Business Update
APVO436
APVO436, Aptevo's CD3 x CD123 bispecific, is currently in clinical development for the treatment of acute myeloid leukemia (AML), of which there are approximately 20,000 new diagnoses and 11,000 deaths annually
In 2023, the Company concluded a multi-center, multi-cohort dose expansion study. Trial results showed a 91% clinical benefit rate in combination with venetoclax + azacitidine in venetoclax naive patients, a less than 30% incidence of CRS across all trial cohorts (the majority were grades 1 &2) and meaningful duration of remission, including three patients who transitioned to transplant after receiving therapy. Transplant is the best possible outcome for AML patients
Upon review of this data and in consultation with the FDA, Aptevo intends to initiate an open- label Phase 1b/2 trial in 1H24 to further evaluate APVO436 in combination with the current standard of care, venetoclax + azacitidine, in frontline, venetoclax naive AML patients
The first part of the trial consists of a Phase 1b dose optimization study that will explore multiple doses of APVO436 in combination with venetoclax + azacitidine and is expected to add to the existing body of clinical data supporting further development of APVO436 in AML
The Company plans to report interim data in late 2H24
'We are excited about our results and have compiled a significant body of data around APVO436 based on the trials we have completed to date. For example, we know it is safe, well tolerated, clinically active and shows a favorable duration of remission. For the next step in our APVO436 clinical program, we will target frontline AML patients who are venetoclax treatment naive. Other populations that may benefit from APVO436, and therefore could be the focus of future clinical trials, include patients with relapsed/refractory AML and patients with myelodysplastic syndrome, both populations having been explored in earlier phases of APVO436 development. For the upcoming frontline trial, we know that the right combination is APVO436 + venetoclax + azacitidine and we have a targeted dose range. This upcoming Phase 1b/2 trial will allow us to further optimize and de-risk the regimen as it progresses to later stage development,' said
ALG.APV-527
ALG.APV-527 is a 5T4 x 4-1BB bispecific currently being evaluated in a multi-cohort, multi-center Phase 1 dose escalation trial initiated in 2023 for multiple solid tumor types representing large patient populations with significant unmet medical needs
The goal of the dose escalation trial is to evaluate safety and tolerability, and to evaluate the compound for signs of clinical activity
ALG.APV-527 is designed to overcome the safety issues of other 4-1BB agonists by 5T4-dependent immune activation. In cytokine release assays performed as part of IND-enabling studies, the Company found no evidence of increased cytokine release, that can lead to potentially serious side effects, in vitro using human peripheral blood mononuclear cells or whole blood
The Company believes ALG.APV-527 has the potential to be clinically important because 4-1BB can stimulate the immune cells (tumor-specific T cells and NK cells) involved in tumor control
Aptevo expects to provide an interim data readout in 1H24
'We are pleased with the progress of the ALG.APV-527 Phase 1 clinical program. We believe this drug has the potential to impact patients in large patient populations that are significantly underserved by available treatment options,' said
2023 Summary Financial Results
Cash Position: Aptevo had cash and cash equivalents as of
Royalty Revenue: Royalty revenue for the period covered by this report reflects revenue recorded only in the first quarter of 2022 due to our Amendment to Royalty Purchase Agreement with HCR. As a result of the amendment, we ceased reporting as royalty revenue, royalties paid by
Research and Development Expenses: Research and development expenses decreased by
General and Administrative Expenses: General and administrative expenses decreased by
Other Income (Expense) Net
Other Income (Expense) from Continuing Operations, Net consists of other income, net of
Gain Related to Sale of Non-Financial Asset consists of a
Gain on extinguishment of liability related to sale of royalties covered by this report reflects a gain of
Milestone income related to sale of royalties related to
Discontinued Operations: Income from discontinued operations was
Net Income (Loss): Aptevo had a net loss of
About
Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, without limitation, Aptevo's expectations about the activity, efficacy, safety, tolerability and durability of its therapeutic candidates and potential use of any such candidates, including in combination with other drugs, as therapeutics for treatment of disease, its expectations regarding the effectiveness of its ADAPTIR and ADAPTIR-FLEX platforms, statements related to the progress of Aptevo's clinical programs, including statements related to anticipated clinical and regulatory milestones such as Phase 1b/2 trial initiation for APVO436 in frontline, venetoclax naive AML patients, whether further study of APVO436 in a Phase 1b dose optimization trial focusing on multiple doses of APVO436 in combination with venetoclax + azacitidine on a targeted patient population will continue to show clinical benefit, whether Aptevo's final trial results will vary from its earlier assessment, the possibility and timing of interim data readouts for ALG.APV-527, statements related to Aptevo's cash position and balance sheet, statements related to Aptevo's ability to generate stockholder value, whether Aptevo will continue to have momentum in its business in the future, and any other statements containing the words 'may,' 'continue to,' 'believes,' 'knows,' 'expects,' 'optimism,' 'potential,' 'designed,' 'promising,' 'plans,' 'will' and similar expressions are intended to identify 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.
There are several 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; further assessment of preliminary or interim data or different results from later clinical trials; adverse events and unanticipated problems, adverse developments in clinical development, including unexpected safety issues observed during a clinical trial and changes in regulatory, social, macroeconomic 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 results of preliminary or interim data and preclinical studies being predictive of the results of later-stage clinical trials, initiation, enrollment and maintenance of patients, and the completion of clinical trials, the availability and timing of data from ongoing clinical trials, the trial design includes combination therapies that may make it difficult to accurately ascertain the benefits of APVO436, 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 or raise funds on acceptable terms or at all and other matters that could affect the availability or commercial potential of Aptevo's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the coronavirus, geopolitical risks, including the current war between
Contact:
Email: IR@apvo.com
Tel: 206-859-6628
(C) 2024 Electronic News Publishing, source