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.

On June 10, 2025 Quest Diagnostics (NYSE: DGX), a leading provider of diagnostic information services, reported a collaboration with The University of Texas MD Anderson Cancer Center (MD Anderson) designed to improve the assessment of elevated risk of cancer in individuals who would benefit from medically appropriate cancer screenings (Press release, Quest Diagnostics, JUN 10, 2025, View Source [SID1234653795]).

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Under terms of the agreement, Quest will develop and validate a laboratory-developed blood test based on circulating protein biomarkers associated with high risk for one or more cancers, including colorectal, lung, breast, pancreatic, ovarian, liver, prostate, esophageal and stomach. Quest will base the test on a developmental license to technology and intellectual property associated with the Multi-Cancer Stratification Test (MCaST), a cohesive risk model developed by the laboratory of Samir Hanash, M.D., Ph.D., at MD Anderson. Dr. Hanash and his team identified a set of biomarkers that inform the model through extensive clinical research conducted on screening study cohorts involving tens of thousands of individuals. Quest plans to refine and further develop and validate the MCaST technology for its own lab-developed test.

Assuming successful test validation, the parties may agree for Quest to exercise rights to commercialize the test, with the goal to make it available to providers in North America in 2026.

Quest expects the future test will supplement, not replace, conventional screening methods, by providing insights to help providers identify patients that would benefit from medically appropriate screening or other forms of evaluation. Conventional screening methods target a limited number of cancers and only one at a time, often with invasive or costly procedures that patients resist. While multi-cancer early detection (MCED) liquid biopsy tests that detect cancer DNA in circulating blood are convenient, they are comparatively expensive, not intended to personalize risk, and may lack well-established protocols for clinical follow-up.

Only 51% of U.S. adults say they have had a routine medical appointment or routine cancer screening in the last year.

"One of the biggest problems in cancer care today is patients skipping preventive screenings because the methods are too invasive, inconvenient or unaffordable," said Mark Gardner, senior vice president, Oncology, Genomics and R&D, Quest Diagnostics. "Another huge problem is a lack of tests for infrequent, but often deadly cancers, like pancreatic cancer. Building on proteomics discoveries from Dr. Hanash and his team, Quest intends to create a simple blood test anyone can conveniently access and reasonably afford to identify risk of a range of cancers. A patient identified with elevated risk may be more inclined to pursue preventive cancer screening or other medical assessments that could identify cancer in early, more treatable stages of disease."