Seven fatalities that could be related to hemorrhagic events in Macrogenics Inc.’s phase II trial of the monoclonal antibody enoblituzumab for treating head and neck cancer has led to the study’s closure.
The recent win in Japan by Otsuka Holdings Co. Ltd. subsidiary Taiho Pharmaceutical Co. Ltd. with oral heat shock protein 90 inhibitor Jeselhy (pimitespib) put gastrointestinal stromal tumors (GIST) at center stage. Jeselhy was cleared for GIST cases that have progressed after chemotherapy. A handful of companies line the runway with candidates meant to defeat the resistance that GIST often develops to approved tyrosine kinase inhibitors.
In a new licensing deal cut with Swedish Orphan Biovitrum AB (Sobi), ADC Therapeutics SA is getting a $55 million up-front payment and could receive $50 million more upon regulatory approval of Zynlonta (loncastuximab tesirine) in third-line diffuse large B-cell lymphoma by the European Commission.
Jiangsu Hengrui Pharmaceuticals Co. Ltd. plans to expand its androgen receptor inhibitor, rezvilutamide, to markets abroad after getting a thumbs up from China’s NMPA for treating metastatic hormone-sensitive prostate cancer patients with high-volume disease burden.
Attention has turned to Cytomx Therapeutics Inc.’s CX-2029 candidate after the company held up its program with the CD166-directed antibody-drug conjugate CX-2009, based on phase II data in patients with hormone receptor-positive/HER2-non-amplified breast cancer.
Beigene Ltd. has formed a partnership with Innorna Co. Ltd. to jointly develop messenger RNA (mRNA)-based therapeutics. Shenzhen, China-based Innorna will get an undisclosed up-front payment and is also eligible to receive additional payments based on development, regulatory and commercial milestones, as well as tiered royalties. Beigene will maintain exclusive global rights to the mRNA candidates co-developed in the deal.
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.
So near and yet so far for Nordic Nanovector ASA, which has ditched the phase IIb trial of its lead product, Betalutin, just short of completing recruitment, after an independent review cast doubts on the level of efficacy previously reported for the targeted radiopharmaceutical.
Clarity Pharmaceuticals Ltd. is progressing three of its targeted copper theranostics through the clinic that are based on its sarcophagine technology that securely holds copper isotopes inside a cage-like structure, called a chelator. The SAR technology allows a unique pairing of copper isotopes, copper-64 and copper-67, for both cancer diagnosis and therapy.
The Hail Mary pass by Syros Pharmaceuticals Inc. – shares of which have dwindled severely since Jan. 3 – foreseen by some on Wall Street, came in the form of a $130 million financing and the merger with Tyme Technologies Inc., bringing in-house pipeline assets as well as net cash in a deal that, after accounting for wind-down and transaction expenses, is worth about $60 million.
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