On October 26, 2016 Active Biotech AB (NASDAQ OMX NORDIC: ACTI) and NeoTX Therapeutics Ltd. reported that they have entered into a licensing agreementfor Active Biotech’s investigational compound Naptomumab estafenatox ("ANYARA") for cancer immunotherapy (Press release, Active Biotech, OCT 26, 2016, View Source [SID1234523671]). NeoTX will be responsible for the worldwide clinical development and commercialization of the drug.This partnership is a key milestone in NeoTX’s strategy to bring tumor recognition enhancing therapeutics to the market.
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"We are very enthusiastic about our collaboration with Active Biotech. At NeoTX, we are strongly committed to developing innovative immunotherapies for unmet medical needs. "Active Biotech brings to our collaboration outstanding scientific and intellectual capital, and a powerful commitment to positively impact the treatment of cancer," said Asher Nathan, Chief Executive Officer of NeoTX.
Dr. Marcel Rozencweig, Chief Medical Officer of NeoTX and former Head of Global Clinical Oncology Research at BMS said "We are looking forward to developing ANYARA for immuno-oncology applications. We believe that the ANYARA technology is well suited to increase tumor recognition by the immune system and has demonstrated synergistic activity in combination with checkpoint inhibitors in animal models. As such, ANYARA would be attractive in combination with checkpoint inhibitors whose efficacy can be limited by poor tumor recognition".
"We are excited about the partnership with NeoTX, who we consider as an ideal partner for ANYARA. This partnership constitutes the next step in the clinical development, as well as the commercialization strategy, for the project." said Tomas Leanderson, President & CEO of Active Biotech.
About the agreement
Under the terms of the agreement, Active Biotech grants NeoTX exclusive rights to develop and commercialize ANYARA worldwide in cancer indications. The total deal value amounts to $71 million and is contingent upon achievement of clinical, regulatory and commercial milestones whereof Active Biotech will receive $250 000 as an initial payment upon signing. In addition, NeoTX will pay Active Biotech progressive, double-digit royalties on its net sales.
About ANYARA
ANYARA is a TTS (Tumor Targeting Superantigen) compound that increases the ability of the immune system to recognize the tumor. Synergy has been reported in vivo with a combination of ANYARA and a checkpoint inhibitor in an experimental tumor model. Clinically, the development of ANYARA has primarily been focused on cancer indications with a high unmet medical need. Positive data was reported from clinical Phase I trials in lung cancer, renal cell cancer and pancreatic cancer, where ANYARA was studied both as a single agent (monotherapy) and in combination with an established tumor therapy – docetaxel (Taxotere) – in patients with advanced cancer. The results showed that ANYARA was well tolerated both as monotherapy and in combination with docetaxel, and increased tumor recognition by T cells.
A Phase 2/3 trial of ANYARA in combination with interferon alpha in renal cell cancer demonstrated acceptable safety but did not meet its primary efficacy endpoint in the ITT population. The upcoming clinical trial will be done in combination with drugs that inhibit checkpoint dampening of the immune system, a combination strategy in line with the mode of action of ANYARA and supported by preclinical data.