Aptevo Regains Worldwide Rights to Novel
Bispecific Prostate Cancer Immunotherapeutic
MOR209/ES414
Aptevo Therapeutics Inc. (Nasdaq:APVO), a biotechnology company
focused on developing novel immuno-oncology and hematology
therapeutics, today announced the end of its partnership with
MorphoSys AG for the joint worldwide development and
commercialization of MOR209/ES414, a targeted immunotherapeutic for
the treatment of metastatic castration resistant prostate cancer
(mCRPC). Aptevo will regain worldwide development and
commercialization rights for MOR209/ES414 (now known as APVO414)
and intends to continue to advance APVO414 through the completion
of Stage 1 of an ongoing Phase 1 continuous infusion,
dose-escalation clinical study evaluating the safety, tolerability
and clinical activity of escalating doses of APVO414 in patients
with mCRPC.
“We’re encouraged by the latest preliminary data
from the ongoing Phase 1 clinical study of APVO414,” said Dr. Scott
Stromatt, Senior Vice President and Chief Medical Officer at
Aptevo. “The data suggest that administration of APVO414 by
continuous infusion, rather than weekly intravenous (IV) dosing, is
effective at reducing the titer of anti-drug antibodies (ADA)
previously observed in the initial weekly IV dosing cohorts.”
In the initial cohorts of the Phase 1 dose
escalation study, twelve patients with mCRPC were treated with
weekly intravenous infusions of APVO414. Seven of these
patients (58%) developed ADA with very high titers (as high as
1:250,000). None of the patients had any adverse reactions
due to the ADA, but patients with high ADA titers cleared the drug
from their blood to undetectable levels.
The amended protocol utilizes continuous
intravenous infusion and two cohorts of patients have completed
dosing without any dose limiting toxicities. Three of six
patients (50%) developed ADA but with markedly lower titers of ADA
(1:160 or 1:320). Additionally, drug was detected in the
serum of all patients.
“These results clearly demonstrate that the
administration regimen markedly reduced the generation of
ADA. Additionally, we have seen early pharmacodynamic effects
of the drug such as redistribution of T cells. We are encouraged
and plan to continue dose escalation in order to determine the
maximum tolerated dose and to examine the clinical activity of
APVO414,” said Dr. Stromatt.
APVO414 is a first-generation bispecific
antibody candidate, developed using Aptevo’s ADAPTIR™ protein
therapeutic platform. APVO414 is engineered to simultaneously
target PSMA on prostate cancer cells, and CD3 on T-cells, and
functions by redirecting cytotoxic T cell activity towards
PSMA-expressing tumor cells.
Promising preclinical data demonstrating the
ability of APVO414 to induce target-dependent tumor cell killing as
well as target-dependent T cell proliferation were previously
presented at the American Association for Cancer Research Annual
Meeting and recently published in the Journal of Molecular and
Cellular Biology (2016 Mol Cancer Ther; 15(9); 2155–65). In
addition, APVO414 demonstrated lower levels of T cell dependent
cytokines compared to other bispecific formats, which, if confirmed
in clinical studies, could offer the potential for enhanced safety
and tolerability compared to other immuno-oncology bispecific
antibody approaches.
“Aptevo has made a number of significant
improvements to our ADAPTIR platform since the development of our
first-generation bispecific candidates, like APVO414,” commented
Jane Gross, Ph.D., Senior Vice President and Chief Scientific
Officer. “Our next generation ADAPTIR technology platform has
been optimized to enable the development of bispecific antibody
candidates with highly-desirable drug-like properties, including,
enhanced potency and stability, prolonged half-life, and excellent
manufacturing attributes – similar to traditional antibodies.
Importantly, we have utilized state-of-the-art technologies to
examine our next generation bispecific candidates and believe that
we identified and eliminated the root cause of the ADA seen with
APVO414. We look forward to obtaining additional information
from the ongoing APVO414 clinical trial and advancing next
generation ADAPTIR bispecific molecules into clinical
development.”
About Prostate Cancer
Although screening, radiation, surgery and
hormone ablation therapy have greatly improved the detection and
treatment of early-stage prostate cancer, the relapse rate
following initial anti-androgen therapy remains high, and there
remains a significant unmet medical need for patients with
metastatic castration resistant prostate cancer for whom current
therapies have demonstrated only a limited increase in overall
survival. The global market for CRPC therapeutics is expected
to reach $9.5 billion by 2020
About the ADAPTIR Pipeline
Two first generation ADAPTIR molecules are
currently in clinical development: APVO414, which is being
investigated in a Phase 1, dose escalation, continuous infusion
study to evaluate safety and tolerability in patients with
metastatic castration resistant prostate cancer; and, otlertuzumab,
a monospecific antibody targeting CD37 under investigation for the
treatment of chronic lymphocytic leukemia. In addition,
Aptevo has several ADAPTIR candidates in preclinical development,
including: APVO436, an optimized, next generation bispecific
antibody candidate designed to simultaneously target CD123 and CD3
and redirect T cell cytotoxicity for the treatment of acute
myelogenous leukemia (AML), a form of blood and bone marrow cancer;
ALG.APV-526, a bispecific antibody candidate, partnered with
Alligator Bioscience, featuring a novel mechanism of action
designed to simultaneously target 4-1BB (CD137) and an undisclosed
tumor antigen, and, APVO210 – a bispecific ADAPTIR candidate with a
novel mechanism of action based on cytokine delivery currently in
preclinical development for autoimmune and inflammatory diseases.
About Aptevo Therapeutics Inc.
Aptevo Therapeutics Inc. is a clinical-stage
biotechnology company focused on novel oncology and hematology
therapeutics to meaningfully improve patients’ lives. The
Company has four commercial products – IXINITY®, WinRho® SDF,
HepaGam B® and VARIZIG® and a versatile core technology – the
ADAPTIR™ modular protein technology platform capable of generating
highly-differentiated, bispecific antibodies with unique mechanisms
of action to treat cancer or autoimmune diseases. Aptevo has
two bispecific antibody candidates currently in clinical
development and a broad pipeline of novel investigational-stage
bispecific antibody candidates focused in immuno-oncology and
autoimmune disease/inflammation. For more information, please visit
www.aptevotherapeutics.com
Aptevo 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 Aptevo’s outlook, financial performance or financial
condition, our technology and related pipeline, collaboration and
partnership opportunities, commercial portfolio, Aptevo’s future
growth rates, Aptevo’s ability to timely manufacture its products,
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 our actual results to differ materially from those
indicated by such forward-looking statements, including possible
negative effects on our business operations, assets or financial
results as a result of the separation; a deterioration in our
business or prospects; the ability of our contractors and suppliers
to supply product and materials; our ability and the ability
of our contractors and suppliers to maintain compliance with cGMP
and other regulatory obligations; the results of regulatory
inspections; adverse developments in our customer-base or markets
and our ability to retain patients; 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 our filings with the Securities and Exchange
Commission, including Aptevo’s most recent Annual Report on Form
10-K, as filed on March 31, 2017, and our 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 our expectations in any forward-looking
statement.
Source:
Aptevo Therapeutics
Stacey Jurchison
Senior Director, Investor Relations and Corporate Communications
Tel: +1 206-859-6628
JurchisonS@apvo.com
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