On June 27, 2025, Kura Oncology, Inc. (the "Company") and Kyowa Kirin, Inc. ("Kyowa Kirin US") reported to have entered into a Co-Promotion and Medical Affairs Agreement (the "Co-Promotion Agreement") to co-promote the Company’s product candidate, ziftomenib, a potent, selective oral menin inhibitor, for the treatment of patients with acute myeloid leukemia and other hematologic malignancies in the United States and perform medical affairs activities with respect thereto (Filing, Kura Oncology, JUN 27, 2025, View Source [SID1234654194]). The Co-Promotion Agreement was entered into under and pursuant to the terms and conditions of that certain Collaboration and License Agreement by and among the Company, Kyowa Kirin US and Kyowa Kirin Co., Ltd. (together with Kyowa Kirin US, "Kyowa Kirin"), dated as of November 20, 2024 (the "Collaboration Agreement").

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United States Co-Promotion. Under the terms of the Co-Promotion Agreement, Kyowa Kirin US will have the right and responsibility to co-promote ziftomenib for up to a certain percentage of the details in the United States, and will be obligated to meet minimum detailing requirements using sales representatives that meet specific qualifications. The parties will perform such co-promotion activities, and share equally in all costs and expenses therefor, in accordance with the Collaboration Agreement.

United States Medical Affairs. Under the terms of the Co-Promotion Agreement, the Company will lead all medical affairs activities for ziftomenib in the United States, while collaborating with and receiving input and coordination from Kyowa Kirin US. Further, the parties will jointly develop the health economics and outcomes research strategy for ziftomenib in the United States. The parties will perform such medical affairs activities, and share equally in all costs and expenses therefor, in accordance with the Collaboration Agreement.

Termination. The Co-Promotion Agreement will remain in effect until the earlier of the parties’ mutual agreement to cease commercialization of ziftomenib in the United States or the expiration of the United States term under the Collaboration Agreement (which expires on the latest of expiration of all valid claims of the Company’s patent rights licensed to Kyowa Kirin in the United States, expiration of the last-to-expire regulatory exclusivity in the United States or ten years after first commercial sale in the United States). The Co-Promotion Agreement will automatically terminate upon termination of the Collaboration Agreement. Either party may terminate the Co-Promotion Agreement for uncured material breach by the other party.

The foregoing description of the material terms of the Co-Promotion Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Co-Promotion Agreement, a copy of which the Company intends to file, with confidential terms redacted, with the Securities and Exchange Commission as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2025.

On June 27, 2025 Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib—a differentiated, dual PARP and WNT pathway inhibitor reported that the second patient has been dosed in its new Phase 2 clinical trial protocol evaluating stenoparib in patients with advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer (Press release, Allarity Therapeutics, JUN 27, 2025, View Source [SID1234654160]).

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Commenting on the development, Thomas Jensen, Chief Executive Officer of Allarity Therapeutics, stated:

"We are pleased to see the second patient enrolled so soon after the trial’s launch. This pace of enrollment suggests a strong level of engagement from our investigators, who appear highly attuned to the opportunity to explore stenoparib’s potential for patients with few or no remaining treatment options."

This new trial builds on earlier Phase 2 data demonstrating durable clinical benefit and favorable tolerability with twice-daily dosing of stenoparib. It focuses on the platinum resistant patient population for whom current treatment options are extremely limited. Stenoparib may represent a novel, targeted and better-tolerated treatment option for these patients who are typically offered only marginally effective, toxic chemotherapies.

In parallel, this trial will serve to advance Allarity’s proprietary Drug Response Predictor (DRP) companion diagnostic and further evaluate the WNT-modulating mechanism of action unique to stenoparib.

About Stenoparib
Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. At present, tankyrases are attracting significant attention as emerging therapeutic targets for cancer, principally due to their role in regulating the WNT signaling pathway. Aberrant WNT/β-catenin signaling has been implicated in the development and progression of numerous cancers. By inhibiting PARP and blocking WNT pathway activation, stenoparib’s unique therapeutic action shows potential as a promising therapeutic for many cancer types, including ovarian cancer. Allarity has secured exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. and was formerly known under the names E7449 and 2X-121.

About the Drug Response Predictor – DRP Companion Diagnostic
Allarity uses its drug-specific DRP to select those patients who, by the gene expression signature of their cancer, may have a high likelihood of benefiting from a specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high, drug-specific DRP score, the therapeutic benefit rate may be enhanced. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines, combined with clinical tumor biology filters and prior clinical trial outcomes. DRP is based on messenger RNA expression profiles from patient biopsies. The DRP platform has shown an ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients across dozens of clinical studies (both retrospective and prospective). The DRP platform, which may be useful in all cancer types and is patented for dozens of anti-cancer drugs, has been extensively published in the peer-reviewed literature.

On June 26, 2025 HotSpot Therapeutics, Inc., a biotechnology company pioneering the discovery and development of oral, small molecule allosteric therapies targeting Smart Allostery platform-identified regulatory sites on proteins referred to as "natural hotspots," reported it will present preclinical data from the Company’s CARD11-BCL10-MALT1 (CBM) program in two poster presentations at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Gastrointestinal Cancers Congress 2025, taking place July 2-5, 2025, in Barcelona, Spain (Press release, HotSpot Therapeutics, JUN 26, 2025, View Source [SID1234654145]).

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Presentation details are as follows:

Title: Synthetic lethality of CBM signalosome inhibition for KRAS-Mutant Colorectal Cancers
Poster Number: 124P
Session: Poster Display Session 2
Session Date and Time: Fri., Jul. 4, 5:30-6:30 CEST
Location: Foyer, International Barcelona Convention Center, Barcelona, Spain

Title: Novel CBM signalosome inhibitor revealed the essentiality of CBM signalosome for KRAS mutant colorectal cancer
Poster Number: 125P
Session: Poster Display Session 2
Session Date and Time: Fri., Jul. 4, 5:30-6:30 CEST
Location: Foyer, International Barcelona Convention Center, Barcelona, Spain

On June 26, 2025 The NextGen EV Therapeutics Forum, hosted by China Medical University and Healthcare System, reported bringing together leading scientists, clinical experts, and biotech industry leaders from Taiwan and the United States to explore the forefront of extracellular vesicle (EV) research and translation (Press release, China Medical University, JUN 26, 2025, View Source [SID1234654146]). The forum showcased emerging EV-based applications in oncology, neurodegenerative disorders, immune modulation, and regenerative medicine, highlighting the rapid advances toward clinical implementation.

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A highlight of the event was the announcement of a strategic partnership between China Medical University Hospital (CMUH) and Shine-On Biomedical Co., Ltd. This collaboration aims to accelerate Taiwan’s leadership in EV-based precision medicine on the global stage. As part of this initiative, Dr. Randy W. Schekman, the 2013 Nobel Laureate in Physiology or Medicine, was appointed International Scientific Advisor. In his keynote address, Dr. Schekman emphasized the critical importance of grounding therapeutic innovation in rigorous basic science, particularly in the evolving roles of EVs in intercellular communication and nucleic acid delivery.

Global Breakthrough: SOB100 Platform Targets HLA-G Tumors

At the center of this three-party collaboration is SOB100, the world’s first engineered exosome platform targeting HLA-G, an immunosuppressive tumor antigen. The platform is capable of crossing the blood-brain barrier and delivering nucleic acid drugs with high specificity, offering a potential therapeutic breakthrough for glioblastoma (GBM) and triple-negative breast cancer (TNBC).

Dr. Hui-Chun Ho, Vice President of Shine-On Biomedical, noted that SOB100 has received U.S. FDA approval to enter Phase I clinical trials and was recently featured in Nature Communications. She emphasized that the platform has demonstrated exceptional targeting precision and delivery efficiency in preclinical studies. With Dr. Schekman’s advises, the company aims to further enhance nucleic acid payload efficiency to unlock even greater therapeutic impact.

U.S.-Taiwan Scientific Exchange and Industry Insight

The forum also featured a keynote speech by Dr. Kenneth Witwer, Professor at Johns Hopkins School of Medicine and President of the International Society for Extracellular Vesicles (ISEV). Dr. Witwer provided a global perspective on the progress and challenges in EV therapeutics and called for greater standardization in EV engineering to support clinical scalability.

CMU System showcased several of its internally developed technologies, including:

In Vivo CAR-T Production via EVs for Solid Tumors
Targeted EV Drug Delivery for Parkinson’s Disease
Mitochondrial EVs from CRISPR-Engineered Stem Cells for MASLD
Engineered EVs for Cardiac Repair in Heart Failure
These innovations demonstrate CMU’s leadership in building an end-to-end EV research and clinical pipeline and underscore its commitment to integrating academia, healthcare, and biotech industry in Taiwan.

Building a Global Innovation Ecosystem for Precision EV Therapeutics

Dr. Mien-Chie Hung, President of China Medical University, remarked, "Extracellular vesicles are one of the most promising delivery vectors for the next generation of precision medicine. This forum not only showcases Taiwan’s research capabilities but also highlights our ability to mobilize global expertise."

Dr. Der-Yang Cho, Superintendent of CMUH, added, "EVs are emerging as a core technology for next-generation therapies. We are committed to building a globally connected precision medicine ecosystem with EVs at its center—driven by translational science and patient benefit."

The forum also gathered leading voices from Taiwan’s top research institutions, including the National Health Research Institutes, Academia Sinica, and National Taiwan University. Prominent researchers such as Prof. Hua-Jung Lee, Prof. Chia-Ning Shen, Prof. Tang-Long Shen, and Prof. Han-Yi Chou shared the latest advancements, strengthening Taiwan’s role in advancing EV-based precision medicine.

On June 26, 2025 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) reported receipt of a Special Protocol Assessment Agreement Letter from the U.S. Food and Drug Administration (FDA) for ADX-2191 (methotrexate injection, USP), an investigational drug candidate, for the treatment of primary vitreoretinal lymphoma (PVRL), a rare and potentially fatal cancer currently lacking FDA-approved therapy (Press release, Aldeyra Therapeutics, JUN 26, 2025, View Source [SID1234654131]).

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"Primary vitreoretinal lymphoma is treated today off label with intravitreal injections of compounded methotrexate," stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. "ADX-2191, a novel, vitreous-compatible formulation of methotrexate that is specifically designed for intraocular injection, potentially allows for a reduced injection volume relative to compounding."

Based on a pre-New Drug Application (NDA) meeting with the FDA in December 2022, Aldeyra submitted a literature-based NDA of ADX-2191 for the treatment of PVRL, which was accepted for Priority Review in March 2023. In June 2023, Aldeyra received a Complete Response Letter that stated that the available literature was not sufficient to demonstrate efficacy and that adequate and well-controlled trials were required for approval. The FDA subsequently agreed that a single clinical trial in addition to literature references will be sufficient to support NDA resubmission.

The clinical trial proposed in the Special Protocol Assessment will compare cancer cell clearance after 30 days of therapy in up to 20 patients following 1:1 randomization to receive either a single intraocular injection or eight intraocular injections of ADX-2191. The frequency of methotrexate injections has been linked to cancer cell clearance in patients with PVRL,[1] and approximately five injections are required on average to achieve cancer cell clearance.[2] The clinical trial is expected to begin in the second half of 2025 and conclude in 2026.

About ADX-2191

ADX-2191 (methotrexate injection, USP) is a sterile, non-compounded intravitreal formulation of methotrexate for the potential treatment of specific rare retinal diseases, including primary vitreoretinal lymphoma and retinitis pigmentosa. The ADX-2191 intravitreal formulation is preservative-free, is designed to be vitreous-compatible, and is optimized for excipient composition, viscosity, density, tonicity, pH, concentration, and volume of administration. ADX-2191 has received FDA Orphan Drug Designation for the treatment of primary vitreoretinal lymphoma and retinitis pigmentosa.

About Primary Vitreoretinal Lymphoma

Primary vitreoretinal lymphoma is a rare, aggressive, and potentially fatal retinal cancer that is diagnosed in approximately 300 to 600 patients in the United States per year. The median survival for newly diagnosed patients is less than five years. No approved treatments are currently available, though intravitreal injection of compounded methotrexate represents the current standard of care.