TransThera is an R&D-driven, clinical-stage biopharmaceutical company focusing on the discovery and development of first-in-class, best-in-class, and highly differentiated small molecule drugs to treat diseases with significant unmet medical needs.
TransThera has a strong leadership and management team with broad expertise and extensive experience from global pharmaceutical and biotech companies, including Merck, BMS, Roche, AstraZeneca, BI, GSK, Genentech, etc. TransThera is unique with agile and dynamic characteristics as delineated below:
1.
Powerhouse for Differentiated Small Molecule Drugs
2.
Proprietary “ACE” platform to generate Differentiated Drug-like Clinical Candidates
3.
7 clinical molecules delivered within 6 years
4.
Efficient and Experienced Clinical & Regulatory Team with high productivity and solid delivery
5.
Global clinical development programs
o Close cooperation with leading PIs in prestigious medical institutions
o Solid engagement with KOLs
o Excellent working relationship with regulatory authorities (FDA and NMPA)
6.
Broad global collaborations with partners from the US, Europe, South Korea, and Japan
7.
Diversified shareholders with a strong Global Network
TransThera has a strong and diverse pipeline, including oncology/hematology , inflammatory, and cardiovascular diseases. 7 assets are undergoing global clinical development:
• 4 oncology assets encompass optimal treatments for relapsed or refractory solid tumors and hematological malignancies
• 3 non-oncology assets are at the forefront of the competition in inflammatory and cardiovascular diseases
Three oncology and three non-oncology assets for Out-Licensing and Co-Development Opportunities (please refer to individual asset segment for more detailed information):
Oncology assets:
++ Tinengotinib (TT-00420): a spectrum-selective multi-kinase inhibitor that targets cell proliferation, angiogenesis, and immune-oncology pathways by inhibiting Aurora kinases A/B and Janus kinases (JAK) involved in cytokine signaling and receptor tyrosine kinases (FGFRs and VEGFRs) involved in the tumor microenvironment. It has been explored in many indications as mono therapy or combination therapy,
o Tinengotinib tablets as monotherapy and combination therapy have been investigated in advanced solid tumors, including phase III ready in Cholangiocarcinoma (CCA), phase II in Metastatic Castration-Refractory Prostate Cancer (CRPC), phase Ib/II in HR+/HER2- Breast Cancer, and phase Ib/II in Triple Negative Breast Cancer (TNBC)
o Preliminary Safety and Efficacy of Tinengotinib Tablets as Monotherapy and Combination Therapy in Advanced Solid Tumors: A Phase Ib/II Clinical Trial will be presented at the 2023 ASCO (Abstract #3019, Board #217; poster session displayed date/time: 6/3/2023, 8-11 AM; poster discussion session date/time: 6/3/2023, 1:15-2;45 PM).
o A randomized, controlled, global multicenter pivotal trial is opened to evaluate further the efficacy and safety of tinengotinib versus Physician’s choice in patients with FGFR2-altered, Chemotherapy- and FGFR Inhibitor-Refractory/Relapsed Cholangiocarcinoma.
o FDA Granted Fast Track and Orphan Drug Designations to TT-00420 for Cholangiocarcinoma
++ TT-01488: a novel, highly potent, and selective, reversible BTK inhibitor with excellent potency against WT and C481S mutation, acquired mutation by Ibrutinib and other irreversible BTK inhibitors in B-cell lymphomas, and better selectivity than potential competitors. Phase I study is ongoing.
++ TT-00973: A novel potent AXL/FLT3 dual inhibitor for treating platinum-resistant ovarian cancer, R/R AML and high-risk MDS. It showed strong inhibition in cellular assays for both FLT3-ITD with or without F691L mutation. IND has been approved for solid tumors in China and for hematological malignancies in the US. Phase I study is ongoing.
++ TT-00434 is a selective FGFR 1-3 inhibitor for gastrointestinal carcinoma. Superior efficacy observed in pre-clinical models. Phase II ready clinical stage.
Non-oncology assets:
++ TT-00920: a potential best-in-class PDE9 inhibitor, in-house tailored-made specifically for heart failure, is a novel approach capable of maximizing NPR pathway activation and cGMP’s beneficial effects, thereby optimizing the cardioprotection effect. Low brain penetration and high target tissue distribution are the key differentiation attributes. Phase I trials conducted in the US and China have been completed.
++ TransThera’s NLRP3 inhibitor, a potential best-in-class molecule, may address a huge unmet medical need across various inflammatory disorders. NLRP3 is a major driver of inflammasome activity, which is implicated in a wide variety of diseases, including inflammatory diseases, cancer, autoimmune disorders, etc.
++ TT-01025: A potential best-in-class SSAO/VAP 1 Inhibitor for NASH and Other Inflammatory Diseases. It has demonstrated low brain penetration rate and high selectivity against MAO-A/MAO-B, which results in minimized risk of drug-drug interation. Global phase I trials have been completed in US/China. Excellent safety profile and PK/PD have been observed in healthy subjects.
Partnering Opportunity: Our Core Strategic Goal is Collaboration with Partners Worldwide. We are seeking global partnering collaboration on the out-licensing of our assets or co-development opportunities.
TransThera Sciences will be well represented at BIO 2023. Please feel free to request a one-on-one meeting with TransThera for a more in-depth discussion on assets of interest. For collaboration opportunities, please contact our business development team bd@transtherabio.com.
TransThera is committed to developing transformative therapies for patients worldwide.
TransThera has a strong leadership and management team with broad expertise and extensive experience from global pharmaceutical and biotech companies, including Merck, BMS, Roche, AstraZeneca, BI, GSK, Genentech, etc. TransThera is unique with agile and dynamic characteristics as delineated below:
1.
Powerhouse for Differentiated Small Molecule Drugs
2.
Proprietary “ACE” platform to generate Differentiated Drug-like Clinical Candidates
3.
7 clinical molecules delivered within 6 years
4.
Efficient and Experienced Clinical & Regulatory Team with high productivity and solid delivery
5.
Global clinical development programs
o Close cooperation with leading PIs in prestigious medical institutions
o Solid engagement with KOLs
o Excellent working relationship with regulatory authorities (FDA and NMPA)
6.
Broad global collaborations with partners from the US, Europe, South Korea, and Japan
7.
Diversified shareholders with a strong Global Network
TransThera has a strong and diverse pipeline, including oncology/hematology , inflammatory, and cardiovascular diseases. 7 assets are undergoing global clinical development:
• 4 oncology assets encompass optimal treatments for relapsed or refractory solid tumors and hematological malignancies
• 3 non-oncology assets are at the forefront of the competition in inflammatory and cardiovascular diseases
Three oncology and three non-oncology assets for Out-Licensing and Co-Development Opportunities (please refer to individual asset segment for more detailed information):
Oncology assets:
++ Tinengotinib (TT-00420): a spectrum-selective multi-kinase inhibitor that targets cell proliferation, angiogenesis, and immune-oncology pathways by inhibiting Aurora kinases A/B and Janus kinases (JAK) involved in cytokine signaling and receptor tyrosine kinases (FGFRs and VEGFRs) involved in the tumor microenvironment. It has been explored in many indications as mono therapy or combination therapy,
o Tinengotinib tablets as monotherapy and combination therapy have been investigated in advanced solid tumors, including phase III ready in Cholangiocarcinoma (CCA), phase II in Metastatic Castration-Refractory Prostate Cancer (CRPC), phase Ib/II in HR+/HER2- Breast Cancer, and phase Ib/II in Triple Negative Breast Cancer (TNBC)
o Preliminary Safety and Efficacy of Tinengotinib Tablets as Monotherapy and Combination Therapy in Advanced Solid Tumors: A Phase Ib/II Clinical Trial will be presented at the 2023 ASCO (Abstract #3019, Board #217; poster session displayed date/time: 6/3/2023, 8-11 AM; poster discussion session date/time: 6/3/2023, 1:15-2;45 PM).
o A randomized, controlled, global multicenter pivotal trial is opened to evaluate further the efficacy and safety of tinengotinib versus Physician’s choice in patients with FGFR2-altered, Chemotherapy- and FGFR Inhibitor-Refractory/Relapsed Cholangiocarcinoma.
o FDA Granted Fast Track and Orphan Drug Designations to TT-00420 for Cholangiocarcinoma
++ TT-01488: a novel, highly potent, and selective, reversible BTK inhibitor with excellent potency against WT and C481S mutation, acquired mutation by Ibrutinib and other irreversible BTK inhibitors in B-cell lymphomas, and better selectivity than potential competitors. Phase I study is ongoing.
++ TT-00973: A novel potent AXL/FLT3 dual inhibitor for treating platinum-resistant ovarian cancer, R/R AML and high-risk MDS. It showed strong inhibition in cellular assays for both FLT3-ITD with or without F691L mutation. IND has been approved for solid tumors in China and for hematological malignancies in the US. Phase I study is ongoing.
++ TT-00434 is a selective FGFR 1-3 inhibitor for gastrointestinal carcinoma. Superior efficacy observed in pre-clinical models. Phase II ready clinical stage.
Non-oncology assets:
++ TT-00920: a potential best-in-class PDE9 inhibitor, in-house tailored-made specifically for heart failure, is a novel approach capable of maximizing NPR pathway activation and cGMP’s beneficial effects, thereby optimizing the cardioprotection effect. Low brain penetration and high target tissue distribution are the key differentiation attributes. Phase I trials conducted in the US and China have been completed.
++ TransThera’s NLRP3 inhibitor, a potential best-in-class molecule, may address a huge unmet medical need across various inflammatory disorders. NLRP3 is a major driver of inflammasome activity, which is implicated in a wide variety of diseases, including inflammatory diseases, cancer, autoimmune disorders, etc.
++ TT-01025: A potential best-in-class SSAO/VAP 1 Inhibitor for NASH and Other Inflammatory Diseases. It has demonstrated low brain penetration rate and high selectivity against MAO-A/MAO-B, which results in minimized risk of drug-drug interation. Global phase I trials have been completed in US/China. Excellent safety profile and PK/PD have been observed in healthy subjects.
Partnering Opportunity: Our Core Strategic Goal is Collaboration with Partners Worldwide. We are seeking global partnering collaboration on the out-licensing of our assets or co-development opportunities.
TransThera Sciences will be well represented at BIO 2023. Please feel free to request a one-on-one meeting with TransThera for a more in-depth discussion on assets of interest. For collaboration opportunities, please contact our business development team bd@transtherabio.com.
TransThera is committed to developing transformative therapies for patients worldwide.
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