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Provides Significant Non-Dilutive Funding to Execute R&D Strategy
Sharpens Focus on Proprietary ADAPTIR™ Protein Therapeutic Platform
Retains IXINITY® Commercial Asset
Under the terms of a definitive purchase agreement executed by the companies, Saol Therapeutics will acquire the three hyperimmune products currently marketed by Aptevo: WinRho SDF for autoimmune platelet disorder and hemolytic disease of the newborn; HepaGam B for the prevention of Hepatitis B following liver transplantation and for treatment following hepatitis B exposure; and VARIZIG for treatment following exposure to varicella zoster virus for individuals with compromised immune systems. The transaction is valued at up to
“We’re extremely pleased to announce our agreement with Saol Therapeutics for the sale of our hyperimmune commercial products. The significant non-dilutive funding provided by this transaction will ensure that Aptevo continues to be solidly capitalized to invest in the opportunities where we see the most potential for long-term value creation for our stockholders,” said
“Our ADAPTIR platform has generated a rich pipeline of novel immunotherapeutic candidates targeting oncology and autoimmune indications. With bispecific antibodies gaining increasing recognition in the scientific and financial communities as the ‘next-generation’ of therapeutic antibodies, we believe that continued investment in this promising technology platform may yield enhanced value for our stockholders. Importantly, this transaction strengthens Aptevo’s cash position and provides us the necessary resources to continue to advance our ADAPTIR product candidates through potentially value-adding inflection points, including an ongoing dose-escalation Phase 1 study of APVO414 in metastatic castration resistant prostate cancer; an ongoing Phase 2 clinical program for otlertuzumab, and future Phase 1 clinical studies of our novel bispecifics focused on engaging the immune system, including, APVO436 and ALG.APV-527, a bispecific targeting ROR1, and a bispecific based on targeted cytokine delivery, APVO210 (formerly known as ES210.)”
The transaction, which is expected to be completed in 2017, is subject to certain customary closing conditions.
In addition to its three marketed hyperimmune products, WinRho SDF, HepaGam B, and VARIZIG, which are the subject of the agreement with Saol Therapeutics, Aptevo owns and markets IXINITY®, an intravenous recombinant factor IX therapeutic for use in people with Hemophilia B.
Aptevo Portfolio: Commercial and Investigational Products
- IXINITY® – an intravenous recombinant factor IX therapeutic for use in people with Hemophilia B – a hereditary bleeding disorder characterized by a deficiency of clotting factor IX in the blood, which is necessary to control bleeding. IXINITY was launched in 2015 and is marketed in
the United Statesby Aptevo.
- APVO414 – a bispecific ADAPTIR candidate, currently in Phase 1 development, targeting prostate specific membrane antigen (PSMA), an enzyme that is expressed on the surface of prostate cancer cells, and, CD3, a component of the T cell receptor complex expressed on all T cells. APVO414 redirects T cells to specifically kill PSMA expressing tumors and is being developed for metastatic castration-resistant prostate cancer, which is advanced prostate cancer that has spread to other organs and no longer responds to hormone blocking therapies.
- Otlertuzumab – a monospecific ADAPTIR candidate currently in Phase 2 development for the treatment of chronic lymphocytic leukemia (CLL). Data from a Phase 2 clinical trial evaluating otlertuzumab in combination with bendamustine, compared to bendamustine alone, demonstrated a significant increase in median progression free survival for the combination, from approximately 10 to 16 months.
- APVO436 – a bispecific ADAPTIR candidate currently in preclinical development targeting CD123, a cell surface receptor highly expressed on several hematological malignancies and CD3, a component of the T-cell receptor. APVO436 is designed to engage T cells to kill tumor cells.
- ALG.APV-527 – 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. 4-1BB, a costimulatory receptor on T cells, is known to enhance the immune response to cancer through activation of tumor-specific T cells and is believed to be a promising target for new immunotherapeutic approaches. ALG.APV-527 could potentially have utility in the treatment of a broad spectrum of cancers over-expressing the tumor antigen, including breast, cervical, non-small-cell-lung, prostate, renal, gastric, colorectal and bladder cancers.
- APVO210 – a bispecific ADAPTIR preclinical candidate with a novel mechanism of action based on targeted cytokine delivery. APVO210 is composed of a humanized anti-CD86 antibody fused with a modified form of IL-10 that specifically induces IL-10 signaling on antigen presenting cells, but not on lymphoid populations. APVO210 functions by suppressing immune responses and inducing certain tolerogenic responses and therefore may have potential benefit for the treatment of autoimmune and inflammatory diseases.
- ROR1 Bispecific – a proof-of-concept bispecific candidate targeting ROR1, an antigen found on several solid tumors and hematologic, or blood-related malignancies. Initial preclinical data demonstrate redirected T cell killing of tumors expressing ROR1 in vitro and in vivo in animal models.
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 the closing of the anticipated sale of the hyperimmune products to Saol Therapeutics, Aptevo’s use of proceeds from such transaction, Aptevo’s outlook, financial performance or financial condition, Aptevo’s 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 Aptevo’s actual results to differ materially from those indicated by such forward-looking statements, including uncertainties as to the satisfaction of closing conditions with respect to the transaction; closing of the transaction may not occur or may be delayed, either as a result of litigation related to the transaction or otherwise; possible negative effects on Aptevo’s business operations, assets or financial results as a result of the transaction; a deterioration in Aptevo’s business or prospects; the parties may be unable to achieve the anticipated benefits of the transaction; 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
For Further Information:
Aptevo Therapeutics Stacey JurchisonSenior Director, Investor Relations and Corporate Communications 206-859-6628 JurchisonS@apvo.com