January 9th, 2023 | 17:35 CET
BioNTech, Defence Therapeutics, Bayer - Is a Corona tsunami imminent?
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"[...] At the end of 2022 or the beginning of 2023, we plan to start a Phase I study around each of our activities against breast cancer and skin cancer. [...]" Dr. Moutih Rafei, Director and VP of research and development, Defence Therapeutics
BioNTech - Cancer therapies in planning in Great Britain
Leading vaccine manufacturer BioNTech would undoubtedly benefit from a new Corona wave. With new mutants, it is likely easier to produce a new adapted vaccine based on past experience. Although many investors were skeptical that profits would remain this high, the Company has raised its revenue forecast to the high end. It expects between USD 16.9 billion and USD 17.9 billion in sales. The adapted Omicron vaccines have been well received by the market. Work is also underway to improve BNT162b5, where a Phase 2 trial is currently underway in the US.
In addition to infectious diseases, the Company is conducting research in oncology, combining two of its platforms. One is BNT211, a chimeric antigen receptor T-cell therapy, and the other is its CARVac technology. This is intended to overcome the current limitations of T therapies for solid tumors. Recently, a Memorandum of Understanding was signed with the UK government, under which 10,000 patients are expected to receive personalized cancer therapies based on mRNA technology by the end of 2030. The first subjects are expected to be enrolled in the study starting in the second half of the year.
Ugur Sahin expressed his delight: "We have seen that drug development can be accelerated - without taking shortcuts - if everyone works seamlessly together towards the same goal. The agreement reached today shows that we are ready to do the same for cancer patients." The product pipeline is full, and the Company has EUR 15 billion in cash, allowing it to move full steam ahead with research and development. The share is currently trading at EUR 142.10.
Defence Therapeutics - Clinical trials in the pipeline
Defence Therapeutics is a Canadian biotech company focused on developing innovative solutions to treat cancer and infectious diseases. It uses its Accum drug and vaccine delivery platform to improve the efficacy and safety of biologics and biosimilar drugs. On December 15, the Company announced that it is working on the interplay of Accum technology with mRNA vaccines to deliver the drugs to the cytoplasm, where they are significantly more potent and can be converted into functional proteins. CEO Sebastien Plouffe expects the Accum mRNA vaccine against cancer to be ready by the end of January, after which it can be tested in an in vivo study in animals with existing tumors. If the trial is successful, Accum's technology can be offered to all pharmaceutical companies with mRNA vaccines.
One step further is the cervical cancer vaccine, AccuVAC-PT007, which has successfully completed the GLP study showing that it can be used not only prophylactically but also to cure existing cancer. The Phase 1 clinical trial can begin. The same applies to AccuTOX, a compound that can be used against a broad spectrum of tumors. Tests in mice have focused on breast cancer and melanoma. A meeting with the FDA is planned to obtain approval to start a phase 1 trial. The compound has also shown synergy with multiple immune checkpoints, making it a highly adaptable molecule that can be used against a range of solid cancer indications.
This is demonstrated by the recent news after an intranasally administered AccuTOX formulation reduced cancer nodules by 50% in animals with lung tumors. This came from a preclinical study in which animals received 6 doses over 2 weeks of a combination of AccuTOX and the PD-1 antibody. With its versatile technology, attractive capital structure and experienced team, the Company is well-positioned for upcoming growth. Since the beginning of October, the stock is up over 90% and has left its downtrend. Currently, one share costs CAD 2.82. More news is expected in the coming weeks, which could provide additional momentum.
Bayer - Pharma business unit without problems
Since the acquisition of the American agrochemical company Monsanto in 2018, the group has been struggling. The acquisition was controversial, as Monsanto was heavily criticized for using pesticides such as glyphosate in agriculture. In subsequent years, Bayer has faced several lawsuits for damages in the US for alleged damage to health from the use of glyphosate. In addition, there is the issue of PCBs, which are also suspected of being harmful to health. In addition to the legal disputes, the Company is also burdened by high raw material and energy costs.
The situation in the pharmaceuticals sector is much better. In November, the EMA recommended approval for the drug Eylea from Regeneron Pharmaceuticals and Bayer. The drug is used to treat premature infants with retinopathy of prematurity. The drug already has approval for certain eye diseases. In December, the EMA proposed an expanded marketing authorization for Kerendia (Finerenon). It is expected that the EU Commission will follow the recommendations. The latest quarterly figures show that things are slowly picking up again after a long, lean period.
Bayer posted third-quarter sales of EUR 11.3 billion and a net income of EUR 552 million, compared with EUR 9.8 billion and EUR 90 million in the year-ago quarter. Free cash flow was EUR 1.7 billion, which was 11% lower than a year earlier due to the strong dollar. The price/earnings ratio of the stock is below 2 and should be considered favorable. While the share price dropped significantly in December, it now seems to have started a countermovement. The share is currently quoted at EUR 50.55.
Even without a new big Corona wave, the biotech and pharma sector will increasingly come into focus because the population in western countries is ageing visibly and thus, the number of sick people is also increasing. BioNTech has been researching cancer therapies for some time and is well capitalized by the success of the COVID-19 vaccine. Defence Therapeutics is working on combining its Accum platform with mRNA molecules. If this succeeds, another major future market will be opened up. Bayer's pharmaceuticals business has been doing well for some time. The Monsanto takeover has had a negative impact, but the wave of lawsuits should sooner or later come to an end.
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