Weekly Quick Hits (BioHealth Capital Region) – Week of July 17, 2023

A strong revenue stream is essential for thriving biopharma companies. Despite a struggling economy, several companies within the BioHealth Capital Region are successfully raising capital to support development of new therapeutics for multiple disorders, while others continue to advance their own experimental assets. 

By Alex Keown 

July 21, 2023

Quick Hits is BioBuzz’s weekly round up of all the life science news you don’t want to miss, in your region of interest. Don’t miss a beat; SUBSCRIBE to our weekly Quick Hits newsletter via LinkedIn (BioHealth Capital Region, Greater Philadelphia, Research Triangle Park) or get it delivered to your inbox every week.

Funding, Awards, and Collaborations

CEL-SCI Announces Pricing of Public Offering

Vienna, Va.-based CEL-SCI Corporation announced the pricing of an underwritten public offering of 2,500,000 shares of its common stock at a public offering price of $2 per share, for gross proceeds of $5,000,000. The company intends to use the net proceeds from the offering to fund the continued development of Multikine and for general corporate purposes.

Eko Health and Astellas Announce Agreement for Eko CORE 500 Digital Stethoscope

Japan’s Astellas Pharma and Columbia, Md.-based Eko Health Inc. announced a License & Supply Agreement for the global supply and license of Eko’s latest digital stethoscope, the CORE 500, and a custom suite of Eko’s AI-powered cardiovascular disease detection software. Astellas intends to integrate Eko’s technology with Welldoc’s cardiometabolic digital therapeutic capabilities to create a proprietary, non-invasive device-DTx solution for patients with heart failure, currently known as Z1608.

OpGen’s Subsidiary Curetis Meets R&D Collaboration Milestones with FIND

Rockville-based OpGen, Inc. reported that its German subsidiary Curetis GmbH has met all milestones under its extended and expanded research and development collaboration agreement with FIND. Following the delivery of a comprehensive milestone report at the end of the second quarter of 2023, FIND recently confirmed that all requirements have been met successfully. The extended and expanded R&D collaboration has successfully addressed the development and feasibility for an antibiotic stewardship module as part of the Unyvero A30 software suite that can be customized to guide usage of specific antibiotics based on their availability from local hospital pharmacies in relevant settings within low- and middle-income countries.

DARPA Awards Ginkgo Bioworks New Manufacturing Contract

Defense Advanced Research Projects Agency (DARPA), based in Virginia, announced that Boston-based Ginkgo Bioworks has been awarded a four-year contract worth up to $18 million to reimagine how to manufacture complex therapeutic proteins. As a performer on DARPA’s Reimagining Protein Manufacturing (RPM) project, Ginkgo aims to deliver revolutionary advances in on-demand protein manufacturing by leveraging Cell-Free Protein Synthesis (CFPS) to enable rapid, high-yield, distributed production of human therapeutic proteins that support national security objectives. Ginkgo will leverage innovative technologies enabled by its high-throughput, automated Foundry and its proprietary genetic data Codebase, a portfolio of reusable biological assets that includes more than one billion proprietary gene sequences. 

Acumen Announces Pricing of Upsized $130 Million Public Offering

Charlottesville-based Acumen Pharmaceuticals, which is developing a novel therapeutic that targets soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease, announced the pricing of an upsized underwritten public offering of $7.75 per share, valued at approximately $130 million. The offering is expected to close on July 21, 2023.

Oxford Biomedica Implements Sapio Sciences’ Electronic Laboratory Notebook

Baltimore-based Oxford Biomedica, a quality and innovation-led viral vector CDMO, has implemented Sapio’s Electronic Laboratory Notebook as part of its digital transformation. The integration of Sapio’s ELN is set to increase the efficiency of completing tasks and bolster the insight gained from the state-of-the-art technologies developed at OXB.

DoD taps Kaléo to Develop Next Generation Nerve Agent Countermeasure

Kaléo, a privately-held U.S. pharmaceutical company based in Virginia, announced their selection by the U.S. Department of Defense to develop a reconstitution auto-injector device that delivers atropine. This will be the first of a new generation of medical countermeasures utilizing an innovative reconstitution technology and is expected to significantly extend the shelf life of the drug as well as its stability under extreme conditions. The reconstitution development contract is valued at more than $39 million over the next five years.

In the Clinic

Alphyn Biologics Posts Encouraging Interim Results of Phase IIa Atopic Dermatitis Trial

Annapolis-based Alphyn Biologics released interim results from the second cohort of its Phase IIa clinical trial program of AB-101a, a novel topical candidate for atopic dermatitis (AD). The interim results evaluating AB-101a on the immune and bacterial components of AD show the therapeutic candidate is meeting all endpoints for efficacy and safety. AB-101a is clearing all AD infections and is demonstrating control of the bacterial microbiome on the AD skin to manage flares driven by bacteria in mild, moderate, and severe levels of the disease, the company reported. AB-101a is also reducing itch and showing improvement in the investigator scores. 

Acumen Pharmaceuticals Sees Positive Topline Results from Phase I Alzheimer’s Study

Virginia-based Acumen Pharmaceuticals, which is developing a novel therapeutic that targets soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease, presented positive topline results from the Phase I INTERCEPT-AD trial of ACU193, the first clinical-stage AβO targeting antibody therapy in early AD. Topline results demonstrated that ACU193 was generally well-tolerated with a compelling overall safety profile, meeting the primary objective of the trial.

IGC Pharma Presents 6 Posters on Impact of IGC-AD1 on Neuropsychiatric Symptoms

Based in Potomac, Md., IGC Pharma, Inc. is presenting six in-person posters highlighting data from its Phase I trials investigating its lead therapeutic candidate, IGC-AD1, at the Alzheimer’s Association International Conference. The company’s low-dose THC-based investigational drug has demonstrated in preclinical trials the potential to be effective in ameliorating Aβ plaque, a key hallmark of Alzheimer’s. IGC-AD1 is currently in Phase II development as a potential treatment for agitation in dementia due to Alzheimer’s. 

New Products

Angry@Arthritis Launches First Global Osteoarthritis Clinical Trial Locator

Alexandria-based Angry@Arthritis, a nonprofit focused on attacking and eliminating Osteoarthritis, announced OA Fix ~Trials in the Mix, the first global OA developmental treatment analysis and clinical trial locator. Designed to empower patients and developers with new insights, the free interactive chart shows viable OA treatments in development, joints where those treatments apply, associated procedures, position in the clinical trial process, and geography (U.S. or overseas). Patients use a single go-to screen to sign up for clinical trials.

Research Roundup

JHU: Vaccine, Immunotherapy, Antibody Spark Immune Response in Pancreatic Cancers

Giving patients with operable pancreatic cancers a three-pronged combination immunotherapy treatment consisting of the pancreatic cancer vaccine GVAX, the immune checkpoint therapy nivolumab and urelemab, an anti-CD137 agonist antibody treatment, is safe, increases the amount of cancer-killing immune system T cells in the tumors and appears effective when given two weeks prior to cancer-removal surgery, according to new research directed by Johns Hopkins investigators. A description of the work was published online June 20 in the Journal Nature Communications. Read more here.

Report Highlights Public Health Impact of Serious Harms From Diagnostic Error

Using novel methods, a team from the Johns Hopkins Armstrong Institute Center for Diagnostic Excellence, as well as partners from the Risk Management Foundation of the Harvard Medical Institutions,  sought to derive what is believed to be the first rigorous national estimate of permanent disability and death from diagnostic error.  The original research article was published by BMJ Quality & Safety. The report can be found here.

On the Hill – Regulatory and Advocacy

FDA Approves New Drug to Prevent RSV in Babies and Toddlers

The U.S. Food and Drug Administration approved Beyfortus (nirsevimab-alip) for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. AstraZeneca’s Beyfortus is a monoclonal antibody with activity against RSV.

People on the Move

Medcura Inc. Appoints Jacob Rodman to Board of Directors

Medcura Inc., based in Riverdale, Md., appointed Jacob Rodman to its Board of Directors. Rodman is CEO of Raleigh Neurosurgical Clinic, Inc., and the president-elect of Nerves (Neurosurgery Executives Resource Value & Education Society).