Personalized cancer vaccine crosses phase III life and death line! Moderna (MRNA.US) stock price surged 177% in a single day, and the mRNA chain ushered in a “second value awakening”
The Zhitong Finance App learned that the market value of Moderna (MRNA.US), a leader in the mRNA vaccine field, doubled its stock price with a record rise in the stock price on Wednesday. As of Wednesday, the US stock price had surged 177%, and driven the stock prices of rivals in the biomedical and healthcare sector to rise sharply; the company and US pharmaceutical giant MRK.US (MRK.US) jointly promoted a cancer vaccine based on messenger ribonucleic acid technology (that is, mRNA), which was mainly successful in late-stage (that is, phase 3) clinical trials for melanoma patients.
As a consensus on the strong growth of biomedical leaders focusing on late-stage clinical phase III trials, William Blair, a well-known Wall Street investment giant, raised the vaccine manufacturer's rating from “consistent with market performance” to “outperforming the market.” Moderna CEO Stefan Bansel said in an interview with the media that this personalized vaccine called “intismeran autogene” may be approved as early as 2027 on the premise that it passes regulatory review.
Wall Street has experienced extreme differentiation since the news was announced: the highest new price target that can be verified now comes from Bank of America. Alec Stranahan raised Moderna from “underperforming the market” to “neutral” and surged the target price from $40 to $170. He believes that IntiSmeran is a “watershed moment” that transformed Moderna from an infectious disease vaccine company to an oncology platform company, which not only released the option value of nine cancer trials, but may also ease the pressure on long-term R&D investment and capital consumption; Piper Sandler maintained the “increase” “Hold” raised the target price from $77 to $167 and Goldman Sachs to $120.
If calculated in favor of the previous closing price of $62.96, $170 meant a potential increase of about 170.0%; however, Moderna then surged 176.97% to $174.38 in a single day, which has already surpassed this highest target price, but instead corresponds to a potential decline of about 2.5%. To a certain extent, this shows that scientific breakthroughs have completely restructured the company's value, but it also means that the stock price has taken into account a significant degree of melanoma commercialization and cross-cancer success expectations within a day; the real valuation anchor in the next phase will shift from “success or not” to phase III risk ratio, patients' absolute survival benefits, the probability of approval in 2027, and the ability to replicate other solid tumors.
Why is Moderna's first Phase III victory called the “Light of Human Cancer Treatment”?
The core of this breakthrough between Moderna and MSD is not the success of an ordinary vaccine, but the clinical efficacy of individualized novel antigen therapy (INT) was verified for the first time in a randomized, double-blind, global phase III trial: Interpath-001 included 1,137 patients with stage IIB-IV melanoma whose tumors had been completely removed but still had a high risk of recurrence. Compared with Keytruda monotherapy, intismeran Autogen combined with Keytruda single drug, also achieved major endpoints without recurrence (RFS) and no distant metastasis Lifetime (DMFS) is a critical secondary end point, and no new safety signals have emerged.
This is also the world's first individualized novel antigen therapy with positive phase III results. It is also the first mRNA cancer treatment to successfully enter phase III verification, and the first time that it has significantly surpassed Keytruda as a standard treatment in adjuvant treatment after melanoma surgery. Accurate differentiation is needed: The previous 5-year follow-up of phase IIb showed a 49% reduction in the risk of recurrence or death and a 59% reduction in the risk of distant metastasis or death; the specific risk ratio, absolute benefit, and overall survival (OS) data for phase III have not been published.
The underlying technology is not a preventative “universal cancer vaccine” for everyone, but rather a treatment platform for “tumor sequencing - new antigen prediction - individualized mRNA design - precise immune activation”: researchers read the patient's unique tumor mutation fingerprint, screen up to 34 new antigens and encode them into synthetic mRNA. After injection, human cells express these antigens to train cytotoxic T cells to recognize cancer cells; Keytruda removes the inhibition of T cells by PD-1 immune checkpoints, respectively addressing the two major bottlenecks of “accurately identifying tumors” and “continuing to launch attacks.”
Moderna and MSD's breakthrough cancer treatment has reached a major end. It can be described as a major blessing for high-risk melanoma patients, and may also open up a new path for solid tumors such as lung cancer, bladder cancer, kidney cancer, and pancreatic cancer. However, at this stage, it cannot be finally interpreted as “overcoming cancer” in humans; it is still necessary to wait for complete phase III data, overall survival benefits, regulatory review, and verification of the production cycle, cost, and large-scale delivery capacity of customized vaccines.
From COVID-19 vaccines to tumor immunity: Moderna rewrites mRNA valuation curve with first phase III victory
The stock price of Moderna's German-based ribonucleic acid ribonucleic acid competitor BioNTech (BNTX.US) also rose after the latest test results, which relied on the sharp rise in mRNA vaccine stock prices during the COVID-19 pandemic, were announced, and the US vaccine manufacturer NVAX.US (NVAX.US) also rose. Meanwhile, the biotech sector, represented by the State Street SPDR S&P Biotech Exchange-Traded Fund (ETF called XBI, XBI.US), rose by more than 4% as a whole; if the increase continues, it will be the ETF fund's best performing continuous daily intraday rise since March and the strongest monthly stock price increase.
The rise stemmed from the success of a late-stage clinical trial. The trial assessed the efficacy of intismeran in combination with Keytruda, the major drug of MSD (MRK); compared with Keytruda monotherapy, combination therapy achieved the primary end point of survival without recurrence and the secondary end point of survival without distant metastases.
MSD (MRK.US) and Moderna (MRNA.US) said that the phase III clinical trial, called Interpath-001, enrolled more than 1,100 high-risk melanoma patients whose tumors had been completely removed, and indicated that this was the first late-stage clinical trial with better efficacy than Keytruda in a melanoma-like treatment scenario.
Miles Minter, a senior analyst from William Blair, wrote when upgrading Moderna's stock rating: “The InterPath-001 study achieved positive results in adjuvant treatment of melanoma, and also brought positive verification significance to Intismeran's ongoing tests on other types of cancer.”
The analyst pointed out that a total of eight phase II and phase III clinical trials are currently evaluating the therapeutic effects of IntiSmeran on various cancers, including a phase III trial for non-small cell lung cancer, and two phase II trials for renal cell cancer and bladder cancer, which have already enrolled all patients.
Minter said that the results of the Phase II study on adjuvant treatment for renal cell carcinoma, which is expected to be announced before the end of this year, may be the next catalyst; this study may have the potential to support registration. At the same time, he pointed out that the two companies are advancing research related to Intismeran based on an agreement where each accounts for 50% of the profit.
This technology transforms the cancer treatment part into a “programmable bioinformation pipeline”: the patient's tumor is sequenced, the new antigen most likely to be recognized by the immune system is screened using bioinformatics and machine learning, and then up to 34 new antigens are encoded into the exclusive mRNA; mRNA is responsible for training T cells to recognize the tumor's mutation fingerprints, and Keytruda removes the brakes on PD-1 immune checkpoints, so that T cells can continue to kill remaining cancer cells.
As a result, the view of optimists such as Musk that “artificial RNA will turn disease treatment into a software problem” clings to the programmability of the platform, yet underestimates complex biological constraints such as antigen presentation, HLA differences, tumor microenvironment, and immune escape. What really determines the value of its platform is whether it can replicate from highly immunogenic melanoma to non-small cell lung cancer, kidney cancer, and bladder cancer: Goldman Sachs adjusted the probability of success for melanoma to 100% and non-small cell lung cancer to 85%, and estimated that the two indications could reach 4.3 billion and 6.6 billion US dollars, respectively, but these are total sales forecasts without deducting the 50/50 share with MSD.