BostonGene to Highlight Omnimodal AI Innovations for Precision Oncology at the 21st Annual Precision Oncology & RadMed Symposium

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])

Nuvation Bio Enrolls First Patient in Global, Randomized Study of Safusidenib for Maintenance Treatment of High-Grade IDH1-Mutant Glioma

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])

Immunome Presents Preclinical Data Showing Proprietary TOP1i ADC Payload HC74 Overcomes Multiple Mechanisms of ADC Resistance

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])

CDR-Life Presents Early Clinical Data Demonstrating Pharmacodynamic Activity of CDR404, a Novel Antibody-Derived T Cell Engager Targeting MAGE-A4+ Solid Tumors

On October 23, 2025 CDR-Life, Inc., a biotechnology company developing highly selective T cell engagers (TCEs) to treat cancer and autoimmune diseases, reported the first clinical data showing that CDR404, the company’s lead M-gager TCE, achieved all four canonical pharmacodynamic (PD) hallmarks of TCE activity in patients with MAGE-A4+ solid tumors. The data, presented 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, Massachusetts, highlights CDR404’s robust immune activation and early signals of clinical activity, including tumor stabilization and biomarker improvements in patients with ovarian cancers and synovial sarcomas.

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CDR404 is an antibody-based TCE designed to target intracellular tumor antigens presented on HLA molecules. It engages MAGE-A4 peptides displayed by HLA-A*02:01 on cancer cells and redirects CD3+ T cells for targeted tumor cell killing. The ongoing Phase 1 CDR404 trial (NCT06402201) is being conducted at leading cancer centers across the United States and Europe. Unlike conventional approaches utilizing T cell receptors, the proprietary M-gager platform leverages antibody-derived binding domains that combine exceptional specificity with strong potency, excellent developability and ease of manufacturing.

At initial dose levels of 100–200 μg, CDR404 triggered the full cascade of immune activation associated with effective TCE therapy, including CD8+ T cell activation and expansion, reprogramming to a memory phenotype and recruitment of lymphocytes into tumors. Notably, repeated dosing did not induce PD-1–mediated T cell exhaustion, suggesting sustained biological activity. In one patient, a transient tumor flare followed by stabilization was observed, which is consistent with tumor infiltration by cytotoxic T cells.

"These early data demonstrate that our M-gager platform can extend the precision and power of antibody-based T cell engagers to intracellular antigens, an area long thought to be accessible only to TCR-based modalities," said Christian Leisner, PhD, Chief Executive Officer of CDR-Life. "Seeing all four pharmacodynamic hallmarks of activity in patients even at low doses underscores the potential of this approach to redefine how we target solid tumors."

The study’s first-in-human dose was guided by quantitative systems pharmacology modeling, enabling detection of pharmacodynamic effects more quickly than traditional approaches. Based on these encouraging signals, the trial will begin to focus on patients with MAGE-A4–positive ovarian cancers, a population with high unmet need.

Additional analyses, including integrated pharmacokinetic-pharmacodynamic and circulating tumor DNA (ctDNA) data, are ongoing.

Presentation Details:
Title:

Hallmarks of pharmacodynamic activity of CDR404, a new antibody-derived T cell engager (TCE) targeted against MAGE-A4+ solid tumors in HLA-A02:01+ patients

Presenter:

Melissa Vrohlings, Head of Translational Science, CDR-Life

Date and Time:

October 23, 2025 | 12:30 – 4 pm ET

Location:

Poster Session A

Level 2, Exhibit Hall D

In addition to the poster presentation on CDR404, CDR-Life is also presenting a poster on CDR609, the company’s newest T cell engager clinical candidate that targets LGR5, a highly cancer-specific cell surface antigen widely expressed on common solid tumors.

Presentation Details:

Title:

CDR609: A First-in-Class LGR5-targeted T Cell Engager for treatment of Colorectal Cancer and other solid tumors

Presenter:

Sophie Barsin, Project Leader, CDR-Life

Date and Time:

October 23, 2025 | 12:30 – 4 pm ET

Location:

Poster Session A

Level 2, Exhibit Hall D

(Press release, CDR-Life, OCT 23, 2025, View Source [SID1234656966])

Verismo Therapeutics to Present at iMig 2025

On October 23, 2025 Verismo Therapeutics, a clinical-stage CAR T company developing a novel KIR-CAR platform technology, reported its participation and sponsorship of the International Mesothelioma Interest Group (iMig) 2025 Conference. The company will highlight STAR-101, an ongoing Phase 1 clinical trial of Verismo’s lead pipeline SynKIR-110 in patients with advanced mesothelin-expressing cancers, including mesothelioma.

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Mesothelioma is a rare, aggressive cancer, with more than 2,500 people diagnosed annually in the United States and 30,000 globally1. Despite recent therapeutic advances, prognosis remains poor and most patients face limited options for long-term treatment. SynKIR-110 targets mesothelin, a protein highly expressed on mesothelioma cells and a validated target for innovative immunotherapies, enabling it to recognize and attack the cancer cells. SynKIR-110 was granted Orphan Drug and Fast Track Designations by the Food and Drug Administration for treatment of mesothelioma in 2022 and 2023, respectively.

"Mesothelioma is one of the most difficult cancers to treat, and it has historically been underserved in terms of new treatment development," said Daniel Sterman, M.D., Thomas and Suzanne Murphy Professor of Pulmonary and Critical Care Medicine at the NYU Grossman School of Medicine, Director of Division of Pulmonary Medicine at the NYU Langone Medical Center and an organizer of iMig 2025. "By sponsoring iMig and presenting the STAR-101 trial design, Verismo is demonstrating its commitment to advancing the science, addressing the unmet medical need, and supporting the global mesothelioma community." Dr. Sterman serves as the Medical Monitor for Verismo’s STAR-101 clinical study.

STAR-101 (NCT05568680) is a multicenter, open-label, Phase 1 study designed to evaluate the safety, feasibility, and preliminary efficacy of SynKIR-110 in patients with advanced mesothelin-expressing tumors. The trial is the first to bring Verismo’s multi-chain KIR-CAR platform into the clinic for solid tumors.

Verismo’s sponsorship of iMig 2025 underscores its dedication not only to scientific innovation but also to supporting patients, clinicians, and advocates working to advance care in mesothelioma worldwide.

Presentation Details:

Title: SynKIR-CAR T Cell Advanced Research (STAR)-101 Phase 1 Clinical Trial for Patients with Advanced Mesothelin-expressing Mesothelioma, Ovarian Cancer, or Cholangiocarcinoma
Session: Novel Combinations and Applications of Immunotherapy; Salon E
Date/Time: Monday, October 27, 2025, 2:30 – 2:45 PM
Presenter: Jun Xu, Ph.D., Executive Director of Translational Science, Verismo Therapeutics

(Press release, Verismo Therapeutics, OCT 23, 2025, View Source [SID1234656965])