TransThera announces that the IND application for TT-01488, a reversible non-covalent BTK inhibitor, for the treatment of B-cell lymphoma has been approved by the FDA in the United States and officially accepted by the NMPA in China

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NANJING, China, February 18, 2022 /PRNewswire/ — TransThera Sciences (Nankeen), Inc. (“TransThera”) announced that the United States Food and Drug Administration (“FDA”) has approved the Investigational New Drug (“INDIANA”) application of TT-01488, a non-covalent reversible Bruton’s tyrosine kinase (“BTK“) inhibitor, for the treatment of B-cell lymphomas on January 24, 2022, and TransThera will soon begin Phase I clinical trials in the United States. TransThera also announced that the National Medical Products Administration of China (“NMPA”) has officially accepted the IND application for TT-01488 for the treatment of B-cell lymphoma on February 14, 2022.

According to Frost & Sullivan, the global and Chinese market for BTK inhibitors has reached $7.2 billion and 1.3 billion RMB respectively in 2020. The market is expected to continue to grow over the next 5 years, growing at a CAGR of 22.7% globally and 58.6% in China from 2020 to 2025. In 2021, there were 5 BTK inhibitors approved in different markets, all of which are covalent irreversible BTK inhibitors. The mechanism of action of irreversible covalent BTK inhibitors is to form a covalent bond with the C481 site of BTK. However, when the C481S mutation occurs, they will not be able to maintain the covalent bond, which eventually leads to drug resistance. Long-term follow-up results of irreversible BTK inhibitor use, according to Frost & Sullivan, demonstrate cumulative discontinuation rates as high as 40%, pointing to the significant unmet medical need.

“Non-covalent BTK inhibitors are unaffected by the C481S mutation and should overcome acquired resistance developed from marketed covalent BTK inhibitors. In a kinase comparison examination, TT-01488 demonstrated potency higher and better selectivity of kinases on EGFR and TEC than peer reversible non-covalent BTK inhibitor under clinical investigation, indicating a potentially better safety profile. Moreover, in the DLBCL CDX model, TT-01488 showed superior antitumor effect compared to peer reversible non-covalent BTK inhibitor,” said Dr. Peng-PengVice President of Project Management and Head of Oncology Portfolio at TransThera, “FDA approval and NMPA acceptance of its IND applications are two important milestones in the development of TT-01488. We will cooperate actively with regulatory authorities to initiate clinical trials of TT-01488 globally as soon as possible.”

About TT-01488:

TT-01488 is a non-covalent and reversible BTK inhibitor to overcome the acquired resistance mutation developed from marketed covalent BTK inhibitors in various types of B-cell lymphoma. In preclinical trials, TT-01488 has shown potential benefits such as overcoming drug resistance, improved target selectivity, antitumor efficacy and favorable safety.

About TransThera:

TransThera Sciences (Nankeen), Inc. is an R&D-driven, clinical-stage biopharmaceutical company dedicated to developing innovative therapies to target diseases with high unmet medical needs through internal research platform and open innovation. TransThera’s current portfolio covers therapeutic areas such as oncology, cardiovascular and inflammatory diseases.

For more information, visit www.transtherabio.com

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SOURCE TransThera Biosciences

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