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Aptevo Therapeutics Provides Update On Ongoing APVO436 Phase 1 Clinical Trial
Trial Advancing on Schedule with Dosing in Cohort 6 Set to Begin Shortly;
No Evidence of Dose-Limiting Toxicities Observed in Cohort 5
No Evidence of Drug-Induced Anti-Drug Antibodies Observed to Date
At present, dosing in cohorts 1 through 5 has been completed with dosing in cohort 6 scheduled to begin shortly. A total of 19 patients have been enrolled and treated with APVO436 to date. No evidence of dose-limiting toxicities was observed in the latest dose cohort (cohort 5.) A dose-limiting toxicity was observed in 1 of 6 patients in cohort 4. Also, importantly, no evidence of drug-induced anti-drug antibodies (ADA) has been observed in the 17 patient blood samples analyzed to date.
One patient in the study with a diagnosis of MDS is currently finishing an 8th cycle of dosing. Preliminary analysis showed that this patient has achieved a disease assessment of "marrow complete response," which is defined as a bone marrow with ≤ 5% myeloblasts and a decrease ≥ 50% over pretreatment. Changes in peripheral blood measurements are reported separately and this particular patient continues to require platelet and red blood cell transfusions. Aptevo cautions that these data are preliminary.
"The evolving data from our Phase 1 study of APVO436 continues to look promising," said
Aptevo believes that its differentiated ADAPTIR bispecific technology platform has the potential to offer a more convenient and cost-effective solution compared to other immunotherapies such as CAR-T therapies. While CAR-T therapies have proven effective in generating robust and durable treatment responses, they remain challenging and expensive to manufacture and administer to patients. In contrast, bispecific technologies represent a simpler, more competitive ‘off-the-shelf' solution in the rapidly advancing field of cancer immunotherapy.
About APVO436
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; (ii) unique properties for redirecting T-cell cytotoxicity (RTCC) compared to other bispecific platforms, including a favorable cytokine release profile; (iii) ability to achieve target-dependent induction of RTCC at lower concentrations than other bispecific antibody formats; and (iv) flexibility to build ADAPTIR candidates with diverse mechanisms of action, including RTCC, and targeted cytokine release and others.
About
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, statements regarding potential milestone payments, Aptevo's outlook, financial performance or financial condition, Aptevo's technology and related pipeline, collaboration and partnership opportunities, commercial portfolio, milestones, 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
CONTACT:
Senior Director, Investor Relations and Corporate Communications
206-859-6628
JurchisonS@apvo.com
SOURCE:
accesswire.com
https://www.accesswire.com/580593/Aptevo-Therapeutics-Provides-Update-On-Ongoing-APVO436-Phase-1-Clinical-Trial