| FOR IMMEDIATE RELEASE | NASDAQ:TRIL |
| TSX: TRIL |
TRILLIUM THERAPEUTICS OUTLINES ANTICIPATED ACTIVITIES AND
MILESTONES FOR 2017
-
Advancing the two ongoing clinical trials with TTI-621, an IgG1 SIRPaFc fusion protein targeting CD47; updated data anticipated in 2H/2017
-
Expanding the CD47 franchise with TTI-622, an IgG4 SIRPaFc fusion protein with IND submission planned by end of year; targeting combination therapies
-
Reporting preclinical data throughout the year at various international scientific conferences
-
Executing plans for small molecule pipeline and commencing IO discovery program
TORONTO, Feb. 2, 2017 – Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical-stage immuno-oncology company developing innovative therapies for the treatment of cancer, today outlined its expected 2017 activities and milestones.
Phase 1 trials of TTI-621:
During the year, Trillium
expects to make progress in the Phase 1b TTI-621-01 study (NCT02663518) of its
anti-CD47 checkpoint inhibitor TTI-621 (SIRPaFc), which is designed to evaluate
safety, pharmacokinetics and preliminary anti-tumor activity across a broad
range of hematologic malignancies. One cohort of lymphoma patients is receiving
TTI-621 in combination with rituximab, and the company will consider additional
combination cohorts based on emerging preclinical data. Furthermore, given the
good safety profile of the agent, further dose intensification is planned with
the goal of achieving increased blockade of CD47.
In a second Phase 1 trial, TTI-621-02 (NCT02890368), patients with percutaneously accessible solid tumors are receiving intratumoral injections of TTI-621 with the goal of achieving a high level of localized CD47 blockade. The company expects to complete the dose escalation phase, and potentially begin an expansion phase in 2017. This trial provides a unique opportunity to closely characterize local anti-tumor immune responses and to assess the impact of TTI-621 treatment on the tumor microenvironment. Combination cohorts are also under consideration for this trial.
“We are aggressively advancing the TTI-621 clinical program through multiple efforts. After completing the phase 1a dose escalation trial in patients with lymphoma, where we observed preliminary evidence of anti-tumor activity at well-tolerated doses, we finished the year with robust enrollment in the 10-cohort expansion phase and recruitment continues to progress well. As our data mature, we intend to explore the addition of other cohorts to this trial. The TTI-621-02 solid tumor trial has enrolled its first patient and we expect this study to provide key scientific data for charting the course of our clinical development program, especially as it relates to combination therapies,” said Dr. Niclas Stiernholm, Trillium’s Chief Executive Officer. “In TTI-621 we believe that we have a potent CD47-targeting agent, and we aim to identify cancers that depend upon the CD47 ‘do not eat’ signal to evade the immune system.”
Trillium intends to provide an update on both ongoing TTI-621 trials by year-end. There may be additional opportunities to report on individual cohorts in both trials throughout the year.
Expanding the CD47 Franchise with TTI-622:
In 2017,
Trillium is also planning to advance its second SIRPaFc fusion protein, TTI-622,
into clinical testing. TTI-622 contains an IgG4 Fc region and is thus
anticipated to have a different pharmacologic profile and enable greater
exposures in patients than TTI-621 (IgG1 Fc). Like TTI-621, TTI-622 does not
bind erythrocytes, and the company believes that this property could give
TTI-622 best-in-class status among IgG4-based CD47 blocking agents currently in
development. The company plans to submit an IND by the end of 2017 and begin
enrolling patients in early 2018, with the goal of rapidly advancing this agent
into combination studies.
“With the introduction of TTI-622, we are specifically targeting opportunities for drug combinations that are complementary to TTI-621. Our two SIRPaFc fusion proteins allow us to block CD47 and achieve different levels of Fc receptor engagement on macrophages, which we believe represents a diversified approach to targeting the CD47 axis in the treatment of cancer,” said Dr. Bob Uger, Trillium’s Chief Scientific Officer. “CD47 is in its infancy as a therapeutic cancer target and we have chosen to apply a broad, science-driven investigative approach to maximize our chances of defining patient populations that will derive clinical benefit from TTI-621 or TTI-622 therapy.”
Additional Preclinical Data and Small Molecule Pipeline:
In 2017 Trillium intends to continue investigating SIRPaFc in relevant
preclinical models, focusing on combination strategies and mechanism of action
studies. The company expects to report data at the 2017 American Association for
Cancer Research (AACR) annual meeting in Washington D.C., as well as at other
international scientific conferences throughout the year.
-2-
The company is actively investigating the competitive advantages and positioning of its orally available small molecule bromodomain and EGFR inhibitor programs and expects to provide guidance on the next steps in the first half of 2017. In addition, Trillium recently launched a discovery program against an undisclosed immuno-oncology target using its proprietary fluorine-based chemistry platform.
Trillium’s cash balance at the end of 2016 was approximately $50 million. A major component of the company’s business strategy continues to be a focus on evaluating potential partnering opportunities across all programs, which may help fund future growth.
The company also announced that its ticker symbol on the Toronto Stock Exchange changed to “TRIL” effective Feb. 1, 2017.
About Trillium Therapeutics:
Trillium Therapeutics
Inc. is a clinical stage immuno-oncology company developing innovative therapies
for the treatment of cancer. The company’s lead program, SIRPaFc (TTI-621), is a
fusion protein that consists of the CD47-binding domain of human SIRPa linked to
the Fc region of a human immunoglobulin (IgG1). It is designed to act as a
soluble decoy receptor, preventing CD47 from delivering its inhibitory (“do not
eat”) signal. Neutralization of the inhibitory CD47 signal enables the
activation of macrophage anti-tumor effects by pro-phagocytic (“eat”) signals. A
Phase 1 clinical trial (NCT02663518) evaluating SIRPaFc is ongoing in
advanced hematologic malignancies, and a second Phase 1 trial is underway in
solid tumors (NCT02890368). TTI-622 is an IgG4 SIRPaFc protein being developed
for combination therapy with an IND filing expected in H217. Trillium also has a
proprietary medicinal chemistry platform, using unique fluorine chemistry, which
permits the creation of new chemical entities from validated drugs and drug
candidates with improved pharmacological properties. Stemming from this
platform, the company’s most advanced preclinical program is an orally available
bromodomain inhibitor, followed by an epidermal growth factor receptor
antagonist with increased uptake in the brain. In addition, a number of
compounds directed at undisclosed immuno-oncology targets are currently in the
discovery phase.
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, Trillium's expectations about the progress
in 2017 of the Phase 1 trials, adding additional cohorts and further dose
intensification, the filing of an IND and initiation of a Phase 1 trial with
TTI-622, the potency and the potential safety profile of TTI-622, Trillium's
plans for developing TTI-622, plans to provide guidance and report preclinical
or clinical data on the programs, and Trillium’s unaudited year-end 2016 cash
balance. With respect to the forward-looking statements contained in this press
release, Trillium has made numerous assumptions regarding, among other things:
the effectiveness and timeliness of preclinical and clinical trials; the usefulness of the data; and the
stability of economic and market conditions. While Trillium considers these
assumptions to be reasonable, these assumptions are inherently subject to
significant 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. Known
risk factors include, among others: anticipated preclinical and clinical trials
may be more costly or take longer to complete than anticipated, and may never be
initiated or completed, or may not generate results that warrant future
development of the tested drug candidate; regulatory filings may take longer
than anticipated to prepare; Trillium may not receive the necessary regulatory
approvals for the clinical development of Trillium's products; economic and
market conditions may worsen; and market shifts may require a change in
strategic focus. A more complete discussion of the risks and uncertainties
facing Trillium appears in Trillium's Annual Report on Form 40-F and 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.
-3-
Neither TSX nor its Regulation Services Provider (as that term is defined in the policies of the TSX) accepts responsibility for the adequacy or accuracy of this release.
| Contact: |
| Trillium Therapeutics Inc. |
| James Parsons |
| Chief Financial Officer |
| +1 416 595 0627 x232 |
| james@trilliumtherapeutics.com |
| www.trilliumtherapeutics.com |
| Investor and Media Relations: |
| Mark Corbae |
| Canale Communications for Trillium Therapeutics |
| 619-849-5375 |
| mark@canalecommunications.com |
-4-