Welcome to the Weekly Rundown where the DDN editors cover this week’s top biotech and pharma news.
New wave of health and STEM candidates could reshape US science policy
The election of a new wave of candidates with backgrounds in medicine, science, and engineering could have implications for US health and science policy as the country grapples with healthcare costs, research funding, and disputes over vaccines and public health. The victories included Dr Amy Acton, Ohio’s former health director who was elected governor of Ohio, Dr Abdul El-Sayed, a public health administrator who won a US Senate seat in Michigan, and Dr Jasmine Clark, a microbiologist and molecular geneticist who was elected as Congress woman of the state of Georgia. STEM professionals remain relatively rare in elected office — fewer than 10 percent of members of Congress have backgrounds in medicine, public health, or engineering — potentially giving the incoming lawmakers greater influence and expertise over debates on healthcare access, federal research funding, and public health policy at a time of major changes to the US scientific and public health infrastructure. – Bree Foster
FDA places partial hold on Bright Minds’ Phase 2 trial
On Monday, Bright Minds Biosciences announced that the FDA notified them that they placed a partial hold on their IND application and associated proposed Phase 2 trial for BMB-101, an oral 5-HT2C receptor agonist to treat epilepsy. The notice came as a result of the FDA’s review that observed toxicity in mice, and specifically “inadequate pharmacokinetic and juvenile toxicity data to support the proposed pediatric enrollment,” according to the statement from Bright Minds. The company noted that they believe the partial hold only applies to their proposed Phase 2 trial of the drug to treat patients with developmental and epileptic encephalopathies (DEEs) in the US without impacting other ongoing clinical trials. The company also stated that they do not believe the toxicity was related to the drug, however, they cautioned: “These are the Company’s beliefs and should not be understood as the FDA findings or as resolving the FDA’s stated concerns.” Bright Minds completed a Phase 1 trial in 64 volunteers, where they said their data showed no serious adverse events. Following the announcement, Bright Minds’ stock dropped by as much as 52 percent. – Allison Whitten
AbbVie licenses gut-targeted EP4 agonist for IBD from Nxera
AbbVie is placing a bet on gut-targeted drugs. This week, the company announced that it signed an exclusive global license with Nxera Pharma for NXE0033744, an oral small molecule that activates the prostaglandin receptor EP4 for inflammatory bowel disease (IBD). Nxera gets $100 million upfront and is eligible for up to $1.37 billion more in development and commercial milestones, plus tiered royalties. Most current IBD drugs work by dialing down the immune response. This candidate takes a different angle, switching on EP4 locally in the gut to calm inflammation and help repair the intestinal lining. Nxera discovered it using its structure-based platform for G protein-coupled receptors, and the company reported that a completed Phase 1 program, which included people with ulcerative colitis, showed a gut-restricted profile and signs of target engagement. The deal signals growing big pharma interest in mucosal healing as a distinct therapeutic target in IBD, where many people still struggle to reach lasting remission. – Andrea Corona
Boehringer turns to China in $7B cancer drug deal
Boehringer Ingelheim has struck a multi-program cancer drug development deal with Sino Biopharmaceutical worth up to $7 billion in milestone payments, as the German drugmaker expands its push into antibody-drug conjugates (ADCs) and T-cell engagers. The agreement covers six preclinical biologic programs developed by Sino and its subsidiaries, with the Chinese company responsible for early development. Boehringer will have the option to secure worldwide rights for two of the drugs, and the ex-China rights for the other four, once agreed clinical milestones are reached. Sino will receive $358 million in upfront and near-term payments and could earn a further $7 billion, plus tiered royalties on future sales. The agreement builds on Boehringer’s broader investment in ADCs, including a deal worth up to $991 million to license an ADC candidate from South Korea’s AimedBio last year and a new $31 million Swiss R&D facility dedicated to ADC development. The deal also highlights the growing role of China’s biopharmaceutical sector as multinational drugmakers increasingly look to Chinese companies for early-stage innovation and drug candidates. – Bree Foster
Sanofi bids farewell to STAT6 autoimmune drug trial
Nurix Therapeutics announced that Sanofi made the decision to stop the first-in-human Phase 1 trial of SAR448272, an oral STAT6 degrader to treat immune-related conditions. The news came not long after Nurix had announced a $10 million milestone payment for the initiation of the clinical trial in August. Sanofi told Reuters that the decision “was based on our assessment of emerging non-clinical data, which did not meet our criteria for continued development.” While Nurix shares slipped by 35 percent following the announcement, the company stated in the press release that the decision does not affect milestone payments and royalties for other licensed programs under the collaboration agreement made with Sanofi in 2019. “While today’s news is disappointing, Nurix remains in a strong position, with a substantial cash runway, three clinical-stage programs across our wholly owned and partnered portfolio, and an exciting preclinical pipeline,” said Arthur Sands, President and CEO of Nurix, in the press release. – Allison Whitten
England trials multi-cancer blood tests in primary care
England is putting multi-cancer blood tests to the test where most diagnoses start, in the general practitioner’s (GP’s) office. A new clinical trial will assess whether GPs using simple blood tests leads to earlier cancer diagnoses and better survival. The tests, developed by the University of Birmingham and its partners, look for signs of several cancers in a single blood sample and suggest where in the body the cancer originated, using approaches that include AI and blood protein measurement. The trial covers 14 cancers often caught late, including prostate, ovarian, bowel, pancreatic, stomach, and liver cancers. At least 200 GP practices across England’s National Health Service will take part, enrolling more than 20,000 people aged 45 and older who come in with abdominal symptoms like persistent bloating or discomfort. Results will help decide whether the tests roll out nationally. For drug developers, broader real-world use of these tests could shift when and at what stage people with cancer enter the treatment pipeline, with knock-on effects for trial recruitment and biomarker strategy. – Andrea Corona
