It has been a volatile year for BioNTech (BNTX -2.39%), an mRNA-based vaccine specialist. The company's financial results have been unimpressive as its coronavirus business continues to struggle, but a major clinical trial win from Moderna (MRNA -0.25%), which also develops mRNA-based vaccines, helped jolt BioNTech's stock. The company's own clinical progress has been mixed, though. Let's look at one recent success -- and one failure -- the company has experienced to try to determine where the stock might be headed next.
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A setback in colorectal cancer
Let's start with BioNTech's recent announcement of Phase 2 clinical trial results for autogene cevumeran, an mRNA-based personalized cancer vaccine for certain patients with colorectal cancer. The biotech said it was ending the trial following the recommendation of an independent committee of external experts who reviewed the data and concluded that continued treatment was unlikely to change the efficacy outcome and identified a numerical imbalance in overall survival between the treatment groups.
All hope isn't lost for autogene cevumeran. It is still undergoing Phase 2 studies as an adjuvant treatment for patients with pancreatic ductal adenocarcinoma. Still, the recent setback in colorectal cancer sent BioNTech's stock down about 10%, and with good reason: There would have been a large addressable market for this indication if autogene cevumeran had received approval.
NASDAQ: BNTX
Key Data Points
BioNTech's lung cancer trial win
BioNTech followed up that setback with a success in a Phase 3 clinical trial for Gotistobart in certain patients with non-small-cell lung cancer (NSCLC). Or more precisely, the biotech company released data from stage 1 of this Phase 3 study. BioNTech noted that in stage 1, Gotistobart led to a median overall survival of 18.5 months versus 10 months for patients receiving the standard chemotherapy docetaxel. Those are strong results for one of the most important endpoints in oncology clinical trials. There's one major caveat, though: BioNTech itself calls this "the non-pivotal stage 1" portion of its Phase 3 study.
It enrolled only 87 patients: 45 who received Gotistobart and 42 who were administered chemotherapy. The pivotal stage 2 is ongoing, and results from that portion will be important for Gotistobart's prospects for regulatory approval in this indication. So, while the data we have gotten so far is highly encouraging, it's too early to celebrate yet -- in fact, the market's reaction was fairly muted. We did not see a 10% jump in BioNTech's stock. So, the magnitude of this win is arguably small and doesn't offset the Phase 2 clinical trial failure of autogene cevumeran in colorectal cancer.
What's next for BioNTech?
Thanks to Moderna's major Phase 3 clinical trial for a personalized cancer vaccine in patients with melanoma -- the first late-stage win for an individualized mRNA-based cancer vaccine -- this market seems to have a bright future. BioNTech has several mRNA-based candidates that could help it establish itself as a leader in this space and significantly improve its financial results. So, progress in upcoming mid- and late-stage clinical trials will be extremely important to the company's long-term prospects. Beyond Gotistobart and autogene cevumeran, one of BioNTech's most exciting candidates is BNT113, an mRNA cancer immunotherapy being developed for HPV16-positive head and neck cancer.
BNT113 is currently being evaluated in a Phase 2/3 study and has received the Fast Track designation from the U.S. Food and Drug Administration, which is designed to accelerate the development of investigational therapies for serious diseases. None of this guarantees that BNT113 will succeed in its ongoing pivotal clinical trial, but these are certainly encouraging signs, and that's just one of the several promising candidates in BioNTech's pipeline. There is the possibility that the biotech will encounter a series of clinical setbacks, but given the depth of its pipeline and the fact that mRNA-based products seem to have a bright future, the stock looks attractive.
