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Share Name | Share Symbol | Market | Type |
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OSE Immunotherapeutics | EU:OSE | Euronext | Ordinary Share |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
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-0.05 | -0.60% | 8.24 | 8.16 | 8.30 | 8.58 | 8.15 | 8.47 | 151,176 | 16:40:00 |
At the Annual Meeting of the Francophone Society of Transplantation, endorsed by the European Society for Organ Transplantation (ESOT)
Regulatory News:
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20231210313768/en/
OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) (Paris:OSE) and Nantes University Hospital presented positive interim data analysis from first use of anti-CD28 FR104/VEL-101 in kidney transplantation at the Annual Meeting of the Francophone Society of Transplantation (SFT, Société Francophone de Transplantation) held in Brest, France (December 5 – 8, 2023).
The oral communication, entitled “First use of FR104, an anti-CD28 molecule in human kidney transplantation, interim analysis”, reported on the first data from the Phase 1/2 clinical trial FIRsT evaluating FR104/VEL-101(emerging locally from the ITUN/CR2TI*) in patients undergoing renal transplant. This study is sponsored and conducted by the University Hospital of Nantes as part of a collaboration agreement with OSE Immunotherapeutics.
Pr. Gilles Blancho, Head of the ITUN at the University Hospital in Nantes / Nantes University and Principal Investigator of the study commented: « We are very pleased to share interim data analysis on post-transplant immune response and one-year safety in patients treated with FR104/VEL-101 in the FIRsT study. There is a lot learned at this stage of the product’s clinical development as we did not observe acute rejection or safety alert after one year follow-up, both key therapeutic issues for patients undergoing renal transplant who require innovative solutions. The therapeutic approach based on selective CD28 blockage by FR104/VEL-101 might represent an effective immunomodulation strategy by reducing the activation of T lymphocytes, while sparing the activity of regulatory T lymphocytes. The exploration of FR104/VEL-101’s safety profile seems promising and encourages moving to a Phase 2 trial.”
Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, concluded: “We thank the University Hospital of Nantes for this major step which marks a key advancement in the clinical development towards a Phase 2 trial of CD28 antagonist FR104/VEL-101. A Phase 2 clinical trial of FR104/VEL-101 in patients undergoing kidney transplantation is under preparation by our partner Veloxis Pharmaceuticals.”
The purpose of the FIRsT Phase 1/2 clinical trial is to investigate the safety, tolerability, and pharmacokinetics of FR104/VEL-101, a novel antagonist pegylated anti-CD28 Fab’ antibody fragment, as well as its potential clinical efficacy on acute rejection prophylaxis and renal function in a de novo renal transplant population receiving an allograft from standard criteria donors (NCT number: NCT04837092). A longer-term follow-up assessment is performed one year after transplantation. One-year safety and efficacy of FR104/VEL-101 is evaluated in terms of renal function, incidence of rejection and suspected potential related adverse events.
Ten patient candidates to a first kidney transplant at low risk of rejection, as planned in the protocol, have been included in the FIRsT study for eight analyzable patients (two patients were screened and enrolled but not transplanted for technical reasons). Tacrolimus (a calcineurin inhibitor) was withdrawn after 6 months post-transplantation. Seven patients completed 1-year treatment with FR104/VEL-101 and one is ongoing (Month 4).
At this interim analysis, no safety alert was detected for FR104/VEL-101. Adverse events were those conventionally observed in kidney transplantation. Pharmacological monitoring made it possible to optimize exposure to FR104/VEL-101 and to maintain high receptor occupancy during the one-year follow-up. No acute rejection under FR104/VEL-101 was observed, especially after discontinuation of Tacrolimus. One of the key challenges in organ transplantation remains to replace calcineurin inhibitors with efficient immunosuppressive treatments with minimal side effects, particularly on renal function in order to preserve patients’ quality of life, and long-term control of post-transplant immune reaction.
* Urology and Nephrology Transplant Institute (ITUN) - Center for Research in Transplantation and Translational Immunology (CR2TI)
ABOUT FR104/VEL-101
FR104/VEL-101 is a pegylated monoclonal antibody fragment that binds to and blocks CD28-mediated effector-T cell co-stimulation, without blocking CTLA-4, an important protein receptor found on T cells that acts as a natural brake on the body’s immune responses. FR104/VEL-101 is, therefore, expected to have a dual-mechanism of action where in a direct manner, it blocks CD28-mediated T cell activation, and in an indirect way, it allows for CTLA-4 mediated immunosuppressive functions.
ABOUT VELOXIS PHARMACEUTICALS
Veloxis Pharmaceuticals, an Asahi Kasei company, is a fully integrated specialty pharmaceutical company committed to improving the lives of transplant patients. Headquartered in Cary, N.C., USA, Veloxis is focused on the global development and commercialization of medications utilized by transplant patients and by patients with serious related diseases. For further information, please visit www.veloxis.com.
ABOUT OSE IMMUNOTHERAPEUTICS
OSE Immunotherapeutics is a biotech company dedicated to developing first-in-class assets in immuno-oncology and immuno-inflammation.
The Company’s current well-balanced first-in-class clinical pipeline includes:
OSE Immunotherapeutics expects to generate further significant value from its two proprietary drug discovery platforms, which are central to its ambitious goal to deliver next-generation first-in-class immunotherapies:
Additional information about OSE Immunotherapeutics assets is available on the Company’s website: www.ose-immuno.com Click and follow us on Twitter and LinkedIn
Forward-looking statements
This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate.
These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which 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 in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Universal Registration Document filed with the AMF on May 2, 2023, including the annual financial report for the fiscal year 2022, available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20231210313768/en/
OSE Immunotherapeutics Sylvie Détry sylvie.detry@ose-immuno.com Nicolas Poirier Chief Executive Officer nicolas.poirier@ose-immuno.com French Media: FP2COM Florence Portejoie fportejoie@fp2com.fr +33 6 07 768 283
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