ImmunityBio inks $320m deal to advance bladder cancer drug and boost pipeline – Pharmaceutical Technology

ImmunityBio has started the year off strong by announcing it has entered into a deal with Oberland Capital involving a $320m revenue interest purchase agreement (RIPA). The investment will advance the company’s commercialisation of its near-approval bladder cancer drug candidate, Anktiva (N-803), and support ImmunityBio’s efforts to expand Anktiva into multiple solid tumour indications. 

The deal cemented $210m in funding at closing and will see the biotech receiving an additional $100m pending the US Food and Drug Administration (FDA) approval of an Anktiva/Bacillus Calmette-Guérin (BCG) combination treatment for BCG-unresponsive high grade non-muscle invasive bladder cancer (NMIBC).

As per a 2 January SEC filing, for an upfront $200m, Oberland gained the rights to receive quarterly tiered payments that range from 3%–7% of ImmunityBio’s net sales in all countries excluding China and its controlled territories. Following a successful approval, the royalty rate range will increase to 4.5%–10%.

Oberland’s rights to interest payments will be terminated when it has received a return of 195%. If the amount is unmet by the twelfth anniversary of the agreement, ImmunityBio will be required to pay a sum that will bring the aggregate amount to 195% of the then cumulative purchaser payments.

At the time of closing, Oberland agreed to a $10m equity investment and gained the option to purchase an additional $10m of common stock in the future.

The Culver City, California-based ImmunityBio has come off a tumultuous 2023. In October 2023, the company announced that the FDA had accepted its resubmitted biologics licence application (BLA) for Anktiva following the agency’s initial rejection in May 2023. In its negative complete response letter, the agency cited deficiencies found with the company’s contract manufacturing organisations. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of 23 April 2024.

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The BLA resubmission was supported by data from the Phase II/III study (NCT03022825) of Anktiva, a cytokine interleukin-15 (IL-15) superagonist fusion protein designed to stimulate cytotoxic T cells and natural killer cells while generating memory T cells.