The news item on Exscientia has been corrected to reflect that the company is eligible to receive up to $5.2 billion, not million, in milestone payments from Sanofi.
NEW YORK – Cullinan Oncology this week said the US Food and Drug Administration granted breakthrough therapy designation to its investigational candidate CLN-081 for the treatment of non-small cell lung cancer patients who harbor an EGFR exon 20 mutation. Recent data from a Phase I/IIa trial of CLN-081 showed a 39 percent confirmed response rate, a median duration of response greater than 15 months, and a median progression-free survival of 12 months among 73 NSCLC patients with EGFR exon 20 insertion mutations.
Aileron Therapeutics this week announced several pipeline updates, including plans to begin a Phase Ib clinical trial of its lead candidate ALRN-6924 alongside neoadjuvant chemotherapy for estrogen receptor-positive, HER2-negative breast cancer during the first half of this year. The firm also announced anticipated readouts from its ongoing randomized trial of ALRN-6924 in p53-mutated non-small cell lung cancer during the second quarter. ALRN-6924 is designed to selectively protect healthy cells and curb chemo side effects in patients with various p53-mutated cancers.
Sanofi and Exscientia this week said they've expanded an existing collaboration and inked a licensing agreement to codevelop 15 small molecule therapeutic candidates in cancer and immunology by leveraging Exscientia's personalized medicine platform. Sanofi will pay Exscientia $100 million upfront. Exscientia will also be eligible to receive up to $5.2 billion if it meets certain research, translational, clinical development, regulatory, and commercial milestones. If Sanofi commercializes a therapeutic from the collaboration, Exscientia may receive tiered royalties on product sales ranging from high single-digits to mid-teens. The company also has the option to make a clinical co-investment and increase the royalty rate up to 21 percent on net sales of cofunded products.
The companies will identify and select projects using Exscientia's platform, which uses machine learning to glean clinically relevant data from human tissue samples and integrate the information into target and drug discovery research. In the deal, Exscientia will be in charge of target discovery, drug design, and lead optimization, while Sanofi will be responsible for preclinical and clinical development, manufacturing, and commercialization of selected therapies.
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 Oncology News.