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MBFT advances checkpoint inhibitor immunotherapy for canine cancer, eyes infectious diseases

US start-up Man's Best Friend Therapeutics (MBFT) aims to conduct a clinical study of its treatment for canine melanoma in late 2019 or early 2020, upon completion and USDA review of its pilot work in dogs.

MBFT is aiming to translate the science behind checkpoint inhibitors (CPIs) in human pharma into animal health. It is developing a gene-based approach to create products for the treatment and prevention of infectious diseases in livestock and companion animals, in addition to cancer indications in pets.

The first product built upon the MBFT platform technology is MBFT-201 – an immunotherapeutic vaccine for canine melanoma, which MBFT believes will receive USDA conditional approval as early as the second half of 2020 and full registration in 2021.

"We've evolved quite a bit in the last two years," the firm's chief executive Thomas Tillett told Animal Pharm at the recent Animal Health Investment USA conference in Boston. "In two pilot safety and immunogenicity studies, we demonstrated MBFT-201 is safe and elicits strong T-cell responses to melanoma antigens representing the signature of the vaccine – a vaccine that activates a targeted cell-mediated immune response, prevents T-cell exhaustion and addresses the tumor microenvironment."

The Philadelphia-based business is currently aiming to raise $10 million to help bring MBFT-201 to the market, to initiate clinical studies for candidates targeting infectious diseases in livestock and to begin development of further canine cancer vaccines.

MBFT's pipeline of products build upon a common platform technology will provide the company with multiple potential exit strategies. To date, the company has raised approximately $1m – funds that are currently supporting ongoing development programs.

Checkpoint inhibitor (CPI) technology is a rapidly evolving space has been "a gamechanger" in human health for indications such as cancer, Mr Tillett said. MBFT has an exclusive agreement with Philadelphia's Wistar Institute to take its gene-based CPI technology into the field of veterinary medicine.

"CPI vaccines will provide durable, broad-spectrum immunity that current products cannot," he explained. "We think we can create a variety of products. We are the only animal health company using a gene-based approach to deliver CPI along with cancer or disease-specific antigens that turbocharge the immune response against cancer or infectious diseases.

"Using DNA delivery rather than monoclonal antibodies is a potentially safer, more efficient and cost-effective way to deliver immunotherapy products into the veterinary market and the basis of our long-term competitive advantage.

"For cancer, we use a multipronged approach that not only attacks tumor cells directly but also destroys the immunosuppressive tumor-protective microenvironment that causes many treatments to be ineffective."

The firm also aims to bring its MBFT-202 multi-cancer canine vaccine to full USDA registration in 2021, with its canine lymphoma vaccine (MBFT-203) scheduled for 2022.

Infectious disease candidates

Mr Tillett added: "For infectious diseases, our multipronged approach combines one or more CPIs, pathogen-specific antigens and immunomodulators. The durable B-cell and T-cell immune memory elicited by CPI-based vaccination will also have a therapeutic role in preventing viral shedding and disease transmission – a major cause of economic loss for livestock producers."

MBFT believes the market for veterinary anti-infectives is worth $6.92 billion in 2019 and is growing at around 8.5% per year.

Also in the firm's pipeline is a vaccine for equine herpes virus, as well as two other vaccines for undisclosed indications – one is for an infectious viral disease in companion animals, while the other is a "durable prophylactic vaccine for more effective herd health management of an endemic disease in livestock".

The company aims to commercialize its companion animal products itself, while MBFT "continues to identify additional livestock collaborators to participate in design, testing and development of our gene-based CPI technology for infectious disease applications". The firm is exploring a variety of exit opportunities including an initial public offering in 2020 to further fund its pipeline and commercial expansion.

Mr Tillett's background with disruptive innovation includes four years as the founder and chief executive of RheoGene – a gene and cell therapy company in the human pharma space that merged with Intrexon in 2007.

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