News

It's always a nice surprise to see that a company you're invested in is making good on its opportunities and planning to grow on your behalf. In that vein, at the 2024 meeting of the American Society of Clinical Oncology (ASCO) on May 31, Iovance Biotherapeutics (NASDAQ: IOVA) offered some news that should please its shareholders and perhaps motivate them to buy more of the stock in the near term.

To appreciate what it disclosed and why it matters, let's start by putting the new findings into the appropriate context.

This program just got an important validation

Iovance currently has one medicine on the market, which was approved in late February 2024. It's a cell therapy called Amtagvi that's indicated to treat unresectable or metastatic melanoma in people who have already been treated with an antibody against the PD-1 receptor. As it just launched, there hasn't been time for it to generate any revenue yet, though more than 100 patients are enrolled for treatment, so it's only a matter of time.

The company is currently performing a slew of mid-stage clinical trials testing Amtagvi for cervical cancer, non-small-cell lung cancer (NSCLC), and a couple of other cancers. The therapy is being investigated in several trials as a monotherapy, typically after patients have received a course of immunotherapy or chemotherapy. There are also a few clinical trials testing it in conjunction with immunotherapy in patients who haven't been treated with the immunotherapy before. And therein lies the exciting new data.

In case you aren't familiar, the most widely used immunotherapy antibody against the PD-1 receptor -- and the first to get approved -- is produced by Merck under the trade name Keytruda. So right now, for Iovance to onboard a patient for treatment with Amtagvi, it can only recruit from a subset of the pool of patients who took Keytruda.

Per a data update from Iovance's phase 2 clinical trial, there are several reasons to believe that Amtagvi's addressable market is about to expand in a big way. The trial is investigating the efficacy and safety of administering Keytruda and Amtagvi together as part of a unified treatment regimen for advanced melanoma.

Of the 23 patients in the trial, 15 responded to the treatment. Seven patients experienced a complete response wherein no further cancer was detectable after treatment even after 45 months, and eight patients experienced a partial response indicative of a reduced disease burden and significantly smaller tumor sizes than before treatment. Only one patient's disease progressed. The combination's side effects were largely as clinicians expected.

These are great results. The data also support another Iovance trial that's in phase 3, which seeks to deploy the combination of Amtagvi and Keytruda as a first line treatment for melanoma. In other words, Keytruda is now fairly likely to become a partner for Amtagvi rather than a gatekeeper of sorts.

That shift, assuming regulators agree to the expanded indication at some point in the future, means that Amtagvi could become an option for patients whose illness hasn't progressed as much.

Aside from driving more top-line growth for Iovance from the larger pool of patients its therapy will be able to help, it could actually lead to lower manufacturing costs for the therapy too. That's something that smart investors have been concerned about. Here's why.

Key questions are getting closer to being addressed

Amtagvi is a cell therapy that's derived from a very rare type of white blood cell. Specifically, it's made from the cells that have managed to infiltrate solid tumors to attempt to destroy them from within, where many of the tumor's defense mechanisms do not operate as efficiently.

To manufacture it, patients need to go to qualified treatment centers, and donate a sample of their tumor. Then, Iovance isolates their tumor-infiltrating lymphocytes (TILs), prompts them to multiply in a test tube using certain chemicals, and cultivates a large number of them over a few weeks' time. Afterwards, the patient gets an infusion of a huge number of their own freshly raised TILs, hopefully leading to their tumors being reduced.

But the more a patient's disease has progressed by the time they start this process, and the more they've been treated with chemotherapies and certain other medicines in the course of their illness beforehand, the fewer and frailer the cells isolated for the manufacturing process will be.

That means more time and resources need to be invested to expand those cells to a sufficient number to meet the requirements of a single dose of Amtagvi, and it is also possible that the patient might need to make more than one donation to avoid a failure of the process. So if more patients are eligible to be treated before they're seriously ill, it may drive manufacturing costs down somewhat, expanding margins and stoking more sales at the same time.

The future for Iovance is probably bright. But the fact remains that investors don't know whether it can profitably manufacture Amtagvi, regardless of whether the biotech eventually gets an expanded indication as a result of late-stage confirmations of the new data discussed here.

Still, the new data support the investing thesis for Iovance stock. If you're comfortable with the march toward profitability taking a while and having some uncertainty, it's a decent purchase. Just be aware that it's a riskier pick than what one might normally expect from a biotech that just commercialized its first medicine.

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Alex Carchidi has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Iovance Biotherapeutics and Merck. The Motley Fool has a disclosure policy.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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