First-in-Human Novel Immunotherapy Combination: The Cancer Memory Vaccine Beyond Checkpoints

The recent successes of immunotherapy, such as checkpoint inhibition, have spawned a wave of enthusiasm for immuno-oncology. 

On November 7, 2018, NantKwest announced promising results from a first-in-human clinical trial of a novel cancer memory vaccine immunotherapy. 

The highlights from this August 2017 to October 2018 clinical study are as follows: 

• Combination in 30 Patients with Advanced Metastatic Cancer Refractory to Multiple Previous Therapies
• Zero Incidence of Cytokine Release Syndrome in Any of the 300 Doses in 30 Patients
• All Patients Received NK Cell Infusion and Novel Cancer Memory Vaccine Combination as Outpatients with No Immune-Related Adverse Events
• In Highly Refractory Late-Stage (4thLine or Greater) Advanced Metastatic Triple Negative Breast Cancer, 80% Disease Control
• In Highly Refractory Late-Stage Advanced Metastatic Pancreatic Cancer (3rdLine or Greater), 90% Disease Control with Median Overall Survival of 9.5 Months, Greater Than Historical Controls (8.7 Months) in Patients with Standard of Care First-Line Therapy
• In Highly Refractory Patients with Advanced Metastatic Head and Neck Cancer (4thLine and Greater), the Cancer Memory Vaccine Resulted in 67% Disease Control with a Complete Response in One Patient
• Utilizing Endogenous NK Stimulation Alone with IL-15 Fusion Protein (N-803) in Refractory Patients with Bladder Cancer who Failed Standard of Care, 86% Complete Response Was Achieved in Patients with Carcinoma In-Situ (CIS) and 100% of Patients with Papillary Carcinoma Remain Disease-Free Following Fusion Protein Activation of NK and T

Unfortunately, only a subset of cancer patients respond to checkpoint inhibitor monotherapy, and many of these checkpoint-responsive patients will eventually relapse.

In addition, cellular therapy in the form of CAR-T cells has shown little evidence of effectiveness in solid tumors.

Thus, there remains a huge unmet need to address the rising pandemic of cancer with a paradigm shift in treatment. 

The vision of Dr. Soon-Shiong’s novel Cancer Memory Vaccine, building on the approved nanoparticle (Nab-Paclitaxel, Abraxane) is to achieve chemo-free, biologically driven immunotherapy for the early treatment and prevention of cancer beyond 2020. 

Dr. Patrick Soon-Shiong, Chairman & CEO of NantKwest said, “High dose, uninformed, toxic chemotherapy damages the immune system and induces what is known as tolerogenic cell death.” 

“Natural Killer cells are the core innate immuno-protective mechanism against cancer.”

“By developing a system of activating the patient’s own Natural Killer cells and T cells, as well as augmenting the patient’s NK killing ability with engineering off-the-shelf NK transfusions, we hypothesize that resistant cancer can be overcome.” 

“We believe that current checkpoint inhibitors alone are insufficient to achieve long-term remission and only by inducing both the innate and adaptive immune system, and by orchestrating the treatment in a temporal-spatial sequence, will we induce T cell memory and long-term durable response,” said Dr. Soon-Shiong. 

NantKwest is an innovative clinical-stage immunotherapy company focused on harnessing the power of the innate immune system by using the natural killer cell to treat cancer, infectious diseases, and inflammatory diseases.