French Ose to enroll up to 400 for “T-cell” coronavirus vaccine trials

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* Focus on the T lymphocyte-based approach

* Up to 400 patients expected for phase I / II trials

* Phase three trial expected from September 2021

* The company claims to be able to produce millions of doses

PARIS, October 19 (Reuters) – French company Ose Immunotherapeutics will recruit up to 400 patients for the first two stages of clinical trials of an experimental coronavirus vaccine which it hopes will provide an additional weapon in the fight against the global pandemic.

Chief Executive Alexis Peyroles told Reuters that Ose hopes to deploy its vaccine in Europe and the United States in 2022, potentially at least a year after the most advanced projects.

However, he said the different modus operandi of Ose’s candidate meant he could still play an important role.

More than 40 drug makers and research groups are conducting human trials of vaccines against a virus that has resulted in more than a million deaths and disrupted economies.

Most of these vaccines are primarily designed to generate “neutralizing antibodies” to counteract the virus. While this is considered the most promising approach, some researchers are wondering if the effect will last when the virus mutates.

Ose, who focuses on oncology and autoimmune diseases, believes that a subgroup of T cells, also known as “killer cells”, can be formed to attack cells infected with a virus and recognize up to 11 of the coronavirus proteins – whereas traditional vaccines typically go after one.

“T cells are like infantry in our bodies,” Peyroles said, adding that the Ose vaccine could be given alone or in combination with other injections for certain immunocompromised individuals or those with co-morbidities such as diabetes. or cancer.

“If you inject an anti-antibody vaccine multiple times to extend protection, you may experience adverse reactions to the vaccine, this is where our product could also complement well.”

OSE is listed as the only company pursuing a T cell-based approach in the World Health Organization’s vaccine count. bit.ly/3dH39As

The potential vaccine is one of the few being developed by French companies or researchers, in particular by Sanofi, Valneva and Osivax as well as by researchers from the Institut Pasteur.

If the first two phases of clinical trials which are due to begin towards the end of the year – and which will assess safety and immune response – go as planned, Ose will aim to team up with an industry partner to conduct the final phase III. studies from September 2021 and possibly distribute the vaccine.

Peyroles did not say whether his company has entered into discussions with potential partners, but said companies such as Sanofi, Merck & Co and AstraZeneca may be interested after obtaining the results of their own end-stage trials.

“We made sure they knew our data,” he said of the three companies when asked if discussions were already underway.

Peyroles said vaccine production could be scaled up easily given the availability of ingredients and OSE’s existing supply agreements.

“We are not in the biologics space with this vaccine. We have partnerships and we can produce millions of doses. “

Report by Matthias Blamont in Paris; Additional reporting by Ludwig Burger in Frankfurt; Editing by Mark Potter

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