The coronavirus pandemic keeps shining light into corners of the economy that just aren't used to the attention. Biotechnology is a wonky and underappreciated industry that's currently front and center, especially companies that might have an effective coronavirus vaccine in development.
Shares of one coronavirus vaccine developer, BioNTech (NASDAQ:BNTX) have soared 129% this year, and the buzz surrounding the Germany-based biotech is at an all-time high. Here are some of the reasons.
The BNT162 program
BioNTech's most popular attraction at the moment is an experimental coronavirus vaccine program partnered with Pfizer (NYSE:PFE) called BNT162. This, like all drugs in BioNTech's development pipeline, delivers strands of messenger RNA (mRNA) that coax a patient's own cells into producing therapeutic proteins.
In the case of BNT-162, the strands of messenger RNA delivered lead to the production of proteins that mimic those found on the surface of SARS-CoV-2, the virus that causes COVID-19. This should train immune systems to recognize the actual virus before it infects.
The BNT162 program took an unusual step along the development pathway and began clinical trials with four similar candidates before choosing one to advance into a 30,000-patient pivotal study that started in July.
If the two-dose regimen successfully reduces volunteers' risk of COVID-19 by a 50% threshold set by the Food and Drug Administration, BioNTech and Pfizer will supply the U.S. government with up to 100 million doses for $1.95 billion beginning as early as October. The government also has an option to buy up to 500 million more doses.
BioNTech does more than develop vaccines to address the latest frightening infectious diseases. In July the company published interim results from a phase 1 trial meant to enroll 115 patients with advanced-stage melanoma (a skin cancer) and treat them with BNT111.
This is a cancer vaccine that leads to the production of four different proteins that mimic those commonly associated with melanoma, and it should incite strong immune responses that blast tumors to bits. Results from a subset of 42 patients who had previous experience with a checkpoint inhibitor, like Keytruda, suggest BNT111 works as intended. Nine patients from this group showed a partial tumor response, and one achieved complete remission.
The development of mRNA-based drugs is relatively easy in the earliest stages, which allows BioNtech's early clinical-stage pipeline to punch above its weight. In addition to BNT111, the company has different vaccine candidates in phase 1 trials for the treatment of prostate cancer, HPV (human papillomavirus)-related cancers, breast cancer, and ovarian cancer.
A good stock to buy now?
During almost every cancer study, tumor response rates tend to slide following the first interim analysis. The numbers we've seen from BioNTech warrant further examination, but they aren't terrific.
The company didn't set out to test BNT111 in patients following unsuccessful previous treatment with Keytruda and other PD-1 inhibitors before the trial began. Before placing any value on this company's cancer vaccine programs, investors want to wait for data from all patients treated with BNT111, as originally intended.
Remember that the development of mRNA-based candidates -- or any unproven class of therapy -- rarely leads to any revenue-producing products. In the largest study of drug-development success rates to date, just 9.6% of drugs that entered clinical trials between 2005 and 2015 went on to earn FDA approval. This dismal success rate doesn't separate potential new classes of drugs from new drug candidates similar to ones that have already been proven effective.
At recent prices, BioNTech sports an inflated $17.9 billion market cap. That could grow further if BNT162 becomes the first mRNA-based candidate to earn approval, but it's a long shot, and the stock doesn't have much further to climb from its current valuation.
Since the U.S. government has agreed to accept all of the financial risks, BNT162 skipped the mid-stage testing process and jumped right into a 30,000-patient phase 3 trial. Based on what we know so far, the odds of success are stacked against BNT162 -- and against a positive return from this risky biotech stock.