Rational Vaccines Receives UK MHRA Innovation Passport for RVx201 for the Treatment of Genital Herpes Resulting From Herpes Simplex Type 2 (HSV-2) Virus

WOBURN, Mass. and OXFORD, U.K., July 22, 2021 /PRNewswire/ -- Rational Vaccines, a company focused on revolutionizing the treatment of herpes to eradicate the disease, today announced that it has been awarded an Innovation Passport under a new process in the United Kingdom (UK) to bring innovative medicines more rapidly to patients. The Company has received the Innovation Passport for RVx201, a live-attenuated therapeutic vaccine being developed for genital herpes resulting from the herpes simplex type 2 (HSV-2) virus. RVx201 is a first-in-human HSV-2 live-attenuated therapeutic vaccine that is modified to be interferon sensitive and destroy the ability of the virus to inhibit immune responses.

The Innovation Passport is awarded by the UK's Innovative Licensing and Access Pathway (ILAP) Steering Group, consisting of the Medicines and Healthcare products Regulatory Agency (MHRA), National Institute for Health and Care Excellence (NICE), and the Scottish Medicines Consortium (SMC). RVx201 is the first vaccine for HSV-2 to be awarded this designation under ILAP, which was launched by MHRA in January 2021. 

"Herpes affects billions of people worldwide and has been shown to interact with other pandemic pathogens, worsening their impact and transmissibility, including HIV. Given the wide reach of the herpes virus and its implications for people of all ages around the globe, advancing a vaccine is critical," said Agustin Fernandez III, chief executive officer, Rational Vaccines. "For the first time, genital herpes is recognized as a seriously debilitating disease by a leading medicines regulator. This award shows the MHRA's commitment to properly addressing the severe disease burden of so many people with herpes worldwide. This designation is the first step in a program of regulatory optimization that Rational Vaccines has initiated to allow us to move RVx201 into the clinic in the swiftest and most effective way possible. We look forward to continuing to work with the MHRA and other regulatory bodies around the world as we fulfill our core mission of helping patients suffering from herpes and herpes-related diseases and eradicating the virus globally."

"Herpes remains one of the most devastating infections in the world that can lead to blindness and death, particularly in neonatal and pediatric populations. At present there is a lack of novel, safe and effective treatment options beyond antiviral drugs that were discovered in the 1970s by UK-based Burroughs Wellcome [later GSK]ⁱ. Today, fifty years on from these studies, Rational Vaccines is delighted to lead a new chapter of HSV treatment research in the UK supported by worldwide partners. The MHRA's robust oversight standards and innovative approach to regulatory affairs were key drivers in RVx's decision to invest in UK clinical development activities, as a platform to international expansion," said Dr. David Brindley DPhil, MEng, MBA, PG Cert (IP), RAC (US), FRSA, FRSB, chief regulatory and IP officer, Rational Vaccines. "The granting of an Innovation Passport and entry into ILAP for RVx201 for the treatment of HSV-2 genital herpes represents a significant milestone for Rational Vaccines as it recognizes the potential of our approach to transform herpes treatment. We look forward to advancing our RVx201 therapeutic program into the clinic."

The MHRA launched ILAP at the start of 2021 to accelerate the development and access to promising medicines in the UK, thereby facilitating and improving patient access to new medicines. The pathway, part of the UK's plan to extend the UK's position as an international leader in life sciences, features enhanced input and interactions with the MHRA and other stakeholders, including NICE and the SMC. Such regulatory innovations are complemented by the UK's commitment to "[Sustain the UK's] position in novel vaccine discovery, development, manufacture and use of vaccines" as outlined in the recently announced HM Government Life Science Visionⁱⁱ; an ambition that Rational Vaccines supports.

To receive an Innovation Passport, an experimental drug needs to meet the following public health and/or patient-centric criteria: (1) the condition is life-threatening or seriously debilitating; (2) the program fulfills at least one of the following: innovative medicine, clinically significant new indication or, it is intended for a special population; and (3) the medicine has the potential to offer benefits to patients. The Innovation Passport designation is the first step in the ILAP process. It triggers the MHRA and its partner agencies to create a target development profile to chart out a roadmap for regulatory and development milestones with the goal of early patient access in the UK. Other benefits of ILAP include a 150-day accelerated assessment, rolling review, and a continuous benefit-risk assessment.

Rational Vaccines was advised by Niche Science and Technology Ltd and Covington and Burling LLP for the Company's ILAP Innovation Passport application.

About RVx201 
RVx201 is a first-in-human herpes simplex virus type 2 (HSV-2) live-attenuated therapeutic vaccine that is modified to be interferon sensitive and destroy the ability of the virus to inhibit immune responses. In preclinical animal models, data have shown that RVx201 is safe and does not establish latency, and the vaccine's immunization protects against lethal challenge with virulent HSV-2 strains.

About Herpes Simplex Virus (HSV)
The herpes simplex virus (HSV), commonly referred to as herpes, is categorized into two types: herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2). HSV-1 is the primary cause of oral herpes but can also cause genital herpes. HSV-2 is the primary cause of genital herpes. According to a 2020 report by the World Health Organization (WHO), herpes infects billions globally – about a half a billion people worldwide are living with genital herpes, and several billion have an oral herpes infection. Both HSV-1 and HSV-2 infections are lifelong.

While some herpes infections are asymptomatic, a significant number of people experience a range of symptoms that vary in frequency and severity. The most common symptoms for both types of herpes are painful blisters or ulcers at the infection site. In addition, many patients experience debilitating neuralgia, skin splits, fissures, minor abrasions, erythema, fever, chills, and myalgias. Both viruses are most contagious during a symptomatic outbreak, but they can still be transmitted in the absence of symptoms. Beyond physical symptoms, herpes patients often suffer from social stigma and isolation because the infection is often transmitted sexually. Strong evidence has emerged that HSV-1 is a major risk factor for Alzheimer's disease.

There is no cure for herpes. There are no approved vaccines or immunotherapies or sufficiently reliable diagnostics currently available. Antiviral medications developed in the 1970s can help to reduce the severity and frequency of symptoms but cannot cure the infection.

Herpes and HIV
People with compromised immune systems, such as those with advanced HIV infection, are impacted by herpes: HSV-1 symptoms can be more severe and recur more frequently for people with HIV; and HSV-2 fuels the HIV epidemic by increasing the risk of acquiring and transmitting a new HIV infection three-fold. Of particular note, the WHO reports that women living in the WHO Africa Region have the highest HSV-2 prevalence and exposure to HIV – putting them at greatest risk of HIV infection.

Neonatal HSV
Neonatal HSV-1 or HSV-2 are both potentially devastating, leading to serious health problems for the newborn and if left untreated, can lead to an 85 percent mortality rate among infected infants. Although typically acquired at the time of delivery when the risk of transmission from an infected mother is high, as the infant is exposed to the herpes virus in the genital tract during delivery, it can also be transmitted post-delivery. Infants exposed at birth can suffer from fatal organ damage, serious viral infections, sores, blindness, deafness, and seizures.

About Rational Vaccines
Rational Vaccines is revolutionizing the treatment, prevention, and diagnosis of herpes and herpes-related diseases with its rationally engineered, live-attenuated viral immunotherapeutic and prophylactic vaccine candidates. Led by a team of world-renowned scientists, the Company is headquartered in Woburn, MA with locations in Miami, FL and Oxford, UK. For more information, please visit www.rationalvaccines.com.

ⁱ https://www.jaad.org/article/S0190-9622(88)70022-5/pdf
ⁱⁱ https://www.gov.uk/government/publications/life-sciences-vision

SOURCE Rational Vaccines

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