FDA Events for Immuneering (IMRX)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Immuneering (IMRX).
Over the past two years, Immuneering has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
IMM-1-104. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
IMM-1-104 - FDA Regulatory Timeline and Events
IMM-1-104 is a drug developed by Immuneering for the following indication: Solid tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IMM-1-104
- Announced Date:
- June 17, 2025
- Indication:
- Solid tumors
Announcement
Immuneering Corporation announced positive data from its ongoing Phase 2a clinical trial evaluating atebimetinib (IMM-1-104), an oral, once-daily novel MEK inhibitor, in combination with modified gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer patients.
AI Summary
Immuneering Corporation announced promising Phase 2a clinical data for atebimetinib (IMM-1-104), an oral, once-daily MEK inhibitor, used in combination with modified gemcitabine/nab-paclitaxel in first-line pancreatic cancer patients. In the trial, 34 patients treated at a once-daily 320 mg dose showed impressive outcomes, with 94% overall survival and 72% progression-free survival at 6 months—far exceeding standard care benchmarks. Notably, the study reported a 39% overall response rate and an 81% disease control rate, with several patients experiencing deep, durable tumor regressions, including some lesions becoming undetectable. The combination treatment was well tolerated, showing a favorable safety profile without notable high-grade adverse events. These encouraging results highlight the potential of atebimetinib plus mGnP to improve outcomes in advanced pancreatic cancer, paving the way for a pivotal trial scheduled for 2026.
Read Announcement- Drug:
- IMM-1-104
- Announced Date:
- June 16, 2025
- Estimated Event Date Range:
- June 17, 2025 - June 17, 2025
- Target Action Date:
- June 17, 2025
- Indication:
- Solid tumors
Announcement
Immuneering Corporation announced that it will host a conference call and live webcast at 8:00 am ET on June 17, 2025.
AI Summary
Immuneering Corporation, a clinical-stage oncology company, announced that it will host a conference call and live webcast at 8:00 am ET on June 17, 2025. The event will include updates on the company’s progress with its Phase 2a clinical trial of IMM‐1‐104, an innovative candidate being tested in first-line pancreatic cancer patients. This trial is a key part of Immuneering’s efforts to enhance treatment options for patients with MAPK pathway-driven tumors, such as those found in pancreatic cancer.
The live webcast will be accessible to investors and interested parties and will later be archived on the Investor Relations section of Immuneering’s website. This call offers an opportunity for the public to learn more about the ongoing research and future prospects of this promising treatment in the fight against cancer.
Read Announcement- Drug:
- IMM-1-104
- Announced Date:
- February 6, 2025
- Indication:
- Solid tumors
Announcement
Immuneering Corporation announced a clinical supply agreement with Regeneron Pharmaceuticals for its anti-PD-1 therapy, Libtayo (cemiplimab).
AI Summary
Immuneering Corporation announced a new clinical supply agreement with Regeneron Pharmaceuticals. Under the agreement, Regeneron will provide its anti-PD-1 therapy, Libtayo (cemiplimab), to support clinical studies using Immuneering’s lead candidate, IMM-1-104. The company plans to evaluate IMM-1-104 in combination with Libtayo in patients with advanced non-small cell lung cancer that cannot be removed or has spread. This Phase 2a trial is focused on patients with RAS-mutant tumors, which are often difficult to treat. Immuneering aims to address unmet treatment needs by combining IMM-1-104 with established immuno-oncology agents like Libtayo. The collaboration highlights a significant step forward, as Immuneering sponsors the study while keeping global development and commercialization rights to IMM-1-104, and it partners with Regeneron, a leader in cancer research, to explore new treatment strategies for advanced cancers.
Read Announcement- Drug:
- IMM-1-104
- Announced Date:
- January 13, 2025
- Indication:
- Solid tumors
Announcement
Immuneering Corporation announced a positive update from its Phase 2a arm studying IMM-1-104 in combination with modified FOLFIRINOX (mFFX) in first-line pancreatic cancer, and provided a corporate update.
AI Summary
Immuneering Corporation announced positive updates from its Phase 2a clinical trial, where two new partial responses were observed in patients with first-line pancreatic cancer treated with IMM-1-104 in combination with modified FOLFIRINOX. With six evaluable patients, the trial achieved an overall response rate of 50%, significantly higher than the historic 32% seen with FOLFIRINOX alone. These findings support IMM-1-104’s potential as a well-tolerated MEK inhibitor that could help drive a new standard in pancreatic cancer care and possibly be used in various combinations for other indications. Additionally, the company reported strong financial momentum by raising nearly $14 million in net proceeds through its ATM facility in January 2025, underscoring its robust support for continued clinical development and upcoming trial updates later in the year.
Read Announcement- Drug:
- IMM-1-104
- Announced Date:
- January 7, 2025
- Indication:
- Solid tumors
Announcement
Immuneering Corporation announced a positive data update from three pancreatic cancer arms of its ongoing Phase 2a trial of lead program IMM-1-104, as well as plans to expand the Phase 2a trial to include three additional combination arms.
AI Summary
Immuneering Corporation announced positive updates from three pancreatic cancer arms in its ongoing Phase 2a trial of IMM-1-104. In the trial, patients receiving IMM-1-104 with modified gemcitabine/nab-paclitaxel showed an overall response rate of 43% and a disease control rate of 86%. Additionally, when used with modified FOLFIRINOX in first-line treatment, all evaluable patients experienced tumor shrinkage, including one case with a 100% reduction. The monotherapy arm in second-line treatment also demonstrated promising activity with a partial response marked by a 67% reduction in target lesions. Building on these encouraging results, Immuneering plans to expand the Phase 2a trial in 2025 by adding three new combination arms. These new arms will explore combinations of IMM-1-104 with a BRAF inhibitor for melanoma and an immune checkpoint inhibitor for both melanoma and NSCLC.
Read Announcement- Drug:
- IMM-1-104
- Announced Date:
- January 7, 2025
- Indication:
- Solid tumors
Announcement
Immuneering Corporation announced that additional combination arms planned to be initiated in 2025 -
AI Summary
Immuneering Corporation, a clinical-stage oncology company, has announced plans to expand the ongoing Phase 2a trial of its lead candidate, IMM-1-104, by launching additional combination arms in 2025. The company intends to investigate IMM-1-104 when paired with different agents to enhance its activity and tolerability. Specifically, one of the new arms will test IMM-1-104 in combination with a BRAF inhibitor for patients with BRAF-mutant melanoma. Additionally, two other combination arms are planned to evaluate IMM-1-104 alongside an immune checkpoint inhibitor, with studies focusing on both melanoma and non-small cell lung cancer (NSCLC).
This expansion aims to broaden the potential indications of IMM-1-104 and provide more treatment options for patients with cancers that have limited therapeutic solutions. The new arms, scheduled to start in 2025, build on promising earlier trial results and represent a key step in developing more effective combination therapies.
Read Announcement- Drug:
- IMM-1-104
- Announced Date:
- January 7, 2025
- Estimated Event Date Range:
- April 1, 2025 - June 30, 2025
- Target Action Date:
- Q2 - 2025
- Indication:
- Solid tumors
Announcement
Immuneering Corporation announced that Further IMM-1-104 Phase 2a data expected in 2Q'25
AI Summary
Immuneering Corporation announced encouraging new findings from its ongoing Phase 2a trial of IMM-1-104. The trial, which evaluates IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel for first-line pancreatic cancer, has shown a 43% overall response rate and an 86% disease control rate. Based on these promising results, the company is planning a pivotal clinical trial to further assess the treatment’s effectiveness. Immuneering also reported early positive data from trials combining IMM-1-104 with modified FOLFIRINOX and as a monotherapy in second-line pancreatic cancer. The company expects to present additional Phase 2a data in the second quarter of 2025 and plans to initiate several new combination arms later in the year. These steps are part of Immuneering’s effort to offer more effective and better tolerated treatments for cancer patients.
Read Announcement- Drug:
- IMM-1-104
- Announced Date:
- December 19, 2024
- Indication:
- Solid tumors
Announcement
Immuneering Corporation nnounced the formation of its Pancreatic Cancer Advisory Board.
AI Summary
Immuneering Corporation has established its Pancreatic Cancer Advisory Board, made up of top oncology experts who will guide the company’s clinical efforts in pancreatic cancer. The board includes renowned researchers from prestigious institutions such as the Mayo Clinic, City of Hope, MD Anderson Cancer Center, and Vanderbilt-Ingram Cancer Center. According to Ben Zeskind, Ph.D., Co-Founder and CEO of Immuneering, the board will provide crucial strategic and clinical advice as the company advances its lead treatment, IMM-1-104. This innovative medicine is designed to offer targeted therapy for pancreatic cancer, reflecting the company’s commitment to developing better treatment options for patients. The formation of the advisory board marks a significant milestone for Immuneering, as it builds on its progress in clinical research and reaffirms its focus on improving outcomes in pancreatic cancer care.
Read Announcement- Drug:
- IMM-1-104
- Announced Date:
- December 17, 2024
- Indication:
- Solid tumors
Announcement
Immuneering Corporation announced that it will hold a virtual Investor Event in early January 2025 to discuss data from its ongoing Phase 2a trial of IMM-1-104.
AI Summary
Immuneering Corporation has announced a virtual Investor Event scheduled for early January 2025 to discuss new data from its ongoing Phase 2a trial of IMM-1-104. At the event, the company will present additional results from IMM-1-104 when used in combination with modified gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer treatment. The event will also cover initial data from IMM-1-104 in combination with modified FOLFIRINOX (mFFX) for first-line treatment, as well as findings from IMM-1-104 monotherapy in second-line pancreatic cancer patients.
This focused presentation aims to update investors with promising trial results that could lead to improved treatment options for those battling pancreatic cancer. More detailed information on accessing the event will be shared by the company in the near future.
Read Announcement- Drug:
- IMM-1-104
- Announced Date:
- December 12, 2024
- Indication:
- Solid tumors
Announcement
Immuneering Corporation announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its lead clinical-stage program, IMM-1-104, as a treatment for patients with unresectable or metastatic NRAS-mutant melanoma who have progressed on or are intolerant to PD-1/PD-L1 based immune checkpoint inhibitors.
AI Summary
Immuneering Corporation announced that the FDA has granted Fast Track designation to its lead clinical-stage program, IMM-1-104, for treating patients with unresectable or metastatic NRAS-mutant melanoma. This designation is significant for patients who have progressed on or are intolerant to PD-1/PD-L1 based immune checkpoint inhibitors, a group with limited treatment options. Fast Track status could allow more frequent communication with the FDA and a quicker review process, which is crucial for medicines that address serious conditions with unmet medical needs.
In early Phase 1 trials, IMM-1-104 was noted for being uniquely well tolerated compared to current MEK inhibitors. The drug is now being evaluated in a Phase 2a clinical trial that includes melanoma patients, highlighting its potential to provide a safer and effective treatment option for advanced melanoma, either by itself or in combination with other therapies.
Read Announcement- Drug:
- IMM-1-104
- Announced Date:
- September 12, 2024
- Indication:
- Solid tumors
Announcement
Immuneering Corporation announced positive initial response data from the first five patients treated with IMM-1-104 in combination with modified gemcitabine/nab-paclitaxel in first line pancreatic cancer as part of its ongoing Phase 2a clinical trial.
AI Summary
Immuneering Corporation announced promising early data from its ongoing Phase 2a clinical trial evaluating IMM-1-104 combined with modified gemcitabine/nab-paclitaxel for first-line pancreatic cancer. In the initial group of five patients, two experienced complete or partial responses, yielding an overall response rate of 40% and a disease control rate of 80%. The treatment has been well tolerated, with all patients continuing on the regimen.
Notably, one patient achieved a complete response and has maintained therapy for over six months, highlighting the potential benefit of this combination. The results at a 240 mg once-daily dose of IMM-1-104 support earlier preclinical findings that combining this agent with chemotherapy may produce deeper, more durable responses than using chemotherapy alone. These positive early trends pave the way for further clinical development and exploration of optimal dosing strategies in this challenging patient population.
Read Announcement- Drug:
- IMM-1-104
- Announced Date:
- July 31, 2024
- Indication:
- Solid tumors
Announcement
Immuneering Corporation announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for its lead clinical-stage program, IMM-1-104, as a first-line treatment for patients with pancreatic ductal adenocarcinoma (PDAC).
AI Summary
Immuneering Corporation announced that the FDA has granted Fast Track designation for its lead clinical-stage program, IMM-1-104, as a first-line treatment for patients with pancreatic ductal adenocarcinoma (PDAC). This designation is expected to accelerate the development and review process, potentially speeding up the submission of the program to the U.S. FDA. IMM-1-104 works through a novel "Deep Cyclic Inhibition" method that targets the MAPK pathway and is offered as a once-daily oral treatment. The ongoing Phase 2a clinical trial includes multiple arms where patients are treated in combination with chemotherapy, along with additional study arms focusing on monotherapy. The company anticipates initial data from various arms of the trial by the second half of 2024, which could soon benefit a wider group of patients facing this challenging type of cancer.
Read Announcement- Drug:
- IMM-1-104
- Announced Date:
- July 31, 2024
- Estimated Event Date Range:
- July 1, 2024 - December 31, 2024
- Target Action Date:
- 2024-H2
- Indication:
- Solid tumors
Announcement
Immuneering Corporation announced that Company expects initial data from multiple arms of its Phase 2a clinical trial in the second half of 2024 -
AI Summary
Immuneering Corporation announced that it expects to share initial data from several arms of its Phase 2a clinical trial in the second half of 2024. The trial is testing the lead candidate, IMM-1-104, in different patient groups, including those with first-line and second-line pancreatic cancer, as well as patients with RAS mutant melanoma and non-small cell lung cancer. This study is designed to assess both combination therapy with chemotherapy and monotherapy approaches. By gathering data across multiple trial arms, the company aims to better understand how IMM-1-104 performs in various settings and determine its potential benefits for a broader population of patients battling difficult-to-treat cancers.
The planned data release later this year is a significant step forward, providing early insights that could help steer the future development of new therapies in oncology.
Read Announcement
Immuneering FDA Events - Frequently Asked Questions
As of now, Immuneering (IMRX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Immuneering (IMRX) has reported FDA regulatory activity for IMM-1-104.
The most recent FDA-related event for Immuneering occurred on June 17, 2025, involving IMM-1-104. The update was categorized as "Positive Data," with the company reporting: "Immuneering Corporation announced positive data from its ongoing Phase 2a clinical trial evaluating atebimetinib (IMM-1-104), an oral, once-daily novel MEK inhibitor, in combination with modified gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer patients."
Currently, Immuneering has one therapy (IMM-1-104) targeting the following condition: Solid tumors.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:IMRX) was last updated on 7/10/2025 by MarketBeat.com Staff
