This week's Philadelphia-area life sciences industry update includes a women's oncology company identifying a lead product candidate, a biopharmaceutical company's multimillion-dollar licensing deal, a biotech firm initiating human clinical trials, and more.
Here's the roundup:
Context Therapeutics
The Philadelphia-based women's oncology company selected CTIM-76 as its lead clinical development candidate targeting Claudin 6 (CLDN6) positive cancers.
CLDN6-enriched cancers include ovarian, endometrial, testicular, and gastric cancer. CLDN6, a protein coding gene that plays a key role in cell-to-cell adhesion and is expressed in various ways on cancer cells but has no or very low expression in normal, healthy tissue.
CTIM-76 is a T cell-engaging bispecific antibody – meaning it can bind to two different antigens at the time time. Context (NASDAQ: CNTX) identified it as its lead clinical development candidate as a result of its research collaboration and licensing agreement with Integral Molecular, a Philadelphia biotechnology company that specializes in the discovery and development of therapeutic antibodies.
“This year has been marked by several exciting and significant milestones for Context, culminating in naming our lead CLDN6 clinical development candidate,” said Context CEO Martin Lehr. “We selected this bispecific based on its potential to address the need for potent therapeutic modalities for cancer without compromising patient safety."
Joseph Rucker, vice president of research and development at Integral Molecular, said the two companies were able to "isolate and optimize" rare antibodies against CLDN6 that do not cross react with other CLDN gene "family members."
Lehr said Context expects to submit an investigational new drug application for CTIM-76 to the U.S. Food and Drug Administration during the first quarter of 2024. If the application is approved, the company will proceed with human clinical testing of the experimental treatment.
Aclaris Therapeutics
Under the terms of a licensing deal it signed with Pediatrix Therapeutics, the Wayne-based biopharmaceutical company will receive $5 million up front with the potential to receive milestone payments of up to $91 million.
Under the terms of the agreement, Pediatrix of Shanghai, China, received the exclusive rights to develop, manufacture and commercialize ATI-1777, Aclaris’ investigational Janus kinase inhibitor, for any disease, including atopic dermatitis, in Greater China. That encompasses Mainland China, Hong Kong, Macau and Taiwan.
Aclaris (NASDAQ: ACRS) will receive royalty payments on any approved products.
Jim Loerop, chief business officer of Aclaris, said the deal expands the potential global reach of AT1-1777 and "serves as continued validation of the ability [of the company's drug discovery platform] to generate valuable assets with potential to have high patient impact.”
Aclaris is retaining the rights to develop, manufacture and commercialize ATI-1777 in the rest of the world.
Mebias Discovery
The Philadelphia biotechnology company has initiated human clinical studies of MEB-1170, its experimental pain medicine designed to be devoid of the adverse effects of opioids.
In preclinical models, Mebias said MEB–1170 was shown to be as effective as morphine and oxycodone in several pain models, showed no evidence of abuse liability, did not cause sedation or constipation and did not impact respiratory function or require dose escalation.
"The importance of our goal, to replace existing opioid therapy with safe and effective new analgesics that avoid addiction as well as other serious opioid side effects cannot be overstated," said Mebias Chief Medical Officer Dr. Scott Reines.
According to the Centers for Disease Control and Prevention's projections, opioid overdose deaths in the United States are expected to top 109,000 this year.
NASDAQ news
Chesterbrook-based Trevena (NASDAQ: TRVN) and AnPac Bio-Medical Science Co. Ltd. (NASDAQ: ANPC), a biotech company with offices in Spring House and China, regained compliance with NASDAQ's minimum $1 per share listing requirement. Trevena is focused on developing and commercializing medicines for patients with central nervous system disorders. It has one approved product, the pain medicine Olinvyk, on the market. AnPac specializes in early cancer screening and detection. Baudax Bio (NASDAQ: BXRX) of Malvern also undertook efforts to regain compliance with the minimum share price. To do so it implemented a 1-for-40 reverse stock split. The company markets Anjeso, a non-opioid, non-steroidal anti-inflammatory drug used to manage moderate to severe pain.
Quick hits
Penn spinout Verismo Therapeutics has established a research and development center at CIC Philadelphia in University City. Verismo plans to use the space to further advance its novel KIR-CAR platform, a dual-chain CAR T-cell therapy that has been shown in preclinical animal models to be capable of combatting solid tumors. … SparingVision, a Paris-based genomic medicine company that has its U.S. operations in Philadelphia, received FDA clearance to begin human testing of its lead gene therapy product SPVN06. The gene therapy candidate is being developed as a treatment for ocular disease retinitis pigmentosa. The company expects to generate Phase 1 clinical trial safety data for the therapy during 2023.
