Novartis taps China's Abogen for autoimmunity TCE

Novartis has added a T-cell engager (TCE) developed by China's Abogen Biosciences for autoimmune disorders in a deal that could be worth over $7.5 billion.

The deal – which includes an upfront payment of $575 million – gives Novartis a worldwide license to ABO2203, an mRNA-based TCE that targets CD19 and CD3 receptors on T-cells and is designed to "reset" B-cells, inhibiting the production of T-cells associated with autoimmune diseases in vivo.

That endogenous mechanism could offer advantages over other approaches to depleting B-cells, like bispecific antibody-based TCEs, according to the two companies, potentially including reduced dosing frequency and a lower risk of serious side effects.

Along with rights to ABO2203, which is already in clinical development for cancer with preliminary results in B-cell non-Hodgkin lymphoma (NHL) reported at this year's AACR cancer congress, Novartis also gets an option on "a number of next-generation therapeutic assets developed on Abogen's RNA platform."

The AACR results provided clinical proof-of-concept for Abogen's mRNA approach to TCE therapeutics, a category that Frost & Sullivan has predicted could be worth $121 billion by 2035.

Novartis is thought to be the first pharma multinational to partner with the Suzhou-based biotech, although it has also been working with fellow Chinese payers Walvax Bio and Genor Biopharma on mRNA-based vaccine and cancer candidates, and has technology-focused alliances with US-based companies Kactus and GenScript ProBio.

"Achieving effective and durable immune reset remains an important goal across a number of autoimmune diseases," said Fiona Marshall, president of biomedical research at Novartis.

"mRNA-encoded T-cell engagers represent an innovative approach that could complement existing therapeutic modalities by enabling in vivo production of these molecules," she added. "We look forward to further developing the potential of ABO2203 and additional possible applications of Abogen's RNA platform."

Along with the upfront payment to Abogen, Novartis has pledged approximately $7.2 billion in other payments, related to the achievement of development, regulatory, and commercial milestones.

"This agreement marks an important milestone for Abogen, underscoring the broad potential of our RNA platform to expand beyond prophylactic vaccines," said the Chinese company's chief executive, Bo Ying.

"ABO2203 is the first mRNA-encoded T-cell engager to enter clinical evaluation for autoimmune diseases," he added.

The deal comes as Novartis has suffered a couple of big late-stage pipeline disappointments – for neuromuscular disease therapy del-desiran and pelacarsen for cardiovascular indications – and needs its pipeline to deliver new products as it faces the loss of market exclusivity for cardiovascular blockbuster Entresto (sacubitril and valsartan) and other big-selling brands.