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Actinium to Present ATNM-400 Preclinical Data Highlighting Durable Tumor Control and Ability to Overcome Resistance to Standard-of-Care Prostate Cancer Therapies at the 32nd Annual Prostate Cancer Foundation Scientific Retreat

On October 13, 2025 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a pioneer in the development of differentiated targeted radiotherapies, reported that compelling preclinical data for ATNM-400, its novel, first-in-class antibody radioconjugate armed with the potent alpha-emitter Actinium-225 (Ac-225), has been accepted for presentation at the 32nd Annual Prostate Cancer Foundation (PCF) Scientific Retreat being held on October 23 – 25, 2025 in Carlsbad, CA (Press release, Actinium Pharmaceuticals, OCT 13, 2025, View Source [SID1234656594]). The presentation will highlight ATNM-400’s ability to induce robust, durable anti-tumor activity in metastatic castration-resistant prostate cancer (mCRPC) models, including tumors resistant to standard-of-care therapies such as the androgen receptor pathway inhibitor (ARPI), enzalutamide (Xtandi, Astellas/Pfizer) and the PSMA-targeted therapy, 177Lu-PSMA-617 (active agent in Pluvicto, Novartis) as well as superior efficacy compared to 225Ac-PSMA-617.

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ATNM-400 PCF Presentation Information

Title: ATNM-400, a first-in-class Actinium-225 antibody radioconjugate, demonstrates potent anti-tumor activity and overcomes resistance to enzalutamide and 177Lu-PSMA-617 in prostate cancer models

Poster Session Date and Time: Thursday, October 23, 2025, 7:30 – 10:30 PM P.T.

Following the PCF presentation, the ATNM-400 poster will be available for viewing online on Actinium’s investor relations page HERE.

Addressing Critical Unmet Needs in mCRPC

Prostate cancer patients who progress to mCRPC face limited treatment options. While ARPI therapies like enzalutamide and PSMA-targeted radiotherapies like Pluvicto have extended survival, resistance and disease progression remain major challenges.

ATNM-400 directly addresses this unmet need by targeting a distinct, non-PSMA tumor antigen strongly linked to treatment resistance, rapid disease progression, and poor survival outcomes in prostate cancer. Leveraging a high-affinity antibody against the novel target, combined with the potent cell-killing power of alpha radiation via the Ac-225 isotope payload, ATNM-400 offers a mechanistically differentiated approach beyond current PSMA-directed therapies. The target antigen of ATNM-400 is overexpressed following ARPI therapy and is associated with a shorter time to castration resistance. This positions ATNM-400 as a differentiated treatment option in the post-ARPI setting, where it has been shown to overcome enzalutamide resistance and enhance the efficacy of ARPI combinations. In preclinical models, synergy with enzalutamide resulted in robust, durable tumor control and significantly improved overall survival. This innovative strategy aims to overcome limitations of current treatments and provide new hope for patients facing advanced prostate cancer.

"ATNM-400’s ability to maintain anti-tumor activity in both PSMA-expressing and PSMA-resistant models, while also synergizing with ARPI therapy, underscores its potential as a differentiated, next-generation alpha therapy for prostate cancer," said Sandesh Seth, Chairman and Chief Executive Officer, Actinium Pharmaceuticals, Inc. "We look forward to highlighting ATNM-400 at PCF and engaging with prostate cancer KOLs as we work to further advance ATNM-400."

About ATNM-400

ATNM-400 is a novel, first-in-class Ac-225 antibody radioconjugate targeting a distinct non-PSMA protein strongly implicated in prostate cancer progression and treatment resistance. Unlike 177Lu-PSMA-617, the active agent in Pluvicto and the majority of radiotherapies under development, which rely on PSMA targeting, ATNM-400 is designed to maintain efficacy in PSMA-low or PSMA-resistant disease, a major unmet clinical need. Ac-225 delivers high-linear-energy-transfer alpha particles that induce irreparable double-strand DNA breaks, offering superior potency over beta emitters like Lutetium-177 (177Lu), and has a shorter tissue path length that may reduce off-target toxicity. Additionally, the antigen specifically targeted by ATNM-400 continues to be expressed at a high level even after androgen receptor inhibitor (ARPI) therapy and ATNM-400 has shown to overcome resistance to the ARPI therapy enzalutamide and work synergistically in combination with enhanced tumor control including complete tumor regression.

Prostate cancer is the most diagnosed cancer in men, with ~1.5 million new cases globally and over 313,000 expected in the U.S. in 2025. While early-stage disease is typically managed with surgery, radiation, and ARPI therapy, up to 20% of cases progress to mCRPC – a lethal stage with limited treatment options. Targeted radiotherapy is a growing field in prostate cancer, dominated by PSMA-targeting agents like Pluvicto, which had sales of over $1.3 billion in 2024, yet many patients either lack PSMA expression and do not respond or develop resistance to Pluvicto. In the U.S., 40,000 – 60,000 mCRPC patients annually progress after ARPI therapy, which as a class had sales of over $10.0 billion in 2024 including enzalutamide (Xtandi) which led the ARPI class with sales of over $5.9 billion in 2024, highlighting a significant unmet need. Actinium intends to evaluate ATNM-400 in other solid tumor indications beyond prostate cancer.

Theriva™ Biologics Announces Upcoming Presentations at Medical Meetings

On October 13, 2025 Theriva Biologics (NYSE American: TOVX), ("Theriva" or the "Company"), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported upcoming presentations at the European Society for Medical Oncology (ESMO 2025) Annual Congress and at Infectious Diseases Week (IDWeek) 2025 Annual Meeting (Press release, Theriva Biologics, OCT 13, 2025, View Source [SID1234656593]).

VCN-01 upcoming mini-oral presentation at ESMO (Free ESMO Whitepaper) 2025
Expanded data from the VIRAGE trial investigating VCN-01 (zabilugene almadenorepvec) are to be presented at a mini oral session at the ESMO (Free ESMO Whitepaper) 2025 Congress:

Presenting author: Dr. Rocío Garcia-Carbonero, Hospital 12 de Octubre, Madrid, Spain
Title: VIRAGE trial: randomized Phase IIb, open-label, study of Nab-Paclitaxel and Gemcitabine with/without intravenous VCN-01 in Patients with Metastatic Pancreatic Cancer (mPDAC)
Abstract #: 2216MO
Date and time: Monday, October 20, 2025, 09:28 a.m. CEST
Session: Mini oral session 2, GI Tumors Upper digestive
Location: Bonn Auditorium – Hall 7.1c, Messe Berlin, Berlin, Germany
SYN-004 upcoming poster presentation at IDWeek 2025
Previously disclosed blinded safety and pharmacokinetic (PK) data from the ongoing Phase 1b/2a randomized, double-blinded, placebo-controlled clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients for the prevention of acute graft-versus-host-disease (aGVHD). These data will be presented at ID Week 2025:

Presenting Author: Erik R. Dubberke, MD, Professor of Medicine, Clinical Director, Transplant Infectious Diseases, Washington University School of Medicine in St. Louis
Title: Safety and tolerability of SYN-004 in allogeneic haematopoietic cell transplant (HCT) recipients receiving meropenem (MER) or piperacillin/tazobactam (P/T)
Abstract #: P-104
Date and time: Monday, October 20, 2025 from 12:15 to 1:30 p.m US EDT
Location: Poster Hall B4-5, Georgia World Congress Center, Atlanta, Georgia
About VCN-01

VCN-01 (zabilugene almadenorepvec) is a systemically administered oncolytic adenovirus designed to selectively and aggressively replicate within tumor cells and degrade the tumor stroma that serves as a significant physical and immunosuppressive barrier to cancer treatment. This unique mode-of-action enables VCN-01 to exert multiple antitumor effects by (i) selectively infecting and lysing tumor cells; (ii) enhancing the access and perfusion of co-administered chemotherapy products; and (iii) increasing tumor immunogenicity and exposing the tumor to the patient’s immune system and co-administered immunotherapy products. Systemic administration enables VCN-01 to exert its actions on both the primary tumor and metastases. VCN-01 has been administered to 142 patients to date in clinical trials of different cancers, including pancreatic ductal adenocarcinoma (in combination with chemotherapy), head and neck squamous cell carcinoma (with an immune checkpoint inhibitor), ovarian cancer (with CAR-T cell therapy), colorectal cancer, and retinoblastoma (by intravitreal injection). More information on these clinical trials is available at Clinicaltrials.gov.

About SYN-004 (ribaxamase)

SYN-004 (ribaxamase) is an oral prophylactic therapy designed to degrade certain IV beta-lactam antibiotics within the GI tract and maintain the natural balance of the gut microbiome for the prevention of Clostridioides difficile infection (CDI), overgrowth of pathogenic organisms, the emergence of antimicrobial resistance (AMR) and acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients. Allogeneic HCT recipients routinely receive long courses of IV beta-lactam antibiotics to treat infection following conditioning therapy. Antibiotic-mediated damage of the gut microbiome in allogeneic HCT recipients may lead to adverse outcomes including CDI, VRE colonization and potentially fatal bacteremia and aGVHD. A previously completed placebo-controlled Phase 2b clinical trial of 412 patients demonstrated SYN-004 protected the gut microbiome from antibiotic-mediated dysbiosis. Patients who received SYN-004 also demonstrated significantly better maintenance and recovery of the gut microbiome as well as lower incidences of new colonization by opportunistic and potentially pathogenic microorganisms such as VRE.

BeOne Medicines’ Sonrotoclax Granted Breakthrough Therapy Designation by U.S. FDA

On October 13, 2025 BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for sonrotoclax, a next-generation and potentially best-in-class investigational BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL) (Press release, BeOne Medicines, OCT 13, 2025, View Source [SID1234656592]). Additionally, the FDA has accepted BeOne’s request for participation in Project Orbis, an initiative that provides a framework for concurrent submission and review of oncology products among participating global health authorities.

"Breakthrough Therapy Designation is reserved for medicines with the potential to transform outcomes for patients with serious diseases. This recognition affirms the strength of the emerging data for sonrotoclax and its potential to become a new standard of care for people with relapsed or refractory mantle cell lymphoma," said Julie Lepin, Senior Vice President, Chief Regulatory Affairs Officer at BeOne. "Additionally, by participating in Project Orbis, we may be able to accelerate access to sonrotoclax, potentially helping patients faster than previously imagined."

The decision by the FDA to grant sonrotoclax BTD and participation in Project Orbis was based on data from the BGB-11417-201 study, a Phase 1/2 study evaluating sonrotoclax in adult patients with R/R MCL, following treatment with a Bruton’s tyrosine kinase inhibitor (BTKi) and anti-CD20 therapy. The recently announced positive topline results for sonrotoclax underscore its potential to deliver deep and durable responses, giving it the potential to be the first and only BCL2 inhibitor approved for use in R/R MCL in the U.S. BeOne plans to present the full data at an upcoming medical meeting. The Phase 3 confirmatory CELESTIAL-RRMCL study (BGB-11417-302; NCT06742996) is underway.

The FDA grants BTD to medicines with early data suggesting they may offer significant advances for patients with serious diseases. Project Orbis, established by the FDA Oncology Center of Excellence in 2019, facilitates collaboration across regulatory bodies on the review of oncology medicines with the goal of making promising cancer therapies available to patients more quickly across participating countries.

This is the first BTD for sonrotoclax and the second for BeOne’s hematology program. The FDA has also granted sonrotoclax Fast Track Designation for MCL and Waldenström macroglobulinemia (WM), as well as Orphan Drug Designation for the treatment of adult patients with MCL, WM, multiple myeloma (MM), and acute myeloid leukemia (AML). These designations help reinforce sonrotoclax’s position as the next major advancement in BeOne’s commitment to redefining care in B-cell malignancies.

About Mantle Cell Lymphoma

Mantle cell lymphoma (MCL) is a rare subtype of aggressive B-cell non-Hodgkin lymphoma (NHL)1 that develops in B-cells located in the mantle zone of the lymph nodes. MCL accounts for approximately 5% of all NHL cases globally2, affecting an estimated 28,000 people3. MCL is often diagnosed at advanced stages4 and nearly all MCL patients will eventually develop refractory or relapsed (R/R) disease.5 The five-year survival rate for MCL is approximately 50%, reflecting the urgent need for new therapeutic options.6

About BGB-11417-201 Study

The BGB-11417-201 (NCT05471843) study is a global, multicenter, single-arm, open-label, Phase 1/2 study, which enrolled 125 adult patients with R/R MCL post-treatment with anti-CD20 therapy and a BTK inhibitor. In Part 1, 22 patients received daily treatment with either 160 mg or 320 mg of sonrotoclax to assess the safety and tolerability of sonrotoclax and identify the recommended dose for Part 2. In Part 2, 103 patients were enrolled to receive the recommended daily dose of sonrotoclax (320 mg), following ramp-up, to assess the efficacy of sonrotoclax. The primary endpoint is overall response rate (ORR), as assessed by an independent review committee (IRC). Secondary endpoints include complete response (CR) rate, duration of response (DOR) and progression-free survival (PFS).

About Sonrotoclax (BGB-11417)

Sonrotoclax is a next-generation and potentially best-in-class investigational inhibitor of B-cell lymphoma 2 (BCL2), which is one of several proteins that help cancer cells survive. It is part of a group of drugs called BH3 mimetics, which mimic natural cell death signals. Studies in the lab and during early drug development have shown that sonrotoclax is a highly potent and specific inhibitor of BCL2 with a short half-life and no drug accumulation. Sonrotoclax has shown promising clinical activity across a range of B-cell malignancies, and nearly 2,000 patients have been enrolled to date across the broad global development program.

Daiichi Sankyo Continues to Transform Standards of Care for Patients with Three Landmark Breast Cancer Trials and Additional Data Across Industry-Leading ADC Portfolio at ESMO

On October 13, 2025 Daiichi Sankyo reported data at ESMO (Free ESMO Whitepaper) will spotlight the company’s advances towards creating new standards of care for patients with breast cancer, including back-to-back presentations during Presidential Symposium I featuring data from the DESTINY-Breast11 (291O) and DESTINY-Breast05 (LBA1) phase 3 trials (Press release, Daiichi Sankyo, OCT 13, 2025, https://daiichisankyo.us/press-releases/-/article/daiichi-sankyo-continues-to-transform-standards-of-care-for-patients-with-three-landmark-breast-cancer-trials-and-additional-data-across-industry-leading-adc-portfolio-at-esmo [SID1234656591]). Results of these two landmark trials will showcase the potential of ENHERTU (trastuzumab deruxtecan) to become a foundational treatment in curative-intent settings of HER2 positive early breast cancer.

Late-breaking DATROWAY (datopotamab deruxtecan) data from the TROPION-Breast02 phase 3 trial (LBA21), representing the first trial ever to demonstrate a significant improvement in overall survival compared to chemotherapy as first-line treatment for patients with locally recurrent inoperable or metastatic triple negative breast cancer (TNBC) for whom immunotherapy is not an option, will be featured in a proffered paper session.

"Data from these three landmark trials demonstrate how the DXd ADC portfolio of Daiichi Sankyo continues to transform standards of care for patients with breast cancer. The findings from DESTINY-Breast11 and DESTINY-Breast05 highlight the potential of ENHERTU to become a foundational treatment in the curative-intent settings of HER2 positive early breast cancer," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "Additionally, the DATROWAY results from TROPION-Breast02 represent the first time ever that an overall survival benefit has been demonstrated in the first-line setting of patients with metastatic triple negative breast cancer for whom immunotherapy is not an option. Couple these impressive results for DATROWAY with previous results seen with ENHERTU in the HER2 positive, HER2 low and HER2 ultralow disease settings, Daiichi Sankyo will now have two medicines with the potential to treat approximately 90 percent of patients with metastatic breast cancer."

Additional breast cancer data at ESMO (Free ESMO Whitepaper) includes a mini oral presentation of data from Arm 7 and Arm 8 of the BEGONIA phase 1/2 trial (555MO) evaluating DATROWAY plus durvalumab in patients with first-line metastatic TNBC. The efficacy and safety of this combination strategy is being further investigated in three phase 3 trials – TROPION-Breast03, TROPION-Breast04 and TROPION-Breast05 – across stages and treatment settings of TNBC.

Trials Supporting Three Recent Breakthrough Therapy Designations Showcased
Data from additional late-stage trials – DESTINY-Breast09, REJOICE-Ovarian01 and IDeate-Lung01 – that supported three recent Breakthrough Therapy Designations (BTD) in the U.S. for ENHERTU, raludotatug deruxtecan (R-DXd) and ifinatamab deruxtecan (I-DXd) will be showcased at ESMO (Free ESMO Whitepaper).

Two late-breaking proffered paper sessions will highlight the primary analysis from the phase 2 part of the REJOICE-Ovarian01 phase 2/3 trial (LBA42) of raludotatug deruxtecan in patients with previously treated platinum-resistant ovarian cancer, and additional analyses of key subgroups of interest from the DESTINY-Breast09 phase 3 trial (LBA18) evaluating ENHERTU plus pertuzumab versus THP (taxane, trastuzumab, pertuzumab) for the first-line treatment of patients with HER2 positive metastatic breast cancer. Results of DESTINY-Breast09 formed the basis for a supplemental Biologic License Application in the U.S. for ENHERTU, which was recently granted Priority Review under the Real-Time Oncology Review program.

Detailed results highlighting the intracranial activity of ifinatamab deruxtecan from the IDeate-Lung01 phase 2 trial (2760MO) in patients with previously treated extensive-stage small cell lung cancer (ES-SCLC) and baseline brain metastases will be highlighted during a mini oral session. The primary results of IDeate-Lung01 were presented last month at the 2025 World Conference on Lung Cancer (#WCLC25).

Progress Continues in Multiple Cancers Across the DXd ADC Portfolio of Daiichi Sankyo
Additional mini oral sessions at ESMO (Free ESMO Whitepaper) will feature the first presentation of data from two early phase trials from the DXd ADC portfolio of Daiichi Sankyo. These include preliminary results from the first-in-human phase 1/2 trial of DS-3939 (917O), the sixth DXd ADC in clinical development, in patients with previously treated advanced solid tumors refractory to standard treatment, as well as initial results from a sub-study of the TROPION-PanTumor03 phase 2 trial (3072MO) evaluating DATROWAY plus rilvegostomig, AstraZeneca’s PD-1/TIGIT bispecific antibody, in patients as first-line or second-line locally advanced or metastatic urothelial carcinoma.

Final analyses from two trials – DESTINY-CRC02 and DESTINY-PanTumor02 – that supported the tumor agnostic indication of ENHERTU, which is now approved in more than 10 countries/regions worldwide, will be presented. A mini oral session will feature the final analysis from the DESTINY-CRC02 phase 2 trial (737MO) of ENHERTU in patients with previously treated HER2 positive metastatic colorectal cancer while two poster presentations will highlight the final results (957P) and an exploratory biomarker analysis (145P) from part 1 of the DESTINY-PanTumor02 phase 2 trial in patients with previously treated HER2 expressing solid tumors. Additional regulatory submissions seeking a tumor agnostic approval in patients with HER2 positive metastatic solid tumors currently are under review in the EU and Japan.

Further sub-analyses from the DESTINY-Gastric04 phase 3 trial of ENHERTU versus ramucirumab plus paclitaxel in the second-line treatment of patients with HER2 positive metastatic gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma will be presented as a poster presentation (2099P) reporting the concordance of central HER2 testing with local HER2 testing along with additional efficacy and safety analyses. Data from DESTINY-Gastric06, a phase 2 trial in patients from China with HER2 expressing advanced gastric or GEJ adenocarcinoma who have received at least two prior regimens including a fluoropyrimidine agent and a platinum agent, will be presented in two poster presentations. The first poster (2105P) will feature an analysis of patients that received prior anti-HER2 treatment other than or in addition to trastuzumab. The second poster (2175P) will report the risk of hepatitis B virus reactivation in patients with past or resolved HBV or inactive chronic HBV infection treated with ENHERTU.

Updates of progress in lung cancer include a mini oral session reporting updated results from a phase 1/2 trial of gocatamig (2758MO), a DLL3 targeting T-cell engager being jointly developed by Merck, in patients with small cell lung cancer and other neuroendocrine cancers, as well as a poster presentation that will highlight the initial safety results from a phase 1b trial of valemetostat (2023P), a dual EZH1 and EZH2 inhibitor, in combination with DATROWAY in patients with previously treated advanced non-squamous non-small cell lung cancer (NSCLC).

Trials-in-Progress Across Daiichi Sankyo’s Oncology Portfolio
Several trials-in-progress poster presentations at ESMO (Free ESMO Whitepaper) further highlight the Daiichi Sankyo R&D strategy of continuing to expand the DXd ADC portfolio to address a broad spectrum of unmet needs for patients with cancer.

A trial-in-progress poster will highlight the design of the DESTINY-Endometrial01 phase 3 trial (1223TiP) evaluating ENHERTU in combination with rilvegostomig or pembrolizumab versus platinum-based chemotherapy (carboplatin and paclitaxel) in combination with pembrolizumab as a first-line therapy in patients with HER2 expressing (IHC 3+/ 2+), mismatch repair proficient (pMMR) primary advanced or recurrent endometrial cancer.

Three phase 2 trials-in-progress will include the HERTHENA-Breast03 trial (463eTiP) evaluating neoadjuvant patritumab deruxtecan (HER3-DXd) plus pembrolizumab before or after pembrolizumab plus chemotherapy in patients with high-risk early-stage TNBC or HR low positive/HER2 negative breast cancer; the REJOICE-GI01 trial (1001TiP) evaluating the efficacy and safety of raludotatug deruxtecan in patients with gastrointestinal cancers, including pancreatic ductal adenocarcinoma, gastroesophageal adenocarcinoma, biliary tract and colorectal cancer; and, the KEYMAKER-U01 sub-studies 01H/01I (2081eTiP) evaluating ifinatamab deruxtecan, raludotatug deruxtecan or docetaxel in patients with stage IV NSCLC.

The design of two additional early phase trials will be shared, including the phase 1/2 trial (2792TiP) evaluating ifinatamab deruxtecan and gocatamig in patients with relapsed/refractory ES-SCLC and a phase 1b trial (977P) of valemetostat in combination with ipilimumab in patients with refractory genitourinary tumors, including prostate cancer, urothelial carcinomas and renal clear cell carcinoma.

Investor Briefing During ESMO (Free ESMO Whitepaper)
Daiichi Sankyo will hold a virtual conference call for investors on Tuesday, October 21, 2025 from 8:00 to 9:30 am EDT / 9:00 to 10:30 pm JST. Executives from Daiichi Sankyo will provide an overview of the ESMO (Free ESMO Whitepaper) data.

Daiichi Sankyo Oral Presentations at ESMO (Free ESMO Whitepaper)

Presentation Title

Author

Abstract

Presentation (CEST)

Breast

Trastuzumab deruxtecan (T-DXd) vs trastuzumab emtansine (T-DM1) in patients with high-risk human epidermal growth factor receptor 2-positive (HER2+) primary breast cancer with residual invasive disease after neoadjuvant therapy: interim analysis of DESTINY-Breast05

C. Geyer

LBA1

Presidential Symposium I

Saturday, October 18

4:30 – 6:15 pm

DESTINY-Breast11: neoadjuvant trastuzumab deruxtecan alone (T-DXd) or followed by paclitaxel + trastuzumab + pertuzumab (T-DXd-THP) vs SOC for high-risk HER2+ early breast cancer

N. Harbeck

291O

Presidential Symposium I

Saturday, October 18

4:30 – 6:15 pm

Trastuzumab deruxtecan (T-DXd) + pertuzumab vs taxane + trastuzumab + pertuzumab (THP) for patients with HER2+ advanced/metastatic breast cancer: additional analyses of DESTINY-Breast09 in key subgroups of interest

S. Loibl

LBA18

Proffered Paper Session

Sunday, October 19

8:30 – 10:00 am

First-line datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients with locally recurrent inoperable or metastatic triple negative breast cancer for whom immunotherapy was not an option: primary results from the randomized, phase 3 TROPION-Breast02 trial

R. Dent

LBA21

Proffered Paper Session

Sunday, October 19

8:30 – 10:00 am

Datopotamab deruxtecan (Dato-DXd) + durvalumab as first-line treatment for unresectable locally advanced/ metastatic triple negative breast cancer: final results from the phase 1b/2 BEGONIA study

P. Schmid

555MO

Mini Oral Session

Monday, October 20

10:15 – 11:45 am

Lung

Intracranial activity of ifinatamab deruxtecan (I-DXd) in patients with extensive-stage small cell lung cancer and baseline brain metastases: primary analysis of IDeate-Lung01

P. Rocha

2760MO

Mini Oral Session

Saturday, October 18

4:30 – 6:00 pm

Updated results from a phase 1/2 study of gocatamig for small cell lung cancer and other neuroendocrine cancers

H. Beltran

2758MO

Mini Oral Session

Saturday, October 18

4:30 – 6:00 pm

Ovarian

Raludotatug deruxtecan (R-DXd) in patients with platinum-resistant ovarian cancer: primary analysis of the phase 2 dose- optimization part of the REJOICE-Ovarian01 study

I. Ray-Coquard

LBA42

Proffered Paper Session

Sunday, October 19

2:45 – 4:15 pm

Bladder

Datopotamab deruxtecan (Dato-DXd) + rilvegostomig in patients with locally advanced or metastatic urothelial cancer: results from the phase 2 TROPION-PanTumor03 study

S. Rha

3072MO

Mini Oral Session

Friday, October 17

4:00 – 5:30 pm

CRC

Trastuzumab deruxtecan (T‑DXd) in patients with HER2 positive (HER2+) metastatic colorectal cancer: final analysis of DESTINY-CRC02, a randomized, phase 2 trial

K. Raghav

737MO

Mini Oral Session

Sunday, October 19

2:45 – 4:15 pm

PanTumor

DS-3939, a tumor-associated mucin 1 (TA-MUC1)-directed antibody drug conjugate (ADC), in patients with advanced/metastatic solid tumors: initial results from a first-in-human study

M. Patel

917O

Proffered Paper Session

Sunday, October 19

2:45 – 4:20 pm

Daiichi Sankyo Poster Presentations at ESMO (Free ESMO Whitepaper)

Presentation Title

Author

Abstract

Presentation (CDT)

Breast

Final real-world safety and effectiveness results of REALITY-01 study: trastuzumab deruxtecan (T-DXd) in patients received ≥2 prior treatment lines for HER2+ metastatic or unresectable breast cancer

J. Pierga

539P

Poster Session

The effectiveness of post-trastuzumab deruxtecan (T-DXd) treatment regimens and the incidence of recurrent interstitial lung disease (ILD) in patients with HER2+ metastatic breast cancer who discontinued T-DXd due to ILD

J. Tsurutani

540P

Poster Session

HERTHENA-Breast03: a phase 2, randomized, open-label study evaluating neoadjuvant patritumab deruxtecan + pembrolizumab before or after pembrolizumab + chemotherapy for early-stage TNBC or HR low+/HER2− breast cancer

M. Danso

463eTiP

ePoster

Lung

Phase 1b study of valemetostat in combination with datopotamab deruxtecan (Dato-DXd) in advanced non-squamous non-small cell lung cancer: initial safety results

A. Spira

2023P

Poster Session

A phase 1b/2 study of gocatamig (MK-6070; HPN328) and ifinatamab deruxtecan for relapsed/refractory extensive-stage small cell lung cancer

J. Sun

2792TiP

Poster Session

KEYMAKER-U01 phase 2 substudies 01H/01I: ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) or docetaxel in stage IV non-small cell lung cancer

E. Nadal

2081eTiP

ePoster

Gastrointestinal

Trastuzumab deruxtecan (T-DXd) vs ramucirumab plus paclitaxel in second-line treatment of patients with HER2+ unresectable/metastatic gastric cancer/gastroesophageal junction adenocarcinoma: additional data from DESTINY-Gastric04

F. Pietrantonio

2099P

Poster Session

Trastuzumab deruxtecan (T-DXd) in patients with HER2+ gastric cancer or gastroesophageal junction adenocarcinoma who received prior anti-HER2 treatment other than/in addition to trastuzumab in DESTINY-Gastric06

Z. Peng

2105P

Poster Session

Risk of hepatitis B virus reactivation in patients with past or resolved HBV or inactive chronic HBV infection treated with trastuzumab deruxtecan (T-DXd) in the DESTINY-Gastric06

L. Shen

2175P

Poster Session

Raludotatug deruxtecan in participants with gastrointestinal cancers: phase 2 REJOICE-GI01 trial

M. Ueno

1001TiP

Poster Session

Endometrial

A randomized phase 3 study of first-line trastuzumab deruxtecan (T-DXd) with rilvegostomig or pembrolizumab in patients with HER2 expressing, mismatch repair-proficient, primary advanced or recurrent endometrial cancer: DESTINY-Endometrial01/GOG-3098/ENGOT-EN24

B. Slomovitz

1223TiP

Poster Session

PanTumor

Trastuzumab deruxtecan (T-DXd) for pretreated patients with HER2 expressing solid tumors: DESTINY-PanTumor02 part 1 final analysis

V. Makker

957P

Poster Session

Trastuzumab deruxtecan (T-DXd) in pretreated patients with HER2 expressing solid tumors: exploratory biomarker analysis of DESTINY-PanTumor02 part 1

D. Oh

145P

Poster Session

DS3201 (valemetostat), an EZH1/2 inhibitor, with ipilimumab in patients with refractory genitourinary tumors

S. Goswami

977P

Poster Session

Transgene and BioInvent to Present
Translational Data and Updated Clinical Results on Armed Oncolytic Virus BT-001, at ESMO 2025

On October 13, 2025 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, reported it will jointly present a poster on translational data and updated clinical results from the Phase I study of BT-001 at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting. ESMO (Free ESMO Whitepaper) will take place in Berlin, Germany, from October 17 to 21, 2025 (Press release, Transgene, OCT 13, 2025, View Source [SID1234656590]).

Key findings of the abstract include:

– Intra-tumoral (IT) BT-001 injection in combination with intravenous (IV) pembrolizumab was well tolerated with a manageable safety profile.

– The data show encouraging and sustained anti-tumor activity in patients with advanced refractory tumors. One patient with PD(L)-1 resistant melanoma and one patient with heavily pretreated and Immune Checkpoint Inhibitor (ICI)-naive leiomyosarcoma showed partial response (iPR) lasting 6 and 16 months respectively, among the 13 patients who received the combination of IT BT-001 (at 107 pfu/mL and 108 pfu/mL) and IV pembrolizumab.

– Tumor shrinkage was observed in both injected and non-injected lesions.

– BT-001 could be an effective option to improve the response to ICI in refractory patients.

The abstract is available on the ESMO (Free ESMO Whitepaper) website (here). The poster will be presented on October 20 during ESMO (Free ESMO Whitepaper) 2025 and will also be available to view on Transgene’s website.

BT-001 is an oncolytic virus generated using Transgene’s Invir.IO platform and its patented large-capacity VVcopTK-RR- oncolytic virus, which has been engineered to encode both a Treg-depleting recombinant human anti-CTLA-4 antibody generated by BioInvent’s proprietary n-CoDeR/F.I.R.S.T platforms, and the human GM-CSF cytokine.

BT-001 is being co-developed as part of a 50/50 collaboration between Transgene and BioInvent. In the Phase I part of this study, BT-001 was well tolerated both as monotherapy and in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA (pembrolizumab)*.

The Phase I/IIa study (NCT04725331) is a multicenter, open label, dose-escalation study evaluating BT-001 as a single agent and in combination with pembrolizumab*. The last patient in the Phase I part was enrolled in August 2024.

Treatment with BT-001 converted "cold" tumors into "hot" ones, and induced T-cell infiltration, as well as PD(L)-1 expression in the tumor microenvironment (ESMO 2024, access press release here).

*KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.