On July 25, 2025 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) a clinical-stage siRNA biopharmaceutical company developing therapeutics using its proprietary INTASYL gene silencing technology to eliminate cancer, reported that pathologic results are available for four of the five patients treated in the fourth cohort (Press release, Agenus, JUL 25, 2025, View Source [SID1234654551]). A complete pathologic response (100% tumor clearance) has been reported for one patient with cutaneous squamous cell carcinoma (cSCC). One patient with metastatic Merkel cell carcinoma was reported as a partial response (> 50% clearance). Two patients with cSCC were reported as having a pathologic non-response (<50% tumor clearance). Pathologic results for the remaining patient with cSCC are still pending.

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Phio’s ongoing Phase 1b dose escalation clinical trial (NCT 06014086) is designed to evaluate the safety and tolerability of neoadjuvant use of intratumoral PH-762 in Stages 1, 2 and 4 cSCC, Stage 4 melanoma, and Stage 4 Merkel cell carcinoma. To date, a total of 15 patients with cutaneous carcinomas have been treated across the four cohorts. There were no dose-limiting toxicities or clinically relevant treatment-emergent adverse effects in the patients receiving intratumoral PH-762 in this trial. Moreover, PH-762 has been well tolerated in all enrolled patients in each escalating dose cohort. No patients exhibited clinical progression of disease.

The cumulative pathologic response in 13 patients with cSCC include five complete response (100% clearance), one patient with a near complete response (>90% clearance) and one with a partial response (>50% clearance) and six patients with a pathologic non-response (< 50% clearance).

The one Merkel cell carcinoma patient with stage 4 metastatic disease had a partial response (>50% clearance). The melanoma patient was a non-responder (<50% clearance).

Phio is now enrolling what is expected to be the 5th and final cohort in the Phase 1b study.

"The positive safety and efficacy outcomes through the fourth cohort continue to indicate that PH-762 may present a viable non-surgical alternative in this large and continually expanding skin cancer market," said Robert Bitterman, CEO and Chairman of Phio Pharmaceuticals.

On July 25, 2025 PDX Pharma reported it has successfully met the Year 1 milestones of its Phase II SBIR grant (R44CA285233) from the National Cancer Institute (NCI) for the development of PETTRA (PLK1 and EGFR Targeted Therapy and Radiation Sensitizer) for lung cancer treatment (Press release, PDX Pharmaceuticals, JUL 25, 2025, View Source [SID1234654548]). As a result, the NCI has issued a Notice of Award for approximately $1.09 million, bringing the total grant funding to $2.4 million. We thank the NCI for its continued support, as well as our dedicated staff and collaborators at OHSU, who worked tirelessly to achieve the project milestones. PETTRA demonstrated superior efficacy compared to the standard of care (SOC) in a metastatic non-small cell lung cancer (NSCLC) mouse model and exhibited strong synergy with radiation therapy. In the final phase of the project, we will conduct additional PK/PD and safety studies of PETTRA, advancing it toward clinical trials as both a monotherapy and a radiation sensitizer.

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On July 25, 2025 Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology, reported that four abstracts highlighting clinical progress across its botensilimab and balstilimab immunotherapy programs have been accepted for presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, taking place in Berlin, Germany from October 17-21 (Press release, Agenus, JUL 25, 2025, View Source [SID1234654537]). The highlight is an oral presentation that will feature emerging survival plateaus from a study of botensilimab plus balstilimab in 343 evaluable patients with refractory metastatic solid tumors across five tumor types. Three additional poster presentations will feature data from investigator-sponsored studies in cervical cancer, MSS metastatic colorectal cancer (mCRC), and non-melanoma skin cancers, underscoring the broad potential of botensilimab and balstilimab based combinations in difficult-to-treat cancers.

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Presentation Details:

1. Oral Presentation Title: Emerging survival plateaus with botensilimab and balstilimab: Pan tumor data from a large phase 1b trial of advanced solid tumors

Presenting Author:
Dr. Michael Gordon; HonorHealth Research Institute-AZ, USA

Mini Oral Session:

Investigational Immunotherapy

Session Date:

Friday, October 17, 2025

Session Time:

2:00-3:00 PM CEST / 8:00-9:30 AM EDT

Location:

Hall 5.2

Abstract Number:

3220

2.

Poster Presentation Title: Efficacy and safety of balstilimab with or without zalifrelimab in recurrent cervical cancer: Results from the global phase 2 RaPiDs trial

Presenting Author: Dr. David O’Malley; The Ohio State University Comprehensive Cancer Center- OH, USA
Session Date:

Saturday, October 18, 2025

Session Time:

12:00-12:45 PM CEST / 6:00-6:45 AM EDT

Location:

Hall 25

Abstract Number:

2952

Poster Number:

1164P

3.

Presentation Title: A Phase I trial of botensilimab, balstilimab and regorafenib (BBR) in chemotherapy-resistant patients with microsatellite stable (MSS) metastatic colorectal cancer

Presenting Author:

Dr. Marwan Fakih; City of Hope- CA, USA

Session Date:

Sunday, October 19, 2025

Session Time:

12:00-12:45 PM CEST / 6:00-6:45 AM EDT

Location:

Hall 25

Abstract Number:

6197

Poster Number:

851P

4.

Presentation Title: A phase 2, open label study to evaluate the safety and clinical activity of balstilimab in patients with advanced/metastatic non-melanoma skin cancers (AGENONMELA)

Presenting Author:

Dr. Iwona Lugowska; Maria Sklodowska-Curie National Research Institute and Oncology Center – Poland

Session Date:

Monday, October 20, 2025

Session Time:

12:00-12:45 PM CEST / 6:00-6:45 AM EDT

Location:

Hall 25

Abstract Number:

7273

Poster Number:

1662P

On July 25, 2025 Taiho Oncology, Inc., a company developing and commercializing novel treatments for hematologic malignancies and solid tumors, reported it will present new data from the REZILIENT2 trial of zipalertinib at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, to be held Oct. 17-21, 2025, in Berlin, Germany (Press release, Taiho, JUL 25, 2025, View Source [SID1234654536]).

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The abstract accepted for a mini oral presentation includes the preliminary efficacy and safety data from the Phase 2b REZILIENT2 trial of zipalertinib, an oral, highly selective, irreversible EGFR tyrosine kinase inhibitor (TKI), in patients with advanced or metastatic NSCLC harboring EGFR ex20ins mutations or EGFR uncommon non-ex20ins mutations and active brain metastases and/or leptomeningeal disease.

"We look forward to presenting the latest findings from Cohort C of our REZILIENT2 trial, which focuses on a subset of patients with ex20ins NSCLC with central nervous system involvement, at this year’s ESMO (Free ESMO Whitepaper) Congress," said Harold Keer, MD, PhD, Chief Medical Officer, Taiho Oncology. "We are excited to share more details from our zipalertinib program, building upon its potential to make a meaningful impact in a disease area of unmet need."

The session title and information for the accepted abstract are listed below. Full abstract details will be available via the conference website at 12:05 CEST a.m. on Oct. 13, 2025.

Title: Activity of Zipalertinib Against Active Central Nervous System (CNS) Metastases in Patients With Non-Small Cell Lung Cancer (NSCLC) Harboring EGFR Exon 20 Insertion (Ex20ins)/Other Uncommon Mutations
Abstract Number: 3778
Session Name: Mini oral session 1: NSCLC metastatic
Session Type: Mini Oral Presentation
Session Date: Oct. 19, 2025
Session Time: 8:30 to 10 a.m. CEST

About Zipalertinib
Zipalertinib (development code: CLN-081/TAS6417) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was selected because of its ability to inhibit EGFR variants with exon 20 insertion mutations, while sparing wild-type EGFR. Zipalertinib is designed as a next generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer. Zipalertinib has received Breakthrough Therapy Designation from the FDA. Zipalertinib is investigational and has not been approved by any health authority.

Zipalertinib is being developed by Taiho Oncology, Inc., its parent company, Taiho Pharmaceutical Co., Ltd., and in collaboration with Cullinan Therapeutics, Inc. in the U.S.

On July 25, 2025 Servier reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of VORANIGO (vorasidenib) in the European Union (EU) for the treatment of predominantly non-enhancing Grade 2 astrocytoma or oligodendroglioma with an isocitrate dehydrogenase-1 (IDH1) R132 or isocitrate dehydrogenase-2 (IDH2) R172 mutation in adult and adolescent patients aged 12 years and older and weighing at least 40 kg who only had surgical intervention and who are not in immediate need of radiotherapy or chemotherapy (Press release, Servier, JUL 25, 2025, View Source [SID1234654535]).

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The marketing authorization application for VORANIGO will now be reviewed by the European Commission (EC), which has the authority to approve medicines for use in the 27 member states of the EU. Decisions by the EC are also applicable in Norway, Liechtenstein, and Iceland.

"Today’s recommendation for EU approval brings us one step closer to offering VORANIGO to patients in the EU with Grade 2 IDH-mutant glioma who have historically had limited treatment options for this relentless disease," said Susan Pandya, M.D., Vice President Clinical Development and Global Head of Oncology LS/LCM, Servier. "We look forward to continuing conversations with the EMA and other regulatory bodies around the world to introduce VORANIGO as a potential new standard of care for patients with IDH-mutant gliomas."

The CHMP opinion is based on the positive results of the Phase 3 INDIGO trial, a global Phase 3 randomized, double-blind placebo-controlled study of vorasidenib in patients with residual or recurrent Grade 2 glioma with an IDH1/2 mutation who have undergone surgery as their only treatment. Results were presented during the plenary session at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and published simultaneously in The New England Journal of Medicine.

VORANIGO was approved by the United States Food and Drug Administration (FDA) in August 2024 after being granted Fast Track, Breakthrough and Orphan Drug Designations and receiving Priority Review. VORANIGO has also been granted marketing authorization in Canada, Australia, Israel, the United Arab Emirates, Saudi Arabia, and Switzerland. Servier has also submitted marketing authorization applications in the United Kingdom, Japan and various other regions, and reviews by the appropriate health authorities are ongoing.

The use of VORANIGO is investigational in the EU and is not yet approved.