WILEX signs antibody license agreement with Telix Pharmaceuticals Limited
- Telix receives exclusive worldwide rights for the development and commercialization of diagnostic agent REDECTANE® (INN: 124I-Girentuximab)
- Telix also receives development rights to Girentuximab for use with therapeutic radionuclides, such as 177Lu (Lutetium)
- Telix is responsible for the manufacturing of Girentuximab for both diagnostic and therapeutic applications
- WILEX to receive upfront payment plus potential clinical and regulatory milestone payments and attractive royalties
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Munich, Germany / Melbourne, Australia, 16 January 2017 – WILEX AG (ISIN DE000A11QVV0 / WL6 / FSE) and Australian biopharmaceutical company Telix Pharmaceuticals Limited (“Telix”), today announced that they have concluded a worldwide license agreement for the development and commercialization of the imaging agent REDECTANE®, a radiolabeled form of the monoclonal antibody Girentuximab. Girentuximab binds to Carbonic Anhydrase-9 (CAIX), an antigen highly expressed on clear cell renal cell carcinoma (ccRCC) cells. Targeting and accumulation of radiolabeled-antibodies in tumor tissue can be visualized by molecular imaging with Positron Emission Tomography (PET) and has significant diagnostic and staging value in the management of renal (kidney) cancer. WILEX has successfully completed a first Phase III trial with REDECTANE® in ccRCC.
WILEX has granted Telix the worldwide licensing rights to further develop and commercialize the REDECTANE® molecular imaging program. Under the agreement, Telix will, as a first step, invest in an improved manufacturing process for the antibody. Under the terms of the agreement, WILEX is eligible to receive upfront and milestone payments totaling USD 3.7 million. In addition, WILEX is eligible to receive significant royalties on global net sales of REDECTANE®, commensurate with a Phase III asset. Telix will be responsible for all development costs, as well as manufacturing and commercialization costs.
Telix will also develop a therapeutic radioimmunoconjugate program based on Girentuximab. Early clinical data suggests that 177Lu-labeled Girentuximab has disease stabilizing effects in patients with advanced staged metastatic renal cancer. Telix is evaluating the use of CAIX-targeting therapeutic agents with both beta- and alpha-emitting radionuclides for a variety of malignancies. Under the terms of the agreement, if a therapeutic product developed by Telix is ultimately granted marketing approval, WILEX will receive single-digit royalties.
Dr Jan Schmidt-Brand, CEO / CFO of WILEX AG, said: “We are pleased to sign this licensing agreement for this promising Phase III product candidate. Telix is one of the few firms, globally, that has the experience and capability to effectively address the dual technical challenge of radiochemistry and biologics development. Telix is an ideal partner to leverage the potential of Girentuximab-based diagnostic and therapeutic radiopharmaceuticals. With this agreement, WILEX will be able to share in the future success of REDECTANE® and potentially other downstream products. This agreement also represents another important step in our strategic realignment and enables us to further focus on our innovative ATAC technology.”
Telix CEO, Dr Christian Behrenbruch, stated: “We are delighted to have partnered with WILEX to complete the development of REDECTANE®. This is a very promising product that has the potential to have a major impact on the way patients with renal cancer are diagnosed, staged and managed. We are confident of the clinical data supporting the final development and commercialization of REDECTANE® and we are pleased to add such an advanced-stage candidate to our portfolio of products.”
About REDECTANE® and the Phase III REDECT Study
REDECTANE® (INN: 124I-Girentuximab) is a radiolabeled form of the monoclonal antibody Girentuximab, which binds to the Carbonic Anhydrase-9 (CAIX) antigen, expressed on the surface of cancer cells of the clear-cell phenotype. Accumulation of this antibody in tumor tissue can be visualized by means of molecular imaging using Positron Emission Tomography (PET). Additional anatomical information provided by computer tomography (CT) can be used to localize the accumulation of the antibody. REDECTANE® has the potential to fundamentally change therapy planning for renal cancer patients, including the avoidance of unnecessary surgery. Furthermore, REDECTANE® may also prove suitable for the diagnosis, staging and treatment response assessment in other kinds of cancers, such as lung and ovarian cancer.
The Phase III REDECT trial demonstrated that REDECTANE® can differentiate between clear cell and non-clear cell renal cell cancer and that PET/CT molecular imaging with REDECTANE® was superior to CT alone. In order to obtain market authorization from the US Food and Drug Administration (FDA), REDECTANE® requires a second Phase III confirmatory study. WILEX has been granted a special protocol assessment (SPA) from the FDA for the planned confirmatory study (REDECT 2).
WILEX AG is a biopharmaceutical company based in Munich, Germany, that serves as a parent and holding company. The Company’s research and development work is conducted by its subsidiary Heidelberg Pharma GmbH in Ladenburg. Heidelberg Pharma is the first company to develop the toxin Amanitin into cancer therapies using its proprietary Antibody Targeted Amanitin Conjugate (ATAC) technology and to advance the biological mode of action of the toxin as a novel therapeutic principle. This proprietary technology platform is being applied to develop the company’s own therapeutic ATACs as well as in third-party collaborations to create a variety of ATAC candidates. The proprietary lead candidate is a BCMA ATAC for multiple myeloma. WILEX’s clinical assets MESUPRON® and REDECTANE® have been partnered, while RENCAREX® is available for out-licensing and further development. WILEX is listed on the Frankfurt Stock Exchange: ISIN DE000A11QVV0 / WKN A11QVV / Symbol WL6. More information is available at www.wilex.com.
Telix Pharmaceuticals Limited is a clinical-stage biopharmaceutical company headquartered in Melbourne, Australia. Telix is developing an advanced portfolio of clinical-stage products that address significant unmet medical needs in renal, prostate and brain (glioblastoma) cancers. Telix’s pipeline consists of “theranostic” radiopharmaceuticals, agents that are able to be used both diagnostically (via PET imaging) and therapeutically for patient benefit. Telix is an unlisted public company. For more information go to www.telixpharma.com.
Tel.: +49 (0)89-41 31 38-29
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MC Services AG
Katja Arnold (CIRO)
Managing Director & Partner
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Telix Pharmaceuticals Limited
Dr Christian Behrenbruch
Tel.: +61 (0)406063247
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