APVO436 is the Latest Investigational AML Therapeutic to be Selected for Participation in the Study; Aptevo Joins Industry Leaders, Bristol-Myers Squib (formerly Celgene) Alexion Pharmaceuticals, Gilead Sciences, Takeda Oncology, Agios Pharmaceuticals, Astellas Pharma and Boehringer Ingelheim as an Industry Participant in the Study
Beat AML Master Clinical Trial Represents a Groundbreaking, First-of-its-Kind Collaboration Between Academia, Leading Clinical Research Centers, Biopharmaceutical Companies and Government
Spearheaded by The Leukemia & Lymphoma Society, the BEAT AML Master Clinical Trial was Established to Accelerate the Development of More Effective, Precision-Targeted Treatments for Patients with Acute Myeloid Leukemia (AML)
Aptevo Participation in the Study Enables Access to Leading Cancer Research Centers and an Evaluation of APVO436 in a Front-Line AML Setting
No Evidence of Treatment-induced Anti-drug Antibodies Observed to date in the Ongoing Phase 1/1b APVO436 Clinical Study
SEATTLE, WA / ACCESSWIRE / January 13, 2020 / Aptevo Therapeutics Inc. (NASDAQ:APVO), a biotechnology company focused on developing novel oncology and hematology therapeutics, announced today that APVO436, the Company's novel investigational bispecific antibody candidate for the treatment of acute myeloid leukemia (AML), was selected to be part of an ongoing national AML master clinical trial spearheaded by The Leukemia & Lymphoma Society (LLS) called the ‘Beat AML Master Clinical Trial."
"We are excited to partner with LLS and other key stakeholders to advance improved treatment options for patients with AML," said Dr. Scott Stromatt, Chief Medical Officer for Aptevo. "Sadly, AML is a disease which, despite new drugs approved recently, still has a dismal prognosis. Patients are typically diagnosed later in life, at which time standard chemotherapy regimens can be especially toxic and difficult to tolerate. Newer, targeted therapies like APVO436 could provide better treatment options tailored to a more personalized medicine approach."
Dr. Stromatt continued, "Our participation in the Beat AML Master Clinical Trial provides important access to leading academic cancer centers and allows us to study APVO436 in a front-line AML setting, in addition to our ongoing Phase 1/1b clinical trial, which is evaluating APVO436 in relapsed/refractory AML patients. We look forward to data readouts from both studies to evaluate APVO436's potential role as an important new targeted therapeutic for AML."
The Beat AML Master Clinical Trial, launched in October 2016, is a groundbreaking collaborative clinical trial being conducted at leading national cancer centers, bringing together renowned experts and key stakeholders in AML research and development. With support and guidance from the U.S. Food and Drug Administration, the ambitious Beat AML Master Clinical Trial seeks to change the treatment paradigm for AML and accelerate the development of novel, targeted therapies using an innovative precision medicine protocol.
"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 Marvin L. White, President and Chief Executive Officer for Aptevo. "The Beat AML Master trial is a bold initiative and a first-of-its kind collaboration spearheaded by The Leukemia & Lymphoma Society, the world's largest nonprofit dedicated to fighting blood cancers. Aptevo is proud to be among the ranks of leading academic and industry stakeholders at the forefront of AML research and development."
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), Alexion Pharmaceuticals, Takeda Oncology, Gilead Sciences and Boehringer Ingelheim, Astellas Pharma and Agios Pharmaceuticals, among others.
"The Beat AML Master Clinical Trial is designed to offer AML patients the best therapy for their subtype of leukemia," said Amy Burd, Ph.D., LLS's vice president of research strategy and lead on the Beat AML trial. "As immunotherapy becomes more of a mainstay in cancer treatment, we are pleased to be adding a study arm with Aptevo's APV0436, as it will provide patients an important immunotherapeutic option."
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 Memorial Sloan Kettering Cancer Center, The Ohio State University Comprehensive Cancer Center, Oregon Health and Science University Knight Cancer Institute, and Mayo Clinic, among others. Since the trial was launched in 2016, more than 800 patients at 16 leading cancer institutes have received treatment.
According to The Leukemia & Lymphoma Society, more than 20,000 Americans are diagnosed with AML and 10,000 die from the cancer annually. The five-year-survival rate for older adults is less than 20 percent.
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 Marvin L. White, President and Chief Executive Officer. "We are entering a key phase of the development process for APVO436, as preclinical modeling suggests that we are now reaching dose levels which are estimated to be in a therapeutic range. As Aptevo previously reported, we saw evidence of biological activity of APVO436 with one patient in cohort 4 experiencing a reduction in bone marrow blasts and a change in their tumor from a complex genotype to a simpler mutation type, a potential early indication of clinical activity despite relatively low drug concentrations at these levels. We are very encouraged by the early evidence of clinical activity and excited to continue to advance the clinical development of APVO436 for patients with AML."
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 Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society® (LLS) is a global leader in the fight against cancer. The LLS mission: cure leukemia, lymphoma, multiple myeloma, and improve the quality of life of patients and their families. LLS funds lifesaving blood cancer research around the world, provides free information and support services, and is the voice for all blood cancer patients seeking access to quality, affordable, coordinated care.
Founded in 1949 and headquartered in Rye Brook, NY, LLS has chapters throughout the United States and Canada. To learn more, visit www.LLS.org. Patients should contact the Information Resource Center at (800) 955-4572, Monday through Friday, 9 a.m. to 9 p.m., ET.
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.
Senior Director, Investor Relations and Corporate Communications
SOURCE: Aptevo Therapeutics