Xpovio (selinexor), a treatment for advanced multiple myeloma, may soon be available in Israel and the Palestinian Authority through Promedico, under an exclusive distribution agreement announced by the treatment’s maker, Karyopharm Therapeutics.
Under the agreement, Promedico has exclusive rights to commercialize Xpovio in these territories, and will carry out the regulatory filings and obligations needed to register the treatment.
Karyopharm holds exclusive production rights for Xpovio, and will provide the therapy for commercial use.
“The addition of Xpovio fits our portfolio of innovative oncology products designed to treat diseases with significant unmet need,” Avishay Zlotnik, the chief executive officer of Promedico, a subsidiary of Neopharm, said in a press release.
Xpovio, an oral treatment, works by increasing the amount of tumor suppressor proteins in the nucleus of cells, potentiating the death of damaged or malignant cells.
Cells contain several or these proteins, which play a key role in ensuring that a cell is healthy can proceed with cell division. If it isn’t, these proteins stop the division process, and either repair the damage or signal for the cell to be destroyed in a process called programmed cell death.
In cancer, mutations in genes encoding for these suppressor proteins allow cell division to get out of control, and for damaged cells to survive and proliferate, eventually leading to malignancy.
Myeloma cells also get rid of suppressor proteins by exporting them out of their nucleus, where they need to be to work as intended. This is achieved by increasing the levels of a protein called exportin 1 or XPO1.
Xpovio is a first-in-class oral inhibitor of XPO1, designed to prevent tumor suppressor proteins from leaving the nucleus, where they can promote cancer cell death. Healthy cells are not believed to be affected by Xpovio.
Xpovio is conditionally approved in the U.S., in combination with dexamethasone, for people with relapsed or refractory multiple myeloma who were treated with, but failed to respond to, at least four prior therapies.
The approval was based on data from the open-label Phase 2b STORM trial (NCT02336815), which showed a 25% response rate in patients who had already failed to respond to therapy with two proteasome inhibitors, Velcade (bortezomib) and Kyprolis (carfilzomib), two immunomodulatory agents, Revlimid (lenalidomide) and Pomalyst (pomalidomide), and the anti-CD38 monoclonal antibody Darzalex (daratumumab).
An ongoing Phase 3 trial — called BOSTON (NCT03110562) — aims to confirm the therapy’s benefits, when used in combination with Velcade and low-dose dexamethasone. If proven effective, Xpovio is likely to receive full FDA approval.
“Neopharm companies have a proven track record of successfully commercializing new therapeutics in Israel, making them an ideal partner to further expand the global reach of Xpovio,” said Sharon Shacham, the founder, president and chief scientific officer of Karyopharm.
“We look forward to working with their world-class team to bring XPOVIO to cancer patients in need of novel therapies,” Shacham added.
In addition to pre-specified payments, Karyopharm is eligible for additional payments if certain regulatory and commercial goals are achieved by Promedico, as well as royalties on future net sales of Xpovio.