Yiviva Presents Phase 2b Results for YIV-906 in Combination with Sorafenib in Advanced Hepatocellular Carcinoma at ASCO and ESMO GI 2025

NEW YORK, July 07, 2025 (GLOBE NEWSWIRE) -- Yiviva, a clinical-stage biotechnology company pioneering systems biology-driven therapeutics, announced data from its multi-regional, randomized, double-blind, placebo-controlled Phase 2b study of sorafenib (SORA) with or without YIV-906 in advanced hepatocellular carcinoma (HCC) patients with chronic hepatitis B (HBV+). Results were highlighted in an American Society of Clinical Oncology (ASCO) Annual Meeting (May 30-June 3) abstract and presented at the European Society for Medical Oncology (ESMO) Gastrointestinal Cancers Annual Congress 2025 (July 2-July 5) poster.

Presented by Dr. Ghassan Abou-Alfa MD, JD, MBA, PhD_(hc), medical oncologist at Memorial Sloan Kettering Cancer Center, the study demonstrated improvements in both efficacy and tolerability for patients treated with YIV-906 plus sorafenib versus sorafenib monotherapy.

• Median Progression-Free Survival (mPFS):
  • 4.1 months vs. 3.5 months in the intention-to-treat (ITT) analysis
• Median Overall Survival (mOS):
  • 14.3 months vs 7.5 months
• Median Time to Tumor Progression (mTTP):
  • 5.59 months vs. 2.33 months
• Safety and Tolerability:
  • Patients on the YIV-906 arm patients demonstrated greater duration of treatment exposure and continuation and were able to remain on treatment longer

Mechanistic and Clinical Insights:

• More than 250 GI (liver, pancreatic, colorectal, rectal) cancer patients treated in YIV-906 clinical studies have demonstrated proof-of-concept efficacy and safety.
• YIV-906 is a novel multi-targeted modality developed using a systems biology approach.
• YIV-906 increases the therapeutic index by acting as an immunomodulator in the tumor microenvironment (TME) and potentiating antitumor activity
  • YIV-906 reprograms and primes the TME (STING, IFNg, IFNb, P-IRF3) and enhances innate immunity by polarizing and increasing M1 like macrophage infiltration and enhancing apoptosis.
  • YIV-906 enhances adaptive immunity by promoting T-cell activation (promoting NFAT, inhibiting SHP1 and SHP2), modulating immune checkpoints (PD1/PDL1), reducing immune tolerance (by suppressing IDO),
    
• YIV-906 increases safety and reduces non-hematological toxicities by cytoprotecting the gastrointestinal tract by reducing GI inflammation (NF-kB, COX2, iNOS, IL-6), promoting damaged tissue repair (Wnt pathway), and reducing pain (NK1).
  

“These results demonstrate the obligation to further study YIV-906’s potential to benefit hepatocellular carcinoma patients with hepatitis B who have limited treatment options,” said co-principal investigator Prof. Dr. Ghassan Abou-Alfa. “YIV-906 could broaden the therapeutic index and improve efficacy, safety and tolerability, and merits further clinical exploration with other studies and standards-of-care as a potential new treatment modality and paradigm.”

About the CALM Study:

The Phase 2b study (NCT04000737) randomized (2:1) patients (n=62) with treatment-naïve, advanced HBV-positive HCC, Child-Pugh A, BCLC Stage B or C, and ECOG ≤1 to either the YIV-906 + sorafenib arm or the placebo + sorafenib arm. Patients were enrolled in multiple regions (United States, Mainland China, Hong Kong, Taiwan) and the study was conducted from January 2020 to November 2024. The primary endpoint was progression free survival (PFS); secondary endpoints included overall survival (OS), time to progression (TTP), objective response rate (ORR), diseases control rate (DCR), safety and tolerability, and quality of life (QoL). More detailed information is available through 2025 ASCO Abstract # e16244 and ESMO GI Poster #P172.

The study was sponsored by Yiviva with grant support from the Henry Bronson Endowment of Yale University, National Foundation for Cancer Research, Asian Fund for Cancer Research, and China 13-5 National Major Scientific and Technological Special Project for Significant New Drug Development.

About YIV-906


YIV-906 (formerly known as PHY906 or KD018) is a patented, orally administered investigational drug that acts as a pan-adjuvant improving the efficacy and safety for a broad spectrum of cancer drugs and regimens (including chemotherapies, immunotherapies, radiation, and cell therapies). YIV-906 has been studied in nine clinical trials in solid tumors (hepatocellular carcinoma, pancreatic cancer, colorectal cancer, and rectal cancer) with data demonstrating the potential for YIV-906 to improve overall survival and/or progression-free survival and reduce non-hematological toxicities (including diarrhea, nausea, vomiting, fatigue, and hand-foot syndrome). YIV-906 was inspired by an 1800-year-old traditional medicine and is being developed under the United States Food and Drug Administration’s (FDA) botanical drug regulatory pathway. The FDA has granted YIV-906 two Orphan Drug Designations (ODD) for the treatment of hepatocellular carcinoma and pancreatic cancers.

About Yiviva

Yiviva is committed to developing innovative medicines using a multi-targeted systems biology approach to improve survival and quality of life for patients with cancer and other serious diseases. The platform biotechnology company was launched with Yale University and Henry Bronson Professor of Pharmacology and Medicine Yung-Chi Cheng as co-founders, with teams in the United States and Asia.

Media Contact:

Email: hello@yiviva.com

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