Not long ago, the idea of turning human cells into miniature factories for the production of therapeutic proteins seemed to be far away, but the Covid-19 messenger RNA vaccine validated this approach. Alzheimer’s disease is Vaxxinity’s main disease target, and the company claims that its method of making the body produce therapeutic antibodies may have advantages over traditional therapies. Biogen’s drug was approved for the treatment of this disease earlier this yearHowever, investors took a colder view of the company’s IPO. Although Vaxxinity was able to raise $88 million from the stock offering, the biotech company had to reduce the size of the transaction to achieve it.
Viral Pricing 6 million shares are issued at a price of $13 per share. The Dallas-based company plans to issue 6.7 million shares at a price of between $14 and $16 per share. Trading began on the Nasdaq on Thursday. After the stock code was “VAXX”, the stock price soared to $21.31 per share, and then closed at $16.55 at the close, which was 27% higher than the reduced IPO price.
Vaxxinity aims to go beyond the category of therapy called monoclonal antibodies. These therapies are made of engineered proteins to produce targeted therapies and have entered the market for the treatment of a series of chronic diseases. But these treatments are carried out through frequent injections or infusions, which many patients think is unwelcome or just inconvenient. Vaxxinity aims to overcome these limitations by allowing the patient’s body to produce therapeutic antibodies.In its Listing applicationVaxxinity said its technology uses synthetic peptides to selectively activate the immune system to produce antibodies against specific targets. These targets can include autoantigens that the body has tolerated.
Compared with monoclonal antibody therapy, Vaxinity technology aims to bring several advantages. Most of the cost of monoclonal antibody therapy comes from manufacturing it. Since the patient’s immune system becomes the manufacturing plant for Vaxxinity therapy, the company’s method avoids most of the costs associated with the material and antibody drug production process. The company also claims to have a dosage advantage. Although antibody therapy may require injections or infusions every two weeks or every month, Vaxxinity said its drug will require three start-up doses, followed by two to four boosters per year.
Vaxxinity’s therapy may also provide safety advantages. Since Vaxxinity therapy is designed to target specific antigens, off-target effects should be avoided. As for the efficacy, the company said that by inducing the body to produce antibodies, this method can avoid the production of anti-drug antibodies. Over time, these antibodies will limit the efficacy of monoclonal antibody therapy.
Leading the Vaxxinity program UB-311 has reached the mid-term clinical development of Alzheimer’s disease. The peptide is designed to allow the body to produce antibodies against amyloid beta, a protein that forms plaques in the brains of patients with Alzheimer’s disease. The company believes that UB-311 may have an advantage over Biogen’s Alzheimer’s drug Aduhelm, which is a monoclonal antibody therapy that is administered every four weeks. Side effects associated with Biogen drugs include brain swelling and bleeding.
So far, Vaxxinity has reported that the drug is well tolerated, without cerebral hemorrhage or swelling, after repeated administration for patients with mild to moderate Alzheimer’s disease for three years. The company plans to advance the drug to a Phase 2b study in 2022 to evaluate the efficacy of the therapy. According to the IPO document, the study will recruit approximately 670 patients with early-stage Alzheimer’s disease. The main goal is to evaluate the effect of the drug on cognitive and functional decline in 78 weeks.
Another Vaxxinity project, UB-312, is in the first phase of testing as a potential treatment for Parkinson’s disease and Lewy body dementia. The second Alzheimer’s treatment aimed at addressing the accumulation of tau protein is preclinical, as are potential therapies for migraine and hypercholesterolemia.
Vaxxinity’s Covid-19 vaccine UB-612 has completed the second phase of testing. The vaccine is designed to activate antibody production and cellular immunity against multiple parts of viral antigens. The company reported that clinical trial results showed that the vaccine produced antibodies that neutralized SARS-CoV-2 and triggered a T cell response. However, Vaxinity’s emergency use authorization application in Taiwan was rejected by the local regulatory agency, and the company is appealing.
The peptide technology that underpins Vaxxinity was originally developed in-house by United Biomedical Inc. (UBI), a private biotechnology company with a history of more than 35 years. According to the IPO document, UBI initially developed peptide vaccine technology for animals, which the company has improved over the past two decades.In order to develop technologies for human use, Vaxxinity was established in April by Combine COVAXX and United Neuroscience, Originated from the two companies of UBI.
In addition to corporate relationships, Vaxxinity also has multiple family relationships. According to the document, Hu Meimei, co-founder, President and CEO of Vaxxinity, and Louis Reese, executive chairman of the company’s board of directors, are married. Hu is the daughter of Chang Yi Wang, the founder of UBI and a member of the Vaxxinity Scientific Advisory Board.
According to the document, Vaxinity’s main shareholder-a shareholder who owns 10% or more of the company’s shares-voted to grant Ms. Hu the right to vote on her shares on all voting matters. This power gives her 58.57% of the voting rights, making Vaxxinity a “controlled company”, in which more than half of the voting rights are held by one person or a group.
As of the end of September, Vaxinity reported a total cash position of $89.4 million. This capital, combined with the proceeds of the IPO, will provide funding for the development of the pipeline. Approximately US$90 million has been reserved for the company’s chronic disease drug candidate, which is mainly used to complete the phase 2b test of the Alzheimer’s drug candidate UB-311. The cash will also be used to incorporate preclinical projects into the pipeline through the first phase of development. The company’s Covid-19 vaccine candidate program has invested between US$15 million and US$20 million. The candidate vaccine is being tested as a booster shot for people who have previously received different vaccines. Approximately US$10 million is used to invest in the company’s technology and new product candidates.
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