Global rights to Advaxis Inc.’s preclinical cancer immunotherapy, ADXS-NEO, are going to Amgen Inc. for a combined pledge of up to $540 million, giving Advaxis new cash to fuel its FDA fast-tracked phase III cervical cancer treatment, AXAL, while feeding Amgen’s ongoing interest in cancer vaccines, a pursuit that led to approval of the first FDA-approved oncolytic virus therapy, Imlygic (talimogene laherparepvec), last October. Read More
In the midst of what CEO Aya Jakobovits told BioWorld Today is “growth spree,” Adicet Bio Inc. bagged a $25 million up-front, five-year deal with Regeneron Pharmaceuticals Inc. to come up with off-the-shelf immune cell therapies that could attack solid tumors as well as blood cancers. Read More
After seeding gene therapy start-up Avrobio Inc. earlier this year, Atlas Venture stepped back up to the plate, joined by Clarus and SV Life Sciences, to fund the company’s $25 million series A. The round will accelerate development of Avrobio’s initial programs in Fabry disease and acute myeloid leukemia (AML), both expected to enter the clinic this year, and allow the company to expand its pipeline in rare diseases and solid and liquid cancers. Read More
HONG KONG – New draft regulations in China for the registration of drugs could make it harder for companies that don’t have innovation capabilities. Read More
Shares of Biogen Inc. were halted temporarily Tuesday after news surfaced that the Cambridge, Mass.-based firm could be a takeout target, reportedly drawing early interest from the likes of Merck & Co. Inc. and Allergan Inc. Read More
The Institute for Clinical and Economic Review (ICER), a U.S.-based nonprofit organization, is seeking comment on a draft scoping document that will guide the development of a report on drug therapies to treat rheumatoid arthritis. Read More
Agilis Biotherapeutics LLC, of Cambridge, Mass., said it became the first company to gain an FDA orphan drug designation for a gene therapy for Friedreich’s ataxia. The company’s candidate, AGIL-FA, is focused on delivering corrective DNA to specific CNS cells to restore frataxin protein levels. Read More
Vaxart Inc., of South San Francisco, said it started a phase I trial of an oral norovirus tablet vaccine. The randomized, double-blind, placebo-controlled, dose-ranging study will assess the safety and immunogenicity of the VP1 protein-based vaccine in 66 healthy adult volunteers. Study participants will be followed for 12 months for safety, and a broad range of systemic and local immune responses will be evaluated at multiple time points over the study. Read More
