Advaxis, Inc. (NASDAQ: ADXS) is rocketing in the market this morning, trading on gains of more than 14% thus far today. Investors are excited after the comapny announced updated prolonged survival data for ADXS-PSA in combination with KEYTRUDA. Here’s what’s going on:
ADXS Stock Pops On Updated Data
In a press release issued early this morning, issued early this morning, Advaxis announced updated survival data from its Phase 1/2 KEYNOTE-046 clinical trial. In the trial, the company is using the combination of ADXS-PSA and KEYTRUDA as a potential option to treat patients with metastatic, castration-resistant prostate cancer.
In the release, ADXS said that median overall survival across 37 patients in the combination arm has climbed to 33.6 months. At the AACR Annual Meeting in April, the company announced median overall survival in the trial of 21.1 months.
in a statement, Kenneth A. Berlin, President and CEO at ADXS, had the following to offer:
We are excited to report these updated data which show a meaningful increase in median overall survival for patients in the combination arm of the KEYNOTE-046 study. We believe that ADXS-PSA in combination with KEYTRUDA® has the potential to be an important new treatment option for patients with advanced metastatic, castration-resistant prostate cancer, which based on these data, warrants further evaluation. We are currently assessing next steps for a potential new study for ADXS-PSA in combination with KEYTRUDA® in mCRPC and we look forward to providing additional details about the program’s path forward.
Investors Are Excited For Multiple VERY Good Reasons
At the end of the day, the data released by Advaxis today proved to be overwhelmingly positive, and investors know that the implications of this data could be massive. Here are a few reasons that I believe the data is so important:
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Reason #1: 33.6 Month MOS Is Unheard Of
In a recent study 170 patients with metastatic, castration resistant prostate cancer were followed through treatment. The study found that the median overall survival rate across these 170 patients was 13 months.
The median overall survival rate of 33.6 months suggests that at present, the combination of ADXS-PSA and KEYTRUDA can extend life expectancy after diagnosis by more than 258%!
The truth of the matter is that this type of cancer is very aggressive and very difficult to treat. The data today suggests that ADXS may have found the key to effective treatment options for patients with this grim prognosis and the physicians that treat them.
Importantly, the follow up peariod is not over. This means that with every day that passes, the median overall survival rate across the 37 patients included in this study could continue to rise.
All in all, this data is great for patients, and as such, it’s great for investors.
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Reason #2: The Market Opportunity Here Is Incredible
With such strong data to date, I’d be comfortable suggesting that there is a strong chance that ADXS-PSA in combination with KEYTRUDA will find its way to the market over the next few years, or possibly sooner.
Should this be the case, the market opportunity here is incredible. At the moment, it is estimated that by the year 2025, the catration resistant prostate cancer market will grow to be worth $5.86 billion annually.
While it would be foolish to suggest that a single product would take all of, or even the lion’s share of a market of this size in the future, ADXS doesn’t need the lion’s share. The company trades with a market cap of well under $10 million.
Think about it. if ADXS were to tap into just 1% of this vast market, it would be tapping into an opportunity worth north of $50 million annually. Moreover, considering the strong data, suggesting that the combination therapy leads to such a strong survival rate, 1% of the market is being incredibly modest!
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Reason #3: Approval Could Happen Very Fast
ADXS-PSA is a drug that has achieved Orphan Drug designation. This means that Advaxis benefits from improved communication with the FDA, and several other perks associated with Orphan drugs.
importantly, one of the benefits is the potential for a fast track to approval. in some cases, when data is overwhelmingly positive, and the indication has few effective options, the FDA will speed up the process from development to approval.
In some cases, this means that drugs are approved after an overwhelmingly positive Phase 1 or Phase 2 trial. In the case of ADXS-PSA, I believe that this could be a real possibility.
Remember, at present the median overall survival for patients with castration resistant prostate cancer sits at around 13 months. In this trial the combination treatment led to a median overall survival rate of 33.6 months, and the follow up isn’t even over yet. So, there’s a strong chance that this MOS will grow.
Considering that the indication is a very grim one, and that the treatment is proving to be a very effective one, approval could happen far faster than you might think!
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