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Moderna (MRNA) Soars on Upbeat Data From Cancer Therapy Study

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Shares of Moderna (MRNA - Free Report) were up 9.3% on Thursday after management reported median follow-up data of around three years from a mid-stage study on its individualized neoantigen therapy (INT) candidate mRNA-4157/V940 in melanoma indication. The candidate is being developed in collaboration with Merck (MRK - Free Report) .

The phase IIb KEYNOTE-942 study evaluated the combination mRNA-4157 and Merck’s blockbuster immuno-oncology drug Keytruda in patients with resected high-risk melanoma (stage III/IV) following complete resection.

At a median planned follow-up of approximately three years, treatment with mRNA-4157/Keytruda combination reduced the risk of recurrence or death by 49% compared with those treated with Keytruda alone. Treatment with this combination also reduced the risk of developing distant metastasis or death by 62% compared with Keytruda alone.

We remind investors that Moderna/Merck had reported last year that the KEYNOTE-942 study achieved its primary endpoint of recurrence-free survival (RFS). Earlier this year, the companies reported two-year follow-up data from the KEYNOTE-942 study wherein treatment with the mRNA-4157/Keytruda combination cut the risks of recurrence/death by 44% and the risk of distant metastasis or death by 65%.

The above results demonstrate the significant benefit of combining mRNA-4157 with Keytruda over a longer period of time compared with Keytruda alone. Moderna’s share price likely rose on the back of this encouraging update.

Year to date, the stock has lost 52.2% compared with the industry’s 16.2% fall.

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Based on the two-year follow-up data from the KEYNOTE-942 study, Moderna/Merck initiated the pivotal phase III INTerpath-001 study in July, evaluating the mRNA-4157/Keytruda combination as an adjuvant treatment in patients with resected high-risk (Stage IIB-IV) melanoma.

Earlier this week, Moderna and Merck initiated a second pivotal late-stage study (INTerpath-002) evaluating the mRNA-4157/Keytruda combo in non-small cell lung cancer (NSCLC) indication. Over time, the companies intend to develop mRNA-4157 in other oncology indications.

Merck and Moderna entered a strategic partnership in 2016 to develop and commercialize mRNA-based therapeutics to treat various types of cancer. Last year, Merck exercised its option to develop the INT with Moderna. Per the terms of the collaboration, the companies will share costs and profits equally.

Unlike other therapies that are uniformly designed to treat all patients, INT 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.

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

 

Zacks Rank & Key Picks

Moderna currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the overall healthcare sector include Galapagos (GLPG - Free Report) and Ocuphire Pharma (OCUP - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, Galapagos’ estimates for 2023 have improved from a loss of $1.96 per share to 79 cents. During the same period, loss estimates per share for 2024 have narrowed from $3.22 to $1.68. Galapagos’ shares have lost 9.2% in the year-to-date period.

Galapagos’ earnings beat estimates in three of the last four quarters while missing the estimates on one occasion. On average, the company witnessed an average surprise of 91.97%. In the last reported quarter, Galapagos’ earnings beat estimates by 140.78%.

In the past 60 days, Ocuphire’s estimates for 2023 have improved from a loss of 60 cents per share to 42 cents. During the same period, loss estimates per share for 2024 have narrowed from 85 cents to 57 cents. Shares of Ocuphire have lost 25.2% in the year-to-date period.

Ocuphire’s earnings beat estimates in three of the last four quarters while missing the estimates on one occasion. On average, the company witnessed an earnings surprise of 59.28%. In the last reported quarter, Ocuphire’s earnings beat estimates by 178.13%.

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