On January 9th, ElsaLys Biotech announced that its flagship drug ABU had been released. This was thanks to a positive assessment by the ANSM and other clinical experts of results gathered in clinical trials since November 2015.
This authorization requires enhanced monitoring (as defined in the TUP) of efficacy and safety data obtained in patients treated with this UTAc. Management with Inolimomab can only be considered if there is no possibility of including the patient in an ongoing clinical trial.
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ElsaLys Biotech offers therapeutic emergency
According to Dr. David Liens, Chief Medical Officer of ElsaLys Biotech “We have data that supports the benefits of Inolimomab treatment in patients with graft-versus-host disease with Glucksberg Grade II to IV corticosteroid-resistant or corticosteroid-dependent acute graft-versus-host disease. We are delighted with this decision made by the ANSM, which allows us to once again make Inolimomab (1 mg/mL, the solution to be diluted for infusion) available to hematology specialists in the event of a therapeutic emergency in this pathology.”
Dr. Christine Guillen, CEO, and co-founder of ElsaLys Biotech stated that “As we continue to work on the filing of marketing authorization applications (MAA) in Europe and the U. S., this UTA demonstrates the therapeutic value of Inolimomab in the management of acute graft-versus-host disease (aGvHD). The ATU program in France allows patients, whose survival is at stake, to have access to a therapeutic solution before marketing in Europe, in close collaboration with the competent authority, the ANSM. The implementation of this ATUc is effective immediately.”
The company recommends that hematology specialists anticipate the administrative procedures by contacting the ATU Unit, which is at their disposal for any additional information.
Inolimomab is an immunotherapy monoclonal antibody that targets the interleukin-2 (IL-2) receptor, a biochemical molecule called a cytokine, which contributes to the development and proliferation of certain white blood cells, including T cells that cause acute graft-versus-host disease. By binding specifically to the receptor (CD25) chain, Inolimomab prevents the binding of IL-2 to the surface of the donor’s overactivated T-lymphocytes, thereby inhibiting their multiplication.
The efficacy of Inolimomab in aGvHD is primarily due to its specificity and preferential affinity for the CD25 receptor on the surface of T cells.
Formerly known as bone marrow transplant, Hematopoietic Stem Cell Transplantation (HSCT) is a last resort for patients with blood cancer or serious immune deficiency who are at a therapeutic standstill. In practice, the treatment aims to replace the patient’s blood cells with hematopoietic stem cells from a compatible donor (allograft). After the transplant, these stem cells will create new healthy and functional blood cells, including leukocytes, which will enable the patient to replenish immune deficiency or eliminate surviving cancer cells.
Although in 60 years this technique has progressed a lot, half of the transplant recipients still suffer from complications: collateral effects of conditioning (the pre-treatment to prevent graft rejection), lasting susceptibility to infection, and graft-versus-host disease. In the latter case, the donor’s overactive T cells “flip” against the patient’s tissues: mucous membranes, skin, digestive system, liver, and lungs. The acute form of the disease appears immediately after transplantation, with the chronic form occurring a few months later (with or without aGvHD).
Affecting from 30% to 50% of patients, graft-versus-host disease is the main complication of transplantation. To slow the progression of this “autoimmune disease,” doctors combine corticosteroids with other immunosuppressive agents. However, about 30%-50% of aGvHD patients gradually become resistant to or dependent on these first-line treatments. To date, clinicians do not have an approved treatment standard in Europe to manage these patients in a therapeutic impasse. For example, in Europe, 4,000 children and adults die from aGvHD each year.
ElsaLys Biotech is creating next-gen treatments
ElsaLys Biotech is an immuno-oncology company in a clinical phase that designs and develops a new generation of therapeutic antibodies that target tumors and their immune and vascular microenvironment.
To convert these new targets into drug candidates, the company is conducting 3 proprietary development programs including Inolimomab (LEUKOTAC®), an immunotherapy antibody demonstrating a clinical benefit in Phase 3 that is on the verge of registration in an orphan disease with a very poor prognosis: graft versus acute corticosteroid-resistant host disease.
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First published in caducee.net, a third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.
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