Aptevo Therapeutics Receives Orphan Drug Designation for APVO436 for the Treatment of Acute Myelogenous Leukemia
December 06 2019 - 9:00AM
Aptevo Therapeutics Inc. (Nasdaq: APVO), a biotechnology company
focused on developing novel oncology and hematology therapeutics,
announced today that the United States Food and Drug Administration
(FDA) has granted Orphan Drug Designation to APVO436, a bispecific
antibody candidate intended for the treatment of acute myelogenous
leukemia (AML). APVO436 is currently being evaluated in a Phase
1/1b clinical trial in patients with AML and myelodysplastic
syndrome (MDS).
The U.S. Orphan Drug Act is intended to
encourage companies to develop safe and effective therapies for the
treatment of rare diseases and conditions, specifically those
expected to affect fewer than 200,000 people in the United States.
Orphan drug designation provides important benefits to companies
such as eligibility for a special seven-year period of market
exclusivity upon approval, potential tax credits for research,
potential grant funding for research and development, reduced
filing fees for marketing applications, and assistance with
clinical trial protocol review.
“We are making steady progress in our ongoing
Phase 1/1b clinical trial of APVO436 and are pleased to have been
granted orphan drug designation for APVO436, as this designation
affords important benefits as we continue to advance APVO436
through clinical development,” said Marvin L. White, President and
Chief Executive Officer of Aptevo. “We look forward to providing
future updates on the APVO436 clinical development program as
additional data from the Phase 1/1b clinical trial becomes
available.”
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 safety and pharmacokinetics. 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) ability to achieve target-dependent induction
of redirected T-cell cytotoxicity (RTCC) at lower concentrations
than other bispecific antibody formats; and (iii) flexibility to
build ADAPTIR candidates with diverse mechanisms of action,
including RTCC and T-cell co-stimulation.
About Aptevo Therapeutics
Inc.
Aptevo Therapeutics Inc. is a clinical-stage
biotechnology company focused on developing novel oncology and
hematology therapeutics to meaningfully improve patients’ lives.
Aptevo has a commercial product, IXINITY® coagulation factor IX
(recombinant), approved and marketed in the United States for the
treatment of Hemophilia B, and a versatile core technology – the
ADAPTIR™ modular protein technology platform 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 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 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 18, 2019 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.
Source: Aptevo Therapeutics
Stacey JurchisonSenior Director, Investor Relations and Corporate
Communications206-859-6628JurchisonS@apvo.com
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