The misidentified cell line on which Heat Biologics Inc. based its cancer therapy HS-410 (vesigenurtacel-L) represents "a labeling problem that occurred very early in development," chief scientific officer Taylor Schreiber told BioWorld Today, and the paperwork matter should be resolved quickly with the FDA. Read More
Takeda Pharmaceutical Co. Ltd. committed to pay Mersana Therapeutics Inc. $40 million up front, plus up to $750 million in milestone payments plus royalties to gain ex-U.S. and Canada rights to the company's lead candidate, a preclinical antibody-drug conjugate (ADC) targeting HER2-expressing tumors, and to advance a potential new slate of ADCs, one of which Mersana can opt to co-develop following phase I studies. Read More
LAM Therapeutics, a portfolio company of Connecticut biotech start-up incubator 4Catalyzer, closed a $40 million financing to advance lead programs, LAM-001, an inhaled mTOR kinase Inhibitor in phase I development to treat lymphangioleiomyomatosis – also known as LAM lung disease – and LAM-002, a selective kinase inhibitor that is cytotoxic for certain cancers with little or no effect on normal cells. Read More
In its earnings call, John Martin, chairman and CEO, and soon to be executive chairman, of biopharmaceutical company heavyweight Gilead Sciences Inc., described 2015 as an "exceptional year" for the company, which experienced progress on a number of therapeutic fronts including HIV and hepatitis. The Foster City, Calif.-based company reported an increase in total revenues for both the fourth quarter of 2015 and full year beating Wall Street estimates. Read More
DUBLIN – Enyo Pharma SAS closed a €22 million (US$24.4 million) series A round to move its lead drug, EYP001, into clinical development in chronic hepatitis B virus (HBV) infection in the coming months. Read More
OXFORD – Things may never have been better for UK bioscience in terms of funding, but the capital available still fails to match the quality of the science and the translation gap between academic research and its commercialization persists. Read More
Galera Therapeutics Inc., of Malvern, Pa., said it received an additional $5 million in funding from Enso Ventures bringing its series B financing to $42 million. The company generated $37 million from its original series B round in October 2015. The investment capital will be used to advance the company's lead candidate GC4419 in a phase IIb trial that is currently enrolling head and neck cancer patients receiving chemoradiation therapy to prevent against oral mucositis. The proceeds will also support continued development of Galera's pipeline of selective dismutase mimetics to modulate oxygen metabolic pathways. (See BioWorld Today, Oct. 15, 2015.) Read More
Living Cell Technologies Ltd., of Auckland, New Zealand, received approval from the Northern A Health and Disability Ethics Committee for the phase IIb trial of Ntcell for Parkinson's disease. The New Zealand Minister of Health authorized the application to conduct the trial last November. Ntcell is a choroid plexus cell product with the potential to treat neurodegenerative diseases, the company said, and choroid plexus cells help produce cerebrospinal fluid as well as a range of neurotrophins that have been shown to protect against neuron cell death in animal models. Read More
Promis Neurosciences Inc., of Toronto, said it identified a second distinct epitope on misfolded strains of amyloid beta and acquired an exclusive global license to the Alzheimer's disease (AD) target through an expanded license agreement with the University of British Columbia. The company also submitted a provisional patent application for the target to the U.S. Patent and Trademark Office. Read More
The FDA's Psychopharmacologic Drugs Advisory Committee voted 8-2 Wednesday in support of an expanded label for Takeda Pharmaceutical Co. Ltd.'s Brintellix (vortioxetine) that would recognize cognitive dysfunction in adults with major depressive disorder (MDD) as a distinct indication. Brintellix was approved in 2013 to treat MDD. Read More
