Shares of Shattuck Labs Inc. (NASDAQ:STTK) were trading at $2.08, down $1.41, or 40%, after the company said its clinical program with SL-172154 is ending as efforts shift to SL-325, its DR3 antagonist antibody, and plans first development in patients with inflammatory bowel disease (IBD), where TL1A/DR3-blocking antibodies have shown compelling monotherapy efficacy. Phase I-stage SL-172154, in combination with azacitidine in TP53 mutant acute myeloid leukemia (AML) and higher-risk myelodysplastic syndromes turned up only modest improvement in median overall survival compared to azacitidine monotherapy benchmarks, said Shattuck, of Austin, Texas. The drug is an ARC fusion protein designed to simultaneously inhibit the CD47/SIRP alpha checkpoint interaction and activate the CD40 co-stimulatory receptor.

Gritstone rolls lower with interim cancer data

Gritstone Bio Inc. has had a tough year and new interim phase II data of Granite haven’t helped. The company called the progression-free survival (PFS) results “encouraging” in the ongoing phase II/III trial of its neoantigen-targeting immunotherapy for treating front-line microsatellite stable colorectal cancer. However, investors thought otherwise as Gritstone’s stock (NASDAQ:GRTS) had sunk deeply by midday, with shares down 57% to 25 cents each. Granite produced disappointing results in April from the same study when short-term circulating tumor DNA data yielded no difference between study arms, although the trial showed an early trend in benefit on PFS. Gritstone lost 49% of its value that day. Gritstone stock, through July, is one of the year’s largest decliners in the BioWorld Cancer Index.

Kailera launches with $400M series A, Hengrui’s metabolic assets

In one of the top series A financings in biopharma history, new company Kailera Therapeutics Inc. emerged with $400 million raised and a pipeline of next-generation obesity and diabetes assets. Industry veteran Ron Renaud will head the Boston-based firm, which has lead program, KAI-9531, an injectable glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide receptor dual agonist. KAI-9531 and Kailera’s three other assets were acquired in May 2024 through an exclusive global development and commercialization license from the original developer, China’s Jiangsu Hengrui Pharmaceuticals Co. Ltd. Kailera’s series A is within the top five highest series A or launch rounds recorded by BioWorld since the year 2000.

US strike, hurricane threaten global drug, device supply chain

Depending on how long it lasts, the dockworkers strike that hit 14 ports on the U.S. East Coast and along the Gulf today could literally unload a world of hurt to patients and the biopharma/med-tech industries, as it will impact both U.S. imports and exports of life-saving drugs and technologies. The affected ports, stretching from Maine to Texas, handle more than 91% of containerized imports and 69% of containerized exports of U.S. biopharma products, according to Everstream Analytics. The strike comes just as the rare mines in western North Carolina that are the largest global source of ultra-pure quartz, which is used in semiconductor chips, were forced to shut down due to Hurricane Helene. That closure could further aggravate a supply shortage that’s been plaguing medical device makers since the pandemic.

Akeso scores two new China approvals

Akeso Pharmaceuticals Inc. scored two approvals from China’s National Medical Products Administration on Sept. 30 before the long Labor Day holiday – one for its PCSK9 inhibitor, ebronucimab, and the second to expand use of PD-1/CTLA4 bispecific antibody cadonilimab in unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, marking the second indication for cadonilimab in China.

Phylogeographics, phage typing combo fights antibiotic resistance

The spread of drug-resistant bacteria is a global health concern and could once again become a leading cause of mortality. The World Health Organization has flagged carbapenem-resistant Acinetobacter baumannii as a top priority pathogen requiring innovative therapies for its management, which has a mortality rate of 25%-60% and caused more than 100,000 deaths worldwide in 2019. Therapy based on the use of bacteriophages (phages) to fight antibiotic-resistant bacteria is one such innovative strategy.

BioWord Insider podcast: Capricor’s CEO pursues a BLA and talks rare disease

Capricor Therapeutics Inc. just wrapped up a visit with the U.S. FDA and is prepping to file a BLA in October for its Duchenne muscular dystrophy treatment. Linda Marbán, Capricor’s CEO, is the guest on the newest BioWorld Insider podcast and she talks about deramiocel (CAP-1002), the company’s allogeneic cardiac-derived cell therapy, for treating the rare disease and how the FDA has made strong efforts in helping lay the groundwork for deramiocel. Marbán has been working on the Duchenne treatment for many years and she has strong insights into how to tackle a rare disease development program and how the FDA has changed its ways over time to help out. She has been in the biopharma space for more than 20 years and also is a co-founder of Capricor.

Also in the news

Abbvie, Aktis, Aligos, Alnylam, Anagram, Angitia, Ascendis, Astronautx, Biomea Fusion, Biosenic, Bridgebio, Bristol Myers Squibb, Cereno, Clene, CSL, Cour, Eligo, Emglev, Engeneic, Enliven, Estrella, Formycon, GE Healthcare, Henlius, Hyloris, Intract, Johnson & Johnson, Kalvista, Kezar, Legend, Madrigal, Mannkind, Mesoblast, Modalis, Neurobo, Nxera, Ocuphire, Omass, Pop, Poseida, Poxel, Regor, Rivus, Tharimmune, TME, Valerio, Windtree