The coronavirus pandemic continues to shine in corners of the economy that are not usually used to. Biotechnology is an agile and undervalued industry that is currently at the forefront and most importantly, especially companies that could have an effective coronavirus vaccine.
Actions of a coronavirus vaccine developer, BioNTech (NASDAQ: BNTX) they have risen 129% this year, and the bustle surrounding German-based biotechnology is at an all-time high. These are some of the reasons.
The BNT162 program
BioNTech’s most popular attraction today is an experimental coronavirus vaccine program associated with it. Pfizer (NYSE: PFE) called BNT162. This, like all drugs in BioNTech’s development pipeline, provides messenger RNA (mRNA) strands that fit into the patient’s own cells to produce therapeutic proteins.
In the case of BNT-162, the delivered messenger RNA strands 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 the immune systems to recognize the actual virus before it becomes infected.
The BNT162 program took an unusual step on the development path and began clinical trials with four similar candidates before choosing one to advance a pivotal study of 30,000 patients that began in July.
If the two-dose regimen successfully reduces the risk of COVID-19 from volunteers 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 dollars as of October. . The government also has the option to buy up to 500 million more doses.
BioNTech does much more than develop vaccines to treat the latest fearsome infectious diseases. In July, the company published provisional results of a phase 1 trial aimed at enrolling 115 patients with advanced stage melanoma (a skin cancer) and treating them with BNT111.
It is a cancer vaccine that leads to the production of four different proteins that mimic those commonly associated with melanoma and that should trigger strong immune responses that burst tumors into pieces. The results of a subset of 42 patients who had previous experience with a checkpoint inhibitor, such as Keytruda, suggest that BNT111 works as intended. Nine patients in this group showed a partial tumor response and one achieved complete remission.
The development of mRNA-based drugs is relatively easy in the early stages, allowing the initial channeling of the BioNtech clinical stage to rise above its weight. In addition to BNT111, the company has different vaccine candidates in phase 1 trials for the treatment of prostate cancer, HPV-related cancer (human papillomavirus), breast and ovarian cancer.
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During almost all cancer studies, tumor response rates usually slip after the first interim analysis. The numbers we’ve seen from BioNTech justify a deeper look, but they’re not excellent.
The company did not intend to test BNT111 in patients after unsuccessful prior treatment with Keytruda and other PD-1 inhibitors before beginning the trial. Before establishing any value in this company’s cancer vaccine programs, investors want to wait for the data all patients treated with BNT111, as initially planned.
Remember that the development of mRNA-based candidates (or any kind of uncredited therapy) rarely produces income-producing products. In the largest study of drug development success rates to date, only 9.6% of drugs that went into clinical trials between 2005 and 2015 went on to gain FDA approval. This timid success rate does not separate possible new drug classes from new drug applications similar to those that have already been shown to be effective.
At recent prices, BioNTech is exporting an inflated market cap to $ 17.9 billion. This could increase if BNT162 becomes the first mRNA-based candidate to get approval, but it’s a long turnaround, and stocks don’t have much further back from their current valuation.
Since the U.S. government agreed to accept all financial risks, BNT162 skipped the mid-phase testing process and jumped right into a trial of 30,000 patients in phase 3. Based on what we know so far , the odds of success come together in relation to BNT162 and against a positive return of this risky biotech stock.