Abbisko Therapeutics Co. Ltd. has out-licensed China rights to its colony-stimulating factor 1 receptor inhibitor, pimicotinib, to Merck KGaA in a deal worth up to $605.5 million. Pimicotinib is in phase III trials in patients with tenosynovial giant cell tumors in China, the U.S., Canada and Europe. Under terms of the deal, Merck will be granted an exclusive license to commercialize products comprising pimicotinib (ABSK-021) for all indications in mainland China, Hong Kong, Macau and Taiwan. Abbisko will receive $70 million up front and is eligible for development and commercialization milestone payments that are worth up to $605.5 million inclusive of the up-front payment. Abbisko is also eligible for double-digit sales-based royalties. Merck has the option to commercialize the drug globally for an additional payment, Hua Jiang, Abbisko’s business development director told BioWorld.

Replimune’s lead candidate misses two phase II endpoints

Replimune Group Inc.’s lead candidate, RP-1 (vusolimogene oderparepvec), has taken a hit as it missed both primary endpoints in a phase II study of skin cancer. The study’s primary analysis showed RP-1 combined with Libtayo (cemiplimab) in treating advanced or metastatic cutaneous squamous cell carcinoma missed the complete response (CR) rate and the overall response rate (ORR). Replimune noted the overall data indicated the combination led to a higher rate of CRs and a favorable ORR compared to cemiplimab alone. To extend its cash runway, Replimune is halting development of RP-2 and RE-3 in squamous cell carcinoma of the head and neck and colorectal cancer. However, that didn’t keep the company’s stock (NASDAQ:REPL) from sagging at midday as shares were trading at $6.89 each, down 44% from the opening bell.

Neurosense offers phase IIb data in ALS; shares fall  

Neurosense Therapeutics Ltd. rolled out top-line data from its phase IIb study called Paradigm with PrimeC, a fixed-dose combination of ciprofloxacin and celecoxib, in amyotrophic lateral sclerosis (ALS). The drug is designed to synergistically target several key mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation, and impaired RNA regulation. Primary safety and tolerability endpoints were met, with a profile in those regards that proved comparable to placebo. Efficacy results were measured by Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) and slow vital capacity (SVC). Findings showed a 29% difference in favor of PrimeC in ALSFRS-R (p=0.12) and a 13% difference in favor of the drug in SVC (p=0.5), based on data from 68 out of 69 patients, due to one participant who was misdiagnosed. Shares of the firm (NASDAQ:NRSN) were trading midday at $1.11, down 38 cents, or 25%.

Genentech drug improves survival for PIK3CA-mutated breast cancer

The oral drug inavolisib, when added to two other therapies, significantly improved progression-free survival in the first-line phase III treatment of advanced hormone receptor (HR)-positive, HER2-negative breast cancer in which patients have a PIK3CA mutation. Inavolisib, developed by Roche AG’s Genentech unit, works through a dual mechanism that inhibits phosphoinositide 3-kinase alpha (PI3Kα) and triggers the breakdown of mutant PI3Kα protein. PIK3CA mutations are found in about 40% of HR-positive breast cancers. In the phase III trial, called Inavo120, inavolisib was dosed in combination with Ibrance (palbociclib, Pfizer Inc.) and Faslodex (fulvestrant, Astrazeneca plc), showing a statistically significant and clinically meaningful improvement in progression-free survival compared to either palbociclib or fulvestrant alone. The combination was well-tolerated and adverse events were consistent with available data. No new safety signals were observed. More details are expected in the next analysis.

Samsung Bioepis, Intocell partner for ADC drug development

Samsung Bioepis Co. Ltd. will partner with South Korean biotech Intocell Inc. to develop antibody-drug conjugate (ADC) drugs, continuing the Samsung Group and the wider industry’s hunt for novel ADCs. Under the joint research agreement inked on Dec. 5, the Daejon-based ADC platform technology firm Intocell will supply the Songdo, Incheon-based Samsung Bioepis its linker technology, coined OHPAS, or ortho-hydroxy protected aryl sulfate, upon which Samsung Bioepis will develop ADC drugs for up to five cancer targets.

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89bio, Abbvie, Adiso, Akeso, Alexion, Alpha Cognition, Amylyx, Apollomics, Aqemia, Atsena, Avicanna, Axcella, Bighat, Brainchild, Can-Fite, Carsgen, Crispr, Cytomed, Cytonus, Eligo, Eli Lilly, Enveric, Exelixis, Exscientia, Eyepoint, Fennec, Geneoscopy, Geron, Gossamer, GT, Hansa, Hyloris, Inhibikase, Intelgenx, Junshi, KBI, Kling, Nanobiotix, Obulytix, Odyssey, Okyo, Osivax, Polaris, Relief, Rumi, Sana, Sanofi, Sellas, Springworks, Spyglass, Skye, Spexis, Star, Stoke, Tautomer, Technoderma, Thermosome, Tonix, Transcode, Travere, Valirx, Valneva, Versameb, Viracta, Xenon