BioNTech Declines Autolus' CD19/CD22 CAR-T Option Amid Pipeline Prioritization

BioNTech, the German biopharmaceutical company, has decided not to exercise its option on Autolus Therapeutics' dual-targeting CAR-T cell therapy, AUTO1/22. This decision comes as part of BioNTech's ongoing portfolio prioritization efforts and marks a significant development in the collaboration between the two companies.

Option Expiration and Pipeline Strategy

Autolus Therapeutics granted BioNTech a time-limited option on AUTO1/22 in February 2024 as part of a broader deal. The option, which expired last month, would have allowed BioNTech to co-develop the cell therapy in exchange for an upfront fee and milestone payments. However, BioNTech chose not to pursue this opportunity, aligning with its current focus on streamlining its pipeline.

AUTO1/22 is an autologous CAR-T cell therapy that builds upon Autolus' CD19-targeting obe-cel by incorporating an additional CD22 CAR. This dual-targeting approach aims to address a major cause of treatment failure in current CAR-T therapies.

Autolus' Ongoing Development Plans

Despite BioNTech's decision, Autolus remains committed to advancing its CAR-T pipeline. Christian Itin, CEO of Autolus, announced during the company's full-year earnings call that they plan to provide an update on AUTO1/22 and other candidates in their pipeline at an upcoming R&D day scheduled for late April.

Itin stated, "We are moving forward, or have been active in, AUTO1/22, AUTO6NG and AUTO8 and we continue to progress the activities around those programs, collecting more information around the programs, and are planning to also give a short update at the R&D day... towards the end of April."

Ongoing Collaboration on GD2-Targeting Therapy

While BioNTech has passed on AUTO1/22, the collaboration between the two companies continues. BioNTech still holds an option on AUTO6NG, a programmed T-cell therapy targeting GD2. This therapy is designed to treat neuroblastoma and other GD2-expressing solid tumors.

Regarding AUTO6NG, Itin commented, "We're still obviously running through the current clinical study we're conducting with [University College London]. We would expect that trial to actually deliver results and then after we have the results in and the path forward is clear, that would actually be the time point for an option exercise, so it's still a little bit ahead of us."

The ongoing development of AUTO6NG and the potential for BioNTech to exercise its option in the future underscores the dynamic nature of partnerships in the pharmaceutical industry, where decisions are often contingent on clinical results and strategic priorities.