Darmstadt, Germany, New York, US and Waltham, Mass., US, January 4, 2016 – Merck KGaA, Darmstadt, Germany, Pfizer and Syndax Pharmaceuticals, Inc. announced today that they have entered into a collaboration agreement to evaluate avelumab*, an investigational, fully human anti-PD-L1 IgG1 monoclonal antibody, in combination with Syndax’s entinostat, an investigational oral, small molecule that targets immune regulatory cells (myeloid-derived suppressor cells and regulatory Tcells), in patients with heavily pre-treated, recurrent ovarian cancer. Avelumab is currently under clinical investigation across a broad range of tumor types by the alliance between Merck KGaA, Darmstadt, Germany, and Pfizer. This is an exclusive agreement between the alliance and Syndax to study the combination of these two investigational agents in ovarian cancer. Syndax will be responsible for conducting the Phase Ib/II clinical trial in ovarian cancer.
Merck KGaA, Darmstadt, Germany, Pfizer and Syndax Announce Collaboration to Evaluate Combination of Avelumab and Entinostat in Ovarian Cancer
Afferent Pharmaceuticals Advances Novel Molecule, AF-130, to Phase 1 Clinical Trial
San Mateo, CA – December 8, 2015 – Afferent Pharmaceuticals, a leader in the development of small molecule compounds for the treatment of poorly managed and common neurogenic disorders, announced today initiation of the company’s Phase 1 trial of AF-130, a selective and differentiated P2X3 antagonist. Afferent’s Phase 1, double-blind, randomized, placebo-controlled trial is designed to assess the safety, tolerability and pharmacokinetics of single ascending doses and, in a second cohort, multiple ascending doses of AF-130 administered to healthy subjects. Further information regarding the study can be found at https://clinicaltrials.gov/.
Syndax Announces Initiation Of Entinostat Clinical Program In Japan By Partner Kyowa Hakko Kirin
WALTHAM, Mass., December 1, 2015 – -- Syndax Pharmaceuticals, Inc., a clinical stage biopharmaceutical company focused on developing entinostat as a combination therapy in multiple cancer indications, announced today the initiation of the entinostat clinical program in Japan by its partner Kyowa Hakko Kirin, Co., Ltd. Entinostat, an oral, small molecule drug candidate that targets both cancer cells and immune regulatory cells, is being developed by Syndax as an immuno-oncology therapeutic and evaluated as a treatment for advanced hormone receptor positive (HR+) breast cancer in an ongoing Phase 3 clinical trial (designated E2112) in the United States. In September 2013, entinostat was granted breakthrough therapy designation by the U.S. Food and Drug Administration in advanced HR+ breast cancer following positive results from the Phase 2b clinical trial, ENCORE-301.
CoLucid Pharmaceuticals Provides SAMURAI Enrollment Update
CAMBRIDGE, MA, November 30, 2015 – CoLucid Pharmaceuticals, Inc. (NASDAQ: CLCD) today announced that over 50% of the migraine patients needed to complete the Company’s SAMURAI trial, the first of two pivotal Phase 3 clinical trials, have now been randomized. The objective of SAMURAI is to evaluate the efficacy of lasmiditan (100 mg and 200 mg) oral tablets in comparison to placebo two hours following dosing. The primary endpoint is freedom from migraine headache pain and the key secondary endpoint is freedom from the most bothersome associated symptom of migraine (nausea, phonophobia or photophobia).
SAMURAI is a randomized, double-blind, placebo-controlled parallel group study that is expected to randomize 2,225 migraine patients and treat a single migraine in up to 1,483 migraine patients with lasmiditan at approximately 80 U.S. sites. SAMURAI is being conducted under a Special Protocol agreement with the U.S. Food and Drug Administration.
Afferent Pharmaceuticals Expands Executive Leadership Team With Appointments of Prabha N. Ibrahim, PhD, as Chief Technology Officer and Michelle Carpenter, JD, RAC, as Vice President, Regulatory Affairs and Project Management
San Mateo, CA – November 19, 2015 – Afferent Pharmaceuticals, a leader in the development of small molecule compounds for the treatment of poorly managed and common neurogenic disorders, today announced the appointments of Prabha N. Ibrahim, Ph.D., as chief technology officer and Michelle Carpenter, J.D., RAC, as vice president of regulatory affairs and project management. The Company is expanding its executive team as it advances its lead program and first-in-class drug candidate, AF-219, to late-stage clinical development and potential registration. AF-219 is a selective, non-narcotic, and orally administered P2X3 antagonist that targets the mechanism by which certain nerve fibers become hyper-sensitized and can lead to chronic and debilitating symptoms.
Afferent Pharmaceuticals Announces Phase 2 Clinical Trial with AF-219 in Cough in Idiopathic Pulmonary Fibrosis (IPF) Patients
San Mateo, CA, November 11, 2015 – Afferent Pharmaceuticals, a leader in the development of small molecule compounds for the treatment of poorly managed and common neurogenic disorders, today announced that it has initiated a Phase 2 clinical trial with AF-219 in idiopathic pulmonary fibrosis patients (IPF) with cough. AF-219 is a selective, non-narcotic and orally administered P2X3 antagonist that targets the mechanism by which certain nerve fibers become hyper-sensitized and can lead to chronic and debilitating symptoms. The study is expected to enroll at least 30 patients at more than 15 sites in the United States, including leading pulmonary fibrosis specialty treatment centers.
Thrasos Strengthens Composition of Matter Coverage on THR-184 with Japanese Patent Decision
MONTREAL, November 10, 2015 – Thrasos Therapeutics, a biotherapeutics company focused on delivering new solutions for kidney disease, announced today that it received notice of a Decision to Grant on an important composition of matter patent from the Japanese Patent Office. This decision covers Application No. 2012-193673, entitled "Tdf-related compounds and analogs thereof." This patent provides coverage for Thrasos' lead product THR-184, currently in Phase 2 clinical testing for the prevention of acute kidney injury (AKI) in patients undergoing cardiac surgery. The Company's 452 patient Phase 2 trial has completed enrollment and data is expected in early 2016.
CoLucid Pharmaceuticals Announces Election of Mark Corrigan, M.D., to Board of Directors
CAMBRIDGE, Mass., Oct. 27, 2015 – CoLucid Pharmaceuticals, Inc. (NASDAQ:CLCD), a Phase 3 clinical-stage biopharmaceutical company that is developing its lead product candidate, lasmiditan, for the acute treatment of migraine headaches in adults, announced today that Mark Corrigan M.D., has been elected by the Board of Directors to serve as a director. Dr. Corrigan is filling a seat created by the resignation of Richard Markham, and will serve as a class II director of the Company with a term expiring at the annual meeting of stockholders to be held in 2017. In addition, Dr. Corrigan has been elected as Chairman of the Compensation Committee. CoLucid's Board remains at seven directors, six of whom are independent.
ENVISIA THERAPEUTICS’ LEAD PRODUCT CANDIDATE, ENV515 (travoprost XR), ACHIEVES PRIMARY EFFICACY ENDPOINT IN PHASE 2A GLAUCOMA CLINICAL TRIAL
RESEARCH TRIANGLE PARK, NC – OCTOBER 6, 2015 – Envisia Therapeutics, a clinical-stage biotechnology company focused on the development of novel extended-release therapies in ophthalmology, today reported results from its first clinical trial of the Company’s lead product candidate, ENV515 (travoprost XR). In this phase 2a trial, ENV515 achieved its primary efficacy endpoint by demonstrating a statistically significant and clinically meaningful reduction in intraocular pressure (IOP) with results comparable to topical once-daily TRAVATAN Z® (travoprost ophthalmic solution).
Chimerix Presents Preliminary Data on Brincidofovir in Liver Transplant Recipients With Adenovirus Infections at IDWeek in San Diego
DURHAM, N.C., Oct. 7, 2015 – Chimerix, Inc. (NASDAQ:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, announced today preliminary data from liver transplant patients who received brincidofovir for adenovirus infection through the ongoing AdVise trial and the brincidofovir expanded access program. These data will be presented at IDWeek in San Diego.
