Redx Pharma plc has closed its biggest transaction to date, selling a preclinical KRAS inhibitor program to Jazz Pharmaceuticals plc in a potential $880 million deal. Of that, $10 million will be paid up front, with the balance to come in development and commercialization milestones. For any product that makes it to market, Redx will in addition receive tiered mid-single digit percentage royalties. The first milestone will be triggered when an IND is filed for the lead candidate. In a separate agreement, Jazz will pay Redx to complete preclinical development and IND-enabling studies for the orally available small molecules.
Amgen and Lilly financials driven by obesity
Amgen Inc. reported its latest financial numbers but much of the conversation on the Feb. 6 conference call was about obesity. Just released phase I data of monthly dosed AMG-133 (maridebart cafraglutide/Maritide) showed rapid and sustained weight loss, with a 14.5% reduction in body weight. The optimized GIPR/GLP-1R bispecific molecule is engineered by conjugating a fully human monoclonal anti-human GIPR-Ab with two GLP-1 analogue agonist peptides. The subject also dominated Eli Lilly and Co.’s fourth quarter of 2023 numbers as global Zepbound revenue was $175.8 million following its November launch to treat adults who are obese or overweight with weight-related comorbidities.
Immunome, ROR1 in spotlight after Ayala tie-up
Immunome Inc.’s recent deal to acquire the phase III-stage small-molecule gamma secretase inhibitor AL-102, along with drug candidate AL-101, drew more eyeballs to the firm’s pipeline, especially the ROR1 program. AL-102, with its different mechanism, came to Immunome by way of an agreement with Ayala Pharmaceuticals Inc. ROR1 is an antigen expressed in various solid and liquid tumors.
Gilead dropping work on anti-CD47 antibody magrolimab
A day after Gilead Sciences Inc. disclosed in its full-year earnings plans to discontinue magrolimab in hematological cancers following a futility analysis from the phase III Enhance-3 study in acute myeloid leukemia (AML), the company reported the U.S. FDA had placed a full clinical hold on all trials of the anti-CD47 antibody. Magrolimab was acquired in the 2020 buyout of Forty Seven Inc. for $4.9 billion. Gilead previously halted phase III trials of magrolimab in myelodysplastic syndromes and AML with TP53 mutations.
US FDA seeks more visibility into drug supply chain
Shadowed by prescription drug shortages at their highest level since 2014, the U.S. FDA issued a draft guidance yesterday to help drug manufacturers comply with legal requirements to notify the agency in advance of a permanent discontinuation or disruption in manufacturing of certain finished drugs or active pharmaceutical ingredients that could lead to a drug shortage. The guidance goes beyond the law, recommending that manufacturers “provide additional details and follow additional procedures to ensure FDA has the specific information it needs to help prevent or mitigate shortages,” according to a notice published in the Feb. 6 Federal Register. The goal is to give the FDA greater visibility into the drug supply chain, something that’s lacking where APIs are concerned.
Mixed results for Hutchmed’s fruquintinib phase III in gastric cancer
Hong Kong’s Hutchmed (China) Ltd. reported mixed phase III results of fruquintinib as a second-line combination therapy for advanced gastric cancer on Feb. 6, with the oral vascular endothelial growth factor receptor inhibitor hitting just one co-primary endpoint. Results of the Frutiga study, presented at the ASCO Plenary Series Session, may have bumped fruquintinib down to another option in the gastric cancer toolbox, but it nonetheless pushed up Hutchmed’s shares on the Nasdaq, London and Hong Kong stock exchanges.
Opportunities for IVD, vaccine makers in US vector-borne disease plan
The U.S. Department of Health and Human Services has released a sweeping plan that is designed to help manage vector-borne pathogens, such as the Zika virus, with the ultimate goal of reducing the related disease burden to zero. This plan creates opportunities for developers of in vitro diagnostics (IVDs) and vaccines related to these diseases to enter or expand their footprints in these spaces.
Deliberate AI anxiety/depression model accepted into ISTAND
In a first, the U.S. FDA accepted an artificial intelligence (AI)/machine learning-model into its Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program for drug development. The program will support use of Deliberate AI Inc.’s anxiety and depression assessment tool, called the AI-generated Clinical Outcome Assessment, as a qualified drug development tool.
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