Arix Bioscience Plc - Harpoon doses first patient in multiple myeloma trial
Harpoon doses first patient in multiple myeloma trial
Initiation of the clinical trial triggers milestone payment from AbbVie
, : (“Arix”) (LSE: ARIX), a global venture capital company focused on investing in and building breakthrough biotech companies, notes that its portfolio company (NASDAQ: HARP), today announced that the first patient has been dosed with its product candidate, HPN217, in a Phase 1/2 clinical trial focused on relapsed, refractory multiple myeloma (RRMM). HPN217 is being developed under a global license and option agreement with (NYSE:ABBV) and dosing of the first patient in a clinical trial has triggered a milestone payment to Harpoon.
HPN217 is Harpoon’s third product candidate to enter the clinic 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 destroy tumours.
The announcement can be accessed on Harpoon's investor website and full text of the announcement from Harpoon is contained below.https://ir.harpoontx.com/news-releases
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HARPOON THERAPEUTICS DOSES FIRST HPN217, A BCMA TARGETING TRITAC, FOR MULTIPLE MYELOMA
Initiation of the clinical trial triggers milestone payment from AbbVie
SOUTH SAN FRANCISCO, Calif., April 27, 2020 -- (NASDAQ: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, today announced that the first patient has been dosed with HPN217 in a Phase 1/2 clinical trial focused on relapsed, refractory multiple myeloma (RRMM). HPN217 is being developed under a global license and option agreement with (NYSE:ABBV) and dosing of the first patient in a clinical trial has triggered a $50 million milestone payment to Harpoon. HPN217 targets B-cell maturation antigen (BCMA), a well-validated antigen expressed on malignant multiple myeloma calls. HPN217 is Harpoon’s third product candidate to enter the clinic 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 destroy tumors.
“The initiation of a clinical trial for our third product candidate is another significant milestone for Harpoon and demonstrates the outstanding progress we are making in advancing our innovative oncology pipeline,” said Gerald McMahon, Ph.D., President and CEO of Harpoon Therapeutics. “The $50 million milestone payment adds additional financial resources to support the HPN217 program and other development activities that we are conducting. The first patient was treated at Colorado Blood Cancer Institute and the Sarah Cannon Research Institute at HealthONE’s Presbyterian St. Luke’s Medical Center We are excited to be advancing HPN217 in the clinic and look forward to reporting our progress as this program matures.”.
“Therapeutic choices for patients with RRMM are limited, and there is a need for additional therapeutic options,” said Natalie Sacks, M.D., Chief Medical Officer of Harpoon. “Our non-clinical data suggest that HPN217 has substantial anticancer activity and provide the rationale to investigate its potential benefit as an effective immunotherapy for patients with multiple myeloma.”
About the Phase 1/2 Clinical Trial for HPN217
This Phase 1/2 trial is a multicenter, open-label study designed to evaluate the safety, tolerability, pharmacokinetics and activity of HPN217 in patients with RRMM. The Phase 1 portion of the trial is a dose escalation phase, with the goal of determining a recommended dose for the Phase 2 portion of the trial. HPN217 will be administered to patients once weekly by intravenous infusion. The primary outcome measures will be an assessment of safety and tolerability, pharmacokinetics, and determination of a dose for the Phase 2 portion of the trial. Secondary endpoints include overall response rate, progression free and overall survival, and duration of response.
The Phase 2 portion of the trial will further evaluate the safety and activity of HPN217 in patients with RRMM. The trial is titled, “A Phase 1/2 open-label, multicenter, dose escalation and dose expansion study of the safety, tolerability, and pharmacokinetics of HPN217 in patients with relapsed/refractory multiple myeloma. For additional information about the trial, please visit using the identifier NCT04184050.www.clinicaltrials.gov
About the Agreement with AbbVie
In November 2019, Harpoon entered into a Development and Option Agreement with AbbVie pursuant to which Harpoon granted AbbVie an option to license worldwide exclusive rights to HPN217. Harpoon will be responsible for developing HPN217 through a Phase 1/2 clinical trial. Upon exercise of the option, AbbVie would be responsible for all future clinical development, manufacturing and commercialization activities. The licensing option for HPN217 may be exercised at any time up to the completion of the Phase 1/2 clinical trial. The Development and Option Agreement represents a potential transaction value of up to $510 million in upfront, option and milestone payments, plus royalties on global commercial sales. In November 2019, Harpoon also expanded its existing discovery collaboration agreement by up to six additional targets for a total of eight targets. AbbVie has the right to select four targets, representing a deal transaction value of approximately $1.2 billion plus royalties, with an option to select up to four additional targets. Harpoon would be eligible to receive up to $310 million plus royalties for each additional target selected. Harpoon received an initial upfront payment of $50 million in November 2019, with an additional $50 million payment due upon dosing the first patient with HPN217.
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’s first product, HPN424, targets PSMA and is in a Phase 1 trial for metastatic castration-resistant prostate cancer. Harpoon’s second product, 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. 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 anticipated safety, efficacy and patient management benefits of HPN217 for the treatment of patients with relapsed/refractory multiple myeloma, anticipated advantages the TriTAC platform may have over other therapies, the progress, timing, scope and results of clinical trials, the association of data with treatment outcomes and the timing and likelihood 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, 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.
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