CryoVax® is being tested to determine if this next generation immunotherapy can overcome the limited efficacy of immunotherapy in mCRC.
Jerusalem, Israel – November 7, 2016—Immunovative Therapies, Ltd., on behalf of its’ subsidiary, ImmunoCare, Ltd., today announced the start of a Phase IIb study of CryoVax®, a next generation immunotherapy cancer vaccine product, for patients with chemotherapy-refractory (third line) metastatic colorectal cancer (mCRC). The trial is being conducted by Banner MD Anderson Medical Center, in Phoenix, AZ, which is partnered with the world renowned University of Texas MD Anderson Cancer Center in Houston, TX, Recruitment in the trial is underway, and the first volunteers have received their initial vaccine doses. Enrollment is expected to be completed by the end of July 2017.
Immunovative today announces that it has released its first batch of AlloStim produced with blood collected in compliance with 21 CFR 1271 regulations. These cells will be used in our Phase II clinical trial in metastatic colorectal cancer being conducted at Banner-MD Anderson Medical Center in Phoenix, AZ.
Immunovative's wholly-owned subsidiary, Immunovative Clinical Research, Inc. (ICRI) in Phoenix, AZ announces that its blood donor screening, collection, testing , processing and shipping operations have passed a baseline independent audit as being in compliance with 21 CFR 1271 (GTP)regulations. CGTP requirements govern the methods used in, and the facilities and controls used for, the manufacture of biological products derived from blood.
Frozen T-Stim batches are converted to AlloStim in a 4h incubation process. Previously, the incubation media contained bovine serum. Company scientists have now developed a method to eliminate the use of animal derived products in the formulation process. Scientists have also developed a customized, closed, sterile disposable product and successfully transferred this technology to the final formulation process.
Immunovative announces successfully passing baseline audit from independent auditors of its GMP manufacturing facility in Jerusalem. The manufacturing facilities in Jerusalem were inspected for compliance with current good manufacturing practices (cGMP) pursuant to 21 CFR, CGMPs provide for systems that assure proper design, monitoring, and control of biopharmaceutical manufacturing processes and facilities.
For over a century, scientists have envisioned developing a vaccine that would unleash the power of the immune system to cure cancer. However, these efforts have been a great disappointment.
Scientists first approached the problem with great optimism with the idea of designing vaccines against cancer much in the same way vaccines were designed to wipe out serious diseases like Polio and measles.
Checkpoint blockade drugs such as Yervoy, Opdivo and Keytruda have created a lot of excitement as they have been shown to unleash a tumor destructive immune response and long term remissions in some patients.
However, these drugs work only in a small percentage of patients with only a few types of tumors. Much research is now devoted to discovering ways to increase the applicability of these drugs.
This new initiate has been made possible and is a result of our earlier announced manufacturing and business model breakthroughs which enable us to produce our products at high profit margins with unprecedented low pricing.
Liver cancer is a major health problem in Asia, with the highest incidence rates in the world. The high incidence is related to the high rates of hepatitis B and hepatitis C in these regions.
New methods have been developed to preserve previous immune data in biopsy tissues from the time they are collected until time they are processed into slides.
A key component of this discovery is the need to standardize the methods for processing the tissues.
Immunomonitoring is the study of the intersection of the immune system and the tumor. The immune system is known to be capable of recognizing and eliminating tumors and remembering the tumor for fast elimination in the event of recurrence. However, in cancer the tumor evades immune destruction and grows unaffected by immune killing mechanisms.