CANCER BREAKTHROUGH: Moderna, Merck report cancer discovery

Moderna CEO Stéphane Bancel on Cancer Breakthroughs, Vaccine Strategy & Future Growth

Key Concepts:

• Personalized Cancer Treatment: Moderna’s collaborative work with Merck focuses on creating individualized cancer vaccines tailored to each patient’s tumor.
• mRNA Technology: Utilizing messenger RNA (mRNA) to instruct the immune system to target and destroy cancer cells.
• Keytruda: Merck’s existing immunotherapy drug (pembrolizumab) used in combination with the Moderna vaccine.
• Endemic COVID-19: Shifting focus from pandemic response to targeted vaccination for high-risk individuals.
• GLP-1 Drugs: A new class of drugs showing promise for weight loss and broader health benefits (cardiovascular, kidney disease, potentially dementia).
• Patent Protection: The importance of intellectual property rights for incentivizing pharmaceutical innovation.
• Manufacturing in the US: Moderna’s commitment to domestic production of its vaccines and therapies.

I. Cancer Vaccine Breakthroughs with Merck

Moderna, in partnership with Merck, has achieved significant breakthroughs in individualized cancer treatment, specifically focusing on melanoma (skin cancer). This collaboration, representing nearly a decade of investment in innovation, centers around creating personalized vaccines. The unique aspect of this approach is that a different medicine is created for each patient diagnosed with cancer, even if diagnosed on the same day by the same doctor. This individualized medicine can be produced within 30 days.

Phase 2 trial data, involving 157 randomized U.S. patients, demonstrated a 50% improvement in recurrence-free survival compared to patients receiving Keytruda (pembrolizumab) alone. This means patients treated with the combined Moderna vaccine and Keytruda had a significantly lower rate of cancer returning or causing death over a five-year period. Stéphane Bancel emphasized the meaningful impact this could have on patients and families. Phase 3 trial results are expected this year, with potential FDA filing for approval shortly thereafter, aiming for availability to American patients in 2027.

Currently, nine additional studies are underway with Merck, exploring the application of this technology to lung, kidney, bladder, gastric, and pancreatic cancers. The underlying mechanism involves precisely targeting the immune system to attack the patient’s specific cancer cells. Importantly, the safety profile of the vaccine has been favorable, with no additional safety risks or side effects observed.

II. COVID-19 Vaccine Strategy & Market Shift

As the COVID-19 pandemic transitions to an endemic phase, Moderna is adapting its vaccine strategy. The company has “right-sized” its operations, acknowledging a decrease in broad vaccine demand. The current focus is on providing vaccinations to high-risk individuals – those with comorbidities or advanced age – aligning with FDA guidelines issued in Spring 2023.

Despite anticipated sales declines, Moderna anticipates a resurgence in growth starting in 2026 and accelerating into 2027. This growth will be driven by expansion into the respiratory virus vaccine market in the European Union and long-term partnerships in Latin America. Moderna has already received three product approvals from the FDA under the current administration, all of which were tested using placebo-controlled trials.

III. Cost Reduction & Investment in Innovation

Moderna is actively pursuing cost reduction measures. The company achieved a substantial $2 billion cost reduction in the previous fiscal year and aims for further, albeit more modest, reductions this year. These savings will be reinvested in ongoing studies, particularly in the area of rare genetic diseases. Bancel highlighted the importance of continued investment in science to drive the launch of new products, with the potential for up to five new approvals this year.

IV. Response to New Vaccine Guidance & Importance of Science

Addressing recent guidance from Health and Human Services Secretary RFK Jr. regarding vaccine schedules, Bancel reaffirmed Moderna’s commitment to a science-based approach. He emphasized the rigorous testing procedures employed by Moderna, including placebo-controlled trials, for its approved vaccines. He stated, “We are a science based company and we always look at the data and the facts to be able to protect people and we look of course at efficacy and safety and we take safety very, very seriously.”

V. GLP-1 Drugs & the Future of Preventative Medicine

Bancel acknowledged the significant excitement surrounding GLP-1 drugs, noting their potential benefits beyond diabetes and weight loss, including positive impacts on cardiovascular health, kidney disease, and potentially dementia. He emphasized the importance of preventative medicine, drawing parallels between the benefits of vaccines in preventing hospitalization and GLP-1 drugs in preventing cardiovascular and liver disease. He stated, “If we can we help people enjoy their lives and that's one of the biggest benefits of what we're doing the industry for innovation.”

VI. Rare Genetic Disease Collaboration & Patient Impact

Moderna is collaborating with Italian pharmaceutical company Recordati to develop a treatment for a rare genetic liver disease. This disease prevents children from producing a vital protein, leading to a buildup of acid in the blood and impacting brain function. Phase 1 and 2 trials have shown promising results, with children on the medication demonstrating significant improvement. The partnership aims to accelerate access to this treatment for affected children and families.

VII. Drug Pricing & Innovation Incentives

Bancel addressed the ongoing efforts to lower drug prices, emphasizing the need for global contributions to pharmaceutical innovation. He argued that sustained investment in research and development is crucial for continued advancements, and that patent protection is vital to incentivize these investments. He stated, “Without innovation the industry will not survive and this will impact Americans so we need people around the world to contribute to value for products so innovation can continue.” He highlighted the importance of American innovation, exemplified by the rapid development of COVID-19 vaccines.

VIII. Manufacturing & Future Outlook

Moderna is committed to maintaining its manufacturing base in the United States, with all production processes for the cancer vaccine currently taking place in Massachusetts. Looking ahead, the company expects growth to be driven by international expansion and the launch of new products. Fourth-quarter earnings are expected to be released next Friday, providing further insights into the company’s performance and future outlook.

Notable Quote:

“This is a very important – patent protection is very important. Those investments sometimes take five, ten years and as you know, most medicines that are going to clinical trials fail and because they don't have the right safety, efficacy profile, they are not approved which is the right thing for society.” – Stéphane Bancel, CEO of Moderna.

Technical Terms:

• mRNA (messenger RNA): A molecule that carries genetic instructions from DNA to ribosomes, where proteins are made. Moderna’s technology uses mRNA to instruct cells to produce proteins that trigger an immune response.
• Comorbidity: The presence of two or more diseases or medical conditions in a patient.
• Placebo-Controlled Trial: A clinical trial where participants are randomly assigned to receive either the treatment being tested or a placebo (an inactive substance).
• Endemic: A disease that is constantly present in a population, but at relatively low levels.
• Recurrence-Free Survival: The length of time after treatment that a patient remains free of cancer.
• Keytruda (Pembrolizumab): An immunotherapy drug that helps the immune system fight cancer.
• GLP-1 Drugs: Glucagon-like peptide-1 receptor agonists, a class of drugs initially developed for diabetes but now used for weight loss and other conditions.