On September 30, 2025 KYORIN Pharmaceutical Co., Ltd. reported that it has entered into an exclusive license agreement with Hinge Bio Inc. (BURLINGAME, CA, CEO：Harold E. "Barry" Selick, "Hinge Bio") on September 30, 2025, for HB2198, new drug candidate for systemic lupus erythematosus (SLE), discovered by Hinge Bio (Press release, Kyorin, SEP 30, 2025, View Source [SID1234656345]).

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Under the terms of this agreement, KYORIN has obtained the exclusive rights in Japan to develop and commercialize HB2198 for the treatment of SLE and other diseases. KYORIN will make an upfront payment of USD 10 million to Hinge Bio. Hinge Bio is also eligible to receive milestone payments of up to USD 95 million for the SLE indication upon the progress of development, approval and the achievement of certain net sales. For indications other than SLE, and separate payment will be made. In addition, royalties based on net sales will be provided to Hinge Bio, and KYORIN will bear a portion of the clinical development costs incurred by Hinge Bio.

Autoimmune diseases such as SLE are caused by an aberrant immune system that mistakenly identifies the body’s own tissues as foreign, leading to excessive immune responses that cause chronic inflammation and organ damage. Many patients cannot get their symptoms under control with existing treatments and suffer from conditions such as joint pain, skin problems, kidney damage, and central nervous system issues.

HB2198 is a humanized bispecific antibody discovered using Hinge Bio’s proprietary GEM-DIMER technology platform. It aims to "reset" the immune system by simultaneously targeting both CD19 and CD20 molecules on the surface of B cells, which play a major role in the development of autoimmune diseases, and by rapidly and deeply depleting B cells in both the circulating blood and lymphoid tissues. Preclinical in vivo studies have demonstrated HB2198’s deep and rapid B cell depletion activity, and it is expected to provide an excellent new treatment option for patients suffering from autoimmune diseases. A Phase 1 clinical trial for patients with SLE is currently being prepared in the United States.

KYORIN aims to create high-value new drugs that meet medical needs and has prioritized "Expand development pipeline" under its medium-term business plan "Vision 110 —Stage1—". With this agreement, we are committed to advancing the development of new treatment options for patients as soon as possible, contributing to people’s health.

The impact on the consolidated earnings forecast for the fiscal year ending March 2026 is expected to include the upfront payment to Hinge Bio under this agreement, which will be recorded as SG&A expenses (R&D expenses) for the current fiscal year.

On September 30, 2025 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, reported the expansion of FLAMINGO-01 clinical trial to Portugal (Press release, Greenwich LifeSciences, SEP 30, 2025, View Source [SID1234656343]).

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The Company’s application to European regulators has been formally approved, adding Portugal as an approved country in FLAMINGO-01 in addition to Spain, France, Germany, Italy, Poland, Romania, Ireland, and the US.

According to the latest data collected by the European Cancer Information System (click here), a total of 9,065 new cases of breast cancer were diagnosed in Portugal in 2022, which is the most common cancer diagnosed in women, representing approximately 30% of all cancers in women. Breast cancer is the leading cause of death from cancer in women in Portugal with 2,211 deaths in 2022.

Luís António Marques da Costa, MD, PhD, will be serving as the national principal investigator in Portugal for FLAMINGO-01. Dr. Costa is an Associate Professor of Medicine, Oncology & Oncobiology, FML-UL, Lisbon, Portugal, and Head of the Clinical Translational Oncology Research Unit at the Institute of Molecular Medicine. He has also served as Director of the Oncology Department at Hospital de Santa Maria in Lisbon since 2005. At the School of Medicine, he is the Coordinator Professor of "Oncobiologia" a new teaching unit that aims to teach the understanding of clinical oncology through molecular medicine. He is involved in multiple clinical trials in breast cancer and other solid tumors, and his research interests have long centered on the area of bone metastases. In recent years, his research has focused on understanding the molecular mechanisms of tumor progression at metastatic sites using bone metastases as a paradigm.

CEO Snehal Patel commented, "We look forward to collaborating with Dr. Costa and his colleagues. We were introduced to Dr. Costa by a member of our steering committee. We recently visited Lisbon to begin start-up activities and to meet our investigators to develop a strategy for Portugal. We are in the process of activating sites in Lisbon and are reviewing additional sites in central and northern Portugal."

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On September 30, 2025 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a clinical-stage biotechnology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease, reported that its management will participate in the second annual Oncology Venture, Innovation, and Partnering Summit being held September 29-30, 2025, at the Westin Boston Seaport in Boston, MA (Press release, Calidi Biotherapeutics, SEP 30, 2025, View Source [SID1234656341]).

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Eric Poma, Ph.D., Chief Executive Officer, will participate in a fireside chat with Dr. Aydin Huseynov, Managing Director and Senior Analyst at Ladenburg Thalmann, on the intersection of science and capital to develop and advance effective cancer treatments on September 30, 2025, at 10:10 a.m. E.T. Dr. Poma’s presentation will highlight Calidi’s RedTail platform, which is engineered to protect virus from immune clearance and induce tumor lysis and deliver potent therapeutic genetic medicines to metastatic sites through systemic administration.

Dr. Poma will be available to participate in one-on-one meetings with participants registered to attend the conference.

On September 30, 2025 ADC therapeutics presented its corporate presentation (Presentation, ADC Therapeutics, SEP 30, 2025, View Source [SID1234656340]).

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On September 29, 2025 Hanmi Pharm reported that it has entered into a global licensing and collaboration agreement with Gilead Sciences, Inc. ("Gilead") and Health Hope Pharma ("HHP") granting Gilead the exclusive rights to develop and commercialize encequidar.

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Orascovery is an innovative oral drug delivery proprietary platform owned by Hanmi that enables the conversion of injectable medicines into oral formulations. Encequidar is a P-gp inhibitor that was discovered through Hanmi’s Orascovery platform and originally developed by Hanmi.

Under this agreement, Hanmi and HHP will grant Gilead exclusive global rights to Encequidar within the field of virology. Hanmi and HHP will also provide drug supply, share technical know-how, and participate as key project partners. Hanmi and HHP will each receive an upfront payment and remain eligible for development, regulatory and sales milestones in addition to low single digit royalties on net sales.

Dr. Dennis Lam, founder of HHP said: "We are pleased to announce the licensing agreement with Gilead and Hanmi. This demonstrates the potential of Encequidar as a first-in-class P-gp inhibitor to create more oral formulations in multiple fields. This agreement is also a milestone of successful innovation for both the Hong Kong biotech industry and HHP as a biotech company headquartered in Hong Kong. We will build on this momentum to accelerate HHP’s development of Oraxol and explore other applications of Encequidar in oral formulations."

Jae-Hyun Park, CEO of Hanmi Pharm, said: "This agreement validates Hanmi’s formulation technology and R&D capabilities, while also opening the door to new growth opportunities through collaboration with a leading global partner. We will continue to expand strategic partnerships that can accelerate innovation and patient access worldwide."

Hanmi originally out-licensed Encequidar along with the oral anticancer drug Oraxol to Athenex in 2011. However, following Athenex’s insolvency, rights were transferred to HHP and others. HHP is currently conducting clinical trials of Oraxol in the U.S., Hong Kong, and New Zealand since June 2025, with plans to sequentially launch the product in Europe, Asia, and the U.S.

(Press release, Hanmi, SEP 29, 2025, View Source,Europe%2C%20Asia%2C%20and%20the%20U.S [SID1234660988])