NEWTON, Mass., July 17, 2020 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), an innovation-driven pharmaceutical company, today announced that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute’s (NCI) Cancer Therapy Evaluation Program (CTEP). The CRADA will focus on advancing XPOVIO (selinexor), the Company’s first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound, which blocks the cellular protein XPO1. XPO1 plays a key role in regulating the activity of tumor suppressor proteins and other oncoproteins relevant in cancer cell biology and cancer cell survival. XPO1 may be an important, novel target in the treatment of numerous cancer types. XPO1 is frequently overexpressed in both hematologic and solid tumors, and the degree of XPO1 over-expression correlates with higher tumor grade and poor overall patient survival.
“We are looking forward to combining our expertise with those at the NCI to explore XPOVIO’s potential benefit in a wider range of cancer indications,” said Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer of Karyopharm. “The studies conducted under this partnership will be designed with the goal of identifying and optimizing combinations and indications that hold the greatest chance of clinical success. This CRADA is an important collaboration for Karyopharm as we work to realize the full potential of XPOVIO and bring this novel medicine to as many patients as possible.”
Under the terms of the CRADA, the NCI will collaborate with Karyopharm on studies to investigate the safety and efficacy of XPOVIO in various oncology indications, based on encouraging anti-tumor activity observed in earlier studies. As data from the NCI-sponsored studies and other Karyopharm-sponsored studies emerge, the NCI and Karyopharm plan to collaborate on trials to complement and support the further development of XPOVIO that could address important patient unmet medical need. The NCI may also support non-clinical studies to explore important future combinations of XPOVIO with other targeted or standard of care cancer agents.
“We are excited to work with the NCI on this new initiative which may lead to important research that could address important unmet needs for cancer patients,” stated Jatin Shah, MD, Executive Vice President and Chief Medical Officer of Karyopharm. “We believe there is tremendous opportunity for scientific advancement working with the NCI.”
XPOVIO is currently approved in the U.S. and marketed for two oncology indications: (i) in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody, and (ii) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. These indications were approved under the U.S. Food and Drug Administration’s (FDA) Accelerated Approval Program based on response rate. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. In addition to these marketed indications, Karyopharm has submitted a supplemental New Drug Application (sNDA) to the FDA requesting an expansion of its current multiple myeloma indication to include the treatment of patients with multiple myeloma after at least one prior line of therapy.
About XPOVIO® (selinexor)
XPOVIO is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). XPOVIO blocks the nuclear export of tumor suppressor, growth regulatory and anti-inflammatory proteins, leading to accumulation of these proteins in the nucleus and enhancing their anti-cancer activity in the cell. The forced nuclear retention of these proteins can counteract a multitude of the oncogenic pathways that, unchecked, allow cancer cells with severe DNA damage to continue to grow and divide in an unrestrained fashion. Karyopharm received accelerated U.S. Food and Drug Administration (FDA) approval of XPOVIO in July 2019 in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. Karyopharm has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with a request for conditional approval of selinexor in this same RRMM indication. Karyopharm submitted a supplemental New Drug Application (sNDA) to the FDA requesting an expansion of its current indication to include the treatment for patients with multiple myeloma after at least one prior line of therapy based on the positive results from the Phase 3 BOSTON study which evaluated selinexor in combination with Velcade® (bortezomib) and low-dose dexamethasone. In June 2020, Karyopharm received accelerated FDA approval of XPOVIO for its second indication in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including as a potential backbone therapy in combination with approved myeloma therapies (STOMP), in liposarcoma (SEAL) and in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.
