Acquisitions, Alzheimer's data, collaborations, and more..
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CLINICAL TRIAL NEWS
Gracell Biotechnologies
Presented longer-term follow-up data from a first-in-human study evaluating GC012F, a CD19 and B-cell maturation antigen (BCMA) dual-targeted autologous CAR-T therapeutic candidate, in patients with relapsed/refractory B-cell non-Hodgkin’s Lymphoma (r/r B-NHL) as an oral presentation at EHA 2023.
Journey Medical Corporation
Announced positive topline data from their Phase 1 clinical trial assessing the impact of DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) on the microbial flora of healthy adults. DFD-29 is being developed for the treatment of papulopustular rosacea (“PPR”) in collaboration with Dr. Reddy’s Laboratories Ltd.
Acumen Pharmaceuticals
Announced that it will present topline results from their Phase 1 trial of ACU193, an AβO-directed antibody therapy, at the Alzheimer’s Association International Conference (AAIC) 2023 taking place from July 16-20, 2023.
REGULATORY NEWS
Mersana Therapeutics
Announced that the FDA has issued a partial clinical hold pausing new patient enrollment in UP-NEXT and UPGRADE-A, the company’s ongoing clinical trials of UpRi in platinum-sensitive ovarian cancer. Mersana’s recent assessment determined that serious bleeding events appear to occur at a higher rate than background.
M&A / COLLABORATION NEWS
Chinook Therapeutics
Announced that they have entered into an agreement and plan of merger with Novartis AG pursuant to which Novartis will acquire Chinook for $3.2 billion. Total consideration including the contingent value right, if the milestones are achieved, would be approximately $3.5 billion.
Agile Therapeutics
Announced an agreement with vitaCare Prescription Services, to expand patient access and streamline fulfillment for Twirla (levonorgestrel ethinyl estradiol) transdermal system. VitaCare is a technology and services platform that helps patients navigate key access barriers for branded medications. Company projects 2023 overall net revenue of $25-$30 million.
Verve Therapeutics
Announced an exclusive research collaboration with Eli Lilly focused on advancing Verve’s preclinical stage in vivo gene editing program targeting lipoprotein(a) (Lp(a)). Under the terms of the collaboration, Verve will advance the research and development of the Lp(a) program through the completion of Phase 1 clinical development. Lilly will be responsible for subsequent development, manufacturing, and commercialization of the Lp(a) program.
Coherus Biosciences
Announced they will acquire Surface Oncology, a clinical-stage immuno-oncology (I-O) company developing next-generation immunotherapies that target the tumor microenvironment. The acquisition adds two differentiated clinical stage assets to Coherus’ novel I-O pipeline: SRF388, a novel IL-27-targeted antibody currently being evaluated in Phase 2 clinical trials in lung cancer and liver cancer, and SFR114, a CCR8-targeted antibody currently in a Phase 1/2 study as a monotherapy in patients with advanced solid tumors.
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