Voices of doubt arise, Moderna CEO reassures the market: Personalized cancer vaccines will cover more types of cancer

Moderna's CEO has expressed strong confidence in the prospects of its personalized mRNA cancer vaccine, claiming that this technology will play a role in various tumor types, but analysts’ doubts about its commercial value persist.

On Monday, October 26, Moderna CEO Stephane Bancel said in a Bloomberg TV interview that the company’s personalized mRNA cancer vaccine “intismeran autogene,” developed jointly with Merck, "will be effective in cancer types beyond melanoma."

In the interview, Bancel clearly conveyed his confidence in the “personalized mRNA tumor vaccine technology platform,” citing Merck’s star oncology drug Keytruda as a reference. He stated:

As long as the tumor type is one in which Keytruda is effective, in theory, the platform can work as well.

Keytruda is a blockbuster cancer immunotherapy drug under Merck, currently approved for the treatment of multiple cancers.

Meanwhile, Bancel revealed that data from a large kidney cancer trial may be released as early as the end of this year or early next year, and he clearly expressed an optimistic outlook for the kidney cancer trial results.

This is the first time Bancel has publicly confirmed the "pan-tumor" prospects of the platform as the company’s highest decision-maker. Previously, in market valuation models, the contribution of cancer vaccines was mainly anchored to the melanoma indication. However, whether the "pan-tumor" narrative can translate into valuation recovery is a point of clear market divergence.

Previously, Jefferies analysts warned that it remains uncertain whether the positive signal in melanoma can be replicated in other indications. Citi analysts maintained a “sell” rating on Moderna, believing that there are significant limitations to the vaccine’s commercial application.

Just last week, the company disclosed detailed phase III trial data for melanoma at the ESMO (European Society for Medical Oncology) annual meeting in Madrid, which left some investors disappointed and led to sharp fluctuations in Moderna’s share price.

intismeran autogene is a vaccine customized for each patient, utilizing genetic information extracted from the tumor to build a personalized anti-tumor immune response. Current research is ongoing in multiple cancers such as kidney cancer, lung cancer, and bladder cancer.

Regarding scaling up production, Bancel responded to external concerns, stating that the development and production of the COVID-19 vaccine "was a far greater challenge than that of personalized cancer vaccines," and noted that the company accumulated a wealth of engineering experience from COVID-19 vaccine production.

He also revealed that during the phase III trial, the vaccine’s production cycle was about nine weeks, and with ongoing process optimization, this period is expected to be further reduced. Analysts expect intismeran to obtain regulatory approval next year.

In August this year, Moderna and Merck disclosed that the vaccine reduced recurrence rates in the pivotal phase III melanoma trial, drawing widespread market attention. Since then, the stock price soared and at one point increased nearly 780% year-to-date.

However, the recently officially released detailed data disappointed some investors who felt the data did not fully meet previous high expectations. Moderna’s stock price plunged, reflecting intense market attention and the coexistence of great uncertainty regarding this technology.

According to Bloomberg, oncologists generally acknowledged the melanoma data, but controversy among investors regarding whether the technology can be widely extended to other cancer types continues.

Another unresolved issue is the comparative value of intismeran versus existing neoadjuvant immunotherapy.

Neoadjuvant immunotherapy refers to the use of drugs such as Keytruda, or Bristol Myers Squibb’s Yervoy or Opdivo, before surgical removal of the tumor. Multiple neoadjuvant studies show these therapies can significantly extend the time some patients survive without cancer recurrence or death.

If the efficacy is similar, the highly personalized production process and potentially high costs of intismeran will face reasonable scrutiny.

However, oncologists pointed out that not all melanoma patients are suitable for neoadjuvant immunotherapy, and analysts believe there are essential differences in the design of the two kinds of trials, so direct comparisons are unfair. Seigerman said:

In the absence of head-to-head data, it’s expected that currently, the choice between the two approaches will be made by physicians on a case-by-case basis.

Although the management maintains a positive stance, external analysts remain sharply divided on the vaccine’s commercial potential.

Jefferies analyst Akash Tewari estimated in a client note on October 22 that peak sales of intismeran autogene could reach $4.6 billion, but also warned there is “no conclusion" on whether the positive melanoma signal can be replicated in other indications.

In a subsequent updated report, he pointed out that data suggested the benefit from the vaccine may increase over time.

Citi analyst Geoff Meacham took a more cautious view. In a “sell” rating report, Meacham noted that at the ESMO conference, management and key opinion leaders focused on the vaccine’s new antigen-specific immune response, its efficacy in different melanoma risk groups, and confidence that recurrence-free and distant metastasis-free survival metrics would ultimately translate to overall survival benefit.

However, Meacham noted there was little emphasis at the conference on manufacturing, patient eligibility, sequencing of lines of therapy, and the importance of mature overall survival data.

He further pointed out that only a small number of melanoma patients met the inclusion criteria for "large-volume resectable lesions," which means that the actual clinical application of intismeran "may be more limited than some investors expect."

Additionally, Meacham indicated that while a monotherapy route for intismeran is attractive in theory, since Keytruda’s efficacy and safety are already established, "this path remains highly theoretical in practice."

He concluded that this investor call “reinforced management’s confidence in the platform, but did not materially change our view of its commercial limitations and valuation discrepancy.”