Transcenta Received IND Clearance from FDA for Its First-In-Class Gremlin1 Targeting Antibody TST003 for the Treatment of Solid Tumors

SUZHOU, China, Sept. 14, 2022 /PRNewswire/ –Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announces that TST003, its first-in-class, high affinity humanized monoclonal antibody targeting Gremlin1, has received IND clearance from U.S. Food and Drug Administration (FDA).

Gremlin1, a member of the TGF-β super family, is highly expressed by stromal cells in diverse human carcinomas, such as esophageal cancer, pancreatic cancer, gastric cancer, colon cancer, lung cancer, breast cancer and prostate cancer and is associated with tumorigenesis, contributing to the proliferation, migration, invasion and metastasis of cancer cells. TST003 has displayed significant anti-tumor activities both in vitro and in vivo in preclinical studies. TST003 has the potential to become a novel cancer treatment, either as monotherapy or in combination with immune checkpoint inhibitor and/or other anti-tumor agents.

In May 2022, Nature Cancer published the study results by Transcenta and Shanghai Jiao Tong University scientists on the potential application of the its first-in-class Gremlin1 targeting antibody in the treatment of androgen receptor-negative/low prostate cancer. The study results revealed that Gremlin1 protein can promote lineage plasticity and drive castration resistance in prostate cancer. Gremlin1-specific antibodies can effectively control tumor growth in androgen receptor-negative/low prostate cancer. The study also demonstrated a synergistic activity between the anti-Gremlin1 antibody and enzalutamide against patient-derived castration-resistant prostate cancer models in vitro and in vivo.

"Targeting Gremlin1 with our antibody TST003 has the potential to be transformative in the treatment of high unmet need cancer indications, such as castration resistant prostate cancer. We look forward to initiating our first time in human clinical study which is designed to address key questions to optimize TST003 clinical development plan." said Dr. Caroline Germa, Transcenta’s Executive Vice President, Global Medicine Development and Chief Medical Officer.

About TST003

TST003 is a potentially first-in-class antibody drug candidate around the world targeting a novel immune regulatory protein produced by tumor-associated fibroblasts or tumor cells with mesenchymal phenotype. In preclinical studies, TST003 has demonstrated anti-tumor activities either as a single agent or in combination with targeted agent in "target-expressing" patient-derived xenografts (PDX) tumor model. In addition, TST003 displayed anti-tumor activities as a single agent and enhanced the anti-tumor activity of checkpoint inhibitor in multiple syngeneic tumor models.

About Transcenta Holding Limited

Transcenta (HKEX: 06628) is a clinical stage biopharmaceutical company with fully integrated capabilities in antibody-based biotherapeutics discovery, research, development and manufacturing.

Transcenta has established global footprint, with Headquarters and Discovery, Clinical and Translational Research Center in Suzhou, Process and Product Development Center and Manufacturing Facility in Hangzhou, and Clinical Development Centers in Princeton, US and in Beijing, Shanghai and Guangzhou of China, and External Partnering Center in Boston and Los Angeles, US. Transcenta has also initiated the construction of the Group Headquarters and the second high-end biopharmaceutical facility with ICB as its core technology in Suzhou Industrial Park. Transcenta is developing ten therapeutic antibody molecules for oncology and selected non-oncology indications including bone and kidney disorders.

For more information, please visit www.transcenta.com and https://www.linkedin.com/company/transcenta.

Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Transcenta, are intended to identify certain of such forward-looking statements. Transcenta does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Transcenta with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Transcenta’s control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Transcenta’s competitive environment and political, economic, legal and social conditions.

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