The majority of patients with acromegaly who switched from therapy with injected somatostatin receptor ligands to Crinetics Pharmaceuticals Inc.’s once-daily, oral drug paltusotine maintained stable levels of insulin-like growth factor (IGF) 1 in a phase III trial, moving the company’s first-in-class lead closer to becoming the potential new standard of care for the rare hormonal disorder. In the study, named Pathfndr-1, 83% of patients on the therapy saw their IGF-1 level – a key disease measure – remain at ≤ 1.0 times the upper limit of normal (xULN), vs. 4% of those on placebo, a “highly statistically significant” primary endpoint, according to Crinetics. Shares (NASDAQ:CRNX) jumped sharply by 64% on the Sept. 11 announcement, trading at $26.14 at midday.

Immatics pact with Moderna in cancer efforts worth up to $1.7B

Moderna Inc. and Immatics NV inked an oncology deal that could be worth more than $1.7 billion for the latter, which will bank $120 million up front and collect research funding as well. The big money would come in the form of potential development, regulatory, and commercial milestone rewards, with tiered royalties included. Efforts will pair Cambridge, Mass.-based Moderna’s mRNA technology with Immatics’ T-cell receptor platform, and therapeutic modalities will be pursued, include bispecifics, cell therapy and cancer vaccines.

Biolinerx’s stem cell mobilizer approved for MM patients

The U.S. FDA has approved Biolinerx Ltd.’s stem cell mobilization agent Aphexda (motixafortide) for treating multiple myeloma (MM) patients. The approval combines Aphexda with filgrastim (granulocyte colony stimulating factor) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation. The company said it anticipates Aphexda being available later in September. Motixafortide is a short synthetic peptide that targets CXCR4, a chemokine receptor that is overexpressed in many human cancers. CXCR4 plays a role in tumor growth and its overexpression is often correlated with a poor prognosis.

Rx pricing clause finds its way into US R&D contract

If the recent $326 million extension of Regeneron Pharmaceuticals Inc.’s contract with the U.S. Biomedical Advanced Research and Development Authority (BARDA) is anything to go by, pricing clauses may once again become a common feature in biopharma contracts involving government R&D funding. Modified last month as part of the Project NextGen program, the Regeneron contract now includes a clause specifying that if a new product is commercialized as a result of the company’s partnership with BARDA, the U.S. list price of the therapy will be equal to or less than its retail price in comparable markets globally.

Daiichi Sankyo’s HER3 ADC shows promise in EGFR-mutated advanced NSCLC

Daiichi Sankyo Co Ltd.’s HER3-directed antibody-drug conjugate patritumab deruxtecan (HER3-Dxc) showed clinically meaningful and durable responses in patients with EGFR-mutated locally advanced or metastatic non-small-cell lung cancer (NSCLC) in the Herthena-Lung1 phase II trial. The Tokyo-based company said it expects to submit a BLA to the FDA in the second half of fiscal year 2023. The U.S. FDA granted patritumab deruxtecan breakthrough therapy designation in December 2021 for treating patients with EGFR-mutated locally advanced or metastatic NSCLC with disease progression on or after treatment with a third-generation tyrosine kinase inhibitor and platinum-based therapies.

KIW 2023: Lunit moves from AI-imaging cancer diagnostics to I/O success prediction

Springboarding off the success of its AI-based imaging software for cancer detection, the deep learning-based artificial intelligence (AI) company Lunit Inc. has another AI software, called the Lunit Scope, up its sleeve for which it hopes to gain FDA approval by 2025. “Cancer treatment is often specialized by target area because of the complexity of the disease – the approach is known as precision medicine,” Lunit CEO Brandon (Beom-seok) Suh said to audience members at the Korea Investment Week (KIW 2023) conference on Sept. 11 at the Conrad Seoul. “And precision medicine comes down to the data [in medicine] and how to best employ the data to find effective biomarkers.”

BioWorld Insider Podcast – AI: driving drug development from effective to remarkable

Google’s Scott Penberthy joins the podcast for a visionary discussion that scans the horizon for startling changes artificial intelligence will bring to drug development in the relatively near future. Among the gems and eyebrow raisers is talk of dramatic reductions in the time it takes to identify the right molecule for development and how digital clinical trials in the not-too-distant future will substantially shrink study times. This episode also provides a preview of the annual Biofuture conference. Each year, a group of trailblazers, disruptors and forward-thinking executives converge to evaluate and forecast the future of health care. This year, BioWorld is a gold sponsor of the Oct. 4-6 event in New York. If you attend, you'll have the chance to hear panels and join workshops and fireside chats with key opinion leaders like Penberthy.

Also in the news

Acticor, Adrenomed, Alnylam, Aprinoia, Avalyn, Benevolentai, Bioinvent, Citius, Coeptis, Cormedix, Coya, Cymabay, Deverra, Eledon, Eli Lilly, Evaxion, Genentech, Gryroscope, Herophilus, Immunitybio, Janssen, Madrigal, Mendus, Neumora, Nextcure, Nordic, Novartis, Okyo, Orano, Orbit Discovery, Oxurion, Palisade, Parion, Pfizer, Plus, Rayzebio, Regeneron, Sandoz, Solu, Syncona, Valneva