Harpoon Therapeutics Announces Updated Interim Tolerability and Response Data from Phase 1/2 Clinical Trial of T Cell Engager HPN328 at ESMO Congress 2023
22 10월 2023 - 12:31AM
Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage
immunotherapy company developing novel T cell engagers, today
announced the updated interim monotherapy data from its Phase 1/2
clinical trial evaluating HPN328 in small cell lung cancer (SCLC)
and other neuroendocrine tumor types in a poster at the European
Society of Medical Oncology Congress (ESMO) 2023. HPN328 targets
delta-like ligand 3 (DLL3) and is derived from Harpoon’s
proprietary Tri-specific T cell Activating Construct (TriTAC®)
platform designed to recruit a patient’s own immune cells to kill
tumor cells.
HPN328 was generally well tolerated across all dose cohorts
(N=71). Treatment-related adverse events (TRAEs) occurred in 67
patients (94%), and Grade ≥ 3 TRAEs in 18 patients (25%). CRS was
most common (59%) and was primarily Grade 1 or 2. No dose limiting
toxicities (DLT) occurred at target doses, and the target maximum
tolerated dose (MTD) has not been reached as of the data cut off on
September 12, 2023.
The preliminary response data for evaluable patients treated in
1 mg priming dose cohorts showed confirmed response rate of 35%
(11/31) across all tumor types. In SCLC, the confirmed response
rate was 32% (6/19) with one confirmed complete response. In
patients with other neuroendocrine tumor types, such as prostate
cancer, small cell cervical, small cell bladder, and large cell
lung cancer, 42% (5/12) confirmed response rate was observed,
including two confirmed complete responses in small cell bladder
and small cell cervical tumor types. The duration of response data
in the 1 mg priming dose cohorts continues to mature.
“HPN328’s antitumor activity and tolerability profile are
promising given the aggressive nature of SCLC and other
neuroendocrine tumor types included in the study. The preliminary
response data from the 1 mg priming dose cohorts suggests HPN328’s
activity in a broad spectrum of tumor types with similar
histology,” said Noura Choudhury, M.D., of Memorial Sloan Kettering
Cancer Center, Principal Investigator in this study. “I look
forward to continuing to study this promising candidate to
potentially improve outcomes for patients with very limited
treatment options and aggressive cancers.”
“The interim data provides a solid foundation for the next steps
in our future clinical development plans for HPN328, underscoring
its potential to serve patients with high unmet medical needs. It
enables us to rapidly move towards identifying the recommended
Phase 2 regimen(s) in the monotherapy setting by the end of this
year and supports the initiation of potential registrational
studies in multiple tumor types in 2024,” said Luke Walker, M.D.,
Chief Medical Officer of Harpoon Therapeutics.
The poster (presentation #698P) is now available on the ESMO
website and under the Publications section on Harpoon’s
website.
Webcast Registration InformationThe live
webcast will take place on Monday, October 23, 2023, from 8:00 a.m.
to 9:00 a.m. ET / 2:00 p.m. to 3:00 p.m. CEST. To register for the
event, please click here. A replay of the webcast will be available
shortly after the live event and can be accessed at the same
weblink.
About HPN328HPN328 targets delta-like canonical
Notch ligand 3 (DLL3) 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. HPN328 is being evaluated as monotherapy in an ongoing
open-label, multicenter two-part study to assess the safety,
tolerability, and pharmacokinetics in patients with advanced
cancers associated with expression of DLL3.
In March 2022, the U.S. Food and Drug Administration (FDA)
granted Orphan Drug Designation to HPN328 for the treatment of
SCLC.
About Harpoon Therapeutics Harpoon
Therapeutics is a clinical-stage immunotherapy 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
“continue,” “look forward,” “move towards,” “potential,” “suggest,”
“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, the association of interim clinical
data and preclinical results with potential treatment outcomes 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, 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 June 30,
2023, 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.
Contact:Ana KaporHarpoon
Therapeuticsakapor@harpoontx.com
Harpoon Therapeutics (NASDAQ:HARP)
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