Adding new tools to the oncology toolbox
By Dr. Lauren V. Wood
Chief Medical Officer at PDS Biotech
As we learn more about cancers, we realize the tricks they play on the body. For generations the approach to treat cancer has been surgery, radiation and chemotherapy. But today’s immunotherapies have created a myriad of opportunities for the body’s immune system to target cancers.
The body aims toward a type of equilibrium in its immune system – attacking invaders whether they are pathogens or allergens to stimulate an immune response. Yet, cancer has a unique way of tricking the body’s immune system into thinking all is well, effectively sneaking past the body’s defenses.
Head and neck cancers (HNCs) are among the most difficult to treat, given how they can impair eating, speaking, blood flow, nerve function and even the airway, and the number of cases is growing. According to the American Cancer Society, cancers affecting the oral cavity and pharynx in the United States in 2022 are estimated to total 54,000 and kill more than 11,000. Incidence rates increased by 0.8% per year from 2009 to 2018, while mortality rates in the U.S. from this form of cancer have increased by 0.4% annually from 2010-19.
Very often a combination of treatments is necessary to shrink tumors, hamper their ability to grow, and prevent the cancer from spreading. PDS Biotech is developing treatments that aim to help the immune system fight cancer using its Versamune® T cell activating platform technology. The technology is the foundation of PDS0101, which is being studied as a potential treatment for HPV-positive cancers as a combination therapy with checkpoint inhibitors, a class of immunotherapies that unleash the immune system to target cancers, and as a monotherapy.
VERSATILE-002 is a study of PDS0101 as a combination with Merck & Co.’s KEYTRUDA® (pembrolizumab) in two groups of HNSCC patients: one for patients who have never been treated with a checkpoint inhibitor, like KEYTRUDA®, and those who are undergoing treatment with a checkpoint inhibitor for a second or third time. The Phase 2 trial is looking to measure the overall response rate over a 24-month period. A European arm of the study has opened under the guidance of Dr. Kevin Harrington, whose work in 2019 on the KEYNOTE-048 study helped establish KEYTRUDA® as a standard of care in in head and neck cancers.
In that study, KEYTRUDA® was shown to be superior to chemotherapy by improving overall survival for HNSCC. While KEYTRUDA® is a highly effective treatment, approximately 20% of patients respond to treatment.
When the immune system is taxed and exhausted, the body fails to recognize cancers and other pathogens. Our goal is to prove that the addition of PDS0101 to KEYTRUDA® can improve response rates by 50% to create a new standard of care as the pairing may help to recharge the body’s immune system to target cancers more effectively without the toxicity of more traditional treatments.
Patients and caregivers interested in learning more about VERSATILE-002 can contact PDS Biotech’s clinical trials team at clinical_ops@pdsbiotech.com.
