Funding to support expanded clinical development of PVX-410 in combination with lenalidomide in patients with smoldering multiple myeloma
Financing includes equity investment from The Leukemia & Lymphoma Society
August 28, 2014
OncoPep, Inc., today announced the closing of $6.9 million in Series B financing from new and existing investors. The financing included participation from angel groups, family foundations and individuals, as well as equity investment from The Leukemia & Lymphoma Society (LLS). LLS’ decision to participate in the financing round resulted from a review of OncoPep’s application for funding from LLS’ Therapy Acceleration Program (TAP), which identifies therapies that have the potential to change the standard of care for patients with blood cancers. OncoPep’s lead cancer vaccine, PVX-410, is designed to target tumor antigens associated with multiple myeloma (MM), a cancer of the plasma cells, and was granted orphan drug designation from the U.S. Food and Drug Administration in 2013.
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 Doris Peterkin, president and chief executive officer of OncoPep. “We also welcome the addition of Keting Chu, M.D., Ph.D., the vice president of research of TAP, to OncoPep’s Scientific Advisory Board.”
“LLS remains committed to the advancement of promising new treatment options for patients with blood cancers, including those with asymptomatic SMM,” said Lee Greenberger, Ph.D., chief scientific officer of LLS. “Every dollar we invest in the development of potential novel treatments brings us closer to our goal of curing leukemia, lymphoma, multiple myeloma and other blood cancers.”
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 Massachusetts General Hospital (Boston), Dana Farber Cancer Institute (Boston), Beth Israel Deaconess Hospital (Boston), MD Anderson Cancer Center (Houston) and Winship Cancer Institute of Emory University (Atlanta). More information on this study can be found at www.clinicaltrials.gov (Identifier: NCT01718899).
About The Leukemia & Lymphoma Society
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 White Plains, NY, LLS has chapters throughout the United States and Canada. To learn more, visit www.LLS.org. Patients should contact the Information Resource Center at (800) 955-4572, Monday through Friday, 9 a.m. to 9 p.m. ET.
OncoPep is developing targeted immunotherapeutics to prevent the progression of cancer, prolong survival and restore the quality of life of patients. OncoPep’s lead program is a multi-peptide therapeutic vaccine for use in treating smoldering multiple myeloma. www.oncopep.com
1Mateos, et al. N Engl J Med. (2013) 369(5): 438-47.