Aptevo Therapeutics Sells IXINITY Hemophilia B Therapy for Estimated Proceeds in Excess of $100 Million
Transforms Aptevo into a ‘Pure Play' Biotechnology Company Focused on the Development of Proprietary ADAPTIR™ Bispecific Antibody Therapeutics
Strengthens Aptevo's Financial Position; Eliminates MidCap Debt Obligation; Provides Immediate Non-Dilutive Capital Extending Aptevo's Current Cash Runway
Recent Advances in Bispecific Programs Show Compelling Proof-of-Concept Clinical Data; Bispecifics Offer Key Advantages Over Other Cellular Therapies
Aptevo's Lead Bispecific Candidate APVO436 Recently Selected for Inclusion in Groundbreaking Beat AML® Master Clinical Trial
Under the terms of the sale, Medexus acquired the worldwide commercial rights to IXINITY, previously marketed by Aptevo in
"Our divestiture of IXINITY represents a transformative event for Aptevo," said
Recent advances showcased by leading pharmaceutical companies at the latest
Aptevo believes that its differentiated ADAPTIR bispecific technology platform has the potential to offer a more convenient and cost-effective solution compared to other immunotherapies such as CAR-T therapies. While these therapies have proven effective in generating robust and durable treatment responses, they remain challenging and expensive to manufacture and administer to patients. In contrast, Aptevo believes that bispecific technologies represent a simpler, more competitive ‘off-the-shelf' solution in the rapidly advancing field of cancer immunotherapy.
"As bispecifics continue to make tremendous strides forward, we are very enthusiastic about the potential of our ADAPTIR platform and our individual bispecific candidates," said
"We are also excited about the potential for our 4-1BB x 5T4 bispecific antibody candidate, ALG.APV-527, partnered with Alligator Bioscience, which we are focused on partnering for advancement into Phase 1 clinical development. Also, in late 2019 we introduced our newest investigational ADAPTIR candidate, APVO603, featuring a novel mechanism of action designed to amplify the adaptive immune response to cancer and which could have utility in the treatment of a variety of solid tumors. We are very excited about each of these molecules and the potential for our ADAPTIR technology to generate multiple novel bispecific compounds with unique mechanisms of action to engage and augment the immune response."
"With a stronger balance sheet and potential future milestone and deferred payments from IXINITY; a promising and productive technology engine - our ADAPTIR platform, and a streamlined focus, Aptevo is well-positioned to advance its core assets towards value-creating milestones and opportunities as we look forward to realizing the full potential of this robust platform," concluded
About Hemophilia B
Hemophilia B is a congenital bleeding disorder caused by a deficiency of coagulation factor IX. It affects approximately 1:25,000 male births, with approximately 4,000 persons affected in the
IXINITY is indicated for the control and prevention of bleeding episodes and for perioperative management for adults and children ≥12 years of age with hemophilia B. IXINITY is not indicated for induction of immune tolerance in patients with hemophilia B. IXINITY contains recombinant coagulation factor IX (trenonacog alfa). Trenonacog alfa is a purified single chain glycoprotein derived from Chinese hamster ovary (CHO) cells and has an amino acid sequence that is comparable to the Thr148 allelic form of plasma-derived factor IX. No human or animal proteins are added during any stage of manufacturing or formulation of IXINITY. The recombinant factor IX is purified by a chromatography purification process. The process includes three validated steps for virus inactivation and removal. The process also includes a validated manufacturing step to reduce the presence of CHO proteins in the final drug product.
Indications and Important Risk Information
IXINITY [Coagulation Factor IX (Recombinant)] Lyophilized Powder for Solution for Intravenous Injection is a coagulation factor IX (recombinant) indicated in adults and children ≥ 12 years of age with hemophilia B for control and prevention of bleeding episodes, and for perioperative management. IXINITY is not indicated for induction of immune tolerance in patients with hemophilia B. IXINITY is contraindicated in patients who have known hypersensitivity to IXINITY or its excipients, including hamster protein.
Hypersensitivity reactions, including anaphylaxis, may occur following IXINITY administration. Discontinue use of IXINITY if hypersensitivity symptoms occur and initiate appropriate treatment. Regularly evaluate patients for the development of factor IX inhibitors by appropriate clinical observations and laboratory tests. If expected factor IX activity plasma levels are not attained, or, if bleeding is not controlled as expected with a certain dose, perform an assay that measures factor IX inhibitor concentration. An association between the occurrence of a factor IX inhibitor and allergic reactions has been reported. Individuals with factor IX inhibitors may be at increased risk of severe hypersensitivity reactions or anaphylaxis if re-challenged.
Nephrotic syndrome may occur with IXINITY. Nephrotic syndrome has been reported following attempted immune tolerance induction in hemophilia B patients with factor IX inhibitors and a history of allergic reactions. Thromboembolism may occur when using IXINITY (e.g., pulmonary embolism, venous thrombosis, and arterial thrombosis). Patients may develop hypersensitivity to hamster (CHO) protein as IXINITY contains trace amounts. The most common adverse drug reaction observed in >2% of patients in clinical trials was headache.
Please see full Prescribing Information at www.IXINITY.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
Senior Director, Investor Relations and Corporate Communications