Moderna chugs along, moving a second program into phase 2

Moderna manufacturing site
Moderna's programs include a clutch of vaccines, including immunizations for flu, Zika and chikungunya virus, personalized cancer vaccines and treatments for genetic disorders, such as Fabry disease and phenylketonuria. (Moderna)

When Moderna finally went public at the end of last year, it widened eyes for more reasons than one. Its $604 million Wall Street debut set the record for biotech’s biggest IPO, but it was all the more impressive as its mRNA platform had yet to generate a late-stage program, let alone a marketed product. 

But, as the company said on its second-quarter earnings call, it is trucking along with its 21 pipeline programs, moving another four into phase 1 and starting a phase 2 study of its Merck-partnered personalized cancer vaccine for patients with melanoma. The cancer vaccine, dubbed mRNA-4157, joins an AstraZeneca-partnered VEGF-A drug for myocardial ischemia in phase 2. 

The phase 2 study will pit a combination of mRNA-4157 and Merck’s PD-1 drug Keytruda against Keytruda alone in patients at high risk of melanoma recurring after their tumor has been surgically removed. It will enroll 150 patients. 

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Moderna presented early data from that phase 1 study in its ASCO debut in May. The Keytruda combo shrank tumors in six out of 20 patients who had received at least one dose of the treatment. Of those six patients, two had been previously treated with a checkpoint inhibitor. As for the 13 patients who were treated with Moderna’s vaccine alone, 11 of them were disease-free for up to 75 weeks on the study. The phase 1 program has added another group of patients to study: 17 patients whose cancer was resistant or had become resistant to PD-1 inhibitors. 

As for its earlier-stage programs, it finished enrolling a phase 1 study for its cytomegalovirus vaccine and started new phase 1 trials for its Zika and respiratory syncicial virus (RSV) vaccines, as well as a personalized KRAS cancer vaccine that falls under its Merck collaboration and an AstraZeneca-partnered injected interleukin-12 (IL-12) treatment that is injected directly into tumors. 

Moderna is studying the KRAS vaccine, known as mRNA-5671, both on its own and in combination with Keytruda. The phase 1 study will involve patients with advanced or metastatic KRAS-mutated non-small cell lung cancer (NSCLC), colorectal cancer or pancreatic cancer.  

RELATED: Neon Therapeutics' neoantigen vaccine boosts Opdivo response in 3 cancers

“We are pleased by the advancement of our programs and look forward to sharing new clinical data in the near term,” said Moderna CEO Stéphane Bancel. “Additionally, we are excited that Vertex extended our research collaboration based on the teams’ progress to date. Our balance sheet remains strong, and we continue to deploy our capital toward the advancement and expansion of our development pipeline and the creation of potential new modalities.” 

Both of Moderna’s personalized cancer vaccines are based on neoantigens found in individual patients’ tumors. The company then builds custom strands of mRNA containing instructions for the body to make those neoantigens and stimulate the immune system to attack them. The vaccine that Moderna is testing in melanoma, mRNA-4157, codes for 20 different neoantigens, but Moderna CMO Tal Zaks said that the company is working on a version that can select up to 34 neoantigens. 

Moderna isn’t alone in the neoantigen space, with Neon Therapeutics using synthetic peptides that mimic neoantigens in its personalized cancer vaccines. Last month, Neon unveiled topline data showing its vaccine, NT-001 coupled with Bristol-Myers Squibb’s Opdivo staved off cancer longer than Opdivo alone in patients with lung cancer, bladder cancer and melanoma.

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