OncoPep Announces a Phase 1b Clinical Trial of its Multi-Peptide Cancer Vaccine PVX-410 in combination with Citarinostat for Smoldering Multiple Myeloma

BOSTON – August 8, 2018 – OncoPep, Inc. today announced the initiation of a Phase 1b clinical trial evaluating the safety and tolerability of PVX-410, an investigational multi-peptide cancer vaccine, for patients with smoldering multiple myeloma (SMM). Smoldering multiple myeloma is an early precursor to a rare blood cancer known as multiple myeloma, which affects plasma cells. The open-label investigator-sponsored study, led by Noopur Raje, M.D. at Massachusetts General Hospital, will assess two different combinations of the study drugs; a combination of PVX-410 along with an investigational histone deacetylase (HDAC 6) inhibitor, citarinostat (CC- 96241, Celgene) and a triple combination of the PVX-410vaccine, citarinostat, and lenalidomide.

“Currently, there are no active treatment options for smoldering multiple myeloma and standard care for patients diagnosed with SMMis ‘watchful waiting’,” said Dr. Raje, Director of the Center for Multiple Myeloma at the Massachusetts General Hospital Cancer Center and Professor of Medicine at Harvard Medical School. “This Phase 1b clinical trial will further evaluate the safety and tolerability of PVX-410in combination with the HDAC 6 inhibitor, citarinostat, with or without the immunomodulatory drug, lenalidomide, in hopes that the combination will supplement a targeted immune-mediated attack against MM cells.”

The study is expected to enroll approximately 20patients at multiple trial sites, including Massachusetts General Hospital. More information on the trial can be found at clinicaltrials.gov, identifier number NCT02886065.

“OncoPep’s Phase 1b clinical trial of PVX-410in SMM is an important advance for the multiple myeloma cancer community and we are pleased to again be working with Dr. Raje’s team,” said Doris Peterkin, Chief Executive Officer of OncoPep. “Given the extremely limited therapeutic options available for patients diagnosed with SMM who are likely to progress to multiple myeloma, we believe PVX-410has the opportunity to make a significant impact on this patient population.”

About Smoldering Multiple Myeloma
Smoldering multiple myeloma (SMM) is a plasma cell proliferative disorder with a high risk of progression to multiple myeloma (MM). It is estimated that SMM accounts for approximately 15% of all newly diagnosed cases of MM, and the annual risk of progression from SMM to symptomatic MM requiring treatment is estimated to be 10%. The current standard of care for SMM is watchful waiting, and approaches that intend to delay or prevent progression to symptomatic MM are needed.

About PVX-410
PVX-410 is a novel investigational therapeutic cancer vaccine currently in Phase 1b clinical trials in smoldering multiple myeloma and triple negative breast cancer. PVX-410consists of four peptides from unique regions of three tumor -associated antigens which may act to help stimulate an immune response to the targeted tumor cell. PVX-410was granted orphan drug designation from the U.S. Food and Drug Administration in 2013 for the treatment of multiple myeloma.