Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a
clinical stage immuno-oncology company developing innovative
therapies for the treatment of cancer, today announced that it will
be providing updates on its two clinical trials with TTI-621, a
dual function SIRPaFc IgG1 decoy receptor that targets CD47, at two
upcoming scientific conferences. As previously announced, the
presentations will be made on September 28 at the European
Organisation for Research and Treatment of Cancer, Cutaneous
Lymphoma Task Force (EORTC CLTF) meeting in St. Gallen, Switzerland
and the 16th Annual Discovery on Target conference in Boston, MA.
The presentations will be available on the Company’s website after
the presentations have been delivered.
The presentation at the EORTC CLTF meeting will
provide an update on the safety and efficacy of the ongoing
multicenter, open-label phase 1 intratumoral trial of TTI-621 in 23
patients with relapsed/refractory mycosis fungoides/Sézary
syndrome, 20 of whom only received induction therapy consisting of
1-6 injections over 2 weeks. Local delivery of TTI-621 was well
tolerated, with no treatment-related > Grade 3 adverse events or
dose-limiting toxicity observed. Reductions in CAILS scores, which
measure local lesion responses, were observed in 89% of patients,
with 42% exhibiting reductions of 50% or greater. These responses
occurred rapidly within the 2-week induction period. Similar CAILS
scores changes were seen in adjacent non-injected lesions,
suggesting locoregional effects that were not confined to the site
of injection. Evidence of a systemic (abscopal) effect was observed
in 1 of 2 patients receiving continuation monotherapy beyond the
2-week induction therapy. In addition, data suggest a combination
effect with pegylated IFN-alpha-2a.
“These data expand on the observations first
presented at ASH 2017, and highlight the potential value of
localized delivery of TTI-621 in heavily pre-treated mycosis
fungoides/ Sézary syndrome patients,” said Dr. Yaping Shou,
Trillium’s Chief Medical Officer. “We are particularly encouraged
to see reductions in CAILS scores after such a short course of
therapy, and the abscopal effect seen in one of the two patients
receiving continuation treatment suggest that a longer duration of
dosing may offer further opportunity to induce systemic
responses.”
“The ability to induce rapid anti-tumor
responses through local administration with our potent
IgG1-containing Fc fusion protein opens up numerous possibilities,
not only in mycosis fungoides but also in many solid tumors. As is
the case with other agents targeting the innate immune system, such
as STING and TLR agonists, local administration is the route of
choice to ensure instant high local drug concentrations at the site
of the tumor,” said Dr. Niclas Stiernholm, Trillium’s President and
Chief Executive Officer. “We intend to expand the intratumoral
program both with respect to additional indications and combination
therapies with complementary immunostimulatory therapies,
especially those acting downstream of CD47.”
The presentation at the Discovery on Target
conference will provide a high level update of the safety and
efficacy of the ongoing multicenter, open-label phase 1a/b
intravenous trial of TTI-621 in patients with relapsed/refractory
hematologic malignancies. Based on an expanded data set of 163
patients, weekly infusions of TTI-621 were shown to be well
tolerated. Thrombocytopenia was the most frequent grade 3 or higher
treatment-emergent adverse event, occurring in 20% of patients.
Platelet reductions, however, were shown to be transient and
pre-dose platelet levels remained steady during the course of the
study. Notably, the reversible thrombocytopenia did not lead to an
increased risk of bleeding and had no impact on drug delivery, nor
was there a significant impact of TTI-621 on hemoglobin levels.
Monotherapy efficacy was observed in patients with mycosis
fungoides (19% ORR, n=21), peripheral T-cell lymphoma, or PTCL (25%
ORR, n=12), and diffuse large B-cell lymphoma, or DLBCL (25% ORR,
n=8), and in DLBCL patients when combined with rituximab (25% ORR,
n=24). This clinical activity was observed in patients receiving
relatively low doses of drug (0.2 mg/kg for monotherapy or 0.1
mg/kg in combination with rituximab). Dose intensification beyond
0.2 mg/kg is currently ongoing, and doses of 0.5 mg/kg have been
well tolerated for up to 27 weeks.
“These data reinforce our prior observations
that thrombocytopenia, which we believe to be an on-target
pharmacodynamic effect, does not appear to be clinically
consequential. Based on the data in hand, the transient decrease in
platelets is not associated with bleeding events or premature
treatment discontinuations, and has not impacted our ability to
dose intensify patients beyond 0.2 mg/kg,” commented Dr. Shou. “The
monotherapy anti-tumor activity we have observed in multiple
disease indications is particularly intriguing given that patients
have received relatively low doses of drug. Characterizing the
efficacy of TTI-621 at higher doses, which is currently ongoing,
remains a top priority in the intravenous trial.”
“Having concluded this exploratory phase in a
wide variety of hematologic malignancies and having gained
increased clarity with respect to potential registration paths, we
plan to move forward with three distinct clinical programs:
intratumoral mono- and combination-therapy in CTCL, intravenous
monotherapy in both CTCL and PTCL, as well as intravenous
combination therapy in DLBCL,” said Dr. Stiernholm. “While we are
gratified to have observed meaningful clinical responses with
monotherapy at low doses, we are equally excited about how well
tolerated TTI-621 appears to be, allowing us to incorporate dose
intensification as a major component of our clinical efforts moving
forward.”
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 “do not eat” signal that cancer cells frequently use to
evade the immune system. Trillium also has a proprietary
fluorine-based medicinal chemistry platform that is being used to
develop novel compounds directed at undisclosed immuno-oncology
targets.
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, our development plan
(including our proposed clinical trial program), and our belief
that the observed thrombocytopenia is not clinically
significant. 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; 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. Known risk factors include, among
others: positive preliminary results from early-stage clinical
trials may not be indicative of the final results from the trial or
be indicative of favorable outcomes in later-stage clinical trials
and data are subject to audit for inclusion in the final clinical
trial database; clinical data may not demonstrate adequate efficacy
and safety to result in regulatory approval to market any of our
product candidates in any jurisdiction; given the early stage of
Trillium’s product development, there can be no assurance that its
research and development programs will result in regulatory
approval or commercially viable products and that Trillium can
adequately demonstrate TTI-621’s individual contribution in a
combination therapy; 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; 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 discussion
of risks and uncertainties facing Trillium appears in Trillium's
Annual Information Form for the year ended December 31, 2017 filed
with Canadian securities authorities and available at www.sedar.com
and on Form 40-F with the U.S. Securities Exchange Commission and
available at www.sec.gov, 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.
Contact:James ParsonsChief
Financial OfficerTrillium Therapeutics Inc. 416-595-0627
x232james@trilliumtherapeutics.com www.trilliumtherapeutics.com
Investor and Media
Relations:Jessica Tieszen Canale Communications for
Trillium Therapeutics 619-849-5385jessica@canalecomm.com
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