Now that its Pfizer-partnered COVID-19 vaccine has been delivered to hundreds of millions of people globally, BioNTech is ready to hit go on the second-most advanced candidate in its pipeline.
That candidate is a messenger RNA vaccine for colorectal cancer dubbed autogene cevumeran, which has officially entered the clinic. BioNTech said Friday that a phase 2 trial of the drug, also known as BNT122, is now underway for patients with stage 2/3 colorectal cancer who have undergone tumor surgery and completed three to six months of chemotherapy after primary treatment.
BioNTech is employing a different kind of mRNA and a different type of lipid than what were used in the COVID-19 jab, which is now branded as Comirnaty after being approved by the FDA in August.
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The new cancer vaccine will be compared as a single treatment versus standard of care, defined as "watchful waiting" after surgery and chemotherapy to see whether the tumors come back. A proportion of patients are expected to have a recurrence two to three years after treatment.
BNT122 will be tested in about 200 patients who are at high risk of experiencing recurrence of their tumor. BioNTech will identify these patients using a blood test that detects circulating tumor DNA.
“Many cancers progress in such a way that the patient initially appears tumor-free after surgery, but after some time tumor foci that were initially invisible grow and form metastases," said Özlem Türeci, M.D., chief medical officer and co-founder of BioNTech, in a statement.
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BioNTech's primary goal for the trial is to show disease-free survival until study completion, which could last up to five years. Secondary objectives include relapse-free survival, overall survival and safety.
The trial will entail six weekly vaccinations, then two biweekly jabs, followed by shots administered every six weeks for up to 12 months. The study is being conducted in the U.S., Germany, Spain and Belgium, with the first patient being dosed at an undisclosed clinical site in Europe.
The vaccine is meant to be specific to each patient based on mutations unique to their tumor. Production of the individualized vaccines takes four to six weeks.
BioNTech is already testing BNT122 with partner Genentech, part of Roche, in a phase 2 study in patients who had previously not received treatment for advanced melanoma. That midstage study, which began before the pandemic, is testing the vaccine in combination with Merck's anti-PD-1 therapy Keytruda.
While BioNTech is leading the colorectal cancer trial, the company will continue joint development of the vaccine with Genentech in other trials.