Nuclea will assume all assets of Oncogene Science and responsibility for repayment of $2.5 million under an intercompany loan between Oncogene Science and Wilex. In addition, Wilex is eligible for single-digit royalties on net sales on the HER-2/neu and CAIX assays.
Concurrently and as an essential part of the overall deal, Wilex and Nuclea entered a development agreement under which Nuclea will develop an automated CAIX IVD IHC assay (CAIX Dx) to be submitted for FDA allowance under the investigational device exemption. CAIX Dx is intended to be used for patient stratification in a planned pivotal study with RENCAREXand as a potential future companion diagnostic in the adjuvant treatment of clear cell renal cell carcinoma. Nuclea will bear the costs for the development of CAIX Dx as a contribution in kind, which will lead to savings of at least $2.5 million for Wilex.
Oncogene Science specializes in serum based oncoprotein diagnostics and provides the only FDA cleared and CE marked IVD ELISA test for the measurement of serum HER-2/neu in the management and monitoring of patients with metastatic breast cancer. In addition, the company listed the CAIX IHC kit as a Class I 510(k)-exempt medical device with the FDA. This immunohistochemistry (IHC) kit is used to identify the antigen Carbonic Anhydrase IX (CAIX) which plays an important role in various types of cancer.
Nuclea identifies biomarkers and develops proprietary diagnostic assays under the brand Decision Dx that can help predict which courses of treatments will be effective for specific patients, based on their genetic makeup. Nuclea performs in vitro diagnostic assays in the area of oncology in a certified laboratory (CLIA) and also has access through its business relationships with hospitals and research institutions to patients in need of such tests. One such assay is Nuclea’s Decision Dx Fatty Acid Synthase for use in a variety of cancers.
Nuclea and Oncogene Science have been partners in marketing the serum HER-2/neu ELISA since early 2013 and had identified several synergies. The agreement includes the transfer to Nuclea of numerous distribution and marketing agreements for the marketed Oncogene Science tests and Nuclea will acquire the Good Manufacturing Practice (GMP) facility in Cambridge.
“This deal is a major step for Nuclea,” said Patrick J. Muraca, president and chief executive officer of Nuclea. “The commercial platform and the GMP facility acquired through this transaction will serve as a catalyst for the adoption of Nuclea’s Decision Dx Fatty Acid Synthase, which is currently available as a CLIA validated assay, used in clinical trials and under regulatory review.”
Professor Olaf G. Wilhelm, chief executive officer of Oncogene Science and Wilex, said, “The acquisition of Oncogene Science was driven by the CAIX assets. The future development of RENCAREX requires now a companion diagnostic based on CAIX for patient stratification. This transaction delivers not only a partner to develop and commercialise the CAIX Dx, but also further cost savings and allows Wilex to focus on its late-stage drug pipeline and ADC technology platform.”