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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
Compared to the issues that come with, say, a failing liver, skin aging can look like more of a vanity problem. But aging in both tissues, and multiple others, is driven by the same underlying molecular mechanisms. One of those mechanisms is fibrosis, the cross-linking of extracellular matrix (ECM) proteins that leads to tissue stiffening. Anti-aging company Cambrian Biopharma Inc. has argued that stiffening of the ECM should be considered one of the formal hallmarks of aging. Read More
In decrying high U.S. drug prices, lawmakers often cite statistics about the number of patients who forgo or ration their prescriptions because of the out-of-pocket cost. Those discussions overlook the role payer utilization management tactics, including prior authorization, may play in patients abandoning their treatment, be it a specific drug or an imaging service. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Exelixis, Gracell, Iaso, Ironwood, Jubilant, Nrx, Ocuphire, Pfizer, Pharmazz, Sairopa. Read More