Shares of Merus NV (NASDAQ:MRUS) were trading at $54.35, up $12.75, or 30%, on interim data as of Feb. 27 from the phase II trial of bispecific antibody petosemtamab in combination with Merck & Co. Inc.’s Keytruda (pembrolizumab) to treat head and neck squamous cell carcinoma (HNSCC). CEO Bill Lundberg noted that “by essentially every metric” the combo beat Keytruda monotherapy. The HNSCC data will be presented June 2 during the American Society of Clinical Oncology meeting in Chicago.

Imunon ovarian cancer prospect impresses with survival benefits

Imunon Inc. soared by 184% in early trading on the heels of phase II Ovation 2 data showing that its IMNN-001 immunotherapy led to a 13-month increase in overall survival among women with ovarian cancer. Patients in the intent-to-treat population, receiving the IL-12 DNA plasmid vector plus standard-of-care neoadjuvant and adjuvant chemotherapy (N/ACT), achieved median overall survival (OS) at 46 months vs. 33 months with N/ACT alone. Increased activity was seen among patients treated with poly ADP-ribose polymerase inhibitors, with the median OS not yet reached after more than five years vs. 37 months in the control arm. Imunon’s shares (NASDAQ:IMNN) were up 76 cents to $1.18 on May 23.

Yanked from the market in 2022, GSK’s Blenrep gets an EU redo

GSK’s Blenrep (belantamab mafodotin) is heading back to the market three years after being withdrawn, with the EMA’s Committee for Medicinal Products for Human Use recommending approval of the antibody-drug conjugate for the treatment of adults with relapsed or refractory multiple myeloma. Blenrep will be used in combination with bortezomib plus dexamethasone in patients who have received at least one prior therapy, and in combination with pomalidomide plus dexamethasone in patients who have received at least one prior therapy including lenalidomide. The approval is based on superior efficacy results from two phase III trials, Dreamm-7 and Dreamm-8. Blenrep previously was granted conditional approval in the U.S. and Europe in 2020, but was withdrawn by GSK in 2022, when the BCMA-targeted antibody failed to show superiority to standard of care in the confirmatory trial. The FDA is due to give its verdict on whether a fresh approval is granted on July 23.

Adalta sees promise in new ‘East to West’ strategy for T-cell therapies

Adalta Ltd. is outlicensing all of its internal products and focusing instead on inlicensing early stage T-cell assets from Asia, mostly from China, Adalta CEO Tim Oldham told BioWorld. Dubbed its “East to West” strategy, Adalta is integrating Asia's prowess in T-cell therapy development with the efficiency and quality of Australia's clinical and manufacturing ecosystem to create a pathway connecting Eastern innovation in cellular immunotherapies with Western regulated markets and patients. “We're investing in that challenge of migrating technology out of Asia. That's an opportunity cost for big pharma that they don't really want to take at the moment,” Oldham said.

Relaxin target still viable, players advancing after Lilly’s moves

The relaxin pathway remains intriguing to drug developers after headlines from Tectonic Therapeutic Inc. in January quelled at least some concerns after Eli Lilly and Co. decided to stop a pair of phase II studies with volenrelaxin (LY-3540378) for the treatment of chronic heart failure and chronic kidney disease. Astrazeneca plc remains in play, as do a number of others. Tectonic offered positive interim data from the phase Ib acute hemodynamic trial with lead candidate TX-45, a long-acting, Fc-relaxin fusion protein. Findings showed that one intravenous dose turned up improvements in left ventricular function and pulmonary hemodynamics in patients with heart failure with preserved ejection fraction.

Alteogen merges two subsidiaries, forming Alteogen Biologics

Alteogen Inc. completed a merger between two subsidiaries – Altos Biologics Inc. and Alteogen Healthcare Inc. – branding the new entity as Alteogen Biologics Inc. Alteogen Biologics is expected to blend Alteogen Healthcare’s strengths in pharmaceutical distribution, sales and marketing with Altos Biologics’ capabilities in clinical and new drug development.

Cinclus and Zentiva have a plan for reflux in Europe

Cinclus Pharma Holding AB has chosen Zentiva k.s. to handle manufacturing and commercialization duties in Europe for linaprazan glurate, which is being developed to treat severe erosive gastroesophageal reflux disease. The company estimates there are 19 million patients globally who could benefit from the drug that is set to enter a phase III study in the third quarter of 2025. Linaprazan glurate, a potassium-competitive acid blocker originally developed by Astrazeneca plc, is Stockholm-based Cinclus’ lead asset. Zentiva is receiving SEK2.4 billion (US$249 million) in the deal, which includes SEK2.4 billion (US$14.72 million) up front, plus regulatory and commercial milestones. Cinclus could bring in about SEK55 million (US$5.6 million) in near-term milestone payments in 2026.

In search of lower prices, FDA enhances Rx import program

It’s been nearly five years since the U.S. FDA, under the first Trump administration, issued a final rule and guidance on state importation plans (SIP) for importing less expensive prescription drugs from Canada. Yet only one state, Florida, has an approved SIP. In hopes of adding to that number, the FDA is enhancing its drug importation program to ease the way for states and tribes to bring prescription medicines in from Canada, at Canadian prices. The enhancements include the opportunity to submit a draft SIP and to meet with the agency to get feedback before submitting the final plan.

Holiday notice

BioWorld's offices will be closed in observance of Memorial Day in the U.S. No issue will be published Monday, May 26.

Also in the news

Aft, Annji, Bayer, Bioarctic, Biodexa, Celltrion, Cel-Sci, Cureduchenne, Eikon, Eli Lilly, Fore, Hyloris, Insmed, Ose Immunotherapeutics, Relief, Satellos, Scienture, Senti, Sernova, Sichuan Kelun, Taurx, Urogen