AI-driven precision medicine company Exscientia has initiated enrollment for its Phase 1/2 “ELUCIDATE” study, marking the first trial of its precision-designed CDK7 inhibitor, GTAEXS617 (‘617), in the treatment of advanced solid tumours. The trial aims to investigate the safety, efficacy, and pharmacokinetics of GTAEXS617 through multiple ascending doses for patients with advanced solid tumours, including […]
Eagle Pharmaceuticals has secured an additional indication for Pemfexy (pemetrexed injection) in the US, marking the fifth indication for the intravenous medication. Pemfexy in combination with Merck’s Keytruda and platinum chemotherapy has been now approved by the US Food and Drug Administration (FDA) for the initial treatment of patients with metastatic, non-squamous, non-small cell lung […]
Biomea Fusion is all set to take BMF-219 into clinical trials in patients having unresectable, locally advanced, or metastatic non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic ductal adenocarcinoma (PDAC) with an activating KRAS mutation. The upcoming milestone for the NASDAQ-listed biopharma company follows the clearance of the US Food and Drug Administration […]
Lantern Pharma said that the US Food and Drug Administration (FDA) has authorized it to move ahead with its Harmonic phase 2 clinical trial of LP-300, its investigational new drug in never smokers with non-small cell lung cancer (NSCLC). Harmonic will involve 90 patients in a multi-center, two arm, open-label, and randomized study for assessing […]
Bristol Myers Squibb (BMS) has agreed to acquire Turning Point Therapeutics, a clinical-stage precision oncology company based in California, for $4.1 billion. Listed on the Nasdaq, Turning Point Therapeutics is developing drug candidates that are said to target the highly common mutations related to oncogenesis. Its flagship asset is repotrectinib, which is a tyrosine kinase […]
American biopharma company Cullinan Oncology has agreed to sell its subsidiary Cullinan Pearl to Taiho Pharmaceutical, a Japanese specialty pharma company, for $275 million. Cullinan Oncology has also reached an agreement with Taiho Pharmaceutical to co-develop and co-commercialize CLN-081/TAS6417, the lead program of Cullinan Oncology. Cullinan Pearl holds worldwide rights to CLN-081/TAS6417 outside of Japan. […]
The US Food and Drug Administration (FDA) has rejected the biologics license application (BLA) of Eli Lilly and Company (Lilly)’s sintilimab injection in nonsquamous non-small cell lung cancer (NSCLC). Lilly has been issued a complete response letter (CRL) for the BLA for the PD-1 inhibitor in combination with pemetrexed and platinum chemotherapy. The US pharma […]
Genprex has dosed the first patient in the Acclaim-1 phase 1/2 clinical trial of REQORSA immunogene therapy candidate in combination with Tagrisso (osimertinib) in a certain patient population having late-stage non-small cell lung cancer (NSCLC). The combination of REQORSA and Tagrisso is being evaluated in the trial in late-stage NSCLC patients with activating epidermal growth […]
AstraZeneca has reported positive results from the COAST phase 2 trial of its oleclumab or monalizumab in combination with Imfinzi (durvalumab) in patients with non-small cell lung cancer (NSCLC). The pharma giant said that the mid-stage clinical trial showed the experimental combinations to have improved progression-free survival (PFS) as well as objective response rate (ORR). […]
LUMAKRAS FDA approval : Amgen has bagged accelerated approval from the US Food and Drug Administration (FDA) for LUMAKRAS (sotorasib) for the treatment of a type of non-small cell lung cancer (NSCLC) in adults. The approval is for the treatment of patients whose cancer is locally advanced or metastatic and have KRAS G12C mutation, as […]