Trillium Therapeutics Inc.
(“Trillium”
or the
“Company”)
(NASDAQ/TSX: TRIL), a clinical stage
immuno-oncology company developing innovative therapies for the
treatment of cancer, recently presented at the American Society of
Hematology (ASH) Annual Meeting, taking place virtually from
December 5-8, 2020, and provides guidance for 2021.
“Our presentations at ASH, as of a data cutoff
of November 3, build upon our last corporate update from September
8,” said Jan Skvarka, President and CEO of Trillium Therapeutics.
“We presented data where TTI-622 continued to demonstrate a strong
safety profile, as well as further dose-dependent improvements in
receptor occupancy and PK data. We completed a safety evaluation of
the 12 mg/kg dose level, with results indicating no observed
dose-limiting toxicity or other major safety concerns, and we
escalated dosing to 18 mg/kg. As of the November 3 cutoff, one
patient at the 12 mg/kg dose level achieved a stable disease
assessment and continued on therapy. TTI-621 continued dosing at 2
mg/kg. We are looking forward to further progress in 2021, moving
to combination studies in heme malignancies and solid tumors, and
building on a foundation of demonstrated monotherapy activity of
our molecules.”
The posters and oral presentation described
below were presented at ASH:
TTI-622:
Poster Presentation, Publication
Number 1191Investigational CD47-Blocker
TTI-622 Shows Single-Agent Activity in Patients with Advanced
Relapsed or Refractory Lymphoma: Update from the Ongoing
First-in-Human Dose Escalation StudyPresenter: Krish Patel, M.D.,
Center for Blood Disorders and Stem Cell Transplantation, Swedish
Cancer Institute, Seattle, WASession: 626. Aggressive Lymphoma
(Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin
Lymphomas)-Results from Prospective Clinical Trials: Poster I
This poster presentation provided a further
update on the safety and anti-tumor activity observed in the
ongoing open-label Phase 1 dose escalation study of TTI-622 in
patients with relapsed or refractory lymphoma (NCT03530683). As of
the data cutoff date of November 3, a total of 31 patients had been
enrolled in the first seven cohorts, receiving weekly intravenous
doses between 0.05-12 mg/kg. All dose levels were well tolerated
and a maximum tolerated dose (MTD) was not reached. Adverse events
(AEs) were predominantly Grade 1-2; related AEs ≥Grade 3 were
neutropenia (13%), thrombocytopenia (3%) and anemia (3%).
Dose-dependent increases in TTI-622 serum exposure supported
continued dose escalation beyond 12 mg/kg, and dose-dependent
increases in receptor occupancy (RO) durability were observed.
Objective responses were achieved in 6 of 22 (27%)
response-evaluable patients, with an overall response rate (ORR) of
35% (6/17) among response-evaluable patients at dose levels ≥0.8
mg/kg. All responses occurred within the first eight weeks of
treatment across multiple lymphoma indications, and included one
complete response (CR) and five partial responses. The CR patient
treatment was ongoing at 534 days and showed evidence of expansion
of new and existing T-cell clones. The study is currently dosing at
18 mg/kg.
TTI-621: Oral Presentation,
Publication Number 646Updates
from Ongoing, First-in-Human Phase 1 Dose Escalation and Expansion
Study of TTI-621, a Novel Biologic Targeting CD47, in Patients with
Relapsed or Refractory Hematologic MalignanciesPresenter: Steven M.
Horwitz, M.D., Department of Medicine, Lymphoma Service, Memorial
Sloan Kettering Cancer Center, New York, NYSession: 624. Hodgkin
Lymphoma and T/NK Cell Lymphoma—Clinical Studies: Immunotherapy in
T/NK Cell Lymphoma
This oral presentation provided a further update
on the safety and anti-tumor activity observed in the ongoing
open-label Phase 1 dose escalation study of intravenous TTI-621 in
patients with relapsed or refractory hematologic malignancies
(NCT02663518). The study consists of four parts: (a) “Parts 1-3” in
hematologic malignancies, with dosing up to 0.5 mg/kg, conducted
under initial dose-limiting toxicity (DLT) criteria, now complete;
and (b) “Part 4” in cutaneous T-cell lymphoma (CTCL), utilizing
revised DLT criteria for thrombocytopenia and an amended protocol
to allow for dosing above 0.5 mg/kg, currently ongoing. In Part 4,
17 CTCL patients, including two at the 2 mg/kg dose level,
completed DLT evaluation as of the November 3, 2020 data cutoff.
TTI-621 was well tolerated and an MTD in Part 4 was not reached.
Across Parts 1-4, the most common treatment-related AEs were
infusion-related reactions (44%) and thrombocytopenia (30%), which
was transient and not dose-limiting. Monotherapy activity was
observed in CTCL (17% ORR), peripheral T-cell lymphoma (18% ORR)
and diffuse large B-cell lymphoma (29% ORR). The majority of these
patients received doses of 0.5 mg/kg or lower; a dose-efficacy
relationship in Part 4 was difficult to ascertain due to the small
sample sizes. Dose-dependent increases in drug exposure and RO of
40-65% at doses 0.5-1.4 mg/kg were observed. Evidence of changes in
both innate and adaptive immune cells was apparent in a responding
CTCL patient. The study is currently enrolling at the 2 mg/kg dose
level.
The posters are available in the Events &
Presentations section of the Company’s website, and an updated
corporate presentation can also be found on the Company’s website
at www.trilliumtherapeutics.com.
2021 Guidance
Around the end of Q1 2021, Trillium plans to
hold an R&D Day, in which the Company will:
- Provide data updates on TTI-622 and
TTI-621
- Declare TTI-622 and TTI-621
priorities
- Announce disease indication,
patient setting and drug combination priorities
- Outline high-level clinical
development plans
Furthermore, Trillium anticipates initiating the
following studies in 2021:
- 2-3 proof of concept studies in
heme malignancies in combinations with other agents, and
- Signal-seeking solid tumor study in
a variety of indications and drug combinations
Trillium will host a conference call on Monday,
December 7, 2020 at 4:30PM EST to discuss the clinical update. The
conference call may be accessed by telephone or webcast as
described below.
International Dial-In Number: +1
236-389-2162Conference ID: 3169183Webcast
link:https://event.on24.com/wcc/r/2862177/A91BDB88D738527918C13E289B26CED7
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
InformationThis 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, our planned R&D
Day updates and priorities, our expectation of initiating new
combination studies in heme and solid tumor malignancies in 2021
and our expectations regarding our product candidates. 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,
including, among others, that preliminary data from a clinical
trial may not be indicative of final trial results; that clinical
trial results may not be favorable; and uncertainties inherent in
the product development process (including with respect to the
timing of results and whether such results will be predictive of
future results). 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 BeyerSam
Brown Inc.312-961-2502mikebeyer@sambrown.com
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