Sanofi Returns Rights to Two Gene Therapy Candidates, SAR422459 and SAR421869, to Oxford BioMedica

Compiled by Keke

Oxford Biomedica stated on June 8 that Sanofi plans to return the rights to two gene therapy candidates obtained through a collaboration with the company 11 years ago. The two gene therapies are identified as SAR422459 and SAR421869. The former is indicated for the treatment of Stargardt disease, a hereditary macular degeneration that causes visual impairment; the latter is indicated for the treatment of Usher syndrome, also known as hereditary deafness.

However, in February 2019, Sanofi had already planned to seek new partners for these two gene therapy projects. At that time, Sanofi decided to continue the Phase 1/2 proof-of-concept clinical study of SAR422459, but would halt the long-term safety and tolerability clinical trial of SAR421869 in patients with Usher syndrome type 1B.

According to data from ClinicalTrials.gov, the Phase 1/2 proof-of-concept study of SAR422459 (NCT01367444) has been terminated. This small, open-label clinical trial, which had been conducted for six years, enrolled 27 patients aged 6 years and older with Stargardt macular degeneration (SMD). The primary endpoint was the safety and tolerability of escalating doses of SAR422459; the secondary endpoint was to assess the potential biological activity of SAR422459. The trial duration was up to 52 weeks. At the conclusion of the study, participants were to enter an open-label safety study for long-term follow-up, including ophthalmic examinations and adverse event recording, for an estimated period of up to 15 years.

Oxford Biomedica stated, “The timelines for the return of rights and the specific operational details for the two gene therapies are yet to be determined. Following the return of rights to these two programs, the Company will conduct an internal assessment to determine their potential future and decide whether to allocate additional resources for continued development.”

Oxford Biomedica’s share price was unaffected by the aforementioned news. In fact, the company has recently gained significant prominence due to its collaboration with AstraZeneca in developing an adenovirus vector-based COVID-19 vaccine. AstraZeneca has now assumed global responsibility for the manufacturing, development, and distribution of AZD1222, and on May 28, signed initial multi-batch clinical and commercial supply agreements with Oxford Biomedica. Recently, Oxford Biomedica announced that it had entered into a new five-year manufacturing agreement with the Vaccine Manufacturing and Innovation Centre (VMIC), a non-profit organization supported by the UK government. Under this agreement, VMIC will provide Good Manufacturing Practice (GMP) manufacturing facilities to Oxford Biomedica, which will help expand AZD1222 production to meet vaccine demand in the UK and Europe.

Reference source: After 11 years, Sanofi kicks back the rights to unwanted gene therapies to Oxford Biomedica