Fresh off a major clinical win, Revolution Medicines alleges that Erasca’s pancreatic cancer drug infringes on key patent protections and that the rival has “improperly compared” the companies’ assets publicly.
After securing a prime post in the pancreatic cancer space with impressive data earlier this month, Revolution Medicines is now hustling to maintain its lead. Last week, the California biotech demanded that Erasca, a key competitor, stop working on its pancreatic cancer drug candidate in the U.S.
Erasca revealed the communication in an SEC filing on Monday, noting that Revolution claimed that Erasca’s asset, dubbed ERAS-0015, was “substantially equivalent” to certain formulations used in Revolution’s candidate daraxonrasib. Moving ERAS-0015 forward, according to Revolution, would infringe on patent protections.
Revolution also claimed in its letter that Erasca “improperly compared preclinical data of ERAS-0015 and [daraxonrasib] in public disclosures,” according to the securities document. Revolution has thus “demanded” that Erasca “immediately cease all making, using, offering for sale, selling, and importation of ERAS-0015” in the U.S.
Erasca should also “cease making any deceptive and untrue comparative statements” regarding ERAS-0015 and daraxonrasib.
For its part, Erasca insisted that “the assertions in [Revolution’s] letters are without merit.” Erasca plans to fight these claims “vigorously,” though the biotech did not specify how it plans to do so.
BioSpace has reached out to both Revolution and Erasca for comment.
There may be some merit to Revolution’s claims. Erasca on Monday also released Phase 1 dose escalation data for ERAS-0015, touting a 62% unconfirmed overall response rate (ORR) when used in patients with pancreatic ductal adenocarcinoma (PDAC) who had undergone at least two lines of therapy. Crucially, Erasca in its news release claimed that this ORR “exceeded comparator by 24 percentage points.” The “comparator” that the biotech was referring to is Revolution’s daraxonrasib, pointing to a 2025 article in the Journal of Thoracic Oncology by Punekar et al.
Erasca did not provide the title of the specific journal article used as reference. A BioSpace search through the journal’s database did yield a paper that seems to fit Erasca’s descriptions, showing a 38% confirmed ORR for daraxonrasib—exactly 24 percentage points behind Erasca’s readout on Monday. This journal article, however, was in non-small cell lung cancer. BioSpace has asked Erasca about this discrepancy.
Revolution earlier this month posted Phase 3 data for daraxonrasib in PDAC, touting overall survival of 13.2 months—nearly double the 6.7-month survival of those on chemotherapy. The late-stage victory gave a 40% boost to Revolution’s shares.
Investors also seem encouraged by the company’s action on Erasca, with Revolution trading 8% higher after Monday’s closing bell, reaching $141.94.
Erasca, on the other hand, closed Monday’s trading session down to almost 11% to $19.15, and the company further crashed more than 42% before the opening bell on Tuesday, hitting $11.09. In addition to the legal drama with Revolution, however, Erasca’s data drop also included the disclosure of a patient death, which likely contributed to the stock drop.
Specifically, a 66-year-old trial participant who had received ERAS-0015 suffered severe lung inflammation and was initially treated aggressively before choosing to withdraw supportive care. Erasca CEO Jonathan Lim suggested on an analyst call Monday that the outcome may have been different had the patient chosen to continue supportive care, Reuters reported.
Analysts were not overly concerned by the death, with H.C. Wainwright calling it “likely an isolated case in a complex patient” and J.P. Morgan analyst Anupam Rama similarly saying it was “more of a one-off case versus a clear drug-related concern,” as per Reuters.
Nevertheless, Wainwright added, “it introduces tension with the otherwise benign safety narrative and raises questions around attribution and reporting consistency.”
Cancer cocktails pairing Moderna’s mRNA-4359 with Merck’s Keytruda and Marengo’s invikafusp alfa with Gilead Sciences’ Trodelvy showed promising results, while a complex combination by Agenus and MiNK Therapeutics failed to elicit an overall response.
Combinations continue to be a primary focus in cancer drug development, as researchers seek out therapeutic cocktails that target tumor cells with optimum efficiency while also mitigating side effects and potential drug resistance.
Indeed, the next wave of combo therapies was on display at the American Association for Cancer Research’s annual meeting in San Diego last week. Companies including Moderna, Marengo Therapeutics and Akeso presented new data at AACR showcasing new uses for existing combinations, as well as blends of experimental therapies with tried-and-true treatments like chemotherapy and more recently approved drugs.
A combination approach is “very, very important,” Zhen Su, a physician-scientist and CEO of Marengo, told BioSpace, pointing as an example to the “transformative care” now available to patients with certain types of lung cancer and multiple myeloma thanks to high-powered drug combos.
“For frontline cancer, the treatment’s oftentimes a combination therapy because tumors are not easy to tackle, and sometimes you need a multi-modality approach to really hit tumors from different angles,” Su said.
Such combos might include a chemotherapy or antibody-drug conjugate (ADC) that can give a tumor “a big hit from the get-go,” he said, alongside an immunotherapy capable of activating cancer-fighting T cells.
When experimental meets approved
At AACR, Marengo shared initial data from a Phase 2 study of invikafusp alfa, an investigational dual T cell agonist, in combination with Gilead Sciences’ ADC Trodelvy, which is FDA-approved for certain forms of heavily pretreated breast cancer. Of 10 patients with heavily pretreated metastatic breast cancer, two had confirmed complete responses to the combo, two had confirmed partial responses and six saw their disease remain stable.
The drug cocktail is one of the first to combine a precision immunotherapy with a precision ADC, Su said, bringing “two of the most potent modalities into a tumor and [lighting] up a fire in their cancer.” The results so far, he continued, are a sign of “the next frontier,” an exciting new phase in the industry after his nearly three decades as a drug developer.
Marengo plans to continue expanding the trial and, “if we continue to see the benefits we’re seeing,” will potentially seek FDA Fast Track designation for the combo in breast cancer before moving into a pivotal trial. Invikafusp alfa already holds the designation as a monotherapy in advanced colorectal cancer.
Also unveiling combo data at AACR last week was Moderna, specifically, early results from a Phase 2 trial of its investigational antigen therapy mRNA-4359 in combination with Merck’s blockbuster immunotherapy Keytruda as a first-line treatment for locally advanced and metastatic melanoma. As of Dec. 1, 2025, two of 12 patients achieved a complete response, while eight had a partial response, for an overall response rate of 83%.
There are several reasons for mRNA-4359’s promise in melanoma, David Berman, Moderna’s recently appointed chief development officer, told BioSpace via email. For one, he said, “this is a novel dual mechanism therapy where we activate T cells to kill cancer cells and recalibrate the tumor microenvironment to a more immune favorable state.”
Berman also pointed to the benefits shown in a study of the combo among patients previously treated with immune checkpoint inhibitors and in late-stage data “from another company using a similar approach.”
Following Monday’s AACR presentation, in a video posted to Moderna’s website, Berman called the early trial results “quite intriguing,” while noting that “it’s hard to tease apart” the contributions of each component of the drug cocktail. Therefore, the next steps will be to determine if, in the larger cohort of patients who have progressed on checkpoint inhibitors, there is sufficient reason to believe that mRNA-4359 is bringing additional activity, he said. Those data should arrive “over the next year.”
In a Monday note to investors, Leerink Partners said that while the patient sample is very small, the 83% ORR “represents a promising signal,” though the analysts cautioned that it is “unlikely to garner meaningful investor enthusiasm.”
Hits and misses
Another promising drug is a combination of Akeso’s PD-1/CTLA-4 bispecific antibody cadonilimab with chemotherapy. The Chinese biotech is evaluating the combo in the Phase 2 Compassion-26 study as a first-line treatment for advanced cases of pancreatic ductal adenocarcinoma, the most common form of pancreatic cancer.
Data presented at AACR showed an objective response rate of just under 34% and disease control rate of 96.4% among 56 patients. The drug combination appeared to be especially effective in patients with locally advanced disease, with a median overall survival rate of more than 23 months and median progression-free survival of 11.1 months, compared to 10.5 months and 7.2 months, respectively, among those with metastatic disease.
“The efficacy of cadonilimab in hard-to-treat tumors is driven by its innovative molecular design and novel mechanism of action,” a company spokesperson told BioSpace via email. “It harnesses the therapeutic benefits of both PD-1 and CTLA-4 pathways while overcoming the traditional efficacy and safety limitations of each target.” This translates into breakthrough clinical value, the spokesperson continued. “For example, it addresses the toxicity challenges that have historically limited the use of CTLA-4 agents and improves response in PD-L1 low/negative populations where PD-1/L1 inhibitors often underperform.”
With these attributes, Akeso’s spokesperson added, “cadonilimab is well-positioned as a backbone agent to combine with novel therapies.”
Less successful, meanwhile, were results from a Phase 2 study of Agenus’ experimental immunotherapies botensilimab and balstilimab plus MiNK Therapeutics’ allogeneic cell therapy agenT-797, alongside the approved VEGFR2 antagonist Cyramza and chemotherapy. The cocktail elicited a 0% response rate among the study’s 15 eligible gastroesophageal adenocarcinoma patients.
Despite missing the study’s primary endpoint, Agenus remained optimistic, suggesting in an April 17 press release that the secondary factors of durability and survival may in fact “be the most clinically relevant endpoints” among the study’s particular population. The combo was tied to a 73% stable disease rate, while three patients experienced overall survival of more than 20 months.
The FDA has renewed calls for Amgen’s Tavneos to be pulled from the market, saying it has discovered new evidence that study personnel doctored the results of the drug’s pivotal study in order to make it look effective.
The FDA is stepping up its campaign calling for Amgen to remove its autoimmune therapy Tavneos from the market, casting doubt on the integrity of the evidence that led to the drug’s approval nearly five years ago.
“New information that only became known to CDER [Center for Drugs Evaluation and Research] more than three years after approval shows that unblinded study personnel manipulated the results of the pivotal clinical study so the drug looked effective when the original analysis did not support that conclusion,” the FDA said in a statement on Monday.
The regulator did not provide evidence to back up these allegations. The FDA added that Amgen violated the agency’s regulations by not disclosing the original analysis in its application.
CDER “can no longer conclude that there is, or has ever been, a valid demonstration that Tavneos is effective,” according to the press announcement.
“Patient safety guides every decision we make,” an Amgen spokesperson told BioSpace in an email. “We remain confident in TAVNEOS as a safe and effective medicine, supported by years of clinical data and real-world evidence. Our perspective on the benefit-risk profile of TAVNEOS differs from the Agency’s. We will evaluate next steps and respond to the FDA, while keeping patient needs and support at the forefront.”
Tavneos, an oral complement blocker, was approved in October 2021 for severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis. This condition, more commonly known as ANCA vasculitis, is a group of rare autoimmune inflammatory diseases that damage blood vessels. Tavneos was originally developed by ChemoCentryx, which Amgen acquired in 2022 for $3.7 billion.
The FDA first called for Tavneos’ withdrawal in January after the agency found problems with the way ChemoCentryx re-adjudicated the primary endpoint in the pivotal study to support the drug’s application. Amgen refused.
Then in March, the regulator put out a safety alert flagging 76 cases of liver injury and eight deaths in patients who were given Tavneos. These safety signals, which were detected through post-marketing surveillance, had “reasonable evidence of a causal association” with the drug, the agency said.
While Amgen has identified liver toxicity as a safety risk associated with Tavneos in its clinical program—a risk that is reflected in the product’s label—the cases outlined in the FDA’s alert, especially those with fatal outcomes, “represent new safety concerns,” the FDA said in its alert.
The FDA again pointed to Tavneos’ side effects in its statement on Monday, noting that CDER “is increasingly concerned about the safety profile” of the drug.
Despite ramping up its rhetoric against Tavneos, the FDA has not yet begun pulling levers to force Amgen to pull the product from the market. For now, Tavneos will remain available to patients and prescribers.
Weight loss giant Eli Lilly has penned a DNA editing deal with Profluent Bio, continuing its dealmaking spree as well as its commitment to artificial intelligence.
Lilly and AI-driven Profluent Bio are joining forces in a deal worth up to $2.25 billion biobucks in an attempt to unlock the “holy grail” of genetic medicines.
The freshly inked research pact focuses on creating new DNA editing tools and ultimately developing more precise treatments for genetic conditions with severe unmet need, according to a Tuesday release from Profluent.
The biotech will use its AI models to design site-specific recombinases—enzymes that cut and rejoin DNA—for several genomic targets. Lilly will then have the chance to exclusively license and move selected assets through preclinical and clinical development, plus commercialization.
Together, the pair are putting faith in their abilities to insert larger pieces of DNA than is possible with current technology. Many genetic diseases are caused by numerous different mutations rather than a singular mutation, which can make it challenging to create targeted medicines that help all patients. Profluent and Lilly believe they can create such therapies through a process known as kilobase-scale DNA editing.
“Kilobase-scale DNA editing remains a holy grail in genetic medicine,” Profluent cofounder and CEO Ali Madani said in a statement. “Our work with Lilly is aimed at unlocking these therapeutics previously thought impossible. We believe only AI can create the designer recombinases needed to precisely target any location in the genome.”
California-based Profluent will receive an undisclosed upfront payment amount and will have the opportunity to collect additional R&D funding from Lilly. The AI biotech could also garner up to $2.25 billion in development and commercial milestone payments, plus royalties on net sales, according to the company.
Formed in 2022, Profluent most recently raised $106 million at the end of last year—a financing round co-led by tech investor Altimeter Capital and Amazon founder Jeff Bezos’ family investment office Bezos Expeditions.
Lilly has been on a dealmaking spree, announcing a cancer biotech buyout for up to $2.3 billion on Monday. That acquisition followed takeovers of two other oncology outfits—CrossBridge Bio and Kelonia Therapeutics—in the last few weeks.
While today’s deal is a departure from the oncology streak, Lilly has already put down roots in site-specific recombinases efforts, signing on Seamless Therapeutics earlier this year. That deal could be worth more than $1 billion, with Lilly leveraging Seamless’ platform to target mutations relevant to hearing loss.
The newest research pact also fits nicely into Lilly’s dedication to AI. The pharma has recently joined forces with AI biotech Insilico and unveiled a supercomputer with NVIDIA designed to help accelerate drug discovery and development.
AbbVie is setting up a shot to buy Kestrel Therapeutics down the line, as the biotech doses patients in a Phase 1 trial for the oral pan-KRAS inhibitor KST-6051 in solid tumors.
AbbVie is staking claim to Kestrel Therapeutics, should the biotech meet certain milestones associated with its oral pan-KRAS inhibitor for solid tumors. The exclusive right to acquire would value the deal at up to $1.45 billion.
Kestrel announced the potential transaction Tuesday, at the same time as it revealed that dosing had begun for a Phase 1 clinical trial of KST-6051 for patients with KRAS-driven cancers. KRAS is one of the most common drivers of cancers, with about 20% of all malignancies associated with the mutation.
Many Big Pharmas have been digging into the space, including Amgen, which achieved approval of the first KRAS drug, Lumakras, in 2021. AstraZeneca has also recently been hunting for KRAS inhibitors in China, inking a $2 billion deal with Jacobio in December 2025.
AbbVie’s Eleni Lagkadinou, vice president of Oncology Early Development, said the partnership will explore broader KRAS mutations, whereas the earlier drugs have targeted very specific ones and had limited patient impact.
With the agreement, AbbVie will fund the KST-6051 program. The companies did not list the development and regulatory milestones that must be reached to trigger AbbVie’s right to buy Kestrel.
Zohran Mamdani and city Democrat leaders stand accused of “racially engineering” New York City’s elite public high schools, according to a Brooklyn mom who last week brought a federal lawsuit against the mayor and the Department of Education.
Yi Fang Chen, 45, is challenging the admissions process for the city’s nine Specialized High Schools (SHS) after her eldest son was denied admission to Stuyvesant High School, despite scoring in the top five percent on the admissions exam, which he took in November.
Some 26,000 students take the Specialized High Schools Admissions Test each year, competing for around 5,000 places.
Brooklyn mom Yi Fang Chen is suing New York City Mayor Zohran Mamdani over what she says is discrimination against her son who was denied entry to Stuyvesant High School.Brian Zak/NY Post
Chen told The Post her 13-year-old son scored 558 in the rigorous exam and Stuyvesant requires a score of 561, but he was still rejected. Her lawsuit challenges revisions to the admissions for the 2019 school year, which allocate 20 percent of all available seats for students who specifically got lower test scores but meet other criteria, such as coming from a lower-income background.
“Starting in 2020, the City began reserving 20 percent of its SHS seats for a separate admissions pathway — the Discovery program — that excludes students based on criteria the City purposefully selected to change the racial composition of those schools,” according to the lawsuit.
“The City adopted and continues to enforce that policy in an effort to reduce the number of Asian-American students and increase the number of black and Hispanic students admitted to the SHSs.
Chen says her son did not meet any of the qualifications for the Discovery Program.
“Any student who scored a 495 or above is not eligible for the Discovery program,” states the NYC public school website.
Chen told The Post students who scored up to 100 points below her son will be granted admission to Stuyvesant instead. “It’s very upsetting,” the data scientist and mother of three added.
The criteria were “deliberately designed” to reduce Asian American enrollment, according to thePacific Legal Foundation, a nonprofit that filed the suit on her behalf.
“The City inverted the purpose of the Discovery Program by making certain disadvantaged kids categorically ineligible for Discovery through middle-school screens calculated to exclude heavily Asian-American schools.
“So rather than expand opportunity for disadvantaged students generally, the City rewrote the program in an effort to engineer a different racial result,” a representative for the foundation told The Post.
The Discovery program was started long before Mamdani became mayor this year. Former Mayor Bill de Blasio had expanded it, with the explicit intent of admitting more black and Hispanic students.
To qualify, students must attend and be recommended by a “high-poverty public school,” and come from a family who receive welfare or food stamps, be in foster care, or classed as an “English language learner,” according to the schools department.
Yi Fang Chen said she would continue to fight for her son and other Asian-American students in New York City.Brian Zak/NY Post
The Pacific Legal Foundation says the change in the rules violates the federal Equal Protection Clause of the 14th Amendment. The Department of Education did not respond to The Post’s request for comment.
Chen arrived in the US in 1996 as a teenager from China with limited English skills. She eventually earned a PhD in statistics from Stanford University, says she filed the lawsuit in order to help hundreds of other Asian-American students stuck in the same predicament.
She said she wanted to ensure that her other two children — a son and a daughter — would not face the same discrimination.
“Yi Fang Chen…has lived and worked in New York City for decades and raised her family with the expectation that merit — not race — would determine their opportunities in public education,” says the lawsuit, which also names the city’s Department of Education Chancellor, Kamar Samuels, as a defendant.
Stuyvesant High School is one of nine high-performing Specialized High Schools in New York City.Helayne Seidman
Chen was also a plaintiff in a similar suit against the city and de Blasio in 2018. The case was dismissed in 2022, but that decision was reversed in 2024 by the Second Circuit Court, which said the city acted with “discriminatory intent,” according to the Pacific Legal Foundation.
Chen said that she consulted with her son before she filed the second lawsuit, and said that he understood what she was doing and supported it.
“Regardless of outcome, I have to do this because it’s not just my son but each year there are hundreds of students who are victims of racial discrimination,” said Chen. “I don’t understand Mamdani. He went to Bronx Science, and he benefited from that experience.”
A Brooklyn mom is suing Department of Education Chancellor Kamar Samuels, alleging discrimination against Asian-Americans at New York’s elite public high schools.Stephen Yang for the NY Post
The Bronx High School of Science is one of the SHSs in the city.
Chen said she would continue to fight for as long as it takes to change the policy.
“As a mother, I do what I think is the right thing to do,” she said.
