NMD Pharma A/S has announced top-line results showing its orally available ion channel inhibitor, NMD-670, has a positive clinical impact in myasthenia gravis (MG), with patients having stronger hand grip and improvements in quantitative MG scores.
CSPC NBP Pharmaceuticals Co. Ltd. entered an agreement that will grant it exclusive rights to Harbour Biomed Co. Ltd.’s anti-FcRn antibody, batoclimab (HBM-9161), in greater China, including Hong Kong, Macau and Taiwan.
Tumor mutational burden (TMB), a biomarker used to assess whether a patient will respond to immunotherapy, needs to be recalculated in order to be useful for patients of Asian or African descent. Scientists at the Dana-Farber Cancer Institute found a significant bias in the estimated TMB values affecting these populations and adjusted them for those patients.
The Nobel Prize in Physiology or Medicine 2022 was awarded to Svante Pääbo today "for his discoveries concerning the genomes of extinct hominins and human evolution." Pääbo, who is currently the director of the Max Planck Institute for Evolutionary Anthropology in Leipzig, Germany, and his colleagues overcame extreme technical challenges to sequence the DNA of ancient hominids – because after tens of thousands of years, there is no such thing as aging well for DNA.
Simcere Pharmaceutical Group has out-licensed its autoimmune drug candidate SIM-0278 for all indications to Almirall SA in a deal worth up to $507 million. Simcere granted exclusive global rights to the candidate to Almirall for development and commercialization excluding mainland China, Hong Kong, Macau, and Taiwan. In return, Almirall will pay Simcere $15 million up front.
Innocare Pharma Ltd. raised ¥2.92 billion (US$412 million) in a second listing on the Shanghai STAR Market. Its shares opened at ¥10.86 apiece, sliding 15.4% to close at ¥9.33 on the first trading day, Sept. 21. The company will use the proceeds to support cancer and autoimmune drug R&D, improve its drug development platform, build its sales network, and upgrade its information technology, said Chief Commercial Officer Jin Xiaodong.
DBV Technologies SA blindsided investors by disclosing that the U.S. FDA had placed a partial clinical hold on its phase III Vitesse trial of its Viaskin Peanut patch immunotherapy for peanut allergy, calling for several changes to the study protocol. Its demands came just two weeks after the company claimed to have finalized the protocol in consultation with the agency.
After an eight-year odyssey, the first cytidine triphosphate synthase 1 (CTPS1) inhibitor has entered the clinic, with Step Pharma SAS announcing it has simultaneously begun studies in the U.S. and the U.K. The phase I/II trial is assessing Step’s lead program, STP-938, in relapsed/refractory B- and T-cell lymphomas, with the first U.S. site opening for enrollment this week.
Microbiome specialist Enterome SA has out-licensed its lead human hormone mimetic, EM-1010, to Nestlé Health Sciences SA, in a deal that underlines the potential of its approach to generating novel drugs from proteins expressed by gut bacteria. EM-1010, the first program derived from Enterome’s Endomimics platform, is an orally available molecule that acts by promoting local release of interleukin 10 in the gut, with the aim of reducing inflammation. It is in development for the treatment of inflammatory bowel disease and food allergies and due to enter clinical trials in 2023.
Skyhawk Therapeutics Inc. has cut a deal with Sanofi SA to discover and develop small molecules to treat targets in oncology and immunology, adding to its lengthy list of partnerships.