CULVER CITY, Calif. - ImmunityBio, Inc. (NASDAQ: IBRX) has entered into an exclusive global arrangement with the Serum Institute of India (SII), the world's largest vaccine producer by volume, to manufacture Bacillus Calmette-Guerin (BCG) for use in conjunction with ImmunityBio’s ANKTIVA, a treatment for non-muscle invasive bladder cancer (NMIBC).
The partnership aims to address the global shortage of BCG supplies by producing both standard BCG (sBCG), currently used outside the U.S., and a next-generation recombinant BCG (iBCG) that is undergoing clinical trials in Europe. This collaboration is expected to make BCG more widely available for all approved indications, including the treatment of NMIBC in combination with ANKTIVA, which stimulates natural killer cells, T cells, and memory T cells.
SII will immediately provide additional supplies of sBCG for trials, while also working to expedite the ongoing Phase 2 trials of iBCG in Europe. The recombinant version has shown promise with a safety profile that may be superior to that of standard BCG, as well as increased immunogenicity.
This agreement follows the U.S. Food and Drug Administration's (FDA) approval of ANKTIVA for NMIBC with carcinoma in situ (CIS). ImmunityBio plans to conduct further clinical trials to study the combination of iBCG and sBCG with ANKTIVA for the treatment of various types of bladder and other cancers. The supply of BCG is anticipated to be available once the FDA authorizes the trial protocol, which ImmunityBio expects to submit to the FDA and global regulatory bodies within the next 30 days.
The collaboration is a significant step in improving access to BCG for cancer treatment and ensuring a complete solution for bladder cancer, potentially improving patient outcomes and saving lives.
BCG, originally a tuberculosis vaccine, has been the standard care for NMIBC patients since 1977. It is a benign bacterium that induces an immune response to help clear cancer in many patients. SII's production capacity and quality of vaccines, including over 2 billion doses of the COVID-19 vaccine delivered globally, are expected to contribute significantly to this initiative.
InvestingPro Insights
As ImmunityBio, Inc. (NASDAQ: IBRX) embarks on this pivotal collaboration with the Serum Institute of India, it's important to note the company's recent financial and market performance which might be of interest to investors monitoring this biotechnology firm. According to InvestingPro data, ImmunityBio has a market capitalization of $6.07 billion, reflecting its significant presence in the biotech industry. Despite the company's aggressive growth strategies, the latest metrics indicate a negative P/E ratio of -10.54 for the last twelve months as of Q4 2023, suggesting that the company has not been profitable during this period.
Nonetheless, the company's revenue growth has been impressive, with a surge of 159.17% for the same timeframe. This could be indicative of the potential market demand for their products and the scalability of their operations. In terms of stock performance, ImmunityBio has experienced a substantial return over the past year, with a 177.27% increase, which might catch the eye of growth-focused investors.
InvestingPro Tips highlight that analysts are expecting sales growth in the current year, which could be a positive signal for future revenue streams. However, they also caution that ImmunityBio is not expected to be profitable this year. With these insights, investors may want to consider the company's future growth prospects against its current lack of profitability. For those looking to delve deeper into ImmunityBio's financials and stock performance, there are additional InvestingPro Tips available at: https://www.investing.com/pro/IBRX. Utilize coupon code PRONEWS24 to receive an additional 10% off a yearly or biyearly Pro and Pro+ subscription, and discover a wealth of information, including 12 more InvestingPro Tips tailored to ImmunityBio.
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