IOVA - Iovance Biotherapeutics: More Than A One-Shot Wonder

2023-07-10 18:11:11 ET

Summary

• Iovance Biotherapeutics, Inc. had a positive Type B Pre-Phase 3 meeting with the FDA, whereby IOV-LUN-202 trial will be allowed for Accelerated Approval of LN-145 for the treatment of NSCLC patients.
• Positive preliminary results achieved in registrational single-arm phase 2 IOV-LUN-202 trial, which used LN-145 to treat patients with NSCLC; Median duration of response not achieved and 26.1% objective response rate.
• The global non-small cell lung cancer therapeutics market is expected to reach $43.71 billion by the end of 2026.
• A PDUFA date of November 25, 2023 was established, whereby the FDA will decide upon whether or not lifileucel should be approved for the treatment of patients with advanced melanoma.

Iovance Biotherapeutics, Inc. ( IOVA ) is a good speculative biotech play to look into. The reason why I state that is because it just recently achieved positive results from the registrational single-arm phase 2 IOV-LUN-202 trial, which used its LN-145 TIL therapy for the treatment of non-small cell lung cancer [NSCLC] patients who have progressed on or after chemotherapy and anti-PDD-1 therapy without genomic mutations.

Not only was positive preliminary data achieved from this phase 2 study, but it was also noted that a positive development was obtained in a Type B Pre-phase 3 meeting with the FDA. It was stated after such a meeting that the phase 2 IOV-LUN-202 trial would be appropriate for it to ultimately receive FDA Accelerated Approval of LN-145 as a TIL therapy for the treatment of this patient population. There is another opportunity for investors to see further gains from this biotech, which is why I believe it is important to go over.

That is, Iovance is expected to meet with the FDA in 2023 to discuss plans of advancing a confirmatory trial, which is going to explore the use of LN-145 for the treatment of patients with frontline advanced non-small cell lung cancer patients. Lastly, there is one other catalyst for investors to look forward to which is expected before the end of 2023. I'm talking about the PDUFA date of November 25, 2023, which has been established for the FDA to decide upon whether or not it will approve lifileucel for the treatment of patients with advanced melanoma. With positive developments of LN-145 for the treatment of patients with non-small cell lung cancer, plus a rapidly approaching PDUFA date of November 25, 2023 for review of lifileucel for advanced melanoma, these are the reasons why I believe that Iovance Biotherapeutics is a good speculative biotech play to look into.

Positive LN-145 Developments Makes This A Must Watch

As I stated above, Iovance Biotherapeutics is a good biotech to look into. Especially, after the recent positive developments it was able to obtain with respect to the use of LN-145 for the treatment of patients with non-small cell lung cancer, which I will be going over below. Non-small cell lung cancer [NSCLC] is a type of cancer whereby the cancer originates in the lungs. The cancer starts off on the lining of the surface of the lung airways, which includes the following: Bronchioles, bronchi, and alveoli. Symptoms that these NSCLC patients might experience are as follows:

• Weight loss
• Shortness of breath
• Cough that lasts

The global non-small cell lung cancer therapeutics market is expected to reach $43.71 billion by the end of 2026 . This is a large market opportunity for sure, but you have to consider what I stated above. In that, even if LN-145 achieves the primary endpoint of the registrational single-arm phase 2 IOV-LUN-202 study, it is only being used for a specific NSCLC patient population. That is, a NSCLC patient population who have progressed on or after chemotherapy and anti-PD-1 therapy without genomic mutations. Still, the goal is to eventually start another registrational study, which then might allow for it to expand upon the possible NSCLC patient population that could be targeted. This would be with respect to being able to use LN-145 for the treatment of frontline advanced NSCLC patients. A meeting with the FDA on advancing such a study is expected in 2023 and I believe it could act as another catalyst to cause the stock price to trade higher.

There were two positive developments as it relates to Iovance Biotherapeutics using LN-145 for the treatment of NSCLC patients. The first is that a Type B Pre-Phase 3 meeting was held between it and the FDA. It was noted that positive feedback was given with respect to the phase 2 IOV-LUN-202 study, in that such a trial would be acceptable upon completion for Accelerated Approval of LN-145 for the treatment of advanced NSCLC patients who have progressed on or after chemotherapy and anti-PD-1 therapy without genomic mutations. The goal is to recruit a total of 120 patients into this registrational study and such enrollment is expected to complete during the 2nd half of 2024.

This wasn't the only positive development noted at this time, either. It was also stated that treatment of LN-145 resulted in substantial efficacy in this patient population. For starters, with respect to the recent data cut off, it was noted that there was an objective response rate [ORR] of 26.1%. That is, about 6 out of 23 patients who received LN-145 had responded. For the patients who did respond to this TIL therapy, the median duration of response [mDOR] had not yet been reached. It is early in this study, but it is still nice to see that patients have been able to respond to this TIL therapy for an extended period of time. The median duration of response [mDOR] ranged from 1.4+ months to 9.7 months +. However, this is just the range for now, as the mDOR has not yet been reached.

With these positive developments achieved, why do I believe that it's possible that the stock price might trade higher? It is because there might be another positive development as it relates to advancing LN-145 for the treatment of patients with NSCLC. That is, the goal is for Iovance to meet with the FDA in 2023 to discuss a randomized confirmatory trial in frontline advanced NSCLC. If this biotech states to the public that the FDA is in alignment with allowing such a confirmatory study for LN-145 for this specific NSCLC patient population, then I believe that the stock price could trade higher on the back of such news.

Financials

Iovance Biotherapeutics had approximately $632.7 million in cash as of March 31, 2023 . This includes net proceeds made from an at-the-market [ATM] equity financing facility of about $260.1 million, which was raised during Q1 of 2023. The biotech believes that it has enough cash on hand to fund its operations at least into the 2nd half of 2024. I believe that it will need to continue to raise cash through this ATM before the end of 2023. The reason why I state that is because it is gearing up to launch lifileucel for the treatment of patients with advanced melanoma. Should the FDA review of this drug for this patient population go well, then it will need to start thinking about pre-commercialization efforts so that it can launch it effectively.

A good thing, as I highlighted directly above, is that it was able to raise cash from its ATM equity financing agreement. It will still be able to do so again if needed, because of an amended agreement was made back on November 18, 2022 , whereby it could sell up to $500 million of shares of its common stock under this ATM. Thus, it still has room to raise cash by using this ATM, should it need to raise additional cash in the coming months.

Risks To Business

There are several risks that investors should be aware of before investing in Iovance Biotherapeutics. The first risk to consider would be with respect to the positive results achieved from the registrational single-arm phase 2 IOV-LUN-202 trial, which is using LN-145 for the treatment of patients with NSCLC who have progressed on or after chemotherapy and anti-PD-1 therapy for advanced NSCLC without genomic mutations. Even though positive preliminary results were achieved in this study using LN-145 for these patients, there is no guarantee that the final study data will turn out to be positive. Especially, when you consider that enrollment is being increased to 120 patients.

A second risk to consider might be with respect to eventual filing of a Biologics Licensing Application [BLA] to the FDA of LN-145 for the treatment of this patient population. There is no assurance that even if such a BLA is submitted, that it will be accepted by the FDA for review. In addition, even if the BLA is accepted for review, there is no guarantee that LN-145 will ultimately be approved to treat these patients with NSCLC.

A third risk to consider would be with respect to the PDUFDA date of November 25, 2023, which is the date which the FDA will decide upon whether or not lifileucel should be approved for the treatment of patients with advanced melanoma. There is no assurance that the FDA will approve lifileucel for the treatment of this specific patient population.

The fourth and final risk to consider would be with respect to its financials. Even though Iovance Biotherapeutics already raised approximately $260.1 million in cash through an ATM agreement in Q1 of 2023, it's quite possible that it might choose to do so again this or the next quarter. The reason why I believe this to be the case is because it has to start to consider pre-commercialization efforts of lifileucel, just in case the FDA approves it for patients with advanced melanoma.

Conclusion

The final conclusion is that Iovance Biotherapeutics is a good speculative biotech play to look into. The reason why I state that is because it has two recent positive developments as I described above, relating to the use of LN-145 for the treatment of patients with non-small cell lung cancer [NSCLC].

One of which is that it achieved a positive Type B Pre-Phase 3 meeting with the FDA, whereby the agency stated that it would allow for Accelerated Approval of LN-145 for the treatment of patients with NSCLC through the use of the registrational single-arm phase 2 IOV-LUN-202 study. The other positive development of which relates to the release of successful results from this phase 2 IOV-LUN-202 trial, which used LN-145 for the treatment of this NSCLC patient population. It was noted that the mDOR was not reached and that the ORR was 26.1%. There is a PDUFA catalyst date of November 25, 2023 as well, whereby Iovance might receive FDA approval of lifileucel for the treatment of patients with advanced melanoma. With positive developments of LN-145 for the treatment of patients with non-small cell lung cancer, plus a rapidly approaching PDUFA date of November 25, 2023 for review of lifileucel for advanced melanoma, these are the reasons why I believe that Iovance Biotherapeutics is a good speculative biotech play to look into.

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