Daraxonrasib

Erasca, Inc. (USA) announced on April 27, 2026, via a US Securities and Exchange Commission Form 8-K filing, that Revolution Medicines, Inc. (RevMed, USA) had transmitted a letter alleging that ERAS-0015, Erasca’s pan-RAS molecular glue, infringes RevMed’s US Patent No. 12,409,225. The dispute centers on the molecular glue class of RAS-targeting agents, where compounds are designed to suppress oncogenic RAS signaling by stabilizing inhibitory protein-protein interactions rather than occupying a conventional active site, a mechanistic distinction that has drawn substantial competitive interest across the oncology sector. RevMed’s letter, received by Erasca on April 24, 2026, asserted three distinct claims: that ERAS-0015 is substantially equivalent to compositions claimed in the ‘225 Patent and therefore infringes it under the doctrine of equivalents; that a third party misappropriated RevMed’s alleged trade secrets in connection with a patent relating to ERAS-0015, rendering Erasca liable as a licensee under applicable trade secret law; and that Erasca made improper comparative statements in public disclosures contrasting preclinical data for ERAS-0015 and RevMed’s own RMC-6236. RevMed demanded that Erasca immediately cease all making, using, offering for sale, selling, and importation of ERAS-0015 in the United States for any purpose not protected by the Hatch-Waxman safe harbor, and that Erasca discontinue comparative statements RevMed characterized as deceptive. Erasca stated it believes the assertions are without merit and intends to contest the allegations vigorously. The ‘225 Patent, based on the “compositions claimed” language cited in the 8-K, appears to cover composition-of-matter claims directed at pan-RAS molecular glue compounds. The full claim text was not disclosed in the filing, and specific patent term or expiry data were not provided. The doctrine-of-equivalents theory advanced by RevMed suggests that ERAS-0015 may not be literally identical to the claimed compositions but is alleged to be functionally or structurally analogous within the scope of the granted claims. ERAS-0015 is currently in a Phase I first-in-human study designated AURORAS-1 (NCT06983743), evaluating safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity in patients with advanced or metastatic RAS-mutant solid tumors. On the same day the 8-K was filed, April 27, 2026, Erasca announced a conference call and webcast to present preliminary Phase I dose-escalation data from that study. Earlier company disclosures from March 2026 referenced favorable safety and tolerability observations, linear pharmacokinetics, and confirmed and unconfirmed partial responses in the dose-escalation cohort. Those characterizations originated from company press releases rather than peer-reviewed publications, and Erasca has described the data as preliminary. Specific clinical results including patient counts, response duration, and adjudicated efficacy outcomes have not been disclosed in the materials available from this filing. The dispute between Erasca and RevMed reflects the degree of competition that has emerged around pan-RAS and RAS-ON inhibition strategies, a class that has moved from conceptual interest to active clinical development over the past several years. RAS mutations are present across a broad range of solid tumor histologies, and agents capable of suppressing multiple RAS isoforms or mutant variants have attracted attention from multiple development organizations. RevMed’s own RMC-6236 is a RAS-ON multi-selective inhibitor, meaning it targets the active GTP-bound state of RAS rather than a specific mutant allele. RMC-6236 is being evaluated in a Phase I/II program (NCT05379985) in patients with RAS-mutant solid tumors including pancreatic ductal adenocarcinoma, non-small cell lung cancer, and colorectal cancer. RevMed’s letter to Erasca explicitly referenced comparative preclinical disclosures involving RMC-6236 and ERAS-0015, indicating that RevMed views the two programs as operating in overlapping mechanistic and commercial territory. A second program from RevMed, RMC-6291, targets KRAS G12C specifically in the active state and is in Phase I evaluation (NCT05462717). Within the broader molecular glue and pan-RAS space, Navire Pharma (USA) has advanced BBP-398, a SHP2 inhibitor that functions upstream of RAS to reduce RAS activation, in Phase I/II combination studies (NCT04528836). While SHP2 inhibition is mechanistically distinct from a direct RAS molecular glue, both strategies aim to suppress RAS pathway output across tumor genotypes rather than targeting a single mutant allele. Mirati Therapeutics, now part of Bristol Myers Squibb (USA), developed adagrasib (KRAS G12C-specific covalent inhibitor) as a mutation-selective agent; its US FDA approval in KRAS G12C-mutant non-small cell lung cancer and colorectal cancer established a regulatory precedent for RAS-directed therapy but does not address the broader RAS-mutant population that pan-RAS strategies are designed to reach. The patent dispute introduced by RevMed’s letter adds a legal dimension to an already competitive development environment. Erasca has not indicated any intention to pause the AURORAS-1 trial or alter its development plans for ERAS-0015 in response to the letter. The Hatch-Waxman safe harbor referenced in RevMed’s demand would, if applicable, protect clinical research activities from infringement liability under US law. Resolution of the underlying patent and trade secret claims would require either negotiated settlement or litigation proceedings, neither of which has been initiated as of the filing date. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Welcome back to another edition of Endpoints Weekly! We’re doing a little bit of celebrating here at Endpoints, as we took home three Neal Awards, which recognize excellence in B2B journalism . The winning entries came from Max Bayer’s government, legislative and regulatory coverage, Ryan Cross’ series on CRISPR, and our JP Morgan healthcare conference event, which was led by Nicole Wetsman and our events team. We also had two other finalists — Max’s pharma “frequent fliers” story and our coverage of China’s biotech industry. Congrats to all, and have a great weekend! — Max Gelman 📊 Sanofi reported its first-quarter earnings this week, and new CEO Belén Garijo starts next week. But the company will likely face a reckoning on its immunology strategy before she even begins, given the mixed track record in the clinic under predecessor Paul Hudson. It probably doesn’t make sense for Garijo to continue down the same path, Jefferies managing director Michael Leuchten said in an interview. “I think that’s off the table,” he said. The Hudson strategy homed in on a dozen potential blockbuster immunology drugs, three of which were projected in late 2023 to reach at least $5 billion in annual peak sales. One succeeded in a Phase 2 study for multiple sclerosis and now has pivotal trials underway, but the second brought new safety concerns and the third flunked multiple mid-stage tests. Sanofi also held a call with reporters before Thursday’s earnings event, where executives defended the Garijo appointment and said the company is “fully committed” to immunology. The call was an exercise in redirecting the narrative , Ayisha Sharma writes. Elsewhere in earnings news, Roche also recapped its first quarter, with CEO Thomas Schinecker making bold predictions about its experimental breast cancer pill giredestrant. Schinecker said it could reach three times as many patients as blockbuster Herceptin, which at its peak in 2018 had sales of about $7 billion. Read more on Roche here from Elizabeth Cairns. 💰 Eli Lilly is going big on in vivo CAR-T, Elizabeth Cairns wrote this week . The company struck a deal worth up to $7 billion to buy Kelonia Therapeutics, which has a Phase 1 program for multiple myeloma and a couple of preclinical candidates. The deal includes $3.25 billion upfront. The deal is Lilly’s second for an in vivo CAR-T biotech, following its February bid for Orna Therapeutics. Competition is heating up, as AbbVie, AstraZeneca, Bristol Myers Squibb and Gilead all acquired in vivo cell therapy startups last year. It’s still early days for the approach. BMO Capital Markets analysts cautioned that in vivo CAR-T remains “an unproven and risky area of development.” Traditional CAR-Ts involve removing T cells from a patient, altering their genetic makeup and reinfusing them back into the patient. Kelonia’s lead program KLN-1010 works by generating anti-BCMA CAR-Ts within the patient. Early data from a first-in-human study presented at last year’s ASH meeting showed that a single infusion eliminated detectable cancer cells in four heavily refractory multiple myeloma patients. Kelonia’s investors are probably happy. Unlike many startups that have raised multiple $100 million-plus rounds, Kelonia only raised a total of $60 million in private capital. One lead investor, Venrock, put in $20 million and will make $900 million back on the upfront payment. 🥼 Revolution Medicines’ pancreatic cancer data were all the talk at the annual American Association for Cancer Research conference this week. The stunning results, which showed its drug daraxonrasib doubled the survival time of second-line patients, could be a “Herceptin moment” for pancreatic cancer , Stifel managing director Tim Opler told Endpoints. Before Herceptin’s approval , chemotherapy was often the only treatment for breast cancer. Herceptin, the first targeted cancer therapy, extended survival by three months. Now, almost three decades later, many patients respond to targeted breast cancer therapies for multiple years. The hope is that something similar happens in pancreatic cancer. “It reinvigorates the whole field,” said Daniel Von Hoff of the Translational Genomics Research Institute and City of Hope. Also at the conference, KRAS drugmakers are taking another, better swing at lung cancer, reporting early-stage data for the next generation of drugs. Read all about it from Lei Lei Wu, who was on the ground in San Diego, here . 🧬 Serif Biomedicines debuted this week with $50 million and a bold mission: delivering DNA into the body without the aid of an engineered virus. Swapping viruses for other delivery vessels like lipid nanoparticles could lead to safer and cheaper treatments, Ryan Cross describes in his story . It’s no small challenge: Several other startups have tried and failed to get the idea to work. But Serif has been working on its technology since 2021, and it thinks it could be close. Serif is calling the technology “modified DNA,” which CEO Jacob Rubens said is “meant to draw a direct analogy to modified RNA.” Viruses are a natural choice for sneaking genes into cells, in part because the viral shell helps shield the DNA itself from the immune sensors that reside within cells. Serif’s solution was to tweak DNA’s shape and chemical structure until it found versions of the molecule that didn’t trigger those alarm bells. Rubens didn’t give much detail on how long the company’s current funding will last or where it will take Serif. Ryan spells out all the information we have for now here . 🤝 Regeneron agreed to a “most favored nation” deal with the White House, marking the last of the 17 drugmakers that President Donald Trump singled out in letters last summer to make a deal. HHS chief counselor and head of Medicare Chris Klomp said there’s more work for the administration to do, adding that it’s negotiating “with the many hundreds of biotechnology and pharmaceutical companies” that were not among those initially singled out. Regeneron also announced that it won approval for its first commercial gene therapy. The drug, called Otarmeni, was approved under the Commissioner’s National Priority Voucher program to treat a type of inherited hearing loss caused by mutations to a gene called otoferlin. The company said it plans to offer the treatment for free in the US, though that does not include the cost of administration. DON’T MISS: Endpoints is fielding the next Biopharma Sentiment Index (BPSI) — a concise, three-minute survey that distills thousands of industry views into a clear quarterly benchmark. This year is pivotal for biopharma, and we need your perspective on where things are going. Take the survey here.