»Xenothera: LIS1’s safety and efficacy results, a new induction treatment in transplantation mypharma version

Posted on Thursday, June 9th, 2022

The results of clinical trials of LIS1 were presented at the American Transplant Congress (ATC) in Boston, USA from June 4 to 8, 2022, on the genotype glyco-humanized polyclonal antibody and immunosuppressant for solid organ transplantation.

At the American Congress of Transplantation, Professor Ondrej Wickley of the IKEM Institute – one of the leading kidney transplant centers in Europe for decades (Prague, Czech Republic) – NCT04431219 – Chief Investigator of the trial, presented the first results of LIS1 Episode I / (H) Clinical trials that took place from September 5, 2019 to March 28, 2022 (last seen by a patient).

Clinical trials of immunosuppressants dedicated to LIS1 transplants consist of two groups of first kidney transplant patients with limited immunological risks, who have received 5 consecutive LIS1 administrations starting the day after transplantation. AD team[1] Increasing doses of LIS1 ranging from 0.6 to 8 mg / kg were found in 5 patients. TD team[2] 5 patients received therapeutic doses of LIS1.

The initial end point was product safety, LIS1 was well tolerated. Side effects are mild or moderate, and all patients have recovered.

Ten patients, 4 females and 6 males, thus regained their renal function within the normal period after transplantation. No side effects such as leukopenia or thrombocytopenia were observed. Overall, the test results provide a reassuring overall security profile for LIS1.

At the same time, the first pharmacokinetic and pharmacodynamic results are promising. Pharmacokinetic analyzes have shown long half-lives; No anti-product antibodies (ADA)[3]) Was detected. Pharmacodynamics demonstrates an innovative and original mechanism of combining lymphocyte reduction and alopecia activity, confirming the promising status of LIS1 as a new induction treatment in solid organ transplantation.

Xenothera is the sponsor of this first clinical study of LIS1 on humans, a product derived from its glyco-humanized antibody platform, which is intended to prevent acute rejection in transplantation.

“It’s a big step for Xenothera and the whole team. It’s been almost eight years since the company was born, and today we’re getting the results of our research. This is great news for the Nantes ecosystem, I especially think of the Center for Research in Transplantation and Immunology, which incubated the LIS1 technology and the whole ecosystem, especially Atlanteol, at the beginning of the company. . Transplantation is a major public health problem, and these encouraging results show that Xenothera can bring innovation to transplant patients or patients on the waiting list, of which we would be very proud, ”commented Odil Duvax, President and co-founder of Xenothera.

Induction treatments available today create safety issues or limitations of effectiveness. The ambition of LIS1 is better efficacy than anti-IL2R and better protection than conventional corrosive agents, two major types of replacement therapy. For example, transplant recipients who are at risk of toxicity from agents used in transplants may be of interest, with an increased risk of infection in the first year after LIS1 transplantation.

LIS1, through the controlled reduction that it allows, can provide increased comfort to transplant patients, as well as provide the same efficacy in preventing their acute transplant rejection.

Biotech is preparing for the next phase of clinical development of LIS1, a confirmatory trial (Phase II / III) is planned for 2023 and will be conducted at several transplant centers in Europe and the United States.

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[1] Ascending dose

[2] Therapeutic dose

[3] Anti-drug antibodies

Source and visual: XENOTHERA

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