# Calluna Pharma

> Calluna Pharma is an Oslo-based clinical-stage biotech building first-in-class antibodies that switch off the upstream signals driving inflammation and fibrosis. Formed in 2024 from the merger of Oxitope Pharma and Arxx Therapeutics and backed by a EUR 75 million Series A, the company targets damage-associated molecular patterns (DAMPs) such as S100A4 to halt diseases like idiopathic pulmonary fibrosis at their root rather than managing symptoms.

- **Founded:** 2024
- **Headquarters:** Oslo, Norway
- **Founders:** Jonas Hallen (Co-Founder & Chief Medical Officer)
- **Team size:** ~27 employees
- **Products:** CAL101, CAL102, AURORA Phase 2 Study
- **Notable:** Launched in January 2024 via merger of Oxitope Pharma and Arxx Therapeutics with a EUR 75M Series A led by Forbion, Completed Phase 1 of CAL101 in 2024 with a clean safety profile, once-monthly dosing potential and complete target engagement, Initiated the Phase 2 AURORA study of CAL101 in IPF in August 2025

## Products & services

- **CAL101** — First-in-class monoclonal antibody that neutralizes S100A4, a DAMP protein implicated in idiopathic pulmonary fibrosis, systemic sclerosis, chronic kidney disease, rheumatoid arthritis and severe asthma. Lead clinical program, currently in the Phase 2 AURORA study for IPF; granted U.S. FDA Orphan Drug Designation in October 2025.
- **CAL102** — Monoclonal antibody neutralizing oxidized phospholipids (oxPL), which drive onset and progression of acute and chronic inflammatory and fibrotic diseases including reperfusion injury, rheumatoid arthritis and inflammatory bowel disease.
- **AURORA Phase 2 Study** — Randomized, double-blind, placebo-controlled trial of CAL101 in idiopathic pulmonary fibrosis. Enrolled 161 patients across 50+ sites in the US, UK, EU, Turkey and South Korea; results expected Q1 2027.

## Achievements

- Launched in January 2024 via merger of Oxitope Pharma and Arxx Therapeutics with a EUR 75M Series A led by Forbion
- Completed Phase 1 of CAL101 in 2024 with a clean safety profile, once-monthly dosing potential and complete target engagement
- Initiated the Phase 2 AURORA study of CAL101 in IPF in August 2025
- Completed AURORA enrollment with 161 patients more than six months ahead of schedule
- Received U.S. FDA Orphan Drug Designation for CAL101 in IPF in October 2025

## Latest updates

- **2025-10** — U.S. FDA granted Orphan Drug Designation to CAL101 for the treatment of idiopathic pulmonary fibrosis.
- **2025-08** — First patients dosed in the Phase 2 AURORA study of CAL101 for IPF; enrollment later completed at 161 patients ahead of schedule, with results expected Q1 2027.
- **2024-10** — Calluna completed Phase 1 of CAL101 and appointed Mark Gaffney as CEO and Mark Altmeyer as Independent Chair of the Board.
- **2024-01** — Company launched via merger of Oxitope Pharma and Arxx Therapeutics with a EUR 75M Series A.

## Links

- Website: https://www.callunapharma.com
- LinkedIn: https://www.linkedin.com/company/callunapharma

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Last updated: 2026-06-07