Advances in science and technology have brought about a new wave of promising cancer immunotherapies, which harness the body’s immune system to detect and fight cancer. Researchers have coined immunotherapy as the “beginning to the end of cancer” and we continue to see the space flourish.
Cancer immunotherapy is expected to make big waves in the cancer treatment landscape and biopharmaceutical industry. In less than 10 years, cancer immunotherapy is projected to form the backbone of over 60% of global cancer management programs. By conservative estimates, this translates to a projected market value of over $35 billion by 2023.
Today, the leading immunotherapy drugs target an immune pathway called programmed-cell death, or PD-1. These drugs, called checkpoint therapies, inhibit this PD-1 pathway and help critical immune cells to better recognize and kill cancer. While checkpoint therapies can produce durable responses, the majority of patients (70-80%) do not respond to this type of immunotherapy, representing a huge unmet need in oncology.
Researchers are eager to answer the most pressing question in oncology today: Is there a way to transform these non-responder patients into responders?
In melanoma, still one of the deadliest skin cancers today, OncoSec has developed an innovative immunotherapy that can be combined with checkpoint therapies to boost response rates in patients that may not have another treatment option. The intratumoral cancer immunotherapy, ImmunoPulse IL-12, is DNA engineered to produce IL-12, a naturally occurring protein with immune-stimulating functions. By increasing the number of tumor infiltrating lymphocytes (TILs) in the tumor, ImmunoPulse IL-12 can generate an anti-tumor T-cell response. Therefore, the body’s immune system is better equipped to target and attack cancer cells.
An ongoing Phase II study is the first clinical trial that demonstrated a response in a population of patients who were predicted to not respond to anti-PD-1 therapy. The combination of ImmunoPulse IL-12 with the anti-PD-1 drug, pembrolizumab, yielded a 48 percent clinical response in anti-PD-1 “non-responder” patients and a favorable safety profile.
Based on positive Phase I and II data, OncoSec was granted Fast Track designation from the FDA for patients who do not respond to PD-1 checkpoint therapies in metastatic melanoma. OncoSec could potentially be the first approved therapy in combination with checkpoint therapies in this large melanoma population. Today, OncoSec announced a collaboration with a global immune-oncology leader, Merck, to evaluate the combination of ImmunoPulse IL-12 and checkpoint therapies, which signifies the initiation of the first registration-directed study in this non-responder patient population.
We believe the combination approach with ImmunoPulse IL-12 and checkpoint therapies represents a billion-dollar opportunity in melanoma as there are approximately 10,000 patient cases that are anticipated to fail treatment with checkpoint therapies each year. At OncoSec, we are uniquely positioned to address this unmet need by increasing response rates in these patients through our intratumoral immunotherapy technology.
It’s becoming more apparent that the way forward in cancer immunotherapy lies in a combination approach that harnesses the benefits of two or more existing paths. Already, we are seeing progress being made in studies combining checkpoint inhibitors and innovative drug delivery.
The statements or opinions expressed on this site are my own and do not necessarily represent those of my employer OncoSec Medical Incorporated.