Is Iovance Biotherapeutics Stock a Millionaire Maker?

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The biotech industry has been described as the Wild West of the stock market. Although some companies manage to develop and commercialize a life-changing therapeutic, countless more start-ups inevitably fail. Nevertheless, the risk could be worth the reward if a new blockbuster drug creates massive shareholder wealth.

While that level of success is only obvious in hindsight, Iovance Biotherapeutics (NASDAQ: IOVA) is an emerging industry leader with significant potential. The company's tumor-infiltrating lymphocyte (TIL) therapy is seen as a revolutionary treatment for a wide range of cancers, highlighting the attractiveness of the stock.

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Could buying shares of Iovance make you a millionaire? Here's what you need to know.

Iovance TIL therapy breakthrough

This has been a milestone year for Iovance Biotherapeutics. In February, the company received accelerated approval from the Food and Drug Administration (FDA) for lifileucel. The treatment, marketed as Amtagvi, is the first-of-its-kind cellular therapy to be approved for solid tumor cancers and advanced melanoma.

TIL therapy stands out through its unique mechanism of action. It begins by harvesting T cells directly from the patient's tumor. This is important, as no two tumors are identical, and it allows the therapy to enhance the body's natural cancer-fighting response with patient-specific immune targets.

From an extracted tumor sample, Iovance manufactures a personalized TIL monotherapy, which is returned to the patient as a one-time intravenous infusion. The clinical data has been impressive, demonstrating Amtagvi's long-lasting response and ability to keep cancer from getting worse, specifically in advanced melanoma patients who had already failed to benefit from alternative immunotherapies.

Iovance estimates that the initial addressable market is 30,000 patients annually, but that more than 70,000 could benefit each year through an expanded label indication for all frontline advanced melanoma, currently in a phase 3 trial.

An Iovance investor relations presentation slide, describing the addressable market for lifileucel.
Image source: Iovance Biotherapeutics.

Iovance's pipeline includes lifileucel applications in separate phase 2 studies for non-small cell lung cancer (NSCLC), which could be an even bigger prize for the company given the much larger global patient population. Longer-term, endometrial cancer is also an area of development.

Overall, there's a lot to like about Iovance, which has taken the critical step of transforming from a clinical-stage biotech to launching a novel therapy into the market. Still, the company has a lot of work to do to confirm the viability of its business model.