Proceeds raised will support the clinical development of PVX-410, currently being studied in patients with smoldering multiple myeloma (SMM), an asymptomatic stage of MM. To date, 12 patients have been treated with vaccine alone in the ongoing Phase 1/2a clinical trial of PVX-410, and the trial has been expanded to include a second treatment arm adding concurrent courses of lenalidomide. Lenalidomide, which is commercially available for the treatment of MM, is an immunomodulatory agent that may complement the mechanism of action of PVX-410. It has demonstrated clinical benefit when combined with dexamethasone in a Phase 3 clinical study treating patients with SMM.1
“We are delighted to have received financial support from both existing and new investors, including LLS. Their investment translates directly into advancing the only clinical stage immunotherapy for SMM patients, whose current treatment paradigm is routine monitoring for progression through watchful waiting,” said
“LLS remains committed to the advancement of promising new treatment options for patients with blood cancers, including those with asymptomatic SMM,” said
About the PVX-410 Phase 1/2a Clinical Trial
OncoPep’s Phase 1/2a clinical trial is an open label, dose escalation study designed to evaluate the safety and tolerability of PVX-410, alone and in combination with lenalidomide, for the treatment of patients with smoldering multiple myeloma. While the primary endpoint is evaluating safety, secondary endpoints are measuring immune and clinical response to the vaccine.
In a dose escalation arm of the study, patients received either a 0.4 mg or 0.8 mg dose of PVX-410 over 10 weeks in six bi-weekly subcutaneous injections along with the adjuvant poly ICLC. Patients receiving only PVX-410 completed active treatment and are currently in follow up.
Patients who currently enroll in the trial are assigned to a second arm, in which patients receive PVX-410, adjuvant and lenalidomide. These patients concurrently receive the 0.8 mg dose of PVX-410 over 10 weeks and three, 21-day courses of orally administered lenalidomide.
The treatment centers include the cancer centers at
The Leukemia & Lymphoma Society® (LLS) is the world's largest voluntary health agency dedicated to blood cancer. The LLS mission: Cure leukemia, lymphoma, Hodgkin’s disease and myeloma, and improve the quality of life of patients and their families. LLS funds lifesaving blood cancer research around the world, provides free information and support services, and is the voice for all blood cancer patients seeking access to quality, affordable, coordinated care.
Founded in 1949 and headquartered in
1Mateos, et al. N Engl J Med. (2013) 369(5): 438-47.