Trillium Therapeutics Announces Dosing of First Patient in Phase 1b/2 Study of TTI-622 in Combination With Azacitidine in TP53-Mutated Acute Myeloid Leukemia

Rhea-AI Summary

Trillium Therapeutics (NASDAQ/TSX: TRIL) has initiated dosing of its first TP53-mutated acute myeloid leukemia (AML) patient with TTI-622, an investigational checkpoint inhibitor. This treatment is combined with azacitidine and aims to improve patient outcomes in a group with limited therapeutic options. The Phase 1b/2 study will enroll 25 patients to assess safety and response rates. Trillium continues to expand its clinical programs targeting CD47, enhancing its solid foundation with a robust cash position, and is expected to release significant data over the coming years.

Positive

• Dosing of the first TP53-mutated AML patient with TTI-622 marks a significant milestone.
• Combination therapy shows potential to improve outcomes for AML patients with limited options.
• Company has a robust cash position and is executing on its Phase 1b/2 program.

Negative

• There are inherent risks and uncertainties in clinical trials, which could affect results.

CAMBRIDGE, Mass., Aug. 09, 2021 (GLOBE NEWSWIRE) -- Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, today announced that it has dosed the first TP53-mutated acute myeloid leukemia (AML) patient with TTI-622 (SIRPα-IgG4 Fc), an investigational checkpoint inhibitor of the innate immune system, in combination with azacitidine.

TTI-622 is a fusion protein that is designed to block the inhibitory activity of CD47, a molecule that is overexpressed by a wide variety of tumors. CD47 binds to SIRPα on macrophages and delivers a “don’t eat me” signal that inhibits the ability of macrophages to engulf and destroy cancer cells. Preclinical studies have shown that TTI-622 exhibits anti-tumor activity against AML cells as a monotherapy that is enhanced when combined with azacitidine.

“The dosing of this patient marks the third combination cohort that has been initiated with TTI-622,” commented Dr. Ingmar Bruns, Trillium’s Chief Medical Officer. “This is our second study in AML and demonstrates our commitment to these patients.”

The combination of TTI-622 and azacitidine is being assessed as part of the ongoing, open-label study (NCT03530683). Approximately 25 patients with newly diagnosed TP53-mutated AML will be enrolled. The primary endpoints are safety and complete response rate.

“There are very few therapeutic options for TP53-mutated AML patients, and their prognosis is poor,” added Dr. Bruns. “We believe TTI-622 added to standard-of-care azacitidine has the potential to improve patient outcomes.”

Trillium continues to build on its robust foundation and strong cash position and is now executing on its ambitious Phase 1b/2 program, in multiple patient settings across hematologic and solid tumor cancers. The company looks forward to generating a strong flow of data over the next couple of years.

About Trillium Therapeutics
Trillium is an immuno-oncology company developing innovative therapies for the treatment of cancer. The company’s two clinical programs, TTI-622 and TTI-621, 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 the Private Securities Litigation Reform Act of 1995 and applicable United States federal securities laws and forward-looking information within the meaning of Canadian securities laws (collectively, "forward-looking statements"). The use of words such as "may," "will," "could", "should," "expects," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "seeks," "endeavor," "potential," "continue" or the negative of such words or other similar expressions can be used to identify forward-looking statements. Forward-looking statements in this press release include express or implied statements regarding the therapeutic potential and monotherapy activity of our programs, including the potential for TTI-622 in combination with azacitidine to have a significant impact on the treatment of acute myeloid leukemia, our clinical development plans, including the expected timing of the release of further data on Trillium’s TTI-622 and TTI-621 studies, and our expectations with respect to the timing of clinical development milestones, including with respect to enrolling patients in Phase 1b/2 studies in hematological and solid tumor malignancies, and our expected cash runway. 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 Report on Form 10-K for the year ended December 31, 2020, 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.

Company Contact:
Rosemary Harrison
SVP, Corporate Development and Strategy
Trillium Therapeutics Inc.
857-412-7029 x225
investors@trilliumtherapeutics.com
www.trilliumtherapeutics.com

Media Relations:
Mike Beyer
Sam Brown Inc.
312-961-2502
mikebeyer@sambrown.com

FAQ

What is Trillium Therapeutics' latest achievement with TTI-622?

Trillium has dosed the first patient with TP53-mutated AML using TTI-622 in combination with azacitidine.

What is the study design for TTI-622 in AML?

The ongoing study (NCT03530683) will enroll approximately 25 newly diagnosed TP53-mutated AML patients to assess safety and complete response rates.

What is the significance of TTI-622's combination with azacitidine?

The combination is designed to enhance anti-tumor activity for patients who currently have few treatment options.

What are the primary endpoints of the clinical study for TTI-622?

The primary endpoints are safety and complete response rates in the treatment of TP53-mutated AML.

What are the future expectations for Trillium Therapeutics?

Trillium anticipates a strong flow of clinical data over the next couple of years as it continues its Phase 1b/2 program.