Shares in Moderna were ticking upwards today after Merck & Co took up an option on a personalised RNA-based cancer vaccine with a payment of $250 million.
It is the first time that Merck has exercised an option in its collaboration with the mRNA vaccine specialist, first agreed in 2016 and expanded two years later to include additional candidates.
The deal focuses on mRNA-4157 – also known as V940 – which targets up to 34 unique tumour-associated antigens or neoantigens that are expressed by a patient’s cancer cells.
The neoantigens are selected based on gene sequencing of either a tumour biopsy or a blood sample, with an individual vaccine tailored to the patient manufactured and administered in a matter of weeks.
mRNA-4157 is being tested in a 157-subject phase 2 alongside Merck’s PD-1 checkpoint inhibitor Keytruda (pembrolizumab) as an adjuvant treatment after surgery for patients with melanoma who are at high risk of recurrence.
The primary endpoint is recurrence-free survival at 12 months, with first results expected late this quarter, according to Moderna’s president Stephen Hoge.
“We continue to be excited about the future and the impact mRNA can have as a new treatment paradigm in the management of cancer,” he said.
“Continuing our strategic alliance with Merck is an important milestone as we continue to grow our mRNA platform with promising clinical programmes in multiple therapeutic areas.”
Phase 1 results from a dose-ranging trial of the combination reported at the SITC congress in 2020 showed an overall response rate of 50% in checkpoint inhibitor-naïve patients with head and neck cancer, and a disease control rate of around 90%.
Under the original personal cancer vaccine (PCV) agreement in 2016, Merck made a cash payment to Moderna of $200 million to discover and develop individually tailored cancer vaccines for patients across a spectrum of cancers through proof of concept.
Share in Moderna rose around 9% after the news was announced, as investors welcomed the progress in the biotech’s pipeline beyond its COVID-19 vaccine, which is predicted to make around $21 billion in sales this year but is its only commercial product and could see orders fall if the pandemic comes under control.
Fuelled with the windfall cash from its COVID-19 shot, Moderna has been accelerating development of its R&D pipeline, which along with follow-up COVID-19 shots also includes vaccines for flu, respiratory syncytial virus (RSV), cytomegalovirus (CMV), and therapeutics for cancer, rare disease and cardiovascular indications.
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