Weekly Quick Hits (BioHealth Capital Region) – Week of January 30, 2023

By Alex Keown, Mark Terry, and Sarah Ellinwood
February 3, 2023

Funding

Systemic Sclerosis with Interstitial Lung Disease Fund Open at HealthWell Foundation

The HealthWell Foundation, an independent non-profit  based in Germantown, opened a new fund to support  individuals living with systemic sclerosis with interstitial lung disease (SSc-ILD). HealthWell will provide up to $9,000 in medication copayment or insurance premium assistance to eligible patients with annual household incomes up to 500 percent of the federal poverty level for the management of their condition.

In the Clinic

ExeGi Pharma Heads to Clinic with Live Biotherapeutic Biologic Drug

Rockville-based ExeGi Pharma LLC will takes its biologic drug candidate, EXE-346 into the clinic as a potential treatment for patients with an ileal pouch-anal anastomosis who experience excessive stool frequency. The FDA cleared the company’s Investigational New Drug application for the Phase I study. EXE-346 is a unique live biotherapeutic biologic drug that contains strains of live probiotic bacteria in extremely high potency. 

An ileal pouch-anal anastomosis is a surgical procedure due to unresolved inflammatory bowel disease. The surgery creates an intestinal J-Pouch with a portion of the lower intestine, allowing patients to avoid an ostomy bag and pass stools normally.

Deka Biosciences Receives FDA Clearance for DK2 Study

Germantown-based Deka Biosciences received the greenlight from the FDA to initiate a Phase I trial for DK2. The Phase I study seeks to characterize the safety, and biomarkers for response of DK2 in patients with advanced solid cancer who are overexpressing epidermal growth factor receptors.

DK2 is the first of several experimental therapeutics developed from Deka’s platform of molecules. Each Diakine in Deka’s platform consists of two cytokines coupled onto a single chain variable fragment targeting system. This enables the cytokines to accumulate more specifically into specific tissues.

Cartesian Therapeutics Initiates Trial for Generalized MG

Gaithersburg-based Cartesian Therapeutics dosed the first patient in its Phase IIb clinical trial assessing an experimental RNA-engineered chimeric antigen receptor T-cell therapy as a potential treatment for generalized myasthenia gravis (MG).

The company believes this is the first placebo-controlled study of an engineered cell therapy, and the most advanced investigational cell therapy in clinical development for any autoimmune disease. The Phase IIb study is a randomized, placebo-controlled, multi-center trial enrolling 30 patients with MG. The primary endpoint is the proportion of participants who achieve a 6-point or greater improvement in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score at 12 weeks. Secondary endpoints include safety and other validated measures of MG disease severity.

People on the Move

Inteleos Appoints Two New Members to Board of Directors

The not-for-profit healthcare certification organization Inteleon appointed Vera M. Zlidar and Neil Sahota to its board of directors. 

Both Zlidar and Sahota are expected to expand the Rockville-based organization’s mission to improve global health through assessments while enhancing patient safety.

Zlidar has worked in global health implementing partners, donors, multilateral development banks, host country governments, NGOs, impact investors and more. She currently serves as the Director of Global Business Development for US Pharmacopeia’s Global Health Programs.

Sahota currently serves as the interim Chief Executive Officer for ACSI Labs where his work involves combining neuroscience, AI, the metaverse and gamification. That work is expected to solve complex business problems, accelerate problem solving abilities and enhance creative and disruptive thinking.

Vaccitech Appoints Nadège Pelletier, Ph.D., as CSO

Nadege Pelletier is stepping into the role formerly held by Tom Evas. Evas is retiring but will remain involved as a scientific consultant to the company. She will lead Vaccitech’s scientific teams in all phases of drug discovery and platform development, as well as build and oversee the strategic technical direction of the company. Pelletier brings extensive experience to Vaccitech in the areas of immunology, inflammation and infectious diseases.

New Patents

OpGen subsidiary Ares Genetics snags key patent in China

Ares Genetics GmbH, a subsidiary of Rockville-based OpGen, Inc. secured a key patent from the China National Intellectual Property Administration (CNIPA) for its work in anti-microbial resistant infections. 

The patent ZL 201680044780.7 is dubbed “Genetic resistance prediction against antimicrobial drugs in microorganism using structural changes in the genome.” The patent describes the invention of a computer implemented method for the identification of genetic variations associated with antibiotic resistance (AMR) in bacteria.

The patent covers “the use of bioinformatics to determine in a first step genomic differences between bacteria susceptible to antibiotic therapy and strains that are antibiotic resistant, and to identify in a second step those variants associated with AMR using statistical correlation methods,” according to the company.