ImmunoRestoration, Inc. Announces IND Transfer Completed

November 13, 2018 |

2 min read

HER-2 Pulsed DC Vaccine

DOYLESTOWN, Pa.--(BUSINESS WIRE)-- ImmunoRestoration, Inc., a biotech recently formed to lead the development and commercialization of a novel immunotherapeutic cancer cell therapy platform, announces the receipt of the previously held Investigator IND, BB-IND-11043 from Dr. Brian Czerniecki, MD., Ph.D, of the H. Lee Moffitt Cancer Center & Research Institute. All Phase I and Phase II active protocols will remain operating and the Regulatory and Financial sponsorship has been transferred to ImmunoRestoration, Inc. who is focused on the next phase of development. Manufacturing of the Investigational Product will remain at the MCC Cell Therapies Core Facility (CTC).

Michael Strand, Founder and CEO of ImmunoRestoration, Inc. stated, “We are excited to lead the clinical and commercial development of BB-IND-11043 which focuses on the integrated dendritic cell-based immune system (Immune Conditioning via Activated Innate (autologous) Transfer - ICAIT^©). This platform has the potential to overcome some of the known obstacles facing anti-cancer cell therapies including some harmful side effects that accompany other therapeutic treatments.”

“We will focus our efforts to maintain the research momentum demonstrated in the Phase I and II breast cancer studies. Our development plan will expand into a multi-center trial focused on Ductal Carcinoma In Situ (DCIS).”

Interest in immunotherapy, which uses a person’s own immune system to treat often difficult life- threatening conditions, has exploded over the past few years with hundreds of trials currently assessing a variety of approaches. Recently, therapeutic cell therapies have received increased attention due to approval of a Novartis drug that also emanated from the University of Pennsylvania. The approval was widely seen as a benchmark moment for patients desperate for new treatments in areas previously considered incurable.

About ImmunoRestoration, Inc.

ImmunoRestoration, Inc., based in Doylestown, PA is dedicated to commercializing groundbreaking immunotherapeutic oncology therapies. The company’s core technology is a novel, integrated dendritic cell-based immunization system that helps patients battle cancer by rejuvenating their own immune response. The current investigational product is a cell therapy for breast cancer patients. To date our breast cancer therapy is demonstrating a higher efficacy than other treatments on the market based on Clinical Phase I and Phase II data. Additional therapeutic areas are currently being developed as a result of the efforts of Drs. Czerniecki and Gary Koski.