Weekly Quick Hits (BioHealth Capital Region) – Week of March 20, 2023

By Sarah Ellinwood, Alex Keown, and Mark Terry
March 24, 2023

Funding, Awards and Collaborations

MacroGenics Earns $15 Million Milestone Following U.S. FDA Approval of ZYNYZ™

Following the FDA approval of Incyte’s Biologics License Application (BLA) for ZYNYZ™ (retifanlimab-dlwr), the MacroGenics (NASDAQ: MGNX) will receive a $15 million milestone payment from Incyte. ZYNYZ, a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), was previously developed by MacroGenics and licensed to Incyte pursuant to an exclusive global collaboration and license agreement in October 2017. Under the terms of the license agreement, beyond the $15 million approval milestone, MacroGenics is also eligible to receive up to a total of $320 million in potential remaining development and regulatory milestones and up to $330 million in potential commercial milestones from Incyte.

OncoC4 Joins Up With BioNTech to Co-Develop and Commercialize Checkpoint Antibody Therapies for Solid Tumors

BioNTech (Nasdaq: BNTX) and Rockville-based OncoC4 have entered into an exclusive worldwide license and collaboration agreement to develop and commercialize OncoC4’s next-generation anti-CTLA-4 monoclonal antibody candidate, ONC-392, as monotherapy or combination therapy in various cancer indications. The transaction is expected to close in the first half of 2023, subject to customary closing conditions and regulatory clearances. OncoC4’s CTLA-4 antibody candidate ONC-392 aims to delete immunosuppressive T cells (regulatory T cells, “Tregs”) in the tumor microenvironment, but spare Tregs in healthy tissues. 

Under the terms of the agreement, OncoC4 will receive a $200 million upfront payment and is eligible to receive development, regulatory and commercial milestone payments as well as double-digit tiered royalties. BioNTech and OncoC4 will jointly develop ONC-392 as monotherapy and in combination with anti-PD-(L)-1 antibodies in a range of solid tumor indications, including NSCLC, until approval, with the parties equally sharing development costs for such studies.

Gain Therapeutics Receives Grant Award by Eurostars with Innosuisse for Alpha-1 Antitrypsin Deficiency Research Program

Gain Therapeutics, Inc. (Nasdaq: GANX), who is discovering novel allosteric binding sites and creating small molecules to interrogate those sites, announced that Eurostars and Innosuisse have awarded a grant in the aggregate amount of €1.2 million to a consortium led by Gain Therapeutics which includes the Institute for Research in Biomedicine, Newcells Biotech and the University of Helsinki. This grant supports a research project to develop novel small molecule allosteric regulators against Alpha-1 Antitrypsin (AAT) Deficiency, a rare genetic condition that can result in serious lung and liver diseases.

Frederick County Public Schools and Battelle National Biodefense Institute Announce Recipients of STEM Mini-Grants

The grant money, totaling $34,000, provides up to $750 for STEM teachers to make purchases for their classrooms. The FCPS/BNBI STEM partnership was established in 2009 with the long-term goal of getting more students interested in and better prepared to major in math, science or engineering in college. Since its inception BNBI has directly gifted $617,000 to FCPS, and BNBI staff has committed thousands of hours of time to assisting curricula development, classroom instruction and STEM activities outside the classroom.

Aziyo Biologics and Sientra Partner to Improve Women’s Access to Biologics for Soft Tissue Reconstruction

Aziyo Biologics (Nasdaq: AZYO) and Sientra, Inc. (Nasdaq: SIEN) have entered into an agreement to expand the distribution of Aziyo’s SimpliDerm product line. Under the agreement terms, Aziyo will grant Sientra certain non-exclusive rights in the United States to market, sell and distribute SimpliDerm for select use in reconstruction surgery. SimpliDerm is a pre-hydrated human acellular dermal matrix (hADM) that uses a proprietary process to preserve key growth factors of native dermis that support faster integration and more rapid revascularization while demonstrating a lower risk of inflammatory response.

In the Clinic

Aziyo Biologics’ CanGaroo® RM Antibacterial Envelope Receives “Not Substantially Equivalent” Determination from FDA

The CanGaroo® RM Antibacterial Envelope is intended to securely hold a cardiac implantable electronic device or neurostimulator, creating a stable environment when implanted in the body. The CanGaroo RM Antibacterial Envelope contains the antibiotics rifampin and minocycline, which have been shown in preclinical testing to reduce bacterial colonization on the envelope. The notice, which was given on March 16, defined the outstanding items that need to be addressed in order to obtain market clearance. The items relate to drug testing, primarily to modify an in vitro drug release assay employed as a manufacturing control. Aziyo does not expect to appeal the decision and plans to work with FDA to provide the additional data requested.

Altimmune Announces Positive Results for Two Clinical Trials

Gaithersburg-based Altimmune (Nasdaq: ALT) announced topline results from a Week 24 interim analysis of 160 subjects in its 48-week MOMENTUM Phase 2 obesity trial of pemvidutide along with the results of the 12-week Phase 1b safety trial of pemvidutide in subjects with obesity or overweight and type 2 diabetes. For the MOMENTUM trial, at Week 24, subjects receiving pemvidutide achieved mean weight losses of 7.3%, 9.4% and 10.7% at the 1.2 mg, 1.8 mg, and 2.4 mg doses, respectively, with the placebo group experiencing a mean weight loss of 1.0% (p < 0.001 at all three doses vs placebo). For the Type 2 Diabetes Phase 1b, subjects receiving pemvidutide achieved mean weight losses of 4.4%, 6.1% and 7.7% at the 1.2 mg, 1.8 mg, and 2.4 mg doses, respectively, over only 12 weeks of treatment, with the placebo group experiencing a mean weight gain of 0.8%.

Research Roundup

MyMD Pharmaceuticals® and Charles River Share Encouraging Pre-Clinical Data for Oral TNF-α Inhibitor MYMD-1® in Rheumatoid Arthritis

Baltimore-based MyMD presented the data at the 2023 Society of Toxicology Annual Meeting in Nashville. The study was designed to investigate the anti-inflammatory effects of MYMD-1® in a rheumatoid arthritis model that mimics features of arthritis in humans and included commonly used clinical arthritis endpoints. The poster, titled, ““A Naturally Occurring Novel Therapeutic and Oral Selective Inhibitor of TNF-α, MYMD-1® (Isomyosamine) Significantly Reduced the Inflammation and Disease Severity in Murine Model of Collagen Antibody-Induced Arthritis,” showed MYMD-1 reduced histopathological changes and the severity of standard arthritis clinical trial measures. The poster is also linked in the press release.

VerImmune Shares New MoA Data at AACR, Will Present at International Papillomavirus Conference in DC

VerImmune, located at JLABS@Washington DC, will be presenting the three-step mechanism of action (MoA) data for its AIR-ViP technologies at AACR. ViPs are based on a modified mouse papillomavirus capsid protein that self-assemble and are then conjugated on their surface with a CD8+ T cell viral peptide antigen. This peptide-conjugated platform specifically targets solid tumors and delivers viral peptide antigens to class I major histocompatibility complex (MHC-1) on the tumor cell surface. The company will also be presenting an oral presentation titled “Redirection Pre-existing Viral Immunity Twoards Cancers Via Murine Papillomavirus T=1 Virus-Inspired Particles (ViPs) at the International Papillomavirus Conference in DC.

Fat Burning-Linked Molecule Promising Target for Most Common Childhood Brain Cancer

Research from Johns Hopkins Kimmel Cancer Center experts revealed that non-coding circular RNA (circRNA) may help doctors distinguish and treat a subgroup of patients with medulloblastoma.The findings are reported in the journal Acta Neuropathologica Communications. Publicly available RNA sequencing (RNA-seq) data from 175 medulloblastoma patients were looked at to identify circRNAs that differentiate between disease subgroups. The group identified that a particular circRNA, called circ_63706, and upon researching further uncovered data suggesting it may reprogram global lipid metabolism in medulloblastoma cells to enhance tumorigenesis.

People on the Move

Children’s National to Bring on Michelle Riley-Brown as New President, CEO

On July 1, Riley-Brown will succeed Dr. Kurt Newman, recipient of the 2022 BioBuzz “John Holaday” BioHealth Leadership Award, who is retiring after 11 years as president and CEO. She is currently an executive vice president at Texas Children’s Hospital at the Texas Medical Center in Houston, where she serves concurrently as the president of two hospitals in the system while leading the construction and staffing of a third. She also leads system-level operations, strategic planning, physician practice acquisition, quality performance, clinical operations, fund development, marketing, brand management and public relations for the nation’s largest pediatric and women’s healthcare organization.

Maryland Tech Council Opens Nominations for Board Positions

The Maryland Tech Council announced that it has open positions available for directors in the life sciences and technology industries. Nominations can be submitted online and are due April 21.