Image: Moderna’s therapeutics pipeline continues to advance, and the company recently received positive news regarding its personalized cancer vaccine (PCV), ID # mRNA-4157, when combined with Merck’s KEYTRUDA. Image Source: Moderna
By Brian Nelson, CFA
Modern medicine continues to advance. Our favorite idea in biotech remains Vertex Pharma (VRTX), which has a fantastic and commercialized cystic fibrosis portfolio and exposure to CRISPR technology, but the latest data to turn our heads came from Moderna’s (MRNA) personalized cancer vaccine (PCV). Investors perhaps are most familiar with Moderna in part because it has produced one of four authorized COVID-19 vaccines available for use in the US: Pfizer (PFE)-BioNTech’s (BNTX), Novavax’s (NVAX), Johnson & Johnson’s (JNJ) and Moderna’s. The PFE-BNTX and MRNA vaccines are both mRNA (messenger RNA) vaccines, which unlike other vaccines that put a germ into our bodies, train the human body’s cells how to make a protein to create antibodies that prevent us from getting sick.
Messenger RNA technology is also being used in cancer research, too. According to the National Library of Medicine (NLM), mRNA offers great hope for cancer and other incurable diseases. mRNA cancer vaccines for prostate cancer and non-small-cell lung cancer have been evaluated clinically, while mRNA vaccines for renal cell carcinoma, glioblastoma, melanoma, and acute myeloid leukemia showed an active response to therapies. Many experts believe further exploration in mRNA vaccines for cancers could be promising. At last tally, there have been at least ten mRNA vaccines that have been tested for melanoma, and according to the NLM, BioNTech has “developed a personal mRNA vaccine for metastatic melanoma, had no detectable lesions on radiology, and remained recurrence-free after 23 months of i.n. vaccination (source).”
But what actually is a cancer vaccine? Is it something that we take and then we won’t ever get cancer? Well, not exactly. There are two vaccines in existence that can help to prevent cancer, but these vaccines actually protect against the viruses such as the human papillomavirus (HPV) and hepatitis B virus (HBV) that can cause cervical cancer and liver cancer, respectively. They don’t prevent cancer directly, but rather viruses, HPV and HBV. They perhaps can be best described as virus vaccines, not cancer vaccines.
Instead of preventing the onset of cancer, cancer vaccines help the human body better fight off the existing cancer in a patient; these vaccines are called treatment/therapeutic vaccines or immunotherapy. Unfortunately, these cancer vaccines are unlike what we might hope for in a cancer vaccine, as cancer vaccines aren’t given to healthy people to prevent cancer but rather to people already with cancer to help their bodies better seek and destroy cancer cells (antigens). This is still great, but not the miracle we are all hoping for. Personalized cancer vaccines are created for an individual person and target the unique antigens of a particular person’s tumor.
Cancer vaccines are back in the news in a big way December 13 following a Phase 2b trial for an investigational personalized mRNA cancer vaccine from Moderna that, when combined with Merck’s (MRK) KEYTRUDA met its efficacy end point. According to the press release, there were three major headlines:
mRNA-4157/V940, in combination with KEYTRUDA, demonstrated a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death compared to KEYTRUDA monotherapy in stage III/IV melanoma patients with high risk of recurrence following complete resection
Results are the first demonstration of efficacy for an investigational mRNA cancer treatment in a randomized clinical trial
Companies plan to discuss results with regulatory authorities and initiate a Phase 3 study in melanoma in 2023 and rapidly expand to additional tumor types
Moderna and Merck have revealed what could be a big breakthrough with respect to investigational cancer treatment, but we remind investors that the news is a Phase 2b study, and there is still a meaningful probability that the Phase 3 trial for the immunotherapy may be unsuccessful. Still, the Phase 2b results for the PCV-KEYTRUDA combination showed an impressive 44% reduction in the risk of recurrence or death in patients with late-stage melanoma, and the adverse effects from the combined PCV-KEYTRUDA therapy occurred in just 14.4% of patients, which was not terribly different than those receiving KEYTRUDA alone. There are a plethora of players dabbling in mRNA vaccine technology these days, and we remain excited about its future potential to improve patient outcomes, as much as we are about CRISPR gene-editing technology.
Concluding Thoughts
We continue to play the areas of mRNA and CRISPR technology in the simulated newsletter portfolios in a more diversified fashion through the Healthcare Select Sector SPDR (XLV). Whether it will be BioNTech or Moderna or another mRNA player that develops first-line therapy in cancer vaccines is difficult to handicap at this point in the game, and we think staying diversified across the entire healthcare sector to benefit from the sector’s collective advancements makes the most sense to us. As it relates to individual names, we like Vertex Pharma, in particular, given its commercialized cystic fibrosis franchise, exposure to CRISPR technology, and strong financials, as well as J&J for the company’s tried-and-true dividend growth potential. J&J will split into two companies next year.
Tickerized for VRTX, CRSP, MRNA, NVAX, PFE, BNTX, SRNAF, ARCT, CVAC, MRK, REGN, RHHBY, RHHBF, AUTL, GRTS, IBRX, VBIV, AGEN, ANIX, GOVX, DTCFF, SIEGY, XLV, IBB, BMY, GILD
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Brian Nelson owns shares in SPY, SCHG, QQQ, DIA, VOT, BITO, and IWM. Valuentum owns SPY, SCHG, QQQ, VOO, and DIA. Brian Nelson’s household owns shares in HON, DIS, HAS, NKE, RSP. Some of the other securities written about in this article may be included in Valuentum’s simulated newsletter portfolios. Contact Valuentum for more information about its editorial policies.
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