EnGen Bio

The flu has an Achilles’ Heel — and EnGen Bio has discovered it.

This biotech company has developed an effective, easy-to-manufacture, shelf-stable vaccine and therapy. These solutions can potentially provide long-term immunity to all Type A influenza strains, including all flu pandemics, all Type A seasonal flus, and all animal flus.

In other words, with one or two shots, you could be protected from the worst seasonal influenza viruses, and all pandemic influenza strains, for life. And if you’ve already been exposed to or come down with the flu, this company’s therapy could offer fast relief.

EnGen Bio’s vaccine and therapy are based on the discovery of a small region of a particular flu protein. This region has strong constraints against mutation. And when targeted in animal-based vaccination tests, this region of the protein elicited a highly protective antibody response.

EnGen Bio is led by Dr. Mark Alfenito, a 20-year veteran of the biotech industry who has founded three pharmaceutical startups. Two of these companies went public and one was acquired. Assisting him is Dr. Mark Baer, who has spent two decades researching and developing therapeutic antibodies. And advisor Dr. Geoff Yarranton was instrumental in creating three FDA-approved pharmaceuticals (Mylotarg, Bexxar, and Cimzia).

EnGen Bio has been issued seven patents, including two in the U.S. (No. US9999662 and US10080792). And its therapies have shown promise in early animal testing. The company is raising funds to continue development and move toward human clinical trials.

EnGen Bio has created three main products. These include vaccines for humans and animals, and a therapy for humans. Here are the details:

1. Human Influenza Vaccine: This vaccine stimulates a durable immune response to all Type A and pandemic influenza strains.

The next steps in development of this vaccine are to improve the peptide immunogenicity to increase antibody response and document results in testing on mice. From there, the vaccine will be tested for efficacy in mice, followed by human clinical trials.

U.S. demand for the seasonal flu vaccine has been forecasted to surpass $3 billion by 2024. Annual global sales of GlaxoSmithKilne’s seasonal flu vaccine stand at $1.5 billion.

At a price point similar to that of conventional flu shots, EnGen Bio’s vaccine could reach sales of $2.6 billion in the U.S. alone. FDA “fast-tracking” is possible, which may help expedite clinical development and reduce costs.

2. Human Therapeutic Antibody: This therapy targets the Type A, M1 protein epitope exposed on the viral surface, helping to speed up recovery of the seasonal flu.

EnGen Bio is working to identify a new therapeutic antibody with greater potency and confirmed universal Type A binding. This antibody will be tested in mice, and then converted into a form suitable for human use. A manufacturing cell line will then be constructed and the company will begin discussions to license this therapy to larger pharmaceutical corporations.

Annual sales of flu therapies range from $800 million to $3 billion a year. However, the efficacy of the three main medications — Tamiflu, Xofluza, and Relenza — is low. They’re only effective at the earliest stages of infection.

EnGen Bio’s therapy, in contrast, could potentially be used for effective treatment at any time during an infection, or even in anticipation of exposure.

3. Veterinary Influenza Vaccine: Although veterinary vaccines are available from several large pharma companies, the value of these products is calculated via the product’s need vs. its efficacy vs. its cost of goods. The efficacy of current solutions, along with the savings they create, are low. Current swine flu vaccines, for example, decrease mortality by only about 10%, resulting in a savings of just $3 to $10 per animal.

While influenza has historically been considered a veterinary problem only in avian, swine, and equine populations, new strains affecting canines have recently been identified. As a result, the United States Department of Agriculture (USDA) is offering funding for new solutions in all affected animal species.

The projected higher rate of efficacy of EnGen Bio’s animal vaccine, combined with potentially lower cost of goods, make its product a prime candidate for funding, or even acquisition.

EnGen Bio is seeking capital to fund ongoing operations of each of its three products. Focus will be placed on R&D and establishing intellectual property.

In addition to equity crowdfunding, EnGen Bio could receive additional capital from the National Institutes of Health. It’s already been granted access to use the NIH’s influenza facility and animals.

Furthermore, with positive results in its preclinical proof of principle work, the Biomedical Advanced Research and Development Authority (BARDA) and Defense Advanced Research Projects Agency (DARPA) may fully fund both manufacturing and human clinical trials through their on-going influenza programs.

Additionally, EnGen Bio was recently notified by the Bill and Melinda Gates Foundation of interest in funding around $1 million of the company’s initial work in the human vaccine program. This would be provided once proof of concept data was created. Based on these results, the foundation could also fund all preclinical development work required to reach human clinical trials.

Team Background

Dr. Mark Baer - Vice President of Research

Mark has spent 20 years researching therapeutic antibodies. His knowledge of drug discovery and development practices is backed by decades of manufacturing therapeutics for cancers and microbial diseases.

Prior to his time with EnGen Bio, he was Director of Research at KaloBios Pharmaceuticals. Before that, he was a research consultant with Viro Dynamics, a biotech company.

He earned a Bachelor’s degree in Biochemistry from Cornell University, a Ph.D. in Biochemistry from the University of North Carolina, and completed postdoctoral research at the National Cancer Institute.

Dr. Mark Alfenito - President & CEO

Mark has more than 20 years of experience in the biotech industry.

Prior to starting EnGen Bio, he founded KaloBios Pharmaceuticals. And before that, he was Vice President at Dyax Corp., a pharmaceutical company acquired in 2015.

Earlier, Mark founded Target Quest, a pharmaceutical company acquired by Dyax Corp. Before that, he was Associate Director of Corporate Development for Hyseq Pharmaceuticals.

Throughout his career, he has negotiated more than $600 million worth of corporate deals and transactions. He’s also obtained 13 patents for his work.

Mark earned a Bachelor’s degree from Cornell University, a Master’s degree and Ph.D. in Cellular and Developmental Biology from Harvard, and conducted postdoctoral research at Stanford.

Dr. Geoffrey Yarranton - Science Advisor

Dr. Yarranton is a 35-year veteran of the biotech industry. He has been instrumental in the development of three FDA-approved pharmaceuticals and led two successful bio/pharma mergers. He’s also been issued 36 patents for his work.

Most recently, he was Executive Vice President of R&D with KaloBios Pharmaceuticals. Before that, he was CEO of Celscia Therapeutics, a biotech startup. Earlier, he was VP of R&D with CoulterPharmaceuticals.

Dr. Yarranton earned a Bachelor’s degree from the University of Leicester, as well as a Ph.D. from the National Institute for Medical Research in the UK. He also completed postdoctoral research at MIT.

Co-Investors