PDS Biotechnology Corp. (NASDAQ:PDSB) Uses Cancer Immunotherapy to Infiltrate and Disable Tumors from Within

May 14, 2024

Photo courtesy of National Cancer Institute

PDS Biotechnology is a mid- to late-stage clinical development company working in the area of cancer immunotherapy, with a current focus on HPV-associated cancers.

PDS Biotech President and CEO Frank Bedu-Addo MD uses cancer immunotherapy to treat HPV-related cancers

Dr. Frank Bedu-Addo

Dr. Frank Bedu-Addo has served as president and CEO of PDS Biotechnology (NASDAQ:PDSB) since its inception in 2005. Dr. Bedu-Addo is a veteran biotech executive with experience successfully starting and growing biotechnology organizations.

As Vice President of Drug Development at KBI BioPharma, he oversaw all business and drug development operations. Before KBI, he successfully started and managed Cardinal Health’s East Coast biotechnology drug development operations. Prior, Dr. Bedu-Addo was an Associate Director at Akzo-Nobel, Senior Scientist at Elan (The Liposome Co.), and Principal Scientist at Schering-Plough.

He obtained his M.S. degree in chemical engineering and a Ph.D. in pharmaceutics from the University of Pittsburgh.

Dr. Bedu-Addo says that the cancer therapy they are developing attacks tumors from within.

One of the ways that cancer thrives in the body is essentially by hiding from the immune system or building defense mechanisms against the immune system. That’s how the cancer continues to thrive and grow in bodies.

What we’re doing is training our immune system and reactivating it to specifically recognize and attack cancer. That’s what we mean by cancer immunotherapy. We have progressed over the last several years.

PDS Biotechnology became a publicly traded company approximately five years ago via a reverse merger with a company called Edge Therapeutics. Since we’ve had that merger and gone public, we’ve gone from having no Phase II human clinical trials to where we are today, where we are running approximately eight Phase II clinical trials, have completed one and are close to completing a second and then moving into the final stages of clinical development.

We have several collaborations. One is with the National Cancer Institute … Others include MD Anderson Cancer Center and the Mayo Clinic. At the National Cancer Institute, we’ve just completed one trial which was looking at all types of HPV-associated cancer.

So, you may know that head and neck cancer, for example, is growing quite significantly. Previously, head and neck cancer incidences were associated primarily with tobacco and alcohol use, and these are now on a steep decline.

However, HPV-associated head and neck cancers are on a steep incline in terms of those incidences increasing dramatically. Cervical cancer is also an HPV-driven cancer, as is anal cancer, vaginal and vulva cancers.”

Thus far, clinical trials have demonstrated encouraging results.

“The National Cancer Institute evaluated our technologies and our products in these cancers together in a clinical trial, demonstrating interesting results in patients who had previously failed initial treatment with chemotherapy and radiation.

Traditionally, those patients will be treated with a checkpoint inhibitor, like Keytruda and Opdivo. With these products, about 50% of these patients will live one year and beyond. At three years, the results drop to a 20% to 25% survival rate.

The trial with our products demonstrated a 75% survival rate at three years. Our proprietary drug combination appears to dramatically promote the survival of these patients.

What was also very interesting is that the NCI took the patients who had also failed traditional approaches with drugs like Keytruda and Opdivo, who traditionally would have about a three to four months survival after failing on all these available therapies.

In those patients, the NCI trial demonstrated that treatment with our triple combination of our IL-12 fused antibody drug conjugate PDS01ADC, Versamune HPV (formerly PDS0101) and an investigational immune checkpoint inhibitor extended survival from about three to four months to about 20 months.

These findings have been very important for PDS Biotechnology to understand how our technologies could potentially help these patients with advanced cancer.

The NCI is also conducting studies in advanced prostate cancer. The initial data from one of those trials was presented at a cytokines conference last year in November, which demonstrated good tolerability of that combination.

They’re combining our IL-12 fused antibody drug conjugate PDS01ADC with chemotherapy, which showed good survival in these patients. That trial is continuing. There’s another trial ongoing in Kaposi sarcoma, which is associated with HIV infection, looking at patients who failed standard therapies and treating them with PDS01ADC.”

Another trial, done in conjunction with MD Anderson Cancer Center, is focused on cervical cancer.

“Today, the standard of care for cervical cancer has been chemoradiotherapy, which has a high rate of recurrence. Even though chemoradiotherapy may work initially in high-risk patients, within six months to a year, patients with large, bulky tumors have a high rate of recurrence.

The team at MD Anderson has found using chemoradiotherapy in combination with Versamune HPV has led to a significantly reduced rate of recurrence to date in their study. At one year, there were no recurrences of the cancer and 100% of the patients responded to treatment.

It was a small population, initially eight patients. And they showed that seven out of the eight had complete elimination of the cancer and no recurrence during that one-year period of evaluation.

We are looking forward to giving updates on these trials as we go through the remainder of the year and in 2025.”

Dr. Bedu-Addo adds that the company’s platform technologies can be applied beyond HPV-associated cancers.

“HPV-associated cancers are really the proof of concept with these technology platforms.

We are now also branching out into the MUC1-related cancers, colon cancer, colorectal, breast, and ovarian cancers. Some ongoing studies at the National Cancer Institute are also looking at prostate cancer and liver cancer.

We are 100% focused today on getting the HPV cancer product to FDA approval, but due to our collaborations, we also have our partners working beyond HPV-associated cancer. So we can quickly bring all those pieces together and expand into a broad range of solid tumors.”

Learn more about the potential benefits of PDS Biotechnology Corp.’s approach to cancer immunotherapy in our exclusive interview.