Immuneering Comments on Today’s FDA Approval in Second-Line Metastatic Pancreatic Cancer, Reiterates Focus on First-Line Patients

Immuneering (Nasdaq: IMRX) commented on the FDA’s newly approved second-line metastatic pancreatic cancer treatment and reiterated its focus on first-line patients.

Rhea-AI Summary

Immuneering (Nasdaq: IMRX) commented on the FDA’s newly approved second-line metastatic pancreatic cancer treatment and reiterated its focus on first-line patients. The company emphasized that its MEK inhibitor atebimetinib is being evaluated in the global, randomized, pivotal Phase 3 MAPKeeper 301 trial in first-line metastatic pancreatic cancer, which is now enrolling and lists more than 35 sites on ClinicalTrials.gov.

Immuneering highlighted previously reported Phase 2a data in 55 first-line metastatic pancreatic cancer patients treated with atebimetinib 320 mg once daily plus modified gemcitabine/nab-paclitaxel. As of the April 24, 2026 cutoff, median overall survival was 17.3 months with median follow-up of 11.6 months; 84% of evaluable patients maintained or gained weight at three months. The only Grade 3 or higher treatment-related adverse events occurring in ≥10% of patients were anemia (16%) and neutropenia (18%), both described as chemotherapy-related.

Positive

• Phase 3 MAPKeeper 301 global randomized pivotal trial in 1L metastatic pancreatic cancer now enrolling
• 17.3-month median overall survival in 55 first-line patients in Phase 2a as of April 24, 2026
• 84% of evaluable patients maintained or gained weight at three months in Phase 2a
• Grade 3+ treatment-related AEs ≥10% limited to anemia (16%) and neutropenia (18%), both chemotherapy-related

Negative

• None.

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News Market Reaction – IMRX

$348.72M Market Cap

On Aug 27, the first trading day after this news, IMRX closed 1.17% above the previous close. Our momentum scanner recorded 2 alerts for this stock that day.

Data tracked by StockTitan Argus for the Aug 27 session.

Key Figures

Median overall survival: 17.3 months Study population: 55 patients Dose: 320 mg once daily +5 more

Median overall survival

17.3 months

Phase 2a study in first-line metastatic pancreatic cancer

Study population

55 patients

First-line metastatic pancreatic cancer Phase 2a study

Dose

320 mg once daily

Atebimetinib in the Phase 2a study

Median follow-up

11.6 months

April 24, 2026 data cutoff

Weight maintained or gained

84%

Evaluable patients at three months

Grade 3+ anemia

16%

Treatment-related adverse events; chemotherapy-related

Grade 3+ neutropenia

18%

Treatment-related adverse events; chemotherapy-related

Trial locations

More than 35

MAPKeeper 301 locations listed on ClinicalTrials.gov

Historical Context

5 past events · Latest: Aug 05

5 events

1. Aug 05

   Second-quarter earnings

   24h Move

   -0.2%

   Quarterly results reiterated clinical progress, cash runway, expenses, and net loss.

2. Jul 21

   Preclinical publication

   24h Move

   +0.2%

   Cancer Research publication described broad preclinical activity and favorable tolerability.

3. Jul 17

   Inducement awards

   24h Move

   -7.5%

   New-hire options covered 682,400 shares at a $4.78 exercise price.

4. Jun 15

   CFO appointment

   24h Move

   +0.0%

   Andrew Gengos was appointed CFO effective July 16, 2026.

5. Jun 11

   Phase 3 dosing

   24h Move

   +5.1%

   MAPKeeper 301 dosed its first patient in metastatic pancreatic cancer.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

metastatic pancreatic cancer, overall survival, open-label, single-arm, +1 more

5 terms

metastatic pancreatic cancer medical

"For patients with second-line (2L) metastatic pancreatic cancer"

A serious form of cancer that began in the pancreas and has spread to other parts of the body, such as the liver or lungs; think of it like a fire that started in one room and has moved through the house. It matters to investors because metastatic disease usually signals advanced illness with limited treatment options, influencing the commercial prospects of therapies, clinical trial success, healthcare costs, and the financial outlook for companies working on diagnostics or treatments.

overall survival medical

"17.3-month median overall survival previously reported"

Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

open-label medical

"Immuneering's open-label, single-arm Phase 2a trial"

Open-label describes a situation where everyone involved in a study or process knows the full details, such as who is receiving a treatment or intervention. For investors, understanding whether a project or product is open-label helps gauge the level of transparency and potential biases, influencing trust and decision-making. It’s like knowing whether a test or experiment is conducted openly or behind closed doors.

single-arm medical

"Immuneering's open-label, single-arm Phase 2a trial"

A single-arm study is a clinical trial that gives all participants the same treatment and does not include a separate comparison group or placebo. Think of it like testing a new recipe by serving it to diners without offering a control dish — you can see how people respond, but you can’t directly compare results to another option. For investors, single-arm trials can speed development and reduce cost but leave more uncertainty about how a treatment stacks up against existing therapies and how regulators will view the evidence.

treatment-related adverse events medical

"The only treatment-related adverse events observed at Grade 3"

Treatment-related adverse events are harmful or unwanted health effects that doctors or regulators determine were caused by a drug, vaccine, device, or other medical therapy. Investors care because how often and how severe these side effects are can shape regulatory approval, labeling, sales potential and legal risk — similar to how product defects can stop or damage a company's ability to sell an item.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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- For patients with second-line (2L) metastatic pancreatic cancer, today’s FDA approval of a new treatment is an important milestone – 

- For patients with first-line (1L) metastatic pancreatic cancer, Immuneering’s atebimetinib is being evaluated in a global randomized Phase 3 trial, MAPKeeper 301 –

- 17.3-month median overall survival previously reported from Immuneering’s Phase 2a study of atebimetinib plus modified gemcitabine/nab-paclitaxel (mGnP) in 1L pancreatic cancer -

- In the same Phase 2a study, the only Grade 3+ treatment-related adverse events in ≥10% of patients were anemia (16%) and neutropenia (18%), both chemotherapy-related -

NEW YORK, Aug. 26, 2026 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a late-stage clinical oncology company focused on keeping cancer patients alive and helping them thrive, today shared comments following the recent FDA approval of a new second-line pancreatic cancer treatment.

“Approval of this new treatment is good news for the subset of pancreatic cancer patients who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy,” said Ben Zeskind, Ph.D., CEO of Immuneering. “The top priority for the pancreatic cancer field now turns to the development of treatments for first-line metastatic pancreatic cancer patients. Immuneering is focused on treating these patients, and our Phase 3 MAPKeeper 301 study is enrolling them now. Atebimetinib is designed to help cancer patients live longer through a balance of attacking tumors and protecting patients. From the beginning, we have sought to control disease in parallel with maintaining body weight and minimizing harsh side effects such as rash, diarrhea, stomatitis, and fatigue. Our goal is to give first-line pancreatic cancer patients a choice that can help them live long, stay strong, and feel well.”

MAPKeeper 301 (NCT07562152) is a global, randomized pivotal trial evaluating atebimetinib in combination with chemotherapy in patients with first-line metastatic pancreatic cancer. More than 35 trial locations are already listed on ClinicalTrials.gov.

As previously reported, Immuneering's open-label, single-arm Phase 2a trial achieved 17.3 months median overall survival in 55 first-line metastatic pancreatic cancer patients treated with atebimetinib 320 mg once daily plus modified gemcitabine/nab-paclitaxel (mGnP), as of the April 24, 2026 data cutoff, with median follow-up of 11.6 months. Notably, 84% of evaluable patients maintained or gained weight at three months. The only treatment-related adverse events observed at Grade 3 or higher in ≥10% of patients were anemia (16%) and neutropenia (18%), both chemotherapy-related.

About Immuneering Corporation

Immuneering is a late-stage clinical oncology company dedicated to keeping cancer patients alive and helping them thrive, with an initial focus on patients with RAS, RAF, and other MAPK-driven cancers. The Company is developing an entirely new category of cancer medicines, Deep Cyclic Inhibitors, designed to improve overall survival by three mechanisms: shrinking tumors durably with less resistance, preserving body mass by countering cachexia, and minimizing side effects to maximize performance status and combinability. Immuneering’s lead product candidate, atebimetinib, is an oral, once-daily Deep Cyclic Inhibitor of MEK, designed to improve survival across many cancer indications. The Company is conducting a global randomized pivotal trial, MAPKeeper 301, evaluating atebimetinib in combination with chemotherapy in first-line pancreatic cancer patients. The Company’s development pipeline also includes additional combination opportunities and preclinical 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: the treatment potential of atebimetinib, alone or in combination with other agents to treat cancer, including modified Gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer and its potential to deliver overall survival with both durability and tolerability; the timing of dosing and preliminary readout of the planned Phase 2 lung cancer trial and the Phase 3 topline readout of the MAPKeeper 301 trial; the timing of beginning IND-enabling studies in a second DCI program; our operating plans and anticipated cash runway, and the potential ability of the three design mechanisms of atebimetinib to shrink tumors durably, improve overall survival and overcome the limitations of conventional MAPK inhibition and provide a more sustained clinical benefit for patients.

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: we are a late-stage clinical oncology company with a limited operating history and have not completed any registrational clinical trials; we have incurred significant losses, are not currently profitable and may never become profitable; limitations on our cash runway and potential increases in expenditures; our need for additional funding; our unproven approach to therapeutic intervention; our ability to address regulatory questions and changing regulatory standards, and the uncertainties relating to regulatory filings, reviews and approvals; the lengthy, expensive, and uncertain process of clinical drug development, including the uncertainty of whether positive preclinical or early clinical efficacy and safety results are confirmed in later-stage trials, potential delays in activation of trial sites or enrollment of trial participants, 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, 2026, 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.

Investor Contact:
Laurence Watts
New Street Investor Relations
laurence@newstreetir.com

Media Contact:
David Caouette
dcaouette@immuneering.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Immuneering (IMRX) say about today’s FDA approval in second-line metastatic pancreatic cancer?

Immuneering said the new FDA-approved second-line treatment is good news for patients who have received prior systemic therapy or are not candidates for multiagent regimens. According to Immuneering, this shifts the field’s top priority toward developing therapies for first-line metastatic pancreatic cancer patients.

What is the MAPKeeper 301 Phase 3 trial for Immuneering’s atebimetinib in first-line metastatic pancreatic cancer (IMRX)?

MAPKeeper 301 is a global, randomized pivotal Phase 3 trial evaluating atebimetinib plus chemotherapy in first-line metastatic pancreatic cancer. According to Immuneering, the study is currently enrolling, with more than 35 trial locations already listed on ClinicalTrials.gov for patient access and participation.

What were the Phase 2a overall survival results for atebimetinib in first-line metastatic pancreatic cancer reported by Immuneering (IMRX)?

Immuneering reported a 17.3-month median overall survival in its open-label, single-arm Phase 2a trial of atebimetinib plus modified gemcitabine/nab-paclitaxel in 55 first-line metastatic pancreatic cancer patients, as of April 24, 2026, with median follow-up of 11.6 months, according to Immuneering’s disclosure.

What safety profile did Immuneering (IMRX) report for atebimetinib plus chemotherapy in its Phase 2a pancreatic cancer study?

According to Immuneering, the only Grade 3 or higher treatment-related adverse events occurring in at least 10% of patients were anemia (16%) and neutropenia (18%). Both events were described as chemotherapy-related in the first-line metastatic pancreatic cancer Phase 2a trial.

How did atebimetinib affect patient weight in Immuneering’s Phase 2a first-line metastatic pancreatic cancer trial (IMRX)?

Immuneering reported that 84% of evaluable patients maintained or gained weight at three months when treated with atebimetinib plus modified gemcitabine/nab-paclitaxel. According to Immuneering, preserving body weight aligns with its goal of controlling disease while minimizing harsh treatment side effects.

What patient population is Immuneering (IMRX) targeting with atebimetinib in pancreatic cancer?

Immuneering is targeting first-line metastatic pancreatic cancer patients with atebimetinib in combination with chemotherapy. According to Immuneering, its MAPKeeper 301 Phase 3 trial is enrolling these patients, aiming to offer a treatment option focused on survival, strength, and quality of life.