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. Hengrui will also be paid royalties based on net sales at a rate of between 10% to 12.5%.
Harbour, Cullinan ink $600M+ bispecific antibody agreement
Harbour Biomed Holdings Ltd. licensed exclusive U.S. rights to B7H4 x 4-1BB bispecific immune activator HBV-7008 to Cullinan Oncology Inc. in a deal worth up to $625 million. 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. In turn, Cullinan obtained rights to develop and commercialize HBM-7008 in the U.S. and would be responsible for the costs of development in the country. Harbour retained all rights to the candidate outside the U.S.
Soligenix considers options for dealing with refusal to file letter
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. The company’s options include asking for a type A meeting with the agency to clarify the letter’s contents and to ask for more information that could lead to an acceptable NDA. The company’s stock (NASDAQ:SNGX) was suffering at midday as shares were trading 25% downward.
‘Rip’ it up and start again: Halda Therapeutics unveils Riptac platform, $76M investment
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 company has been quietly refining the technology since its formation in 2019 and has already secured $76 million in series A and B rounds.
Replay’s Syena aims to be first in the clinic with TCR-NK therapy
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. Building on this, Syena aims to generate a pipeline of engineered TCR-NK programs targeting a range of intracellular tumor antigens, including cancer-specific neoantigens.
Newco news: In aging, fibrosis problems are much more than skin-deep
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.
Prior authorization reforms needed now, medical groups tell US CMS
In railing about high U.S. drug prices, lawmakers often cite statistics about the number of patients who forego or ration their prescriptions, especially for insulin, because of out-of-pocket cost. Those discussions overlook how payer utilization management tactics, including prior authorization, impact patient outcomes. According to a 2021 American Medical Association (AMA) survey on prior authorization, 82% of participating doctors reported that such authorization requirements have resulted in patients abandoning their recommended course of treatment, and 34% said the delays or disruptions caused by prior authorization have led to serious adverse events, including death, for their patients. Those survey results are at the heart of a letter 75 medical groups sent yesterday to the Centers for Medicare & Medicaid Services (CMS) urging that it implement proposed reforms on payer use of prior authorization in Medicare Advantage plans.
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