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Our Pipeline

Our clinical and discovery pipeline programs are centered on restoring immune homeostasis in patients with severe inflammatory and autoimmune diseases.

For pipeline inquiries, please contact: BD@q32bio.com.

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IL-7/TSLP Program

Bempikibart (ADX-914) showed promising clinical activity in Q32 Bio’s Phase 2a clinical trial. Bempikibart was observed to have a well-tolerated safety profile, pharmacokinetic/pharmacodynamic results at desired exposures, inhibition of Th2 and Th1 biomarkers consistent with expected target engagement, and encouraging clinical activity in patients with alopecia areata (AA). The U.S. Food and Drug Administration (FDA) granted Fast Track designation (FTD) to bempikibart for the treatment of AA. Q32 Bio is currently evaluating bempikibart in patients with AA in the ongoing SIGNAL-AA Phase 2a clinical trial.

Bempikibart is a fully human anti-IL-7Rα antibody that is designed to re-regulate adaptive immune function by blocking IL-7 and TSLP signaling via their cognate receptors. The IL-7 and TSLP pathways have been genetically and biologically implicated in driving several T cell-mediated pathological processes in numerous autoimmune diseases.

In AA, Th1 has long been implicated in the pathogenesis of AA supporting the potential for bempikibart to directly address the underlying driver of follicle damage and hair loss. In addition, given that AA is a disease often diagnosed in young adults, there is a critical need for effective novel treatments with a safety profile suitable for long-term, chronic treatment.

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Complement Program

 

Q32 Bio is currently evaluating strategic options for our complement inhibitor platform which includes the development candidate ADX-096, a C3d – CR1 fusion protein, and other earlier stage assets, including C3d mAb fusions and nanobodies designed for tissue-targeted complement inhibition. Q32 Bio has developed a novel discovery platform that is enabling the advancement of tissue-targeted complement inhibitors which have potential therapeutic activity across the numerous diseases in which C3 complement fragments are deposited in diseased tissue.