On July 24, 2019 Trillium Therapeutics Inc. ("Trillium" or the "Company") (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported a corporate update. "Trillium continues to make progress with both our intratumoral and intravenous development programs for TTI-621, our novel CD47 immune checkpoint inhibitor," said Robert L. Kirkman, M.D., Executive Chair of Trillium (Press release, Trillium Therapeutics, JUL 24, 2019, View Source [SID1234537704]). "We believe the single agent anti-tumor activity we have observed in our trials of TTI-621 to date is unique and, as we move these programs forward, positions Trillium to be a leader in this exciting new approach to the treatment of cancer."
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Trillium is focusing the intratumoral administration of TTI-621 for the treatment of cutaneous T-cell lymphoma (CTCL). The U.S. Food and Drug Administration (the FDA) has accepted the Company’s request for an in-person meeting, currently scheduled to take place later this quarter, to discuss the Company’s proposed pivotal pathway for intratumoral administration of TTI-621 in early-stage CTCL. This proposal builds upon the anti-tumor activity observed in the ongoing phase 1b expansion trial (NCT02890368). As reported at the American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in December 2018, a reduction in Composite Assessment of Index Lesion Severity (CAILS) scores, which measure local lesion responses, was observed in 91% (20/22) of CTCL patients receiving intratumoral TTI-621.
The current goal of Trillium’s intravenous program for TTI-621 is the identification of a recommended phase 2 dose. Trillium has amended the intravenous study protocol (NCT02663518) to enable dosing beyond 0.5 mg/kg and is currently enrolling the first cohort in the new dose-escalation design. The Company also has completed enrollment for the first Simon’s 2-stage CTCL cohort in the TTI-621 intravenous study. The Safety Review Committee reviewed the preliminary data from this cohort and recommended that patients on study continue to be followed until all response assessments are available. The Company has decided not to initiate the second Simon’s 2-stage cohort until the outcome of the ongoing dose escalation is known. "While we have seen meaningful activity of intravenous TTI-621 in a variety of malignancies at the current doses, we believe it is important to identify the optimal dose before proceeding with additional studies," said Yaping Shou, M.D., Chief Medical Officer at Trillium. "We believe this approach is the best use of resources and will maximize the opportunity for success."
"Obtaining guidance from the FDA regarding the development pathway for intratumoral TTI-621 in early-stage CTCL will be an important step for Trillium, as we believe this indication may be a potential first-to-market approach for this product candidate," said Dr. Kirkman. "In addition, identifying an optimal dose for intravenous TTI-621 and building on what we believe is its unique single agent activity should enable a significant expansion of our opportunities."