Harpoon Therapeutics Granted Orphan Drug Designation from FDA for HPN217 for Treatment of Multiple Myeloma
January 13 2021 - 7:30AM
Harpoon Therapeutics, Inc. (NASDAQ: HARP), a clinical-stage
immunotherapy company developing a novel class of T cell engagers,
today announced that the U.S. Food and Drug Administration (FDA)
has granted Orphan Drug Designation for HPN217 for the treatment of
multiple myeloma. HPN217, a tri-specific T cell activating
recombinant protein construct (TriTAC®) targets B-cell maturation
antigen (BCMA), a well-validated antigen expressed on malignant
multiple myeloma cells. Harpoon has four drug product candidates in
clinical development for the treatment of solid and hematologic
malignancies based on its proprietary TriTAC platform.
“Orphan Drug Designation for multiple myeloma represents a
significant milestone in the development of HPN217 and recognizes
its potential to address a significant unmet medical need for the
patients suffering from this condition,” said Jerry McMahon, Ph.D.,
President and Chief Executive of Harpoon Therapeutics. “I am
pleased with the clinical progress we are making with this program
and we are planning to present interim data from the ongoing Phase
1/2 dose escalation trial later this year.”
The FDA's Orphan Drug Designation program provides orphan status
to drugs defined as those intended for the safe and effective
treatment, diagnosis or prevention of rare diseases that affect
fewer than 200,000 people in the United States. Orphan Drug
Designation qualifies the sponsor of the drug for certain
development incentives, including tax credits for qualified
clinical testing, prescription drug user fee exemptions and
seven-year marketing exclusivity upon FDA approval.
About the Phase 1/2 Trial for HPN217
In April 2020, Harpoon announced dosing of the first patient
with HPN217 (BCMA TriTAC) in a Phase 1/2 clinical trial focused on
relapsed/refractory multiple myeloma (RRMM). HPN217 is covered by a
global development and option agreement with AbbVie Inc. (NYSE:
ABBV). Dose escalation for HPN217 in the Phase 1/2 clinical trial
is progressing rapidly. HPN217 has been well tolerated, and no DLTs
had been observed as of the most recent December 1, 2020 data
cutoff date. A presentation of interim data is anticipated in 2021,
with initiation of a dose expansion cohort in the second half of
2021.
For additional information about the trial, please visit
clinicaltrials.gov using the identifier NCT04184050.
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. HPN424 targets PSMA and is in a Phase 1/2a trial for
metastatic castration-resistant prostate cancer. HPN536 targets
mesothelin and is in a Phase 1/2a trial for cancers expressing
mesothelin, initially focused on ovarian and pancreatic cancers.
HPN217 targets BCMA and is in a Phase 1/2 trial for relapsed,
refractory multiple myeloma. HPN328 targets DLL3 and is in a Phase
1/2 trial for small cell lung cancer and other DLL3-associated
tumors. 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. For additional information
about Harpoon Therapeutics, please visit www.harpoontx.com.
Cautionary Note on 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 “may,” “will,” “expect,” “plan,” “anticipate,”
“target,” “estimate,” “intend” 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 progress, timing, scope and anticipated results of
clinical trials, the timing of the presentation of data, the
association of data with potential treatment outcomes, the
development and advancement of product candidates, the timing of
development milestones for product candidates, and the anticipated
potential impacts to Harpoon Therapeutics’ business from the
ongoing COVID-19 pandemic. Many factors may cause differences
between current expectations and actual results, including
unexpected safety or efficacy data observed during clinical
studies, 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, and
unexpected litigation or other disputes. 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 the “Risk
Factors” sections contained therein. 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:
Harpoon Therapeutics, Inc.Georgia ErbezChief Financial
Officer650-443-7400media@harpoontx.com
Westwicke ICRRobert H. UhlManaging Director858-356-5932
robert.uhl@westwicke.com
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