U.S.-based immunotherapy company, ImmunityBio Inc. (NASDAQ: IBRX), recently confirmed that it has successfully completed manufacturing the Drug Substance (DS), a key component required for creating its biotherapeutic drug, ANKTIVA (nogapendekin alfa inbakicept-pmln). With this critical process accomplished, an estimated 170,000 doses of 400mcg ANKTIVA are deemed ready to be rolled out post packaging and vial filling - a procedure commonly referred to as fill finish.
This latest developmental stride follows the progressive launch of ANKTIVA ’ a clinical-stage immunotherapy developed with the potential to stimulate natural killer cells and boost patients’ immune responses. The successful production of this Drug Substance will cater to the fill finish process, which involves transferring the drug substance into its final drug product format, such as vials, syringes, or cartridges, preparing it for distribution and use.
In terms of ACTIVATE’s quantity, the current production level of the drug substance will result in approximately 170,000 doses of ACTIVATE’s 400mcg formulation. The sufficient production rate implies ImmunityBio’s readiness and planning in robust coverage and drug availability once it reaches the market post-regulatory approvals.
Meanwhile, ImmunityBio Inc. also made
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