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In Brief This Week: IMIDomics, Eli Lilly, Point Biopharma, Crescendo Biologics, ImmunoGen

NEW YORK – IMIDomics, a San Rafael, California-based drug-discovery company, said this week that it has expanded an existing collaboration with Bristol Myers Squibb. In 2016, the companies began a collaboration in which BMS uses IMIDomics' clinical and molecular database and multidimensional analyses to understand the molecular underpinnings of immune-mediated inflammatory diseases (IMIDs) such as ulcerative colitis, Crohn's disease, psoriatic arthritis, rheumatoid arthritis, psoriasis, and systemic lupus erythematosus. Under the expanded collaboration, the companies will collect clinical and epidemiological data from patients with Sjögren's disease and atopic dermatitis. Data generated through the collaboration will be incorporated into IMIDomics' proprietary Clinical Discovery Engine, which integrates and analyzes comprehensive epidemiological, clinical, and multiomic biomolecular data. 

Eli Lilly said this week that it has extended its tender offer to acquire radiopharmaceutical firm Point Biopharma until Dec. 15, 2023. Originally, the offer to buy Point for $12.50 per share in cash was set to expire on Dec. 1, 2023.  

Crescendo Biologics said this week that it has treated the first patient in the US in its Phase Ib clinical trial of CB307. Through the trial, Crescendo is evaluating its investigational bispecific both as a monotherapy and combined with Merck's Keytruda (pembrolizumab) for patients with prostate specific membrane antigen (PSMA)-positive metastatic castration resistant prostate cancer.  

ImmunoGen said this week that the US Food and Drug Administration granted priority review to its supplemental biologics license application for conversion of its accelerated approval of Elahere (mirvetuximab soravtansine-gynx) as a treatment for patients with folate receptor alpha (FRα)-positive ovarian cancer to full approval. Elahere received accelerated approval for patients with platinum-resistant disease who have received one to three prior systemic treatment regimens. A marketing application the FDA is evaluating under priority review commits the agency to issuing a decision within six months, as opposed to the 10 months the agency has for standard reviews. The agency expects to make a decision on Elahere by April 5, 2024. 

Biological Dynamics announced this week that it is expanding enrollment for its ExoLuminate study with the addition of four new institutions: the Dana-Farber Cancer Institute; Moores Cancer Center at UC San Diego Health; University of Florida Health; and MedStar Georgetown. 

The study (NCT05625529) aims to validate the firm's ExoVita Pancreas assay for early cancer detection in individuals with high risk of pancreatic cancer based on genetic mutations, strong family history, the presence of cystic lesions in the pancreas, and pancreatitis. Biological Dynamics previously partnered with the PRECEDE Consortium to accelerate enrollment of at least 5,000 subjects.  

Leiden, the Netherlands-based ProQR Therapeutics this week completed its divestment of two late-stage ophthalmic RNA candidates, sepofarsen and ultevursen, for Leber congenital amaurosis 10 and Usher syndrome type 2a, respectively. Under the terms of the deal, originally announced in August, French pharmaceutical firm Laboratoires Théa will acquire the assets for €8 million ($8.6 million), with up to €165 million in development, regulatory, and commercial earn-out payments and other royalties based on commercial sales in the US and EU, and continue their development. ProQR said the divestiture will allow it to focus on developing its proprietary Axiomer RNA editing technology platform. 

Kura Oncology this week said that the Leukemia and Lymphoma Society selected its menin inhibitor ziftomenib to be tested with chemotherapy in a Phase I trial in pediatric patients with relapsed or refractory KMT2A-rearranged, NUP98-rearranged or NPM1-mutant acute leukemia as part of its Pediatric Acute Leukemia (PedAL) master clinical trial. LLS is sponsoring the trial in North America and the Princess Maxima Center for Pediatric Oncology in Utrecht, the Netherlands, is sponsoring the trial in Europe.  

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.