Valneva: positive data from the chikungunya vaccine trial – 08/28/2023 at 08:35

(AOF) – Valneva SE, a vaccines company, today announced positive early Phase 3 safety data in adolescents for its single-dose chikungunya (CHIKV) vaccine candidate, VLA1553. Immunogenicity data from this clinical trial are expected to be available in November 2023.

Funded by the Coalition for Epidemic Preparedness Innovations (CEPI) and conducted in collaboration with the Butantan Institute, the VLA1553-321 trial in adolescents is being conducted with the aim of being able to request, if successful, an extension of for use in this age group if VLA1553 is first cleared in adults by the US Food and Drug Administration (FDA).

The trial could also allow the vaccine to be licensed in Brazil, which would then constitute the first marketing authorization for use in an endemic population.

The current safety analysis could also allow the filing of a marketing authorization application with the European Medicines Agency (EMA) later this year.

Early safety data generated in the ongoing VLA1553-321 trial, Valneva’s first clinical trial conducted in an endemic area and including participants previously infected with the chikungunya virus, showed that VLA1553 was generally safe and well tolerated in adolescents aged 12 to 17, whether or not they have been previously infected with the virus.

AOF – LEARN MORE

Key points

– Specialist in the development of prophylactic vaccines against infectious diseases with limited therapeutic options;

– Turnover of €361 million from vaccines, in particular for travellers, for 32% and for the rest mainly from contracts for the supply of vaccines against COVID-19;

– Business model: portfolio of diversified vaccines for the general public, financing of clinical developments by a specialized infrastructure, 2 commercial vaccines (Ixiaro and Dukoral against Japanese encephalitis and cholera) and distribution rights for third parties;

– Capital held at 9.9% by the Grimaud la Corbière group, 8.92% by BPI France, 7.6% by Deep Track Capital and 6.9% by Pfizer, Frédéric Grimaud chairing the supervisory board of 7 members and Thamas Lingelbach the management board;

– Solid balance sheet reinforced by the call to the market in September 2022, with available cash close to €289m, providing financial visibility until the end of 2024.

Challenges

– Medium-term strategy based on financing R&D through sales of the Ixiaro and Dukoral vaccines, extension of the manufacturing network (3 sites, in Scotland, Sweden and Austria) and partnerships promoting the group’s assets;

– Innovation strategy inherent in the business model, rich in a portfolio of 398 patents and supported by €173 million in R&D costs, with 3 main assets and 3 preclinical programs:

– the only vaccine in clinical development against Lyme disease,

– the only single injection vaccine against chikungunya,

– candidate vaccines against human metapneumovirus, parvovirus and norovirus;

– Environmental strategy: energy efficiency, minimization of waste, optimal use of water and reduction of 5%, vs 2016, of CO2 emissions by 2025;

– Good visibility of the activity thanks to the agreements on vaccines with: with Pfizer to co-develop and sell the one against Lyme disease ($308 million),

– with Bavarian Nordic for the marketing and distribution of specialized vaccines,

– with Batavia Biosciences to develop an inexpensive polio vaccine,

– with the Butantan institute against chikungunya for low-income countries;

– Continued growth of Ixiaro and Dukoral vaccines

Challenges

– After the end of the production of the anti-covid vaccine, two major challenges: VLA1553 against chikungunya and VLA15 against Lyme disease:

– VLA1553: waiting for marketing authorization by the United States Health Authority for August, application to the European Union expected for the 1st quarter;

– VLA15: end of phase 3 clinical trials of the vaccine in the 2nd quarter;

– Launch of the marketing, in partnership with VBI Vaccines, of PreHevbri, the only vaccine authorized in Europe against hepatitis B;

– After an 11% increase in revenues and a net loss of €143.3 million, 2023 objectives:

– revenues of €220 to €260 million including €140 million from product sales, including marginal sales of anti-COVID-19 vaccines in the Kingdom of Bahrain, and €110 million from other operating income,

– R&D expenditure of approximately €80 million.

Find out more about the Pharmacy sector

Biotechs put to the test

These companies are suffering from a much less favorable economic cycle, which is reflected in particular by a drop in financing by venture capital for start-ups. These companies are therefore obliged to carry out redundancy plans. Added to this is a much more restrictive regulatory framework. First, in the United States, the measures linked to the Inflation Reduction Act (IRA) could have a strong impact on the margins of the participants. Indeed, from 2026, the federal Medicare program will be able to renegotiate the price of drugs marketed for nine years (chemicals) or 13 years (biologicals), with discounts that could range from 35 to 60% for biotechs. Similarly, in Europe, with the new drug regulations presented in Brussels in April, the duration of patent protection will be reduced if the innovative treatment is not marketed in all member countries within two years.