Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.
Endpoints will be covering #ESMO24 throughout the weekend, so make sure to follow along online. Deputy editor Reynald Castañeda and reporters Kyle LaHucik, Lei Lei Wu and Ayisha Sharma will be reporting from Barcelona. — Max Gelman
House passes Biosecure Act
On Monday, the US House of Representatives passed the Biosecure Act with broad bipartisan support. The bill would force biopharma companies to cut ties or restrict their work with contract manufacturers WuXi AppTec, WuXi Biologics and three genetic sequencing companies by 2032. However, it still faces an uncertain future in the Senate. Opponents have argued that the bill was written to quickly and too broadly. Zachary Brennan has the latest.
Moderna revises projections downward
Biotech’s Covid-19 superstar has faced a rough go of it since the pandemic ended, saying since late last year that it would adopt a more “restrained” approach. But after leading off 2024 with $4 billion in expected cuts, Moderna said this week that it’s planning even more. Executives mapped out an additional $1.1 billion in cuts by 2027 and pushed back the company’s breakeven point by two years, from 2026 to 2028. Moderna’s stock is down more than 80% over the last three years. Our Andrew Dunn also framed how to think about this news in our Post-Hoc newsletter.
What’s happening at #ESMO24
Our reporters shared updates from #ESMO24, including lackluster data on Amgen’s PRMT5 inhibitor, a Phase 2 look at Jazz’s HER2 antibody, Bicycle’s early case for its Padcev competitor, mid-stage data for GSK and iTeos’ PD-1 and TIGIT doublet, and more. Stay tuned for more conference coverage throughout the weekend.
Summit backs up Keytruda competitor data
In May, Summit surprised the industry by claiming its PD-1/VEGF bispecific antibody called ivonescimab beat Merck’s Keytruda in a head-to-head Phase 3 study. This Sunday, Summit backed up its case. Ivonescimab reduced the risk of lung cancer progression or death by 49% in the study, with patients going an average of 11.1 months before their disease worsened. Keytruda recorded an average of 5.8 months. Summit’s stock is up more than 800% since the May reveal, and more than 900% for the whole year.
SEC’s Illumina probe
Friday afternoon, Jared Whitlock reported that the SEC’s probe of the Illumina-Grail deal is focused on sales forecasts made by Grail’s management in the run-up to the 2021 transaction. In June, Illumina spun off Grail and it began trading as a public company.
GLP-1 readouts
We covered a string of early-stage GLP-1 readouts this week, including from Roche’s dual GLP-1/GIP candidate which showed promising weight loss, but also high rates of vomiting in a Phase 1b study. Terns also offered an early look at its oral GLP-1 agonist, which it says could be more tolerable at higher doses than currently marketed GLP-1s that are administered the same way. And Zealand’s GLP-1/GLP-2 receptor dual agonist showed promising weight loss after a previous effort with lower doses ended with “underwhelming” efficacy.
SPOTLIGHT
- Exclusive: A male contraceptive may prevent 99% of pregnancies. Now it’s up to a small biotech to finish testing it
- #WCLC24 roundup: ArriVent thinks its drug can fill Tagrisso’s gaps; Boehringer, Bayer’s data in HER2-mutated lung cancer
- Sofinnova’s Jim Healy on ‘more rational market’ as four biotech startups near their IPOs
R&D
- Mid-stage clinical trial results show why Merck and Daiichi Sankyo recently moved an antibody-drug conjugate from their $4 billion partnership into Phase 3 studies for an aggressive form of lung cancer.
- Roche says its Carmot-acquired obesity pill is effective in early study
- Seres’ microbiome therapy reduces infections in stem cell transplant patients, but next steps are unclear
- AstraZeneca’s monoclonal antibody misses primary endpoint in mid-stage trial in COPD
- GSK says long-acting asthma hopeful significantly cut attacks
- BridgeBio ends development of gene therapy for adrenal gland disorder
- Fulcrum’s Phase 3 for old GSK drug fails, stock sinks
PHARMA
- Sanofi is still showing interest in oncology. The company announced licensing deals with the radiopharma companies RadioMedix and Orano Med worth a total of €100 million, with plans to take the companies’ experimental radioligand quickly to regulators and onto the market.
- FDA advisors late Friday recommended against giving Intercept’s Ocaliva full approval by a 13-1 vote. Panelists said there were too many questions involving a confirmatory study and real-world trial conducted to try to prove clinical benefits.
- Gilead says twice-yearly HIV prevention shot succeeds in second pivotal trial
- Lilly again hires from within for CFO post, elevating 23-year company veteran
- Adicet follows other cell therapy biotechs in autoimmune pivot
- Viridian reveals first Phase 3 eye disease data in bid to compete with Tepezza
- Bayer’s treatment for menopause symptoms hits primary endpoints in third late-stage trial
FINANCING
- Ken Song’s new biotech Candid Therapeutics, emerged from stealth on Monday with more than $370 million and two clinical-stage T cell engagers.
- Vironexis Biotherapeutics also launched this week with $26 million in seed financing. The company is developing what it calls “off-the-shelf” gene therapy, hoping to launch a Phase 1/2 trial in October for CD19-positive acute lymphoblastic leukemia.
- Eli Lilly invests in Superluminal’s $120M Series A round as AI-focused startups eye the clinic
- Bicara, Zenas and MBX rekindle IPO market with rare Friday tripleheader
- MBX seeks $114M IPO to compete with Ascendis and get a long-acting GLP-1/GIP prodrug into the clinic
FDA
- CDER director Patrizia Cavazzoni said 2025 will be a “crucial year for us to really get back to where we would like to be” on a backlog of surveillance inspections conducted by the FDA.
- Roche received two approvals for subcutaneous versions of existing drugs this week. On Thursday, Tecentriq became the first PD-1 checkpoint inhibitor approved as an injection under the skin, and on Friday, the multiple sclerosis blockbuster Ocrevus snagged a thumbs up for its subcutaneous version too.
- FDA revisits new structure for drug review documents, aiming to better explain its decisions
- J&J expands Tremfya into IBD with new FDA approval
- FDA criticizes AbbVie’s ‘misleading’ ad with Serena Williams
DEALS
- Bain Capital Life Sciences has reeled in about $3 billion for its fourth fund, Endpoints News’ Kyle LaHucik has learned.
- Roivant unveils its next deal, hoping for TL1A-sized potential from a shelved Bayer lung disease therapy
- Gilead partners with AI startup Genesis Therapeutics to make small molecule drugs
- Debiopharm, ITM ink €300M licensing deal for cancer treatment
MANUFACTURING
- GSK is closing down a facility and winding down antibiotic manufacturing operations at another factory as Novartis’ Sandoz chooses to end its four-year contract.
- Sanofi opens ‘world first’ modular vaccines and biologics factory in France
- Lilly budgets $1.8B to boost Kisunla, GLP-1 manufacturing in Ireland
- Charles River to lay off 3% of staffers as it streamlines spending
HEALTH TECH
- A General Catalyst-backed startup raised $38M to help workers buy health coverage on their own
- Optum’s biosimilar business to exclude brand-name Stelara, Humira in 2025
- Former Verily execs launch effort to transform clinical trials
DON’T MISS