OSE Immunotherapeutics Provides Positive Long Term Memory Responses with CoVepiT, its T Lymphocyte Multi-Target Anti-COVID Vaccine

  • Positive long-term immunological results at 6 months with robust T cell memory responses against virus proteins in healthy volunteers.
  • CoVepiT, based on 13 peptides, elicits durable T-cell immunity against a wide range of structural and non-structural. Viral protein.
  • The vaccine remains independent of the mutations identified in current and emerging forms*.

Nantes, France, March 16, 2022 (Globe Newswire) — OSE Immunotherapeutics (ISIN: FR0012127173; Mnemo: OSE) today announces positive analysis of long-term immune T cell responses to CoVepiT, its prophylactic vaccine candidate against COVID-19, with positive immunological results at 6 months on T cell memory response are received. In parallel, resolution of local durations related to T cell mechanisms of action (1) And good security profile confirmed.

This durability and longevity of the T cell memory response at 6 months comes in addition to the initial immune T cell results obtained at week 6 as the primary endpoint for all clinical trial subjects. This long-term positive immune response is of strong interest. ,2, More multi-specific memory T cells are expected to be efficient for immunocompromised patients in the case of any newly emerging coronavirus or forms of concern.

Dominic Costantini CEO of OSE Immunotherapeutics commented: “It was important for OSE Immunotherapeutics to validate the concept and paradigm that long-term immunity against coronavirus can be achieved in humans with its T-cell vaccine platform by inducing durable memory T lymphocytes, with additional properties in the lung. Resident T cells as already described. In preclinical studies. For immunocompromised patients, it has been established that they are more exposed to COVID-19 hospitalization. Newer treatments such as monoclonal antibodies or anti-viral treatments Treatments are available for immunocompromised patients. Booster shots in addition to registered vaccines are also recommended for this vulnerable population with poor antibody response. Given the new therapeutics and multiple boosters recommended in these patients, the addition of CoVepiT under current circumstances Clinical development is difficult. Strategy for OSE is now an easy industrial scale to take advantage of these long-term T cell response positive results and select the most relevant peptides. allowing us to prepare for any new pandemic crisis with a novel version of anxiety. We thank Bpifrance for supporting this project, including its industrial dimensions.”

*These epitopes, viral protein fragments, are antigenic determinants recognized by T cell receptors during an adaptive T immune response. They are not affected by mutations currently described for various extant variants (particularly delta, omicron) and emerging variants due to epitopes selected in conserved regions of the virus without recurrent mutations.

(1) Hetman, JS et al. Nature 2022

(2) Swaddling et al. Nature 2022

About CoVepiT
CoVepiT is a next-generation multi-target, multi-variant vaccine against SARS-CoV-2 in clinical phase 1. The vaccine candidate was designed using optimized epitopes selected after examining more than 67,000 global SARS-CoV-2 genomes, as well as previous human-infecting CoVs, SARS and MERS, with the lowest likelihood of natural mutations. To identify vaccine targets. Targeting 11 virus proteins, including spike, membrane, nucleocapsid and several non-structural proteins, this second generation vaccine covers all early and novel SARS-CoV-2 variants globally identified to date. In preclinical testing, CoVepiT demonstrated the ability to activate T cell protection through CD8 T-cell multi-epitope responses to long-term T memory cell immunity. In a clinical trial, long-term memory response was confirmed at 6 months.

The project is supported by Nantes Metropol and BiPiFrance (‘Capacity Building’ and ‘PSCP-Covid’).

About OSE Immunotherapeutics

OSE Immunotherapeutics is an integrated biotechnology company focused on developing and partnering with therapies to modulate the immune system for immuno-oncology and autoimmune diseases. Its balanced first-class clinical and preclinical portfolio has a diversified risk profile:

Immuno-oncology first-class products

  • Tedopee® (Innovative combination of Neopitopes): the company’s most advanced product; Positive results for a phase 3 trial (Atlante 1) in patients with non-small cell lung cancer secondary to resistance after checkpoint inhibitor failure.
    Other ongoing combination trials sponsored by Cooperative Clinical Research Groups in Oncology:
    Sponsors GERCOR, Phase 2 in Pancreatic Cancer (TEDOPaM).
    Sponsors ARCAGY-GINECO, in combination with pembrolizumab (TEDOVA), stage 2 in ovarian cancer.
    In non-small cell lung cancer stage 2, in combination with nivolumab, the Italian Foundation sponsors FORT.
  • BI 765063 (OSE-172, anti-SIRPα mAb on the CD47/SIRPα pathway): developed in partnership with Boehringer Ingelheim in advanced solid tumors; Positive Phase 1 dose escalation results of BI 765063 in monotherapy and in combination with azabenalimab (PD-1 antagonist); Ongoing Expansion Phase 1.
  • OSE-279Anti-PD1 – advanced preclinical stage.
  • Bicky®: a bispecific fusion protein platform built on the key backbone component of anti-PD1 has been combined with a new immunotherapy target (for example: BiCKI®-IL7, preclinical stage) to enhance anti-tumor efficacy.

Immunity & Inflammation First Class Products

  • OSE-127/S95011 (humanized monoclonal antibody antagonist of the IL-7 receptor): developed in partnership with Server; Positive Phase 1 result; Phase 2 ongoing in ulcerative colitis (sponsor OSE) and ongoing phase 2a in Sjögren’s syndrome (sponsor server).
  • FR104 (anti-CD28 monoclonal antibody): in transplantation from Veloxis Pharmaceuticals, Inc. Licensing Partnership Agreement with; Ongoing Phase 1/2 in Renal Transplantation (sponsored by the University Hospital of Nantes); Veloxis Pharmaceuticals, Inc. for clinical trials. US IND received by; Stage 2 is planned in an autoimmune disease indication.
  • OSE-230 (chemR23 agonist mAb): a preclinical stage therapeutic agent that has the potential to resolve chronic inflammation by driving the affected tissues to tissue integrity.

CoVepiT: A prophylactic second-generation vaccine activating cytotoxic T lymphocytes against COVID-19, developed using epitopes adapted from the SARS-CoV2 viral protein, epitopes not affected by multi-versions. Shows good tolerability and very good level of T cell immune response. In a clinical trial, long-term memory response was confirmed at 6 months.

for more information: https://ose-immuno.com/en/
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forward-looking statements
This press release contains information and statements expressed or implied that may be considered forward-looking information and statements with respect to OSE Immunotherapeutics. They do not constitute historical facts. These information and statements contain financial projections that are based on certain assumptions and assessments made by OSE Immunotherapeutics Management in light of their experience and their assumptions about historical trends, current economic and industry conditions, expected future growth and other factors, which may be considered. they consider appropriate. ,
These forward-looking statements typically include conditionals and statements using verbs such as “expect”, “estimate”, “believe”, “goal”, “plan”, or “estimate”, their declaration and conjugation and words of similar import. Are included. Although OSE Immunotherapeutics Management believes that forward-looking statements and information are appropriate, OSE Immunotherapeutics shareholders and other investors are cautioned that meeting such expectations is subject to various risks, known or not, and uncertainties by nature. are difficult. To predict and generally beyond the control of OSE immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed or implied or implied in forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with AMF. Such forward-looking statements are not a guarantee of future performance. This press release contains summary information only and should be read along with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on April 15, 2021, including the Annual Financial Report for Fiscal Year 2020, available on the OSE Immunotherapeutics website. Except as required by applicable law, OSE Immunotherapeutics issues this press release as of the date herein and assumes no obligation to update or revise further information or statements.

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