Personalized cancer vaccine results are a 'home run': Moderna CEO

Preliminary results from a personalized cancer vaccine jointly studied by Moderna (MRNA) and Merck (MRK) marks the first significant breakthrough for cancer vaccines.

Moderna CEO Stéphane Bancel went so far as to call it "immunotherapy 2.0," in an interview with Yahoo Finance Tuesday.

The results showed that a vaccine created based on a person's tumor cells can teach T-cells how to fight the melanoma with a 44% reduction in risk of recurrence of cancer and death.

Data has not yet been published, and the results have a number of caveats. Most notably is that the vaccine is given post-surgery (after the removal of tumors) and in combination with Merck's blockbuster drug Keytruda. The 44% represents the improvement in efficacy when compared to Keytruda alone. In addition, the vaccine is given in nine doses every 21 days, in combination with one dose of Keytruda every 21 days up to 18 times.

The duo have partnered since 2016 with a focus on cancer, where Merck is a dominant player for therapies, but the Phase 2 results are the first promising for a any cancer vaccine.

Bancel said he came into the attempt "humbly" and said the company needed to "do better or should we go home," when compared to Keytruda's success.

Keytruda "is an amazing drug, but it doesn't work for everybody," Bancel said.

Bancel said he hopes the vaccine will also prove efficacious for those patients for whom Keytruda alone did not work.

Market and manufacturing

Merck invested $250 million into the endeavor, and Moderna boasts $17 billion of cash on hand from the success of its Covid-19 vaccine Spikevax.

"We're not going to be shy on deploying that cash to create impact for patients and value for shareholders," Bancel said.

Keytruda is a leader in cancer therapy, with 54% of the melanoma market share, bringing in about $17.2 billion in revenue per year — that's the equivalent of Moderna's cash on hand by comparison.

Keytruda is used for more than melanoma, however, including for cancers that affect breasts, skin, colon, uterus, cervix, stomach, kidney, gut, liver, bladder, as well as Hodgkins lymphoma and B-cell lymphoma.

The ongoing clinical trial has proven that Moderna's vaccine works well side-by-side with Keytruda, with about the same safety profile.

That opens the door to testing all the other indications of Keytruda, which Bancel said will be happening quickly. The hope is to have multiple trials simultaneously that will test these indications, so that more patients can be eligible for the vaccine more quickly.

Bancel noted that the buildout of manufacturing from the COVID vaccine will come into play in the potential ramp up, but there is a key difference.

It has to be set up to produce personalized, targeted products per patient, rather than "to make a very big cut of mRNA like we did for the COVID-19 vaccine," he said.

That is where the endeavor could become a more costly one. Keytruda already costs hundreds of thousands of dollars per year per patient. When asked how the vaccine would be priced, Bancel balked.

"We will work on pricing with Merck as we get closer to launch, but now the focus is getting the drug to patients," he said.

Next steps

How soon Moderna and Merck will enter the market with the product remains to be seen. The companies hope to start a Phase 3 trial soon, as well as begin other indications in 2023. Bancel said the companies are already looking on how to prioritize the other indications.

This could finally give Moderna the break it needs to move out of the category of having a single revenue stream, which Bancel has been aiming for as he often highlights the dozens of other vaccine candidates in Moderna's R&D pipeline.

When asked about potential for side effects, such as the myocarditis concerns that arose from the COVID vaccine, Bancel said that the safety profile was strong and the makeup of the cancer vaccine was exactly the same as the COVID vaccine.

He noted that the results Tuesday were beyond his wildest expectations.

"In my books, total kind of home run," Bancel said.

Follow Anjalee on Twitter @AnjKhem

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