IMGN - ImmunoGen: Elahere Data Mid-2024 To Expand Targeted Population

2023-11-27 17:41:15 ET

Summary

• ImmunoGen, Inc. expects to convert the Accelerated Approval of its drug Elahere to "Full Approval" in the 1st half of 2024.
• Potential European approval of Elahere for treatment of patients with FRa-high platinum-resistant ovarian cancer expected late 2024, with commercialization following after.
• Full results from the single-arm phase 2 PICCOLO study, using Elahere for the treatment of patients with FRa-high platinum-sensitive ovarian cancer, expected mid-2024.
• Potential to expand Elahere for FRa-high platinum-resistant ovarian cancer patient population for other territories besides European Union, include China and Japan.

ImmunoGen, Inc. ( IMGN ) has been making great progress in being able to advance its pipeline. The reason why I state that is because it is gearing up to have a meaningful year in 2024. That's because it has already been given Accelerated Approval of its drug Elahere, which was approved to treat Folate Receptor alpha high platinum-resistant ovarian cancer. However, it is expecting to convert this Accelerated Approval to "Full Approval" with a supplemental Biologics Licensing Application [sBLA] in the 1st half of 2024.

Not only that, but it expects to be able to possibly receive European Medicines Agency [EMA] approval of Elahere for the treatment of this same patient population. Should its review go well, then it should be able to commercialize this drug in the European Union in the latter part of 2024. Lastly, there is another catalyst opportunity to expect in the coming year, which is a data readout. It is expected that full data from the single-arm PICCOLO study, using mirvetuximab for the treatment of folate receptor alpha high platinum-sensitive ovarian cancer patients, will be released in mid-2024. Based on the sBLA and expansion opportunity of Elahere, plus the data readout expected in the middle part of 2024, I believe that investors can benefit from any gains made.

Mirvetuximab Can Eventually Be Expanded Into Another Ovarian Cancer Patient Population

As I stated above, Elahere [mirvetuximab] was given Accelerated Approval by the FDA for the treatment of adult patients with folate receptor alpha positive, platinum-resistant ovarian cancer patients who have received one to three prior systemic treatment regimens. The thing is that this biotech is on the right track with Elahere, especially since it is already gearing up to convert such Accelerated Approval into a "Full Approval." It is expected that this could happen in the 1st half of 2024, making this one catalyst opportunity that investors can look forward to.

Another catalyst to consider would be the ability for ImmunoGen to be able to expand the use of mirvetuximab for the treatment of this FRa high platinum-resistant ovarian cancer patient population to the European Union. It could achieve this because the European Medicines Agency [EMA] accepted the regulatory application that it filed last month for Elahere. Should the review process go well, then the company should be able to start to commercialize its drug in the European territories. It has even made significant progress towards expanding the use of this drug towards other territories as well. This would be with respect to the following advancements as follows:

• Expansion into China - Partner Huadong Medicine - obtained acceptance of New Drug Application [NDA] it submitted to the National Medical Products Administration [NMPA] of Elahere for treatment of FRa-positive platinum-resistant ovarian cancer
• Expansion into Japan - Partnership established with Takeda Pharmaceutical ( TAK ) to develop and commercialize Elahere for Japan. An upfront payment of $23.2 million was given to ImmunoGen and then potential to receive up to $135 million in regulatory and commercial milestone payments, along with tiered royalties in the low double-digits to mid-twenties

Besides being able to expand the use of Elahere towards the treatment of FRa-high platinum-resistant ovarian cancer, there is an ability to eventually expand the use of this drug towards another type of ovarian cancer patient population. This would be with respect to the use of Elahere for the treatment of FRa-high platinum-sensitive ovarian cancer. An interim assessment done on a single-arm phase 2 trial, using Elahere for the treatment of this FRa-high PSOC population, showed that the primary endpoint of objective response rate [ORR] was met.

However, why I believe that investors might be able to capitalize with an opportunity with respect to this particular program, is because full results from this phase 2 single-arm study are expected to be released in mid-2024. Should this study go well, then this is another subpopulation of ovarian cancer patients that can be treated with Elahere.

Financials

According to the 10-Q SEC Filing , ImmunoGen had cash and cash equivalents of $605.5 million and accounts receivable of $130.7 million as of September 30th of 2023. This biotech is in good shape, because it has plenty of cash runway. It believes that this cash on hand should be enough to fund its operations over a two-year period.

In the meantime, this biotech has already been able to generate sales of its drug Elahere, which as I described above has already been given Accelerated Approval for the treatment of patients with FRa-high platinum-resistant ovarian cancer. It generated strong Elahere sales of $105.2 million for its third-quarter 2023 earnings.

Risks To Business

There are several risks that investors should be aware of before investing in ImmunoGen. The first risk to consider would be with respect to the potential conversion of the Accelerated Approval of Elahere to "Full Approval." While it is highly probable that this will happen, it is still not guaranteed to happen and remains a huge investment risk.

A second risk to consider would with respect to the possible expansion opportunities of Elahere for China and Japan. In terms of a possible launch of this drug in China or Japan, that will largely depend upon whether or not the regulatory agencies there are ultimately satisfied with clinical data submitted.

A third and final risk to consider would be with respect to the ongoing single-arm phase 2 PICCOLO study, whereby Elahere is being given to treat patients with FRa-high platinum-sensitive ovarian cancer. The intended goal is for this study to achieve at least an objective response rate [ORR[ of at least 48% or higher, when this data is released next year. While Elahere has done well to treat FRa-high platinum-resistant ovarian cancer patients, there is no assurance that a good outcome will be achieved in targeting FRa-high platinum-sensitive ovarian cancer [PSOC].

Conclusion

ImmunoGen, Inc. has made great progress in being able to advance its pipeline, especially when you consider that it has already been able to achieve Accelerated Approval from the FDA of Elahere for the treatment of patients with FRa-high platinum-resistant ovarian cancer. The thing is that this company now has the ability to convert such Accelerated Approval to "Full Approval" in the 1st half of 2024. Plus, the European Medicines Agency [EMA] has already accepted the regulatory application for review. Should the review go well, plus marketing approval given for the European territory, then it should be able to commercialize Elahere for FRa-high platinum-resistant ovarian cancer by the 2nd half of 2024. It is doing well to expand the use of Elahere beyond only a few territories, and this is evidenced by the moves it made to also expand the use of this antibody-drug conjugate [ADC] in other territories like China and Japan.

I believe that there is value here because there is an additional catalyst that investors can look forward to next year. This would be with the release of full data from the single-arm phase 2 PICCOLO study, which is using Elahere for the treatment of patients with FRa-high platinum-sensitive ovarian cancer. Such clinical data is expected to be released in mid-2024. If positive, this could yield another ovarian cancer patient population that ImmunoGen could go after.

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