The Dallas-based, fully-integrated biotechnology company Gradalis, Inc. has announced the results of its personalized cancer vaccine, FANG™, which exerts its action by eliciting an immune response and delaying recurrence in ovarian cancer patients.
FANG™ is a leading tumor based, personalized cancer vaccine that delays the risk of recurrence by one year in advanced-stage ovarian cancer patients as compared to the standard therapy, as evidenced by the results of Phase II clinical trials recently conducted by Gradalis, Inc.
The analytical results of phase II randomized trials of FANG will be presented at the American Society of Gene and Cell Therapy in Salt Lake City, Utah by Neil Senzer, MD, researcher from Mary Crowley Cancer Research Center, under the presentation title, “Randomized Phase II Trial of Adjuvant Autologous Tumor Cell Vaccine (FANG) for High Risk III/IV Ovarian Cancer: Preliminary results”
Phase II randomized clinical trial:
After the success of the phase 1 clinical study, 17 patients were enrolled in a phase II randomized clinical study with advanced ovarian disease (Stage III c or IV ovarian cancer with widespread disease and metastasis to organs). 12 of 17 patients received FANG treatment along with standard care (that includes surgical removal of cancer tissue, followed by chemotherapy) and 5 patients received only the standard care.
At the interim analysis, over 71% patients with FANG therapy showed positive immune response that was assessed by enzyme-linked immunospot (ELISPOT) analysis. Researchers also identified that FANG therapy is well-tolerated overall, with no reported therapy induced side effects in any study participants. In addition, mean time of recurrence is 470 days in FANG therapy subjects as opposed to only 193 days in standard therapy group (that is 140% shorter than the mean time of recurrence in group receiving FANG therapy).
The lead investigator of the study from Texas Oncology, Minal Barve, MD commented:
“In this study of women who otherwise have a very poor prognosis, we are seeing a significant delay of recurrence in the FANG treatment group which is increasing daily. This interim analysis of the Phase II study suggests that FANG is very promising as a potential treatment for ovarian cancer and lays the groundwork for a pivotal Phase III study of FANG in this patient population desperately in need of better treatment options.”
Overview of Phase I FANG clinical study:
32 patients with advanced ovarian cancer were enrolled in phase 1 clinical study for FANG treatment, showed a median survival of 562 days as opposed to only 86 days in the control group of 23 patients (who underwent other treatment options). An expected survival benefits of 6.2 and 8.4 months was reported in patients who underwent FANG therapy as suggested by risk factor analysis of database of 1,181 patient assessments from the MD Anderson Clinical Center.
Chief medical officer and Executive medical director of the Mary Crowley Cancer Research Centers, John Nemunaitis, MD, who is also co-founder of Gradalis, will present the analysis of Phase I study of FANG in a poster titled:
“Long Term Follow Up – Phase I Study of the ‘triad’ autologous (FANG) vaccine, incorporating bifunctional shRNAfurin and GMCSF Transgene Expression in Advanced Cancer Patients.”
FANG treatment doubles the survival rate in patients with widespread and advanced ovarian disease and poor prognosis by about 18.7 months.
Dr. Nemunaitis commented:
“Taken together, the results of the Phase I and Phase II studies are quite exciting, as we have demonstrated that FANG elicits a robust and lasting immune response that delays cancer recurrence and prolongs life. By harnessing the power of the patient’s own immune system, the triad approach which is designed into the FANG vaccine may one day make cancer a manageable chronic condition by activating immune cells and preventing production of proteins that tumors use to avoid detection by the immune system.”
The results of trials were also shared by Dr Nemunaitis in a podium presentation on May 15th, 2013 with the presentation titled: “Clinical Update of bi-shRNA furin/GMCSF DNA Transfected Autologous Tumor Vaccine (FANG) in Cancer Patients.”
The tumor tissue removed during the surgery is utilized in the manufacturing of vaccine from cell suspension. Electroporation process is used in order to introduce Gradalis’ proprietary bifunctional short hairpin RNA construct and granulocyte macrophage colony stimulating factor (GMCSF), an immune activator to modify patient’s cells. The tumor cells then undergo various developmental stages overnight under an incubator (including irradiation, freezing and QC-testing). The vaccine is then sent back to the hospital where it can be given via intradermal injections in once monthly dose to the patients after thawing. The manufacturing of FANG requires two-day cGMP processing that is applicable to most of the tumor types without requiring any modification or apheresis other than surgical removal of tumor cells.
Gradalis, Inc. is based in Dallas, Texas and focuses mainly on the development, manufacturing and commercialization of drugs, vaccines, tools and diagnostics for the management and treatment of a variety of cancers.
The two primary platforms focus on the development of personalized autologous vaccines and on manufacturing of bifunctional short hairpin RNA delivered via a proprietary lipoplex. The modern and fully integrated state of the art GMP manufacturing facility of Gradalis is further supplied by highly-skilled technical leadership and staff.
research additional company information about Gradalis, Inc. at BioNews Texas.