What To Know
- “The current data, which conclusively demonstrates the induction of immunological memory to cancer, as well as the natural killer cell as a mechanism of action, will position us to provide the FDA responses to their questions from our submitted IND,”.
- “Given the fact that we have human safety data from outside of the United States, combined with these new mechanistic findings, we are confident in a smooth interaction with the FDA as we get closer to clearing of our IND application.
January 19, 2021
StemVacs cellular immunotherapy update: Therapeutics Solutions has reported positive animal data in the 4T1 breast cancer model using StemVacs cellular immunotherapy.
In a series of experiments, it was demonstrated that StemVacs™ administration resulted in a) regression of established breast cancer in mice; b) that regression was dependent on natural killer cells, and c) that immunity to breast cancer could be transferred by CD4 T cells to naïve mice.
Previously the Company announced positive safety data in 10 patients treated with StemVacs™1. Additionally, the Company has filed an Investigational New Drug Application (IND) which is currently pending based on the Company responding to questions posed by the FDA.
“The current data, which conclusively demonstrates the induction of immunological memory to cancer, as well as the natural killer cell as a mechanism of action, will position us to provide the FDA responses to their questions from our submitted IND,” said Dr. James Veltmeyer, Chief Medical Officer of the Company and voted Top Doctor of San Diego. “Given the fact that we have human safety data from outside of the United States, combined with these new mechanistic findings, we are confident in a smooth interaction with the FDA as we get closer to clearing of our IND application.”
“It is known that numerous immunotherapies such as Herceptin® are dependent on the ability of natural killer cells to function properly,” said Famela Ramos, Vice President of Business Development. “The current data provides a scientific basis for us to collaborate with other immuno-oncology companies to identify and leverage possible synergies with other drugs that work via the natural killer pathway of the innate immune system.”
“Therapeutic Solutions International is a ‘science-driven’ organization,” said Timothy Dixon, President and CEO. “Having key opinion leaders such as Drs. Santosh Kesari and Francesco Marincola as advisors allows us to design and execute experiments with the highest level of academic rigor. We believe that the FDA and our scientific and medical peers will appreciate our philosophy.”