• TTI-622 (SIRPa-IgG4 Fc) com­pleted 8 mg/kg safety assess­ment in the on­go­ing dose escalation study in re­lapsed / re­frac­tory lym­phoma; now es­ca­lat­ing to 12 mg/kg dose level.
• TTI-622 mono­therapy shows 6/18 (33%) objective re­sponses at 0.8 to 8 mg/kg dose levels, in­clud­ing 3/6 (50%) objective re­sponses at 8 mg/kg.
• TTI-621 (SIRPa-IgG1 Fc) well tol­er­ated at 1.4 mg/kg; con­tinues to show mono­therapy signal and dose-depen­dent im­prove­ment in skin dis­ease scores in the on­go­ing dose escalation study in re­lapsed / re­frac­tory CTCL.
• Trillium to host conference call at 5:30 p.m. ET to­day

Cambridge, MA (Press Release) – Trillium Thera­peutics Inc. (“Trillium” or the “Company”) (NASDAQ/TSX: TRIL), a clin­i­cal stage immuno-oncology com­pany devel­op­ing inno­va­tive ther­a­pies for the treat­ment of can­cer, to­day an­nounced up­dated data from its on­go­ing TTI-622 and TTI-621 dose escalation stud­ies.

“We are exceedingly en­cour­aged by the evolving profile of TTI-622, our SIRPa-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 SIRPa-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 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 https://ir.trilliumtherapeutics.com/events-and-presentations or at https://event.on24.com/wcc/r/2645255/C032FE41D7E0F23D4D47E9DFA2D71982. The archived webcast will be avail­able on Trillium’s website for 30 days fol­low­ing the call.

About Trillium Thera­peutics

Trillium is an immuno-oncology com­pany devel­op­ing inno­va­tive ther­a­pies for the treat­ment of can­cer. The com­pany’s two clin­i­cal pro­grams, TTI-621 and TTI-622, target CD47, a “don’t eat me” signal that can­cer cells fre­quently use to evade the im­mune sys­tem.

For more in­for­ma­tion visit: www.trilliumtherapeutics.com

Caution Regarding Forward-Looking In­for­ma­tion

This press re­lease con­tains for­ward-looking state­ments within the meaning of appli­cable United States se­cu­ri­ties laws and for­ward-looking in­for­ma­tion within the meaning of Canadian se­cu­ri­ties laws (collectively, "forward-looking state­ments"). Forward-looking state­ments in this press re­lease in­clude state­ments about, without lim­i­ta­tion, the ex­pected timing of the re­lease of fur­ther data on Trillium’s TTI-621 and TTI-622 stud­ies, and timing of ex­pected max­i­mum tol­er­ated doses or rec­om­mended phase 2 doses. With respect to the for­ward-looking state­ments con­tained in this press re­lease, Trillium has made nu­mer­ous assump­tions re­gard­ing, among other things: the im­pact of the Covid-19 pan­dem­ic on its op­er­a­tions, the ef­fec­tiveness and timeliness of pre­clin­i­cal and clin­i­cal trials; and the com­pleteness, accuracy and usefulness of the data. While Trillium con­siders these assump­tions to be reason­able, these assump­tions are in­her­ently subject to sig­nif­i­cant sci­en­tif­ic, business, eco­nom­ic, competitive, mar­ket and social un­cer­tainties and contingencies. Addi­tionally, there are known and un­known risk factors that could cause Trillium's actual re­­sults, per­for­mance or achieve­ments to be ma­teri­ally dif­fer­en­t from any future re­­sults, per­for­mance or achieve­ments ex­pressed or im­plied by the for­ward-looking state­ments con­tained in this press re­lease. A dis­cus­sion of risks and un­cer­tainties facing Trillium appears in Trillium's Annual In­for­ma­tion Form for the year ended De­cem­ber 31, 2019 filed with Canadian se­cu­ri­ties author­i­ties and on Form 40-F with the U.S. Se­cu­ri­ties Ex­change Com­mis­sion, each as up­dated by Trillium's con­tin­uous disclosure filings, which are avail­able at www.sedar.com and at www.sec.gov. All for­ward-looking state­ments herein are qualified in their entirety by this cautionary state­ment, and Trillium disclaims any obli­ga­tion to revise or up­date any such for­ward-looking state­ments or to pub­licly an­nounce the re­­sult of any revisions to any of the for­ward-looking state­ments con­tained herein to reflect future re­­sults, events or de­vel­op­ments, except as re­quired by law.

Source: Trillium Thera­peutics.