Harpoon Therapeutics Presents HPN217 Phase 1 Clinical Data in Relapsed/Refractory Multiple Myeloma (RRMM) at ASH 2023 and Announces Selection of Recommended Phase 2 Dose (RP2D)
December 11 2023 - 8:15PM
Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage
immunotherapy company developing novel T cell engagers, today
reported data from the Phase 1 study of HPN217 in patients with
RRMM in an oral presentation at the 65th American Society of
Hematology (ASH) Annual Meeting and Exposition in San Diego.
Harpoon also announced the selection of 12 mg as the HPN217 RP2D.
During the trial, 97 patients with RRMM who had
received at least three prior therapies were enrolled across 15
dose escalation cohorts and three expansion regimens. As of the
data cut-off of October 17, 2023, the data demonstrated:
- Clinical activity across a wide dose range (2.15 mg to 24 mg).
The maximum tolerated dose (MTD) was not reached at the target dose
using a step up approach.
- Optimal activity and safety profile was seen at 12 mg, which
was declared the RP2D.
- The Overall Response Rate (ORR) across 12 mg cohorts was 63%
(12/19, 95% CI: 38, 84). In addition, the depth of response was
most significant at 12 mg, with 53% (10/19) of patients having a
Very Good Partial Response (VGPR) or better.
- The median time to first response in the 12 mg and 24 mg cohort
was 1.2 months, and the median duration of response for all
responders was 20.5 months as of the data cutoff date. Out of all
the responders, 58% (22/38) remain on treatment.
- In the 12 mg and 24 mg cohorts, nine patients were previously
exposed to BCMA-targeting agents, and six of those patients
responded to the HPN217 treatment.
- The incidence of cytokine release syndrome (CRS) was lowest
(16%) in the 12 mg cohorts, all Grade 1-2. No immune effector cell
associated neurotoxicity syndrome (ICANS) events were observed at
the 12 mg dose.
“The data presented at ASH today demonstrates that
HPN217 has the potential to provide a meaningful benefit for
patients with relapsed/refractory multiple myeloma, even in
patients with prior anti-BCMA therapy,” said Sumit Madan, M.D.,
Hematologist and Oncologist at Banner MD Anderson Cancer Center
and Associate Professor (Adj) of Myeloma and Lymphoma at UT MD
Anderson Cancer Center. "The low rate of CRS seen in this
study is noteworthy and can help enable future studies of HPN217 in
combination and in earlier lines of therapy.”
“The HPN217 Phase 1 data set represents important
progress for the program and validates the potential of HPN217 to
deliver a wider therapeutic index. We observed a compelling 63%
response rate in patients treated with the 12 mg target dose, with
only a 16% rate of CRS,” said Luke Walker, M.D., Chief Medical
Officer for Harpoon Therapeutics. “These data and our interactions
with the FDA have enabled us to declare a RP2D that can be used to
support further clinical development.”
For more details about the ASH Annual Meeting,
please visit:
https://www.hematology.org/meetings/annual-meeting
For additional information about the trial, please
visit www.clinicaltrials.gov using the identifier NCT04184050.
The presentation will also be available on
Harpoon’s website under Publications following the session.
About HPN217HPN217 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. BCMA, a clinically validated target, is a tumor necrosis
factor receptor super family member and is a receptor protein
expressed on nearly all multiple myeloma cells.
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.
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and plans pertaining to Harpoon Therapeutics’ clinical trials,
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forward-looking statements contained herein to reflect any change
in expectations, even as new information becomes available.
Contact:Ana KaporHarpoon
Therapeuticsinvestors@harpoontx.com
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