Regeneron Partners with Tessera in $275M Deal for Alpha-1 Antitrypsin Gene Writing Therapy

December 01, 2025-Regeneron Pharmaceuticals and Tessera Therapeutics have announced a global collaboration to develop and commercialize TSRA-196, Tessera’s investigational in vivo Gene Writing program for alpha-1 antitrypsin deficiency (AATD). The partnership, valued at up to $275 million, aims to bring a potential one-time, disease-modifying genetic treatment to patients suffering from the rare disorder.

Deal Details and Financial Commitment

Regeneron will acquire half of the global development and commercialization rights to TSRA-196 in exchange for $150 million in upfront cash and an equity investment in Tessera. Tessera is also eligible to receive an additional $125 million in development milestone payments.

Under the agreement, both companies will equally share the worldwide development costs for TSRA-196, and if approved, profits from its commercialization will be split 50:50.

TSRA-196: A Gene Writing Approach

TSRA-196 is designed to precisely and durably correct the underlying genetic mutation in the $SERPINA1$ gene, which is responsible for AATD. This gene encodes the alpha-1 antitrypsin (AAT) protein, which is essential for protecting the lungs from damage.

Preclinical studies demonstrated robust and durable $SERPINA1$ locus editing in both mice and non-human primates following a single dose. This “Gene Writing” mechanism is hypothesized to replace the inactive $SERPINA1$ gene with a functioning version, restoring the production of normal AAT protein.

The therapy is delivered using a proprietary non-viral delivery platform (often a Lipid Nanoparticle (LNP) system, as is common in gene editing), though the possibility of future AAV applications remains a key area in the broader field of genetic medicines.

Tessera is currently preparing an Investigational New Drug (IND) application and multiple Clinical Trial Applications (CTA) for TSRA-196, which are expected to be submitted to the U.S. Food and Drug Administration (FDA) by the end of 2025. Tessera will lead the initial first-in-human study, after which Regeneron will take the lead on subsequent global development.

AATD Landscape Broadens

AATD is a rare genetic disorder characterized by the degeneration of the respiratory and hepatic systems. Globally, the illness impacts between 0 and 30 in 100,000 individuals.

Currently, treatment is limited to augmentation therapies, which require weekly infusions of plasma-derived AAT protein to protect the lungs but do not address the root cause of the condition—the body’s inability to produce the protein itself.

TSRA-196 aims to be the first-ever disease-modifying treatment. It joins a competitive and growing pipeline of genetic therapies for AATD, including:

• Beam Therapeutics’ BEAM-302: An in vivo base editing candidate delivered via LNP, which has shown promise in Phase 1/2 trials.

• CRISPR Therapeutics’ CTX460: A gene therapy expected to enter clinical trials in mid-2026.

Analysts at GlobalData forecast the AATD market, valued at $1.2 billion in 2023 across the US and Germany, to grow significantly, reaching $3.48 billion by 2031 with a Compound Annual Growth Rate (CAGR) of 11.2%.