Five Questions With: Dr. Anne S. De Groot

Dr. Anne S. De Groot is the founder, immune engineer, chief scientific officer and CEO of Providence-based vaccine company EpiVax, which champions the “vaccines-on-demand” movement. She talks with Providence Business News about her experience as a panelist on a program sponsored by the University of Chicago Life Sciences Alumni Group. That program was held during a health care conference, “The Immunology Revolution: Here Now or Hurry Up and Wait?” that J.P. Morgan Chase & Co. sponsored.

PBN: Describe the scope and substance of your presentation at the recent conference?

DE GROOT: I was on a panel with other experts in the field of cancer immunotherapy. We focused on the new concept that cancer treatments will need to be personalized for each patient. Now that anti-PD-1 [a novel immunotherapy] and other “check point” inhibitors are in use for cancer immunotherapy, there is new evidence that better outcomes (cures) are seen in patients who have strong immune responses to tumor-unique mutations. Since the tumor mutations are unique for each patient, cancer immunotherapy will involve designing a “personalized” vaccine. This is doable … but the big question we discussed on the panel was: “How are we going to pay for it?”

PBN: What were the take-aways for you from the conference – what did you learn that might inform your work with EpiVax, and what surprised you?

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DE GROOT: I learned (once again) that cancer experts’ idea of success is not what we would call success. They are happy to see that “cures” are happening for about 20 percent of patients. I would be much happier with 100 percent. I think that we shouldn’t settle for less and I think that our tools can help cancer immunotherapy get there.

PBN: What is the immunology revolution and what role might EpiVax play in that revolution?

DE GROOT: We predict that, in combination with checkpoint inhibitors, personalized vaccines will rock the cancer world. Patients and their physicians want this now, if our email inbox is any indication. If we are going to make this revolutionary therapy available to patients, we need to get going, testing the concept in clinical trails and, perhaps even more important, getting the FDA to clear the path for personalized vaccines on the regulatory pathway.

PBN: What regulatory impediments or supports hinder or help companies like EpiVax manage their research and development initiatives?

DE GROOT: The biggest impediment faced by personalized cancer vaccines would be “regulatory approval.” In theory, it would have to be done for each vaccine! I believe that there are ways to simplify the process. One approach is to use exactly the same adjuvant, the same delivery vehicle and the same manufacturing process for each vaccine. The only thing that would change would be the “cassette” representing the individual patient’s tumor mutations. In comparison, the FDA can approve easily justified changes to influenza vaccines (e.g., insertion of sequences from recently emergent strains) in less than 24 hours after the company files a formal request, without additional preclinical work, as long as the rationale is justified and comparability studies can be performed.

PBN: What are the most exciting initiatives underway at EpiVax now?

DE GROOT: In December, we received an urgent email asking us to design a vaccine for a single patient, based on the unique mutated peptides in the individual’s cancer. We said: “Yes, we can.” (Read the full story here.) The next day, we had the patient’s sequences by email and the day after we were working on the vaccine; it was ready to ship 72 hours later. Will it work? All signs point to yes; there is now extensive evidence that targeting immune response to mutated epitopes will improve survival. But, will the patient have permission to try the vaccine? That’s a more complex question.

What we know for sure is that our tools can be used to pinpoint the sequences that are useful for immunotherapy. They have other uses, too. The tools can also be used for designing “vaccines on demand” for the next epidemic. Imagine being able to predict the human immune response to an antigen from a newly emerging infectious diseases. Or, perhaps you want to evaluate the efficacy of an available vaccine against a newly emerging disease variant. Advances in computational vaccinology make all of these scenarios possible. Collaborative studies carried out at the University of Rhode Island and EpiVax Inc. have demonstrated the importance of computational vaccine design and vaccine efficacy studies. This is the cutting-edge technology behind The Immunology Revolution.

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