Unum Therapeutics Announces Strategic Focus on Developing Best-in-Class Cellular Therapies for Solid Tumor Cancers
November 04 2019 - 4:00PM
Unum Therapeutics Inc. (NASDAQ: UMRX), a clinical-stage
biopharmaceutical company focused on developing curative cell
therapies for cancer, today announced a strategic shift to focus
development on its ACTR and BOXR product candidates in solid tumors
and supportive platform capabilities.
“We are uniquely positioned to address the
challenge of treating solid tumor cancers, and now is the time to
focus our efforts, having recently validated our ACTR technology in
the hematologic setting and with preclinical data emerging from
BOXR1030, the first product candidate from our BOXR platform. Our
ACTR technology enables selective T cell targeting for on-tumor
attack, while our BOXR platform makes it possible to overcome solid
tumor immunosuppression, the fundamental challenge that has limited
the effectiveness of cell therapies,” said Chuck Wilson Ph.D.,
President and Chief Executive Officer of Unum. “Our priorities in
solid tumors include completing the ongoing Phase 1 trial of
ACTR707 in HER2+ cancers; advancing BOXR1030 towards the clinic
with an anticipated IND filing in 2020; and expanding our BOXR
platform to accelerate discovery of new product candidates across a
broad range of immune cell therapies, including both autologous and
allogeneic approaches.”
ACTR707 was engineered for properties that
optimize its function in solid tumors including increased
proliferation, cytokine secretion, and persistence. With Unum’s
focus on developing therapies for solid tumors, the company will
de-prioritize investment in its hematologic programs. Testing
through the first four dose levels in the ongoing ATTCK-20-03 Phase
1 trial in non-Hodgkin lymphoma has now established
proof-of-concept for ACTR707. Given favorable tolerability to date
at relatively low doses, Unum is announcing today plans to continue
limited dose escalation to inform potential future development of
the program in 2020.
Separately, Unum and its partner, Seattle
Genetics, Inc., have suspended further dose-escalation of the
ATTCK-17-01 Phase 1 trial of ACTR087 with SEA-BCMA in multiple
myeloma pending a further review of this program. No dose-limiting
toxicities (DLTs) following ACTR087 administration were reported
and no severe adverse events of cytokine release syndrome (CRS) or
neurologic events have been observed to date.
Solid Tumor Program
Highlights
- Phase 1 ATTCK-34-01 Trial:
ACTR707 combined with trastuzumab to treat advanced HER2+ solid
tumor cancers. Five clinical sites are now activated to
support the Phase 1 trial that is currently enrolling patients.
Unum expects to report preliminary safety data from patients
treated in the first dose cohort of the trial by the end of this
year and to report safety and clinical response data from multiple
dose cohorts in 2020.
- BOXR1030: Incorporating the
GOT2 transgene and targeting GPC3+ solid tumor cancers.
Unum’s first product candidate selected from its Bolt-On Chimeric
Receptor (BOXR) platform, BOXR1030, continues to progress towards
first-in-human clinical trials. BOXR1030 expresses a glypican-3
(GPC3) targeted chimeric antigen receptor (CAR) and leverages the
“bolt-on” transgene glutamic-oxaloacetic transaminase 2 (GOT2) to
improve T cell function in the solid tumor microenvironment by
enhancing T cell metabolism. Preclinical studies have characterized
the mechanism of action of BOXR1030’s bolt-on transgene with
further details to be presented at the upcoming Society for
Immunotherapy of Cancer (SITC) conference during November 6-10,
2019. Based on recent progress, Unum now plans to file an
investigational new drug (IND) application for BOXR1030 in late
2020, enabling subsequent clinical testing in GPC3+
cancers.
- BOXR Platform
Expansion: Unum's BOXR platform was established over two
years ago with the aim of discovering novel transgenes that can be
co-expressed with chimeric-targeting receptors to improve the
function of T cells in the solid tumor microenvironment. As part of
its strategic shift to target solid tumors, Unum will be scaling up
its BOXR platform capabilities with the objectives of: (1)
expanding the scope of biological mechanisms and transgenes in its
proprietary BOXR library, (2) enabling BOXR bolt-on applications
for a broad range of immune cell therapies, including both
autologous and allogeneic approaches, and (3) advancing new BOXR
product candidates into the clinic.
Hematologic Program
Highlights
- Phase 1 ATTCK-20-03 trial:
ACTR707 combined with rituximab for relapsed/refractory non-Hodgkin
lymphoma. As a preliminary update provided today for the
six patients treated in Cohort 4 (80M ACTR707+ T cells), complete
response was achieved at the first response assessment in two of
six patients as of the October 2019 analysis, yielding a complete
response rate of 40% (eight of 20 patients) in Cohorts 1 through 4.
Of the eight complete responders, four remained in complete
response at six months of follow-up, two remain in complete
response but have not yet reached the six-month timepoint for
evaluation, and two progressed before the six-month timepoint. In
Cohorts 1 through 4, ACTR707 was well-tolerated in combination with
rituximab. No DLTs, no adverse events of CRS, and no severe
neurological adverse events including neurotoxicity have been
reported as of the October 2019 cutoff. Further results will be
presented at the American Society for Hematology (ASH) Annual
Meeting during December 7-10, 2019. Unum plans to enroll up to two
additional cohorts (three to four patients per cohort) in the
trial, escalating the maximum dose up to 180M ACTR707+ T cells.
With patient screening and planned dosing underway, Unum
plans to report preliminary results from this dose escalation
during 2020. The ability to differentiate on both efficacy and
safety relative to currently available therapies and those in
development from these additional cohorts will drive a decision
during 2020 whether to advance the program into an expanded dose
cohort and potential pivotal studies.
- Phase 1 ATTCK-17-01 trial:
ACTR087 combined with SEA-BCMA for relapsed/refractory multiple
myeloma. Two additional cohorts of patients have been
treated in the Phase 1 trial in 2019, escalating doses of the
SEA-BCMA antibody to 2.0 mg/kg and of the ACTR087+ T cells to 50M.
Unum and Seattle Genetics have suspended further dose-escalation of
the trial and are reviewing the next steps with this program.
Investor Call and Webcast
Information
Unum will host a live conference call and
webcast today, November 4, 2019, at 4:30 p.m. ET, to discuss these
company updates. To access the call, please dial 866-300-3411
(domestic) or 636-812-6658 (international) and refer to conference
ID number 2177408. A webcast will be available at unumrx.com at
least 10 minutes before the event begins. The archived webcast will
be available at the same location approximately two hours after the
event and will be archived for 90 days.
About Unum Therapeutics
Unum Therapeutics is a clinical-stage
biopharmaceutical company focused on developing curative cell
therapies to treat a broad range of cancer patients. Unum’s novel
proprietary technologies include Antibody-Coupled T cell Receptor
(ACTR), an autologous engineered T-cell therapy that combines the
cell-killing ability of T cells and the tumor-targeting ability of
co-administered antibodies to exert potent antitumor immune
responses, and Bolt-On Chimeric Receptor (BOXR), designed to
improve the functionality of engineered T cells by incorporating a
“bolt-on” transgene to overcome resistance of the solid tumor
microenvironment to T cell attack. Unum has multiple programs in
Phase 1 clinical testing and preclinical testing, including;
ACTR707 used in combination with trastuzumab in adult patients with
HER2+ advanced cancer and used in combination with rituximab in
adult patients with r/r NHL; and BOXR1030 expressing the GOT2
transgene and targeting GPC3+ solid tumor cancers. The Company is
headquartered in Cambridge, MA.
Follow Unum Therapeutics on social media:
@UnumRx, and LinkedIn.
Forward looking Statements
This press release contains forward-looking
statements including, without limitation, statements regarding our
future expectations, plans and prospects, including projections
regarding future revenues and financial performance, our long-term
growth, enrollment and results for our preclinical and clinical
activities, the development of our product candidates, including
the ACTR product candidates and the BOXR platform and product
candidates, our plans for the ATTCK-17-01 Phase 1 trial, and the
anticipated timing and success of any of our preclinical studies,
clinical trials and regulatory filings, as well as other statements
containing the words "anticipate," "believe," "continue," "could,"
"estimate," "expect," "intend," "may," "might," "plan,"
"potential," "predict," "project," "should," "target," "will," or
"would" and similar expressions, constitute forward-looking
statements within the meaning of the safe harbor provisions of The
Private Securities Litigation Reform Act of 1995, as amended. We
may not actually achieve the forecasts disclosed in our
forward-looking statements, and you should not place undue reliance
on our forward-looking statements. Actual results could differ
materially from the projections disclosed in the forward-looking
statements we make as a result of a variety of risks and
uncertainties, including risks related to the accuracy of our
estimates regarding expenses, future revenues, capital
requirements, and the need for additional financing, the success,
cost and timing of our product development activities and clinical
trials, our ability to obtain and maintain regulatory approval for
our product candidates, and the other risks and uncertainties
described in the "Risk Factors" sections of our public filings with
the Securities and Exchange Commission. In addition, the
forward-looking statements included in this press release represent
our views as of the date hereof. We anticipate that subsequent
events and developments may cause our views to change. However,
while we may elect to update these forward-looking statements at
some point in the future, we specifically disclaim any obligation
to do so. These forward-looking statements should not be relied
upon as representing our views as of any date subsequent to the
date hereof.
Investor Contact: Stern Investor Relations, Inc. Stephanie
Ascher, 212-362-1200 stephanie@sternir.com
Media Contact:Lissette Steele,
202-930-4762lsteele@vergescientific.com
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