announces the signing of a strategic platform license (SPL) with Intima Bioscience, Inc., a clinical stage biotechnology company developing genetically engineered cell therapies for solid tumor cancer. Intima joins a group of 15 other leading cell therapy companies who have partnered with MaxCyte.

Under the terms of the agreement, Intima obtains non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform. In return, MaxCyte is entitled to receive platform licensing fees and program-related milestone payments.

Intima is currently running a Phase 1/2 clinical study (NCT04426669) of its lead checkpoint cell therapy candidate, which targets the immune checkpoint CISH in patients with gastrointestinal and colon cancers.

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2021 Global life sciences sector outlook | Deloitte

Navigating the pandemic has been an all-encompassing, once-in-a-lifetime challenge. Globally, life sciences companies responded with leadership and are emerging stronger. How will life sciences companies continue to respond and what areas can they build resiliency going forward?

The life sciences sector has played a pivotal role amid the COVID-19 pandemic. To cope with the global crisis, traditional competitors partnered to accelerate research and develop the fastest novel vaccine in the history. Governments, health systems, payers, retail pharmacies, and nonprofits are now working collaboratively with the sector to provide widespread distribution and administration.

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How Johns Hopkins Inventors’ Vision for Early Cancer Detection Got a $2.1B Boost – Johns Hopkins Technology Ventures

Johns Hopkins researchers Nickolas Papadopoulos, Ken Kinzler and Bert Vogelstein have spent their careers working on ways not just to treat cancer but to detect it before it becomes a threat. The goal: a blood test for the earlier detection of cancer incorporated into routine medical care. Their dream is closer to reality thanks in part to a $2.15 billion acquisition of their company, Thrive Earlier Detection Corp., one year ago by Exact Sciences Corp., a global leader in cancer-detection testing.

The heart of the researchers’ work is the liquid biopsy, a test done on a blood sample to look for signals derived from cancer cells circulating in the blood. In 2011, they invented SafeSeqS, a next-generation gene sequencing technology that simultaneously and individually analyzed millions of DNA molecules to identify mutations in the bloodstream more accurately than other methods.

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Amalgam named Best SaaS-Enabled Digital Health Platform!

Global Health & Pharma recently presented their seventh annual Biotechnology Awards and named Amalgam the Best SaaS-Enabled Digital Health Platform. The Global Health & Pharma Biotechnology Awards are given strictly on merit, so we’re extremely honored to be among those whose innovation, determination and outstanding levels of care have earned them this prestigious recognition.

Contact us today for a capabilities demonstration to see how we can enable success for your digital solution, clinical decision support, or patient ID needs.

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Key lawmaker: ARPA-H won’t be part of NIH – STAT

WASHINGTON — A new research agency aimed at developing breakthrough medical technologies won’t be housed within the National Institutes of Health, a key lawmaker said on Wednesday.

Instead, the agency, known as ARPA-H, will exist as a distinct unit within the Department of Health and Human Services, said Rep. Anna Eshoo (D-Calif.).

Image: https://eshoo.house.gov/about-anna/biography

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Fresh Off Best Year Ever, Lab Giant Alexandria To Venture Into New Territory

The leading developer of life sciences properties rode the industry’s wave last year, recording 4.1M SF of leases signed between October and December, more than double its best total for any quarter in Alexandria Real Estate Equities’ nearly 30-year history.

Its pace of activity is spurring the Pasadena, California-based real estate investment trust to venture into new territory — it is paying $402M for a nearly 1M SF life sciences campus in Texas, it disclosed in its quarterly earnings release this week.

Image: Courtesy of Alexandria Real Estate Equities Vaccine-maker Moderna inked one of the year’s biggest deals with Alexandria Real Estate Equities for a new Kendall Square headquarters.

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The Clues to the Next Variant Surge Are All Around Us

When scientists in South Africa noticed an uptick in Covid-19 cases in the Gauteng Province last November, they began investigating the source. These researchers and others in Botswana quickly discovered the Omicron variant and heroically shared their discovery with the rest of the world. And yet it was still too late — Omicron was already rapidly infecting people across the globe.

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American Gene Technologies’ HIV Clinical Trial Shows Blood Markers of Efficacy in Two More Patients

ROCKVILLE, MD. (PRWEB)  FEBRUARY 02, 2022

Data from a Total of Five Patients Demonstrates Critical Markers of the Company’s HIV Cure Gene & Cell Therapy American Gene Technologies (AGT), a clinical-stage biotechnology company working to cure HIV, announced that it has reached another important milestone for its HIV cure program. Five participants were treated with AGT103-T and are stably engrafted with genetically modified cells.

Laboratory studies confirmed substantial increases in virus-specific T cells consistent with improved immunity against HIV in all participants. The early data addresses key trial endpoints and is aligned with the objective of restoring natural immunity against HIV.

“These latest laboratory studies of clinical material are extremely encouraging,” said AGT CEO Jeff Galvin. “To see these markers in all five trial participants indicates that prospects are bright for a potential one-and-done therapy to functionally cure HIV. This milestone brings us another step closer to our goal of returning people living with HIV to a normal life without the side effects of ART and having no further consequences of HIV.”

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2 technologies of which hospitals should be wary

Blockchain and “connected health” technology are two trends hospitals should not rush to adopt, according to two hospital innovation executives.

Discussions of blockchain have been increasingly prominent in the technology industry in recent years, and it shows potential for healthcare applications. However, it can be tricky for hospitals to figure out how to deploy the technology, Michelle Stansbury, vice president of IT innovation at Houston Methodist, told Becker’s.

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