NEW YORK – Kinnate Biopharma this week said it is prioritizing the clinical development of the MEK inhibitor KIN-7136 and the c-MET inhibitor KIN-8741 but deprioritizing its CDK12 program. The company wants to study KIN-7136 in adults with MAPK-driven advanced solid tumors and KIN-8741 in advanced non-small cell lung and other solid tumors with a broad range of resistance mutations. The former is slated to enter the clinic in the second half of 2023, while the latter is headed for human trials in the first half of 2024. In order to focus on these two programs, Kinnate said it will evaluate strategic alternatives for its CDK12 program. As of March 31, the company said it has $231 million in cash, cash equivalents, and investments, which will fund its operations until early 2025.
Shanghai- and Clinton, New Jersey-based HuidaGene Therapeutics this week said its investigational new drug application for a clinical trial of HG004 has been approved in China. HG004 is a gene replacement therapy that HuidaGene is testing in patients suffering from inherited retinal dystrophies associated with mutations in the RPE65 gene. Earlier this year, the US Food and Drug Administration also approved HG004's IND and granted it orphan drug designation.
Philanthropic venture fund SOLVE FSHD this week said it has invested an undisclosed amount into South San Francisco, California-based Epic Bio, a biotechnology company developing therapies that control gene expression with non-cutting dCas proteins. The investment will support development of Epic Bio's lead program, EPI-321, a treatment for facioscapulohumeral muscular dystrophy (FSHD) that's designed to correct epigenetic alterations in the D4Z4 region of chromosome 4.
AI software development company Evo Pricing of the UK said this week that it has partnered with Dante Genomics to offer genome sequencing to all of its employees and "ecosystem partners" as part of its employee benefits program. Dante, based in Italy, is providing needleless at-home blood collection kits and its clinical whole-genome sequencing test under the deal. Evo also said that it plans to build a new AI service that Dante can use to market its offering.
Daiichi Sankyo said this week that the US Food and Drug Administration has extended its review period for the firm’s new drug application seeking approval for Vanflyta (quizartinib) plus chemotherapy as treatment for newly diagnosed FLT3-ITD-positive acute myeloid leukemia patients. The FDA said it will now decide on whether to approve Vanflyta by July 24, 2023, three months after the original target date. The delay is intended to allow the FDA to review additional information about the drug’s proposed safety measures, though no additional efficacy or safety data is involved.
TED's Audacious Project said this week that it is providing $70 million in funding to a research initiative led by Jennifer Doudna and Jill Banfield at the Innovative Genomics Institute (IGI) at the University of California, Berkeley. The initiative, called Engineering the Microbiome with CRISPR to Improve our Climate and Health, is a collaboration between UC Berkeley, UC Davis, and UC San Francisco. It will combine CRISPR genome editing of microbes with metagenomics to create a precision microbiome editing platform, with the goal to develop treatments for human disease and reduce greenhouse gas emissions. The initial focus will be on childhood asthma as well as mitigation of agricultural methane emissions.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Medicine Online.