On September 24, 2025 Veracyte, Inc. (Nasdaq: VCYT), a leading genomic diagnostics company, reported that the first prospective validation data for a molecular signature to predict hormone therapy benefit in men with recurrent prostate cancer will be presented at ASTRO 2025, the annual meeting of the American Society for Radiation Oncology (Press release, Veracyte, SEP 24, 2025, View Source [SID1234656199]). The findings were derived using Veracyte’s Decipher GRID (Genomic Resource for Intelligent Discovery) research tool. The study is among nine Decipher-focused abstracts—including six selected for podium presentations—in prostate cancer that will be presented at the conference, being held September 27 to October 1 at the Moscone Center in San Francisco.

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"We look forward to the presentation of important new data examining the role of adverse molecular features in predicting disease progression and treatment response for patients with prostate cancer," said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology. "Such insights will ultimately make prostate cancer care more precise, giving greater molecular dimension to the classification and treatment of the disease. We believe that our Decipher GRID research tool, combined with our extensive database of prostate tumor whole-transcriptome-derived genomic profiles—the largest of its kind in prostate cancer research—uniquely positions Veracyte to usher in the next generation of cancer diagnostics."

The following Decipher-focused presentations examining the role of adverse molecular features in prostate cancer are among those being presented at ASTRO 2025:

Title:

A Double-Blinded Placebo-Controlled Biomarker Stratified Randomized Trial of Apalutamide (APA) and Radiotherapy for Recurrent Prostate Cancer (NRG GU006, BALANCE trial) (LBA-04)

Presenter:

Daniel Spratt, M.D., University Hospitals Seidman Cancer Center, Case Western Reserve University

Format:

Podium

Date/Time:

Sunday, Sept. 28; 1:00-1:10 p.m. PDT

Room:

San Francisco Ballroom

Title:

Discordance of Adverse Molecular Features between the 22-Gene Genomic Classifier Score, Histologic Grade, and NCCN Risk Groups: Analysis of Over 200,000 Patients​ (Abstract #1116)

Presenter:

Michael Zelefsky, M.D., FASTRO, NYU Langone Laura and Isaac Perlmutter Cancer Center

Format:

Podium

Date/Time:

Wednesday, Oct. 1, 8:15-8:20 a.m. PDT

Room:

155/157

Information about all of the Decipher-related abstracts being presented at ASTRO 2025 can be found here. Meeting attendees can also visit Veracyte’s booth (#3001).

About Decipher GRID

The Decipher GRID database includes more than 200,000 whole-transcriptome profiles from patients with urologic cancers and is used by Veracyte and its partners to contribute to continued research and help advance understanding of prostate and other urologic cancers. GRID-derived information is available on a Research Use Only basis. More information about Decipher GRID can be found.

About Decipher Prostate

The Decipher Prostate Genomic Classifier is a 22-gene test, developed using RNA whole-transcriptome analysis and machine learning, that helps inform treatment decisions for patients across the full spectrum of prostate cancer. The test is performed on biopsy or surgically resected samples and conveys the aggressiveness of the cancer. For patients with localized or regional prostate cancer, the Decipher score indicates a patient’s risk of metastasis, helping to determine treatment timing and intensity. For patients with metastatic prostate cancer, the Decipher score indicates the likelihood of cancer progression and survival benefit with treatment intensification. Armed with this information, physicians can better personalize their patients’ care. The Decipher Prostate test’s performance and clinical utility has been demonstrated in over 90 studies involving more than 200,000 patients. It is the only gene expression test to achieve "Level I" evidence status and inclusion in the risk-stratification table in the most recent NCCN Guidelines* for prostate cancer. More information about the Decipher Prostate test can be found.

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 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 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 FORE Biotherapeutics, a registration stage biotherapeutics company dedicated to developing targeted therapies to treat patients with cancer, reported that following a pre-specified interim efficacy analysis for the Phase 2 FORTE basket study evaluating plixorafenib as a monotherapy in patients with recurrent or progressive BRAF V600-mutated primary central nervous system (CNS) tumors, the Independent Data Monitoring Committee (IDMC) has recommended that the study should continue as planned (Press release, Fore Biotherapeutics, SEP 24, 2025, View Source [SID1234656194]).

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The interim efficacy analysis was conducted by the IDMC and was pre-specified to evaluate plixorafenib at a defined efficacy threshold after the first 25 participants treated in this basket had sufficient data for response assessment, in addition to the IDMC’s ongoing oversight for safety.

"We are very pleased that the BRAF V600 primary CNS basket of the FORTE study has passed the protocol-specified interim analysis supporting that tumor regressions in patients treated with plixorafenib continue to be observed," said Stacie Peacock Shepherd, M.D., Ph.D., Chief Medical Officer of Fore. "We believe this is an encouraging development for the study, and more importantly, for patients in need of novel treatment options for recurrent primary CNS tumors. The data with this novel BRAF inhibitor, known as a paradox breaker, builds on the recent momentum for the potential of plixorafenib to benefit patients across BRAF-altered solid tumors, including the recent presentation of encouraging data in patients with BRAF-altered thyroid cancers, which has generated significant enthusiasm in the field. This significant milestone builds upon the validated approach of targeting BRAF, while avoiding the limitations of the earlier generation compounds that led to rapid recurrence of disease and the need for combination with a MEK inhibitor, and brings us one step closer to our objective of accelerating access to adults and children diagnosed with recurrent BRAF-altered brain or spinal cord tumors. We look forward to completing enrollment and reporting topline results from this registrational CNS basket in the second half of 2026."

Macarena de la Fuente, M.D., Chief of Neuro-Oncology at the University of Miami Sylvester Comprehensive Cancer Center and lead CNS Investigator for both the Phase 1/2a and FORTE Phase 2 plixorafenib clinical studies, commented, "Primary CNS tumors can lead to significant disease and treatment-related morbidity, including neurocognitive deterioration and seizures, and premature death. The unique mechanism and tolerable safety profile seen in early clinical trials set plixorafenib apart from current limited treatments, including lower side effects of rash or fever and less risk of intratumoral bleeding, cardiac, ocular, or growth effects. The data that have been previously presented are very promising with durable clinical activity and favorable tolerability and we look forward to the full readout of data at the completion of this trial. We anticipate plixorafenib, with its unique mechanism of action, has the potential to transform the treatment paradigm for people with BRAF-altered recurrent or refractory primary CNS tumors."

The primary endpoint of overall response rate (ORR), supported by duration of response, in the FORTE CNS basket is being evaluated in up to 50 patients with BRAF V600 primary recurrent CNS tumors.

About the Global Phase 2 FORTE Basket Study

The registration-intended FORTE Master Protocol is a global Phase 2 clinical trial which includes four sub-protocol baskets evaluating plixorafenib in distinct patient populations. The three monotherapy indications currently under evaluation are recurrent or progressive BRAF V600 primary CNS tumors, solid tumors with BRAF fusions and rare BRAF V600 mutated solid tumors. As part of the design of the trial, interim efficacy analyses will be conducted in the other two baskets of FORTE – the advanced solid tumors with BRAF fusions basket and the rare BRAF V600 solid tumors basket – after sufficient scans from approximately 25 patients in each basket are evaluated by the IDMC.

About BRAF Altered Recurrent Primary CNS Tumors

BRAF altered recurrent primary CNS tumors represent a high unmet medical need and a large market opportunity for plixorafenib. In the advanced treatment setting, patients are offered currently approved therapies, but those therapies have significant limitations in efficacy, tolerability, and safety.

About Plixorafenib

Plixorafenib is a novel BRAF inhibitor, with a unique mechanism of action that functions both as a dimer and paradox breaker, and that has demonstrated a differentiated and compelling monotherapy profile in clinical studies. In a previously conducted Phase 1/2 study, in patients with MAPK inhibitor naïve BRAF V600 primary recurrent CNS tumors (n=9), plixorafenib monotherapy demonstrated an ORR of 67% and a clinical benefit rate of greater than 75%. Plixorafenib also demonstrated a favorable safety and tolerability profile across tumor types, including relative to existing standard of care treatments for various BRAF altered tumors, with a discontinuation rate due to drug-related adverse events of less than 2%. Fore Bio believes plixorafenib has the potential to overcome the limitations of currently available BRAF inhibitors through its unique mechanism of action targeting BRAF, while avoiding the limitations of the earlier generation BRAF inhibitors that led to rapid recurrence of disease and the need for combination with a MEK inhibitor.