Anktiva’s tortuous journey ends
The rollercoaster journey of ImmunityBio’s Anktiva rivalled that of Ferring’s Adstiladrin in terms of intrigue, but after the disappointments success has come at last. After a complete response letter last May Anktiva secured approval yesterday, joining Adstiladrin with a US label for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Both drugs will need a significant financial investment to be marketed successfully, and both appear to have got this. Last August Ferring secured $300m from Royalty Pharma, allowing Adstiladrin to be launched over a year after its approval. The following month ImmunityBio struck a $470m equity and debt deal courtesy of its founder and chairman, Patrick Soon-Shiong. That came on top of the $700m of debt Soon-Shiong had already provided in his continuing efforts to support ImmunityBio, which now promises to launch Anktiva in mid-May. Formally the FDA approval was granted to Anktiva’s originator, Altor Bioscience, an entity acquired by an ImmunityBio legacy company in 2017. ImmunityBio is now capitalised at around $4bn, a valuation exceeding the $2.2bn of CG Oncology, which floated in January and is the next NMIBC player to watch. The Bond-003 trial of CG’s cretostimogene grenadenorepvec is to read out by the end of this year.
Recent developments in NMIBC
Drug | Supporting trial | Status |
---|---|---|
Keytruda (Merck & Co) | Keynote-057 | US approved as monotherapy, Jan 2020 |
Adstiladrin (Ferring/ Royalty Pharma) | CD-003 | US approved as monotherapy, Jan 2023 |
Anktiva (ImmunityBio, ex Altor Bioscience) | Quilt-3.032 | US approved in combination with BCG, Apr 2024 (CRL May 2023) |
Cretostimogene grenadenorepvec (CG Oncology) | Bond-003 | Final data due by end 2024 |
Source: OncologyPipeline.
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