Immuneering Corp Stock Price, News & Analysis

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.

Immuneering (Nasdaq: IMRX) announced positive initial Phase 2a data for IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel in first-line pancreatic cancer patients. The initial results show:

• 40% initial response rate (2/5 patients)
• 80% initial disease control rate (4/5 patients)
• One complete response and one partial response observed
• All five patients continuing treatment

The combination has been well-tolerated at 240 mg QD, with additional patients now dosed at 320 mg QD. These results are consistent with preclinical data and exceed expectations for gemcitabine/nab-paclitaxel alone. Immuneering plans to continue clinical development, leveraging IMM-1-104's Fast Track designation for pancreatic cancer treatment.