On September 8, 2020 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 updated data from its ongoing TTI-622 and TTI-621 dose escalation studies (Press release, Trillium Therapeutics, SEP 8, 2020, View Source [SID1234564746]).
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"We are exceedingly encouraged by the evolving profile of TTI-622, our SIRPα-IgG4 Fc fusion protein, as demonstrated in the ongoing dose escalation study in relapsed and refractory lymphomas," said Jan Skvarka, Trillium’s President and Chief Executive Officer. "TTI-622 is showing substantial monotherapy activity in highly pre-treated patients, with a broad therapeutic window, a rapid onset of action, and across a range of lymphoma indications. With no significant safety signals observed, we are further escalating the dose. TTI-621, our SIRPα-IgG1 Fc fusion protein, is showing a strong safety profile, and we have not observed any dose limiting thrombocytopenia for doses up to 1.4 mg/kg. We continue to see a monotherapy activity signal, and are further dose escalating to characterize clinical activity at higher doses. We expect to declare maximum tolerated doses or recommended phase 2 doses for both molecules either towards the end of this year or in the first half of 2021. Abstracts for both trials have been submitted to the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting, and we look forward to presenting further details and additional data in December."
TTI-622 Study Update:
TTI-622 is being evaluated in a two-part, multicenter, open-label, phase 1a/1b study in patients with advanced relapsed or refractory lymphoma or multiple myeloma (NCT03530683).
In the phase 1a portion of the study, the safety assessment of the 8 mg/kg dosing cohort has been successfully completed. One Grade 4 thrombocytopenia dose-limiting toxicity (DLT) was reported among the six evaluable patients; no additional Grade 3 or higher thrombocytopenia events have been observed.
A total of six objective responses (33%; 1 complete response, 5 partial responses) have been observed among 18 response evaluable patients treated at dose levels of 0.8, 2.0, 4.0 and 8.0 mg/kg. Responses have occurred across all dose levels in this range, with three of six (50%) patients achieving responses in the 8.0 mg/kg cohort (response assessment for one additional patient at 8 mg/kg dose not yet available).
Clinical responses have been observed across multiple lymphoma indications, including diffuse large B-cell lymphoma, cutaneous T-cell lymphoma with large cell transformation, peripheral T-cell lymphoma, and follicular lymphoma.
All responses were observed at the first assessment at 8 weeks.
The study is currently enrolling patients at the 12 mg/kg dose level.
TTI-621 Study Update:
TTI-621 is being evaluated in a four-part, multicenter, open-label phase 1 study in patients with advanced relapsed or refractory hematologic malignancies (NCT02663518). In the ongoing Part 4, TTI-621 dosing is being escalated beyond 0.5 mg/kg in patients with cutaneous T-cell lymphoma.
Preliminary data from Part 4 indicate the weekly infusions of TTI-621 up to 1.4 mg/kg are well tolerated without dose-limiting thrombocytopenia. Platelet decreases generally occurred on dosing days, recovered in 2-4 days, and have not worsened with increasing dose levels. Infusion-related reactions (IRRs) typically occurred during initial infusions and often resolved without recurrence. One Grade 3 IRR DLT was observed at 1.0 mg/kg.
Antitumor activity in the 1 mg/kg cohort includes 1 partial response and 1 skin complete response (overall assessment stable disease) in 6 evaluable patients; 2 patients were bridged to allogeneic transplantation. Preliminary data suggest dose-dependent improvements in modified severity weighted assessment tool (mSWAT) scores in the 0.5 to1.0 mg/kg cohorts (1.4 mg/kg cohort data not yet available).
The study is currently enrolling patients at the 2.0 mg/kg dose level.
Webcast Information:
Trillium will host a live conference call and webcast at 5:30 p.m. ET today to discuss this clinical data update. The conference call may be accessed by (833) 670-0758 and with conference ID 7695694. The webcast may be accessed on Trillium’s Events and Presentations page at View Source or at View Source The archived webcast will be available on Trillium’s website for 30 days following the call.