HyperAcute® immunotherapies are designed to harness multiple components of a patient's immune system to combat cancer, either as a monotherapy or in combination with current treatment regimens, without incremental toxicity.
HyperAcute cancer immunotherapies are standardized, off-the-shelf products composed of live, irradiated, allogeneic human cancer cells that have been genetically modified to add α(1,3)-Galactosyl (αGal) residues to their cell-surface lipids and proteins.Cells bearing this carbohydrate structure on their surface are recognized as foreign by the immune system of humans and Old World primates as a result of binding by pre-existing, high-titer, circulating anti-αGal antibodies. This response gives rise to the observed phenomenon of hyperacute rejection of xenotransplants. The human immune system attacks cells on which αGal is present through the activation of complement, an important component of the immune system capable of rapid cell destruction.
After complement-mediated destruction of HyperAcute immunotherapy cells, we believe the resulting cellular fragments bound by anti-αGal antibodies are efficiently processed by a patient’s immune system in a manner that produces an enhanced, multi-faceted immune response targeting tumor-associated antigens common to both the HyperAcute immunotherapy and the patient’s tumor cells. The objective of HyperAcute immunotherapies is to elicit immune cells that are “educated” to attack a patient’s own cancer cells.
We are currently engaged in clinical development of HyperAcute immunotherapies specific for pancreatic cancer,lung cancer, and melanoma. We have also initiated clinical development of product candidates for prostate cancer and breast cancer, and are developing the HyperAcute technology for other indications.
We believe our HyperAcute immunotherapy technology offers several advantages over other cancer immunotherapy approaches. Specifically, our HyperAcute products are designed to:
- harness the human body's innate immune response to α-Gal to fight cancer;
- utilize a complex targeted approach that is multi-faceted and involves combined antibody-mediated and multi-cellular responses; and
- use allogeneic (non-patient specific) cells from previously-established cell lines, enabling a simpler, more consistent and scalable manufacturing process than therapies based on autologous (patient-specific) tissues or cells.
Although NewLink's technology is applicable to antigen-specific molecular constructs, we believe allogeneic, whole cell-based vaccines represent the best approach for effective cancer immunotherapy. Whole tumor cells express diverse arrays of TAAs, thus increasing the probability of generating an immune response against shared tumor antigens present in the patient's tumor cells. The use of allogeneic cell lines affords substantial benefits in relation to cost-effectiveness and scalability as compared to autologous approaches.