Exelixis In-Licenses Aurigene’s Novel CDK7 Inhibitor and Files Investigational New Drug Application for Phase 1 Clinical Trial in Advanced Solid Tumors

Exelixis, Inc. (Nasdaq: EXEL) and Aurigene today announced that Exelixis has exercised its exclusive option for Aurigene’s novel CDK7 inhibitor under the companies’ July 2019 agreement. Exelixis has now assumed responsibility for the future clinical development, commercialization, and global manufacturing of the compound now known as XL102 (formerly AUR102). Exelixis also announced that it has submitted an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) to evaluate XL102 alone or in combination therapy for the treatment of inoperable locally advanced or metastatic solid tumors. XL102 is a potent, selective, and orally bioavailable covalent inhibitor of cyclin-dependent kinase 7 (CDK7), which is an important regulator of the cellular transcriptional and cell cycle machinery. Aurigene presented positive preclinical data demonstrating that XL102 has potent anti-proliferative activity and induces cell death in a large panel of cancer cell lines at the 32^nd EORTC-NCI-AACR (ENA) Symposium (Abstract 170) in October 2020.

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“With single-agent and combination potential across a variety of forms of cancer, XL102 is an important addition to the growing Exelixis pipeline,” said Peter Lamb, Ph.D., Executive Vice President and Chief Scientific Officer of Exelixis. “Aurigene has done an excellent job advancing the program and maintaining development timelines during a year in which global biopharmaceutical research came under pressure from COVID-19. We are excited to begin clinical development for XL102 following the FDA’s recent acceptance of our IND. As we maximize the opportunity for cabozantinib, our lead medicine, we are committed to building a diversified high-value pipeline with the potential to become novel medicines that could one day help patients with cancer recover stronger and live longer.”

“Exelixis’ decision to in-license XL102 and file its IND with the FDA provides important validation of Aurigene’s discovery and preclinical development capabilities and the value of our partnership with Exelixis overall,” said Murali Ramachandra, Ph.D., Chief Executive Officer of Aurigene. “The preclinical data generated to date for XL102 demonstrate that this novel CDK7 inhibitor is orally available and has significant potential to improve care and outcomes for patients with diverse cancer indications, including breast cancer, prostate cancer, leukemia, and lymphoma. We continue to generate additional data from the other programs that are part of our partnership with Exelixis and believe that these programs will provide additional value-creating opportunities for both companies.”