IOVA - Iovance: Completion Of BLA Submission Brings Substantial Catalysts

2023-04-24 18:41:25 ET

Summary

• Acceptance of the BLA of Iovance Biotherapeutics' Lifileucel for review by the FDA is expected in the coming months; the first step towards potentially receiving U.S. marketing approval of this therapy.
• Upon BLA acceptance of Lifileucel, the FDA will review the regulatory application and then possibly grant FDA Accelerated Approval thereafter based on safety/efficacy.
• It is said that the global melanoma market is expected to reach $9.5 billion by 2030.
• Iovance Biotherapeutics should have enough cash to fund its operations until the 2nd half of 2024; will likely need to raise cash again in the 2nd half of 2023.

Iovance Biotherapeutics, Inc. ( IOVA ) is a great speculative biotech play to look into. The reason why I state that is because it was able to complete its rolling Biologics Licensing Application ((BLA)) submission of Lifileucel to the FDA several weeks ago.

Having said that, there are two potential catalyst opportunities that can come out of this. The first relates to the FDA accepting the submission of the entire BLA package. The agency has 60 days to determine if it does indeed accept the submission of this particular BLA package. The second catalyst opportunity that this creates for Iovance would be the possibility of receiving FDA approval of Lifileucel for the treatment of patients with advanced melanoma, who had progressed on or after prior anti-PD-1/L1 therapy and targeted therapy.

Should the BLA submission be accepted for review, plus FDA approval being given, then the company believes that it could start to commercialize this drug in the 2nd half of 2023.

Lifileucel For The Treatment Of Patients With Advanced Melanoma

The main clinical program in the pipeline for Iovance Biotherapeutics would be Lifileucel, which is being advanced for the treatment of patients with advanced melanoma. Specifically, advanced melanoma patients who had progressed on or after prior anti-PD-1/L1 therapy and targeted therapy. Melanoma is a type of cancer where malignant cells form in cells that color a person's skin. Melanoma can occur anywhere on the body and is characterized by an unusual skin growth. There are a couple of treatment options, but they are not ideal, and they are as follows:

• Radiation
• Medications
• Chemotherapy
• Surgery

Unusual moles and exposure to the sun might increase the risk of one developing melanoma. It is a very large market opportunity as well. It is said that the global melanoma market is expected to reach $9.5 billion by 2030 . It is a pretty large market opportunity, especially when looking only at this specific advanced melanoma patient population. That's because, again, Iovance is targeting advanced melanoma patients who progress on or after prior anti-PD-1/L1 therapy and targeted therapy. Why is this fact important? That's because, at the moment, there are no FDA-approved therapies at all to treat this patient population. Thus, if Iovance obtains FDA approval of Lifileucel for this patient population, it would be a first. In essence, it would cover an unmet medical need.

The ability for Iovance to attempt to obtain FDA-accelerated approval of Lifileucel for the treatment of this patient population was made possible because of positive results from the C-144-01 clinical study. This was a study which recruited advanced post-anti-PD1 melanoma patients. It was noted that in a pooled analysis of cohorts 2 and 4 , that the objective response rate (ORR) as assessed by an independent review committee ((IRC)) using RECISTv1.1 was 31.4%. This is broken down into 9 complete responses (CRs) and then 39 partial responses (PRs).

One item to point out is that while this was pooled data of cohorts 2 and 4, it doesn't mean the data isn't substantial. Why is that? That's because this is only one part of the rolling BLA submission of data sent to the FDA. Iovance also did well when only including the pivotal cohort 4 data alone when using Lifileucel against this advanced melanoma patient population. That is, in the registrational cohort 4 portion of the study, the objective response rate (ORR) as assessed by an independent review committee ((IRC)) using RECIST 1.1 criteria was 29%. This is broken down into 3 CRs and then 22 PRs.

The thing is that the rolling BLA is intended for FDA Accelerated Approval. The biotech has already reached an agreement to convert a potential Accelerated Approval of Lifileucel for advanced melanoma patients to a full one. This will be possible with an agreement from the FDA to advance a phase 3 study known as TILVANCE-301. Such a study has not yet been initiated but is expected to start in the latter part of 2023. Another fact to make note of would be that this late-stage trial has an additional function. Successful completion of this phase 3 TILVANCE-301 study would also support full FDA approval of Lifileucel in combination with pembrolizumab (KEYTRUDA) as a therapy for front-line advanced melanoma patients. That is, advanced melanoma patients who have not yet received prior treatment options.

Financials

According to the 10-K SEC Filing , Iovance Biotherapeutics had $478.3 million in cash, cash equivalents, investments and restricted cash as of December 31, 2022. In addition to this cash, it also was able to raise $450 million of net proceeds through an ATM equity financing facility, which was established in Q4 of 2022 and Q1 of 2023. The biotech believes that it has enough cash to fund its operations into the 2nd half of 2024. My feeling is that it will have to raise additional cash, at least at some point in the 2nd half of 2023. Not only because of the estimate that its cash is only expected to be enough until the 2nd half of 2024 but also because it used a large chunk of the cash it raised to purchase Proleukin, which is an IL-2 therapy product.

Another reason why I believe it may need to raise cash would be the possible FDA approval of Lifileucel for the treatment of patients with advanced relapsed/refractory melanoma. Should it receive FDA approval of this therapy, then it will need funds to commercialize it in the 2nd half of 2023.

Risks To Business

There are several risks that traders/investors should be aware of before investing in this biotech. The first risk to consider would be with respect to the BLA filing of Lifileucel for the treatment of patients with advanced relapsed/refractory melanoma. First, the FDA has to accept the BLA filing of Lifileucel, and this has not happened yet. Secondly, even if the BLA filing is accepted, it will still have to be reviewed by the FDA thereafter. This means that the FDA will ultimately decide if regulatory approval is to be given for this therapy for the treatment of this patient population, and there is no guarantee that this will happen.

A second risk to consider would be with respect to the financial position it is in. That's because it believes that it only has enough cash to fund its operations until the 2nd half of 2024. This means that it will likely have to raise additional funds at least before the end of 2023. However, it is my belief that if the stock price goes up considerably on positive news, then it will choose to raise cash immediately. This could either be on the back of receiving FDA approval of Lifileucel for the treatment of patients with advanced relapsed/refractory melanoma or another positive news event.

A final risk to consider would be with respect to the accelerated approval of Lifileucel. That's because the phase 3 TILVANCE-301 study is being used to convert the potential accelerated approval of Lifileucel for advanced relapsed/refractory melanoma into a full one. If this confirmatory study fails later on, then it's possible that this treatment could be pulled off of the market.

Conclusion

The final conclusion is that Iovance Biotherapeutics, Inc. is a good speculative biotech play to look into. That's because it has a few catalysts that traders/investors can look forward to in the coming months. The first of such catalysts would be the rolling BLA of Lifileucel for review first. Considering that the 60-day review period initiated on March 24, 2023, then news of BLA rejection/acceptance should be coming within the next few months. If the BLA of Lifileucel is accepted by the FDA, then that would set up another catalyst.

Another catalyst to then watch for would then be for possible FDA approval of Lifileucel for the treatment of patients with advanced relapsed/refractory melanoma by the 2nd half of 2023. It is said that the global melanoma market is expected to reach $9.5 billion by 2030. As I noted above, the phase 3 TILVANCE-301 study will be important to convert/keep Lifileucel on the market for the treatment of patients with advanced relapsed/refractory melanoma. However, it will also be important for an expansion opportunity. The FDA has already agreed with Iovance in that this phase 3 trial would also allow for marketing approval of Lifileucel plus Keytruda for the treatment of frontline advanced melanoma patients as well.

With the possibility of FDA Accelerated approval of Lifileucel for advanced relapsed/refractory melanoma in 2023, plus the ability to expand the market opportunity thereafter, these are the reasons why I believe that Iovance Biotherapeutics, Inc. is a good speculative biotech play to look into.

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