On June 10, 2025 Curadev Pharma, Inc., a clinical-stage biotechnology company developing novel immuno-oncology therapeutics, and Memorial Sloan Kettering Cancer Center (MSK), a world-leading cancer research and treatment institution, reported to have expanding their collaboration through the MSK Therapeutics Accelerator program to advance the development of Curadev’s small-molecule allosteric Stimulator of Interferon Genes (STING) agonist, CRD3874-SI, to be delivered systemically to patients with advanced/metastatic cancer (Press release, Curadev, JUN 10, 2025, View Source [SID1234653800]).

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The collaboration builds on the ongoing Phase 1a/b dose escalation and expansion clinical trial (NCT06021626) currently underway at MSK for sarcoma and Merkel cell carcinoma patients, and aims to explore the potential of CRD3874-SI in treating additional types of cancer. Through the MSK Therapeutics Accelerator program, MSK will provide Curadev with expertise and institutional resources, including medical, clinical, and regulatory advice, to further the development of CRD3874-SI. This expanded collaboration marks a significant milestone in translating promising STING pathway research into broader clinical application and will be overseen by William Tap, MD, Chief of the Sarcoma Medical Oncology Service at MSK, and Ciara Kelly, MBBCh BAO, Interim Clinical Director of MSK’s Sarcoma Oncology Service.

Dr. William Tap said, "MSK and its Division of Solid Tumors are excited to co-develop CRD3874-SI, a novel first-in-class allosteric STING agonist, with Curadev. CRD3874-SI has demonstrated an encouraging safety and efficacy profile in a first-in-human study at MSK. CRD3874-SI is moving forward into multiple solid-tumor expansion cohorts, guided by disease specific experts and the support and structure of the MSK Accelerator Program, which is designed to enhance and expedite the development of novel compounds across malignancies. CRD3874-SI has the potential to offer patients a new treatment option with continued innovation and exploration of the benefits of immunotherapy in cancer care."

Dr. Arjun Surya, Co-founder and CEO of Curadev, added, "We are encouraged by the early readouts with CRD3874-SI systemic monotherapy from our ongoing clinical trial in patients with treatment refractory cancers at MSK and are honored by the opportunity to deepen our collaboration through the MSK Therapeutics Accelerator program. The research and development collaboration between oncologists at MSK and the inventors of CRD3874-SI at Curadev could become a role model for advancing bench to bedside medicines.
MSK’s historic leadership position in the development of cancer immunotherapy and the exemplary dedication of the oncologists we work with is inspiring and make it an ideal partner in Curadev’s effort to investigate the therapeutic potential of its systemically administered allosteric STING agonist in patients with advanced/metastatic cancer."

On June 10, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") reported that results from the Phase 1/2 study (KL264-01/MK-2870-001) evaluating the novel TROP2 antibody drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT) as monotherapy were published in the international medical journal, Journal of Hematology & Oncology (Impact Factor (IF) = 29.9) (Press release, Kelun, JUN 10, 2025, View Source [SID1234653799]). Published results include those from the Phase 1 dose-escalation part of the study which evaluated sac-TMT in advanced solid tumors, and those from the Phase 2 expansion cohorts of the study, evaluating sac-TMT in metastatic triple-negative breast . The results of the study demonstrated the therapeutic potential of sac-TMT in this patient population.

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Results

KL264-01/MK-2870-001 is a Phase 1/2 first-in-human trial of sac-TMT as monotherapy in patients who have an unresectable locally advanced or metastatic solid tumor which is refractory to standard therapies, which is a global multi-centre study. Presented results include those from the Phase 1 portion of this study, and the Phase 2 expansion cohorts for TNBC and HR+/HER2– breast cancer. The results of the study showed that sac-TMT demonstrated a manageable safety profile in patients with unresectable locally advanced/metastatic solid tumors and promising antitumor activity in metastatic TNBC and HR+/HER2− breast cancer. Currently, sac-TMT is being investigated in several Phase 3 studies in China, led by the Company, as well as globally, where MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) holds the exclusive rights. In May 2022, the Company licensed the exclusive rights to MSD to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (includes Mainland China, Hong Kong, Macau, and Taiwan).

About sac-TMT

Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (includes Mainland China, Hong Kong, Macau, and Taiwan).

To date, two indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) and EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. Sac-TMT became the first domestically developed and fully approved-for-marketing ADC in China with global intellectual property rights. It is also the world’s first TROP2 ADC to be approved for marketing in a lung cancer indication. In addition, two new indication applications for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy and with unresectable locally advanced, metastatic HR+/HER2- BC who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting were accepted by the NMPA, and were included in the priority review and approval process. As of today, Kelun-Biotech has initiated 8 registrational clinical studies in China. MSD has initiated 14 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other agents for several types of cancer. These studies are sponsored and led by MSD.

On June 10, 2025 Foresight Diagnostics, a leading developer of ultra-sensitive minimal residual disease (MRD) detection technologies, reported that validation data demonstrating the prognostic performance of its CLARITY MRD assay in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) will be featured as encore oral presentations at two upcoming international conferences: the 2025 European Hematology Association (EHA) (Free EHA Whitepaper) Congress (June 12–15, in Milan, Italy) and the 18th International Conference on Malignant Lymphoma (ICML) (June 17–21, in Lugano, Switzerland) (Press release, Foresight Diagnostics, JUN 10, 2025, View Source [SID1234653798]).

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This multi-center study, conducted in collaboration with Amsterdam University Medical Centers, the Hemato-Oncology Foundation for Adults in the Netherlands (HOVON), and the Netherlands Comprehensive Cancer Organization (IKNL), highlights real-world results using Foresight CLARITY MRD on patients who were treated with frontline chemotherapy across over 50 centers in the Netherlands and Belgium.

"We’re grateful to present our data at major medical meetings this spring, validating our science and the real-world utility of ultra-sensitive ctDNA-MRD technology," said David Kurtz, M.D., Ph.D., Chief Medical Officer of Foresight Diagnostics. "These presentations and the recent incorporation of ctDNA-MRD testing in B-cell lymphoma clinical guidelines give us confidence as we prepare to launch in the clinical market in 2026 and integrate Foresight CLARITY into routine clinical practice."

Lead study authors Steven Wang, M.D., and Martine Chamuleau, M.D., Ph.D., Amsterdam UMC, added: "Our findings confirm that ultra-sensitive ctDNA-MRD detection provides meaningful prognostic information beyond standard imaging and clinical factors. We believe this assay can support better risk stratification than imaging alone and inform post-treatment management decisions in DLBCL."

Oral presentation details for EHA (Free EHA Whitepaper):

Title: Prospective validation of end of treatment ctDNA-MRD by PhasED-Seq in DLBCL patients from a national trial
Presenter: Martine Chamuleau, MD, PhD (Amsterdam UMC)
Session: Aggressive Non-Hodgkin lymphoma – Clinical (Observational)
Time: Thursday, June 12 | 5:00 p.m. – 5:15 p.m. CEST / 11:00 a.m. – 11:15 a.m. ET
Room: Brown Hall 3
Abstract number: S240
Oral presentation details for ICML:

Title: Prospective validation of end of treatment ctDNA-MRD by PhasED-Seq in DLBCL patients from a national HOVON trial
Presenter: Martine Chamuleau, MD, PhD (Amsterdam UMC)
Session: Session 6: Liquid biopsy for response assessment
Time: Thursday, June 19 | 2:15 p.m. – 2:30 p.m. CEST / 8:15 a.m. – 8:30 a.m. ET
Room: Polivalente room, East Campus USI
Article number: 041
In addition to the oral presentation, Foresight’s technology will be highlighted in other presentations, including:

Title: Prognostic Value of Circulating Tumor DNA (ctDNA) Detection by PhasED-Seq After Axicabtagene ciloleucel (Axi-cel) Therapy in Relapsed/Refractory Large B-Cell Lymphoma (LBCL)
Meeting: EHA (Free EHA Whitepaper) 2025
Sponsor: Kite Pharma
Presenter: Jeffrey Gregg, MD (Foresight Diagnostics)
Session: Poster Session I | Poster Hall
Date/Time: Friday, June 13 | 6:30 p.m. – 7:30 p.m. CEST / 12:30 p.m. – 1:30 p.m. ET
Abstract: #PF1002

Title: The Correlation of Mutational Profiles and Valemetostat Efficacy in Patients With R/R PTCL in the Phase 2 VALENTINE-PTCL01 Trial
Meeting: ICML 2025
Sponsor: Daiichi Sankyo
Presenter: Pier Luigi Zinzani, MD, PhD (University of Bologna)
Session: "Focus On" Session Biology and Therapy of T-cell Lymphomas | Room B
Date/Time: Saturday, June 14 | 10:05 a.m. – 10:15 a.m. CEST / 4:05 a.m. – 4:15 a.m. ET
Article Number: 164

On June 10, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") reported that its TROP2-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT) in combination with the PD-L1 monoclonal antibody tagitanlimab was granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for the first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without actionable genomic alterations (Press release, Kelun, JUN 10, 2025, View Source [SID1234653797]). Breakthrough Therapy Designation is granted for treatment options that demonstrate significant clinical advantages over currently available treatments and is aimed at expediting the research, development and marketing of innovative treatment options that address clinically urgent medical needs. This designation is based on the efficacy and safety data from the non-squamous cohort of the Phase II OptiTROP-Lung01 study.

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This marks the fifth Breakthrough Therapy Designation granted to sac-TMT by the NMPA. Sac-TMT has previously received this designation for:

Locally advanced or metastatic triple-negative breast cancer (TNBC) in July 2022;
EGFR-mutant, locally advanced or metastatic NSCLC after progression on EGFR-TKI therapy in January 2023;
Locally advanced or metastatic hormone-receptor positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer (BC) in patients who have previously received at least two lines of systemic chemotherapy in June 2023；
First-line treatment of unresectable locally advanced, recurrent or metastatic PD-L1 negative TNBC in March 2024.
Results from a Phase 2 OptiTROP-Lung01 study of sac-TMT in combination with tagitanlimab in first-line advanced or metastatic non-squamous NSCLC patients were presented in a poster session at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting[1].

Dr. Michael Ge, CEO of Kelun-Biotech said, "This designation by the NMPA highlights the importance of developing novel therapeutic options for diverse NSCLC subtypes. Sac-TMT in combination with tagitanlimab demonstrated clinically meaningful outcomes in key endpoints for patients with non-squamous NSCLC without actionable genomic alterations as a first-line treatment. We are excited about the therapeutic potential of TROP2 ADC- immunotherapy combinations, and we look forward to working with regulatory authorities in China to bring this combination therapy to patients in need as soon as possible."

About sac-TMT
Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, BC, gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (includes Mainland China, Hong Kong, Macao, and Taiwan).

To date, two indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) and EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. Sac-TMT became the first domestic ADC with global intellectual property rights to be fully approved for marketing. It is also the world’s first TROP2 ADC to be approved for marketing in a lung cancer indication. In addition, two new indication applications for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy and with unresectable locally advanced, metastatic HR+/HER2- BC who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting were accepted by the CDE, and were included in the priority review and approval process. As of today, the Company has initiated 8 registrational clinical studies in China. MSD has initiated 14 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab2 or other agents for several types of cancer. These studies are sponsored and led by MSD.

About Tagitanlimab
Tagitanlimab is the first PD-L1 mAb globally to receive authorization for the first-line treatment of NPC. Previously, the NMPA has approved the marketing in China of tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment of patients with R/M NPC and monotherapy for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy, respectively.

On June 10, 2025 XL-protein GmbH, a pioneer in the area of biopolymers for pharmacokinetic optimization, reported that it has entered into a worldwide License, Development and Commercialization Agreement with Grifols, a global healthcare company and leading manufacturer of plasma-derived medicines, for a novel, long-acting biopharmaceutical product (Press release, XL-protein, JUN 10, 2025, View Source [SID1234653796]).

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Under this collaboration, XL-protein will leverage its proprietary, clinical-stage PASylation technology to extend the circulation of Grifols therapeutics, paving the way for a more effective and long-lasting treatment. XL-protein will actively support preclinical development activities while Grifols will be entitled to further developing as well as, manufacturing and marketing the PASylated-enhanced biologic.

Under the terms of the agreement, XL-protein will receive an upfront payment as well as payments for achievement of preclinical, clinical, regulatory and commercial milestones. Furthermore, XL-protein will receive tiered royalties on sales from marketed therapeutics resulting from the collaboration. Grifols will have worldwide exclusive marketing rights under the agreement. Further financial terms have not been disclosed.

"Grifols continues to innovate across its therapeutic portfolio to develop new treatments and enhancing existing ones for patients", said Dr. Jörg Schüttrumpf, Grifols Chief Scientific Innovation Officer. "We look forward to collaborating with XL-protein and combining our advanced scientific efforts in this leading initiative".

"We are excited to work with Grifols to enhance the pharmacological properties of their therapeutics", said Dr. Michaela Gebauer, Managing Director of XL-protein. "This partnership leverages the potential of our PASylation technology, together with other PASylated drugs currently under development, and creates added value for Grifols", commented Uli Binder, Managing Director of XL-protein.