Specialised Therapeutics (ST), an independent biopharmaceutical company, announced the expansion of its existing supply and distribution agreement with Incyte Biosciences International Sàrl to include two additional oncology medicines in Australia, New Zealand and Singapore. The expanded partnership adds axatilimab (Niktimvo®) and retifanlimab (Zynyz®) to the current portfolio of Minjuvi® (tafasitamab) and Pemazyre® (pemigatinib).
Under the expanded agreement terms, Incyte will handle development, manufacturing and supply of both therapies to the region, while ST will manage regulatory affairs, distribution, and local marketing and medical activities. The partnership, which began in 2021, has already successfully commercialized Minjuvi in Australia and Pemazyre in Australia and Singapore.
First-in-Class Treatment for Chronic GVHD
Axatilimab represents a significant advancement as a first-in-class colony stimulating factor-1 receptor (CSF-1R)-blocking antibody. The US Food and Drug Administration approved the therapy in August 2024 for treating adults and children with chronic graft-versus-host disease (GVHD) who have received at least two prior systemic treatments and require additional therapy.
Chronic GVHD typically occurs three months after transplantation, most commonly following hematopoietic stem cell or bone marrow transplantation, where donor cells attack the recipient's cells. The condition can affect multiple organs but commonly impacts the skin, mouth, eyes, lungs, stomach, bowel, and liver. The Phase II clinical trial for axatilimab enrolled 79 patients from 13 countries, including Australia and Singapore.
The therapy is currently being studied in frontline combination trials, including a Phase 2 combination trial with ruxolitinib and a Phase 3 combination trial with steroids. Additionally, axatilimab is being investigated in an ongoing Phase 2 trial for patients with idiopathic pulmonary fibrosis.
PD-1 Inhibitor for Rare Cancers
Retifanlimab is an intravenous immune checkpoint (PD-1) inhibitor with multiple approved indications in the United States. The therapy is approved in combination with carboplatin and paclitaxel for first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). It is also approved as a single agent for treating adult patients with locally recurrent or metastatic SCAC with disease progression or intolerance to platinum-based chemotherapy.
The drug has additional approval in both the US and Europe for treating adults with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). MCC is a rare and aggressive skin cancer that is often difficult to diagnose due to lack of specific distinguishing features from other common skin cancers. Notably, Australia has the highest incidence of MCC globally.
The pivotal Phase II clinical trial of retifanlimab in MCC enrolled 101 chemotherapy-naïve patients from 12 countries, including Australia. Beyond MCC, retifanlimab in combination with chemotherapy is being investigated as a potential treatment for other hard-to-treat cancers, including metastatic non-small cell lung cancer.
Regional Expansion Strategy
ST Chief Executive Officer Carlo Montagner emphasized the strategic importance of the expanded partnership. "The addition of axatilimab and retifanlimab to the partnership agreement with Incyte recognises our strong track record of working with local stakeholders to bring innovative medicines to patients where unmet medical needs persist, despite the availability of existing treatments," he stated.
Incyte CEO Hervé Hoppenot highlighted ST's proven capabilities in navigating complex regional regulatory pathways. "ST has already demonstrated its ability to navigate complex regional regulatory pathways for Minjuvi and Pemazyre, and we look forward to continuing our work together to make these new therapies available for the oncology community in the Asia-Pacific region," he said.
ST anticipates submitting both axatilimab and retifanlimab for local regulatory and reimbursement approval in 2025, with the goal of ensuring equitable access to these treatments for patients as soon as practicable. The expanded agreement also includes an option to add further countries in the Asia-Pacific region, potentially broadening access to these innovative therapies for patients with rare and hard-to-treat conditions.
