USA — Moderna and Merck & Co. have announced positive results of a midstage trial, revealing that the addition of an experimental mRNA-based vaccine reduced the risk of the most deadly form of skin cancer spreading by 65% when compared to treatment with immunotherapy alone.
The findings, presented at the American Society of Clinical Oncology meeting in Chicago, have prompted Moderna to consider seeking expedited approval from regulators for this groundbreaking treatment.
Moderna President Stephen Hoge expressed optimism about the potential of the mRNA-based vaccine, stating that the recent data is alleviating some uncertainties surrounding its approval prospects.
Earlier data from the trial had already demonstrated promising results, indicating that the personalized mRNA vaccine, when combined with Merck’s Keytruda, reduced the risk of death or recurrence of melanoma by 44% compared to treatment with Keytruda alone.
These findings contribute to the growing body of evidence supporting the use of mRNA technology, which gained prominence during the COVID-19 pandemic, in developing personalized vaccines that train the immune system to target specific cancer cells present in a patient’s tumors.
For decades, scientists have been pursuing the dream of cancer vaccines with limited success. However, the combination of mRNA vaccines, which can be produced in a remarkably short time frame of eight weeks, and immune-boosting drugs holds great potential for a new era of cancer therapies.
Dr. Jane Healy, a Merck executive overseeing early cancer treatment development, expressed hope for a revolutionary treatment paradigm in cancer, one that is tailored to individual patients’ tumors and offers improved tolerance.
This innovative approach has the potential to transform cancer treatment and create unique therapies for each patient.
Moderna further revealed its plans to commence a Phase 3 confirmatory study, with the aim of opening it in the third quarter of this year.
The collaboration between Merck and Moderna represents one of several partnerships that combine potent immune system-targeting drugs with mRNA vaccine technology to combat different types of cancer.
Similar approaches are being pursued by Pfizer’s COVID-19 vaccine partner, BioNTech SE, and Gritstone Bio Inc, utilizing the capabilities of mRNA technology.
Promising mRNA vaccines target cancer mutations
The development of mRNA vaccines targeting neoantigens, unique mutations present only in tumors, has emerged as a groundbreaking approach in cancer treatment.
By directing the immune system to attack cancer cells while sparing healthy tissue, these vaccines offer new hope in the fight against cancer.
The key challenge lies in identifying the specific mutation responsible for driving the growth of cancer. To accomplish this, tumors are surgically removed, and their genetic makeup is analyzed using advanced next-generation DNA sequencing techniques.
Companies utilize artificial intelligence to predict the most effective mutations to target, forming the basis for an individualized vaccine tailored to the patient’s tumor.
Throughout this process, patients typically receive immunotherapy treatments such as Keytruda or Roche’s Tecentriq, which disrupt the mechanisms used by cancer cells to evade the immune system.
Even before the COVID-19 pandemic, researchers had been exploring messenger RNA (mRNA) technology as a delivery system for cancer vaccines.
mRNA carries instructions to cells for producing specific proteins, making it an ideal candidate for delivering personalized cancer vaccines.
Partnerships between companies like Merck and Moderna, established since 2016, and collaborations between Memorial Sloan Kettering Cancer Center (MSK) in New York and Germany’s BioNTech since 2017, have driven significant progress in this field.
Early successes were observed in “hot” tumors with high mutation rates, such as melanoma. However, there was little hope for “cold” tumors with few mutations, such as pancreatic cancer.
Dr. Vinod Balachandran of MSK conducted research on long-term pancreatic cancer survivors and discovered that their immune systems contained T cells capable of recognizing cancer-derived mutations. This finding opened the possibility of developing targeted vaccines.
In a small ongoing trial, a personalized BioNTech vaccine combined with Roche’s Tecentriq was administered to 16 pancreatic cancer patients.
Encouragingly, half of the patients demonstrated an immune response, and none experienced relapse after 18 months, as reported in Nature last month.
These results offer hope for pancreatic cancer patients who typically face a grim prognosis, with 90% succumbing to the disease within five years of diagnosis.
Gritstone Bio is pursuing a different approach by combining two types of customized vaccines to address metastatic colon cancer, which has shown limited response to immunotherapy.
The treatment strategy involves priming the immune system with a chimpanzee adenovirus vaccine that specifically targets the patients’ tumors, followed by a personalized self-amplifying mRNA vaccine.
The mRNA vaccine includes an enzyme that increases the production of antigens, reducing the required vaccine dose.
Gritstone anticipates releasing data from a later-stage trial of this dual vaccine therapy in the first quarter of 2024.
“Based on everything we’ve shown and we’ve published, we’re really excited,” said Gritstone CEO Andrew Allen.
Merck and Moderna are planning a larger Phase 3 trial in melanoma and are also testing its combination in lung cancer.
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