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Moderna (MRNA), Merck Start 2nd Late-Study on Cancer Therapy

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Moderna (MRNA - Free Report) and partner Merck (MRK - Free Report) have initiated the pivotal phase III INTerpath-002 study evaluating their individualized neoantigen therapy (INT) candidate, V940 (mRNA-4157), in non-small cell lung cancer (NSCLC) indication.

The INTerpath-002 study is evaluating V940 combined with Merck’s blockbuster immuno-oncology drug Keytruda, compared with Keytruda alone, as an adjuvant treatment in adults with completely resected Stage II, IIIA or IIIB (with nodal involvement [N2]) NSCLC. The study has started global recruitment, having enrolled the first participants in Australia.

The primary endpoint of the late-stage study is disease-free survival (DFS). Secondary endpoints consist of overall survival (OS), distant metastasis-free survival (DMFS), lung cancer specific survival (LCSS), safety and quality of life.

The INTerpath-002 study is Moderna/Merck’s second clinical study in the INTerpath program evaluating V940 in multiple cancer indications. In July, Moderna/Merck initiated the phase III INTerpath-001 study evaluating V940 plus Keytruda in melanoma patients.

The initiations of both studies in the INTerpath program are based on data from the phase IIb KEYNOTE-942 study on the V940-Keytruda combination in melanoma indication, reported in first-half 2023. The study achieved its primary and key secondary endpoints, thereby demonstrating the meaningful benefit of combining V940 with Keytruda compared with Keytruda alone.

Over time, Moderna and Merck intend to expand V940 in other oncology indications.

Year to date, the stock has lost 54.4% compared with the industry’s 20.4% fall.

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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 V940 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. V940 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 further demonstrated the significant 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 & Stocks to Consider

Moderna currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the overall healthcare sector include CytomX Therapeutics (CTMX - Free Report) and Novo Nordisk (NVO - Free Report) , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, CytomX Therapeutics’ estimates for 2023 have improved from a loss of 37 cents per share to earnings of 2 cents. During the same period, loss estimates per share for 2024 have narrowed from 51 cents to 6 cents. Shares of CytomX have lost 13.1% in the year-to-date period.

CytomX Therapeutics’ 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 45.44%. In the last reported quarter, CytomX Therapeutics’ earnings beat estimates by 123.53%.

In the past 60 days, estimates for Novo Nordisk’s 2023 earnings per share have increased from $2.51 to $2.62. During the same period, the earnings estimates for 2024 have risen from $2.95 to $3.14. Shares of NVO have surged 42.8% in the year-to-date period.

Novo Nordisk’s earnings beat estimates in two of the last four quarters while meeting the mark on one occasion and missing the estimates on another. On average, the company witnessed an earnings surprise of 0.58%. In the last reported quarter, Novo Nordisk’s earnings beat estimates by 5.80%.

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