Under the terms of the agreement, TRIGR will receive an advance payment of $ 7 million and is eligible to receive additional development and commercial milestones from $ 110 million plus license fees for the annual net sales of TR009. Elpiscience receives the exclusive development and marketing rights for TR009 for Greater China across all oncology indications and will lead clinical development and commercialization using his translational scientific, clinical and regulatory experience to accelerate the path to approval of TR009 in his field. A Joint Development Committee (JDC) is being formed to collaborate and harmonize the clinical development of TR009 worldwide.
George UyTRIGR Founder and Chief Executive Officer stated, “TRIGR was founded with a vision to globalize drug development and accelerate transformative care for patients worldwide. Our partnership with Elpiscience in Greater China is an important milestone in this endeavor. We would also like to thank ABL Bio (KOSDAQ: 298380), the creator of TR009 (also known as ABL001 / NOV1501), for their support in the Phase 1 clinical trials and their immense contribution to this program HANDOK (KOSDAQ: 002390), National Oncoventure (NOV) and Binex (KOSDAQ: 053030). ”
DR. Darren JiElpiscience Co-Founder, Chairman and Chief Executive Officer stated, “Elpiscience is committed to bringing the next generation of cancer immunotherapy to patients who may not benefit from current treatment. TR009 has demonstrated impressive single-agent activity in tumor types that are poorly responding. We present immunotherapies and are highly synergistic with our next generation immunomodulators. The addition of TR009 to our pipeline will further strengthen our efforts to fight “cold tumors” and provide more effective therapeutics. ”
Miranda Toledano, TRIGR’s Chief Operating / Financial Officer, stated: “New data from our Phase 1 studies show that TR009 is a highly differentiated dual angiogenic blocker that can block both DLL4-mediated notch signals and VEGF with activity across multiple DLL4- Safely inhibits overexpressed tumors. We believe this profile could position TR009 as the next generation angiogenic flagship with multiple rational combinations and sBLA possibilities. “DR. Steve ChinElpiscience’s Chief Medical Officer added, “We have been particularly encouraged by TR009 data in heavily pretreated tumors that are VEGF-resistant, such as colon and gastric cancer. We look forward to working with the TRIGR team to address these Expedite delivery to patients. “”
TR009 (also known as ABL001 / NOV1501) is an anti-VEGFxDLL4 bispecific antibody that consists of an anti-VEGF antibody backbone C-terminally linked to a proprietary DLL4 targeting single chain variable fragment. Data from ongoing phase 1 dose escalation / expansion monotherapy and phase of TR009 1B Combination studies (n ~ 60 patients) show a clinical benefit rate of 67% with deep and sustained partial reactions according to RECIST criteria in heavily pretreated patients with colon and gastric cancer, in whom at least 3 lines of the previous therapy have failed and who are resistant to multi – VEGF (Avastin®, Stivarga®, Cyramza®), EGFR, Anti-PD-1 / PD-L1 and chemotherapy. The phase 1B Results testing the safety of TR009 in combination with irinotecan or paclitaxel also have deep and sustained partial responses in difficult-to-treat patients with 3rd / 4th grade intrahepatic cholangiocarcinoma. Lineage (biliary tract cancer) and non-small cell cancer patients who have failed multiple chemolines, biological therapy and anti-PD-1. TR009 was safely administered up to a dose of 17.5 mg / kg with no dose limiting toxicity (DLT). Unlike historical DLL4 and other Notch-targeted therapies, administration of TR009 was not hampered by pulmonary hypertension or other cardiac toxicities. Further updates to these studies will be released later in 2021.
About TRIGR Therapeutics
TRIGR is an emerging next-generation cancer therapy company that has joined the company April 2018 and administered by veterans of the biopharmaceutical industry. TRIGR focuses on the clinical development and commercialization of targeted and immunomodulating drugs with validated mechanisms of action and novel formats for the US, European and Asian markets. The company’s pipeline includes a clinical-stage bispecific dual angiogenesis antibody program (TR009) and two world-class preclinical bispecific 4-1BB antibodies against conditional agonists, paired with BCMA (TRIA001) and B7H-IO (unnamed checkpoint, TRIA002). TRIGR Therapeutics owns the worldwide rights to TR009 (also known as ABL001 / NOV1501) outside of the Republic of Korea. ABL Bio (KOSDAQ: 298380), a leading biotechnology company focused on cancer and neurodegenerative diseases, has licensed the worldwide rights to TRIGR in November 2018.
TRIGR contact: Miranda Toledano, Chief Operating / Financial Officer, [email protected]
About Elpiscience Biopharmaceuticals
Elpiscience is a clinical-stage biopharmaceutical company focused on cancer immunotherapy. The company is committed to innovating and developing the next generation of cancer immunotherapies for the benefit of cancer patients worldwide. Elpiscience has a pipeline of more than 10 innovative molecules covering a wide range of targets with a particular focus on innate immunity and the tumor microenvironment. The ES101 and ES102 clinical resources are completing Phase I clinical trials, while three in-house developed candidates with world class and world class potential are currently in IND-eligible studies. Elpiscience’s sustainable pipeline forms a strong cornerstone for the development of the next generation and more effective immunotherapies.
Elpiscience contact: Judy Shi, Head of business Development, [email protected]
SOURCE TRIGR Therapeutics, Inc.