Saint-Herblain (France), October 10, 2022 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a uniqueness vaccine corporate, publicizes nowadays it’s going to provide on its single-shot chikungunya vaccine candidate at a number of main medical meetings all through the fourth quarter of 2022.
On the International Vaccine Congress Europe in Barcelona, Valneva will provide “One step nearer to a chikungunya vaccine: replace on Valneva’s live-attenuated vaccine candidate,” on October 13, 2022 at 2:45pm CEST. The Corporate will even have a show within the showcase house at sales space #46 in the course of the Congress, from October 11 via 14, 2022.
On October 27, 2022 at 10:30am ICT, Valneva will provide “Development of Scientific Building of a Are living-Attenuated Unmarried Shot Chikungunya Vaccine Candidate” as a part of the Vaccines for Tropical Illnesses symposium on the twentieth World Congress for Tropical Medication and Malaria (ICTMM2020) in Bangkok.
Valneva may even provide at the Section 3 medical building of its single-shot chikungunya vaccine candidate on the American Society of Tropical Medication and Hygiene (ASTMH) 2022 Annual Assembly, going down October 30 via November 3, 2022 in Seattle. The Corporate will provide an summary on November 1, 2022 at 10:15am PST all through an in-person medical consultation.
On the World Society for Pharmacoeconomics and Results Analysis (ISPOR) Ecu Congress going down November 6 via 9, 2022 in Vienna and on-line, two posters can be offered: “Burden of Sickness and Paucity of Remedy of the Mosquito-Borne Chikungunya Virus (CHIKV)” and “The Financial Burden of the Globally Spreading Chikungunya Virus: A Systematic and Centered Evaluate.”
In spite of everything, the Corporate will provide on the Joint World Tropical Medication Assembly (JITMM) 2022 in Bangkok from December 7 via 9, 2022.
Shows can be made by means of Valneva’s senior medical management, together with Juan Carlos Jaramillo, MD, Leader Scientific Officer of Valneva; Katrin Dubischar, VP Program Director – Chikungunya Vaccine; and Susanne Eder-Lingelbach, VP Scientific Building, amongst others.
Valneva initiated rolling submission with the U.S. Meals and Drug Management (FDA) of a Biologics License Utility (BLA) for licensure of its single-shot chikungunya vaccine candidate in people elderly 18 years and above in August 2022.
This BLA submission follows ultimate pivotal Section 3 information reported in March 20221 and ultimate lot-to-lot consistency effects reported in Might 20222. A medical learn about of VLA1553 in teenagers is ongoing in Brazil3, which would possibly give a boost to long run regulatory submissions on this workforce if VLA1553 is authorized in adults.
This system gained FDA Rapid Observe and Step forward Treatment designations in 2018 and 2021, respectively. VLA1553 was once additionally granted PRIority MEdicine (PRIME) designation by means of the Ecu Drugs Company (EMA) in 2020, and Valneva plans to make regulatory submissions for VLA1553 in Europe within the first part of 2023.
Chikungunya is a mosquito-borne viral illness brought about by means of the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by means of Aedes mosquitoes. An infection results in symptomatic illness in 72-92% of people after 4 to seven days following the mosquito chew. Whilst mortality with CHIKV is low, morbidity is excessive, and the worldwide marketplace for vaccines towards chikungunya is estimated to exceed $500 million every year by means of 20324. Scientific signs come with acute onset of fever, debilitating joint and muscle ache, headache, nausea, rash and protracted arthralgia. Chikungunya virus incessantly reasons surprising massive outbreaks with excessive assault charges, affecting one-third to three-quarters of the inhabitants in spaces the place the virus is circulating. The high-risk spaces of an infection for vacationers are puts the place chikungunya virus-carrying mosquitos are endemic, together with the Americas, portions of Africa, and Southeast Asia, and the virus has unfold to greater than 120 international locations. As of July 2022, greater than 3 million instances had been reported within the Americas5 and the commercial have an effect on is thought of as to be vital. The clinical and financial burden is predicted to develop because the CHIKV number one mosquito vectors proceed to unfold geographically. There aren’t any preventive vaccines or efficient therapies to be had and, as such, chikungunya is thought of as to be a significant public well being danger.
VLA1553 is a live-attenuated, unmarried dose investigational vaccine candidate concentrated on the chikungunya virus, which has unfold to over 120 international locations. It’s been designed by means of deleting part of the chikungunya virus genome.
Valneva reported ultimate information from the pivotal Section 3 trial of VLA1553 in March 20226 and ultimate lot-to-lot consistency ends up in Might 20227.
If authorized, VLA1553 would enlarge Valneva’s current industrial vaccines portfolio and as such, Valneva intends to commercialize this vaccine leveraging its current production and industrial operations.
To make VLA1553 extra obtainable to Low- and Heart-Source of revenue Nations (LMIC), Valneva and Instituto Butantan in Brazil signed an settlement in January 2021 for the advance, production and advertising and marketing of VLA15538. The collaboration falls throughout the framework of the settlement signed between the Coalition for Epidemic Preparedness Inventions and Valneva in July 20199, which supplies investment of as much as $23.4 million with give a boost to from the Ecu Union’s Horizon 2020 program.
About Valneva SE
Valneva is a uniqueness vaccine corporate targeted at the building and commercialization of prophylactic vaccines for infectious illnesses with vital unmet clinical want. The Corporate takes a extremely specialised and focused option to vaccine building after which applies its deep working out of vaccine science to broaden prophylactic vaccines addressing those illnesses. Valneva has leveraged its experience and functions each to effectively commercialize 3 vaccines and to swiftly advance a wide vary of vaccine applicants into the sanatorium, together with applicants towards Lyme illness and the chikungunya virus.
Media & Investor Contacts
Joshua Drumm, Ph.D.
Ahead-Taking a look Statements
This press unlock comprises sure forward-looking statements on the subject of the industry of Valneva, together with with appreciate to regulatory approval of VLA1553, timing and plans for medical systems and product applicants and income forecasts. As well as, although the real effects or building of Valneva are in step with the forward-looking statements contained on this press unlock, the ones effects or trends of Valneva is probably not indicative of long run effects. In some instances, you’ll be able to determine forward-looking statements by means of phrases similar to “may,” “will have to,” “would possibly,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “targets,” “goals,” or identical phrases. Those forward-looking statements are in line with the present expectancies of Valneva as of the date of this press unlock and are topic to quite a few identified and unknown dangers and uncertainties and different components that can motive exact effects, efficiency or achievements to be materially other from any long run effects, efficiency or fulfillment expressed or implied by means of those forward-looking statements. Specifically, the expectancies of Valneva might be suffering from, amongst different issues, uncertainties concerned within the building and manufacture of vaccines, sudden medical trial effects, sudden regulatory movements or delays, festival on the whole, foreign money fluctuations, the have an effect on of the worldwide and Ecu credit score disaster, the power to acquire or take care of patent or different proprietary highbrow assets coverage and the have an effect on of the COVID-19 pandemic. In mild of those dangers and uncertainties, there will also be no assurance that the forward-looking statements made on this press unlock will actually be discovered. Valneva is offering the ideas on this press unlock as of the date hereof and disclaims any aim or legal responsibility to publicly replace or revise any forward-looking statements, whether or not on account of new data, long run occasions, or another way.
1 Valneva Effectively Completes Pivotal Section 3 Trial of Unmarried-Shot Chikungunya Vaccine Candidate
2 Valneva Effectively Completes Lot-to-Lot Consistency Trial for its Unmarried-Shot Chikungunya Vaccine Candidate
3 Valneva Broadcasts Initiation of Adolescent Section 3 Trial for its Unmarried-Shot Chikungunya Vaccine Candidate – Valneva
4 VacZine Analytics Chikungunya virus vaccines World call for research. February 2020
5 PAHO/WHO information: Choice of reported instances of chikungunya fever within the Americas (Cumulative Instances 2018-2022 and Instances in keeping with 12 months 2013-2017). https://www.paho.org/information/index.php/en/mnu-topics/chikv-en/550-chikv-weekly-en.html. Ultimate accessed 25 Jul 2022.
6 Valneva Effectively Completes Pivotal Section 3 Trial of Unmarried-Shot Chikungunya Vaccine Candidate
7 Valneva Effectively Completes Lot-to-Lot Consistency Trial for its Unmarried-Shot Chikungunya Vaccine Candidate
8 Valneva and Instituto Butantan Signal Ultimate Settlement on Unmarried-Shot Chikungunya Vaccine for Low and Heart Source of revenue Nations
9 CEPI awards as much as $23.4 million to Valneva for late-stage building of a single-dose Chikungunya vaccine