TRANSCENTA HOLDING - A Global Fully Integrated Biotherapeutics Company
Transcenta, Biologics, Antibody, Claudin 18.2
2023 - 05 - 17
SUZHOU, China, May. 17, 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 encouraging phase I clinical data of TST002 (Blosozumab) in Chinese patients with reduced bone mineral density (BMD). TST002 (Blosozumab) was well tolerated and significantly increased BMD at day 85 following single intravenous injection at various doses.
Transcenta in-licensed the Great China rights of Blosozumab from Eli Lilly and Company (“Eli Lilly”) for development and commercialization in Greater China in 2019. Blosozumab Phase II trials in postmenopausal women in the United States and Japan have been completed by Eli Lilly.
Transcenta conducted a phase I study (NCT05391776) to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of single dose of TST002 (Blosozumab) in Chinese postmenopausal women and elder men with reduced BMD. It was a randomized, double-blind, placebo-controlled, dose-escalation, phase I study with single intravenous injection of TST002 (Blosozumab) at doses of either 200, 400, 800 or 1,200 mg or matching placebo. A total of 32 patients have been enrolled and treated. Database lock and data unblinding have been completed as of May 12, 2023.
Preliminary analysis of the unblinded data shows that the overall safety and tolerability of TST002 (Blosozumab) in all dose cohorts is favorable. Compared with previous clinical studies of Blosozumab in European, American and Japanese subjects, no new safety signals were found. There were no dose limiting toxicity, SAE, AE led to dose modification or death reported. All the adverse events were transient.
On the efficacy side, all dose cohorts from 200-1,200 mg have shown a clinically meaningful increase in lumbar spine BMD on 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 D85 from baseline ranged from 3.52% to 5.94% across dose cohorts, all exceeding the least significant difference (2.77%). The increase of lumbar spine BMD in the placebo group was only 0.3%. These results indicate that TST002 (Blosozumab) has the potential to treat osteoporosis, supporting Transcenta’s plan to initiate phase II clinical studies with multiple doses once every two to three months.
“We have observed encouraging preliminary BMD data with TST002 (Blosozumab) and the data generated support further exploration of our compound in a phase II. Targeting sclerostin is a well validated approach and we are confident that TST002 (Blosozumab) differentiated profile, with a reduced dosing frequency and potential for improved efficacy, will allow 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.
For more information, please visit www.transcenta.com and https://www.linkedin.com/company/transcenta.
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