Full Press Release Details
THERAPEUTICS ANNOUNCES SECOND COMPLETE REMISSION
ONGOING APVO436 PHASE 1 CLINICAL TRIAL
Complete Remission Observed in a Patient in Cohort 6
in Cohort 8 Has Started
WA - November 9, 2020 - Aptevo Therapeutics Inc. ("Aptevo") (NASDAQ: APVO), a clinical-stage
biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR platform,
today provided an update on its ongoing APVO436 Phase 1 clinical trial.
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), in a Phase 1/1b open-label, dose-escalation
study evaluating the safety and pharmacokinetic profile.
Friday, November 6, Aptevo received preliminary data regarding cohort 6, which indicated complete remission in a second patient,
in addition to the one previously announced. In total, there are now two patients with clinical remission in cohort 6. The data
received also showed one patient exhibiting stable disease status, and six patients where the disease had progressed. A total
of nine patients were listed in cohort 6 of the clinical trial.
related to the second patient with complete remission are as follows:
very encouraging that two complete remissions have been observed in Cohort 6, as we are now enrolling in cohort 8," said
Marvin White, President and CEO of Aptevo Therapeutics. "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," concluded Mr. White.
was built on Aptevo's next generation 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.
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.
will be presenting a poster at the 62nd Annual American Society of Hematology
(ASH) this year, to be held virtually December 5-8, 2020.
ASH conference has already posted an abstract on APVO436 titled: "Preliminary Results from a Phase 1 Study of APVO436, a
Novel Anti-CD123 x Anti-CD3 Bispecific Molecule, in Relapsed/Refractory Acute Myeloid Leukemia and Myelodysplastic Syndrome"
publicly available on the conference site, which provides details on the clinical trial : https://ash.confex.com/ash/2020/webprogram/Paper141619.html
will continue to provide updates on its ongoing APVO436 Phase 1 Clinical Trial as and when appropriate.
defines complete remission (CR), stable disease, and progressive disease in a manner consistent with the European LeukemiaNet
(ELN) 2017 criteria, reference: D hner H, Estey E, Grimwade D, et al. Diagnosis and management of AML in adults: 2017
ELN recommendations from an international expert panel. Blood. 2017; 129(4): 424-447.
Aptevo Therapeutics Inc.
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
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
advancement of its clinical trials and its expectations regarding the effectiveness of its ADAPTIR platform, 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.
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. For instance, actual results may differ materially from those indicated by such
forward-looking statements as a result of various important factors, including the uncertainties inherent in the initiation and
enrollment of future clinical trials, availability and timing of data from ongoing clinical trials, expectations for the timing
and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products,
our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial
potential of the Company's product candidates, business or economic disruptions due to catastrophes or other events, including
natural disasters or public health crises such as the novel coronavirus (referred to as COVID-19). 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.
Director, Investor Relations and Corporate Communications
Email: mcdonalde@apvo.com