On October 23, 2025 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported preclinical data showing its proprietary antibody-drug conjugate (ADC) payload HC74 overcomes multiple mechanisms of ADC resistance, including payload efflux and target heterogeneity.

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HC74 is a novel topoisomerase I inhibitor that serves as the payload in IM-1021, a ROR1-targeted ADC currently in a Phase 1 trial for solid and liquid tumors, and as the payload in several preclinical candidates within the Immunome pipeline.

The data were presented on Oct. 23, 2025, in a poster entitled "HC74, a novel topoisomerase I inhibitor payload for antibody-drug conjugates that overcomes multi-drug resistance" at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in Boston.

Highlights of the poster include:

Over-expression of drug efflux transporters such as ABCC1 and ABCB1 drives primary and acquired resistance to approved ADC payloads and standard chemotherapies but not to HC74
HC74 exhibits high membrane permeability, leading to enhanced cytotoxicity and robust bystander activity
ADCs incorporating HC74 show meaningful efficacy in multiple preclinical tumor models, including:
Colorectal cancer refractory to trastuzumab-DXd and irinotecan
Models with acquired resistance to trastuzumab-DXd
Non-small cell lung cancer with heterogenous target expression
"HC74 is designed to overcome key limitations of existing ADC payloads," said Immunome’s Chief Scientific Officer, Jack Higgins, Ph.D. "Clinical data show high levels of efflux transporters and target heterogeneity can reduce ADC efficacy. We believe HC74’s ability to overcome those resistance mechanisms supports its potential as a best-in-class payload. We look forward to advancing IM-1021 and our broader HC74 pipeline."

A copy of the poster is available in the "Events & Presentations" portion of Immunome’s website.

(Press release, Immunome, OCT 23, 2025, View Source [SID1234656967])

On October 23, 2025 Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported enrollment of the first patient into part 2 of G203 (NCT05303519), a global, randomized study evaluating the efficacy and safety of safusidenib versus placebo for the maintenance treatment of patients with high-grade IDH1-mutant astrocytoma following standard-of-care radiation or chemoradiation and adjuvant temozolomide. Safusidenib is a novel, oral, potent, brain-penetrant targeted inhibitor of mutant IDH1.

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"Following surgery and standard-of-care treatment, these patients and their healthcare providers are left to watch and wait for progression or recurrence," said Dr. Katherine Peters, professor of neurology and neurosurgery at the Preston Robert Tisch Brain Tumor Center at Duke Cancer Institute and a trial investigator. "Patients with this form of glioma need effective, well-tolerated options that can further delay this eventuality. Safusidenib has shown promising activity in a Phase 1 study of patients with recurrent or progressive high-grade IDH1-mutant gliomas, with higher response rates than other IDH inhibitors have demonstrated in this setting. We look forward to further studying its potential in this trial."

A protocol amendment is in progress to finalize G203 as a global Phase 3 study by increasing the study size to support potential regulatory approvals. Based on this amendment, which has been aligned on with the U.S. Food and Drug Administration (FDA), G203 part 2 is now enrolling approximately 300 patients with newly diagnosed IDH1-mutant astrocytoma—either grade 3 with high-risk features or grade 4—in the U.S., Australia, and China. Following resection, radiation or chemoradiation, and adjuvant chemotherapy, patients will be randomized 1:1 to receive 250 mg safusidenib or placebo twice daily. The primary endpoint is progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) per Response Assessment in Neuro-Oncology (RANO) 2.0; FDA agreed that the primary endpoint of PFS could support full approval in this setting. Secondary endpoints include overall survival, PFS as assessed by the investigator, objective response rate, and duration of response, among others.

"No targeted therapies have been approved to delay recurrence or progression in these patients, who are dealing with an aggressive disease that inevitably returns," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "With our first patient now enrolled in the U.S., we look forward to expanding the study into additional sites to support potential registration, as we continue our commitment to bringing therapies with meaningful clinical benefits to more patients with cancers that have severe unmet treatment needs."

Nuvation Bio will provide further updates on the progress of the safusidenib program in the upcoming earnings call on November 3, 2025.

About IDH1-Mutant Glioma
Gliomas are the most common type of brain cancer in adults worldwide. In the U.S., nearly 2,400 people are diagnosed with IDH1-mutant gliomas each year. Most patients are diagnosed in their 30s and 40s. While patients with IDH1 mutations generally have longer survival times than those with wild-type IDH1, prognosis worsens for those with high grade tumors.

About Safusidenib
Safusidenib is a novel, oral, potent, brain-penetrant, targeted inhibitor of mutant IDH1. In a Phase 1 clinical study, safusidenib was well-tolerated and demonstrated anti-tumor activity and high blood-brain barrier penetration.

(Press release, Nuvation Bio, OCT 23, 2025, View Source [SID1234656968])

On October 23, 2025 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK-pathway-driven cancers, reported encouraging preliminary data from the first two dose levels in its ongoing Phase 1/2a clinical trial evaluating VS-7375, a potential best-in-class oral KRAS G12D (ON/OFF) inhibitor, in patients with previously-treated advanced KRAS G12D mutant solid tumors. In addition, while monotherapy dose escalation continues, the Company announced it has initiated patient enrollment for the first dose escalation combination cohort evaluating VS-7375 with cetuximab.

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"Preliminary safety and tolerability data from our ongoing Phase 1/2a trial indicate that VS-7375, a potential best-in-class oral KRAS G12D (ON/OFF) inhibitor, can be administered at efficacious doses while effectively managing gastrointestinal side effects," said Dan Paterson, president and chief executive officer of Verastem Oncology. "While still early, we are pleased to see anti-tumor activity among pre-treated patients with advanced pancreatic cancer and other solid tumors. As we continue monotherapy dose escalation, we are excited to open the combination cohort evaluating VS-7375 with cetuximab just months after trial initiation. By starting this combination cohort at a dose of VS-7375 that has previously demonstrated monotherapy efficacy, we expect to accelerate our clinical development program with other standard-of-care combination cohorts."

VS-7375-101 is a Phase 1/2a study being conducted in the U.S., with plans underway to expand globally, and is evaluating the safety and efficacy of VS-7375 in patients with previously-treated advanced KRAS G12D mutant solid tumors, including advanced pancreatic ductal adenocarcinoma (PDAC), both as monotherapy and in combination with other standard of care treatments.

In the study, VS-7375 cleared both the 400 mg daily (QD) and 600 mg QD monotherapy doses with no dose-limiting toxicities (DLTs) observed. In addition, no new safety signals have been observed relative to earlier data presentations in both PDAC and non-small cell lung cancer (NSCLC) by our partner, GenFleet Therapeutics, in its ongoing Phase 1 /2 clinical study in China evaluating VS-7375 (known as GFH375). Specifically, at the two dose levels evaluated in the U.S. cohorts, no nausea, vomiting, or diarrhea greater than Grade 1 were reported. Monotherapy dose escalation in the VS-7375-101 study started at the efficacious doses identified in GenFleet’s study, 400 mg QD and 600 mg QD. GenFleet chose 600 mg QD as their recommended Phase 2 dose (RP2D) in China.

Of the five efficacy evaluable patients in the VS-7375-101 study with at least one scan, four out of five patients have had a tumor reduction and are still on treatment. The remaining patients receiving either the 400 mg QD or 600 mg QD doses have not yet reached their first response assessment. The study’s dose escalation continues with evaluating 900 mg QD monotherapy and the combination cohort evaluating VS-7375 with cetuximab is now open and enrolling patients. The cohort will enroll patients with advanced solid tumors, including colorectal cancer.

"We’re encouraged by the early safety experience in this study, including the GI tolerability we’ve seen to date and absence of cutaneous toxicities, along with the early signs of anti-tumor activity. These preliminary findings are promising, and we look forward to the continued evaluation of VS-7375 both as monotherapy and now in combination with cetuximab as there remains a significant unmet need for treatments specifically targeting KRAS G12D-mutant cancers," said John Hayslip, M.D., chief medical officer of Verastem Oncology.

Subject to the results of the Phase 1 dose escalation combination of VS-7375 and cetuximab, Verastem plans to initiate a combination expansion cohort in colorectal cancer. Following the ongoing monotherapy dose escalation to 900 mg QD, the Company expects to select the recommended Phase 2 dose and advance subsequent efficacy and safety analysis of monotherapy VS-7375 in patient expansion cohorts with advanced PDAC and NSCLC. The Company plans to report an interim safety and efficacy update on the Phase 1/2a trial of VS-7375 in the first half of 2026.

About KRAS G12D

KRAS G12D represents 26% of all KRAS mutations, making it the most prevalent KRAS mutation in human cancers. The KRAS G12D mutation occurs most commonly in pancreatic (37%), colorectal (12.5%), endometrial (8%), and non-small cell lung (5%) cancers. Currently, no therapies are approved by the U.S. Food and Drug Administration (FDA) specifically targeting KRAS G12D mutations in cancer.

About VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor

VS-7375 is a potential best-in-class, potent, and selective oral KRAS G12D (ON/OFF) inhibitor. VS-7375 is the lead program from the Verastem Oncology discovery and development collaboration with GenFleet Therapeutics. Verastem announced in April 2025 that the U.S. Investigational New Drug (IND) application for VS-7375 was cleared and initiated a Phase 1/2a clinical trial in June 2025. GenFleet’s IND for VS-7375 (known as GFH375 in China) was approved in China in June 2024, and the first patient was dosed in a Phase 1/2 study in July 2024. Verastem selected VS-7375 as its lead program in December 2023 and the license for VS-7375 that was exercised in January 2025 is the first one from this collaboration. This license gives Verastem development and commercialization rights outside the GenFleet markets of mainland China, Hong Kong, Macau, and Taiwan.

About the Phase 1/2a Study of VS-7375

VS-7375-101 is a Phase 1/2a clinical trial being conducted in the U.S., with the potential to expand globally, and will evaluate the safety and efficacy of VS-7375 in patients with advanced KRAS G12D mutant solid tumors. The starting dose for the Phase 1 study of 400 mg is based on the dose identified in the initial data from the GenFleet study to accelerate the trial’s progress. Verastem plans to dose escalate across levels where responses were observed in GenFleet’s study and will assess in the Phase 2a portion the efficacy and safety of VS-7375, both as monotherapy and in combination, in patients with advanced solid tumors, such as pancreatic, colorectal, and non-small cell lung cancers.

(Press release, Verastem, OCT 23, 2025, View Source [SID1234656952])

On October 23, 2025 BostonGene, developer of the leading AI foundation model for cancer and the immune system, reported its participation at the 21st Annual Industry/Academia Precision Oncology & RadMed Symposium, where global leaders in life sciences will explore the latest innovations in AI and immuno-oncology, molecular imaging, targeted therapies and more. The event will be held on November 5 at The Alexandria at Torrey Pines Conference Center in San Diego, California.

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During the symposium, BostonGene will present "Omnimodal AI for Precision Oncology: Integrating Data to Drive Discovery." The presentation will highlight how BostonGene’s foundation model integrates genomic, transcriptomic, immune and clinical data to generate biologically grounded insights that drive discovery, inform therapeutic development and improve patient outcomes. Through real-world applications and case studies, BostonGene will demonstrate how AI-driven integration of complex molecular and clinical datasets accelerates biomarker discovery, identifies novel therapeutic targets and supports patient stratification strategies that enhance trial design and translational success.

"The 21st Annual Industry/Academia Precision Oncology & RadMed Symposium provides a unique opportunity to highlight how omnimodal AI is reshaping the way we approach cancer research and treatment," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "By integrating diverse biological and clinical data types, BostonGene’s solutions deliver the insights necessary to match patients with the right therapies, de-risk development and accelerate drug development."

To learn more or to schedule a meeting with BostonGene during the event, please contact Hannah Oman at [email protected]. For additional details, visit the 21st Annual Industry/Academia Precision Oncology & RadMed Symposium website.

(Press release, BostonGene, OCT 23, 2025, View Source [SID1234656969])

On October 23, 2025 Nantes-based biotech company XENOTHERA is accelerating its developments in oncology with several multispecific glyco humanized antibody (GH-pAb) programs, reported new clinical milestones and major publications in international journals and conferences.

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Clinical advances for XON7 in solid tumors

The XON7 program is developing a GH-pAb antibody targeting a unique combination of tumor antigens expressed in several solid cancers. The clinical trial, conducted in France and Belgium since late 2023 (FIPO trial, NCT06154291), is supported by BPI France.

In September 2025, the scientific committee approved the start of a backfilling phase at a dose of 16 mg, based on pharmacokinetic data obtained from patients.

The most recent results will be presented at the ESMO (Free ESMO Whitepaper) 2025 congress in Berlin (poster 984B, October 19, 12:00 p.m.–12:45 p.m.).

LIS22: positive signals in peripheral T-cell lymphomas

The LIS22 program, dedicated to peripheral T-cell lymphoma (PTCL) – a serious disease with high unmet medical need – has been in clinic in France and Italy since mid-2024 (PALT trial, NCT06495723), with funding from France 2030 i-DEMO program.

The scientific advisory board has recently approved the move to a 7.5 mg dose, highlighting the candidate’s lack of toxicity and therapeutic potential.

LIS22 was the subject of an oral presentation and an abstract published in the proceedings of the ICML 2025 world congress in Lugano (International Conference on Malignant Lymphoma).

International publication for XON9 in hepatocellular carcinoma

The XON9 program explores the therapeutic potential of a new GH-pAb antibody targeting hepatocellular carcinoma.

The results have just been published in the special edition on hepatology of the International Journal of Molecular Sciences (IJMS).

The article, entitled "XON9 – A Glyco-Humanized Polyclonal Antibody Effective Against Hepatocellular Carcinoma" (Royer et al.), describes the in vitro and in vivo data and demonstrates the superiority of XON9 over Sorafenib, the current standard of care for this cancer.

These results reinforce XENOTHERA’s strategy of developing a new generation of multispecific antibodies to address unmet needs in oncology.

"We are delighted to be advancing science for the benefit of patients and confirming the value of our first-in-class technology in serious cancers. The multispecific and multimodal approach represents a tremendous innovation, and we believe that the future will confirm its value for patients. These results already confirm XENOTHERA’s credibility in the field of oncology. I would like to congratulate our teams on these magnificent advances and thank the patients and investigators for their commitment to these trials." — Dr. Odile Duvaux, President of XENOTHERA

(Press release, Xenothera, OCT 23, 2025, View Source [SID1234656953])