TRANSCENTA HOLDING - A Global Fully Integrated Biotherapeutics Company
Transcenta, Biologics, Antibody, Claudin 18.2
2023 - 07 - 31
SUZHOU, China, July 31, 2023 -- 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 it has received approval from China Center for Drug Evaluation (CDE) to initiate Phase II clinical trial of TST002(Blosozumab). This study aims to evaluate the safety, tolerability, and pharmacokinetics of TST002(Blosozumab) after single and multiple intravenous administrations in patients with reduced bone mineral density.
Osteoporosis is a significant health concern for the middle-aged and elderly population in China. It is estimated that by 2050, the number of osteoporosis patients will reach 120 million. Compared with RANKL mAbs, sclerostin mAbs successfully achieve the dual goal of preventing bone loss and rebuilding the bone. Evenity (Romosozumab) of Amgen is the only anti-sclerostin antibody drug that has been approved by the FDA in the United States. Up to the present, there was no anti-sclerostin antibody drug approved in China.
In May 2023, Transcenta presented Phase I unblinded data, which showed that the overall safety and tolerability of TST002 (Blosozumab) in all dose cohorts is favorable. On the efficacy side, all dose cohorts from 200-1,200 mg have shown a clinically meaningful increase in lumbar spine BMD on day 85 (D85) after a single dose of TST002 (Blosozumab) and comparable to those of Blosozumab single dose study at the similar dose levels. The average increase of lumbar spine BMD at day 85 (D85) from baseline ranged from 3.52% to 6.20% across dose cohorts, all exceeding the least significant difference (2.77%). The increase of lumbar spine BMD in the placebo group was only 0.30% even with optimal calcium and vitamin D supplemental treatment. In addition, encouraging BMD increase in total hip from 1.30% to 2.24% across dose cohorts were observed after single dose of TST002 (Blosozumab). In comparison, the mean percent change in lumbar spine BMD from baseline to month 12 was 5.4% after one year of Denosumab treatment.1
"We are excited to have received the clearance to move forward from CDE. Our Phase II will assess several regimens of TST002 (Blosozumab) with reduced dosing frequency, bringing us closer to our Phase III. We look forward to fully exploring the differentiated profile of TST002 to address the unmet medical need of the large patient population who suffers from osteoporosis," said Dr. Caroline Germa, Transcenta's Executive Vice President, Global Medicine Development and Chief Medical Officer.
About TST002 (Blosozumab)
TST002 (Blosozumab) is a humanized anti-sclerostin monoclonal antibody as a drug candidate for osteoporosis and other bone loss diseases. It has a dual effect possessing both anabolic and anti-resorptive effects, which stimulates bone formation and inhibits bone absorption, resulting in fast increase in bone mineral density and bone strength. Blocking sclerostin activity in human treated with anti-sclerostin antibody or with naturally occurring genetic deletion has been shown to be an effective approach in increasing bone mineral density (BMD) and reducing bone fracture. Currently there is no approved anti-sclerostin antibody therapy in China yet although Romosozumab from Amgen has been approved in the United States, Europe and Japan.
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 13 therapeutic antibody molecules for oncology and selected non-oncology indications including bone and kidney disorders.
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.
Transcenta, the Directors and the employees of Transcenta assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.
CONTACT: Public Relations: firstname.lastname@example.org, Investor Relations: email@example.com, Business Development: firstname.lastname@example.org
Transcenta Unveils Updated Efficacy Data from Osemitamab (TST001) Plus CAPOX as First-Line Treatment for G/GEJ Cancer Study at ESMO 2023
FDA Grants Transcenta Clearance to Proceed with Global Phase III Trial of Osemitamab (TST001) as First-Line Treatment for Gastric/Gastroesophageal Cancer Patients
Transcenta Anti-sclerostin Monoclonal Antibody TST002 (Blosozumab) Received Approval from China CDE to Initiate Phase II Clinical Trial in Patients with Reduced Bone Mineral Density
Transcenta Received Approvals from China CDE and South Korea MFDS to Initiate TranStar 301 Global Phase III Pivotal Trial of Osemitamab (TST001)
Transcenta Presented PFS Data by CLDN18.2 Expression Level from Phase I/II Study of Osemitamab (TST001) plus CAPOX as the First-Line Treatment of Advanced G/GEJ Cancer at 2023 ESMO GI Annual Congress
Transcenta Presents Updated Data of Osemitamab (TST001) in Combination with CAPOX as a First-Line Treatment of G/GEJ Cancer at 2023 ASCO Annual Meeting