TST005 / Transcenta - LARVOL DELTA

Study of TST005 in Patients With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=19 | Terminated | Sponsor: Suzhou Transcenta Therapeutics Co., Ltd. | N=55 ➔ 19 | Trial completion date: Dec 2023 ➔ Sep 2023 | Active, not recruiting ➔ Terminated | Trial primary completion date: Dec 2023 ➔ Sep 2023; Corporate Decision

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Trial termination • Oncology • Solid Tumor

Study of TST005 in Patients With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=55 | Active, not recruiting | Sponsor: Suzhou Transcenta Therapeutics Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jul 2023 ➔ Dec 2023

Enrollment closed • Metastases • Trial primary completion date • Oncology • Solid Tumor

A phase 1, first-in-human, open-label, dose escalation and dose expansion study of TST005 in patients with locally advanced or metastatic solid tumors. (ASCO 2023) - P1 | "TST005 monotherapy demonstrated a good safety and tolerability, nonlinear PK characteristics and significant target engagement in patients with advanced solid tumors. Continue investigation of TST005 as monotherapy or in combination with other therapies are warranted. Clinical trial information: NCT04958434."

Clinical • Metastases • P1 data • Anemia • Dermatology • Fatigue • Hematological Disorders • Immune Modulation • Musculoskeletal Pain • Non-melanoma Skin Cancer • Oncology • Pain • Pruritus • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • PD-L1 • TGFB1

TST005, a bifunctional fusion protein of PD-L1/TGF-βRII, demonstrates potent anti-tumor activities with good safety profiles (AACR 2022) - P1 | "Here we report TST005 anti-tumor activities in MC38 colorectal cancer and EMT-6 breast cancer models compared to M7824 (Merck’s PD-L1/TGF-βRII) analog and its safety profiles following single or repeated doses in rats and non-human primates (NHP). Based on the exposure of TST005 in monkeys and predicted exposure at First in Human (FIH) dose, the safety margin of TST005 will be higher than 200 and 500 folds calculated on Cmax and AUC respectively. In conclusion, we have demonstrated the antitumor activity of TST005 in PD/PD-L1 sensitive and resistant tumor models as well as the safety profile in NHP, TST005 has been granted for phase 1 clinical trials in USA (NCT04958434)."

Clinical • IO biomarker • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • PD-L1 • TGFB1

Transcenta Presented Two Scientific Posters at SITC 2022 Annual Meeting (PRNewswire) - "Transcenta Holding Limited...announces that it has presented two scientific posters at the 37th Society for Immunotherapy of Cancer's (SITC) Annual Meeting....The other is a Trial in Progress (TiP) abstract on TST005, a bi-functional anti-PD-L1 and TGF-β trap fusion protein: a phase 1, first in human, open-label, dose escalation and dose expansion study in patients with locally advanced or metastatic solid tumors....This study is ongoing at 4 sites in the US and China. As of Aug 24, 2022, the first three dose cohorts have been completed and no DLT was observed."

Trial status • Oncology • Solid Tumor

A phase 1, first in human, open-label, dose escalation and dose expansion study of TST005 in patients with locally advanced or metastatic solid tumors (SITC 2022) - P1 | "- Salus IRB (NXSAT20.69) - Advarra IRB (SSU00157936) - Mary Crowley Medical Research Center IRB (21-37) - Shanghai Cancer Center IRB (2112248-1-2203) Consent Written informed consent was obtained from the patient for publication of this abstract and any accompanying images. A copy of the written consent is available for review by the Editor of this journal."

Clinical • P1 data • Cervical Cancer • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • TGFB1

Transcenta to Present Two Scientific Posters at SITC 2022 Annual Meeting (PRNewswire) - "Transcenta Holding Limited...announces that it will present two scientific posters at the 37th Society for Immunotherapy of Cancer's (SITC) Annual Meeting in Boston, MA, November 8-12, 2022: one related to Claudin18.2 and PD-L1 expression in gastric/gastro-esophageal adenocarcinoma, relevant for TST001 (Osemitamab) clinical development and the other on TST005 (PD-L1/TGF-β bifunctional antibody) trial in progress."

Clinical data • Trial status • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Transcenta Announces Presentation of Preclinical Data of TST005 at the 2022 American Association for Cancer Research (AACR) Annual Meeting (PRNewswire) - "Transcenta Holding Limited...announces the preclinical data of TST005, a bifunctional fusion protein of PD-L1/TGF-βRII, will be presented as a poster at the upcoming 2022 American Association for Cancer Research Meetings (AACR 2022), taking place from April 8th to April 13th in New Orleans via in person or virtual attendance."

Preclinical • Oncology • Solid Tumor

Study of TST005 in Patients With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1; N=55; Recruiting; Sponsor: Transcenta Therapeutics

Clinical • New P1 trial • Oncology • Solid Tumor

Transcenta Announces First Patient Dosed in Global Phase I Clinical Trial of PD-L1/TGF-β Bi-functional Antibody TST005 (PRNewswire) - “Transcenta…announces that the first US patient has been dosed in the global Phase I clinical trial of PD-L1/TGF-β bi-functional antibody TST005…TST005 induced significant increase of CD8 T-cell infiltration into PD-L1 expressing tumors and displayed dose-dependent tumor growth inhibition in tumor model not sensitive to PD-(L)1 treatment due to high level TGF-β. TST005 is well tolerated in non-human primates and displayed a linear PK profile. TST005 is a potential novel bi-functional immunotherapy candidate with improved therapeutic window.”

Trial status • Oncology • Solid Tumor

[VIRTUAL] The preclinical characterization of TST005, a bi-functional anti-PD-L1 and TGF-β trap fusion protein (AACR 2021) - "In conclusion, we have demonstrated that TST005 has enhanced immunomodulatory properties and can induce potent antitumor activity in preclinical tumor models that are not sensitive to PD-1/PD-L1 monotherapy. These results provide the rationale for further clinical evaluation of TST005 in patients with advanced solid tumors and less optimal response to first generation PD(L)-1 based immunotherapy."

IO biomarker • Preclinical • Oncology • Solid Tumor • CD8 • IFNG • TGFB1

Transcenta Received IND Clearance from US FDA for Initiating Phase I Clinical Trial for its Bi-functional Anti-PD-L1/TGF-β Antibody TST005 (PRNewswire) - "Transcenta Holding Limited...announced that it has received clearance of its IND for TST005 from US FDA for initiating Phase I clinical trial of its bi-functional anti-PD-L1/TGF-β antibody....'With the IND Clearance for TST005 in the US, we will accelerate the clinical development globally by allowing Chinese patients dosed at the current dose level when joining the study upon Chinese IND clearance.'"

Clinical • IND • Oncology • Solid Tumor

Transcenta Announced Presentation of Preclinical Data of TST005 at 2021 AACR Virtual Annual Meeting (PRNewswire) - "Transcenta Holding Limited (Transcenta)...presented preclinical data of TST005, a bi-functional anti-PD-L1 and TGF-β trap fusion protein, in a poster during the 2021 American Association for Cancer Research (AACR) Virtual Annual Meeting, being held from April 10th to 15th and May 17th to 21st."

Preclinical • Oncology