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Friday, September 1, 2017

Aptevo Therapeutics (APVO)

Aptevo Therapeutics and MorphoSys (MPSYY) end joint development and commercialization agreement for MOR209/ES414; Aptevo regains worldwide rights - preliminary phase I data show markedly lower anti-drug antibody titers
  • Co announced the end of its partnership with MorphoSys AG for the joint worldwide development and commercialization of MOR209/ES414, a targeted immunotherapeutic for the treatment of metastatic castration resistant prostate cancer (mCRPC). Aptevo will regain worldwide development and commercialization rights for MOR209/ES414 (now known as APVO414) and intends to continue to advance APVO414 through the completion of Stage 1 of an ongoing Phase 1 continuous infusion, dose-escalation clinical study evaluating the safety, tolerability and clinical activity of escalating doses of APVO414 in patients with mCRPC.
  • In the initial cohorts of the Phase 1 dose escalation study, twelve patients with mCRPC were treated with weekly intravenous infusions of APVO414. Seven of these patients (58%) developed ADA with very high titers (as high as 1:250,000). None of the patients had any adverse reactions due to the ADA, but patients with high ADA titers cleared the drug from their blood to undetectable levels. The amended protocol utilizes continuous intravenous infusion and two cohorts of patients have completed dosing without any dose limiting toxicities. Three of six patients (50%) developed ADA but with markedly lower titers of ADA (1:160 or 1:320). Additionally, drug was detected in the serum of all patients.

Aptevo Therapeutics also signs agreement for up to $74.5 million to sell hyperimmune commercial products; provides significant non-dilutive funding to execute R&D Strategy
  • Co has agreed to sell its three marketed hyperimmune products, WinRho SDF, HepaGam B, and VARIZIG, to Saol Therapeutics for total consideration of up to $74.5 million.
  • 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 $74.5 million, including an upfront payment of $65 million, and an additional potential milestone payment of up to $7.5 million related to the achievement of gross profit milestones. In addition, Aptevo may receive up to $2 million related to collection of certain accounts receivable after the closing.
  • The transaction is expected to be completed in 2017.Aptevo anticipates that proceeds from the sale of the three hyperimmune products will be used to (i) satisfy its current debt obligation to MidCap Financial, and (ii) advance its clinical and preclinical ADAPTIR candidates.
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