The U.S. FDA granted Nanjing Iaso Biotherapeutics Co. Ltd. both regenerative medicine advanced therapy and fast track designations for its new drug, BCMA CAR T-cell therapy CT-103A (equecabtagene autoleucel), allowing it to speed up development and commercialization in the U.S. for the treatment of relapsed/refractory multiple myeloma.
Soligenix Inc. is scratching its chin as it decides how to react to the U.S. FDA’s refusal to file letter regarding Hybryte (synthetic hypericin) for treating early stage cutaneous T-cell lymphoma. The letter means the FDA won’t review the application, which was submitted in December, because there are deficiencies that cannot promptly be resolved, rendering the application essentially incomplete.
Replay Holdings LLC said it will be first into the clinic with a T-cell receptor natural killer (TCR-NK) cancer immunotherapy, after forming its latest satellite company around technology from the University of Texas MD Anderson Cancer Center. No financial details were disclosed, but the newco, Syena, is funded to run a basket trial that will assess an NY-ESO-1-targeted TCR-NK in a number of hematological and solid tumors, and said it will start treating patients in the second half of 2023.
A preclinical data presentation at the American Society of Clinical Oncology Genitourinary Cancers Symposium later this week has prompted Halda Therapeutics Inc. to emerge from stealth and unveil its novel Riptac (Regulated Induced Proximity Targeting Chimera) platform for creating heterobifunctional small molecules designed to kill cancer cells selectively. The New Haven, Conn.-based company has been quietly refining the technology since its formation in 2019 and has already secured $76 million in series A and B rounds.
Harbour Biomed Holdings Ltd. licensed exclusive U.S. rights to B7H4 x 4-1BB bispecific immune activator HBM-7008 to Cullinan Oncology Inc. in a deal worth up to $625 million. China-based Harbour will obtain a $25 million up-front payment and is eligible to receive up to $600 million in development, regulatory and sales-based milestones, as well as tiered royalties of up to 20% on U.S. commercial sales.
Hengrui Pharmaceuticals Co. Ltd. licensed its EZH2 inhibitor, SHR-2554, to Treeline Biosciences Inc. in a deal worth more than $700 million. Treeline will be granted worldwide exclusive rights to the lymphoma drug, except for greater China, in exchange for an up-front payment of $11 million, development milestone payments of up to $45 million, and milestone payments of up to $650 million based on annual net sales once commercialization begins.
Corbus Pharmaceuticals Holdings Inc. signed a back end-loaded licensing deal worth up to $692.5 million with CSPC Megalith Biopharmaceutical Co. Ltd, a subsidiary of CSPC Pharmaceutical Group Ltd., for the latter’s Nectin-4-targeting antibody-drug conjugate CRB-701 (SYS-6002).
Disappointing phase II antitumor results with a drug that is designed to preserve the bone marrow during chemotherapy have dashed G1 Therapeutics Inc.’s hopes of expanding Cosela’s label to include metastatic colorectal cancer patients, at least for now. Cosela (trilaciclib) is an intravenous-administered transient CDK4/6 inhibitor designed to mitigate the side effects patients experience with current cytotoxic drug regimens used to treat aggressive cancers by offering myeloprotection and by preserving immune system function, so enabling patients to receive chemotherapy for longer and at higher doses.
Leveraging ferroptosis, or iron-mediated cell death, Hillstream Biopharma Inc. has turned up intriguing early stage data in non-small-cell lung cancer (NSCLC) when the company’s candidate called HSB-1216 was paired with the anti-PD-1 antibody Keytruda (pembrolizumab, Merck & Co. Inc.).
South Korea’s GI Innovation Inc. announced its IPO on the Kosdaq market with plans to raise up to $34 million in March 2023. Funds raised from the IPO will go toward phase I/II clinical trials of immunotherapy agent GI-101 in the U.S. and Korea, and a phase I trial of allergy treatment GI-301 (also known as YH-35324) in Korea.
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