Toad Pharmaceuticals announces the results of the ADC drug TAA013 Phase I study

On December 9th Toshio Pharmaceuticals announced that the results of its self-developed antibody association drug, TAA013 Phase I Clinical Research, were released at the 2020 San Antonio Breast Cancer Conference (SABCS) and presented in the form of E-Poster.
This study, completed by Professor Yin Yumei of Jiangsu Provincial People's Hospital, is an open-label, single-arm, dose-climbing study used to treat HER2-positive breast cancer patients who have progressed through the treatment of curto-pearl monotherapy, with the aim of evaluating the safety, tolerance, pharmacodynamic/pharmacological characteristics of TAA013.
study used a "3 plus 3" dose climbing design, including 0.6 mg/kg, 1.2 mg/kg, 2.4 mg/kg, 3.6 mg/kg, 4.8 mg/kg 5 dose groups, intravenous infusion of TAA013, once every 3 weeks.
7 subjects were added to the group at the clinically recommended dose of 3.6 mg/kg, and a total of 22 HER2-positive breast cancer patients who failed through multi-line anti-HER2 targeted therapy were added to the group.
results showed: safe tolerance: dose-limiting toxicity was not observed in each dose group, most adverse events were level 1-2, clinically controllable, and drug-resistant antibodies were negative; Pharmacodynamics: Cmax in the 3.6mg/kg dose group was 70.6mg/ml, AUC0-∞ was 256.04 days x mg/mL, and t1/2 was 2.7 days; Effectiveness: At the recommended dose of 3.6m/kg, the objective remission rate was 10%, the disease control rate reached 70%, the medium non-progression survival period was more than 5 months, and the treatment of 1 subject was more than 500 days.
results showed that TAA013 had good safe tolerance and showed initial efficacy in HER2-positive breast cancer patients who were treated with excessive line anti-HER2 targeted drugs.
Currently in the process of TAA013 Phase III clinical studies, this is a multi-center, randomized, parallel control, open labeling study, for patients with failed, non-excisible local late stage or metastasis HER2-positive breast cancer treatment, compared to the effectiveness and safety of Rapateni combined carpedabin, to further verify the effectiveness and safety of TAA013. The lead researcher of
, Professor Yin Yumei of Jiangsu Provincial People's Hospital, said: TAA013 is a targeted HER2 antibody combination drug for breast cancer, and good safety has been observed in Phase I clinical studies, and the initial effectiveness has been observed in patients who have experienced a variety of anti-HER2 targeted drugs such as clostomal monoanti, pyridoxine, rapatini.
In order to further explore the safety and effectiveness of TAA013 in HER2-positive breast cancer patients, phase III corroro viable key clinical studies have been initiated, I hope that Phase III clinical studies can be completed as soon as possible and get positive results, for HER2-positive breast cancer patients to provide more treatment options.
Dr. Jun Liu, CHIEF Executive Officer, Chief Scientific Officer and Executive Director of Dongxuan Pharmaceuticals, said: ADC is the long-term strategic development direction of Dongxuan Pharmaceuticals, TAA013 is the company's fastest-growing ADC in the research products, we are very pleased to see the drug in Phase I clinical trials show good safety and efficacy, which also proves that Dongxuan Pharmaceuticals in antibody conjunctory drugs leading results.
is currently undergoing Phase III research on the product, the company has also established ADC drug key technical capabilities and GMP-compliant raw fluids and preparations integrated into a complete commercial production platform.
We look forward to providing this high-quality and cost-effective treatment for HER2-positive breast cancer patients as soon as possible About TAA013 TAA013 is an in-study ADC drug containing a new derivative of curtoju-MCC-DM1, designed to provide both high-quality and affordable treatment options for HER2-positive breast cancer patients.
TAA013, with the help of the targeting of curto-bead monoantigen, binds to specific antigens on tumor cell membranes to induce cytotoxicity, which induces the highly active cytotoxic drug DM1 to enter the cells, which in turn induces apoptosis.
ADC drug has the characteristics of strong single anti-drug targeting and strong cytotoxic drugs, and has the advantages of high drug ability and low side effects.
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