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www.bioworld.com/articles/719509-akeso-chalks-fda-nasopharyngeal-cancer-win-with-penpulimab

Akeso chalks FDA nasopharyngeal cancer win with penpulimab

April 25, 2025

Akeso Inc. scored U.S. FDA approval of the PD-1 monoclonal antibody penpulimab in combination with cisplatin or carboplatin and gemcitabine for the first-line treatment of adult recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC). The drug also gained the go-ahead as a single agent for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemo and with at least one other prior line of therapy. Akeso has been on a roll lately, offering up solid data with a VEGFxPD-1 bispecific antibody and nailing approval by China’s National Medical Products Administration of ebdarokimab for moderate to severe plaque psoriasis in adults. Shares (OTCMKTS:AKESF) were trading at $13.02, down 18 cents.

Cassidy calls on US Congress to fix longstanding 340B flaws 

It’s time for the U.S. Congress to finally put some guardrails on the 340B prescription drug discount program it created more than 30 years ago as a way to help fund health care for low-income patients. That’s the overall conclusion of a majority staff report from the Senate Health, Education, Labor and Pensions (HELP) Committee that follows a years-long investigation into the program. “This investigation underscores that there are transparency and oversight concerns that prevent 340B discounts from translating to better access or lower costs for patients,” HELP Chair Bill Cassidy, R-La., said in releasing the report yesterday. “Congress needs to act to bring much-needed reform to the 340B program.”

Vaccine Integrity Project launched to tackle ‘unfortunate reality’

Nervousness about the Trump administration’s attitude to vaccines has spurred the formation of the Vaccine Integrity Project, which has the aim of safeguarding the use of vaccines and ensuring vaccine policy “remains grounded in the best available science,” and is “free from external influence.” The project has been launched by the Center for Infectious Diseases Research and Policy (CIDRAP) at the University of Minnesota. Doing so “acknowledges the unfortunate reality that the system we’ve relied on to make vaccine recommendations and to review safety and effectiveness data faces threats,” said Michael Osterholm, director of CIDRAP.

March sees multiple phase III successes, boosting Corcept and Mineralys

In March 2025, BioWorld tracked 25 positive phase III trial results. In the cancer space, Corcept Therapeutics Inc.’s phase III Rosella study of relacorilant plus nab-paclitaxel in platinum-resistant ovarian cancer met its primary endpoint, showing a 30% reduction in the risk of disease progression compared to nab-paclitaxel alone (p=0.008). After the news, the company’s stock (NASDAQ:CORT) closed up 109% on March 31.

PIKfyve enzyme is target to ‘starve’ pancreatic cancer cells

A metabolic vulnerability of pancreatic ductal adenocarcinoma could be used to address this type of cancer that often resists treatments. Scientists at the University of Michigan have discovered that inhibiting the PIKfyve enzyme prevented tumor development and reduced tumor growth by altering the lipid synthesis these cells rely on. The KRAS-MAPK pathway is involved in this process, leading the researchers to suggest that dual inhibitors of PIKfyve and KRAS-MAPK could be an effective therapeutic strategy.

The BioWorld Insider podcast: Two CEOs discuss bracing for tariffs, NIH grant cuts and gifting China biopharma leadership position

As pharma deals with the impact of NIH grant cuts and what could follow with the imposition of tariffs, Robert Williamson, CEO of Triumvira Immunologics Inc., and Hernan Bazan, CEO of South Rampart Pharma LLC, brought their extensive experience in the industry to the podcast. Their concerns include how tariffs will bring lower margins for U.S. companies, higher costs and eventually drug shortages. They also spoke about the impact on drug development as more than 90% of all drugs are NIH-supported and the challenges private investment faces as it steps in to fill the gap. “What we’re doing by freezing the domestic biotech innovation and supply space, is that … we're gifting China this future leadership in the biotech space with some of these tariffs,” Williamson said.

Also in the news

AB Science, Abbvie, Aboleris, Actimed, Alcyone, Araceli, Asahi Kasei, Astex, Avidicure, Basilea, Bioxodes, Bristol Myers Squibb, Cocrystal, Dyne, Ensysce, Equillium, Evotec, Ferring, Hansa, Inmagene, Innate, Insmed, Ipsen, Mineralys, Mosaic, Orphan, Oryzon, Recce, Sanofi, Seaport, Spyglass, Tonix