Mazdutide

A biotech trying to disrupt substance use disorders has paused development of its Phase 2 drug and is looking for alternatives. Tempero Bio, a portfolio company of Aditum Bio, has “temporarily halted advancement of the TMP-301 program and is assessing strategic alternatives,” as of “late October,” according to a quarterly update from Nxera Pharma on Friday. Nxera out-licensed the candidate to Tempero. Tempero declined to comment. Oakland, CA-based Tempero was testing TMP-301, an mGluR5 allosteric modulator, in a Phase 2 trial for alcohol use disorder. That 110-person study is listed as “active, not recruiting” as of a July update to the federal clinical trials database. The startup also completed a Phase 1 drug-drug interaction study for cocaine use disorder. Tempero anticipated having the Phase 2 AUD data around the end of this year, President and Chief Scientific Officer Ricardo Dolmetsch told Endpoints News at the time of the company’s $70 million Series B unveiling in March. Aditum, 8VC and Khosla Ventures contributed to the round. Aditum, led by former Novartis CEO Joe Jimenez, creates single-asset companies to house experimental medicines that it in-licenses from other drug developers. The firm has an R&D team that helps its companies get to clinical proof-of-concept to attract pharma buyers. Eli Lilly bought its obesity biotech Versanis in 2023. Jimenez previously told Endpoints that he doesn’t expect all Aditum offshoots to make it. Renal biotech Anteris shuttered in 2024. Another biotech, Stalicla , is also working on an mGluR5 drug for substance use disorders. Its candidate is called mavoglurant and is derived from Novartis. Meanwhile, Lilly said last week that its protein-based drug brenipatide entered Phase 3 for AUD. Lilly is also running a Phase 2 of its GLP-1/glucagon agonist mazdutide in AUD.

Takeda's third-quarter pipeline cull, a head-to-head win against Novo Nordisk's semaglutide and a potential $1 billion-plus licensing deal by Roche made our news this week. Takeda tightened its pipeline in the third quarter. Innovent Biologics reported a head-to-head win against semaglutide in a Chinese phase 3 trial. Roche licensed a respiratory bispecific candidate in a potential $1 billion-plus deal. And more.1. Takeda drops AstraZeneca-partnered neurological program after phase 2 failureTakeda’s AstraZeneca-partnered alpha-synuclein antibody, TAK-341/MEDI1341, has failed in a phase 2 study in multiple system atrophy. The Japanese pharma also stopped developing the orexin-2 receptor agonist danavorexton (TAK-925) for narcolepsy “due to strategic considerations,” while phase 2 development in respiratory conditions remains ongoing.2. Innovent, Lilly's mazdutide trumps Novo's semaglutide in head-to-head diabetes, weight loss studyInnovent Biologics’ China-approved mazdutide has topped Novo Nordisk’s 1-mg semaglutide in a Chinese phase 3 trial conducted in patients with early-stage Type 2 diabetes and obesity. A 6-mg dose of the first-in-class GLP-1/glucagon dual receptor agonist outperformed semaglutide on the proportion of patients who met certain blood sugar and body weight benchmarks. The drug is partnered with Eli Lilly in the country.3. Roche pens $1B biobucks deal for Chinese company's respiratory disease bispecificRoche is paying $75 million upfront and committing up to $995 million in milestones to license a long-acting TSLPxIL-33 bispecific from China’s Qyuns Therapeutics. Coded QX031N, the drug holds promise for chronic obstructive pulmonary disease and asthma, according to Qyuns. The long-acting TSLP mechanism last year attracted GSK to a $1 billion buyout of Aiolos, which got its candidate from China’s Jiangsu Hengrui Pharma.4. Merck, Eisai scrap ambitions for Keytruda-Lenvima pairing in liver cancer subtype after survival missMerck & Co. and Eisai’s Keytruda and Lenvima failed to significantly extend patients’ lives when added to standard transarterial chemoembolization in unresectable, non-metastatic liver cancer. The overall survival miss at an interim analysis has led the pair to close the phase 3 Leap-012 trial. While an FDA expansion appears unlikely, the regimen was recently approved in China based on a positive progression-free survival readout.5. Boehringer returns to Kyowa Kirin with €640M pact for preclinical autoimmune moleculeIn a deal worth up to 640 million euros ($743 million), Boehringer Ingelheim has licensed a preclinical program from Kyowa Kirin that the German pharma hopes could become a “first-in-class … treatment of autoimmune diseases.” No details on the drug’s target or specific indications were given.6. WuXi AppTec sharpens focus by selling off China-based clinical research unitsWuXi AppTec is selling its China-based CRO WuXi Clinical and site management organization WuXi MedKey to Hillhouse. With the divestments, the company aims to emphasize its drug discovery, laboratory testing, process development and manufacturing services, according to a securities filing.7. BIO’s John Crowley urges ‘strategic action’ to strengthen FDA amid China’s biotech rise (Testimony before Congress)In a testimony before the Senate Health, Education, Labor, and Pensions Committee, Biotechnology Innovation Organization chief John Crowley called for “proactive, strategic action” to strengthen the FDA to secure “America’s biotech future” amid China’s rapid rise in biotech. His long list of recommendations includes reducing the time, cost and complexity of early drug development and improving the agency’s first-cycle review success rate.Other News of Note:8. Birds, lizards and cats, oh my: FDA blasts generic drug maker Hetero in scathing Form 4839. Roche's Chugai strikes $200M M&A deal to take over IgAN asset in several Asian countries10. Biogen boosts sales outlook on 'resilient' legacy MS franchise as new launches build momentum11. Astellas taps social media star Babs Costello to promote Izervay for geographic atrophy12. Samsung Bioepis gains full rights to Lucentis, Eylea biosimilars from Biogen in Europe (release)