Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage
immuno-oncology company developing novel T cell engagers, today
presented updated interim data from its Phase 1 clinical trial
evaluating single-agent HPN217 in relapsed/refractory multiple
myeloma (RRMM) in a poster presentation at the 64th American
Society of Hematology (ASH) Annual Meeting and Exposition
being held in person and virtually in New Orleans. HPN217
targets B-cell maturation antigen (BCMA) and is based on Harpoon’s
proprietary Tri-specific T cell Activating Construct (TriTAC®)
platform designed to recruit a patient’s own immune cells to kill
tumor cells.
The interim results, as of the data cut-off date of October 17,
2022, showed that HPN217 demonstrated continued evidence of
clinical activity and a tolerable safety profile in heavily
pre-treated patients with RRMM (62 patients treated across fixed
dose and step dose regimens). HPN217 was active across a wide dose
range (2.15 to 24 mg), with 77% (10/13) ORR observed across the
highest step doses (12 and 24 mg). A majority of responders had
decreases in the serum BCMA biomarker (sBCMA, a marker correlated
with disease prognosis) by week two of treatment. Additionally, 86%
(18/21) of responders remain on study treatment with sustained
response, with many responders on treatment for over a year. Three
patients in the study were evaluated for minimal residual disease
(MRD), and all three were MRD negative (<10-5). sBCMA remained
undetectable at 9 months in many responders who achieved very good
partial response (VGPR) or better.
Low-grade CRS occurred in 29% of patients across the highest
step dose regimens (12% Grade 1 and 18% Grade 2) and was seen
primarily in the earliest doses. No Grade 3 or higher CRS or any
immune effector cell associated neurotoxicity syndrome (ICANS)
events have been observed.
“The encouraging initial clinical activity with deepening and
durable responses observed in patients who have received multiple
prior lines of therapy, combined with a generally well-tolerated
safety profile, suggest the investigational T cell engager HPN217
may offer meaningful clinical benefits for patients with
relapsed/refractory multiple myeloma,” said Al-Ola A. Abdallah,
M.D., of University of Kansas Medical Center, a Principal
Investigator in this study. “I look forward to continuing to study
this promising drug candidate in these patients with advanced
disease for whom there remains a significant unmet need for new
treatment options.”
“These data provide further validation of our proprietary TriTAC
T cell engager platform, demonstrating robust clinical activity for
HPN217 at higher doses, while maintaining tolerability in this
heavily refractory patient population,” said Luke Walker, M.D.,
Chief Medical Officer of Harpoon Therapeutics. “These data support
our continued clinical development efforts, and we look forward to
continuing dose optimization with ongoing patient enrollment in the
Phase 1 trial expected to reach completion in the first half of
2023.”
For more details about the ASH Annual Meeting, please visit:
https://www.hematology.org/meetings/annual-meeting
The poster (publication #3240) will be available on Harpoon’s
website following today’s presentation.
Conference Call and Webcast Details
Harpoon’s management will host a live call/webcast on Monday,
December 12, 2022, at 4:30 ET/3:30 CT/1:30 PT, to review the
interim results of its Phase 1 HPN217 clinical program and provide
an update on other pipeline programs. The live call may be accessed
by dialing 1-877-407-9039 for domestic callers and 1-201-689-8470
for international callers with conference ID code number 13734677.
A live webcast of the call will be available from the Events and
Presentations section of Harpoon’s website here and will be
archived there shortly after the live event.
About HPN217
HPN217 targets B-cell maturation antigen (BCMA) and is based on
Harpoon’s proprietary Tri-specific T cell Activating Construct
(TriTAC®) platform designed to recruit a patient’s own immune cells
to kill tumor cells.
In November 2019, Harpoon Therapeutics and AbbVie announced a
licensing agreement and option to advance HPN217 and expand an
existing discovery collaboration. Under the terms of the agreement,
AbbVie may exercise its option to license HPN217 after completion
of the Phase 1 clinical trial.
In March 2022, the FDA granted Fast Track designation to HPN217,
underscoring its potential to address a serious unmet medical need
for patients with relapsed, refractory multiple myeloma.
About the HPN217 Clinical Trial
HPN217 is being evaluated in an ongoing Phase 1, multicenter,
open-label dose escalation study designed to evaluate safety,
tolerability, pharmacokinetics (PK) and clinical activity in
patients with relapsed/refractory multiple myeloma who have had at
least three prior systemic treatments, including a proteasome
inhibitor, an immunomodulatory drug and an anti-CD38 antibody,
including patients with prior exposure to BCMA therapy. Primary
objectives are characterization of safety, tolerability, PK and
determination of the recommended Phase 2 dose.
As of the cutoff date on October 17, 2022, maximum tolerated
dose has not yet been reached in the step-dose regimen. Assessment
of the Q2 cohort dosing schedule is ongoing.
For additional information about the trial, please visit
www.clinicaltrials.gov using the identifier NCT04184050.
About Harpoon Therapeutics
Harpoon Therapeutics is a clinical-stage immuno-oncology
company developing a novel class of T cell engagers that harness
the power of the body’s immune system to treat patients suffering
from cancer and other diseases. T cell engagers are engineered
proteins that direct a patient’s own T cells to kill target cells
that express specific proteins, or antigens, carried by the target
cells. Using its proprietary Tri-specific T cell Activating
Construct (TriTAC®) platform, Harpoon is developing a pipeline of
novel TriTACs initially focused on the treatment of solid
tumors and hematologic malignancies. Harpoon has also developed a
proprietary ProTriTAC™ platform, which applies a prodrug
concept to its TriTAC platform to create a therapeutic T cell
engager that remains inactive until it reaches the tumor. Harpoon’s
third proprietary technology platform, extended release TriTAC-XR,
is designed to mitigate cytokine release syndrome. For additional
information about Harpoon Therapeutics, please visit
www.harpoontx.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Words such as “look forward,” “may,” “suggest,” “expect,”
“potential,” “continued,” “will,” and similar expressions (as well
as other words or expressions referencing future events, conditions
or circumstances) are intended to identify forward-looking
statements. These forward-looking statements are based on Harpoon
Therapeutics’ expectations and assumptions as of the date of this
press release. Each of these forward-looking statements involves
risks and uncertainties that could cause Harpoon Therapeutics’
clinical development programs, future results or performance to
differ significantly from those expressed or implied by the
forward-looking statements. Forward-looking statements contained in
this press release include, but are not limited to, statements
about the expected timing, progress, and results of Harpoon
Therapeutics’ clinical trials, including the anticipated timing of
patient enrollment in the HPN217 Phase 1 trial; the association of
interim clinical data and preclinical results with potential
treatment outcomes; the possibility and timing of AbbVie’s option
to license HPN217 and other statements that are not historical
fact. Many factors may cause differences between current
expectations and actual results, including unexpected safety or
efficacy data observed during clinical studies, preliminary data
and trends may not be predictive of future data or
results, may not demonstrate safety or efficacy or lead to
regulatory approval by the FDA or other regulatory agencies,
clinical trial site activation or enrollment rates that are lower
than expected, unanticipated or greater than anticipated impacts or
delays due to COVID-19, changes in expected or existing
competition, changes in the regulatory environment, the
uncertainties and timing of the regulatory approval process, the
timing and results of unexpected litigation or other disputes, and
the sufficiency of Harpoon Therapeutics’ cash resources. These and
other factors that may cause Harpoon Therapeutics’ actual results
to differ from those expressed or implied in the forward-looking
statements in this press release are discussed in Harpoon
Therapeutics’ filings with the U.S. Securities and Exchange
Commission, including under “Risk Factors” in Harpoon Therapeutics’
quarterly report on Form 10-Q for the quarter ended September 30,
2022, and future filings by Harpoon Therapeutics. Except
as required by law, Harpoon Therapeutics assumes no
obligation to update any forward-looking statements contained
herein to reflect any change in expectations, even as new
information becomes available.
Contacts:
Investors:ICR WestwickeRobert H. UhlManaging
Director858-356-5932 robert.uhl@westwicke.com
Media:Uncapped
Communications512-825-2603monique.greer@uncappedcommunications.com
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