It’s been a rapid year of change for Coimmune Inc., which was incorporated only 12 months ago and now has FDA approval of an IND clearing the way for a phase IIb trial using CMN-001 to treat advanced metastatic renal cell carcinoma (mRCC).
Privately held Zhittya Genesis Medicine Inc. received approval from Mexico’s Comisión Federal para la Protección contra Riesgos Sanitarios (Cofepris) to begin a phase I trial at the Zambrano Hospital in Monterrey for patients with Parkinson’s disease.
Mark Tepper, the founder of newly launched Eumentis Therapeutics Inc., plans to use the company’s recent $2 million Small Business Innovation Research (SBIR) grant to fund IND-enabling studies for EM-036, a nitro-aminoadamantane N-methyl-D-aspartate receptor antagonist to treat Alzheimer's disease and autism spectrum disorders.
Christian Peters, CEO of the newly launched and privately held Pinpoint Therapeutics Inc., said he has a relatively unusual pedigree that allows him a unique perspective in drug development. That combination of working in academia and in the corporate sphere has given him a more well-rounded view than most.
The three founders of newly launched Volastra Therapeutics Inc. had plenty in common when they decided to create the company. Their offices happened to be a half block apart on 69th Street in midtown Manhattan. Their interests in oncology were similar but each approached the disease from different angles.
Top-line results from Biohaven Pharmaceutical Holding Co.’s phase III trial of troriluzole against placebo in treating generalized anxiety disorder (GAD) failed to hit its primary endpoint, prompting the company CEO to say the poor results support halting development plans for the glutamate modulator as a monotherapy in GAD.
Two of three oncology drugs selected for blockbuster status in the Cortellis Drugs to Watch analysis are antibody-drug conjugates (ADCs), highly targeted cancer therapies designed to leave the healthy cells be and zap the bad ones. What once was a dead end for development has morphed into a competitive space with 57 ADC candidates for cancer indications in phase I or later trials, according to Cortellis.
Privately held Sonoma Biotherapeutics Inc. plans to take its newly raised $40 million series A financing to develop regulatory T-cell therapies to control inflammatory responses in autoimmune diseases such as rheumatoid arthritis, inflammatory bowel disease and multiple sclerosis.
An interim analysis of the phase III Recovery study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for treating post-traumatic stress disorder (PTSD) compelled Tonix Pharmaceuticals Holding Corp. to halt enrollment in the clinical trial.
Aimmune Therapeutics Inc. wasted no time moving ahead after last week’s FDA approval of Palforzia for peanut allergy as the Brisbane, Calif.-based company obtained an exclusive worldwide license to develop and commercialize Xencor Inc.’s humanized monoclonal antibody, XmAb-7195, for treating allergic asthma.
