On October 24, 2025 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company developing innovative treatments that exploit specific cancer cell vulnerabilities while minimizing damage to healthy cells, reported an update on the ongoing Phase 1 ACESOT-1051 (A Multi-Center Evaluation of WEE1 Inhibitor in Patients with Advanced Solid Tumors, APR-1051) study. The latest results show that, at the 100 mg APR-1051 dose level, 3 out of 4 patients achieved stable disease, as measured using RECIST v1.1 criteria.

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A poster titled Early safety and efficacy of APR-1051, a novel WEE1 inhibitor, in patients with cancer-associated gene alterations: Updated data from ACESOT-1051 Phase 1 trial will be presented today 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). The poster, to be presented by Drs. Timothy Yap MBBS, PhD, FRCP, University of Texas MD Anderson Cancer Center and lead investigator of the study, and Philippe Pultar, MD, Senior Medical Advisor at Aprea, summarizes preliminary results from the trial with a cutoff date of September 17, 2025. A copy of the poster will be available on Investors page of the Aprea corporate website under "Investor Presentations & Resources."

"We continue to be encouraged by these early clinical findings, which demonstrate signals of anti-tumor activity with APR-1051 in a heavily pre-treated patient population," said Dr. Pultar. "We believe the observation of disease control in tumors harboring FBXW7, CCNE1, and KRAS mutations align with our mechanistic understanding of WEE1 inhibition and reinforces the scientific rationale for APR-1051 development. We believe these promising data provide an important foundation as we continue with dose escalation in the ongoing study and we look forward to providing further updates as we advance to higher dose level in the ongoing study."

ACESOT-1051 Clinical Update (data cutoff October 19, 2025)

The primary objective of the trial is to characterize the safety profile, dose-limiting toxicity, maximum tolerated dose or maximum administered dose, and recommended Phase 2 dose of APR-1051. Secondary objectives are to 1) to characterize the pharmacokinetics of APR-1051 and the major metabolites and active metabolites of APR-1051, and 2) to assess preliminary efficacy of APR-1051
Results from Dose Level 6 (100 mg), show 3 out of 4 patients achieved stable disease, per RECIST v1.1 in heavily pretreated gastrointestinal and gynecologic malignancies
Disease stabilization was observed in patients with FBXW7, CCNE1, and KRASG12V + TP53 alterations
Favorable tolerability: No dose limiting toxicities (DLTs) or unexpected safety issues reported to date.
Following successful clearance of the 100 mg cohort, dose escalation has progressed to Dose Level 7 (150 mg)
For more information on ACESOT-1051, refer to ClinicalTrials.gov NCT06260514.

Individual Patient Results

86-year-old female with rectal cancer: Treated at a 100 mg dose after five prior lines, the patient achieved stable disease (-13% reduction). Tumor harbored FBXW7 mutation which is a mechanistically relevant biomarker for WEE1 inhibition. 145 days on treatment and ongoing
55-year-old male with rectal cancer: Treated at a 100 mg dose after four prior lines, the patient achieved stable disease (+1%). Tumor harbored KRASG12V + TP53-mutant patient supports mechanistic activity in this genotype. 63 days on treatment and ongoing
73-year-old female with endometrial cancer: Treated at a 100mg after five prior lines, patient achieved stable disease by RECIST v1.1 criteria (+15%) at the first evaluation before voluntarily withdrawing consent after approximately two months of treatment. Tumor harbored CCNE1 and TP53 mutations supports mechanistic activity in this genotype.
50-year-old female with colon cancer: Treated at 100mg after two prior lines. This patient had disease progression at first assessment (8 weeks).

(Press release, Aprea, OCT 24, 2025, View Source [SID1234656973])

On October 23, 2025 Flatiron Health reported its presence at ISPOR—The Professional Society for Health Economics and Outcomes Research Europe 2025 Conference, set to take place November 9-12 in Glasgow, Scotland, UK. Flatiron’s real-world data is featured across more than 18 pieces of research to be presented at the conference, including two Top 5% Award acceptances and ten other Flatiron-authored abstracts. Additionally, Flatiron will participate in a workshop on the opportunities and challenges of transportability analyses in the context of European Union Joint Clinical Assessments.

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"The studies we’re showcasing at ISPOR Europe represent years of methodological advancement enabled by our unique combination of data depth and scientific rigor," said Nathan Hubbard, Chief Executive Officer, Flatiron Health. "Our research teams and collaborators have demonstrated the true potential of real-world data—pioneering new approaches to real-world evidence that address the most challenging questions in oncology research. From transportability studies to bias assessment in AI-extracted data, we’re advancing the science of what real-world data can achieve."

In addition to novel multi-country analyses enabled by Flatiron’s robust multinational real-world data from the US, the UK, Germany, and Japan, the Flatiron FORUM (Fostering Oncology RWE Uses and Methods) research consortium is addressing gaps in representative, locally-available data by bringing together biopharma and academic partners to collaboratively advance a portfolio of research studies focused on the transportability of oncology data across borders.

Research highlights include:

a Top 5% Award Poster presentation assessing if survival outcomes were transportable between the US and Austria, highlighting the challenges of applying RWE across different healthcare settings, as evidenced by the significant differences in survival outcomes between the US and Austrian datasets.
a Top 5% Award Poster presentation comparing patient characteristics and first-line treatment patterns in mNSCLC using the Flatiron Health Research Database and French ESME database providing findings crucial for guiding population adjustment in transportability analyses of real-world outcomes between countries.
a Poster presentation exploring the use of electronic health records (EHRs) to monitor liver function tests in patients with breast cancer treated with CDK4/6 inhibitors across the UK, Germany, and Japan, underscoring the potential of EHRs to enhance drug safety surveillance.
Schedule a meeting with Flatiron Health at ISPOR Europe 2025 and follow Flatiron Health on X and LinkedIn for more updates from #ISPOREurope.

Abstracts and Poster Presentations

Are Real-World Survival Outcomes in Metastatic Breast Cancer Transportable Between the US and Austria?
TOP 5% FINALIST
Harlan Pittell, Uwe Siebert, Per-Olof Thuresson, Lu Chen, Carol Hawkes, Danalyn Byng, Gabriel Rinnerthaler, Simon Peter Gampenrieder, Richard Greil, Mohamed Ali, Philani Mpofu, Elsie Horne, Qianyi Zhang, Amit Samani, Blythe Adamson
Author Affiliations: Flatiron Health, UMIT TIROL, Daiichi Sankyo, Roche, AGMT, Paracelsus Medical University
Poster Session 4
Poster Code: HTA38
Poster Session Date/Time: Tuesday, 11 November, 16:00 – 19:00

Descriptive Comparison of Patient Characteristics and Treatment Patterns in Metastatic NSCLC: US and France Cohorts to Inform Transportability
TOP 5% FINALIST
Alison Antoine, Mathieu Robain, Philani Mpofu, Elsie Horne, Harlan Pittell, Qianyi Zhang, Amit Samani, Per-Olof Thuresson, Thomas Filleron, Matthieu Carton, Olga Tymejczyk, Marian Eberl, Maurice Pérol, Christos Chouaid, Nicolas Girard, Didier Debieuvre, Xavier Quantin, Hervé Léna, David Pérol, Blythe Adamson
Author Affiliations: Flatiron Health, Unicancer, Institut Claudius Régaud, PSL Research University, Daiichi Sankyo, Centre Léon Bérard, CHI Créteil, Institut Curie, Groupe hospitalier de la région de Mulhouse Sud Alsace, CHU Montpellier, CHU Rennes
Poster Session 2
Poster Code: RWD56
Poster Session Date/Time: Monday, 10 November, 16:00 – 19:00

Comparing Countries’ Time to Treatment Initiation: A Study of Metastatic Breast Cancer in Austria and the United States
Harlan Pittell, Mohamed S. Ali, Philani Mpofu, Elsie Horne, Per-Olof Thuresson, Qianyi Zhang, Amit Samani, Blythe Adamson
Author Affiliations: Roche, Flatiron Health
Poster Session 1
Poster Code: HSD26
Poster Session Date/Time: Monday, 10 November, 10:30 – 13:30

Advancing Real-World Evidence in Diffuse Large B-Cell Lymphoma: Insights from EHR-Derived Data in the UK
Elsie Horne, Christoph Buhl, Tamra Downing, Harlan Pittell, Blythe Adamson
Poster Session 1
Poster Code: HSD4
Poster Session Date/Time: Monday, 10 November, 10:30 – 13:30

Assessing Bias in LLM-Extracted Real-World Data: A Health Equity Analysis of Access to Care and Outcomes in Metastatic Breast Cancer
Olive Mbah, Gene Ho, Catherine Keane, Qianyu Yuan, Cleo Ryals
Poster Session 1
Poster Code: MSR39
Poster Session Date/Time: Monday, 10 November, 10:30 – 13:30

Fit-for-Purpose Real-World Data: Lessons from FDA QCARD and EMA Data Quality Framework
Angela Chen, Lockwood Taylor, Lou Palladino, Vanessa Maniuszko
Poster Session 2
Poster Code: HPR96
Poster Session Date/Time: Monday, 10 November, 16:00 – 19:00

Laboratory Testing Patterns in Patients with Breast Cancer Treated With CDK4/6 Inhibitors: A Multi-Country Electronic Health Record Study From the UK, Germany, and Japan
Elsie Horne, Amit Samani, Sascha van Bömmel-Wegmann, Blythe Adamson, Lockwood Taylor
Poster Session 3
Poster Code: SA59
Poster Session Date/Time: Tuesday, 11 November, 10:30 – 13:30

Incidence of Neutropenia Adverse Events Identified in Electronic Health Care Records Among Initiators of CDK4/6 Inhibitors With Advanced Breast Cancer in the UK
Lockwood Taylor, Elsie Horne, Amit Samani, Qianyu Yuan, Sascha van Bömmel-Wegmann, Blythe Adamson
Poster Session 3
Poster Code: EPH143
Poster Session Date/Time: Tuesday, 11 November, 10:30 – 13:30

Real-World Insights into Prostate Cancer Management Using EHR-Derived Data from the UK
Elsie Horne, Amit Samani, Arun Sujenthiran, Tamra Downing, Deepika Singh, Harlan Pittell, Blythe Adamson
Poster Session 4
Poster Code: RWD161
Poster Session Date/Time: Tuesday, 11 November, 16:00 – 19:00

Real-World Insights Into Breast Cancer in the UK: Findings From UK EHR-Derived Data
Amit Samani, Mohamed Ali, Arun Sujenthiran, Blythe Adamson
Poster Session 5
Poster Code: RWD159
Poster Session Date/Time: Wednesday, 12 November, 9:00 – 11:30

Real-World Study of Breast Cancer Epidemiology and Treatment Patterns: A Pilot Study to Assess EHR-Derived Data in the United Kingdom
Peter McMahon, Kevin Nolan, Natalia Sadetsky, Matthew Hodgeson, Blythe Adamson, Amit Samani
Author Affiliations: Gilead Sciences, Flatiron Health
Poster Session 5
Poster Code: RWD163
Poster Session Date/Time: Wednesday, 12 November, 9:00 – 11:30

Transportability of Overall Survival in Multiple Myeloma From the US to Germany: A Benchmarking Study
Elsie Horne, Marco DiBonaventura, Per-Olof Thuresson, Felipe Castro, Christoph Buhl, Mohamed S. Ali, PharmD, Harlan Pittell, Philani Mpofu, Blythe Adamson
Author Affiliations: Pfizer, Roche, Flatiron Health
Poster Session 5
Poster Code: HTA340
Poster Session Date/Time: Wednesday, 12 November, 9:00 – 11:30

(Press release, Flatiron Health, OCT 23, 2025, View Source [SID1234656970])

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 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 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])