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Moderna (MRNA), Merck's Cancer Jab Gets EMA's PRIME Tag

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Moderna (MRNA - Free Report) recently announced that the European Medicines Agency (“EMA”) granted Priority Medicines (“PRIME”) scheme designation to its personalized cancer vaccine (“PCV”) candidate mRNA-4157/V940 in melanoma indication.

The PRIME designation has been granted by the EMA to the combination of mRNA-4157/V940 and Merck’s (MRK - Free Report) blockbuster cancer drug Keytruda as an adjuvant treatment of patients with high-risk stage III/IV melanoma following complete resection.

The PRIME designation is granted by the EMA to support the development of medicines, which target an unmet need. Treatments and therapies which are granted this designation are offered early and proactive support by the agency, including being eligible for an accelerated assessment at the time of applying for marketing authorization.

Merck and Moderna entered a strategic partnership in 2016 to develop and commercialize mRNA-based personalized vaccines for treating various types of cancer. Last October, Merck exercised its option to develop the PCV vaccine with Moderna. Per the terms of collaboration, the companies will share costs and profits equally.

Similar to the EMA, the FDA also granted the breakthrough therapy designation to the PCV plus Keytruda combination for a similar indication earlier this year in February.

In the year so far, Moderna has lost 11.9% compared with the industry’s 4.7% fall.

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Both the PRIME and breakthrough therapy designations granted by the regulatory agencies are based on positive data from phase IIb KEYNOTE-942 which evaluated the PCV vaccine plus Keytruda against Keytruda alone as an adjuvant treatment for stage III/IV melanoma patients with a high risk of recurrence following complete resection. Last December, Moderna announced that the study achieved its primary endpoint of recurrence-free survival (“RFS”).

Data from the study showed that the mRNA-4157/Keytruda combination exhibited a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death by 44%. The study’s results also suggest that a personalized neoantigen approach may benefit melanoma patients.

Based on the above data, Moderna and Merck are currently discussing the above results with regulatory authorities and also intend to start a phase III study in melanoma patients later this year. The companies also plan to expand the PCV vaccine to other cancer indications, including non-small cell lung cancer.

Unlike other vaccines that are uniformly designed to treat all patients, the PCV vaccine aims to bring individualized treatment to cancer patients. mRNA-4157 is tailored for each patient based on the unique mutational signature of a patient's tumor.

Keytruda is already approved for multiple melanoma indications. Keytruda is approved by the FDA as an adjuvant treatment for patients aged 12 years and older with stage IIB/IIC/III melanoma patients following complete resection. It is also approved for treating patients with unresectable or metastatic melanoma.

As opposed to traditional vaccines, mRNA-based vaccines teach the body how to make a specific protein that can help your immune system prevent or treat certain diseases.The COVID-19 pandemic has further demonstrated the significant potential of mRNA-based therapeutics. By way of COVID vaccines, Moderna and Pfizer have generated immune responses against the virus at record-high levels compared to traditional protein-based and adeno-based vaccines.


Zacks Rank & Stocks to Consider

Moderna currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the overall healthcare sector include Certara (CERT - Free Report) and CRISPR Therapeutics (CRSP - Free Report) . While Certara sports a Zacks Rank #1 (Strong Buy), CRISPR Therapeutics carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Certara’s 2023 earnings per share have increased from 46 cents to $1.24. During the same period, the earnings estimates per share for 2024 have risen from 54 cents to $1.85. Shares of Certara are up 43.2% in the year-to-date period.

Earnings of Certara missed estimates in two of the last four quarters, beating the mark on one occasion while meeting the mark on another. On average, the company’s earnings witnessed a negative surprise of 3.25%. In the last reported quarter, Certara’searnings beat estimates by 14.29%.

In the past 60 days, estimates for CRISPR Therapeutics’ 2023 loss per share have narrowed from $8.21 to $7.35. Shares of CRISPR Therapeutics have risen 11.7% in the year-to-date period.

Earnings of CRISPR Therapeutics beat estimates in two of the last four quarters while missing the mark on the other two occasions, witnessing an earnings surprise of 3.19%, on average. In the last reported quarter, CRISPR Therapeutics’ earnings beat estimates by 39.22%.

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