The coronavirus pandemic continues to shine light in corners of the unnoticed economy. Biotechnology is an underrated and currently centralized industry, especially companies that may have an effective coronavirus vaccine in development.
Share of a developer coronavirus vaccine, BioNTech (NASDAQ: BNTX) That’s up 129% this year and the buzz around Germany-based biotechnology is at an all-time high. Here are a few reasons.
BioNTech’s most popular attraction at the moment was the experimental coronavirus vaccine program in partnership with Pfizer (NYSE: PFE) called BNT162. This, like all drugs in BioNTech’s development, provides messenger RNA (mRNAs) strands that attract the patient’s own cells to produce therapeutic proteins.
In the case of BNT-162, messenger RNA strands are delivered resulting in the production of proteins that mimic those found on the surface of SARS-CoV-2, the virus that causes COVID-19. This will train the immune system to recognize the real virus before it infects.
The BNT162 program took an unusual step in development and started clinical trials with four similar candidates before selecting one to enter the key 30,000-patient study that began in July.
If the two-dose regimen successfully reduces a volunteer’s risk of COVID-19 to the 50% threshold set by the Food and Drug Administration, BioNTech and Pfizer will provide the US government up to 100 million doses with price 1.95 billion USD since the beginning of October. The government also has an option to purchase up to 500 million additional doses.
BioNTech isn’t just developing vaccines to tackle the latest fearsome infectious diseases. In July, the company released interim results from a phase 1 trial that recruited 115 patients with end-stage melanoma (a type of skin cancer) and treated them with BNT111.
This is a cancer vaccine that leads to the production of four different proteins that mimic those commonly associated with malignancies, and it triggers powerful immune responses that explode tumors into pieces. . Results from a small group of 42 patients who had ever used a control point inhibitor, such as Keytruda, showed that BNT111 was working as intended. Nine patients from this group showed partial tumor response, and one patient had complete remission.
The development of mRNA-based drugs was relatively easy in the early stages, which allowed BioNtech’s early clinical stage pipeline to surpass its weight. In addition to BNT111, the company has different vaccine candidates in phase 1 trials for prostate cancer, HPV-related cancer (human papillomavirus), breast cancer, and Ovarian Cancer.
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In most cancer studies, tumor response rates tend to decrease after the first interim analysis. The numbers we’ve seen from BioNTech guarantee further examination, but they’re not terrifying.
The company did not initiate testing of BNT111 in patients after previously unsuccessful treatment with Keytruda and other PD-1 inhibitors before starting the trial. Before placing any value on the company’s cancer vaccine programs, investors want to wait for data from all The patient was treated with BNT111, as originally intended.
Remember that the growth of mRNA-based candidates – or any kind of unproven therapies – rarely leads to any revenue-generating product. In the largest study of drug development success rates to date, only 9.6% of drugs that took part in a clinical trial between 2005 and 2015 were approved by the FDA. This incredible success rate does not separate potential new classes of drugs from new drug candidates similar to drugs that have been shown to be effective.
At recent prices, BioNTech has an increased market cap of $ 17.9 billion. That could develop even further if BNT162 becomes the first mRNA-based candidate to get approval, but it’s a long step and the stock doesn’t have much to go up from its current valuation.
Since the US government has agreed to accept all financial risks, BNT162 skipped the mid-stage trial process and immediately moved on to the phase 3 trial of 30,000 patients. Based on what we know so far, the success rates are stacked against BNT162 – and against the positive returns from this risky biotech stock.