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


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-410 vaccine,
citarinostat, and lenalidomide.

"Currently, there are no active treatment options for smoldering
multiple myeloma and standard care for patients diagnosed with SMM is
‘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-410 in
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 20 patients at multiple
trial sites, including Massachusetts General Hospital. More information
on the trial can be found at, identifier number

"OncoPep's Phase 1b clinical trial of PVX-410 in 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-410 has 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-410 consists 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-410 was granted orphan drug designation from the U.S. Food and
Drug Administration in 2013 for the treatment of multiple myeloma.

About OncoPep
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 an investigational, multi-peptide therapeutic vaccine being
evaluated in treating smoldering multiple myeloma.

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