Advaxis entered into a collaboration with the Icahn School of Medicine at Mount Sinai on a Phase 2 study investigating the effects of AXAL in patients newly diagnosed with HPV-positive head and neck cancer during the “window of time” between initial diagnosis and prior to receiving any treatment, including surgery, chemotherapy or radiation.
Advaxis has collaborated with Brown University Oncology Group on a Phase 1/2 clinical study assessing the safety and efficacy of AXAL administered with concurrent standard chemotherapy and radiation treatment in HPV-associated locally advanced anal cancer. Preliminary data show treatment with AXAL indicated a clinical complete response and no recurrence in all 10 patients who completed the treatment regimen.
Advaxis entered into a collaboration with the GOG Foundation, Inc. (GOG), now part of NRG Oncology, on a two-stage Phase 2 study of AXAL in patients with persistent or recurrent metastatic cervical cancer (PRmCC) who had progressed on at least one prior line of systemic therapy. The trial is being conducted in the U.S. by GOG, under the sponsorship of the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI).
Advaxis has a Special Protocol Assessment (SPA) and Fast Track Designation by the FDA for the Phase 3 AIM2CERV study, conducted in collaboration with the GOG Foundation, Inc, evaluating the safety and efficacy of AXAL in high-risk, locally advanced cervical cancer (HRLACC).
Advaxis entered into a clinical trial collaboration agreement with the Radiation Therapy Oncology Group (RTOG) Foundation to evaluate the safety and efficacy of AXAL in a pivotal Phase 2/3 anal cancer trial, which will be run by NRG Oncology.
Advaxis entered into a collaboration agreement with the Children’s Oncology Group (COG) to initiate a clinical study of ADXS-HER2 in pediatric osteosarcoma. COG is a National Cancer Institute (NCI) supported clinical trials group.
Advaxis entered a partnership with investigators at City of Hope in the development of a vaccine for the treatment of certain forms of leukemia and lymphoma based upon Advaxis’ proprietary Lm Technology platform.
Advaxis is collaborating with Baylor College of Medicine on a Phase 2 trial of AXAL in HPV-associated oropharynx (throat) cancer, a type of head and neck cancer. In September 2015, the trial was awarded a grant totaling $1.1 million over three years from the FDA’s Office of Orphan Products Development (OOPD).
Two Phase 1/2 research projects involving ADXS-PSA in metastatic, treatment-resistant prostate cancer were selected as 2015 Movember Foundation-PCF Challenge Awards, sponsored by the Movember Foundation and the Prostate Cancer Foundation (PCF). Grants amounting to $1 million each have been awarded to the two ADXS-PSA teams conducting the trials. Both ADXS-PSA projects involve principal investigator Adam P. Dicker, MD, Ph.D., from the Sidney Kimmel Cancer Center at Thomas Jefferson University.
Advaxis entered into a collaboration agreement with University of California, San Francisco (UCSF) Medical Center on the evaluation of several Lm Technology immunotherapy constructs, including ADXS-PSA.
Advaxis entered into a research collaboration with Memorial Sloan Kettering Cancer Center (MSK), a premier cancer center committed to patient care and innovative research, to evaluate the immunologic and anti-tumor activity of patient tumor-specific, neoepitope-based immunotherapy. The collaboration will use Advaxis’ Lm Technology to develop neoepitope immunotherapies based on an individual patient’s tumor (ADXS-NEO) and potentially bring about a next generation of truly individualized cancer immunotherapies.