BeiGene’s Tislelizumab meets its endpoint in Phase 3 in gastric cancer

The anti-PD-1 antibody, which is not yet approved outside of China, has a US PDUFA date of July 12 to treat unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma after prior systemic therapy. Last year, BeiGene granted Novartis rights to develop, manufacture and commercialize tislelizumab in North America, Europe and Japan for $650 million up front. BeiGene, which retains rights in China and elsewhere, is eligible for $1.6 billion in milestones, plus royalties.

Regeneron and Sanofi withdraw FDA application for Libtayo’s expanded use

Because Regeneron and Sanofi couldn’t find common ground with the FDA on postmarketing studies, the two are voluntarily withdrawing the sBLA for Libtayo (cemiplimab-rwlc) as a second-line treatment for advanced cervical cancer. Discussion about the matter continues outside the US. The withdrawal comes four days after another encounter the company had with the agency. Libtayo already has approvals for advanced cutaneous squamous cell carcinoma, advanced basal cell carcinoma and first-line therapy for high PD-L1-expressing NSCLC. Little more than a week ago, the FDA accepted an sBLA for Libtayo combined with chemotherapy as first-line treatment in advanced NSCLC. The decision to not seek approval in the second-line cervical cancer setting was partly due to competitive concerns arising from first-line approval of Merck & Co’s Keytruda for the same indication as well as the other PD-1 blockers seeking to enter the fray in the first-line setting, he wrote.

DEALS AND FINANCING

Adlai and Biotime to develop PD-1 inhibitor and anti-hTNFR2 antibody in China

Adlai Nortye Biopharma entered a global license agreement with Xiamen Biotime Biotechnology to develop, manufacture and commercialize PD-1 inhibitor AN4005 and anti-hTNFR2 antibody AN3025 in Greater China, and AN1005, AN6015 and AN9015 worldwide. Adlai said the total transaction amount will reach hundreds of millions of yuan, including an upfront payment, milestones and tiered royalties on sales.

Faeth raises $20 million for precision nutrition platform

Cancer metabolism company Faeth Therapeutics raised $20 million in a seed round co-led by Khosla Ventures and Future Ventures to apply its machine learning platform to guide cancer treatment with nutrition. The discovery platform, MetabOS, identifies nutrient vulnerabilities of a patient’s cancer based on the cancer’s characteristics, and supplements existing therapies with nutritional programs to increase efficacy. The company’s founding team includes the leading cancer researchers and clinicians including Lew Cantley, Sid Mukherjee and Karen Vousden.