Byondis BV is gearing up for a U.S. filing of an antibody-drug conjugate (ADCs) in advanced HER2-positive breast cancer, but CEO Marco Timmers has grand plans to partner up with big pharma and expand into other diseases.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ananda, Asklepios, Avadel, Bluerock, Chinook, Effector, Icosavax, Incarda, India Globalization, Nanology, Nascent, Noveome, Noxxon, Synaptogenix, Virios.
Data presented to the American Society of Clinical Oncology and taken from Hookipa Pharma Inc.’s ongoing phase I/II study for treating advanced human papillomavirus 16-positive (HPV16+) cancers underwhelmed investors as the stock (NASDAQ:HOOK) sagged 19.25% on June 8.
The FDA has lifted clinical holds on four studies from Bluebird Bio Inc., following recent similar actions with other gene therapy programs. Two of the studies concern phase I/II and phase III clinical trials of the gene therapy Lentiglobin (BB-1111) in treating sickle cell disease. The remaining two studies are phase III clinical trials of betibeglogene autotemcel gene therapy, which share a vector with Lentiglobin, for treating transfusion-dependent beta-thalassemia.
Grail Inc. reported on June 4 the first results of its Pathfinder study evaluating its assay for the early detection of 50 cancers, showing a positive predictive value of 44.6%. With a total of 6,629 study participants across more than 140 clinical study sites, the blood test is supported by what the health care company believes to be the “largest clinical study program in genomic medicine.”
Ortho Regenerative Technologies Inc. received a clinical hold letter from the FDA in connection with its investigational new drug (IND) application to begin a phase I/II trial for Ortho-R. The FDA asked for additional information on chemistry, manufacturing and control for the drug/biologic combination that the company is evaluating as an adjunct to rotator cuff repair surgery.
Dsruptive Subdermals AB has completed a clinical showing body temperatures tracked by its chip implants are comparable to temperature readings from standard clinical thermometers. The Stockholm-based startup is now offering its injectable implants as an open platform for researchers seeking efficient, low-cost tools to monitor changes in body temperature.
The American Society for Clinical Oncology’s (ASCO) virtual annual meeting began June 3 with the release of late-breaking abstracts, including LBA-1 on “Olympia: A phase 3, multicenter, randomized, placebo-controlled trial of adjuvant olaparib after (neo)adjuvant chemotherapy in patients with germline BRCA1 and BRCA2 mutations and high risk HER2-negative primary breast cancer.”
Shares of Cullinan Oncology Inc. (NASDAQ:CGEM) rose 11.3% to close at $33.11 on June 4 as an update on its EGFR inhibitor, CLN-081, suggested it may prove competitive with Johnson & Johnson's recently approved treatment, Rybrevant (amivantamab), for adults with non-small-cell lung cancer (NSCLC) whose tumors bear EGFR exon 20 insertion mutations.
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