IMGN - 2 Regulatory Submissions Of ELAHERE In 2023 Make ImmunoGen A Must Watch

2023-05-09 14:36:35 ET

Summary

• ImmunoGen, Inc. ELAHERE succeeds in phase 3 confirmatory MIRASOL trial; all endpoints achieved with statistical significance when FRa-high positive platinum-resistant ovarian cancer patients received ELAHERE.
• Submission of BLA of ELAHERE to the FDA to convert Accelerated Approval to a Full approval is expected in the 2nd half of 2023.
• Submission of Marketing Authorization Application of ELAHERE to the European Medicines Agency to receive European marketing approval expected in the 2nd half of 2023.
• Several studies ongoing using ELAHERE either alone or in combination with other treatments to target platinum-sensitive ovarian cancer patients.

ImmunoGen, Inc. ( IMGN ) is a good speculative biotech play to look into, because it just recently reported positive results from the ongoing phase 3 MIRASOL study. This was a crucial late-stage clinical study, because it confirmed what was observed from the prior SORAYA trial. In addition, a successful outcome was needed from the phase 3 MIRASOL study so that ELAHERE would not be pulled from the market. That's because ELAHERE had already received Accelerated FDA approval for the treatment of patients with folate receptor alpha [FRa]-positive platinum-resistant ovarian cancer who have received one to three prior lines of therapy. This happened back in November of 2022, but again this was only Accelerated Approval.

Now, there are two new catalyst opportunities for investors to look forward too. The first would be the submission of a supplemental Biologics License Application [sBLA] to the FDA of ELAHERE to convert it to full FDA approval, instead of the current Accelerated Approval granted. The second catalyst opportunity for investors to look forward to would be the submission of a Marketing Authorization Application [MAA] of ELAHERE for the treatment of patients with FRa-positive platinum-resistant ovarian cancer who have received one to three prior lines of therapy. The submission for both of these regulatory applications is expected in the 2nd half of 2023.

What makes this biotech an attractive trade opportunity, besides the upcoming catalysts, would be the fact that there is potential to develop treatment for another ovarian cancer patient population. That's because there are three ongoing studies using mirvetuximab [ELAHERE] in combination with other drugs to target patients with FRa-High platinum-sensitive ovarian cancer. Lastly, there is another clinical candidate being developed in the pipeline, which is known as IMGN151. This clinical candidate is a next-generation antibody drug conjugate [ADC] which is designed to target lower levels of folate receptor alpha [FRa] ovarian cancer patients.

Positive Results From MIRASOL Trial Establish A Promising Future

As I noted in the beginning above, ImmunoGen was able to obtain positive results from the phase 3 MIRASOL study . This was a randomized phase 3 study which used ELAHERE to treat patients with FRa-positive platinum-resistant ovarian cancer who have received one to three prior lines of therapy. Again, these are ovarian cancer patients who have high levels of FRa and who have already been treated with three other prior lines of therapies. Patients in this study were randomized to receive either ELAHERE or investigator's choice of a single-agent chemotherapy. Such chemotherapy options available to investigators of this study were as follows:

• Topotecan
• Pegylated liposomal doxorubicin
• Paclitaxel.

The primary endpoint of this phase 3 MIRASOL STUDY was progression-free survival. Secondary endpoints for this study were objective response rate [ORR] and overall survival [OS]. The results were outstanding, because ELAHERE was able to achieve statistical significance with respect to all the endpoints of this late-stage study. In particular, the primary endpoint of progression-free survival [PFS] was achieved with statistical significance. It was revealed that ELAHERE achieved statistical significance over Investigator's choice [IC] chemotherapy with a p-value of p<0.0001.

In essence, patients who were given ELAHERE saw a 35% reduction in the risk of tumor progression or death, compared to IC chemotherapy arm. The PFS primary endpoint of course was important in order to move on to file the sBLA of ELAHERE to convert it to full FDA approval. However, there was another important finding from this particular study. This other finding has to do with overall survival benefit of patients who took ELAHERE, compared to those who took IC chemotherapy. As of March 6, 2023, the median OS was 16.46 months in the ELAHERE arm, compared to 12.75 months in the IC chemotherapy arm. In essence, patients who took ELAHERE obtained a 33% reduction in the risk of death.

Financials

According to the 10-Q SEC Filing , ImmunoGen had $201.2 million in cash and cash equivalents as of March 31, 2023. It also was able to establish a way to obtain non-dilutive credit facility financing with Pharmakon Advisors, LP for up to $175 million. It received $75 million as the first tranche upon closing of this loan agreement and has potential to get additional cash from this loan agreement of $100 million.

The second tranche of $50 million is contingent upon confirmatory positive results from the phase 3 MIRASOL study and then reaching a specific sales threshold for ELAHERE. This amount given could be doubled to $100 million, barring a mutual agreement being established between both parties. As I stated above, ELAHERE had already been given Accelerated FDA approval back in November of 2022. Well, with the recently released earnings, it was noted that sales of ELAHERE reached $29.5 million.

This was a crucial quarter, because it was the first full quarter of sales for this drug. ImmunoGen believed that it would have enough cash on hand to fund its operations for more than 12 months. However, despite a credit facility it made in March of 2023, it had decided to sell shares of common stock to raise additional cash. It did this back on May 4, 2023, where it announced the pricing of an underwritten public offering of 26,000,000 shares of its common stock at a price of $12.50 per share. It also granted the underwriters a 30-day option to purchase up to an additional 3,900,000 shares of its common stock at the very same public offering price.

With this newly added cash on hand now, I believe that further ImmunoGen, Inc. dilution is off the table in 2023. It may have to start looking at cash raising activities again in early 2024.

Risks To Business

There are several risks to ImmunoGen, Inc. that traders/investors should be aware of before investing in this biotech. The biggest risk to consider would be with respect to the NDA of ELAHERE to the FDA in the 2nd half of 2023. That's because even though it is highly likely that the FDA should now convert ELAHERE to full FDA approval, the application submitted still needs to be reviewed by it. There is a possibility that there might be a discrepancy in the application.

A second risk to consider might be with respect to the MAA submission of ELAHERE expected in the 2nd half of 2023. There is no guarantee that ImmunoGen will end up receiving European Marketing approval of ELAHERE for the treatment of folate receptor alpha [FRa]-positive platinum-resistant ovarian cancer.

The next risk to consider would be with respect to all the other ongoing ovarian cancer studies using ELAHERE in combination with other drugs. There is no assurance that adding in other treatments in combination with ELAHERE will yield an improved outcome for these ovarian cancer patients.

Conclusion

The final conclusion is that ImmunoGen, Inc. is a good speculative biotech play to look into. That's because it holds the potential to convert its Accelerated FDA approval of ELAHERE, for the treatment of patients with folate receptor alpha [FRa]-positive platinum-resistant ovarian cancer who have received one to three prior lines of therapy, to a full one. In addition to submitting such a BLA to the FDA, it is also looking at submitting a MAA to the European Medicines Agency [EMA] so that it can seek European approval of ELAHERE for the treatment of this very same patient population.

This would only be the beginning for ImmunoGen, Inc., that's because it is looking to expand its potential in this ovarian cancer market. It hopes to accomplish this through two methods. The first method is to combine ELAHERE together with other treatments to target platinum-sensitive ovarian cancer patients. The second method would be the advancement of a next generation antibody anti-body drug conjugate [ADC], which is being developed for FRa-low ovarian cancer patients. Through both of these methods, it might be able to expand its target market in this sector. It is also advancing a drug by the name of pivekimab for the treatment of patients with BPDCN and acute myeloid leukemia.

With two regulatory submissions of ELAHERE in the 2nd half of 2023, plus the ability to expand into the platinum-sensitive ovarian cancer market, these are the reasons why I believe ImmunoGen, Inc. is a good speculative biotech play to look into.

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