European Commission Approves CAR-T Therapy AUCATZYL Produced by AGC Biologics

The European Commission has approved CAR-T therapy AUCATZYL, developed by Autolus Therapeutics, manufactured by AGC Biologics. This marks the CDMO's 10th product approval from the European Medicines Agency or the U.S. Food and Drug Administration. The therapy is approved to treat adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia in 27 European Union member states.

The European Commission (EC) has granted marketing authorization to Autolus Therapeutics' CAR-T therapy, AUCATZYL, also known as obe-cel, for the treatment of adults aged 26 years and older with relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukemia (B-ALL). This approval marks a significant milestone for Autolus Therapeutics and its CDMOs, AGC Biologics, which has now achieved its 10th product approval from the European Medicines Agency (EMA) or the U.S. Food and Drug Administration (FDA) [2].

The EC's approval is based on the findings of the pivotal phase 1b/2 FELIX clinical trial, which evaluated obe-cel in adult patients with r/r B-ALL. The trial reported a complete response (CR) rate/CR with incomplete hematological recovery rate (CRi) of 76.6% for patients in the pivotal cohort, with a median duration of response of 21.2 months and a median event-free survival (EFS) of 11.9 months [2].

The EC's approval applies to the 27 member states of the EU, as well as Iceland, Norway, and Liechtenstein. Notably, obe-cel has already been approved in the United States since late 2024 [2]. The FDA's approved indication differs slightly from the EC's, allowing the therapy to be used for adults with r/r B-cell precursor acute lymphoblastic leukemia (B-ALL) without the age stipulation [2].

Autolus Therapeutics' stock has seen mixed performance in recent quarters, with a year-to-date gain of 8.7% but a 45% decline over the past 52 weeks. The company's price-sales ratio of 69.4xx is markedly above the sector's median of 3.54x, while its 1.89x price-book ratio remains below group averages of 2.47x [1]. Despite this, analyst sentiment remains bullish, with nine surveyed analysts rating AUTL a consensus "Strong Buy," implying a mean target of $9.84 and 285% upside potential from current levels [1].

This approval adds to Autolus Therapeutics' portfolio of advanced autologous CAR-T cell therapies for blood cancers, which includes AUCATZYL. The company's strategic partnership with AstraZeneca is also a key driver of growth, with the latter investing $140 million in Cellectis, granting exclusive rights to 25 genetic targets [1].

In conclusion, the EC's approval of AUCATZYL represents a significant advancement in the treatment of r/r B-ALL and further solidifies Autolus Therapeutics' position in the CAR-T therapy landscape. The company's strong analyst backing and upcoming clinical and regulatory catalysts suggest potential upside for investors.

References:
[1] https://finance.yahoo.com/news/unlocking-oncology-future-3-trending-165930163.html
[2] https://www.cgtlive.com/view/european-commission-approves-obe-cel-adults-b-cell-precursor-acute-lymphoblastic-leukemia