Phase II data from Iovance Biotherapeutics Inc. in advanced melanoma at the recent meeting of the American Society of Clinical Oncology turned up an important relationship between previous anti-PD-1 therapy exposure and the durability of treatment response. Findings added weight to the idea that tumor-infiltrating lymphocytes (TILs) should be deployed earlier in therapy.
With Pharmabcine Inc.’s anti-angiogenic antibody TTAC-0001 (olinvacimab) already in testing against recurrent glioblastoma multiforme (GBM) and metastatic triple negative breast cancer, CEO Jin-San Yoo is now giving serious thought to starting trials to test it in children with brain tumors. Plans to begin four additional trials between the end of 2021 and the beginning of 2022 are also underway.
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.
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.
Updated interim data from the ongoing dose-escalation portion of Harpoon Therapeutics Inc.’s phase I/IIa study of HPN-424 showed the metastatic castration-resistant prostate cancer therapy may move on to a dose expansion.
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