New anti-transplant drugs! IL-2 Receptor Targeting Immunotherapy Leukotac is on the market in the United States, significantly prolonging patient survival!

July 24, 2020 /PRNewswire/ -- Elsaly Biotech, a subsidiary of Mediolanum Farmaceutici Spa, recently announced that the U.S. Food and Drug Administration (FDA) has agreed to initiate the submission process for leukotac biological product licensing application (BLA) for the treatment of patients with SR-aGvin disease in the class II-IV steroid refractive acute transplantation (SR-aGv).
the BLA will be reviewed through the FDA Real-Time Oncology Review Pilot Program (RTOR), an initiative launched by the FDA Center for Oncology Excellence.
RTOR project aims to explore a more effective review process to ensure that patients receive safe and effective treatment as early as possible, while maintaining and improving the quality of FDA reviews.
aGvHD is the main complication of hematopoietic stem cell transplantation (HSCT) and is the main cause of morbidity and mortality in this case. about half of aGvHD patients in the
had no response to the initial steroid treatment and had few other treatment options.
so far, there is only one approved standard therapy in Europe for such patients.
inolimomab (Leukotac) is an immunotherapy monoclonal antibody that targets leukocyte interleukin-2 (IL-2) receptors, a cytokine that contributes to the development and proliferation of certain white blood cells, including T cells associated with aGvHD.
by binding the alpha chain of the receptor (CD25) specifically, inolimomab blocks the surface of IL-2 and the donor's overactive T cells, blocking its proliferation.
's role in SR-aGvHD is mainly its specificity and priority affinity to the CD25 receptor on the surface of T lymphocytes.
inolimomab's mechanism and therapeutic benefits (click on the image) As of 24 December 2019, the French National Drug and Health Products Safety Agency (ANSM) has approved the temporary use authorization (ATU) for SR-aGvHD indications (including paediatric patients).
this means that inolimomab treatment may be considered when patients are not included in an ongoing clinical trial.
data from a randomized, multi-center, controlled, parallel group 3 study (INO-107-EUDRACT 2007-005009-24) confirmed that inolimomab had a robust and long-lasting response rate in the treatment of Patients with SR-aGvHD.
, inolimomab had a significant advantage in long-term survival compared to the control group for ATG (anti-thymosin) treatment. data from the
follow-up 8.5 years show that the total survival rate of the inolimomab treatment group was 30.6% (n-15/49), the ATG treatment group was 19.6% (10/51), and the adjusted HR was 0.572 (95%CI: 0.346, 0.947;
this represents an absolute difference of 11 per cent in total survival, equivalent to a 43 per cent reduction in the relative risk of death.
these results clearly confirm the clinical benefits of inolimomab and indicate that the drug is an alternative treatment option for patients with Grade II-IV SR-aGvHD. Dr David LIENs, chief medical officer of elsa Lys Biotech,
, said: "The increase in the number of hematopoietic stem cell transplants worldwide has led to a demand for a large number of newly approved drugs for the treatment of aGvHD, particularly steroid-resistant, and often with very poor outcomes. reliable clinical data( including positive safety) from more than 1,400 individuals treated in
indicate that inolimomab is a meaningful alternative to the treatment of steroid refractive aGvHD. "While we remain committed to submitting sales authorization applications (MAAs) in Europe and the United States, the ATU approval of the French regulator demonstrates the value of inolimomab treatment aGvHD," said Dr. Christine Guillen, CEO and Co-Founder of Elsa Lys Biotech,
.
France's ATU program allows patients whose survival is threatened to obtain therapeutic drugs in close cooperation with the competent authority ANSM before inolimomab is available in Europe.
the at-tul at the ATU was immediate.
" () Original origin: Elsa Lys Biotech silet siphons license application to FDA for LEUKOTAC ® (inolimomab) for the treatment of graft-versus-host in disease adult patients.