− Anivive Aims to Develop and Commercialize Verdinexor for the Treatment of Cancer in Companion Animals –
− Karyopharm to Receive $1 Million Upfront Payment, Then Eligible to Receive Up To $43.5 Million in Future Milestones, Plus Royalties –
NEWTON, Mass., May 03, 2017 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, and Anivive Lifesciences, a privately-held biotech company focused on innovations in the veterinary drug and bioinformatics space, today announced their entry into a licensing agreement whereby Anivive licensed from Karyopharm exclusive worldwide rights to research, develop and commercialize verdinexor (KPT-335) for the treatment of cancer in companion animals.
Under the terms of the agreement, Anivive will make a one-time upfront payment of $1 million to Karyopharm. Karyopharm is eligible to receive up to $43.5 million dollar payments from future regulatory, clinical and commercial milestones, assuming approval in both the United States (US) and the European Union (EU). In addition, Anivive agreed to pay Karyopharm up to low double-digit royalty payments based on future net sales of verdinexor.
“We admire Anivive’s passion and dedication to innovation in the discovery and development of new veterinary medicines in the rapidly growing companion animal health marketplace,” said Michael G. Kauffman, MD, PhD, Chief Executive Officer of Karyopharm. “Anivive has the expertise and resources to advance cutting-edge drug candidates like verdinexor toward becoming a potential new treatment for companion animals that may benefit from it. Therefore, we believe Anivive is the ideal partner to maximize verdinexor’s value in veterinary medicine and look forward to working with them on future animal health technologies. This partnership enables us to monetize our non-core assets, as we continue to focus on advancing the development of selinexor in our lead human indications of multiple myeloma, lymphoma and liposarcoma.”
Dylan Balsz, Founder and Chairman of Anivive Lifesciences, commented, “We strive to identify and develop the most innovative and promising new therapies for pets, and we are highly encouraged by the clinical data Karyopharm has generated to date for verdinexor in canine lymphoma, as well as the overall potential of this promising compound.” Kwansun Ahn, Chief Executive Officer of Anivive Lifesciences remarked, “We look forward to working with the team at Karyopharm and to building a strong, long-lasting relationship.”
About Verdinexor (KPT-335)
Verdinexor (KPT-335) is a novel, oral Selective Inhibitor of Nuclear Export (SINE™) compound being evaluated for the treatment of canine cancers, including lymphoma. The U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) has found the effectiveness and safety technical sections for verdinexor complete to support conditional approval under a New Animal Drug Application (NADA) for the treatment of canine lymphoma. The use of verdinexor to treat canine lymphoma has been designated a "minor use" in accordance with the Minor Use Minor Species (MUMS) Act. This makes the product eligible for conditional approval similar to orphan drug/accelerated approvals used for submissions of human therapeutics. Karyopharm's SINE™ compounds, including selinexor (KPT-330) currently being tested in humans with advanced cancers, and verdinexor, inhibit the nuclear export function of Exportin-1 (XPO1 or CRM1). This inhibition prevents the export of tumor suppressor proteins and leads to their accumulation in the nucleus, which reinitiates and amplifies their natural apoptotic function. Nuclear localized tumor suppressor proteins detect cancer-associated DNA damage, leading to the selective apoptosis of cancer cells; normal cells, which do not have significant DNA damage, are spared.
About Karyopharm Therapeutics
Karyopharm Therapeutics Inc. (Nasdaq:KPTI) is a clinical-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport and related targets for the treatment of cancer and other major diseases. Karyopharm's SINE™ compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). The Company's initial focus is on seeking regulatory approval and commercialization of its lead drug candidate, oral selinexor (KPT-330). To date, over 2,000 patients have been treated with selinexor and it is currently being evaluated in several mid- and later-phase clinical trials across multiple cancer indications, including multiple myeloma in combination with low-dose dexamethasone (STORM) and backbone therapies (STOMP), diffuse large B-cell lymphoma (SADAL), and liposarcoma (SEAL), among others. Karyopharm plans to initiate a pivotal randomized Phase 3 study of selinexor in combination with bortezomib (Velcade®) and low-dose dexamethasone (BOSTON) in patients with multiple myeloma in early 2017. In addition to single-agent and combination activity against a variety of human cancers, SINE™ compounds have also shown biological activity in models of neurodegeneration, inflammation, autoimmune disease, certain viruses and wound-healing. Karyopharm, which was founded by Dr. Sharon Shacham, currently has five investigational programs in clinical or preclinical development. For more information, please visit www.karyopharm.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding the licensing agreement with Anivive Lifesciences and the therapeutic potential of and potential clinical development plans for Karyopharm's drug candidates, including the timing of initiation of certain trials and of the reporting of data from such trials. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from Karyopharm’s current expectations. For example, there can be no guarantee that any of Karyopharm's SINE™ compounds, including selinexor (KPT-330), will successfully complete necessary preclinical and clinical development phases or that development of any of Karyopharm's drug candidates will continue. Further, there can be no guarantee that any positive developments in Karyopharm's drug candidate portfolio will result in stock price appreciation. Management's expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: Karyopharm's results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies, including with respect to the need for additional clinical studies; Karyopharm's ability to obtain and maintain requisite regulatory approvals and to enroll patients in its clinical trials; unplanned cash requirements and expenditures; development of drug candidates by Karyopharm's competitors for diseases in which Karyopharm is currently developing its drug candidates; and Karyopharm's ability to obtain, maintain and enforce patent and other intellectual property protection for any drug candidates it is developing. These and other risks are described under the caption "Risk Factors" in Karyopharm's Annual Report on Form 10-K for the year ended December 31, 2016, which was filed with the Securities and Exchange Commission (SEC) on March 16, 2017, and in other filings that Karyopharm may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by law, Karyopharm expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.