ImmunityBio Inc ( IBRX ) shares are trading down after an early morning high on Friday after the company announced an exclusive global arrangement with the Serum Institute of India, the world’s largest manufacturer of vaccines by number of doses produced, to supply ImmunityBio ( IBRX ) with Bacillus Calmette-Guerin (BCG). 

Increasing the available supply of BCG is intended to address shortages for the combination therapy with Anktiva.

The agreement covers the manufacturing of standard BCG (sBCG) that is currently approved for use outside the U.S., and a next-generation recombinant BCG (iBCG) undergoing testing, intended for use in combination with ImmunityBio’s Anktiva (nogapendekin alfa inbakicept-pmln) for currently approved and potential future indications.

In April, the FDA approved Anktiva plus BCG for BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors.

The arrangement will result in additional supplies of the current standard sBCG immediately for trials. 

At the same time, the two companies will work to accelerate the ongoing Phase 2 clinical trials of iBCG currently being conducted in Europe.

Originally used as a tuberculosis vaccine, BCG administered via intravesical instillation (delivery to the bladder via a catheter) has been the standard of care for patients with non-muscle invasive bladder cancer since 1977. 

BCG is a benign bacterium that induces an immune response in the bladder near the cancer cells, leading to cancer clearance in many patients.

BCG is one of the most widely used vaccines worldwide and has been given to over 4 billion individuals. 

SII is the largest manufacturer of BCG vaccine across the world, while Merck & Co Inc ( MRK ) currently is the only manufacturer of BCG (TICE BCG) in the U.S.

ImmunityBio ( IBRX ) plans to conduct clinical trials to study recombinant BCG (iBCG) and sBCG manufactured by Serum Institute in combination with Anktiva for different types of bladder and other cancers. 

The supply of BCG is expected to be available once the FDA has authorized the trial protocol. ImmunityBio ( IBRX ) plans to submit the protocol to the FDA and global regulatory bodies in 30 days.

IBRX Price Action: ImmunityBio shares are down 0.056% at $8.97 at publication Friday.

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