On October 15, 2025 PeptiDream Inc., a public Kanagawa, Japan-based biopharmaceutical company (President: Patrick C. Reid, hereinafter "PeptiDream")(Tokyo: 4587), PDRadiopharma Inc. (President: Masato Murakami, Headquarters: Chuo-ku, Tokyo, Japan, "PDRadiopharma"), a wholly owned subsidiary of PeptiDream, and Curium Group, a world leader in nuclear medicine (CEO: Renaud Dehareng, Headquarters: Boston, Massachusetts, the United States), reported that a registrational Phase 2 clinical trial (jRCT: 2031250225) has been initiated in Japan for 64Cu-PSMA-I&T, a PET radiopharmaceutical targeting prostate-specific membrane antigen (PSMA) expressed on prostate cancer cells.

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64Cu-PSMA-I&T is being assessed as a diagnostic PET imaging agent labeled with the radioisotope Copper-64, being developed with its therapeutic pair, 177Lu-PSMA-I&T. The development is conducted under the strategic collaboration between PDRadiopharma and Curium aiming at advancing innovative radiopharmaceuticals for prostate cancer in Japan.

The open-label, single-arm Phase 2 study will evaluate the sensitivity, specificity, and safety of 64Cu-PSMA-I&T. The trial will enroll approximately 70 patients who have been newly diagnosed with unfavorable intermediate, high or very high-risk prostate cancer and are scheduled for prostatectomy with pelvic lymph node dissection. This study is being conducted as a registrational trial in Japan and will utilize bridging data from Curium’s ongoing global clinical trials.

In parallel, a clinical trial for 177Lu-PSMA-I&T as a therapeutic agent is being planned to evaluate its efficacy and safety in patients with metastatic castration-resistant prostate cancer (mCRPC).

Patrick C. Reid, President & CEO of PeptiDream commented: "Targeted radiopharmaceuticals are rapidly revolutionizing how we both diagnose and treat cancer. At PeptiDream and PDRadiopharma we are focused on expanding our pipeline of these targeted therapies, and we are thrilled to be able to accelerate those efforts by partnering with Curium to bring their prostate cancer targeting radiopharmaceuticals to patients in Japan."

Masato Murakami, President of PDRadiopharma & CMO of PeptiDream commented: "We are excited to initiate the development of 64Cu-PSMA-I&T in Japan. Both 64Cu-PSMA-I&T and 177Lu-PSMA-I&T are considered potential products for diagnosing and treating PSMA-expressing prostate cancer. There is demand in Japan for PSMA PET diagnosis, as many urologists wish to use this imaging modality in clinical practice. In collaboration with Curium, we aim to address this need and utilize radiopharmaceuticals to provide new medical treatments for patients."

Renaud Dehareng, CEO of Curium Group commented: "Conducting these registrational trials, in partnership with PeptiDream and PDRadiopharma, marks a significant milestone in our mission to expand access to cutting-edge radiopharmaceuticals to patients with prostate cancer across Asia. By combining Curium’s global development expertise with PDRadiopharma’s deep local knowledge and infrastructure, we are well-positioned to deliver transformative solutions to prostate cancer patients in Japan."

Global Clinical Trial Progress

For 177Lu-PSMA-I&T, a PSMA-targeting ligand conjugated with the radioisotope Lutetium-177, has been tested by Curium in a global Phase 3 ECLIPSE trial (ClinicalTrials.gov identifier; NCT05204927). It reported that the primary endpoint was met, demonstrating a statistically significant and clinically meaningful benefit for patients with mCRPC.
For 64Cu-PSMA-I&T, trials are being conducted to diagnose biochemical recurrence of prostate cancer (SOLAR RECUR trial, ClinicalTrials.gov identifier NCT06235099) and for men newly diagnosed with unfavorable intermediate to very high-risk prostate cancer, electing to undergo surgery (SOLAR STAGE trial, ClinicalTrials.gov identifier; NCT06235151). The first in human Phase 1/2 SOLAR trial met the co-primary endpoints of region-level correct localization rate and patient-level correct detection rate in patients with histologically-proven metastatic prostate cancer.

(Press release, PeptiDream, OCT 15, 2025, View Source [SID1234656689])

On October 15, 2025 OncoNano Medicine, Inc. ("OncoNano") reported a late-breaking research poster presentation at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics, to take place in Boston, Massachusetts, October 22 – 26, 2025. Details on the posters are below.

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Presentation Details

Title:

Results from part-1 of ON-5001: a multi-center, dose escalation and dose finding Phase 1 trial of ONM-501, a dual-acting STING agonist, alone or in combination with cemiplimab in patients with solid tumors and lymphoma

Session:
Poster Session A

Date & Time:
Thursday, October 23, 12:30-4 pm

About ONM-501

ONM-501 is a dual-activating agonist of the stimulator of interferon gene ("STING") pathway composed of cGAMP (the endogenous activator of STING) linked to a proprietary pH-activated polymer (the OMNI polymer). ONM-501 is presently being studied in a Phase 1 clinical trial (ON-5001). In preclinical models, the dual activation of STING by ONM-501has been shown to lead to direct anti-tumor effect, as well as leading to an anti-tumor immune response over an extended period of time. Development of ONM-501 was funded in part by the Cancer Prevention and Research Institute of Texas.

(Press release, OncoNano Medicine, OCT 15, 2025, View Source [SID1234656688])

On October 15, 2025 Novocure (NASDAQ: NVCR) reported that it will present data at two upcoming oncology congresses, the 2025 European Association of Neuro-Oncology (EANO) Meeting, being held October 16-19 in Prague, Czech Republic, and the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, being held October 17-21 in Berlin, Germany.

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At the EANO 2025 Meeting, Novocure will present pre-clinical data highlighting the potential of Tumor Treating Fields (TTFields) therapy to enhance radiosensitivity of glioblastoma cells by downregulating DNA repair pathways.

At the ESMO (Free ESMO Whitepaper) Congress 2025, Novocure will present a post-hoc analysis of its successful Phase 3 PANOVA-3 trial, which evaluated the use of TTFields therapy concomitantly with gemcitabine and nab-paclitaxel (GnP) as a first-line treatment for adults with unresectable, locally advanced pancreatic adenocarcinoma, compared to GnP alone. The post-hoc analysis assessed the efficacy of TTFields therapy based on daily device usage as well as levels of cancer antigen (CA) 19-9.

Data at the EANO 2025 Meeting

Poster: P18.24.B​: Short exposure to TTFields induces DNA repair pathway downregulation and radiosensitization in glioblastoma cells​

Presenting Author: Anat Klein-Goldberg, Novocure​, Ltd., Haifa, Israel

Date/Time: Saturday, October 18, 5:00-6:30 PM CEST, ​ Forum Hall Foyer 3​

Data at the ESMO (Free ESMO Whitepaper) Congress 2025

Poster: 2235P: Phase 3 study of TTFields in locally advanced pancreatic adenocarcinoma (PANOVA-3): post-hoc subgroup analyses based on device usage and CA 19-9

Presenting Author: Hani Babiker, MD, Mayo Clinic, Jacksonville, FL

Date/Time: Sunday, October 19, 12:00-12:45 PM CEST, Hall 25

About Tumor Treating Fields

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. These multiple, distinct mechanisms work together to target and kill cancer cells. Due to these multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors.

To learn more about TTFields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.

(Press release, NovoCure, OCT 15, 2025, View Source [SID1234656687])

On October 15, 2025 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") reported it will host an ESMO (Free ESMO Whitepaper) Data Update and Third Quarter Earnings Call on Monday, October 20, 2025, before the market opens. The ESMO (Free ESMO Whitepaper) data relates to the planned disclosure of the HARMONi-6 clinical trial data.

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As a reminder, the Phase III HARMONi-6 trial, conducted in China and sponsored by our partner, Akeso, Inc. (HKEX Code: 9926.HK), featuring the novel, potential first-in-class investigational bispecific antibody, ivonescimab, will be featured as part of the Presidential Symposium at the European Society for Medical Oncology 2025 Congress (ESMO 2025) which takes place from October 17–21, 2025, in Berlin, Germany. The presentation will take place on Sunday, October 19 during the Presidential Symposium from 4:30pm – 6:30pm CEST (10:30am – 12:30pm EDT).

HARMONi-6 is evaluating ivonescimab in combination with platinum-based chemotherapy compared with tislelizumab, a PD-1 inhibitor, in combination with platinum-based chemotherapy in patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) irrespective of PD-L1 expression. HARMONi-6 is a single region, multi-center, Phase III study conducted in China sponsored by Akeso with all relevant data exclusively generated, managed, and analyzed by Akeso.

Summit will host a live webcast of the conference call at 8:00am ET, which will be accessible through our website, www.smmttx.com. An archived edition of the session will be available on our website.

(Press release, Summit Therapeutics, OCT 15, 2025, View Source [SID1234656686])

On October 15, 2025 Eikon Therapeutics, Inc., a late-stage clinical biopharmaceutical company dedicated to integrating advanced engineering with cutting-edge laboratory and in silico research to accelerate drug discovery, reported that new data from an ongoing Phase 2 study of EIK1001 (TeLuRide-005) will be presented at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, taking place in Berlin, Germany from October 17-21, 2025.

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The presentation, titled "TeLuRide-005: Phase II study of EIK1001, a toll-like receptor 7/8 (TLR7/8) co-agonist with pembrolizumab (pembro)+chemotherapy (chemo) as first-line (1L) therapy in stage 4 non-small cell lung cancer (NSCLC)", will be delivered by Richard J. Gralla, M.D., Albert Einstein College of Medicine, during the Mini Oral Session 2 (1850MO – NSCLC metastatic) on Monday, October 20 at 10:55AM CEST.

"EIK1001 represents a unique approach to stimulating the immune system, and we are encouraged by its potential to improve outcomes for patients with advanced non-small cell lung cancer," said Roy Baynes, M.D., Ph.D., Chief Medical Officer of Eikon Therapeutics. "By combining a systemically administered TLR7/8 co-agonist with standard-of-care pembrolizumab and chemotherapy, our goal is to broaden immune activation and enhance anti-tumor responses in this hard-to-treat population. These results, reviewed in a successful end-of-Phase-2 meeting with the FDA earlier this year, support the continued advancement of this program into a registration-enabling Phase 2/3 trial. We look forward to sharing these data at ESMO (Free ESMO Whitepaper)."

TeLuRide-005 (NCT06246110) is a Phase 2 study evaluating EIK1001 in combination with pembrolizumab (KEYTRUDA) and histology-appropriate chemotherapy (carboplatin plus either pemetrexed or paclitaxel) in patients with Stage 4 NSCLC. By stimulating a broad immune response through TLR7/8 co-activation, EIK1001 is designed to enhance T-cell recognition and tumor killing, potentially overcoming immune resistance often observed in advanced NSCLC. The molecule is designed to activate innate and adaptive immunity, providing both direct anti-tumor activity and complementary effects when used in combination with checkpoint inhibitors. The trial’s primary objective is to evaluate the safety and tolerability of EIK1001 in the triplet combination. In addition, Eikon hopes to explore whether the immunomodulatory mechanism of EIK1001 might improve lung cancer treatment regimens. EIK1001 is also being studied in a seamless Phase 2/3 trial (TeLuRide-006; NCT06697301) evaluating its addition to standard-of-care pembrolizumab for the treatment of patients with advanced melanoma.

"The data being presented at ESMO (Free ESMO Whitepaper) mark another step forward for EIK1001 and underscore the increasing momentum across our oncology portfolio," said Roger M. Perlmutter, M.D., Ph.D., Chief Executive Officer of Eikon Therapeutics. "This progress reflects the deep expertise of our team in advancing groundbreaking cancer therapies through clinical development, and we are eager to build on this foundation as we work to deliver important new medicines that address grievous illnesses."

Eikon is also advancing a portfolio of differentiated oncology programs, including both mid-stage clinical assets and internally derived candidates informed by the company’s proprietary single-molecule tracking (SMT) platform. They include:

EIK1003-001 (NCT06253130): A highly selective non-CNS-penetrant PARP1 inhibitor, currently being evaluated in a Phase 1/2 study of adults with advanced solid tumors. Initial pharmacokinetic, safety, tolerability, and early efficacy findings from the monotherapy dose-escalation cohort were reported at ASCO (Free ASCO Whitepaper) 2025.
EIK1004-001 (NCT06907043): A CNS-penetrant PARP1 inhibitor currently in a Phase 1/2 study assessing safety, pharmacokinetics/pharmacodynamics, and preliminary antitumor activity in patients with advanced solid tumors, including those with brain metastases.
EIK1005: A novel, internally derived program targeting Werner (WRN) helicase for microsatellite unstable cancers and sensitive cancers that have other defects in DNA repair. EIK1005 is expected to begin Phase 1 clinical testing in Q4, 2025.

(Press release, Eikon Therapeutics, OCT 15, 2025, View Source [SID1234656685])