Genetic Leap receives FDA IND clearance for first-in-class, oral natural IL-2 modulator

- GL-IL2-138 is a small molecule RNA agent that modulates natural IL-2, allowing for downregulating or upregulating the immune system to fight devastating diseases

- Potential to unite Humira-grade inflammation control and Keytruda-class anti-cancer power in a single pill, without the drawbacks

NEW YORK, July 16, 2025 /PRNewswire/ -- Genetic Leap, a clinical stage, AI-native biotech pioneering RNA genetic therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for GL-IL2-138, the company's small-molecule modulator of natural interleukin-2 (IL-2).  

IL-2 is a pleiotropic cytokine that regulates the careful homeostatic balance between immune tolerance and activation. The tremendous potential of IL-2 to address multiple major diseases is universally recognized. Recombinant IL-2 protein (rIL-2) was the first FDA-approved immunotherapy proven effective against cancer at high dose, though toxicity has historically limited its use. And low dose rIL-2 is clinically effective in autoimmune and neurodegeneration diseases. But numerous attempts by pharma companies to remove toxicity from rIL-2 muteins have flopped, earning IL-2 its reputation as an impossible target.

Genetic Leap addressed this herculean challenge by developing a small molecule drug that binds endogenous IL-2 mRNA to drive controlled, systemic production of natural IL-2 protein by immune cells, which has many advantages over rIL-2 including:

• Superior potency and durability
  
  
• Oral dosing with high tolerability
  
  
• Broad "pipeline-in-a-pill" potential across oncology, immunology (I&I), and neurodegeneration

"We created the Genetic Leap AI platform to deliver breakthroughs like GL-IL2-138," said Dr. Bertrand Adanve, Founder and CEO of Genetic Leap. "Innovative medicine that defies known scientific limitations, like a sci-fi drug made real. GL-IL2-138 is like combining Humira (leading autoimmune biologic) and Keytruda (leading cancer biologic) into one oral pill without the downsides and applicable to even more diseases. GL-IL2-138 is poised to be a giant leap for human health, and Genetic Leap is the company making it happen."                 

The drug will now be tested in a randomized, double-blind, placebo-controlled phase 1 clinical trial to evaluate its tolerability, pharmacokinetics and pharmacodynamics in humans.

About Genetic Leap
Genetic Leap is innovating at the cutting edge of AI and RNA genetic therapeutics to redefine drug development and more quickly address the health needs of millions of people. For more information, please visit www.genetic-leap.com or our LinkedIn.

For Media Inquiries:
press@genetic-leap.com

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SOURCE Genetic Leap