(Photo credits: Grupo Valneva -)
(AOF) – Valneva has announced the first positive data, as part of its phase 1/2 study on the use of its inactivated and adjuvanted vaccine candidate against Covid-19, VLA2001, as a booster dose. These initial data confirm that VLA2001 significantly increased the immunity of participants who received the same vaccine as their primary immunization.
77 of 153 study participants, ages 18 to 55, received a booster dose of VLA2001 seven to eight months after completing their primary vaccination cycle with a low, medium, or high dose of VLA2001.
All participants received a single booster vaccine with VLA2001 at the same dose (high) used in the pivotal phase 3 trial.
IgG antibody titers (based on peak protein) were measured at the time of the boost as well as two weeks after the boost. 45 of 77 participants who received a booster dose were included in the final analysis.
The third dose of VLA2001 generated an excellent anamnestic response, with similar antibody levels seen whether participants were initially vaccinated with a low, medium, or high dose.
This demonstrates a strong booster effect, with an increase in antibody levels against Wuhan virus 42 to 106 times compared to the antibody levels seen before the booster dose.
Antibody titers measured two weeks after the booster dose were approximately four times higher than those seen two weeks after the primary vaccination.
In addition to these initial data, Valneva plans to announce more data on homologous withdrawals from the pivotal Phase 3 study.
At the same time, Valneva is preparing to launch a study dedicated to heterologous boosters, which will evaluate a booster dose of VLA2001 injected at least six months after a primary vaccination with other vaccines or after a natural Covid-19 infection. This study should start in early 2022.
Valneva will also evaluate the ability of VLA2001 to generate neutralizing antibodies against variants of interest, including Omicron, using booster participant serum.
Clinical trials (Phases I, II, III)
Phase I: human small-scale testing of the molecule to assess its safety, tolerance, metabolic and pharmacological properties. Phase II: Evaluation of safety and efficacy in several hundred patients to identify side effects. Phase III: evaluation of the overall risk / benefit ratio in several thousand patients.
AOF – MORE INFORMATION
= / Key points / =
– Specialist in the development of prophylactic vaccines against infectious diseases with limited therapeutic options;
– Revenues of 110 million euros from Europe by 56%, ahead of America (27%), then Asia-Oceania (9%) and Africa-Middle East (8%);
– Business model: portfolio of diversified vaccines for the general public, financing of clinical developments through a specialized infrastructure, 2 commercial vaccines (Ixiaro and Dukoral against Japanese encephalitis and cholera) and rights to distribute vaccines for third parties;
– Capital 15.07% owned by the Grimaud la Corbière group, 8.78% by the British MVM Life Science and 8.20% by BPI France, Frédéric Grimaud chairs the five-member supervisory board and Thamas Lingelbach chairs the board of directors ;
– Solid balance sheet with € 449 million of capital compared to € 196 million of debt, reinforced by a net cash of € 330 million in cash at the end of June, and then by the listing on Nasdaq and the first payments from Pfizer (€ 140 million ) and the United Kingdom. Government.
= / Problems / =
– Medium-term strategy for the further development of the Ixiaro and Dukoral vaccines to finance their R&D, the expansion of the manufacturing network (3 centers, in Scotland, Sweden and Austria) and partnerships that enhance the group’s assets;
– Innovation strategy inherent to the business model, backed by 85 million euros in R&D investments, with 3 main assets and 3 preclinical programs:
– the only vaccine in clinical development against Lyme disease,
– the only single injection vaccine against chikungunya,
– the only inactivated and adjuvanted whole virus COVID-19 vaccine currently in clinical trial in Europe,
– candidate vaccines against human metapneumovirus, parvovirus and norovirus;
– Environmental strategy for the regular reduction of environmental impacts;
– Good visibility of the activity thanks to agreements with:
– the British government (orders for 100 million doses of anti-Covid vaccines by 2022 and options for 190 million by 2025, that is, 1,400 million euros in total),
– with Pfizer to co-develop and commercialize a $ 308 million Lyme disease vaccine,
– with the US authorities for the Ixiario vaccine against Japanese encephalitis ($ 70 million),
– with Bavarian Nordic for the commercialization and distribution of specialized vaccines,
– with Batavia Biosciences for the development of an inexpensive polio vaccine,
– with the Butantan institute for a chikingunya vaccine for low-income countries.
= / Challenges / =
– Sensitivity to the results of studies of vaccines against Lyme disease (phase 2) in particular (application for commercialization by 2024) and against chikingunya and Covid 19 (phase 3);
– Result of discussions with the European Commission on the supply of 60 million doses of anti-Covid vaccine and the commercialization of this vaccine by the end of the year;
– Impact of the pandemic: stable business volume at € 47.5 million and expansion of the net loss to € 86.4 million due to R&D spending on Covid 19;
– 2021 Goals: excluding the Covid vaccine, turnover between 80 and 105 million euros and R&D expenses between 65 and 75 million euros.
Boost to the French pharmacy
At the end of a recent CSIS, the French authorities announced an unprecedented amount of credits (7,000 million euros): 1,500 million for research in university hospitals, 2,000 million for investment in health through bpi France, 1,500 million in aid for the relocation of industrial projects. and 2 billion to strengthen investment in three sectors of the future (bioproduction, digital medicine and pandemic preparedness). In addition, the annual growth of drug expenses reimbursed by Medicare will be 2.4%, which should generate at least 0.5% growth in laboratory turnover.
Above all, the normal drug marketing procedure will be sped up (up to 500 days saved) if the actual benefit is sufficient.
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