Trillium Therapeutics Announces Updated Data From Its Ongoing TTI-622 and TTI-621 Dose Escalation Studies
September 08 2020 - 4:05PM
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.
Investor Relations:James
ParsonsChief Financial OfficerTrillium Therapeutics Inc.
416-595-0627 x232james@trilliumtherapeutics.com
www.trilliumtherapeutics.com
Media Relations:Mike Beyer Sam
Brown Inc. 312-961-2502mikebeyer@sambrown.com
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