On August 13, 2025 CuraCell reported that the Paul-Ehrlich-Institut (PEI), the German federal authority for vaccines and biomedicines, has approved the company’s Clinical Trial Application (CTA) to initiate a Phase I/IIa clinical trial evaluating its novel autologous TIL (Tumor-Infiltrating Lymphocyte) therapy, CC-38, in patients with metastatic colorectal cancer and metastatic prostate cancer. The clinical trial is planned to commence in the second half of 2025.

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The open-label Phase I/IIa trial will enroll up to 16 patients with advanced solid tumors, including colorectal and prostate cancer (EU-CT-Number: 2025-521227-70-00). The study will be conducted at Krankenhaus Nordwest in Frankfurt. The trial will assess the feasibility of repeated administration, with safety and tolerability as the primary endpoints. Secondary objectives include evaluating preliminary anti-tumor activity and immune responses.

"This CTA approval marks a major milestone for CuraCell and affirms the strength of our science and clinical strategy," said Jonas Båtelson, CEO of CuraCell. "Our dedicated team, together with our expert collaborators, has worked tirelessly to advance our first TIL therapy from bench to bedside. This is a big step forward in our mission to provide curative treatments for the toughest and most deadly solid tumors."

(Press release, CuraCell, AUG 13, 2025, View Source [SID1234661187])

On August 13th 2025, Suzhou, China, Evopoint Biosciences, a platform-based innovative pharmaceutical company dedicated to addressing major unmet clinical needs worldwide through a disease-oriented, innovation-driven approach, reported the completion of the first patient dosing of XNW27011 in a Phase III clinical trial for the treatment of patients with locally advanced, unresectable, or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma who have received at least two prior lines of systemic therapy (Press release, Evopoint Biosciences, AUG 13, 2025, View Source [SID1234656288]).

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XNW27011 is an investigational next-generation antibody-drug conjugate (ADC) targeting CLDN18.2, independently developed by Evopoint and classified as a Category 1 therapeutic biological product in China. The product has achieved significant milestones in clinical development and demonstrated strong global competitiveness: In December 2022, XNW27011 received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) followed by the IND approval from China’s National Medical Products Administration (NMPA) in April 2023, achieving an efficient dual filing in both countries; it was subsequently granted for Fast Track Designation (FTD) by the FDA in June 2024, and was included in the Breakthrough Therapy Designation (BTD) list by the NMPA’s Center for Drug Evaluation (CDE) in May 2025.

Businesswise, Evopoint has licensed the rights for global development and commercialization, excluding mainland China, Hong Kong, Macau, and Taiwan, to Astellas Pharma Inc. (Tokyo Stock Exchange: 4503). Under the license agreement, Evopoint is eligible to receive upfront and milestone payments totaling up to USD 1.54 billion, and royalties on net sales following the product’s launch in overseas markets.

Gastric cancer remains to be a major challenge in oncology due to its persistently high incidence and mortality worldwide. According to WHO data, approximately 968,000 new cases and 660,000 deaths were reported in 2022 globally. In China, the numbers for new cases and death of gastric cancer were reported as 358,000 and 260,000 respectively in 2022 by China’s National Cancer Center. Current first- and second-line regimens for gastric cancer typically combine the HER2-targeted agent trastuzumab with chemotherapy. However, in patients with advanced disease having mid/low or negative HER2 expression, the pronounced heterogeneity of gastric cancer and its complex tumor immune microenvironment often limit the efficacy of chemotherapy, resulting in minimal survival benefit and poor tolerability. Novel therapeutic targets, agents, and treatment strategies are urgently needed to improve clinical outcomes for this patient population.

In the Phase I/II clinical study, XNW27011 demonstrated promising efficacy in the target population, which is significantly superior to that of the currently recommended regiments, suggesting considerable potential for clinical benefit.

On August 13, 2025 Evotec reported half-year interim report for the year 2025 (Filing, 3 mnth, JUN 30, Evotec, 2025, AUG 13, 2025, View Source [SID1234655617]).

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On August 13, 2025 Evotec reported first half 2025 financial results (Presentation, Evotec, AUG 13, 2025, View Source [SID1234655615]).

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On August 13, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW, BCTXZ), (TSX: BCT) (" BriaCell " or the " Company "), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported its acceptance into Memorial Sloan Kettering Cancer Center’s (MSK’s) Therapeutics Accelerator 2025 Cohort program (Press release, BriaCell Therapeutics, AUG 13, 2025, View Source [SID1234655429]). This project aims to accelerate the clinical development of Bria-OTS+, BriaCell’s next generation personalized off-the-shelf immunotherapy, for multiple cancer indications including metastatic breast cancer, prostate cancer, and other cancers.

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As one of the world’s foremost cancer research and treatment institutions, MSK has more than 135 years of leadership in patient care, education and discovery. Through the MSK Therapeutics Accelerator Cohort program, BriaCell will explore access to MSK’s expertise and institutional resources, including GMP manufacturing services, Investigational New Drug (IND) Application preparation and submission and regulatory strategy support to expedite Bria-OTS+ development.

"We are honored to work with the scientific and clinical experts at MSK Therapeutics Accelerator," stated Dr. William V. Williams, BriaCell’s President and CEO. "MSK’s deep expertise in cancer therapy development and state-of-the-art resources make it an ideal partner to accelerate our personalized off-the-shelf immunotherapy platform."

"We are excited to welcome BriaCell into the cohort program," stated Eileen Flowers, PhD, Director, Technology Development & Licensing, in the Office of Entrepreneurship and Commercialization at MSK.

"We believe Bria-OTS+ has the potential to transform cancer care, offering meaningful advances in efficacy and safety for thousands of patients," stated Dr. Miguel Lopez-Lago, BriaCell’s Chief Scientific Officer. "Our participation in this cohort program is yet another step towards achieving that vision."