Following a data-cleaning delay and mixed results in Alzheimer’s disease, Annovis Bio Inc. reported phase III Parkinson’s disease data showing treatment with buntanetap stops cognitive decline and improves motor and other functions, including postural instability and gait difficulty, meeting all primary and secondary endpoints. The data initially confused investors, with company shares (NYSE:ANVS) sinking by 14% to a 52-week low of $4.53 in early trading, recovering somewhat a few hours later to reach $5.08, then soaring by 76% to $9.29 by midday. The early drop may relate to a changed primary endpoint or a lack of activity in recently diagnosed patients. Annovis plans to now move buntanetap into a longer study.

Cartesian hits primary endpoint in MG phase IIb but stock wilts

Cartesian Therapeutics Inc.’s phase IIb study of its lead candidate, Descartes-08, in treating generalized myasthenia gravis hit its primary endpoint while the company also notched a $130 million private placement equity financing. The Descartes-08 study is the first placebo-controlled clinical trial using mRNA CAR T to treat an autoimmune disease. Results showed the primary endpoint was hit with statistical significance, with 71% of participants posting a clinically meaningful improvement at month three, compared to 25% of those receiving a placebo. The PIPE financing came from new and existing investors. The company’s stock (NASDAQ:RNAC) had taken a nosedive at midday, as shares were trading 31% lower at $16.75 each.

Tracon quits work on anti-PD-L1 envafolimab after phase III flop

Tracon Pharmaceuticals Inc. is shuttering all development of its subcutaneous PD-L1 antibody, envafolimab, after the pivotal trial failed to meet the primary endpoint in soft tissue sarcoma. The Envasarc pivotal trial showed an objective response rate (ORR) in 80 evaluable patients of 5% (four responders), which is lower than the primary endpoint of 11% ORR and does not support a potential BLA. The trial failure is also a blow to originator company Suzhou-based Alphamab Oncology Co. Ltd., which believed envafolimab would be its first asset to enter the U.S. market.

Unwinding of Chevron could bring down HHS, FDA, CMS policies

The U.S. Department of Health and Human Services (HHS) and the FDA already are getting a glimpse of the post-Chevron world and how the Supreme Court’s unwinding of the 40-year-old Chevron deference could rein in agency policies that defy Congress’ expressed intent. In separate letters to HHS Secretary Xavier Becerra and FDA Commissioner Robert Califf, Sen. Bill Cassidy (r-La.), ranking member of the Senate Health, Education, Labor and Pensions Committee, noted that both the HHS and the FDA have ignored congressional directives in choosing how and whether to enact specific statutory provisions. He cited examples ranging from HHS’ work to create a new Bayh-Dole framework that includes price as a factor for a government march-in on patent rights to the FDA’s assertion of jurisdiction over laboratory developed tests when Congress hasn’t granted the agency that authority. While Cassidy didn’t write to the Centers for Medicare & Medicaid Services (CMS), some of its rules, including those pertaining to Medicare drug price negotiations, also could face Chevron challenges.

FDA grants approvals to Stelara, Neupogen, Eylea biosimilars

The U.S. FDA approved three biosimilar products from Samsung Bioepis Co. Ltd., Tanvex Biopharma Inc. and Formycon AG as follow-on biologics to Stelara (ustekinumab), Neupogen (filgrastim) and Eylea (aflibercept), respectively, on June 28. As of July 1, the FDA had approved 56 biosimilar products, most of which were developed by U.S.-based pharmaceutical firms (24 products), followed by those from South Korea (12), Switzerland (6) and Germany (5), analysis by Korea Biotechnology Industry Organization showed.

China approves first cetuximab biosimilar

China’s National Medical Products Administration authorized the country’s first cetuximab biosimilar with the approval of Simcere Zaiming’s Enlituo (CMAB-009, cetuximab beta injection) in combination with chemotherapy as first-line treatment for RAS/BRAF wild-type metastatic colorectal cancer. The biosimilar references originator drug Erbitux (cetuximab, Eli Lilly and Co.). Enlituo is a new-generation anti-EGFR antibody developed in collaboration with Mabpharm Ltd. Enlituo represents the first EGFR monoclonal antibody drug developed in China with independent intellectual property rights for first-line treatment of mCRC.

Also in the news

4Moving, Agenus, Alkeus, Amneal, Ardelyx, Astrazeneca, Can-Fite, Carthera, Cassava, Dormer, Formycon, Graviton, Humacyte, Idorsia, Johnson & Johnson, Kashiv, Longboard, Mesoblast, Mirum, Ovid, Recce, Sandoz, Sitryx, Springworks, Syncromune, Taurx, Teva, Tiziana, Tracon, Valneva, Vaxcyte, Verrica, Y-Mabs