Mirati Therapeutics Inc. posted new data for its highly anticipated KRAS cancer fighter, adagrasib (MRTX-849), showing mixed results compared to its already-marketed competition, Lumakras (sotorasib) from Amgen Inc. The new data came from a cohort of patients with KRAS-G12C non-small-cell lung cancer enrolled in Mirati’s registration-enabling phase II Krystal-1 study. Each had received at least one prior systemic therapy, most with a PD-1/L1 inhibitor following or in combination with chemotherapy. Read More
Phase II melanoma data characterized by Iovance Biotherapeutics Inc. as positive failed to excite Wall Street, which took away 53.6% of the company’s share value (NASDAQ:IOVA), or $8.10, and pushed the closing price to $7.02 on May 27. The San Carlos, Calif.-based firm offered results from registrational cohort 4 (n=87) of the C-144-01 study testing lifileucel (LN-144, autologous tumor infiltrating lymphocytes) in advanced melanoma. Read More
A U.K. biotech is aiming to build a new pipeline around a unique drug delivery system employing a naturally occurring protein called a “nanosyringe” to overcome the technical challenges of delivering therapeutic payloads to target cells. Nanosyrinx Ltd., of Warwick, based its technology on a naturally occurring bacterial toxin mechanism, which produces tiny virus-like particles. The synthetic biology approach has allowed the company to tweak the cellular machinery of bacteria to produce these nanosyringes loaded with drugs. Read More
A rule forcing the FDA and other agencies in the U.S. Department of Health and Human Services (HHS) to evaluate and clean out old regulations will never see the light of day. Read More
Facing the global threat of antimicrobial resistance (AMR), the EMA issued a final revised guideline on the evaluation of new antibiotics. In accordance with an agreement with the U.S. FDA and Japan’s Pharmaceuticals and Medical Devices Agency, the EMA’s guideline aligns as much as possible with the data requirements of those regulators so drug developers can design clinical trials that meet the evidence needs of all three agencies, the EMA said. Read More
Among the latest guidances pouring out from the U.S. FDA are ones addressing development programs for hormone analogues intended to treat advanced prostate cancer and prescription drug importation from Canada. Read More
New and updated preclinical and clinical data to be presented by biopharma firms at American Society of Clinical Oncology annual meeting, including: Aadi, Adagene, Adaptimmune, Adicet, Advaxis, Amgen, Aura, Biomea. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Arrivo, Axcella, Cytomx, Laekna, Modus, Moleculin, Nurix, Q32, Scioto, Sellas, Tikomed, Yingli. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Academab, Menarini, Mereo, Neurona, Neurosene, Total Brain, Verisim, Zymeworks. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avadel, Biomind, Clearmind, Cynata, Hyundai, Innocare, Janssen, Merck, Pfizer, Reata, Revive, Roche, Scisparc, Servier. Read More
