For a whopping $7.1 billion up front, Roche AG is buying Telavant Holdings Inc., a firm owned by Roivant Sciences Ltd. and Pfizer Inc. The deal also includes $150 million on the back end, and Roche gains rights to develop, manufacture and commercialize a fully human monoclonal antibody targeting tumor necrosis factor-like ligand 1A, RVT-3101, for treating inflammatory bowel disease and possibly other diseases in the U.S. and Japan. Pfizer retains rights for the rest of the world. In early December 2022, Pfizer and Roivant created Telavant as a collaboration to develop the antibody that targets inflammatory and fibrotic pathways. At the time, the two companies estimated commercial markets for the indications at nearly $15 billion per year in the U.S. alone and growing.

Updated phase I/II ESMO data show promise for Harpoon’s DLL3 prospect in SCLC

Harpoon Therapeutics Inc. provided updated interim monotherapy data from 71 patients in its phase I/II trial testing HPN-328 in small-cell lung cancer (SCLC) and other neuroendocrine tumor types in a poster at the European Society of Medical Oncology Congress. The drug takes aim at delta-like ligand 3 and is derived from Harpoon’s Tri-specific T-cell Activating Construct platform, which recruits a patient’s own immune cells to kill tumor cells. Efficacy focused on subjects given the 1-mg priming dose in the SCLC effort, and an unconfirmed overall response rate of 48% (11/23) turned up. Separately, the company said it has entered a securities purchase agreement for a $100 million private placement that could bring $50 million more upon the exercise of warrants. Shares of South San Francisco-based Harpoon (NASDAQ:HARP) were trading midday at $5.82, down $1.06, or 15%.

Drug developers index sees 80% of stocks decline through Q3

Out of the 30 companies comprising BioWorld’s Drug Developers Index (BDDI), 22 stocks saw a decrease in their stock prices in September, while two remained stable, and six showed positive gains. At the end of the third quarter, 80% of companies on BDDI experienced a decline in their stock values, with only six recording an increase.

Chimeric surges on first phase I data for CLTX CAR T in glioblastoma

Chimeric Therapeutics Ltd.‘s chlorotoxin (CLTX) CAR T therapy, CHM-1101, which is derived from scorpion toxin, saw a disease control rate of 55%, exceeding the historical disease control rates of 20% to 37% in heavily pre-treated patients with glioblastoma. Patients who were treated in the phase Ia trial on average received CLTX CAR T as a fourth-line therapy. The trial saw 10 months survival in patients that achieved disease control, and these results were “beyond what we actually expected,” Chimeric CEO Jennifer Chow said during an Oct. 23 conference call.

GSK signs $1B+ licensing deal with China’s Hansoh for ADC candidate

GSK plc is the latest pharma giant to bite the “magic bullet” of antibody-drug conjugate (ADC) drugs, promising to pay the Chinese immunotherapy developer Hansoh Pharmaceutical Co. Ltd. $85 million up front and over $1.4 billion in milestone payments in a licensing deal for HS-20089. “GSK’s R&D expertise and commercial footprint in developing therapies for gynecologic cancers make them the ideal licensee to bring HS-20089 to patients outside of China,” Hansoh said in a statement. The potential $1 billion-plus GSK-Hansoh deal builds upon a flurry of dealmaking in the space.

ESMO 2023: New approaches to old targets, including HER2 and p53

Some cancers with a poor prognosis have had no new treatments in decades. Advances in the genetic characterization of these tumors now offer a range of possibilities for the development of new therapies that could completely change the quality of life and survival of these patients. This year, at the European Society for Medical Oncology (ESMO) Congress in Madrid, three researchers presented clinical data on new drugs designed for diseases for which currently available therapies have been ineffective or caused adverse effects.

US FDA revises guidance on sharing off-label scientific info

The U.S. FDA is once again revising its guidance on the communications drug and device makers can have with health care providers regarding off-label uses of their approved or cleared products. When finalized, the revised draft guidance will replace the 2014 guidance that’s directed such communication for nearly a decade. The draft focuses on the sharing, in any medium, of scientific information about unapproved uses with any provider “engaged in making clinical practice decisions for the care of an individual patient,” according to the guidance. If a firm shares scientific communications with a provider in a manner consistent with the guidance, the FDA said it doesn’t “intend to use such communication standing alone as evidence of a new intended use.”

Biotech, med tech big winners in US tech hub program

With an eye on increasing U.S. competitiveness and expanding the opportunities of technology hubs beyond the two coasts, the Biden administration will announce today the designation of 31 communities across the country as Regional Innovation and Technology Hubs. A third of those will be devoted to biotech/med tech and precision medicine. Authorized by the CHIPS and Science Act passed by Congress last year, the new hubs will bring together industry, state and local governments, academia, workers, tribal communities and nonprofit organizations to compete for up to $75 million in implementation grants to invest in innovation, supply chain resilience and job creation.

Also in the news

Abivax, Aeon, Aligos, Almirall, Amgen, Apellis, Arcutis, Astrazeneca, Avadel, Avenacy, Beigene, Celltrion, Cybin, Cyclo, Dermavant, Eledon, Elevar, Eli Lilly, Foundation Medicine, Gilead, Harpoon, Ipsen, Journey Medical, Lipella, Menarini, Merck, Mithra, Newamsterdam, Novartis, Novo Nordisk, Petros, Pfizer, Quince, Regeneron, Riboscience, Rise, Roche, Sanofi, Seed, Spago, Sumitomo, Tme