Forte Biosciences is being acquired by Argenx for $2.2 billion in a deal that has two stages: phase 2 for a vitiligo product and celiac disease.
The rewarded compound for Argenx is an anti-CD122 antibody called FB102, which had proven to be effective in a phase 1b trial earlier this month. In that trial, Forte was found to be statistically comparable to an improvement in facial vitiligo score of 29.6%. A readout for the phase 2 celiac trial is expected later this year.
Forte previously was an investment of Argenx, and the results of phase 1 trials of FB102 in both indications were “key drivers” that “led Argenx to make the decision to move from strategic investment to acquisition,” the company said.
Beyond celiac disease and vitiligo, “FB102 can be used to treat alopecia areata and other autoimmune diseases, and is a promising opportunity for a pipeline-in-a-product,” according to Argenx in a July 27 press release.
The company said FB102 “complements Argenx’s current portfolio of antibody-based programs, which includes the blockbuster drug for autoimmune disorders, Vyvgart, and C2-targeting antibody empasiprubart, which is currently in the phase 3 stage, for multifocal motor neuropathy and chronic inflammatory demyelinating polyneuropathy, respectively, as well as adimanebart, an antibody directed against muscle-specific kinase, which is still in the early phase of development for the treatment of a neuromuscular disease.”
By introducing a mechanism that targets pathogenic T cells and NK cells, “FB102 extends the company’s disease exposure to other aspects of the immune system,” argenx said.
“It’s a very elegant target, with the ability to block IL-15, IL-2, and yet still can support the proliferation of T regulatory cells — that’s a real differentiator,” Karen Massey, the CEO of argenx, told Fierce in an interview.
The molecule comes “at the right time” at argenx, Massey said. After the asset has been “clinically de-risked” with those two phase 1b studies, argenx can “apply our know-how and our playbook around indication selection [and] indication sequencing, about our product presentation playbook and developing subcutaneous” formulation to maximize the value of the asset, she said.
Vitiligo is a skin condition for which Incyte already has a JAK inhibitor cream, called Opzelura (ruxolitinib), which it has sold. The company recently discontinued development of a drug targeting CD122 after testing it in the skin disease. Compared with a topical treatment, a systemic solution like FB102 could deliver better outcomes for patients who have severe disease over a large part of their body, Massey said.
A few years ago, Argenx began to track CD122. But about the mechanism and recent ‘clinical validation’, Massey told the audience that FB102 appears to be a first-in-class asset, with best-in-class potential.
But Arjen Lemmen, VP of corporate development & strategy at Argenx, indicated Forte is not always the “standard level of validation we need to see every time” when it comes to deal-making.
Argenx closed the second quarter with $5.2 billion of cash, cash equivalents and other financial assets thanks to the success of Vyvgart. That cash balance provides Argenx with the ability to pursue the most exciting science, and the company continues to monitor assets across all stages of development under all types of deals, Massey said.
The buyout ends Forte’s story on a happy note, following a tough period in 2022 when the company came under pressure from its top shareholder to liquidate in the wake of its lead atopic dermatitis asset failing a phase 2 trial.
When the investment firm in question was looking at Forte’s plans to plow the rest of its money into FB102, it was not a big fan of the idea at the time, but it appears that investment may have turned out to be good.
“This represents our great progress in the clinical development of FB102, and we are convinced that argenx is the perfect partner to realize the full potential of this novel anti-CD122 antibody in a wide spectrum of autoimmune diseases,” said Paul Wagner, Forte’s CEO.
“Combined with FB102’s promising clinical profile and argenx’s vast development and commercial expertise, global reach and proven ability, we have an opportunity to accelerate its development and maximize its impact for patients with autoimmune conditions, such as vitiligo, celiac disease and alopecia areata.”
Netherlands-based Argenx is offering to buy Nasdaq-listed Forte stock at $77 a share, or 40.5 cents more than its $54.78 Friday closing price.
Massey also explained the significance of this morning’s deal in light of the Vision 2030 strategy of the biopharma to revolutionize the treatment of severe autoimmune disease. FB102 contributes to that goal, in which Argenx aims to have 50,000 patients on therapy by the end of the decade, treating 10 different indications, with five molecules in late-stage development.
Argenx has announced the acquisition of Forte in a deal valued at $2.2 billion, marking a major expansion of its immunology portfolio. Through this acquisition,
The biotechnology sector continues to experience strong merger and acquisition activity as companies seek to strengthen their pipelines with promising clinical-stage assets. The acquisition of Forte by Argenx for approximately $2.2 billion reflects this trend, providing access to an investigational Phase 2 therapy for vitiligo. The transaction is expected to broaden the company’s presence in immunology while expanding research into autoimmune skin diseases with significant unmet medical needs.
Overview of the Acquisition
The acquisition brings together two organizations focused on developing innovative treatments for immune-mediated disorders. By integrating Forte’s research capabilities and clinical assets, the combined organization aims to accelerate the development of new therapies while expanding its long-term growth strategy.
Industry analysts view the transaction as a strategic investment that strengthens the company’s late-stage research portfolio and diversifies its pipeline beyond existing commercial products.
Strategic Benefits for Argenx
The Forte acquisition provides Argenx with additional scientific expertise, clinical development capabilities, and an innovative late-stage research asset. The transaction also supports the company’s broader objective of diversifying its pipeline while strengthening its competitive position within the global biotechnology industry.
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