Novartis rescinds rights to to develop and commercialize multi-tyrosine kinase inhibitor dovitinib due to a material breach by Allarity for lack of financial payment.
Novartis is terminating its agreement with Allarity Therapeutics, Inc. for the exclusive global rights to develop and commercialize the cancer drug dovitinib due to a material breach by Allarity to keep up with its payments, according to an SEC filing.1 Under the prior name of Oncology Venture, Allarity reached an agreement in 2018 to license dovitinib (TKI258), a small molecule multi-tyrosine kinase inhibitor (TKI), which previously showed promise treating metastatic renal cell carcinoma (mRCC).2
“On January 26, 2024, we received written notice from Novartis indicating their decision to terminate the Agreement based on material breach for lack of financial payment. The termination took effect on January 26, 2024,” Allarity wrote in the filing to the SEC.1
In the filing, Allarity said it would shift its focus to the development of the PARP inhibitor stenoparib, which showed promising data in a Phase II trial treating patients with ovarian cancer.3
“As we disclosed on December 5, 2023, we received encouraging results,” Allarity stated in the SEC filing. “Specifically, that of five evaluable patients included in the initial data analysis, one patient experienced a complete response and the other four demonstrated stable disease.”1
In its announcement of the agreement with Novartis, Allarity noted that dovitinib showed therapeutic equivalence with sorafenib in earlier stage studies across multiple indications, including liver cancer, breast cancer, and other solid tumors.
“Dovitinib has demonstrated clinically relevant efficacy in renal cancer and breast cancer and good efficacy in several other solid tumors, and we are excited to accelerate the development of the compound,” said Peter Buhl Jensen, MD, CEO of Medical Prognosis Institute, in a press release at the time. “We are confident that, by using our Drug Response Predictor (DRP) biomarker for dovitinib to select likely responder patients—and the recent success with a combination of a TKI and a PD-1 inhibitor (Keytruda) in renal cancer—we will raise the chances of success for dovitinib in further clinical development.”2
However, on February 18, 2022, Allarity announced that the FDA issued a Refusal to File letter for the new drug application for dovitinib, along with the accompanying pre-market approval application for its DRP-dovitinib companion diagnostic, in the third-line treatment of mRCC.4
“We remain highly confident in the clinical profile of dovitinib, together with the DRP-Dovitinib companion diagnostic, and remain committed to advancing this product candidate as a potential new treatment option for individuals with mRCC,” said former Allarity CEO Steve Carchedi in a press release. “We are fully determined to work with the FDA staff as quickly as possible to address the open issues and clarify the path to successfully re-filing our applications.”4
Carchedi stepped down from the company “to pursue other opportunities” in June 2022, with James G. Cullem, JD, moving from chief business officer to interim CEO.5
In December 2023, Allarity announced that Cullem was leaving the company. In the SEC filing, Allarity stated that Cullem was fired for cause under his employment agreement, whereas Cullem stated he was resigning as a result of actions by the company’s leadership.
“In the Resignation Email, Mr. Cullem stated that he was resigning from his position as our director due to acts and omissions by our Chairman of the Board and the other directors that he considered directly injurious to us, our stockholders, and our creditors,” Allarity stated in the SEC filing. “As previously disclosed, on December 8, 2023, Mr. Cullem was terminated as our Chief Executive Officer for ‘cause’ under his employment agreement. In addition, Mr. Cullem was also terminated from all other officer positions with us and all other positions with our subsidiaries. Mr. Cullem has indicated that his termination should be ‘without cause.’ Under Mr. Cullem’s employment agreement, disputes are subject to mediation.”1
With the termination of the licensing agreement, the rights to dovitinib have reverted back to Novartis, who has yet to announce any future plans to further develop the drug.
1. Form 8-K. United States Securities and Exchange Commission. January 26, 2024. Accessed February 2, 2024. https://www.sec.gov/ixviewer/ix.html?doc=/Archives/edgar/data/1860657/000121390024009034/ea192600-8k_allarity.htm
2. MPI – Oncology Venture exercises option to inlicense Dovitinib a Phase 3 Multi Tyrosine Kinase Inhibitor. Oncology Venture. News release. April 9, 2018. Accessed February 2, 2024. https://investors.allarity.com/news/news-details/2018/MPI--Oncology-Venture-exercises-option-to-inlicense-Dovitinib-a-Phase-3-Multi-Tyrosine-Kinase-Inhibitor-04-09-2018/default.aspx
3. Allarity’s Early Phase 2 Stenoparib Data Indicates Clinical Benefit in Women with Advanced Ovarian Cancer Selected with DRP® Companion Diagnostic. Allarity Therapeutics, Inc. December 5, 2023. Accessed February 2, 2024. https://investors.allarity.com/news/news-details/2023/Allaritys-Early-Phase-2-Stenoparib-Data-Indicates-Clinical-Benefit-in-Women-with-Advanced-Ovarian-Cancer-Selected-with-DRP-Companion-Diagnostic/default.aspx
4. Allarity Therapeutics Receives Refusal to File Letters from U.S. FDA. Allarity Therapeutics. News release. February 18, 2022. Accessed February 2, 2024. https://investors.allarity.com/news/news-details/2022/Allarity-Therapeutics-Receives-Refusal-to-File-Letters-from-U.S.-FDA/default.aspx
5. Allarity Therapeutics Announces Executive Leadership Transition. News release. Allarity Therapeutics. June 29, 2022. Accessed February 2, 2024.