M&A Frenzy: Incyte & Villaris, AmplifyBio & PACT, Estrella Earns Nasdaq Listing (Updated)

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With eyes on potentially expanding its dermatology pipeline, Incyte Corporation will acquire privately-held Villaris Therapeutics and its experimental vitiligo treatment, auremolimab, for up to $1.4 billion.

Incyte gains exclusive global rights to develop and commercialize auremolimab for all uses, including in vitiligo and other autoimmune and inflammatory diseases. Auremolimab is an anti-IL-15Rβ monoclonal antibody that is expected to enter clinical trials next year. It is designed to target and deplete autoreactive resident memory T cells. 

Vitiligo, the primary indication for auremolimab, is a dermatological condition that causes the skin to lose pigment cells. This can create discolored patches on the skin and hair. Preclinical data for auremolimab demonstrate high potency, selectivity and efficacy in vitiligo, Incyte noted in its announcement.

Incyte's acquisition of auremolimab is seen as complementary to its current portfolio, which includes Opzelura (ruxolitinib) Cream, a treatment approved for nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. 

Under financial terms of the deal, Incyte will make a $70 million upfront payment to Villaris, which Medicxi backs. 

Company shareholders will be eligible for another $310 million upon the achievement of various developmental milestones. Should auremolimab be approved for commercial use, Villaris shareholders will be eligible for an additional $1.05 billion in commercial milestones on net product sales.

AmplifyBio Acquires PACT Pharma

Incyte isn't the only company to flex its M&A muscle this week.

AmplifyBio, a contract research organization based in Ohio, will acquire privately-held PACT Pharma, a company developing neoantigen-specific T cell receptor cell therapies.

This acquisition will allow AmplifyBio to move beyond the safety, efficacy and toxicology services it currently offers. The company gains advanced characterization platforms and bioinformatics capabilities. 

Additionally, the acquisition brings 40 drug development experts under the AmplifyBio umbrella to enhance cell and gene therapy service offerings. Also, AmplifyBio will gain PACT's South San Francisco advanced laboratory space. AmplifyBio plans to add a third site in New Albany, Ohio, that consists of 350,000 square feet of multi-function lab spaces. 

The company intends to add capabilities for complex genotypic and phenotypic characterization analysis for late-stage development in Ohio. AmplifyBio expects to add additional development platforms and partnerships to become a commercial accelerator delivering safe, effective, reproducible advanced therapies to patients, the company said in its announcement. 

Financial terms of the acquisition were not disclosed. 

AmplifyBio President and Chief Executive Officer J. Kelly Ganjei told BioSpace that the acquisition allows the company to expand from a preclinical CRO alone to an integrated environment that will allow clients to access technologies, and platforms and gain an understanding of mechanisms that are focused on biology and immunology. It will also allow an understanding of the characteristic of advanced therapies.

“We had already begun to build this organically, as we believe it's a critical gap in scaling up novel therapies safely and effectively, but finding this skillset at PACT allows us to hit the ground running much sooner than expected,” Ganjei said.

Estrella Merges with SPAC

New York-based Estrella Biopharma will gain a spot on the Nasdaq Exchange through a merger with TradeUP Acquisition Corp., a special purpose acquisition corporation. When the merger is complete, Estrella will be renamed Estrella Immunopharma, Inc.

The new company will continue to be led by the current management team, including Cheng Liu, president and CEO. 

Estrella is a preclinical company developing CD19-targeted ARTEMIS T-cell therapies for hematological and solid tumors. The company has multiple assets in development, including lead assets EB103 and EB104. 

EB103 targets CD19, a protein expressed on almost all B-cell leukemias and lymphoma surfaces. EB104 targets CD19 and CD22, a protein expressed on the surface of mature B lymphocytes.

In addition to those assets, Estrella is collaborating with Imugene Ltd. on developing CF33-CD19t, an oncolytic virus designed to force solid tumor cells to express a CD19 target. The companies hope this will allow a "mark and kill" strategy. 

When the merger is complete, the combined company's value is expected to be approximately $398.5 million. 

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