TapImmune successfully licensed a vaccine candidate from Mayo Clinic (Rochester, MN), which targets folate receptor alpha (FRa), now TPIV 200, following successful completion of a Phase I trial in patients with ovarian, peritoneal, and fallopian tube cancer that showed 95% of evaluable patients generated robust immune responses to TPIV 200 and 100% of patients demonstrated T-cell responses lasing six months or longer.
A Phase II clinical study is currently underway at Memorial Sloan Kettering Cancer Center that combines TPIV 200 with a checkpoint inhibitor (AstraZeneca’s durvalumab) for treating platinum-resistant ovarian cancer. This patient population has very few treatment options, which resulted in both Orphan Drug and FDA Fast Track Designation for TPIV 200.
TapImmune is also sponsoring a separate Phase II trial in platinum-sensitive ovarian cancer, which is currently underway.
HER2/neu Breast Cancer
In 2012, TapImmune signed an exclusive Licensing Option Agreement with Mayo Clinic (Rochester, MN) for clinical development of a breast cancer vaccine technology targeting the HER2/neu receptor present in ~30% of breast cancer cells. TapImmune exercised its option to license the four-peptide vaccine candidate (TPIV 100) and completed a successful Phase I clinical trial, which showed robust and durable T-cell immune responses in the majority of HER2/neu+ breast cancer patients. Subsequently, TapImmune licensed a novel Class I peptide that was added to the vaccine formulation to create TPIV 110, a five-peptide candidate that consists of both Class I and II peptides.
Plans for further clinical development are underway, with two Phase Ib/II studies expected to commence in 2017. The first study, sponsored by TapImmune, will be a larger study in HER2/neu+ breast cancer and the other is expected to enroll patients with DCIS (ductal carcinoma in situ) breast cancer, which will be conducted in collaboration with the Mayo Clinic.
Triple-Negative Breast Cancer
TPIV 200 is also being developed to treat triple-negative breast cancer. In addition to a TapImmune-sponsored Phase II study, which is currently enrolling patients, collaborators at the Mayo Clinic are planning to initiate a large Phase II study in triple-negative breast cancer in 2017, which is fully funded by a grant from the U.S. Department of Defense.