After securing $70 million in series B funding, Chinese biotech Medilink Therapeutics Co. Ltd. is gearing up to enter the clinic with its next-generation antibody-drug conjugates (ADCs).
The beleaguered PI3K-delta inhibitor space took another blow after MEI Pharma Inc. and partner Kyowa Kirin Co. Ltd. said the U.S. FDA won’t greenlight zandelisib without data from a randomized study. The firms had hoped to win accelerated approval in relapsed/refractory follicular lymphoma and marginal zone lymphoma based on a single-arm phase II study called Tidal.
Zai Lab Ltd. has shared positive top-line data from its phase III study for PARP inhibitor Zejula (niraparib) in the treatment of newly diagnosed ovarian cancer following a response to platinum-based chemotherapy. The study, called Prime, involved 384 advanced ovarian cancer patients in China and met its primary endpoint.
Innovent Biologics Co. Ltd. and Eli Lilly and Co. are "assessing next steps" for their jointly developed PD-1 inhibitor, sintilimab, following receipt of a complete response letter (CRL) from the U.S. FDA. The pair sought approval of a BLA for sintilimab plus pemetrexed and platinum chemotherapy for the first-line treatment of people with nonsquamous non-small-cell lung cancer (NSCLC) but found near-unanimous opposition from FDA advisers dissatisfied with China-only trial data submitted in support of the application. The medicine is already approved for multiple indications in China, where it’s marketed as Tyvyt.
The U.S. FDA has approved Novartis AG’s Pluvicto (lutetium Lu 177 vipivotide tetraxetan, formerly referred to as 177Lu-PSMA-617) for treating adults with metastatic prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer. The treatment is the indication’s first FDA-approved targeted radioligand therapy that contains a radioisotope.
Shouyao Holdings Co. Ltd. raised ¥1.48 billion ($233 million) in a listing on the Shanghai STAR Market to support the company’s ongoing clinical programs, led by a second-generation anaplastic lymphoma kinase inhibitor. Company shares (SHA:688197) debuted at ¥39.90, then fell 19.5% to close at ¥32.11 on March 23.
As congressional scrutiny of the U.S. FDA’s accelerated approval path continues, the agency is focusing research efforts into appropriate disclosure on direct-to-consumer websites about a drug’s accelerated approval and the status of confirmatory trials. Previous research by the FDA’s Office of Prescription Drug Promotion (OPDP) found that 27% of DTC websites providing information about a drug with accelerated approval don’t disclose that the products are on the market through accelerated approval.
Researchers at the Albert Einstein College of Medicine have turned pancreatic cancer’s immunosuppressive properties, and mechanisms, against itself. The team have used the bacterium Listeria monocytogenes as a delivery vehicle for tetanus toxoid protein, a highly immunogenic antigen that is used in childhood tetanus vaccinations. In mouse models of pancreatic cancer, treatment reduced both primary tumors and metastases, and extended survival.
In its drive to rewrite the rules of the tumor microenvironment so it can capture of the holy grail of successfully battling solid tumors by using T cells, Affini-T Therapeutics Inc. has completed an oversubscribed $175 million. The focus is to develop multiple oncogene driver programs for treating solid tumors such as those with mutated KRAS variants into the clinic, pursue complementary technology licenses to strengthen its cell therapy platform and to optimize its discovery engine.
Oric Pharmaceuticals Inc. is quitting development of ORIC-101 after interim analyses of two phase Ib studies concluded that the clinical activity does not justify going forward with the compound. The company was testing ORIC-101, a glucocorticoid receptor antagonist, combined with Abraxane in various solid tumors and paired with Xtandi in metastatic prostate cancer.
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