Arcus Biosciences, Inc.

Gilead Sciences has axed half a dozen programmes from its portfolio, including candidates partnered with Novo Nordisk and Arcus Biosciences. The pipeline cull was disclosed in the company's second-quarter financial report on Thursday, when it also announced encouraging early uptake for its HIV prevention shot Yeztugo (lenacapavir) (see – Spotlight On: With Yeztugo's launch off to the races, Gilead ups HIV guidance).The pipeline prioritisation hit four cancer programmes, an experimental infectious disease asset, and Gilead's final metabolic dysfunction-associated steatohepatitis (MASH) hopeful. The drugmaker had been developing a triple-combination MASH treatment in collaboration with Novo Nordisk since at least 2020. The cocktail, comprising the Danish pharma's GLP-1 blockbuster semaglutide along with Gilead's experimental drugs cilofexor and firsocostat, was studied in the Phase II WAYFIND study.The discontinued candidates from Arcus also date back to a 2020 partnership pegged to last a decade. At the time, Gilead paid $175 million upfront and made a $200-million equity investment to co-develop and co-commercialise cancer immunotherapies from Arcus' pipeline — notably, the PD-1 inhibitor zimberelimab and several anti-TIGIT programmes, although the allure of TIGIT has since faded drastically following a number of high-profile setbacks within the class (see – Spotlight On: AstraZeneca leads TIGIT charge as another one bites the dust).In 2021, Gilead exercised options for several additional assets including etrumadenant, a dual adenosine A2a/A2b receptor antagonist, and the small-molecule CD73 inhibitor quemliclustat; both were pruned from the drugmaker's pipeline on Thursday.  The partners had been studying etrumadenant in combination with zimberelimab in the Phase II ARC-9 study for metastatic colorectal cancer, while quemliclustat was being evaluated in the Phase II ARC-8 trial in patients with metastatic pancreatic ductal adenocarcinoma, with or without the PD-1 inhibitor. Separate from the Arcus partnership, Gilead also cut two Phase I oncology programmes from its portfolio: MCL1 inhibitor GS-9716 and DGKα inhibitor GS-9911.The sixth asset to get the axe was the oral antiviral obeldesivir, specifically as a treatment for respiratory syncytial virus (RSV) in both children and adults. Gilead's decision to end development in RSV doesn't come as a surprise, as two trials were terminated in June due to "lower than expected" RSV infection incident rates. At the time, Gilead told FirstWord that a 400-person Phase II study of obeldesivir in Marburg virus disease was continuing as planned. The antiviral also failed the Phase III OAKTREE trial last year after it didn't improve time to symptom alleviation versus placebo in non-hospitalised COVID-19 patients without risk factors for severe disease.

Plus, news about Assembly Biosciences, Vaxcyte, CorMedix, Melinta Therapeutics, Innogen, Sana Biotechnology, SNIPR Biome, Voyager Therapeutics, Gilead, Arcus, Travere and Alltrna: XtalPi to work with DoveTree Medicines: The Chinese AI drug discovery company got $51 million upfront, so that DoveTree can get global R&D and commercial rights for drugs made from the partnership. There’s an additional $49 million of near-term payments on the table, as well as milestones and royalties that could balloon up to $5.9 billion. The disease targets include immunology, inflammation, neurology, oncology and metabolic disease. DoveTree was founded by biotech veteran Greg Verdine. — Reynald Castaneda Regenxbio amends eye deal with AbbVie: The companies first teamed up in 2021 to examine surabgene lomparvovec as a treatment for several eye diseases. The biotech now plans to initiate a Phase 2b/3 study in diabetic retinopathy, noting that it will receive $100 million when the first patient is dosed in that trial and another $100 million if a patient is dosed in the second Phase 3 study. Regenxbio is responsible for paying for the Phase 2b portion of the trial, while AbbVie will cover the costs of a new Phase 3 trial for sura-vec in wet AMD. — Jaimy Lee Assembly Biosciences sees safety signal in hepatitis delta study: The company said a grade 2 liver enzyme elevation was recorded in a healthy volunteer who received the highest single dose level of ABI-6250, its experimental hepatitis delta virus entry inhibitor. Assembly said that “further pharmacological assessment” would be done as it prepares for Phase 2 studies. The company noted the studies would “explore potential factors associated with these elevations given the role of ABI-6250’s target as a bile acid transporter.” — Lei Lei Wu Vaxcyte prunes early-stage pipeline: The company is pausing the advancement of two prophylactic vaccine candidates into the clinic — VAX-A1 for strep infections and VAX-GI for shigella. It is also discontinuing a therapeutic vaccine called VAX-PG for periodontal disease. Vaxcyte said the changes should allow it to focus on its pneumococcal conjugate vaccine. — Ayisha Sharma CorMedix to buy Melinta Therapeutics: The New Jersey biotech companies will come together in a deal that sees CorMedix pay $260 million in cash and $40 million in equity to “Melinta shareholders of Deerfield Management Company.” Deerfield acquired Melinta pursuant to a Chapter 11 reorganization about five years ago. CorMedix said the deal will expand its “reach in infectious disease.” — Kyle LaHucik Innogen’s Hong Kong IPO: The biotech expects proceeds of HK$610 million (about $77 million) from its initial public offering, according to an HKEX filing . The 11-year-old biotech markets a type 2 diabetes drug in China and is also working in MASH, obesity and other areas. DualityBio , Hengrui Pharma and other biotechs have gone public on the Hong Kong exchange this year. — Kyle LaHucik Sana Biotechnology’s $75M offering: The biotech is selling about 21 million shares at $3.35 apiece. — Jaimy Lee SNIPR Biome raises $40.7M Series B: The Copenhagen-based biotech will use the funds to support the development of a CRISPR/Cas therapy for airway infections caused by Pseudomonas aeruginosa bacteria in cystic fibrosis patients, among other programs. The fundraise was supported by both new and existing investors. — Ayisha Sharma Voyager Therapeutics restructures: The company executed “cost-savings measures” in the first half of the year that included changes in trial designs, outsourcing and an undisclosed number of workforce cuts, according to a SEC filing . The move extends its cash runway into 2028, as per a press release . Voyager had $262 million in cash, cash equivalents and marketable securities as of June 30. It had 172 staffers at the end of 2024. — Reynald Castaneda Gilead drops Arcus cancer drug: The partners have decided not to advance etrumadenant into registrational development for colorectal cancer, despite the FDA confirming a potential path forward. Gilead returned its license for the A2a/A2b receptor antagonist in June. It paid $725 million to exercise options for etrumadenant and several other Arcus drugs back in 2021. — Ayisha Sharma Travere gets $17.5M from CSL Vifor: The milestone payment stems from Filspari’s conversion from a conditional to standard approval in the EU and UK. Filspari is Travere’s treatment for IgA nephropathy, which received conditional approvals in Europe last year. The drug also won full FDA approval in 2024, following an initial accelerated approval in 2023. — Lei Lei Wu Flagship’s Alltrna lays off 12% of staff: The biotech let go of eight employees as it aims to get its engineered tRNA drug candidate into the clinic. “Our strategy and vision remain unchanged,” an Alltrna spokesperson said in a statement. — Jaimy Lee

Gilead Sciences secured an option on assets including etrumadenant in 2020. \n Gilead Sciences has returned the rights to a cancer candidate it licensed from Arcus Biosciences in a $725 million, multiprogram deal, confirming its retreat from an asset that was deprioritized earlier this year.After the market closed Wednesday, Arcus revealed Gilead returned the license to etrumadenant, an adenosine A2a/A2b receptor antagonist, in June. The news arrived three months after Arcus said it had opted against advancing into phase 3 following talks with the FDA about data on etrumadenant in third-line metastatic colorectal cancer.The talks confirmed a potential path to market for the drug candidate, Arcus said. However, as Arcus CEO Terry Rosen, Ph.D., told analysts on an earnings call in May, “our plans right now are not to move forward at this time, at least.”Gilead continued to list etrumadenant in its pipeline after Arcus dropped plans for a phase 3. However, Gilead has said little about the program this year and quietly handed back the license in June, a move Arcus revealed in its second-quarter earnings. Arcus reported a cumulative catch-up to revenue of $143 million relating to the return of the license and the pausing of development. The return of the license closes off one of Gilead’s chances of generating a return on its big bet on Arcus. Gilead secured an option on assets including etrumadenant in 2020. Eighteen months later, the company paid $725 million to take up its option on etrumadenant and other clinical-phase programs, including Arcus’ anti-TIGIT antibody domvanalimab. Gilead let its option on casdatifan lapse earlier this year.The Big Biotech still has licenses to domvanalimab and the other two assets from the $725 million deal, namely another TIGIT molecule and the CD73 inhibitor quemliclustat. Gilead also retains a license to zimberelimab, the anti-PD-1 antibody that was covered by the original agreement in 2020. A phase 3 trial of quemliclustat became an independent Arcus study as part of tweaks to the deal early last year.