shares of moderna (NASDAQ:MRNA), management announced encouraging data from part of an early-stage study of mRNA-4157/V940, an investigational personalized neoantigen therapy in certain head and neck cancer patients. It then rose 6.2% on April 9th. INT is developed in cooperation with the following companies: Merck (NYSE:MRK).
This part of the study evaluated mRNA-4157 in combination with Merck's blockbuster immuno-oncology drug Keytruda in patients with human papillomavirus-negative (HPV-) head and neck squamous cell carcinoma (HNSCC).
Data from the study showed that the combination therapy not only achieved a positive clinical response in HPV-HNSCC patients, but also showed evidence of immune response activation. The combination therapy was also found to be safe and well-tolerated by study participants.
Per administration, treatment with this combination achieved an objective response rate (ORR) in 6 of 22 patients, including 2 complete responses and 4 partial responses. The disease control rate was 63.6%. These results were presented earlier this week at the American Society of Cataract and Refractive Surgery (ASCRS).
Moderna and Merck are already evaluating mRNA-4157 in two important late-stage studies in melanoma and non-small cell lung cancer (NSCLC) indications. The companies plan to expand mRNA-4157 across multiple oncology indications and begin additional clinical studies this year. Last month, Moderna/Merck posted details on its government website of a Phase II/III study evaluating INT in patients with cutaneous squamous cell carcinoma (CSCC), a type of skin cancer.
Merck and Moderna entered into a strategic partnership in 2016 to develop and commercialize mRNA-based therapies to treat various types of cancer. Under the terms of the partnership, both companies will share costs and profits equally.
Year-to-date, Moderna's stock has increased 12.2% versus the industry's decline of 5.4%.
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Unlike other treatments that are designed uniformly to treat all patients, INT aims to provide individualized treatment to cancer patients. mRNA-4157 is tailored to each patient based on the unique mutational signature of their tumor.
In contrast to traditional drug treatments, mRNA-based therapies teach the body how to make specific proteins that help the immune system prevent or treat certain diseases. The coronavirus disease (COVID-19) pandemic has further demonstrated the great potential of mRNA-based therapeutics. Across COVID-19 vaccines, mRNA vaccines have elicited record high levels of immune responses against the virus compared to traditional protein-based and adeno-based vaccines.
Currently, Moderna only has one commercial product, the COVID-19 vaccine, but it is currently facing a steep/significant decline in revenue since the pandemic ended. Leveraging the strong cash sales generated during the years of the pandemic, Moderna has significantly accelerated pipeline development and demonstrated strong clinical efficacy across multiple different indications.
Moderna plans to launch 15 new products over the next five years, including four for rare disease indications. These include RSV, CMV, and influenza vaccines. Management anticipates that RSV vaccine mRNA-1345 could receive FDA approval in June. If approved, mRNA-1345 could become Moderna's second product launch, with commercial launch expected in the third quarter of 2024.
Management believes the company's vaccine portfolio targets a large market with an estimated total market size of approximately $52 billion for infectious disease vaccines.
Zacks Rank and Top Picks
Moderna currently carries a Zacks Rank #3 (Hold). Top-ranked stocks across the healthcare sector include: ADMA Biologics (NASDAQ:ADMA) and ANI Pharmaceutical (NASDAQ:ANIP), each sporting a Zacks Rank #1 (Strong Buy).
Over the past 60 days, ADMA Biologics' 2024 earnings per share estimates have increased from 22 cents to 30 cents. Over the same period, his EPS forecast for 2025 improved from 32 cents to 50 cents. ADMA stock has increased 35.2% since the beginning of the year.
ADMA Biologics' earnings have exceeded estimates in three of the past four quarters, and met expectations once. ADMA delivered a 4-quarter average earnings surprise of 85.00%.
Over the past 60 days, ANI Pharmaceuticals's 2024 EPS estimate has increased from $4.06 to $4.43. Meanwhile, over the same period, 2025 EPS estimates improved from $4.80 to $5.04. Since the beginning of the year, ANIP stock has increased 21.6%.
ANI Pharmaceuticals' profits have exceeded expectations in each of the past four quarters. ANI delivered an impressive 4-quarter average return of 109.06% for him.
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