On March 28, 2025 Akeso reported the company and Transthera have entered into a strategic collaboration to jointly advance an open-label, multicenter Ph II clinical study to evaluate the combination of Akeso’s PD-1/CTLA-4 BsAb cadonilimab or PD-1/VEGF BsAb ivonescimab with Transthera’s innovative multi-target small-molecule kinase inhibitor tinengotinib (TT-00420) for the treatment of advanced HCC (Press release, Akeso Biopharma, MAR 28, 2025, View Source [SID1234654273]). The clinical protocol for this collaboration has recently received approval from China NMPA.

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Tinengotinib is an innovative, global Ph III stage spectrum-selective kinase inhibitor that exerts antitumor effects by targeting tumor cells and improving the tumor microenvironment. Ongoing clinical trials in the US and China have revealed the potential of Tinengotinib to be efficacious in various solid tumors. It was granted the Orphan Drug Designation and Fast Track Designation by US FDA for the treatment of CCA. In July 2023, tinengotinib was granted the Breakthrough Therapy Designation by China NMPA.

Cadonilimab is the world’s first approved bispecific immunotherapy for cancer. Previous studies have shown its significant efficacy and favorable safety profile in treating HCC. Data demonstrated that cadonilimab combined with FOLFOX-HAIC as neoadjuvant therapy for resectable multinodular HCC achieved a 100% DCR with manageable safety. Furthermore, cadonilimab combined with lenvatinib as a 1L treatment for advanced HCC showed superior antitumor activity compared to approved therapies, effectively controlling tumor progression and offering long-term survival benefits over current treatment options.

Ivonescimab is a novel global first-in-class PD-1/VEGF bispecific immunotherapy. Ivonescimab was granted marketing approval by China NMPA for the treatment of EGFR mutated locally advanced or metastatic nsNSCLC patients who have progressed after EGFR TKI treatment. Currently, ivonescimab’s first indication has been approved in China, and Akeso is conducting 6 registrational trials versus anti-PD-1/L1 therapeutics. Akeso is also conducting multiple clinical trials of ivonescimab covering 17 indications including GC, HCC and CRC.

On March 28, 2025 Sihuan Pharmaceutical reported full year financial results for the year 2024 (Presentation, Sihuan Pharmaceutical, MAR 28, 2025, View Source [SID1234654104]).

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On March 28, 2025 Genor Biopharma reported its annual report for the year 2024 (Presentation, Genor Biopharma, MAR 28, 2025, View Source [SID1234654103]).

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On March 28, 2025 Turnstone Biologics Corp. ("Turnstone" or the "Company") (Nasdaq: TSBX), a biotechnology company historically focused on the development of a differentiated approach to treat and cure patients with solid tumors by pioneering selected tumor-infiltrating lymphocyte ("Selected TIL") therapy, reported its financial results for the fourth quarter and full year ended December 31, 2024, and provided recent corporate updates (Press release, Turnstone Biologics, MAR 28, 2025, View Source [SID1234651686]).

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Corporate Updates

In November 2024, the Company presented preclinical data on its Selected TIL therapies at the 2024 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) ("SITC") Annual Meeting. Turnstone also presented clinical data at the SITC (Free SITC Whitepaper) TIL Symposium in a presentation titled "TIDAL-01: Enriching for a More Potent TIL Population with Selected TIL Therapy".

In January 2025, Turnstone made the determination to discontinue all TIDAL-01 clinical studies and halted further development of the program. As a result, the Company initiated a process to explore a range of potential strategic alternatives focused on maximizing shareholder value. Turnstone continues to evaluate strategic alternatives and will provide additional updates when it is determined that further disclosure is appropriate or legally required.

Financial Highlights

Cash, Cash Equivalents and Short-Term Investments: As of December 31, 2024, cash, cash equivalents, and short-term investments were $28.9 million.

Research and Development ("R&D") Expenses: R&D expenses for the three months ended December 31, 2024, were $8.2 million, compared to $13.5 million for the same period in 2023. The decrease was due primarily to corporate restructuring, workforce reduction, and strategic prioritization of pipeline.

General and Administrative ("G&A") Expenses: G&A expenses for the three months ended December 31, 2024, were $3.2 million, compared to $4.4 million for the same period in 2023. The decrease was due primarily to reductions in personnel costs, professional service costs, and other general and administrative costs.

Net Loss: Net loss for the three months ended December 31, 2024, was $12.9 million, compared to net loss of $16.5 million for the same period in 2023.

On March 28, 2025 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a novel, FDA-cleared drug-delivery device, reported that a new human pharmacokinetic (PK) data abstract was presented at the Society of Surgical Oncology (SSO) 2025 Annual Meeting on March 27 – 29, 2025 in Tampa, FL: ePoster P379 (Press release, Renovorx, MAR 28, 2025, View Source [SID1234651595]).

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The abstract provides new human PK data relevant to RenovoRx’s proprietary Trans-Arterial Micro-Perfusion (TAMPTM) therapy platform. TAMP is key to the Company’s Phase III investigational drug-device combination oncology product candidate (intra-arterial gemcitabine, with RenovoCath, known as IAG) and is designed to ensure targeted therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapies. RenovoRx’s novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy.

The abstract, titled "Pharmacodynamics of Intra-arterial vs. Intravenous Gemcitabine in Locally Advanced Pancreatic Cancer: Results of a Phase III Randomized Clinical Trial," was authored by Emmanuel E. Zervos, M.D. of East Carolina University, and co-authored by Ramtin Agah, M.D., founder and Chief Medical Officer of RenovoRx and others.

"The data presented in this abstract support the potential for the TAMP therapy platform to provide a meaningful advancement in the standard of care for oncology therapy in difficult-to-treat tumors," said Dr. Zervos. "This study shows additional support for TAMP as a potential treatment option in locally advanced pancreatic cancer (LAPC). Specifically, in this analysis, localized, dual-balloon catheter-mediated IAG resulted in lower systemic levels of gemcitabine compared to intravenous gemcitabine. IAG may prove beneficial in decreasing chemotherapy-related systemic side effects. We are awaiting final outcomes in the ongoing Phase III TIGeR-PaC clinical trial for IAG to validate this benefit."

PK analyses were performed on 19 patients with locally advanced pancreatic cancer receiving IAG from six sites as part of the TIGeR-PaC trial. In this analysis, localized, dual-balloon catheter-mediated IAG resulted in lower systemic levels compared to intravenous delivery of gemcitabine. As such, the study found that IAG may be beneficial in decreasing chemotherapy-related systemic side effects. Correlative patient reported outcomes in patients receiving IAG supports this approach as an alternative for LAPC patients who are having difficulty tolerating more traditional systemic regimens.

About RenovoCath

Based on its FDA clearance, RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use ("IFU"), please see: IFU-10004-Rev.-F-Universal-IFU.pdf.

About the TIGeR-PaC Clinical Trial

TIGeR-PaC is an ongoing Phase III randomized multi-center study evaluating the proprietary TAMP (Trans-Arterial Micro-Perfusion) therapy platform for the treatment of LAPC. RenovoRx’s first investigational drug-device combination product candidate using the TAMP therapy platform enabled with the Company’s FDA-cleared RenovoCath device for the intra-arterial administration of chemotherapy, gemcitabine (IAG).