Acer Therapeutics Inc., of Newton, Mass., is reducing its headcount from 48 to 19 employees and halting precommercial activities for Edsivo (celiprolol) following the FDA complete response letter last month (CRL) for the beta-blocker in vascular Ehlers-Danlos syndrome. The restructuring is expected to provide resources needed for Acer to conduct its planned business operations through 2020. The company plans to pursue discussions with the FDA regarding the CRL and to continue development of its pipeline, including ACER-001 and osanetant. (See BioWorld, June 26, 2019.)
Bioinvent International AB, of Lund, Sweden, said it will receive a $500,000 milestone payment related to the acceptance by the FDA of an IND for TAK-169, a CD38-targeted fusion protein, from Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, under a co-development agreement with Molecular Templates Inc., of Austin, Texas. Takeda is developing TAK-169 under a royalty and milestone agreement with Xoma Corp., of Emeryville, Calif.
Freeline Therapeutics Ltd., of London, presented preclinical data at the European Working group on Gaucher Disease meeting in Auvergne, France, showing that a single infusion of FLT-200, a liver-directed AAV gene therapy, resulted in sustained GCase expression in the liver and greater bioavailability in the bloodstream compared to enzyme replacement therapy. Data collected from a combination of in vitro and in vivo experiments demonstrate that liver expression of GCase results in sustained blood levels of GCase and that the enzyme is taken up by the macrophages in target organs affected by type 1 Gaucher disease.
Novelion Therapeutics Inc., of Vancouver, British Columbia, received written notice from Nasdaq that it is not in compliance with the continued listing requirement to maintain minimum market value of publicly held shares of $15 million. The company also received a second notice from Nasdaq that it continues to be out of compliance with the minimum bid price of $1 per share.