'We are excited to partner with LLS and other key stakeholders to advance improved treatment options for patients with AML,' said Dr.
The Beat AML Master Clinical Trial, launched in
'We are extremely honored that APVO436 has been selected for inclusion in the Beat AML Master Clinical Trial, an unprecedented collaboration between academia, research and government to accelerate cutting-edge, novel AML treatments for patients,' said
As a novel anti-CD123 targeted investigational therapy for AML, APVO436 will be evaluated in one arm of the Beat AML Master Trial and will be studied alongside several different investigational AML therapies currently being evaluated alone or in combination in separate treatment arms, including investigational therapies developed by Bristol-Myers Squib (formerly Celgene),
'The Beat AML Master Clinical Trial is designed to offer AML patients the best therapy for their subtype of leukemia,' said
To participate in the study, patients must be newly diagnosed with AML and be 60 years of age or older. Upon enrollment, patients undergo comprehensive genomic profiling and are assigned to a specific treatment arm based on the molecular mutations identified. If a patient does not have a specific genetic marker they are assigned to a treatment arm with an investigational AML agent that has shown broad activity against AML, such as APVO436.
Multiple prominent cancer research institutions are currently participating in the Beat AML study, including
According to
APVO436 Phase 1/1b Clinical Trial
In addition to the Beat AML Master Clinical Trial, which will evaluate APVO436 in a front-line (initial) AML treatment setting, Aptevo is continuing a separate Phase 1/1b clinical trial in patients with relapsed and refractory (recurrent) AML. Patients in this study have generally tolerated APVO436 well, with no indication of treatment-induced anti-drug antibody (ADA) responses observed in the 16 study participants treated to date. Dosing in cohort 5 of the Phase 1/1b study is currently underway. In cohort 4 of the study, one of six patients evidenced a dose-limiting toxicity that resolved without complications, suggesting that active dose levels have been achieved. Based on these results, Aptevo recently implemented a protocol amendment to allow for step dosing in future dose cohorts to enhance patient safety and reduce the potential for dose-limiting adverse events.
'This is a pivotal year for our APVO436 clinical development program,' said
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 the
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
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Email: JurchisonS@apvo.com
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