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 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported that senior leadership plans to present at the following conference (Press release, Iovance Biotherapeutics, JUN 10, 2025, View Source [SID1234653814]):

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Goldman Sachs Global Healthcare Conference
Fireside Chat: June 11, 2025 at 1:20 p.m. ET
Miami, FL
The live and archived webcasts will be available at View Source

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 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, Salarius Pharmaceuticals reported to have entered into a Second Amendment to the Merger Agreement ("Amendment No. 2") with Decoy Therapeutics to address significant changes in market conditions and secure necessary consents from Decoy noteholders for the completion of the transaction (Filing, Salarius Pharmaceuticals, JUN 10, 2025, View Source [SID1234653816]).

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Since the execution of the original Merger Agreement in January 2025 and following the execution of Amendment No. 1, the Company’s Common Stock price has experienced substantial deterioration, materially affecting the relative valuations underlying the exchange ratio. As a result, the parties have agreed to reduce the Company’s relative valuation from $4.6 million at the time of the original Merger Agreement to $2.31 million. This reduction results in a change in the exchange ratio such that the number of shares of Common Stock underlying the Company’s Series A Preferred Stock to be issued to Decoy stockholders at Closing will be increased by approximately 17 million shares. Accordingly, under Amendment No. 2, the relative ownership percentages of the combined company will result in Company legacy stockholders retaining 7.6% and Decoy’s legacy stockholders retaining 92.4% of the combined company following the completion of the Merger, in each case calculated on a fully-diluted basis, and before taking into account the dilutive effects of the Qualified Financing and any issuance of shares pursuant to such Qualified Financing after June 10, 2025, the date of Amendment No. 2.

In addition, Amendment No. 2 revises the form of Certificate of Designation (the "Certificate of Designation") for Series A Non-Voting Convertible Preferred Stock (the "Series A Preferred Stock") that will be filed upon Closing to include post-closing anti-dilution price protection for holders of Series A Preferred Stock whereby if, following completion of the Qualified Financing and the Merger, the Company conducts any subsequent dilutive financing of at least $2 million at a weighted average effective price per share below the offering price offered to the public in the Qualified Financing, the conversion ratio will be reset to provide additional shares to preferred stockholders in an amount proportional to the dilution caused by such offering, with such protection applying for one year from issuance. The revised Certificate of Designation also provides that the Series A Preferred Stock will not be convertible until the combined company meets the relevant initial listing standards of Nasdaq and contains a provision designed to prevent holders of Series A Preferred Stock from engaging in short sales of the Company’s common stock. As provided in the original Certificate of Designation, the Series A Preferred Stock will also not convert until the Company obtains stockholder approval pursuant to Nasdaq listing rule 5635.

Except as modified by Amendment No. 2, the terms of the Merger Agreement and Amendment No. 1 remain in full force and effect.

The foregoing descriptions of Amendment No. 2 and the Certificate of Designation are not complete and are qualified in their entirety by reference to the full text of Amendment No. 2 and the Certificate of Designation, copies of which are filed as Exhibit 2.1 and Exhibit 2.2, respectively, to this Current Report on Form 8-K and are incorporated by reference herein.