Symptoms of painful blisters or ulcers in an infected area affect billions of people who are diagnosed with the herpes virus. In addition, many patients experience debilitating neuralgia, skin split, fissures, fever, chills, erythema, minor abrasions, and myalgias. Not only do these patients experience pain and discomfort, but also the social consequences associated with isolation and stigma.
But despite being a serious health concern, there has been no cure for the infection. This has led to an urgency for the development of better treatment and prevention, particularly vaccines. Emphasizing such an opportunity, Rational Vaccines is committed to ending the herpes pandemic. It is an investigational-stage infectious disease company that is focused on combating all diseases resulting from herpes simplex virus 1 (HSV-1) and herpes simplex virus 2 (HSV-2) infections.
Using its proprietary technology, Rational Vaccines creates genetically engineered replication-controlled herpes vectors as safe therapeutic and prophylactic vaccines against herpes type 1 and 2. These modified viruses have been also tested preclinically to deliver cancer vaccines and vaccines against other infectious diseases.
In an interview with Insights Care, Agustin Fernandez III, the CEO of Rational Vaccines shares the journey from addressing the severity of herpes to innovating therapeutic solutions against the infection.
Following are the excerpts from the interview.
Kindly tell us the source of inspiration. What led you to venture into the Anti-Infective Medicine Industry?
Like nearly five billion other people, I suffered from oral/facial HSV1 infection. For me, and for millions of other patients, the current standard of care i.e., the 50-year-old antivirals, was completely ineffective. More than 20% of patients suffer from a variety of symptoms, beyond skin outbreaks, that include nerve pain in various parts of the body and brain inflammation that is thought to be a source of brain degeneration and dementia (Alzheimer ’s).
I began this journey, by first studying virology and immunology and subsequently co-founding Rational Vaccines (RVx) to solve a very personal problem. Soon I learned that I shared this problem with over a billion people worldwide and so many others suffer in very severe ways. Not only from the chronic and debilitating sores the virus can cause, but many herpes patients deal with—exacerbated HIV infections, infant mortality due to herpes, and even herpes-induced blindness. What started as an effort to help myself has morphed into a mission for the company to help millions of people suffering from herpes.
Brief us about yourself and shed some light on your role and responsibility at the company.
As the Co-founder and CEO, my main goal is to support the science and the amazing scientists at Rational Vaccines that have cracked the code to this virus and are poised to deliver both therapeutic and preventative vaccines for what may be the oldest virus plaguing humankind.
I conducted several rounds of funding ($41 million), directed the engineering of a new mutant HSV-2 virus, acquired the rights to a mutant HSV-1 virus in collaboration with Dr. Kousoulas of LSU, supervised the GMP production of vaccine vials for the upcoming clinical trials, and organized the preparation of dossiers for regulatory agencies in the UK and the US.
What are the mission, vision, and values shared by the company?
Our mission is to eradicate herpes simplex. And the vision is to create prophylactic vaccines, to protect individuals not yet infected, as well as therapeutic vaccines to reduce the reactivation of the viruses and alleviate symptoms in patients already infected. Our values include transparency, a sense of urgency, an appetite for collaboration, and an aspiration to serve all patients in need around the world.
Our focus is Patients, Patients, and Patients. Sadly, herpes affects nearly everyone, either directly or indirectly through loved ones suffering. The team at RVx has recognized this problem and has chosen to not turn a blind eye. We forego trends and ignore the media. Our only true north is finding and following the best science to battle this virus and its corresponding diseases.
At Rational Vaccines, we were working on vaccines before vaccines were a cause célèbre. We know that replication-competent vaccines are the only solution to the herpes problem, and we stay focused on this truth, by resisting the temptation to follow the herd of failed attempts into the subunit, killed, inactivated, or antigen-specific mRNA vaccine fields. Trends come and go in science, as in any other field.
We are convinced that our technology is the only one that will truly help patients to prevent this virus from infecting and from reactivating if already infected and we stay on course. All that matters at RVx is what will best serve the patient. We were founded by patients, we are supported by patients, and we are led by patients and patient-centric team members.
Tell us about the core products and services that the company offers to support the needs of the clients/patients. How are these different from other companies in the market?
Our vaccines are based on live, replication-limited viruses engineered for safety. This a long explanation but every word counts, using a live virus that can replicate is the only approach that has worked so far in this family of viruses, as demonstrated by the vaccine for chicken pox (HHV3 is a virus of the same alpha herpes virus family).
Instead of old approaches of “attenuation” by “passaging”, we genetically engineer our viruses to be safe. More precisely, they cannot establish latency in the nervous system, and they cannot escape being suppressed by the human immune system as “wild viruses” can both do.
Brief us about the rising need for Anti-Infective medicine in the healthcare sector. How will it impact the way patients receive treatment and the clinical decisions taken by care providers?
Today there is no vaccine approved for herpes and many attempts have failed because researchers tried to use other technologies that do not present the entire spectrum of the 75 epitopes of the virus-like our products do. The only therapeutic treatments are half-a-century-old antibiotics that do not provide satisfactory relief to a large percentage of patients and may cause side effects. By the way, there is no good diagnostic available either and we have patents in that segment.
Our vaccines cover therapeutic and preventative vaccines. Addressing both sides is the best way to reduce the burden of disease. In the case of herpes, the same mode of action that keeps the virus from infecting in the first place is responsible for controlling the reactivation of this virus in patients that have HSV1 or HSV2 latent in their nervous system. This is why we are deploying this technology both to prevent and treat herpes.
What specific R&D operations is your company leading at present? Why do you find them essential in developing or improving anti-infective solutions?
We are currently preparing a Phase II clinical trial under an accelerated approval program for our therapeutic vaccine. We believe that data from this trial will also support the advancement of our prophylactic candidate.
We are also exploring deploying these very safe and stable viral vectors which have roughly 6 times the “payload” capacity of currently available viral vector platforms as a delivery system for a broad range of infectious diseases as well as cancer vaccines.
In what way do you consider technological advances to be a pathway in conducting your company’s operations?
Our development of products would have not been possible without the incredible advancements in molecular biology. In the past, when live-attenuated vaccines were deployed, scientists didn’t have the tools to genetically engineer mutants with very specific and safe properties in the way we do today. Old technologies resulted in efficacious vaccines—with the fear that they could revert and or cause vaccine-derived disease.
Using the latest technologies, we can create a mutant that was never a virulent wild-type strain. A mutant that behaves exactly how we intend it to. For example, we have made our vaccines sensitive to the interferon response—the first line of defense of the immune system. Our vaccines are cleared out by the recipients in a few days. We have seen this unequivocally in our studies.
What endeavors is the company currently pursuing to improve its service measures for the clients/patients?
We are and always have been involved in a worldwide education and advocacy campaign. Herpes is a virus that is too often ignored by government agencies and sometimes even by general practitioners. There is a belief among some that the old antivirals available have solved the herpes problem. They have not. We have run several patient engagement and epidemiology studies that illustrated the huge unmet needs and burden of disease. For example, a recent study shows that over 55 percent of patients still experience recurrent herpetic disease (outbreaks) even while on daily suppressive therapy with antivirals.
What advice would you like to give to budding entrepreneurs and enthusiasts who desire to venture into the industry?
Our main piece of advice would be to never give up. Pick a problem that needs solving that no one else is addressing correctly and ask yourself: If not me, then who? If not now, then when? If the mission that you are fighting for is greater than any discomfort you can imagine going through, then, you will get up every morning with your team and meet the obstacles that always come when you truly want to bring about change.
Don’t ever think of money, or personal success, only ask yourself: Does the world need this problem solved? Will I leave this place better than how I found it if we can rise to this challenge? If the answer is yes to you, then go all in and don’t let anything take your eye off that goal.
How do you envision scaling the company’s services and operations in 2023 and beyond?
In 2023, Rational Vaccines is heading full force into clinical development and scaling up manufacturing of our vaccines in preparation for upcoming commercialization.
Please mention client testimonials or recognitions that your company may have attained along its journey to success (if available/permissible).
Let’s listen to a patient. “I received what some call “The Gift” eleven years ago. 80% of people who have it don’t even know they have it and since they don’t know, they are out there spreading it. But unfortunately for me, I am one of those who suffer chronically from it. For me, it was sort of like having a sunburn with intense neuralgia. This neuralgia is the same type people get from shingles.
I had to take high doses of antivirals to try to keep it under control and sometimes it would still break through. The antivirals made me tired. I thought my love life was over when I found out that antivirals only reduce the risk of transmissions by 49%. I was so scared of passing it on that I couldn’t be in relationships. It can mess with your mind when you suffer quite a bit from it.
I have met some amazing people in the same boat along the way, doing a great amount of volunteer work. We have talked with hundreds of people out of suicide. Sometimes I fail. I lost one amazing young woman to suicide that I had become close to. There was one man who jumped off a bridge. The supposed accidental shooting of another young woman. And one of the saddest things I have seen was the ultrasound of an 8-month-old fetus that was missing its brain. Then there are the people who stop living. They think they are damaged goods and will never have love or a family.”
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