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Arix Bioscience PLC: Harpoon reports clinical progress across all pipeline development programmes

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 
 
 
1: https://eqs-cockpit.com/cgi-bin/fncls.ssp?fn=redirect&url=6b747ef884586fd08f9b1bf9f3b4700a&application_id=1153726&site_id=vwd&application_name=news 
2: https://eqs-cockpit.com/cgi-bin/fncls.ssp?fn=redirect&url=889c637ce21c3a47a35c39202ebd9825&application_id=1153726&site_id=vwd&application_name=news 
3: https://eqs-cockpit.com/cgi-bin/fncls.ssp?fn=redirect&url=749367bd7da2b09c1e52ef6720effe67&application_id=1153726&site_id=vwd&application_name=news 
4: https://eqs-cockpit.com/cgi-bin/fncls.ssp?fn=redirect&url=d9b8b157595a3d6f802959469d26aa6c&application_id=1153726&site_id=vwd&application_name=news 
5: https://eqs-cockpit.com/cgi-bin/fncls.ssp?fn=redirect&url=8e9db19066541f8380de8d4625763588&application_id=1153726&site_id=vwd&application_name=news 
6: https://eqs-cockpit.com/cgi-bin/fncls.ssp?fn=redirect&url=c8c173ca2e3420eedc1ed0f04465abb1&application_id=1153726&site_id=vwd&application_name=news 
 

(END) Dow Jones Newswires

December 08, 2020 10:45 ET (15:45 GMT)

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