TRACON Pharmaceuticals (NASDAQ:TCON) Inc. has entered into a collaborative partnership agreement with China-based Eucure Biopharma for the development of CTLA-4 antibody YH001 in multiple oncology indications, including soft tissue sarcoma.
Under the terms of the agreement, TRACON said it will be responsible for the clinical development and commercialization of YH001 in North America, with the majority of the development activities expected to occur in the US.
TRACON will bear the costs of clinical trials and Eucure Biopharma, a subsidiary of Biocytogen Pharmaceuticals (Beijing) Co. Ltd, will supply YH001. TRACON also will owe its partner escalating double-digit royalties on net sales.
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YH001 was developed to potently inhibit CTLA-4 binding to the CD80/CD86 receptors and deplete regulatory T cells through enhanced ADCC and CDC effector functions. YH001 demonstrated superior activity in vitro and in transgenic syngeneic tumor models compared to ipilimumab (Yervoy), both as a single agent and when combined with a PD-(L)1 antibody.
“We are focused on advancing a dual checkpoint inhibitor strategy focused on the PD-(L)1 and CTLA-4 pathways, that we expect to leverage in sarcoma by combining YH001 with envafolimab, our novel, single-domain PD-L1 antibody, in sarcoma,” said TRACON CEO Dr. Charles Theuer in a statement.
“Going forward, we intend to use YH001 rather than Yervoy in our future dual checkpoint inhibition trials in sarcoma, which we anticipate will result in meaningful cost savings from not needing to purchase Yervoy at retail prices. Moreover, we expect to study YH001 in other solid tumors in combination with PD-(L)1 antibodies, including in patients who have progressed on prior PD-(L)1 treatment.”
Dr. Yuelei Shen, CEO of Biocytogen and Eucure Biopharma, said the collaboration with TRACON has the potential to provide cancer patients in the US with a best-in-class CTLA-4 checkpoint inhibitor.
“YH001 was optimized using Biocytogen’s discovery labs and proprietary transgenic mouse models to inhibit CTLA-4 binding and to deplete regulatory cells,” the CEO said. “In our ongoing Phase 1 clinical trials, YH001 has been tolerable as a single agent and in combination with the PD-1 antibody toripalimab.”
Meanwhile, YH001 is being dosed as a single agent in a Phase 1 trial in China and in combination with the PD-1 antibody toripalimab in a Phase 1 trial in Australia. In July 2021, the US Food and Drug Administration (FDA) approved the Investigational New Drug application to initiate multiple Phase II clinical trials for YH001 in the US.
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