Rational Vaccines (RVx) announces MHRA Innovation Licensing and Access Pathway (ILAP) approval for their live attenuated vaccine candidate for herpes.
RVx201 goes after the herpes simplex virus type 2 (HSV-2) that causes genital sores. Once RVx201 gets into the body, it causes interferons to be released, which makes cells' defences against viruses stronger. The live-attenuated strain in the vaccine is genetically similar to wild type herpes. The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has let RVx 201 become the third candidate to get a passport. Merck, Sharp & Dohme (UK) Limited (MSD UK Limited) and bluebird bio have also been granted Innovation Passports. MSD UK was the first recipient of the accelerated pathway and received the designation for belzutifan, an investigative treatment for a rare cancer-causing disorder, von Hippel Lindau disease. bluebird was granted the designation for LentiGlobin, a gene therapy in development for sickle cell disease. If approved, LentiGlobin, currently in phase III clinical trials, could become the first one-time, potentially curative treatment for SCD in the UK, the company said.
“The ILAP designation for RVx 201 is another step forward in accelerating the review process of this promising therapy,” said Agustin Fernandez, Chief Executive Officer of Rational Vaccines. “RVx 201 continues to show the potential to be differentiated on efficacy, durability and safety over previous attempts develop a vaccine for herpes and could represent an entirely new class of therapeutic and prophylactic herpes treatments.”
"We are very pleased to have been granted the Innovation Passport," stated Dr Luis Rios-Nogales, MD, PhD, Chief Development and Medical Officer. "Herpes affects millions of people worldwide and has been shown to interact with other pandemic pathogens, worsening their impact and transmissibility. Given the wide reach of the herpes virus and its implications for people of all ages around the globe, advancing a vaccine is critical.”
Dr Tim Hardman, Managing Director at Niche Science & Technology Ltd, UK noted, “ILAP is a truly exciting development with the potential for major benefits for patients, the NHS and the life sciences industry. It aims to deliver safe, early and financially sustainable patient access to medicines by providing a mechanism for its partners to work together and to support the companies developing them. We are delighted to have been able to help Rational Vaccines achieve passport approval.”
About ILAP
The ILAP pathway was announced in December 2020 and began offering medicines at the beginning of 2021. Its goal is to speed up the development and availability of potential medicines, and it is aimed at medicines that are still in their early stages of development. The pathway is part of the UK's plan to attract life sciences development after Brexit. It includes more interactions and feedback from the Medicines and Healthcare Products Regulatory Agency (MHRA) and other groups, such as the Scottish Medicines Consortium (SMC) and the National Institute for Health and Care Excellence (NICE).
The innovation passport designation is the first step in the ILAP process. It tells the MHRA and its partner agencies to make a plan for regulatory and development targets so that patients in the UK can get access to the drug as soon as possible. ILAP also gives you access to a variety of development tools, such as the chance for a 150-day accelerated Marketing Authorization Application (MAA) review, a rolling review, and a constant benefit risk assessment.
About Rational Vaccines
Rational Vaccines, based in Cambridge, MA, USA, is developing engineered, live attenuated viral immunotherapeutic and prophylactic vaccine candidates, focused particularly on combating all diseases that derive from herpes simplex virus 1 (HSV-1) and herpes simplex virus 2 (HSV-2) infections. The company has several vaccine candidates in the pipeline. Their first candidate, RVx 201, is approaching a Phase I/IIa trial in patients-infected with herpes.
Rational Vaccines also joined recently the battle against COVID-19 with a serological assay currently in development and a future COVID-19 vaccine planned. For more information please visit www.rationalvaccines.com.
About RVx 201
RVx 201 is a live-attenuated, genetically-modified variant of HSV-2. This mutant establishes a self-limited infection in those who have the vaccine, but is not expected to cause disease or adverse effects at any time after vaccination. The approach of this live HSV-2 vaccine is similar to the existing, and effective, live varicella-zoster virus Oka vaccine, developed in the 1980s. The vaccine strain is known as ‘HSV-2 0∆NLS’ where the term ‘0∆NLS’ references the nature of the attenuating mutation. In the pre-clinical setting, RVx-201 has shown to be highly efficacious in protecting immunised animals against HSV-2 genital herpes relative to naïve animals.
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