Shenglin Biologics and Senti Bio Announce First Patient Dosed in Phase I Clinical Trial of SENTI-301A for Hepatocellular Carcinoma

December 16, 2024Shenglin Biomedical (Shanghai) Co., Ltd. ("Shenglin Bio") announced that the exploratory clinical trial of SENTI-301A in hepatocellular carcinoma, conducted in collaboration with Senti Biosciences, Inc. (NASDAQ: SNTI) ("Senti Bio"), a biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, has completed the first patient dosing. SENTI-301A is a CAR-NK candidate drug produced in China by Shenglin Bio, utilizing Senti Bio's anti-GPC3 + crIL15 and Gene Circuit technology.

In this collaboration, Shenglin Biomedical (Shanghai) Co., Ltd. leads the clinical development, operations, and production of SENTI-301A, while Senti Biosciences provides technology, strategy, and clinical advice. The clinical trial aims to evaluate the safety, pharmacokinetics, and preliminary anti-tumor activity of SENTI-301A, enrolling patients with GPC3-positive advanced hepatocellular carcinoma across multiple dose cohorts. Study endpoints will include safety assessments of adverse events and dose-limiting toxicities, along with efficacy analysis conducted according to standard criteria for liver cancer.

"We are excited to share this progress in the clinical development of SENTI-301A. Following the successful initiation of this trial, we see the potential to integrate Senti’s innovative gene circuit technology with our proprietary expertise in NK cell manufacturing and clinical operations. Importantly, as the second leading cause of cancer-related deaths in Asia, liver cancer remains a significant health threat in China. Statistics reveal that China accounts for over 40% of global HCC cases, underscoring the substantial unmet need we hope SENTI-301A can address."

"Hand in hand, we made great efforts and achieved satisfying results in 2024. In 2025, we will surely ride the wind and break the waves to write a new chapter, and forge ahead to open up a new situation. Here, we summarize the past and envision the future. Today's announcement marks significant progress in the clinical development of our solid tumor pipeline candidate drug SENTI-301A in collaboration with Shenglin Biomedical (Shanghai) Co., Ltd. We are proud of the rapid progress so far and recognize that our partnership with the Celest team plays a crucial role in bringing Senti Biosciences' gene circuit technology to patients who currently have almost no treatment options."

In addition, Shenglin Biomedical and Senti Bio have the opportunity to expand the clinical development of SENTI-301A to Hong Kong, Macao, and Taiwan. Senti Bio will retain all development and commercialization rights outside mainland China, Hong Kong, Macao, and Taiwan.

This single-center, open-label study initiated by the investigator primarily evaluates the efficacy and safety of SENTI-301A in treating GPC3-positive advanced hepatocellular carcinoma. The study includes three different dose groups, and patients will receive at least one 28-day treatment cycle after lymphodepleting chemotherapy. During the treatment cycle, patients will receive SENTI-301A infusions on D0, D7, and D14. After an assessment of safety and efficacy, patients may continue to receive multiple cycles of treatment.

SENTI-301A is an off-the-shelf, healthy donor-derived chimeric antigen receptor natural killer cell (“CAR-NK”) therapy specifically designed to treat tumors expressing GPC3. These engineered NK cells target the GPC3 antigen, which is highly expressed in 70% to 90% of hepatocellular carcinoma (HCC) cases but shows low or no expression on normal adult tissues. Additionally, SENTI-301A incorporates calibrated release interleukin-15 (“crIL-15”), a versatile immunostimulatory payload intended to simultaneously stimulate surrounding immune cells and promote the expansion, persistence, and tumor-killing ability of CAR-NK cells. Senti Bio has demonstrated comprehensive preclinical data showing SENTI-301A’s robust killing of relevant tumor cells both in vitro and in vivo.