Aptevo Therapeutics Provides Update on Ongoing APVO436 Phase 1 Clinical Trial
The Company noted that patient dosing in cohorts 1 through 8 has been completed and enrollment in cohort 9 has commenced. A total of 36 patients have been enrolled and treated with APVO436 to date. No evidence of dose-limiting toxicities (DLTs) was observed in cohorts 5-8.
"2020 was a very busy and exciting year at Aptevo, with progress on many fronts. Notably, two patients in cohort 6 of our APVO436 Phase 1a clinical trial achieved complete remission. This development greatly encouraged our research partners and our inhouse teams, who have poured their passion and energy into this trial," said Mr.
"In 2021, we look forward to advancing our APVO436 clinical trial and improving patient outcomes, while recognizing that each patient is unique. Our first patient in cohort 6 who had complete remission continues therapy, while the second patient in cohort 6 who also had complete remission progressed and discontinued therapy. Importantly, we are now in a critical phase of the study, within the therapeutic range,"
"We believe that the work we are doing is meaningful and important, and we will continue to focus on developing candidates that target cancers, ultimately increasing a patients' chance of survival. We have multiple candidates moving towards clinical development, and our ADAPTIR and ADAPTIR-FLEX technology platforms are uniquely positioned to develop and advance our studies," concluded
APVO436 is an optimized bispecific antibody candidate designed to simultaneously target CD123 and CD3 and redirect T-cell cytotoxicity to the tumor. It is currently being evaluated in a Phase 1/1b open-label, dose-escalation study evaluating the safety and pharmacokinetic profile. APVO436 was built on Aptevo's proprietary ADAPTIR protein therapeutic platform. Focused on generating novel, targeted bispecific antibody-based immunotherapies for cancer the ADAPTIR platform offers key advantages over other bispecific formats, derived in part from the flexible and modular nature of the ADAPTIR structure. These advantages include: (i) achieving potent biological activity and extended half-life while retaining desirable manufacturing characteristics and (ii) unique properties for redirecting T-cell cytotoxicity (RTCC) compared to other bispecific platforms, including a favorable cytokine release profile.
Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including, without limitation, Aptevo's expectations about the activity of its pre-clinical candidates and potential use as a therapeutic, advancement of its clinical trials and its expectations regarding the effectiveness of its ADAPTIR and ADAPTIR-FLEX platforms, and any other statements containing the words "believes," "expects," "anticipates," "intends," "plans," "forecasts," "estimates," "will" and similar expressions are forward-looking statements. These forward-looking statements are based on Aptevo's current intentions, beliefs and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo's expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not undertake to update any forward-looking statement to reflect new information, events or circumstances.
There are a number of important factors that could cause Aptevo's actual results to differ materially from those indicated by such forward-looking statements, including a deterioration in Aptevo's business or prospects; adverse developments in research and development; adverse developments in the
Senior Director, Investor Relations and Corporate Communications
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