Aptevo Therapeutics Provides Update on Ongoing APVO436 Phase 1 Clinical Trial
Aptevo Therapeutics (NASDAQ:APVO) announced progress in its APVO436 Phase 1/1b clinical trial, with two patients dosed in cohort 7. A total of 30 patients have been treated, showing no dose-limiting toxicities or drug-induced anti-drug antibodies to date. Preliminary evidence suggested clinical responses in some patients, particularly in cohort 4, which is noteworthy despite one patient's disease progression. The trial is entering a critical stage, with dosing now in a therapeutic range, enhancing prospects for clinical activity.
- No evidence of dose-limiting toxicities or drug-induced anti-drug antibodies observed.
- Encouraging preliminary clinical response in cohort 4.
- Trial is advancing into therapeutic dosing, potentially increasing clinical activity.
- One patient in cohort 4 progressed despite initial clinical responses.
Trial Advancing on Schedule and Second Patient Dosed in Cohort 7
No Evidence of Drug-Induced Anti-Drug Antibodies Observed to Date
SEATTLE, WA / ACCESSWIRE / September 1, 2020 / Aptevo Therapeutics Inc. (NASDAQ:APVO), a biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR™ bispecific technology platform, today provided an update on its ongoing APVO436 Phase 1/1b clinical trial. APVO436 is a novel anti-CD123 x anti-CD3 targeted investigational bispecific antibody therapy being evaluated for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).
Dosing in cohorts 1 through 6 has been completed, and two patients have been dosed in cohort 7. A total of 30 patients have been enrolled and treated with APVO436 to date. No evidence of dose-limiting toxicities (DLTs) was observed in cohort 6. Also, importantly, no evidence of drug-induced anti-drug antibodies (ADA) has been observed in the 20 patient blood samples analyzed to date.
"The evolving data from our Phase 1 study of APVO436 continues to look promising," said Marvin L. White, President and Chief Executive Officer. "While still preliminary, we are encouraged by the early evidence of a clinical response in bone marrow observed with APVO436 for a patient in cohort 4. Notably, we believe this is a sub-optimal dose, so the potential clinical activity observed is especially intriguing. Although this patient did ultimately progress, we are encouraged by this preliminary evidence of activity," continued Mr. White.
"Importantly, we are now in a critical phase of the study, as pharmacokinetic modelling suggests that dosing in cohorts 5 through 8 is in a therapeutic range, which could result in potential clinical activity of the drug. We look forward to continuing the dose escalation and monitoring potential clinical responses as we advance through the upcoming dose cohorts," Mr. White concluded.
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 may 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 and (ii) unique properties for redirecting T-cell cytotoxicity (RTCC) compared to other bispecific platforms, including a favorable cytokine release profile.
About Aptevo Therapeutics Inc.
Aptevo Therapeutics Inc. is a clinical-stage biotechnology company focused on developing novel immunotherapies for the treatment of cancer. The Company's lead clinical candidate, APVO436, and preclinical candidates, ALG.APV-527 and APVO603, were developed based on the Company's versatile and robust ADAPTIR™ modular protein technology platform. The ADAPTIR platform is capable of generating highly differentiated bispecific antibodies with unique mechanisms of action for the treatment of different types of cancer. For more information, please visit www.aptevotherapeutics.com
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 royalty and milestone payments, Aptevo's ability to successfully sell rights to such payments on terms acceptable to Aptevo, Aptevo's outlook, financial performance or financial condition, estimated cash burn, Aptevo's technology and related pipeline, collaboration and partnership opportunities, 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 U.S. or global capital markets, credit markets or economies generally; and changes in regulatory, social and political conditions. Additional risks and factors that may affect results are set forth in Aptevo's filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K, as filed on March 25, 2020 and its subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Aptevo's expectations in any forward-looking statement.
Contact Information:
Aptevo Therapeutics
Elif McDonald
Senior Director, Investor Relations and Corporate Communications
Direct: (206) 859-6616
Email: mcdonalde@apvo.com
SOURCE: Aptevo Therapeutics
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