Date: 2016-10-26
Type of information: Licensing agreement
Compound: ANYARA (naptumomab estafenatox)
Company: Active Biotech (Sweden) NeoTX (Israel)
Therapeutic area: Cancer - Oncology
Type agreement: licensing development commercialisation
Action mechanism: fusion protein/immunotherapy product. ANYARA is an immunoconjugate. This fusion protein consists of one antigen binding fragment (Fab moiety of a monoclonal antibody recognizing the tumor-associated oncofetal trophoblast glycoprotein antigen 5T4) from a cancer cell binding antibody and a bacterial superantigen. The first one recognizes tumor cells and the latter is thought to bind T lymphocytes, so that the fusion protein can stimulate them to attack and kill the tumor cells recognized by the antibody part of this targeted drug.
The development of ANYARA is mainly focused on renal cell cancer. The product has been gratend orphan status in the EU for the treatment of renal cell carcinoma on 14 September 2007 (EU/3/07/480). Positive data was reported from clinical Phase I trials in lung cancer, renal cell cancer and pancreatic cancer. In July 2009, the results from two Phase I studies of ANYARA were published in the Journal of Clinical Oncology, 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.
Disease:
Details: * On October 26, 2016, Active Biotech and NeoTX Therapeutics announced that they have entered into a licensing agreement for Active Biotech's naptomumab estafenatox ("Anyara") for cancer immunotherapy. 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. 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".
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.
Financial terms: 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.
Latest news:
