On September 24, 2025 Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company focused on keeping cancer patients alive, reported positive updated survival and safety data from its ongoing Phase 2a trial of atebimetinib (IMM-1-104) in combination with modified gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer patients (N=34), with 9 months median follow up (Press release, Immuneering, SEP 24, 2025, View Source [SID1234656195]). The data, to be presented at the Pancreatic Cancer Action Network (PanCAN) Scientific Summit 2025, marks a milestone for the Company in the treatment of one of the deadliest and most treatment-resistant solid tumors. The Company also announced it will not be hosting its previously scheduled conference call.

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"Overall survival is the gold standard in oncology and has been Immuneering’s goal from the very beginning. In cancer nothing matters more than keeping patients alive and helping them thrive. We are beyond thrilled to report that not only was our extraordinary 94% overall survival at 6 months sustained with additional follow up time, but that our observed 9-month overall survival of 86% shows an even larger gap with standard of care benchmarks," said Ben Zeskind, Ph.D., CEO of Immuneering. "To combine such meaningful overall survival with such favorable tolerability has the potential to be truly game-changing for first-line pancreatic cancer patients."

Extraordinary and Growing Survival Advantage Observed
Atebimetinib (320mg dosed once-daily) + mGnP demonstrated remarkable overall survival (OS) and progression-free survival (PFS) at 9 months median follow up in first-line pancreatic cancer patients (N=34). The MPACT pivotal trial for the standard of care, gemcitabine/nab-paclitaxel, reported significantly lower OS and PFS at 9 months.

OS observed at 9 months was 86% in patients receiving atebimetinib + mGnP. The median OS was not yet reached as of the data cutoff date. The standard of care reported a ~47% OS at 9 months.
As previously reported, OS observed at 6 months was 94% in patients receiving atebimetinib + mGnP. The standard of care reported a 67% OS at 6 months.
PFS observed at 9 months was 53% in patients receiving atebimetinib + mGnP. The standard of care reported a ~29% PFS at 9 months.
PFS observed at 6 months was 70% in patients receiving atebimetinib + mGnP. The standard of care reported a ~44% PFS at 6 months.
Unless otherwise specified, all data are reported using a data cutoff date of August 26, 2025, from the same patient cohort (N=34) as previously reported in June 2025. The estimates of (and other references to) standard of care with respect to the nine-month follow-up data were extrapolated and reconstructed by the Company based on the publicly available third-party MPACT pivotal trial data for gemcitabine/nab-paclitaxel. The estimates of (and other references to) standard of care set forth above with respect to the six-month follow-up data were reported out directly from the publicly available third-party MPACT pivotal trial data for gemcitabine/nab-paclitaxel. The Company’s Phase 1/2a clinical trial of atebimetinib does not include a head-to-head comparison against any other agents, and caution should be exercised when comparing data across trials.

The Company believes these compelling updated survival data reflect the potential for a durable, compounding benefit with atebimetinib + mGnP.

Favorable Tolerability Profile Observed:

As of the data cutoff date, Atebimetinib (320mg dosed once-daily) + mGnP continued to demonstrate a favorable tolerability profile in first-line pancreatic cancer patients (N=34), with only two categories of adverse events observed at the Grade 3 level in more than 10% of patients (neutropenia and anemia, both of which are categories commonly observed with standard of care chemotherapy). No new safety signals were identified.

Safety Data for Pivotal Trials and for Atebimetinib + mGnP in 1L PDAC

How Did Atebimetinib Achieve Such Extraordinary Survival?

Atebimetinib is a Deep Cyclic Inhibitor: A New Paradigm in Targeted Therapy

Immuneering’s proprietary Deep Cyclic Inhibitors (DCIs) challenge the conventional model of sustained or continuous inhibition in oncology.
Most therapies are designed for sustained inhibition, driving cancer to adapt and develop resistance so tumors shrink quickly but temporarily.
Deep Cyclic Inhibitors are designed to pulse faster than tumors can adapt, so tumors shrink slowly but durably.
Sustained inhibition also causes suppressed transient signaling in healthy cells, leading to many adverse events.
Deep Cyclic Inhibitors aim to restore full transient signaling to healthy cells, with the goal of leading to fewer adverse events.

Atebimetinib Targets MEK: A Broader, Potentially More Durable Approach

MEK is a key control point in the MAPK pathway (RAS-RAF-MEK-ERK), which is pathologically activated in a majority of cancers, including approximately 97% of pancreatic cancers.
Targeting MEK blocks a broader range of MAPK pathway alterations because it is further downstream, creating the potential for more durable benefit.

"Deep Cyclic Inhibitors like atebimetinib represent a fundamental shift in targeted therapy, away from continuous inhibition and toward pulsatile modulation of key oncogenic pathways," said Brett Hall, Ph.D., Chief Scientific Officer at Immuneering. "This approach has the potential to deliver both durability and tolerability, two patient-centered essentials oncology has long struggled to balance."

"Pancreatic cancer remains one of the most challenging cancers we face in the clinic with far too few treatment options available to patients and survival rates that have remained unacceptably low for decades," said Vincent Chung, M.D., F.A.C.P., Professor, Department of Medical Oncology and Therapeutics Research at City of Hope, principal investigator of the Phase 2a clinical trial and a paid member of the company’s scientific advisory board. "I have seen firsthand in my own patients the benefits of atebimetinib’s durability and tolerability. The remarkable overall survival, progression-free survival, and tolerability data we are seeing with atebimetinib + mGnP in first-line pancreatic cancer patients, now out to 9 months of median follow up, represent an important step towards creating urgently needed new options for these patients. We are also planning a confirmatory study."

Near-Term Milestone Expectations

Immuneering is planning for several near-term anticipated milestones related to atebimetinib, including:

Regulatory feedback on pivotal trial plans in Q4 2025
Announcing further updated OS and PFS data from first-line pancreatic cancer patients (N=34) treated with atebimetinib + mGnP, including at a scientific conference in 2026
Pending regulatory feedback, initiating a pivotal Phase 3 trial of atebimetinib in combination with mGnP in first-line pancreatic cancer by the end of 2025, and dosing the first patient by mid-2026
Initiating additional atebimetinib clinical trial combination arms in 2026, including in non-small cell lung cancer

On September 24, 2025 Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company focused on keeping cancer patients alive, reported a proposed underwritten public offering of shares of its Class A common stock or, in lieu of Class A common stock, pre-funded warrants to purchase Class A common stock (the "Offering") (Press release, Immuneering, SEP 24, 2025, View Source [SID1234656196]). In addition, Immuneering intends to grant the underwriters a 30-day option to purchase up to a number of additional shares of Class A common stock equal to fifteen percent (15%) of the shares of Class A common stock and pre-funded warrants initially offered in the Offering. Immuneering also announced that Sanofi has entered into a securities purchase agreement with Immuneering pursuant to which Sanofi has agreed to purchase $25.0 million of shares of Immuneering’s Class A common stock or, in lieu of such shares of Class A common stock, shares of Immuneering’s non-voting Class B common stock, at a price per share equal to the price to the public of the Class A common stock in the Offering, in a separate private placement transaction that is expected to close concurrently with the Offering (the "Private Placement"). All securities to be sold in the Offering and the Private Placement will be offered by Immuneering. The Offering is subject to market and other conditions, and the Private Placement is contingent upon the closing of the Offering, and there can be no assurance as to whether or when the Offering or Private Placement may be completed, or as to the actual size or terms of the Offering or the Private Placement.

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Immuneering intends to use the net proceeds of the Offering and the Private Placement to advance the preclinical and clinical development of its product candidates and for working capital and other general corporate purposes.

Leerink Partners and Oppenheimer & Co. Inc. are acting as the joint bookrunners for the Offering and as placement agents in connection with the Private Placement.

The Offering is being made pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was filed by Immuneering with the Securities and Exchange Commission (the "SEC") on August 13, 2025 and declared effective by the SEC on August 20, 2025. A preliminary prospectus supplement relating to the Offering will be filed with the SEC. Copies of the preliminary prospectus supplement relating to the offering, when available, may be obtained from: Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; and Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, New York 10004, or by telephone at (212) 667-8055, or by e-mail at [email protected], or by visiting the EDGAR database on the SEC’s website at www.sec.gov.

The shares to be sold in the Private Placement have not been and will not be registered under the Securities Act of 1933, as amended, or any state securities laws and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On September 23, 2025 Taiho Pharmaceutical Co., Ltd. (hereinafter "Taiho Pharmaceutical"), reported a collaboration agreement with Guardant Health, Inc. (hereinafter "Guardant Health") to discover new biomarker signatures by leveraging Guardant Health’s "GuardantINFORMTM" platform for multimodal analysis of real-world data (Press release, Taiho, SEP 24, 2025, View Source [SID1234656173]).

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This collaboration aims to discover new biomarker signatures with clinical and biological significance for addressing unmet needs in early-stage recurrent cancer, where the presence of microscopic cancer cells remaining in the body after surgery is a cause of recurrence. This collaboration leverages unique multimodal and longitudinal cohorts within GuardantINFORM, including those with minimal residual disease (MRD) testing.

This initiative is expected to support the development of treatments for patients at high risk of recurrence and lead to new and clinically relevant approaches enabling medical interventions at an early stage of cancer. The collaboration has an overarching goal of driving significant progress in overcoming cancer.

Taiho Pharmaceutical has a strong track record of developing multiple investigational and approved drugs in Japan, the US, and Europe by utilizing its proprietary "Cysteinomix drug discovery" which enables the creation of drugs that bind specifically and strongly to drug targets. By further analyzing the novel gene signatures identified through this collaboration and integrating these insights with the Cysteinomix drug discovery platform, we anticipate substantial potential to develop precise and effective treatment approaches for new drug targets that were previously difficult to discover.

Takeshi Sagara, Taiho Pharmaceutical’s Executive Director, Clinical Development and Medical Affairs, Discovery & Preclinical Research, said, "We believe that future anticancer drug discovery focusing on research and development not only for advanced cancer but also for early-stage recurrent cancer, with an eye on the patient’s journey, will lead to long-term survival and ultimately the overcoming of cancer. Through our collaboration with Guardant Health, we aim to identify and develop biomarker signatures, that arise in early-stage recurrence and contribute to the creation of next-generation treatment methods."

About Cysteinomix Drug Discovery
Cysteinomix drug discovery is Taiho Pharmaceutical’s original drug discovery technology designed to continuously generate covalent drugs targeting a variety of proteins that contain cysteine. Covalent drugs are pharmaceuticals that irreversibly control the function of target proteins by forming covalent bonds with them. These drugs consist of a ligand that binds to a protein pocket and a reactive group that forms a covalent bond with a specific amino acid. The Cysteinomix drug discovery platform is composed of a target protein database, a covalent compound library, and various compound evaluation systems, among other components. To date, this platform has successfully led to the creation of several pipelines.

On September 24, 2025 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that management is scheduled to participate in the following investor conference (Press release, Kura Oncology, SEP 24, 2025, View Source [SID1234656198]).

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UBS Virtual Oncology Day
Wednesday, October 1, 2025
2:30 p.m. ET / 11:30 a.m. PT

A live audio webcast will be available in the Investors section of Kura’s website at View Source, with an archived replay available following the event.

On September 24, 2025 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, and TerThera BV, a leading provider of GMP-grade Terbium-161, reported a supply agreement for non-carrier-added (n.c.a.) Terbium-161 (Tb-161), a novel medical radioisotope with distinct chemical properties and emerging potential in radiopharmaceutical therapy. Under the terms of the agreement, TerThera will supply Good Manufacturing Practice (GMP)-compliant n.c.a. Tb-161 to ITM to support the development of its Terbium-based pipeline candidates, complementing ITM’s established manufacturing capabilities in cooperation with the Paul Scherrer Institute (PSI).

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"Driving innovation across isotopes, targeting molecules and cancer indications keeps ITM at the forefront of the rapidly evolving radiopharmaceutical industry," said Dr. Andrew Cavey, CEO of ITM. "We see strong potential in Terbium-161 as a critical new isotope for targeted radiopharmaceutical therapy, and our partnership with TerThera will allow us to advance its use in our pipeline. With supply of Terbium-161, we are well-positioned to harness its radiation properties to deliver meaningful advances for people living with cancer."

Currently, Tb-161-based radiopharmaceuticals are being clinically investigated for various types of cancers. Tb-161 is gaining attention in the radiopharmaceutical field for its unique emission profile. Like Lu-177, it emits medium-range beta particles and has a similar half-life. However, Tb-161 also emits low-energy Auger and internal conversion electrons, delivering highly localized radiation that can effectively target isolated cancer cells and micro-metastases with minimal off-target effects.

"As industry interest in Terbium-161 grows, a safe and sustainable supply of this radionuclide is crucial to support the development of new treatment options and strategies and we see this as our core mission," added Philippe van Overeem, CEO of TerThera. "ITM is a true innovator in the dynamic radiopharmaceutical field and we look forward to supplying them with our GMP-grade Terbium-161 as they advance their pipeline candidates and make progress in bringing the benefit of this valuable isotope to patients."

(Press release, ITM Isotopen Technologien Munchen, SEP 24, 2025, View Source [SID1234661163])