1. Transaction to immediately accelerate clinical development of TR009 in Greater China and combine with Elpiscience’s deep pipeline of next generation immunotherapies；
2. TRIGR and Elpiscience intend to harmonize future clinical development globally across multiple DLL4 overexpressed solid tumors；
3. TRIGR to receive a $7 million upfront cash payment, $110 million in potential milestones, and royalties；
IRVINE, CA and SHANGHAI, China, January 20, 2021. TRIGR Therapeutics, Inc. (“TRIGR”), a US based clinical stage biopharmaceutical company focused on the development of multi-targeted angiogenic and immunomodulatory bispecific antibodies for oncology and certain ischemic indications and Elpiscience Biopharmaceuticals, a leading China based clinical stage company focused on developing next generation of cancer immunotherapies announced today that they have entered into an exclusive licensing agreement for the development and commercialization of TR009 in mainland China, Hong Kong, Macau and Taiwan.
Under the terms of the agreement, TRIGR will receive an upfront cash payment of $7 million and is eligible to receive additional development and commercial milestones of $110 million plus royalties on annual net sales of TR009. Elpiscience obtains the exclusive development and commercialization rights of TR009 for Greater China across all oncology indications and will lead the clinical development and commercialization by leveraging on its translational science, clinical and regulatory experience to accelerate the path to approval of TR009 in its territory. A Joint Development Committee (JDC) will be formed to collaborate and harmonize TR009’s clinical development globally.
George Uy, Founder and Chief Executive Officer of TRIGR stated, “TRIGR was formed with a vision to globalize drug development and accelerate transformative treatment to patients worldwide. Our partnership with Elpiscience in Greater China is a significant milestone in this endeavor. We would also like to acknowledge and thank ABL Bio (KOSDAQ: 298380), the originator of TR009 (aka ABL001/NOV1501) for their support in the Phase 1 clinical studies and immense contribution to this program, along with HANDOK (KOSDAQ:095700), National Oncoventure (NOV) and Binex (KOSDAQ:053030).”
Dr. Darren Ji, co-Founder, Chairman and Chief Executive Officer of Elpiscence stated, “Elpiscience is committed to delivering the next generation of cancer immunotherapy to patients who cannot benefit from current treatment. TR009 has demonstrated impressive single agent activity in tumor types that are poorly responsive to present immunotherapies and is highly synergistic with our next generation immune modulators. The addition of TR009 to our pipeline will further strengthen our efforts in tackling “cold tumors” and delivering efficient therapeutics.”
Miranda Toledano, Chief Operating/ Financial Officer of TRIGR stated “Emerging data from our Phase 1 studies demonstrate TR009 is a highly differentiated dual angiogenic blocker, safely inhibiting both DLL4-mediated Notch signaling and VEGF with activity across several DLL4 overexpressed tumors. We believe this profile could position TR009 as a next generation angiogenic flagship molecule with multiple rational combinations and sBLA opportunities.”
Dr. Steve Chin, Chief Medical Officer of Elpiscience added, “We were particularly encouraged by TR009 data in heavily pre-treated tumors refractory to anti-VEGF such as colorectal and gastric cancers. We look forward to working together with the TRIGR team to expedite delivery to patients.”
TR009 (aka ABL001/NOV1501) is an anti-VEGFxDLL4 bispecific antibody, which is composed of an anti-VEGF antibody backbone C-terminally linked with a proprietary DLL4-targeting single-chain variable fragment. Data from TR009’s ongoing Phase 1 Dose Escalation/Expansion Monotherapy and Phase 1B Combination studies (n~60 patients) demonstrate a 67% Clinical Benefit Rate, with deep and sustained partial responses per RECIST criteria in heavily pre-treated colorectal and gastric cancer patients that have failed at least 3 lines of prior therapy and become resistant to multi-VEGF (Avastin®, Stivarga®, Cyramza®), EGFR, anti-PD-1/PD-L1 and chemotherapies. The Phase 1B results testing the safety of TR009 in combination with irinotecan or paclitaxel, have also shown deep and sustained partial responses in difficult to treat 3rd/ 4thline Intrahepatic Cholangiocarcinoma (Biliary Tract Cancer) and Non-Small Cell cancer patients that have failed multiple lines of chemo, biological therapy, and anti-PD-1. TR009 has been safety administered up to 17.5mg/kg dose with no dose limiting toxicities (DLT). In contrast to historical DLL4 and other Notch targeted therapies, the administration of TR009 has not been hampered by pulmonary hypertension or other cardiac toxicities. Further updates on these studies will be provided later in 2021.
About TRIGR Therapeutics
TRIGR is an emerging biotechnology company in the field of next generation cancer therapies that was incorporated in April 2018 and managed by biopharmaceuticals industry veterans. TRIGR focuses on clinical development and commercialization of targeted and immuno-modulatory drugs with validated mechanism of action and novel formats for the US, European and Asian markets. The Company’s pipeline includes a clinical stage dual-angiogenesis bispecific antibody program (TR009) and 2 first in classpre-clinical 4-1BB conditional agonist bispecific antibodies paired with BCMA (TRIA001) and B7H-IO (undisclosed checkpoint, TRIA002). TRIGR Therapeutics holds the global rights to TR009 (a.k.a ABL001/NOV1501), outside of the Republic of Korea. ABL Bio (KOSDAQ: 298380), a premier biotechnology company focused on cancer and neurodegenerative diseases, licensed the worldwide rights to TRIGR in November 2018.
About Elpiscience Biopharmaceuticals
Elpiscience is a clinical stage biopharmaceutical company focusing on cancer immunotherapy. The company is committed to leading the innovation and development of the next generation of cancer immunotherapies for the benefit of cancer patients worldwide. Elpiscience has a pipeline of more than 10 innovative molecules in discovery, covering a wide range of targets with a particular focus on innate immunity and tumor microenvironment. Its clinical assets, ES101 and ES102 are completing Phase I clinical trials, while three in-house developed candidates with first-in-class and best-in-class potential are currently in IND-enabling studies. Elpiscience’s sustainable pipeline forms a strong cornerstone for developing the next generation and more effective immunotherapies.