Selecta Biosciences will review a manufacturing issue stemming from a third party after taking over the rights to an methylmalonic acidemia (MMA) gene therapy program.

Selecta Biosciences and Asklepios BioPharmaceutical (AskBio – acquired by Bayer in October 2020) entered a joint partnership in August 2019 to advance, produce and commercialize adeno-associated virus (AAV) gene therapies using technology platforms from both firms.

While both companies’ will continue their collaboration to assess various gene therapy candidates, after a review of its portfolio AskBio has handed Selecta the full rights to MMA-101 for the treatment of methylmalonic acidemia (MMA), which uses Selecta’s immune tolerance platform, ImmTOR.

Image/iStock: bankrx

ImmTOR is designed to produce antigen-specific immune tolerance ‘by targeting rapamycin to immune cells using nanoparticle technology’ to induce an antigen-specific tolerance.

Selecta hopes to move MMA-101 into the clinic, but said a manufacturing issue related to a component sourced from a third party has led to a delay in its IND submission, and the application will not be made until at least the fourth quarter of 2021.

“Based on our current information from AskBio’s manufacturing partner around delays with the manufacturing of MMA-101, the issue is believed to be related to a component sourced from a third party and is not related to our ImmTOR platform,” a spokesperson for Selecta told BioProcess Insider. “We are in the process of conducting a full review of the issue, which includes a detailed assessment of the manufacturing process.”

The third party has not been divulged but Selecta believes the manufacturing issue “appears to be isolated” and is not related to its ImmTOR platform.

Minimizing delay

Despite the delay caused by the manufacturing issue, the firm remained positive it can submit the IND before the end of this year and told this publication there is no impact on its ImmTOR manufacturing programs.

“As we are currently investigating the cause of the delay, we cannot speak to any specifics, but remain focused on safely expediting the development of MMA-101 for the benefit of patients with this rare disease.”

Selecta said it will provide updates on the issue and the expected timeline for the program when information becomes available. They added: “At this time, we do not foresee any changes to our current timeline and believe we can commence the clinical program in 2022.”

Furthermore, “the addition of the MMA program supplements our wholly-owned Ornithine transcarbamylase (OTC) deficiency gene therapy program and gives us a gene therapy portfolio to independently advance through clinical development.”