Medsenic signs new licensing and commercialization agreements with Phebra PTY Ltd.

BioSenic, a clinical-stage company focused on serious autoimmune and inflammatory diseases and cell therapy, has announced updated global licensing, supply, and commercialization agreements with Phebra Pty Ltd. These new agreements are intended to enhance the development of the first oral formulation of arsenic trioxide for the treatment of chronic Graft-versus-Host Disease (cGvHD), thereby improving the chances for final market access.

The new terms of the licensing agreement between Medsenic SAS, a subsidiary of BioSenic, and Phebra, who became a minority shareholder in Medsenic in May 2021, aim to attract investor interest for the upcoming Phase 3 trial of oral arsenic trioxide (OATO/ArsciCor). The updated agreement is designed to facilitate the manufacturing, clinical validation, and eventual commercialization of the drug for cGvHD.

Under the revised License Agreement, Medsenic SAS will have exclusive global rights for the use of OATO in GvHD, while Phebra will receive royalties on worldwide sales. This simplifies the potential for sublicensing to future partners. Commercial rights for other indications in the initial agreement remain unchanged.

The Supply and Commercialization Agreements stipulate that Phebra will manage and maintain the drug substance file according to regulatory requirements, oversee compliance with Good Manufacturing Practices (GMP), update the OATO drug master file, manage the Contract Manufacturing Organization (CMO), and handle the supply chain for the active pharmaceutical ingredient. Phebra will also cover regulatory, quality, and GMP expenses.

Additionally, Medsenic will have the right to establish an Australian entity to utilize the OATO patents for cGvHD treatment, ensuring no commercial competition with Phebra in the acute promyelocytic leukemia (APL) treatment field.

Prof. François Rieger, President of the Board and CEO of the BioSenic Group, expressed optimism about the collaboration with Phebra, emphasizing that the new agreements position the company well for the development and commercialization of OATO/ArsciCor. He noted that these improvements would likely attract new investors, helping to fund the Phase 3 trial of the cGvHD project. Rieger highlighted the company's commitment to providing a safe, effective, and convenient treatment for GvHD, a severe condition following the transplantation of a foreign immune system.

BioSenic specializes in developing clinical assets from Medsenic’s arsenic trioxide (ATO) platform, targeting autoimmune conditions such as GvHD, systemic lupus erythematosus (SLE), and systemic sclerosis (SSc). Following a merger in October 2022 with Bone Therapeutics, BioSenic has combined strategic strengths to develop new anti-inflammatory and anti-autoimmune formulations using the immunomodulatory properties of ATO.

The ATO platform offers products with immunomodulatory effects on activated immune system cells, making it useful for treating chronic GvHD, a significant complication of allogeneic hematopoietic stem cell transplantation (allo-HSCT). Medsenic has seen success with its intravenous formulation, Arscimed®, which has orphan drug designation by the FDA and EMA, and is now preparing for an international Phase 3 study with its new oral formulation, OATO.

Another target for Medsenic's oral formulation is moderate-to-severe systemic lupus erythematosus (SLE), where ATO has demonstrated safety and efficacy across various organs. Systemic sclerosis is also part of Medsenic/BioSenic’s clinical pipeline, with preclinical studies showing positive results, paving the way for a Phase 2 clinical protocol using new immunomodulatory formulations of APIs.

Currently, BioSenic is concentrating its research and development and clinical activities on rapidly advancing its autoimmune platform, focusing on selective and accelerated development to address unmet medical needs.