In an indication that has few treatment options, Replimune Group Inc. just revealed positive top-line results of its lead candidate, RP-1 (vusolimogene oderparepvec), in anti-PD-1 failed melanoma. The company said it is ready for a phase III confirmatory study this year as well as filing a BLA sometime in the second half of the year. The company’s stock (NASDAQ:REPL) had strengthened 28% at midday with shares going for $7.12 each. Data from the phase I/II Ignyte study of RP-1 plus Opdivo (nivolumab, Bristol Myers Squibb Co.) showed the treatment hitting the primary endpoint with a 12-month overall response rate of 33.6%. All the responses were at least six months from baseline.
No surprises for donanemab adcom
Although the U.S. FDA unexpectedly sprang the news on Eli Lilly and Co. that it would hold an advisory committee meeting on the BLA for the company’s Alzheimer’s drug, donanemab, the agency’s briefing document for Monday’s meeting doesn’t appear to hold any surprises. For the most part, the Peripheral and Central Nervous System Drugs Advisory Committee will be asked to vote on the usual questions of effectiveness overall and in various subgroups, as well as the drug’s risk/benefit profile. The panelists also will be asked to discuss whether there are scientific or clinical considerations that could justify stopping treatment based on a reduction of amyloid plaques on PET imaging.
Arrivent, Alphamab ink $615.5M multitarget ADC partnership
Arrivent Biopharma Inc. and Jiangsu Alphamab Biopharmaceuticals Co. Ltd. have signed a development deal that leverages Alphamab’s antibody-drug conjugate (ADC) research and discovery platform and could bring Alphamab up to $615.5 million. The deal will see Newton Square, Penn.-based Arrivent and Suzhou, China-based Alphamab use Alphamab’s linker-payload platform and glycan-conjugation technology to identify, discover, develop and commercialize novel ADCs for various oncology indications. Arrivent gains exclusive rights to develop and commercialize the ADCs globally, except greater China – including mainland China, Hong Kong, Macau, and Taiwan – where Alphamab retains rights to develop and commercialize the ADCs.
TROP2 hot at ASCO as Gilead, Merck talk up prospects
Trophoblast cell-surface antigen 2 (TROP2) antibody-drug conjugates (ADCs) came up during the recent American Society of Clinical Oncology meeting in Chicago. Gilead Sciences Inc. discussed data with Trodelvy (sacituzumab govitecan), a TROP2-directed antibody and topoisomerase inhibitor pairing first approved by the U.S. FDA in April 2020. It’s indicated for the treatment of breast cancer and urothelial cancer. Merck & Co. Inc. talked up cancer data with investigational ADC sacituzumab tirumotecan. Also known as tumor-associated calcium signal transducer 2 or epithelial glycoprotein-1 antigen, TROP2 is a transmembrane glycoprotein that's encoded by the TACSTD2 gene in humans and overexpressed in many cancers.
Takeout interest continues for Vanda: Cycle offers $8 a share
Washington-based Vanda Pharmaceuticals Inc. has faced a challenging few years involving a federal lawsuit against the U.S. FDA, patent infringement litigation, increasing generic competition and dwindling sales, and a complete response letter nixing plans to expand its melatonin receptor agonist, Hetlioz (tasimelteon), into insomnia, yet a higher, unsolicited acquisition offer of $466 million arrived this week from a second company, Cycle Pharmaceuticals Ltd. The Cambridge, U.K.-based rare disease company proposed an $8-per-share price, up from the rejected cash offer from Future Pak LLC. The interest in Vanda likely relates to the company’s upcoming PDUFA date of Sept. 18 for tradadipant, a neurokinin-1 receptor antagonist, for gastroparesis, as well as with Vanda’s 5HT2/D2 antagonist antipsychotic, Fanapt (iloperidone), gaining approval in April for bipolar I disorder. Investors seemed to like the newest offer, with shares (NASDAQ:VNDA) climbing 25%, or $1.26, to $6.32 in midday trading June 6.
ITM raises €188M for radiopharmaceutical pipeline
Isotope Technologies Munich SE (ITM) raised €188 million (US$204 million) in a funding round that will largely be used to advance and expand the company’s radiopharmaceutical pipeline. The funds, which come a year after ITM raised €255 million, are a sign of growing investor interest in the company’s products and the radiopharma market, Steffen Schuster, CEO of ITM, told BioWorld.