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.

On June 10, 2025 ImmVira, a global leading clinical-stage biotechnology company focused on the development of next-generation novel oncolytic immunotherapy for treatment of cancer, reported that the first patient diagnosed with NMIBC has been dosed in a multi-regional Phase II clinical trial evaluating its lead product candidate, MVR-T3011 (Press release, Immvira, JUN 10, 2025, View Source [SID1234653801]).

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At the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting, ImmVira reported MVR-T3011’s preliminary efficacy data in high-risk BCG-failed NMIBC patients, demonstrating an encouraging complete response rate (CRR) of over 80% at the 2×109 PFU dose cohort. Updated results from the expanded cohort of 16 evaluable patients with papillary diseases (as of April 30, 2025, the data cutoff date) maintained robust efficacy, with a sustained Kaplan-Meier (K-M) estimated 3-month recurrence-free survival (RFS) of over 80%.

Based on discussions with and approval by the U.S. FDA, the primary objectives of this Phase II study are to further confirm the recommended phase II dose (RP2D) of intra-vesically administered MVR-T3011, and based on which, assess the anti-tumor efficacy of MVR-T3011 in patients with BCG-unresponsive NMIBC. ImmVira plans to enroll eligible patients at 15-20 cancer centers in the United States and China for evaluation of the clinical efficacy parameters including CRR, event-free survival rate and RFS rate. Meanwhile, safety and pharmacokinetic data will be evaluated.

"The initiation of this multi-country Phase II study marks a major milestone for ImmVira," said ImmVira co-founder, CEO and chairwoman, Dr. Grace Guoying Zhou. "We are delighted with the notable progress and results achieved in the Phase I clinical trial of MVR-T3011 for the treatment of NMIBC and are extremely excited about working with key thought leaders in the U.S. and China to further explore the potential of this drug in NMIBC patients."

Lead study investigator and the Director of Clinical and Translational Research in Urologic Oncology at Rutgers Cancer Center, Dr. Vignesh Packiam, added, "MVR-T3011 represents a novel drug design and has the potential to address an unmet need in NMIBC. Integration of PD-1 Ab and IL-12 genes into the genome of this novel oncolytic immunotherapy can augment immune responses in the tumor microenvironment and prolong the early-phase antitumor efficacy."

About MVR-T3011

MVR-T3011 is a novel oncolytic immunotherapy combining a proprietary replication competent oncolytic virus backbone with payload expression of PD-1 Ab and IL-12. Upon delivery, locally produced IL-12 induces IFN-γ production, enhances oncolytic activity of NK cells and cytotoxic T lymphocytes, promotes anti-angiogenesis and inhibits tumor growth. Simultaneously, the PD-1 antibody acts as an immune checkpoint inhibitor to augment T-cell tumor-killing activity. Extensive and peer-reviewed in vitro and in vivo data have been presented internationally and the drug has, to-date, been evaluated in over 200 Phase I/II patients.

On June 10, 2025 OS Therapies Inc. (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate biotechnology company, reported to have selected EVERSANA, a leading provider of global commercial services to the life sciences industry, to support the U.S. commercialization of OST-HER2, a novel immunotherapy for recurrent, fully resected, pediatric lung metastatic osteosarcoma (Press release, OS Therapies, JUN 10, 2025, View Source [SID1234653802]).

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OST-HER2, a Listeria monocytogenes-based immunotherapy, is the first potential new treatment in over 40 years for pediatric osteosarcoma, a rare, aggressive bone cancer that often metastasizes to the lungs, primarily affecting children and adolescents. The therapy has received Orphan, Fast Track and Rare Pediatric Disease Designations from the U.S. Food and Drug Administration (FDA), with a Biologics License Application (BLA) rolling submission targeted to begin in the third quarter of 2025, with potential approval coming as early as year end 2025.

"Working with EVERSANA ensures we have the infrastructure, expertise and agility to bring OST-HER2 to patients and families who have long awaited new options without the need to spend significant capital building our own commercial infrastructure," said Paul Romness, CEO of OS Therapies. "By leveraging EVERSANA’s flexible integrated commercialization operations and deep oncology experience, we will be able to rapidly and cost-effectively fulfill our mission of transforming the treatment landscape for pediatric metastatic osteosarcoma while judiciously managing pre-BLA costs."

EVERSANA will activate its dedicated end-to-end EVERSANA ONCOLOGY Commercialization model, including market access, medical affairs, field deployment, patient services and stakeholder engagement. The fully integrated platform accelerates awareness and access to OST-HER2 among healthcare providers treating osteosarcoma, as well as the potential to treat additional HER2-positive cancers.

"We share OS Therapies’ relentless commitment to helping patients facing the devastating diagnosis of cancer," said Jim Lang, CEO at EVERSANA. "We’ve activated the full scale of our commercialization operation and global team of oncology experts to bring this much-needed innovation to market. This product is just the beginning of OS Therapies’ impact for patients around the world."

The announcement follows OS Therapies’ recent issuance of U.S. Patent #12,239,738, securing commercial manufacturing exclusivity for OST-HER2 and its broader Listeria-based immunotherapy platform through 2040.