PDS Biotechnology is a late-stage immunotherapy company focused on developing novel cancer treatments using its proprietary Versamune platform to activate T-cell responses against tumors.
You mentioned in a previous interview that you believe the future of cancer therapies will involve combination therapies. Could you explain why you feel that way?
Yes, I strongly believe that combination therapy will become the most dominant approach to treating cancer effectively. As we learn more about cancer and how it evades our immune system, it’s clear that cancers survive by using various mechanisms to hide from detection. Our immune system is naturally designed to eliminate aberrant cells or viruses before they cause cancer, but once cancer sets in, it uses multiple tactics to avoid immune attack. Let’s take for example our lead program that addresses HPV16-positive head and neck cancer. It is well known that HPV16 is the most oncogenic or cancer-causing type of human papillomavirus and is transmitted by sexual contact. HPV16 is capable of shutting down the body’s immune response, making it harder for the immune system to recognize and fight the resulting cancer.
Cancer also upregulates immune checkpoints, a natural mechanism that tells the immune system not to attack healthy cells. By combining therapies like Keytruda with our HPV16-targeted immunotherapy, Versamune HPV, which trains the immune system to recognize and attack HPV16-positive cancer cells, we can target and overcome these evasive mechanisms. Keytruda works by blocking immune checkpoints, making tumors more visible to T cells, while Versamune HPV enhances the anti-HPV16 immune response. In our head and neck cancer clinical trial, in patients with first-line recurrent or metastatic HPV16-positive head and neck cancer, the Versamune HPV-Keytruda combination has shown a median overall survival of 30 months. The historical published results for Keytruda alone in this patient population is about 12 months.
You also highlighted an acceptable safety profile for combination therapies. Could you elaborate on that?
That is correct. Combining our Versamune HPV with checkpoint inhibitors has been shown to reduce some of the side effects typically seen with checkpoint inhibitors alone. Normally, when immune checkpoints are blocked, the immune system can attack healthy organs, leading to autoimmune side effects. However, in a published preclinical study, adding Versamune HPV to an immune checkpoint inhibitor increased the specificity of the T cells and directed the T cells specifically to the tumors. This effect, in a clinical setting, may reduce the likelihood of indiscriminate attacks on healthy tissue. Our VERSATILE-002 Phase 2 clinical trial showed that with the Versamune HPV-Keytruda combination, only 10% of patients experienced Grade 3 or higher toxicity. The historical published result is about 17% seen with Keytruda® alone.
In addition, when combined with our IL-12 antibody drug conjugate, we have seen even better outcomes, with a smaller proportion of patients experiencing severe toxicities compared to chemotherapy. While chemotherapy leads to significant side effects, including a 70% rate of grade 3 toxicities when combined with checkpoint inhibitors. Our combination therapy has a lower toxicity profile.
Do you feel that your recent progress has helped prove the case for T-cell activating therapies?
We have made significant progress in addressing the skepticism around T-cell activating platforms. While it is too early to say definitively, we’ve gathered data from prestigious institutions like MD Anderson and the National Cancer Institute, which show that our technology is addressing limitations seen in earlier T-cell stimulating therapies. Specifically, MD Anderson’s study in locally advanced cervical cancer patients highlighted that our platform is effective in getting T cells to recognize and accumulate in the tumor site, a critical limitation of earlier therapies. They have shown that our treatment not only activates T cells but also directs them to infiltrate the tumors, which is a major advancement in the field.
We have also demonstrated that our combination therapy can eliminate circulating tumor DNA, a marker for micrometastatic cancer cells, which is a key cause of cancer recurrence. This has been shown to significantly improve survival rates, with patients who had no detectable circulating tumor DNA at 3-4 months having a 93% recurrence-free survival (RFS) rate at two years vs 30% RFS with detectable ctDNA. This data, combined with our ongoing Phase 3 clinical trial, positions us closer to validating our platform and demonstrating that T-cell stimulating approaches can indeed be successful in cancer treatment.
What challenges have you faced in attracting investment, and do you think the environment for biotech financing has improved?
The biotech sector has been through a challenging period, especially over the last few years. The markets have been stressed, and many investors have become more risk-averse, which has made it harder to attract capital. While we’ve made significant progress with our programs, the market valuation hasn’t kept pace with our advancements, and this disconnect has impacted our ability to raise funds. Biotech, particularly drug development, is a high-risk, long-term investment, and many investors are now more inclined to invest later in a company’s development cycle when the risks are somewhat mitigated.
However, despite the difficult environment, we continue to be strategic in how we run our programs and approach financing. In addition to equity financing, we continue to explore partnerships and other methods to secure the capital needed to bring our products to market. The biotech sector is tough right now, but we are hopeful that as our programs progress, particularly as we progress our Phase 3 clinical trial, we will see an improved investment climate.
How do you see PDS Biotechnology’s future and pipeline developing in the next few years?
We are very optimistic about the future of PDS Biotechnology. Our pipeline has shown consistent progress, with strong data from trials. Our Versamune platform is addressing critical limitations of previous T-cell stimulating therapies, and the IL-12 antibody drug conjugate has shown significant potential in targeting tumors effectively and promoting an effective anti-tumor immune response. As we advance our Phase 3 clinical trial for Versamune HPV, we are confident that our platform will continue to show promising results.
Looking ahead, we expect continued success as we expand our pipeline. We announced an update on another clinical candidate, Versamune MUC1, which targets a broader range of solid tumors. Our goal is to keep making progress and validate our platform through ongoing trials, with the hope of moving closer to FDA approval. We are enthusiastic about the future and confident that our technology will continue to progress, bringing new hope to cancer patients worldwide.
