Welcome to our dedicated page for Immuneering news (Ticker: IMRX), a resource for investors and traders seeking the latest updates and insights on Immuneering stock.
Immuneering Corporation (Nasdaq: IMRX) is a clinical-stage oncology company developing Deep Cyclic Inhibitors, with a lead focus on atebimetinib, an oral, once-daily MEK inhibitor for MAPK pathway-driven cancers such as pancreatic cancer. This news page aggregates company announcements, clinical data updates, financing news, and other disclosures that Immuneering releases through press statements and regulatory filings.
Readers can find detailed coverage of Immuneering’s clinical trial progress, including Phase 2a data for first-line pancreatic cancer patients treated with atebimetinib in combination with modified gemcitabine/nab-paclitaxel (mGnP). The company has reported updated overall survival, progression-free survival, response rates, and safety findings from a cohort of 34 patients, as well as case studies of patients treated with atebimetinib plus FOLFIRINOX. Immuneering also provides timelines for anticipated milestones such as additional survival data readouts and the planned initiation of a global Phase 3 registrational trial in metastatic pancreatic cancer.
In addition to clinical results, Immuneering’s news flow includes corporate and financial updates such as quarterly financial results, underwritten public offerings of Class A common stock, private placements with institutional investors, and guidance on expected cash runway. Announcements related to index inclusion, such as the company’s expected addition to the Nasdaq Biotechnology Index, and conference presentations at healthcare and scientific meetings are also part of the regular news cycle.
Investors and followers of oncology drug development can use this page to track Immuneering’s disclosures about regulatory interactions with the FDA and EMA, combination trial agreements in non-small cell lung cancer, and intellectual property developments such as the granting of a U.S. composition of matter patent for atebimetinib. Bookmark this feed to monitor how Immuneering’s Deep Cyclic Inhibitor programs and corporate strategy evolve through official company communications.
Immuneering (NASDAQ: IMRX) has announced a clinical supply agreement with Regeneron Pharmaceuticals to evaluate its lead product candidate IMM-1-104 in combination with Regeneron's anti-PD-1 therapy, Libtayo (cemiplimab). The combination will be tested in patients with unresectable or metastatic RAS-mutant non-small cell lung cancer (NSCLC) as part of Immuneering's ongoing Phase 2a clinical trial.
This marks Immuneering's first collaboration involving IMM-1-104. Under the agreement terms, Immuneering will sponsor the studies while Regeneron provides Libtayo. Immuneering retains global development and commercialization rights to IMM-1-104. The collaboration is supported by preclinical data presented at AACR 2023, which demonstrated the dual-targeting potential of IMM-1-104 in combination with immuno-oncology agents to break tumor MAPK addiction and enhance anti-tumor immunity.
Immuneering (Nasdaq: IMRX), a clinical-stage oncology company, has announced its participation in the Oppenheimer 35th Annual Healthcare Life Sciences Conference. The virtual conference is scheduled for February 11-12, 2025.
The company's management team, including Chief Executive Officer Ben Zeskind and Chief Scientific Officer Brett Hall, will deliver a presentation on February 12 from 2:40 – 3:10 pm ET in Track 2. During the conference, they will discuss Immuneering's pipeline, platform, and business strategy.
The presentation will be accessible through a live webcast and will be archived in the Investor Relations section of Immuneering's website under Events & Presentations.
Immuneering (Nasdaq: IMRX) has announced positive updates from its Phase 2a clinical trial evaluating IMM-1-104 in combination with modified FOLFIRINOX (mFFX) for first-line pancreatic cancer. The trial reported two new partial responses (PRs), resulting in an overall response rate (ORR) of 50%, surpassing the historic benchmark of 32% for FOLFIRINOX alone. As of January 6, 2025, six patients were evaluable, with three achieving partial responses.
The combination therapy was generally well tolerated. Immuneering raised nearly $14 million in net proceeds through its ATM facility, enhancing its cash balance. The company plans to provide further Phase 2a data in the second quarter of 2025 and to initiate new trial arms combining IMM-1-104 with a BRAF inhibitor and a checkpoint inhibitor. Additionally, planning for a pivotal trial of IMM-1-104 with modified gemcitabine/nab-paclitaxel is underway.
Immuneering (NASDAQ: IMRX) reported positive data from three pancreatic cancer arms of its Phase 2a trial for IMM-1-104. The drug showed a 43% overall response rate (ORR) and 86% disease control rate (DCR) when combined with modified gemcitabine/nab-paclitaxel in first-line pancreatic cancer patients.
Initial data for IMM-1-104 with modified FOLFIRINOX in first-line pancreatic cancer showed tumor shrinkage in all evaluable patients, including a 100% reduction. In second-line pancreatic cancer monotherapy, the drug demonstrated a 67% reduction in one patient.
The company plans to expand the trial with three additional combination arms in 2025, including combinations with BRAF inhibitor in melanoma and immune checkpoint inhibitors in both melanoma and NSCLC. Further Phase 2a data is expected in Q2 2025.
Immuneering (Nasdaq: IMRX), a clinical-stage oncology company, announced the formation of a Pancreatic Cancer Advisory Board to advance its lead clinical program, IMM-1-104. This follows recent Orphan Drug and Fast Track designations for IMM-1-104 in pancreatic cancer. The advisory board, comprising world-renowned oncology researchers, will provide strategic medical and clinical guidance. Members include Tanios Bekaii-Saab, M.D. (Mayo Clinic), Vincent Chung, M.D., FACP (City of Hope), Shubham Pant, M.D. (MD Anderson Cancer Center), and Jordan Berlin, M.D., FASCO (Vanderbilt-Ingram Cancer Center). CEO Ben Zeskind emphasized the board’s role in advancing IMM-1-104 and improving options for pancreatic cancer patients.
Immuneering (IMRX) announced plans to hold a virtual Investor Event in early January 2025 to present data from its ongoing Phase 2a trial of IMM-1-104 in pancreatic cancer. The presentation will include additional data from IMM-1-104 combined with mGnP in first-line pancreatic cancer, initial data from its combination with mFFX in first-line pancreatic cancer, and initial data from IMM-1-104 monotherapy in second-line pancreatic cancer.
The company will also share initial PK, PD and safety data from the Phase 1 portion of its Phase 1/2a trial of IMM-6-415. The FDA has granted IMM-1-104 Orphan Drug designation in pancreatic cancer and Fast Track designations for both first and second-line pancreatic cancer, as well as advanced melanoma.
Immuneering (NASDAQ: IMRX) has received FDA Fast Track designation for IMM-1-104 to treat patients with unresectable or metastatic NRAS-mutant melanoma who have progressed on or are intolerant to PD-1/PD-L1 based immune checkpoint inhibitors. The drug is currently in Phase 2a clinical trials for advanced solid tumors, including melanoma.
According to Phase 1 data presented at ESMO 2024, IMM-1-104 demonstrated unique tolerability compared to existing MEK inhibitors used in melanoma treatment. The Fast Track designation may enable more frequent FDA interactions and potential eligibility for accelerated approval and priority review. This is the third Fast Track designation for IMM-1-104, following previous designations for first and second-line pancreatic cancer treatment.
Immuneering (Nasdaq: IMRX), a clinical-stage oncology company focused on universal-RAS/RAF cancer medicines, will participate in the Piper Sandler 36th Annual Healthcare Conference in New York City from December 3-5, 2024. The company's management team will present in a fireside chat format on December 5 from 1:00-1:25 pm ET, discussing their pipeline, platform, and business strategy. The presentation will be available via live webcast and archived on Immuneering's website in the Investor Relations section.
Immuneering (NASDAQ: IMRX) reported Q3 2024 financial results and significant clinical progress. The company announced positive initial data for IMM-1-104 in combination with chemotherapy for first-line pancreatic cancer patients, including complete and partial responses. The FDA granted both Orphan Drug and Fast Track designations for IMM-1-104 in pancreatic cancer treatment.
Financial highlights include cash position of $50.7 million as of September 30, 2024, Q3 net loss of $14.6 million ($0.49 per share), and R&D expenses of $11.3 million. The company expects its cash runway to extend into Q4 2025.
Immuneering (Nasdaq: IMRX) has announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to IMM-1-104 for the treatment of pancreatic cancer. This designation follows the company's recent announcement of positive initial Phase 2a data, including complete and partial responses, for IMM-1-104 in combination with chemotherapy in first-line pancreatic cancer patients.
IMM-1-104 is currently being evaluated in a Phase 2a clinical trial for advanced solid tumors, including pancreatic cancer. The company expects to release initial data from at least one additional arm of the Phase 2a portion of their Phase 1/2a trial by year-end. Immuneering is also studying IMM-1-104 in combination with modified FOLFIRINOX and as a monotherapy for pancreatic cancer.
The FDA's orphan drug designation may qualify Immuneering for incentives such as tax credits for qualified clinical trials, exemptions from certain FDA fees, and additional time for post-approval marketing exclusivity. Earlier this year, Immuneering was also granted FDA Fast Track designation for IMM-1-104 for both first and second-line pancreatic cancer treatment.