Beigene Ltd., of Beijing, and privately held Springworks Therapeutics Inc., of Stamford, Conn., said they formed Mapkure LLC to develop BGB-3245, a preclinical oral small-molecule inhibitor of monomer and dimer forms of activating BRAF mutations, including V600 BRAF mutations, non-V600 BRAF mutations and RAF fusions, that was discovered by Beigene researchers. Springworks made an equity investment in Mapkure and Beigene contributed an exclusive royalty and milestone-bearing license to develop and commercialize BGB-3245 outside Asia, including rights to Japan, in exchange for a majority stake in the joint venture. Additional details of the transaction were not disclosed. Beigene and Springworks said Mapkure is expected to initiate an adaptive phase I dose-escalation and expansion study of BGB-3245 in individuals with solid tumors harboring specific BRAF driver mutations and RAF fusions and in those who developed resistance to first-generation BRAF inhibitors. Mapkure will ink service agreements with Beigene and Springworks to execute the study and to perform other operational activities. Subsequent development efforts with BGB-3245 may include combination therapies, including with MEK inhibitors such as PD-0325901, in development by Springworks, which in April closed a $125M series B financing. The companies have an existing global clinical collaboration agreement to evaluate the combination of Beigene's RAF dimer inhibitor, lifirafenib (BGB-283), and PD-0325901 in advanced solid tumors. (See BioWorld, April 2, 2019.)
Glenmark Pharmaceuticals Ltd., of Mumbai, India, said its Brazilian subsidiary, Glenmark Farmacêutica Ltda., entered an exclusive partnership agreement with Novartis Biosciences SA, a subsidiary of Novartis AG, of Basel, Switzerland, for three respiratory products indicated for treatment of the symptoms of chronic obstructive pulmonary disease in Brazil. The agreement will be effective from July 1 onward. The products involved in the agreement are Seebri (glycopyrronium bromide), Onbrize (indacaterol) and Ultibro (indacaterol/glycopyrronium). Under the terms, Novartis remains the holder of the registration of those medicines and will be responsible to manufacture them, while Glenmark will be responsible for promoting, commercializing and distributing the products in Brazil.
Kleo Pharmaceuticals Inc., of New Haven, Conn., said that CD38-ARM, a CD38-targeting antibody recruiting molecule, or ARM, designed to treat multiple myeloma, will be its first candidate to move into the clinic. Human studies are expected to begin next year. The molecule, the first to emerge from Kleo's 2017 alliance with Peptidream Inc., of Tokyo, was selected on the basis of preclinical safety and efficacy signals. (See BioWorld, July 27, 2017.)
Shionogi BV, the European subsidiary of Shionogi & Co. Ltd., of Osaka, Japan, and Grupo Ferrer Internacional SA, of Barcelona, Spain, said they entered an exclusive promotion agreement for Rizmoic (naldemedine) in Spain for the treatment of opioid-induced constipation (OIC) in adult patients previously treated with a laxative. In February, the product was granted marketing authorization by the European Commission for the treatment of OIC in adult patients. In other news,Shionogi & Co. concluded an agreement with Eddingpharm Inc., of Hong Kong, to license out lusutrombopag, a thrombopoietin receptor agonist, with a brand name of Mulpleta in Japan. Eddingpharm will be granted an exclusive license in mainland China, Hong Kong and Macau, while Shionogi will supply the product to Eddingpharm and receive an up-front payment as well as milestone payments according to post-launch sales achievements. The two companies will cooperate on the application for approval, under the terms.
Wuxi Biologics Co. Ltd., of Shanghai, said it is planning to expand the new state-of-the-art integrated biologics conjugation solution center to include commercial manufacturing in Wuxi City. It is expected to initiate GMP manufacturing later this year and the new 5.5-acre expansion will enable cGMP commercial manufacturing for antibody-drug conjugate drug substance and drug product.