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BioSenic, a top-notch biotech firm, and Phebra, a leading Australian pharmaceutical developer, are working together to amend their existing licensing agreement. The amendment concerns the agreement between Medsenic SAS, an affiliate of BioSenic, and Phebra Pty Ltd, where the stipulation for the launch of the OATO Phase III has been extended to May 2024.
Licensing Agreement Amendment
The original licensing and marketing agreement between Medsenic and Phebra, which was established in May 2021, focused on the oral formulation of arsenic trioxide (OATO). The key areas of this agreement included various diseases such as Graft Versus Host Disease (GvHD), Systemic Sclerosis (SSc), Systemic Lupus Erythematosus (SLE), COVID-19-related infectious diseases, and CNS inflammatory diseases related to Multiple Sclerosis.
The license granted to Medsenic was contingent on the initiation of a clinical study using Phebra's OATO. If Medsenic failed to commence the study before 31 May 2023, Phebra had the right to terminate the agreement unless both parties agreed to delay this deadline. This deadline has now been extended to 31 May 2024.
Further Negotiations
In addition to the amendment, BioSenic and Phebra are considering the potential expansion of the Medsenic Territories and their commercial terms. François Rieger, PhD, Chairman, and CEO of BioSenic, expressed satisfaction at the coordinated efforts between Phebra and Medsenic.
Phebra's Profile
Phebra is an Australian-owned manufacturer dedicated to enhancing skill development and employment opportunities in research and development and commercial product production. With over 120 employees, Phebra manufactures over 65 medicines in critical therapeutic areas and collaborates with hospitals to develop much-needed therapeutic solutions. Phebra also partners with companies to bring critical medicines into Australia and supplies and out-licenses products globally.
BioSenic's Profile
BioSenic specializes in developing clinical assets from its two primary platforms: the allogeneic cell therapy platform ALLOB and the Arsenic TriOxide (ATO) platform. The company targets several key indications, including Graft versus Host Disease (GvHD), Systemic lupus erythematosus (SLE), Systemic Sclerosis (SSc), and high-risk tibial fractures.
In October 2022, BioSenic merged with Medsenic and Bone Therapeutics, combining their strategic positionings and strengths. This merger allowed BioSenic to supplement its innovative cell therapy platform and strong intellectual property for tissue repair protection with a wide range of anti-inflammatory and anti-autoimmune formulations using the immunomodulatory properties of ATO/OATO.
BioSenic's Innovative Platforms
BioSenic's technology stands on two main platforms: the allogeneic cell and gene therapy platform and the Arsenic TriOxide (ATO) platform.
The allogeneic cell and gene therapy platform uses differentiated bone marrow-sourced Mesenchymal Stromal Cells (MSCs) that can be stored at the point of use in hospitals. The ATO platform, developed by Medsenic, showcases the immunomodulatory properties of ATO, demonstrating a double basic effect on cells of the immune system.
Future Developments
Apart from these platforms, BioSenic is also developing an off-the-shelf next-generation improved viscosupplement, JTA-004. It aims to provide added lubrication and protection to the cartilage of arthritic joints and alleviate osteoarthritic pain and inflammation.
In March 2023, BioSenic provided a new post-hoc analysis of its Phase III JTA-004 trial on knee osteoarthritis. The analysis revealed positive action on the most severely affected patient population, possibly allowing for the stratification of patients for a new, optimized Phase III clinical study. BioSenic is now exploring options for the future development of JTA-004 in collaboration with existing and potential partners.
Conclusion
The amendment to the licensing agreement between BioSenic and Phebra marks a new chapter in their partnership. By extending the deadline for the initiation of the clinical study using OATO, both companies have demonstrated their commitment to continued collaboration in the development of innovative therapies for serious diseases. The future holds promise for further developments and breakthroughs in their joint venture.
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