Axatilimab

DelveInsight's 'Graft versus host disease Pipeline Insight 2024' covers 60+ companies and 65+ pipeline drugs, including clinical and nonclinical stage products, with a focus on therapeutics assessment by product type, stage, route of administration, and molecule type. Key companies and promising therapies in development are highlighted.

Incyte to present new oncology data at 2024 ASH Annual Meeting, including late-breaking results from the Phase 3 inMIND study on tafasitamab in follicular lymphoma. The company will also host a virtual analyst and investor event on December 12, 2024, to discuss key data presentations.

Incyte presents 20 oncology data presentations at 2024 ASH Annual Meeting, including Phase 3 inMIND study results on tafasitamab in follicular lymphoma. Hosts virtual analyst and investor event on December 12, 2024.

FDA approves Syndax Pharma's Revuforj, an oral menin inhibitor, for relapsed or refractory acute leukaemia with KMT2A gene translocations, marking the first FDA-backed treatment for this type of blood cancer. This follows a disappointing phase 1/2 trial readout for Revuforj in mutant NPM1 acute myeloid leukaemia, causing a drop in Syndax's shares.

Syndax Pharmaceuticals and Royalty Pharma announce a $350 million synthetic royalty funding agreement for Niktimvo (axatilimab-csfr), expected to fund Syndax through profitability. Syndax retains profit participation and upside potential, positioning them for successful launches of first-in-class medicines. Royalty Pharma sees Niktimvo's potential in treating chronic graft-versus-host disease (GVHD).

Syndax Pharmaceuticals and Royalty Pharma announce a $350 million synthetic royalty funding agreement for Niktimvo™ (axatilimab-csfr), expected to fund Syndax through profitability with proforma cash approaching $800 million as of June 30. The agreement involves a 13.8% royalty on U.S. net sales of Niktimvo, with royalty payments ceasing upon reaching 2.35x the upfront payment. Niktimvo is a first-in-class anti-CSF-1R antibody approved for chronic graft-versus-host disease (GVHD) in the U.S., co-commercialized by Syndax and Incyte, with a planned U.S. launch by early Q1 2025.

Syndax Pharmaceuticals and Royalty Pharma announce a $350 million synthetic royalty funding agreement for Niktimvo™ (axatilimab-csfr), expected to fund Syndax through profitability and support upcoming launches and development of Niktimvo and revumenib.

FDA approved axatilimab for chronic GVHD, targeting CSF-1 receptor. Dr. Wolff highlights its high response rate in heavily pretreated patients and unique side effect profile. Future trials aim to evaluate axatilimab as a primary treatment, potentially reducing reliance on steroids.

The FDA approved Niktimvo (axatilimab) for chronic graft-versus-host disease (GVHD) in patients who have progressed on at least 2 prior systemic therapies. GVHD can be acute or chronic, with chronic affecting more organs and requiring longer-term treatment. Current prevention measures, including calcineurin inhibitors and methotrexate, have reduced chronic GVHD incidence to around 30-35%, with new developments like the Orca-T platform potentially lowering it further to 5-10%. However, complete elimination of GVHD is unrealistic, necessitating ongoing treatment options.

Q3 2024 saw approval of 5 novel antibody drugs, increased ADC research, and $3B in collaborations. Investment in antibodies continues, with startups raising up to $370M. Promising antibodies for Q4 include treatments for genetic disorders and cancers.