ImmunoGen: Possible FDA Approval For Ovarian Cancer Treatment

ImmunoGen (NASDAQ:IMGN) is a speculative biotech that you should keep your eye on. That’s because it trades only at around $3.71 per share and is rapidly approaching towards the end of 2022 with possible Accelerated FDA approval for its drug mirvetuximab soravtansine as a monotherapy for the treatment of patients with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with 1 to 3 prior systemic treatments. There is a PDUFA date set for November 28, 2022 for this possible accelerated FDA approval of this drug for this patient population.

In my opinion, I believe the company’s stock is at a great price at the moment, with the speculative nature it is in. That’s because downside risk is limited but upside potential is huge. There is potential to expand the use of mirvetuximab for the ovarian cancer population by way of several combination studies ongoing as well. Not only that, but there are two other catalysts that could offer additional trade opportunities. One is going to be the release of results from the pivotal phase 2 CADENZA study, which is using pivekimab sunirine for the treatment of frontline and relapsed/refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN). These results are expected before the end of 2022. A third catalyst to look forward to would be the release of results from the phase 1b/2 triple combination study using pivekimab sunirine + Azacitidine + Venetoclax for the treatment of patients with AML. These results will be presented at the ASH medical conference in December of 2022.

With all these catalysts approaching before the end of 2022 and with the stock trading at only at $3.71 per share, these are the reasons why I believe it is a good speculative biotech to look into. A bonus would be that ImmunoGen sparked some interest from Eli Lilly (LLY) due to its technology, as such a deal was fleshed out that could be worth up to $1.7 billion in potential exercise fees and milestone payments.

Mirvetuximab For Patients With High Folate Receptor Alpha Platinum-Resistant Ovarian Cancer

Mirvetuximab is being developed for the treatment of patients with high folate receptor alpha platinum-resistant ovarian cancer. Ovarian cancer is a type that occurs in the ovaries of a woman. The female reproductive system contains two ovaries. These ovaries are important because they produce eggs, release estrogen and progesterone hormones. What makes this type of cancer difficult to treat, like some others, is that it often goes undetected until it has spread. In the case of ovarian cancer, the cancer spreads to the stomach and pelvis areas. When this type of cancer is found early there are hardly any symptoms and can be treated easily. Unfortunately, in the advanced stage this cancer is hard to treat. There are symptoms that occur, but can often be mistaken for other possible diseases. Such symptoms are:

• Urge to urinate frequently
• Quick weight loss
• Pain in the pelvic area
• Abdominal issues/pain

This is quite a large market opportunity for ImmunoGen to go after. It is expected that the global ovarian cancer market is expected to reach $4.6 billion by 2026. Even then, it is growing by 18% each year which is also good news.

However, the thing is that ImmunoGen itself will be targeting a smaller portion of the population. Specifically, it is going after those who have high levels of folate receptor alpha ((FRa)) and who are platinum therapy resistant. Why is that? That’s because the company ran a large phase 3 study and did not succeed in progression-free survival (PFS) primary endpoint for the entire population. However, it saw success when it specifically looked at those patients who had high levels of FRa and resistant to platinum chemotherapy. The biotech believed it could possibly obtain FDA approval for the subpopulation based on its data, but the FDA stated that it had to run a single-arm phase 3 study specifically recruiting those patients with high levels of FRA in ovarian cancer.

The study done was a pivotal single-arm study is known as SORAYA. This trial recruited patients with platinum-resistant ovarian cancer whose tumors expressed high levels of FRa. These were patients who had already been treated with 3 other prior treatments, with at least one of them being Avastin (bevacizumab). The endpoints of this study were are as follows:

• Primary endpoint – Overall response rate (ORR) which is observed by investigator of the study
• Secondary endpoint – Duration of response (DOR)

The reason why the company ran the single-arm pivotal study is because it was allowed to by the FDA. Back in December 2019, the FDA stated that if it was able to prove that mirvetuximab achieved the primary endpoint of such a study, then it would allow for accelerated FDA approval based on this SORAYA study. This is exactly what happened in November of 2021 when it announced top-line results from this pivotal trial. It stated that the trial met the primary endpoint of objective response rate (ORR). The ORR noted by the investigator was 32.4%, which included about 5 complete responses (CRs) achieved. Since then, full results had been released, providing additional insight to the potential the drug has in treating this patient population. Additional results were presented at ASCO 2022, in which updated data from SORAYA study were Selected for Best of ASCO Program. Other efficacy items achieved were tumor reduction observed in 71.4% of patients and preliminary Median Overall Survival (mOS) of 13.8 months.

With the BLA file already having been accepted, plus mirvetuximab being given priority review, I believe there is great potential upside for the stock around November of 2022. One caveat is that even if Accelerated approval is given for this drug for high folate receptor alpha ovarian cancer patients, in order to convert this to full FDA approval it ultimately must also succeed in the other ongoing confirmatory MIRASOL trial. MIRASOL is important because it is a confirmatory randomized study, which will be the real final proof of the drug in this patient population. SORAYA is just a way for ImmunoGen to possibly receive Accelerated Approval in the meantime, until the MIRASOL study is completed. It is expected that results from this randomized confirmatory study will be released in early 2023.

Financials

According to the 10-Q SEC Filing, ImmunoGen had cash and cash equivalents of $437.7 million as of March 31, 2022. The biotech had only received an upfront payment of $13 million for consideration of the Eli Lilly deal, which was established. The reason for the cash on hand was because of an offering it did back in December of 2021. That is when it completed an underwritten public offering in which it sold a total of 17,486,364 shares of common stock at a public offering price of $6.60 per share, plus warrants as well. It raised total gross proceeds of about $295.7 million from this offering. Regardless, it states that it has enough cash to fund its operations into 2024. If it does need to raise cash later on, there are several options it expects to deploy. Such options could be through equity, debt or other financings available to it.

Risks To Business

There are several risks that investors should be aware of before investing in this biotech. The first is that while Priority Review was given for mirvetuximab for the treatment of patients with high folate receptor alpha Ovarian Cancer, there is no guarantee that the FDA will approve it. It’s even possible that the FDA may require the completion of the MIRASOL study first in early 2023, before approving the drug. Speaking of which, the MIRASOL study remains a huge risk factor. Even if the FDA gives Accelerated Approval for mirvetuximab, in order for ImmunoGen to keep the drug on the market, it has to succeed in the MIRASOL study. If it fails the MIRASOL study, then it’s highly likely that the FDA would pull mirvetuximab off of the market.

The final risk would be in terms of financials. While it says it has enough cash to fund its operations into 2024, it’s also possible it may choose to raise cash earlier than expected. This might be due to poor market conditions or preparation for commercialization of mirvetuximab. My guess would be that if a positive catalyst causes the stock to trade higher, it would take advantage of that and raise cash immediately.

Conclusion

ImmunoGen is a great speculative biotech play to look into. That’s because it has the potential to receive Accelerated FDA approval of mirvetuximab for the treatment of ovarian cancer patients with high folate receptor alpha expression. The PDUFA date for such an event is set with a Priority Review date of November 28, 2022. Not only that, but as I stated in the beginning above, it has two additional trial readouts as catalysts expected before the end of 2022. One of them is going to be the release of results from the pivotal phase 2 CADENZA study, which is using pivekimab sunirine for the treatment of frontline and relapsed/refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN). Then, the other trial readout will be from the phase 1b/2 triple combination study using pivekimab sunirine + Azacitidine + Venetoclax for the treatment of patients with AML. These are additional catalysts on top of the potential for FDA Accelerated Approval of mirvetuximab for the treatment of patients with high folate receptor alpha ovarian cancer.