DJ Harpoon reports clinical progress across all pipeline development programmes
Arix Bioscience PLC (ARIX)
Harpoon reports clinical progress across all pipeline development programmes
08-Dec-2020 / 15:45 GMT/BST
Dissemination of a Regulatory Announcement, transmitted by EQS Group.
The issuer is solely responsible for the content of this announcement.
Arix Bioscience plc
Harpoon reports clinical progress across all pipeline development programmes
LONDON, 08 December 2020: Arix Bioscience plc ("Arix", LSE: ARIX) a global
venture capital company focused on investing in and building breakthrough
biotech companies, notes that its portfolio company, Harpoon Therapeutics,
Inc. ("Harpoon", Nasdaq: HARP), today provided a pipeline update across all
development programmes. As part of this, Harpoon reported a confirmed
partial response for its most advanced programme, HPN424 for the treatment
of metastatic castration-resistant prostate cancer, in the highest dose
group as of today in the continuing Phase1/2a dose escalation trial. In
addition, three of seven patients enrolled in the currently highest fixed
dose cohort had serum PSA reductions, including one with a reduction of 50%.
Harpoon notes that dose escalation is continuing in the HPN536 Phase 1/2a
clinical trial for the treatment of ovarian cancer and other
mesothelin-expressing solid tumours and in the HPN217 Phase 1/2 clinical
trial for multiple myeloma. Harpoon expects to report initial data readouts
from both of these trials in 2021. In addition, Harpoon expects that dosing
of the first patient in the Phase 1/2 trial for HPN328, in small cell lung
cancer and other DLL3- associated tumours, will occur by the end of the
year.
The announcement can be accessed on the Harpoon website at
https://ir.harpoontx.com/news-releases [1] and full text of the announcement
from Harpoon is contained below.
[ENDS]
Enquiries
For more information on Arix, please contact:
Arix Bioscience plc
Charlotte Parry, Head of Investor Relations
+44 (0)20 7290 1072
charlotte@arixbioscience.com
Optimum Strategic Communications
Supriya Mathur, Shabnam Bashir, Manel Mateus
+44 (0)20 3922 1906
optimum.arix@optimumcomms.com
About Arix Bioscience plc
Arix Bioscience plc is a global venture capital company focused on investing
in and building breakthrough biotech companies around cutting-edge advances
in life sciences.
We collaborate with exceptional entrepreneurs and provide the capital,
expertise and global networks to help accelerate their ideas into important
new treatments for patients. As a listed company, we are able to bring this
exciting growth phase of our industry to a broader range of investors.
www.arixbioscience.com [2]
Harpoon Therapeutics Reports Clinical Progress Across All Four TriTAC(R)
Pipeline Development Programs
HPN424 has shown confirmed partial response in treatment of metastatic
castration-resistant prostate cancer in highest fixed dose cohort (160
ng/kg) of continuing Phase 1/2a dose escalation trial
Three of seven patients in highest fixed dose HPN424 cohort have shown PSA
reduction
Dose escalation trials advancing for HPN536 and HPN217 with initial data
readouts and initiation of expansion cohorts expected in 2021
Management to host clinical update webcast/call today, December 8, 2020, at
8 a.m. ET
SOUTH SAN FRANCISCO, Calif., Dec. 08, 2020 -- Harpoon Therapeutics, Inc.
(NASDAQ: HARP), a clinical-stage immunotherapy company developing a novel
class of T cell engagers, today provided a pipeline update and reported a
confirmed partial response based on RECIST v1.1 criteria for its most
advanced program, HPN424 for the treatment of metastatic
castration-resistant prostate cancer (mCRPC). As of December 1, 2020, in the
160ng/kg cohort, which is the highest fixed dose tested to date, 7 patients
have been enrolled and one patient has achieved a confirmed partial
response. In addition, 3 patients enrolled in this cohort had serum PSA
reductions, including one with a reduction of 50% (PSA50). Dose escalation
continues in this trial, in the Phase 1/2a clinical trials for HPN536 as a
treatment for ovarian cancer and other mesothelin-expressing solid tumors
and in the HPN217 Phase 1/2 clinical trial for multiple myeloma. Step dosing
is being utilized in all programs to accelerate testing of higher doses.
Dosing of the first patient in the Phase 1/2 trial for Harpoon's fourth
TriTAC development program, HPN328, in small cell lung cancer and other
DLL3-associated tumors is expected to occur by the end of the year.
"We are pleased to provide a trial update to our shareholders today, as well
as outline our expectations for 2021. We have made significant progress in
all of our clinical development programs in 2020," stated Gerald McMahon,
Ph.D., President and CEO of Harpoon Therapeutics. "We are excited to report
our first confirmed partial response in the continuing dose escalation trial
for HPN424, especially in a heavily pretreated patient population with
advanced metastatic disease. We are also excited by the potential for
multiple data releases in 2021 on all four of our programs, which we believe
represent meaningful milestones for our company."
"We are pleased to report the activity we are seeing with HPN424 in
late-stage prostate cancer patients in our highest fixed dose cohort tested
to date," said Natalie Sacks, M.D., Chief Medical Officer of Harpoon. "We
are implementing step dosing in all of our programs, which allows rapid
escalation to higher doses. We look forward to sharing data from these
higher-dose cohorts in 2021."
Clinical Program Updates
(All data as of December 1, 2020)
Dose escalation continues in Phase 1/2a trial for HPN424 in the treatment of
mCRPC. As of the December 1, 2020 data cutoff date, 69 patients have been
dosed across 14 cohorts at fixed doses of 1.3 to 160ng/kg and in step dosing
cohorts up to 300ng/kg administered as a weekly intravenous infusion.
Enrolled patients had a median of 6 prior systemic therapies, and 76% of
patients had prior chemotherapy in the metastatic castration-resistant
setting. Ten of 44 patients (23%) with treatment start dates at least 6
months ago remained on study treatment for more than 24 weeks.
At the highest fixed dose tested to date, 160ng/kg, one patient out of 7 has
experienced a confirmed partial response with tumor lesion reduction of 43%,
and 3 of 7 patients have had serum PSA declines from baseline, including one
patient with a PSA reduction greater than 50%.
HPN424 was generally well tolerated and cytokine-related adverse events have
been manageable. Reported Grade 3 or higher adverse events have included
cytokine release syndrome (CRS) (10%), ALT increase (11%) and AST increase
(11%). CRS events and transaminitis have been transient and have not
resulted in treatment discontinuation. Dose-limiting toxicities (DLTs) have
been observed and have not limited escalation. A maximum tolerated dose
(MTD) has not been identified. Presentation of Phase 1 data and initiation
of an expansion cohort is planned for the first half of 2021. Interim data
from this expansion cohort is anticipated by the end of 2021.
HPN536 (mesothelin TriTAC) Phase 1/2a clinical trial continues escalation.
Dosing has occurred across 9 fixed-dose cohorts of 6 to 280ng/kg and 1 step
dose cohort up to 600ng/kg. Tumor types treated include late-stage ovarian
and pancreatic cancers and peritoneal mesothelioma. Enrolled patients had a
median of four prior systemic therapies, and 66% of patients had progressive
disease as best response to their most recent prior therapy. Pharmacokinetic
analysis shows median half-life of more than 70 hours. Among the
relapsed/refractory ovarian cancer patients with at least one post-baseline
scan, 8 of 12 (67%) patients showed stability of target lesions.
HPN536 appears to be well tolerated. One CRS grade 3 occurred in the absence
of dexamethasone premedication treatment. The CRS resolved, and the patient
continued on study with dexamethasone premedication. As of December 1, 2020,
no DLTs have been observed. Initiation of an expansion cohort is anticipated
by the second half of 2021, with a presentation of Phase 1 data by year-end
2021.
Dose escalation for HPN217 (BCMA TriTAC) Phase 1/2 clinical trial
progressing rapidly. Relapsed/refractory multiple myeloma patients have been
treated across 6 single-patient fixed dose cohorts of 5 to 810µg, reflecting
a more than 100-fold increase in dose in 8 months. HPN217 has been
well-tolerated, and no DLTs have been observed as of the December 1, 2020
cutoff date. A presentation of interim data is anticipated in 2021, with
initiation of a dose expansion cohort in the second half of 2021.
First patient dosing anticipated for HPN328 (DLL3 TriTAC) by the end of
2020. The first site is open and recruiting for the dose escalation portion
of this Phase 1/2 clinical trial. In the first cohort, the patients will
receive a flat dose of 15µg of HPN328 administered once weekly by
intravenous infusion. Eligible patients include small cell lung cancer
patients who have relapsed after platinum chemotherapy and patients with
other tumors associated with DLL3 expression. Presentation of initial data
is planned for the second half of 2021.
Webcast and Conference Call
Harpoon's management will host a webcast and conference call at 8 a.m. ET /
5 a.m. PT on December 8, 2020. The live call may be accessed by dialing
(866) 951-6894 for domestic callers and (409) 216-0624 for international
callers with conference ID code number 1388395. A webcast of the live call
will be available online in the investor relations section of the Harpoon
website at www.harpoontx.com [3]. A replay of the webcast will be available
shortly after the event and can be accessed at the same weblink.
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(R)) 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 Harpoon plans to initiate a Phase 1/2 trial in the fourth quarter
of 2020. Harpoon has also developed a proprietary ProTriTACTM 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 [4].
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, design 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, and the timing of development milestones for product
candidates. 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, the risk that initial or interim
results from a clinical trial may not be predictive of the final results of
the trial or the results of future trials, the risk that trials may be
delayed and may not have satisfactory outcomes, and unexpected litigation or
other disputes that impede clinical trial progress. 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 Erbez
Chief Financial Officer
650-443-7400
media@harpoontx.com [5]
Westwicke ICR
Robert H. Uhl
Managing Director
858-356-5932
robert.uhl@westwicke.com [6]
ISIN: GB00BD045071
Category Code: MSCU
TIDM: ARIX
LEI Code: 213800OVT3AHQCXNIX43
OAM Categories: 3.1. Additional regulated information required to be
disclosed under the laws of a Member State
Sequence No.: 89303
EQS News ID: 1153726
End of Announcement EQS News Service
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(END) Dow Jones Newswires
December 08, 2020 10:45 ET (15:45 GMT)
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