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Curium Group, PeptiDream and PDRadiopharma Enroll First Patient to Registrational Clinical Trial of 177Lu-PSMA-I&T for Prostate Cancer in Japan

On February 5, 2026 Curium Group reported that together with PeptiDream Inc. and PDRadiopharma Inc., the first patient has been dosed in the companies’ registrational clinical trial of 177Lu-PSMA-I&T in Japan for patients with PSMA (*1)-positive metastatic castration-resistant prostate cancer (mCRPC).

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177Lu-PSMA-I&T is a radiotherapeutic agent targeting PSMA conjugated to a chelator radiolabeled with Lutetium-177. The multicenter, open-label, single-arm registrational Phase 2 trial will evaluate efficacy and safety of 177Lu-PSMA-I&T. The trial will enroll patients who have been diagnosed with mCRPC and will be conducted as a registrational trial in Japan, utilizing the bridging data from Curium’s ongoing global clinical trials under the strategic collaboration between PDRadiopharma and Curium.

As announced on 15 October 2025, Curium Group, PeptiDream and PDRadiopharma initiated the clinical trial of 64Cu-PSMA-I&T which is being assessed as a diagnostic PET imaging agent with patients who have been newly diagnosed with prostate cancer (please refer to "PeptiDream, PDRadiopharma and Curium Group Enroll First Patient to Registrational Clinical Trial of 64Cu-PSMA-I&T for Prostate Cancer in Japan"). 64Cu-PSMA-I&T is also used in this trial to confirm PSMA positivity before the administration of 177Lu-PSMA-I&T.

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 patients with prostate cancer in Japan."

Masato Murakami, President of PDRadiopharma & CMO of PeptiDream commented: "We are excited to initiate the development of 177Lu-PSMA-I&T in Japan. Introducing new treatment options is an important part of improving prostate cancer patient care. Together with 64Cu-PSMA-I&T, this program is expected to provide new options to visualize and treat prostate cancer more precisely, helping patients and their physicians make more informed decisions. In collaboration with Curium, PDRadiopharma is committed to bringing these radiopharmaceutical treatments to patients in Japan as safely and as quickly as possible."

About Prostate Cancer

Prostate cancer continues to be widely prevalent in Japan. Annually, there are approximately 90,000 – 100,000 new cases (*2), with patients with metastatic castration-resistant prostate cancer having an overall survival rate of approximately three years in clinical trial settings, and even shorter in the real-world, and there remains a significant unmet medical need for therapies.

*1: PSMA – prostate-specific membrane antigen which is highly expressed on prostate cancer cells

*2: National Cancer Center Japan

Clinical trial progress

Phase 3 ECLIPSE trial – 177Lu-PSMA-I&T, a PSMA-targeting ligand conjugated with the radioisotope Lutetium-177, has been tested by Curium in a global pivotal 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.

Phase 3 trial SOLAR RECUR and SOLAR STAGE – 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.

Partnership Details

Under the terms of the partnership, Curium and PDRadiopharma will jointly collaborate on clinical development activities of 177Lu-PSMA-I&T and 64Cu-PSMA-I&T in Japan, with PDRadiopharma leading regulatory filing, manufacturing, commercialization, and distribution activities in Japan. Curium will continue to lead global development of the two agents and support PDRadiopharma through technology transfer to support the set-up of manufacturing lines in Japan – including a high throughput Copper 64 manufacturing line based on Curium’s proprietary technology.

(Press release, PeptiDream, FEB 5, 2026, View Source [SID1234662465])

DS3790 Enters Clinical Development as First DXd ADC in Hematology from Industry-Leading ADC Portfolio of Daiichi Sankyo

On February 4, 2026 Daiichi Sankyo reported that the first patient has been dosed in a first-in-human phase 1/2 trial evaluating DS3790 in patients with relapsed or refractory B-cell non-Hodgkin lymphoma.

DS3790 is a specifically engineered, potential first-in-class CD37 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568).

CD37 is a transmembrane protein that plays a role in regulating cell survival and is overexpressed on malignant B-cells, making it a promising therapeutic target.1 Currently, there are no CD37 directed therapies approved for any type of cancer.

"The initiation of this trial of DS3790 with its novel CD37 target marks a significant milestone as our first DXd antibody drug conjugate in hematology," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "DS3790 expands our portfolio to seven DXd antibody drug conjugates, all developed using our in-house technology, underscoring our dedication to scientific innovation to create new medicines for patients with cancer."

About the Phase 1/2 Trial
The multicenter, open-label, multi-cohort, first-in-human phase 1/2 trial will assess the safety and efficacy of DS3790 in patients with relapsed or refractory B-cell non-Hodgkin lymphoma.

The first part of the trial (dose escalation) is evaluating DS3790 as a monotherapy to determine the recommended dose for expansion. The second part of the trial (dose expansion) will consist of multiple expansion cohorts to further evaluate DS3790 as a monotherapy.

Following the assessment of preliminary safety and efficacy in the monotherapy part of the trial, subsequent cohorts will evaluate DS3790 in combination with other targeted therapies in both dose escalation and dose expansion phases.

The trial will evaluate safety endpoints including dose-limiting toxicities and adverse events, as well as efficacy endpoints including overall response, disease control rate, duration of response, time to response, progression-free survival and overall survival. Pharmacokinetics and biomarker endpoints also will be assessed.

The trial is expected to enroll approximately 420 patients across multiple sites globally, including Asia, Europe and North America. For more information, please visit ClinicalTrials.gov.

About CD37
CD37 is a transmembrane protein that plays a role in regulating cell survival and is overexpressed in various B-cell hematological malignancies.1 B-cells, which are a type of white blood cell (B-lymphocyte) that help the body fight infection, can uncontrollably multiply and fail to function properly.2 Because of its high prevalence on B-cells, CD37 is considered a promising therapeutic target for the treatment of B-cell cancers.3 Currently, there are no CD37 directed therapies approved for any type of cancer.

About B-cell Non-Hodgkin Lymphoma
More than 604,000 cases of non-Hodgkin lymphoma were diagnosed in 2021, with approximately 267,000 deaths globally.4 B-cell non-Hodgkin lymphoma accounts for more than 85% of all non-Hodgkin lymphoma cases with a five-year survival rate of 74%.5

While advances in targeted therapies have improved outcomes in B-cell non-Hodgkin lymphoma, many patients with relapsed or refractory disease continue to face limited treatment durability and poor long-term survival.6

About DS3790
DS3790 is an investigational, potential first-in-class CD37 directed ADC. Designed using the proprietary DXd ADC technology of Daiichi Sankyo, DS3790 is comprised of a humanized anti-CD37 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

(Press release, Daiichi Sankyo, FEB 4, 2026, https://www.businesswire.com/news/home/20260204176261/en/DS3790-Enters-Clinical-Development-as-First-DXd-ADC-in-Hematology-from-Industry-Leading-ADC-Portfolio-of-Daiichi-Sankyo [SID1234662491])

enGene to Participate in the Guggenheim Emerging Outlook: Biotech Summit 2026

On February 4, 2026 enGene Holdings Inc. (Nasdaq: ENGN or "enGene"), a clinical-stage, non-viral genetic medicines company, reported that Ron Cooper, President and Chief Executive Officer, will participate in a fireside chat at the Guggenheim Emerging Outlook: Biotech Summit 2026 on Wednesday, February 11, 2026, at 2:30 p.m. ET.

A live webcast of the fireside chat can be accessed on the "Events and Presentations" page under the "Investors" section of the enGene website at www.engene.com and will be archived there for 90 days.

(Press release, enGene, FEB 4, 2026, View Source [SID1234662490])

Arcellx Announces Late-Breaking Presentation at TANDEM Demonstrating Unique, High Target-Specificity of anito-cel’s D-Domain Binder

On February 4, 2026 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company focused on delivering a new class of innovative immunotherapies for patients with cancer and other incurable diseases, reported that a late-breaking abstract for its novel D-Domain binder in anitocabtagene autoleucel (anito-cel) has been accepted for presentation at the 2026 Tandem Meetings. BCMA-directed CAR T therapies are effective in treating relapsed and/or refractory multiple myeloma, with the potential for deep and durable responses. Anito-cel is partnered with Kite, a Gilead Company.

The poster (903) describes a preclinical study that explores the role of binder attributes in the specificity of BCMA-directed CAR T cells. CAR constructs representative of cilta-cel (dual VHH), ide-cel (scFv), and anito-cel (D-Domain) were assessed preclinically. In summary, the results showed no tonic signaling or off-target activity with the D-Domain binder, supporting a favorable safety profile. CAR T activation and cytokine release, reflective of tonic signaling, were observed for dual VHH and scFv binders in the absence of BCMA antigen, but not with the D-Domain. Off-target activity, specifically against Claudin-9 (CLDN9), was observed with the dual VHH binder, and no off-target activity was observed with the scFv binder or the D-Domain. Claudin-9 is a member of the Claudin family and is expressed at the tight junctions of endothelial and epithelial barriers. Therefore, binding of CLDN9 in addition to BCMA could increase the risk of off-target toxicities. Claudin family proteins have been implicated in maintaining the structural and functional integrity of the blood–brain and gut–vascular barriers, and disrupted Claudin function is linked to inflammatory, neurodegenerative, and gut disorders.

The Tandem Meetings are being held February 4-7, 2026, at the Salt Palace Convention Center in Salt Lake City, Utah. A copy of the presentation can be accessed on Arcellx’s website at www.arcellx.com under the Pipeline/Scientific publications section.

Tandem Presentation Details
Title and ID: D-Domain Binder In Anitocabtagene Autoleucel Shows Absence of Tonic Signaling and Cross-Reactivity Profile (poster ID: 903) (abstract: 29612)
Speaker: Alexandra Witter, PhD
Session: Poster Session: Late-Breaking Poster Abstracts
Session Date: Thursday, February 5, 2026
Session Time: 6:30 – 8:00 p.m. MT
Location: Hall AB

Abstract Details

Title
D-Domain Binder in Anitocabtagene Autoleucel Confers Potent Anti-Tumor Activity while Minimizing Tonic Signaling and Off-Target Reactivity

Authors
Alexandra Witter, Lawrence P. Andrews, Matthew J. Frigault, Krina K. Patel, Ciara L. Freeman, Sigal Shachar

Introduction
BCMA-directed CAR-T cell therapies are effective in treating relapsed and/or refractory multiple myeloma, with potential for deep and durable responses. Anitocabtagene autoleucel (anito-cel) has demonstrated an encouraging efficacy and safety profile, with no cases of delayed neurotoxicities or immune effector cell-associated enterocolitis (IEC-EC) observed to date (Patel et al., ASH (Free ASH Whitepaper) 2025). This profile differentiation may be attributable to the different BCMA-targeting binders used in these CAR-T cell therapies, as current standard-of-care BCMA-directed CAR-T cell therapies either demonstrate suboptimal efficacy with idecabtagene vicleucel (ide-cel), or a risk of delayed toxicities such as parkinsonism, cranial nerve palsies or IEC-EC with ciltacabtagene autoleucel (cilta-cel). Anito-cel utilizes a novel synthetic D-Domain binder, with binding to BCMA characterized by a fast off-rate and displays minimal antigen-independent aggregation (Hart et al., ASH (Free ASH Whitepaper) 2025).

Objectives
This study aims to further explore the contribution of binder attributes towards specificity of BCMA-directed CAR-T cells.

Methods
We transduced CAR constructs representative of cilta-cel (dual VHH), ide-cel (scFv) and anito-cel (D-Domain) into healthy donor T cells. Key attributes such as phenotypes associated with tonic signaling and target-specific activity were compared between surrogate CAR-T cells with matched CAR-positive frequency and vector copy number.

Results
Dual VHH CAR-T cells show increased expression of FAS, ICAM and TRAIL, compared to D-Domain CAR-T cells, in the absence of antigen-expressing cells suggesting a tonic signaling phenotype. D-Domain CAR-T cells did not show expression of activation markers (CD69, 4-1BB) or IFNγ release, which were elevated 3-fold and 39-fold respectively, with dual VHH CAR-T cells. As previously reported from a membrane surface protein array, cilta-cel bound to Claudin-9 (CLDN9) in addition to BCMA (EPAR EMA/594558/2022, EMA 2022). CLDN9 is expressed in tight junctions of folliculo-stellate cells in the anterior pituitary gland and cerebellum. In this study, dual VHH CAR-T cells stimulated with CLDN9++ HEK293 cells demonstrated upregulation of activation markers, IFNγ release and target cell killing. CLDN9-induced activity was not observed with D-Domain or scFv CAR-T cells under any conditions tested.

Conclusion
Off-target activity with dual VHH CAR-T cells was seen against CLDN9, suggesting that the high avidity dual VHH binder could recognize other cryptic epitopes and lead to off-tumor binding and toxicities. The D-Domain exhibits favorable features such as stability and rapid off-rate differentiating it from the dual VHH binder, which may contribute to the enhanced target specificity and lack of tonic signaling described here.

About Anitocabtagene Autoleucel (anito-cel)

Anitocabtagene autoleucel (anito-cel, previously CART-ddBCMA) is the first BCMA-directed CAR T-cell therapy to be investigated in multiple myeloma that utilizes Arcellx’s novel and compact binder known as the D-Domain. The small, stable D-Domain binder enables high CAR expression without tonic signaling and is designed to quickly release from the BCMA target. This combination may allow for the effective elimination of multiple myeloma cells without severe immunotoxicity. Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the U.S. Food and Drug Administration.

(Press release, Arcellx, FEB 4, 2026, View Source [SID1234662489])

Immunome to Present at the Guggenheim Emerging Outlook: Biotech Summit 2026

On February 4, 2026 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported that Immunome management will present at Guggenheim’s Emerging Outlook: Biotech Summit on February 11, 2026, at 9 a.m. ET.

Interested parties can access the live audio webcast for this conference from the Investor Relations section of the company’s website at www.immunome.com. The webcast replay will be available after the conclusion of the live presentation for approximately 30 days.

(Press release, Immunome, FEB 4, 2026, View Source [SID1234662488])