GALE-301 & GALE-302

Compound: GALE-301
Status: Phase 1/2a Ongoing
Disease: Ovarian and Endometrial Cancer

Compound: GALE-301 & GALE-302
Status: Phase 1b Ongoing
Disease: Ovarian and Breast Cancer

GALE-301 and GALE-302 are cancer immunotherapies that consist of a peptide derived from Folate Binding Protein (FBP) combined with the immune adjuvant, granulocyte macrophage-colony stimulating factor (GM-CSF) for the prevention of cancer recurrence in the adjuvant setting. GALE-301 is the E39 peptide, while GALE-302 is an attenuated version of this peptide, known as E39’. FBP is a well-validated therapeutic target that is highly over-expressed in ovarian, endometrial and breast cancers, and is the source of immunogenic peptides that can stimulate cytotoxic T lymphocytes (CTLs) to recognize and destroy FBP-expressing cancer cells.

Trial Design and Eligibility

Two trials are ongoing with FBP peptides in gynecological cancers:

GALE-301 Phase 2a portion of the Phase 1/2a clinical trial Identifier NCT01580696 

GALE-301 plus GALE-302 Phase 1b clinical trial Identifier: NCT02019524

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About the Disease

According the NCI SEER program, new cases of ovarian cancer occur at an annual rate of 12.1 per 100,000 women in the U.S., with an estimated 21,290 cases for 2015. Although ovarian cancer represents about 1.3% of all cancers, it represents about 2.4% of all cancer deaths, or an estimated 14,180 deaths in 2015.  Approximately 1.3% of women will be diagnosed with ovarian cancer at some point during their lifetime (2010 – 2012 data).  The prevalence of ovarian cancer in the U.S. is about 192,000 women, and the five-year survivorship for women with ovarian cancer is 45.6%.

Due to the lack of specific symptoms, the majority of ovarian cancer patients are diagnosed at later stages of the disease, with an estimated 75% of women presenting with advanced-stage (III or IV) disease. These patients have their tumors routinely surgically debulked to minimal residual disease, and then are treated with platinum- and/or taxane-based chemotherapy. While many patients respond to this treatment regimen and become clinically free-of-disease, the majority of these patients will relapse.  Depending upon their level of residual disease, the risk for recurrence after completion of primary therapy ranges from 60% to 85%.  Unfortunately for these women, once the disease recurs, treatment options are limited and the disease remains incurable.