Albumin-Bound Paclitaxel

NEW YORK, Sept. 16, 2025 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company focused on keeping cancer patients alive, today announced the appointment of Thomas J. Schall, Ph.D., to Chairman of the Board of Directors. Dr. Schall is a renowned biotech executive and scientist with more than 30 years of leadership in drug discovery and development. He is best known as the founder and longtime CEO and Chairman of ChemoCentryx, where he led the development and eventual FDA approval of Tavneos®, a first-in-class oral therapy for ANCA-associated vasculitis. Under his leadership, ChemoCentryx was acquired by Amgen in 2022 for nearly $4 billion. His career has been defined by bringing paradigm-shifting therapies to patients with high unmet need. “Tom’s appointment comes at a pivotal time for Immuneering,” said Ben Zeskind, Ph.D., CEO of Immuneering. “His deep expertise in building companies around first-in-class therapies—and navigating the complex path from early science to regulatory approval to commercialization—will be instrumental as we advance our lead program, atebimetinib, through late-stage development. His insight and leadership will be critical to realizing the full impact of our science for patients.” Immuneering is set to announce updated data with 9 months median follow up from its ongoing phase 2a study of first-line pancreatic cancer patients treated with atebimetinib + mGnP, on September 25 and at the upcoming Pancreatic Cancer Action Network (PanCAN) Annual Scientific Summit on September 28. Dr. Schall has served on Immuneering’s Board of Directors since March 2024 and brings to the Chairmanship a unique combination of scientific vision, operational discipline, and regulatory acumen. His appointment signals the company’s readiness to enter a new phase of execution as it prepares for pivotal studies, registration filings, and ultimately commercialization. “I’ve spent my career working to develop medicines that make a real difference in patients’ lives—and that’s exactly what Immuneering is doing,” said Dr. Schall. “The progress this team has made is remarkable, and I’m honored to serve as Chairman at such a strategically important moment. I believe Immuneering has the potential to redefine what patients and physicians expect from cancer therapies.” About Immuneering Corporation Immuneering is a clinical-stage oncology company focused on keeping cancer patients alive. The Company is developing an entirely new category of cancer medicines, Deep Cyclic Inhibitors. Immuneering’s lead product candidate, atebimetinib, is an oral, once-daily Deep Cyclic Inhibitor of MEK designed to improve durability and tolerability, and expand indications to include MAPK pathway-driven tumors such as most pancreatic cancers. Atebimetinib is currently in a Phase 2a trial in patients with advanced solid tumors including pancreatic cancer. The Company’s development pipeline also includes early-stage programs. For more information, please visit www.immuneering.com. Forward-Looking Statements This press release contains forward-looking statements, including within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding: our plans to develop, manufacture and commercialize our product candidates; the treatment potential of Deep Cyclic Inhibitors, including atebimetinib, alone or in combination with other agents, including modified Gemcitabine/nab-paclitaxel (mGnP), the pivotal timing of Dr. Schall’s appointment, initiation of a pivotal trial and related patient dosing; the ability of targeting MEK to deliver a more durable benefit; the timing and content of future data releases and presentations; and the timing for the initiation of additional atebimetinib clinical trial combination arms. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the risks inherent in oncology drug research and development, including target discovery, target validation, lead compound identification, and lead compound optimization; we have incurred significant losses, are not currently profitable and may never become profitable; our projected cash runway; our need for additional funding and ability to continue as a going concern; our unproven approach to therapeutic intervention; our ability to address regulatory questions and the uncertainties relating to regulatory filings, reviews and approvals; the lengthy, expensive, and uncertain process of clinical drug development, including potential delays in or failure to obtain regulatory approvals; our reliance on third parties and collaborators to conduct our clinical trials, manufacture our product candidates, and develop and commercialize our product candidates, if approved; failure to compete successfully against other drug companies; protection of our proprietary technology and the confidentiality of our trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of our intellectual property; our patents being found invalid or unenforceable; costs and resources of operating as a public company; and unfavorable or no analyst research or reports. These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the period ended June 30, 2025, and our other reports filed with the U.S. Securities and Exchange Commission, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Media Contact: Carson Creehan 817-412-1096 carson.creehan@padillaco.com Investor Contact: Laurence Watts 619-916-7620 laurence@newstreetir.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/193b6211-e88e-4355-853c-ec51b35c86f6

Revolution Medicines said it will begin a late-stage test of its lead asset as a first-line treatment for a form of pancreatic cancer, after a Phase 1 study in this setting yielded promising data. The early-stage trial studied daraxonrasib in patients with treatment-naïve RAS-mutant metastatic pancreatic ductal adenocarcinoma (PDAC). The drug works by inhibiting a protein called RAS that causes unchecked cell growth. The trial investigated the candidate as both monotherapy and in combination with chemotherapy. In the monotherapy cohort of 38 evaluable patients given a 300 mg daily oral dose of daraxonrasib, the objective response rate (ORR) was 47% , and the disease control rate (DCR) was 89%, Revolution said on Wednesday. As of the cutoff date of July 28, most patients remained on treatment, with a median follow-up of 9.3 months. Meanwhile, in the chemo combo arm, daraxonrasib was dosed at 200 mg per day with gemcitabine nab-paclitaxel (GnP) given every two weeks. In 31 patients with sufficient follow-up, the ORR was 55% and the DCR was 90%, with a median follow-up of 6.9 months. Revolution’s stock $RVMD ticked up by as much as 9% before market open on Thursday. Based on these data, the drugmaker is planning to start a global Phase 3 trial in first-line metastatic PDAC towards the end of this year. Dubbed RASolute 303, the trial will have monotherapy and GnP combo arms, which will be compared with a GnP control arm. In the combo arm, the Phase 3 trial will dose daraxonrasib at 200 mg per day, plus GnP, for six months, followed by 300 mg per day as monotherapy, according to a company presentation . Revolution also shared an update from a trial of daraxonrasib in the second-line RAS-mutant PDAC setting. As of June 30, a 300 mg daily pill resulted in ORRs of 35% and 29% in patients with a RAS G12X mutation or any RAS mutation, respectively. DCRs were 92% and 95%, in those respective groups. The median OS was 13.1 months in the RAS G12X mutant patients and 15.6 months in participants with any RAS mutation. Progression-free survival was 8.5 and 8.1 months, respectively. Median follow-up was 16.7 months. OS “compares very favorably” to the six to seven months seen in historic chemo trials, analysts from Jefferies wrote in a Wednesday note. The analysts said that the first-line PDAC opportunity is bigger and underappreciated compared with the second-line setting, where daraxonrasib is already in a pivotal trial and could yield data next year. Another pivotal trial, called RASolute 304, is planned for the fourth quarter of this year and will test daraxonrasib in the adjuvant setting. And the drug is also being tested in non-small cell lung cancer. Revolution recently formed a funding pact with Royalty Pharma for up to $2 billion, which should allow it to fund this suite of late-stage studies.