MBFTherapeutics

Company Overview

2009-11-04T23:35:00.000-08:00

MBF Therapeutics (MBFT), a veterinary oncology company, is advancing the quality of cancer care for companion animals with innovative and humane therapies for the treatment of dogs and cats with cancer. Our product development portfolio includes targeted immunotherapies and small molecule drugs that specifically disrupt tumor cell metabolism and stimulate potent, systemic immune responses without affecting normal, healthy cells and organs.

advancing the quality of cancer care for companion animals

The availability of effective cancer treatments is one of the most significant unmet needs in veterinary medicine today. With an estimated 40% of companion pets in the U.S. over the age of 6 years, dogs and cats are increasingly susceptible to a variety of age-related diseases. It has been estimated that nearly half of all pets over the age of 10 will develop cancer (www.brakkeconsulting.com).

Despite recent advances, including a therapeutics adapted from human medicine, the primary cancer treatment options for dogs and cats are surgery, radiation, and chemotherapy. These palliative measures offer only a nominal extension of life, often with a significant degradation of overall quality of life for pets and their owners.

MBFT’s state-of-the-art oncology products are intended to meet the growing demand for effective cancer treatments that address not only symptoms but also the underlying disease to bring patients into long-lasting remission that will extend and maintain good quality of life. Man’s Best Friends Therapeutics is a development-stage veterinary biotechnology company with products in preclinical and early-stage clinical testing. Additional information about the company is available for investors, veterinary professionals, and pet owners.

For Investors

2009-11-04T05:02:00.000-08:00

MBF Therapeutics Inc. (MBFT) is commercializing innovative and humane therapies for the rapidly evolving, high value veterinary oncology market, taking advantage of significant advances in human cancer treatment by adapting therapies proven safe and effective in human clinical studies for use in companion animals.

The veterinary oncology market offers a significant opportunity to introduce disruptive, innovative technologies that will eclipse the existing markets and set a new standard of cancer care for companion animals. Demographics support strong growth potential and demand for effective, safe and more humane therapeutic products for companion animals that increasingly enjoy ‘family’ social status and whose owners routinely spend significant sums on general and specialized veterinary care.

Approximately 2.4% of the nearly 40 million cared-for dogs in the United States develop cancer each year, representing a potential market opportunity approaching $0.5 billion for cancer treatment in canines in the United States alone. Substantial markets for canines in other developed markets, specifically Western Europe, Canada and Japan, are also anticipated. A further market opportunity is expected for felines in these same markets with estimates exceeding $200M for the US alone.

MBFT has in-licensed two develoment-stage, broad spectrum products and assembled an experienced management team, boards and consultants who are executing a plan for rapid commercialization of these assets. The MBFT strategy reduces development, manufacturing, regulatory and commercialization risks by leveraging knowledge and expertise gained from extensive human testing to create new, proprietary animal health products.

We will implement a phased approach to introduce our products into the marketplace, initially through a limited number of leading veterinary institutions designated as Strategic Centers of Excellence (SCOE). Within two years of introduction to SCOEs, MBFT’s marketing will expand to fully penetrate the specialty veterinary hospital population and progressive, high-level general practices. This targeted marketing approach will position MBFT’s products at the high end of the market and will require only a limited number of specialized MBFT sales associates to execute this strategy.

Investment Highlights

Fast-track development and regulatory strategies in place with the potential to introduce three commercial products under conditional licenses within three years.
Products with broad-spectrum activity capable of treating a variety of solid tumor cancers and lymphoma.
Strong intellectual property based on exclusive licenses to issued US and international patents.
Commercial manufacturing and supply strategies in place for each product.
A phased marketing strategy that will provide direct access to broad user networks.
Significant M&A exit potential in 2 to 5 years with an attractive positive ROI.

For Veterinary Professionals

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MBFT is developing novel, targeted therapies that are intended to treat a broad range of cancer indications in dogs and cats. Each of our development products is supported by extensive preclinical studies in animal models and safety and efficacy studies in human clinical trials.

Our goal is to commercialize effective and humane products that address the underlying causes of disease and that will put patients into long-term remission. Our products will be provided in simple-to-administer formulations to maximize pet owner convenience and compliance over the course of treatment.

MBFT-101

MBFT-101 is a targeted, broad-spectrum Polyamine-Based Therapy (PBT) combination therapy consisting of di-fluoro-methyl-ornithine (DFMO) and the polyamine transport inhibitor, MBF-1569. This drug combination is believed to have broad spectrum activity against numerous forms of solid tumors, including sarcomas and a variety of epithelial tumors.

MBFT-101 acts by starving rapidly growing neoplastic cells of polyamines, which are essential for DNA replication, cell cycle regulation and cell growth, resulting in tumor shrinkage and eradication.

MBFT-101 targets the two critical sources of polyamines:

DFMO specifically and irreversibly inhibits ODC, the key biosynthetic enzyme that converts ornithine to putrescine and is upregulated in tumor cells; and
MBF-1569 prevents uptake of polyamines from the intercellular tumor environment. This dual-targeting mechanism effectively starves the tumor cells but is not deleterious to normal cells.

MBFT is collaborating with Dr. Thomas O’Brien, a leading expert on polyamine and cancer at the Lankenau Institute for Medical Research (LIMR) on product development and clinical evaluation. The first pilot study underway at the University of Pennsylvania’s School of Veterinary Medicine is evaluating MBFT-101 as a treatment for feline non-resectable oral squamous cell sarcoma (SCC), an aggressive cancer and the most common feline oral tumor type. The prognosis in cats with oral squamous cell carcinoma is very poor because of the rapid growth and advanced stage of the disease by the time of diagnosis (Maretta 2001). Extensive studies of PBT therapy by Dr. O’Brien and collaborators have demonstrated the effectiveness of DFMO and polyamine transport inhibitors, producing complete tumor responses and durable cures in proof of principle studies with squamous cell carcinoma.

References

Chen, Y., et al (2006) Int J Cancer. 118:2344-9

Burns et. 2009. J. Med. Chem. 52 (7), 1983-1993

MBFT-102

MBFT-102 is under development as a DNA-based immunotherapy for dogs mediated through the tumor suppressor/cytokine protein mda-7/IL-24. mda-7 (melanoma differentiation-associated gene-7; approved gene symbol IL24) was identified at Columbia University as one of several genes up-regulated during terminal differentiation of melanoma cells. Studies using plasmid-based or adenoviral vector-mediated delivery of mda-7 confirmed that de novo MDA-7 protein expression reduced growth and colony formation in a variety of human cancer types including melanoma, glioblastoma multiforme, osteosarcoma, and carcinomas of the breast, cervix, kidney, colon, lung, nasopharynx, and prostate. No effects on normal cells were observed. Many anti-tumor properties of mda-7 have been studied, including down-regulation of oncogenic and upregulation of tumor suppressor pathways, cell cycle arrest, inhibition of tumor cell invasion and metastasis, and antiangiogenic effects.

The mda-7 gene has been evaluated in human patients by Introgen, Inc., which conducted an open-label Phase I dose-escalation trial on 22 advanced cancer patients with a variety of cancers, including melanoma, breast, colon, head and neck, lymphoma, hepatoma and adrenal carcinoma. The patients received intratumoral injection of the Introgen’s human-specific product INGN 241, a nonreplicating adenovirus vector carrying the mda-7 transgene. Treatment was generally well-tolerated and durable clinical responses were observed in a subset of patients who received multiple intratumoral injections. The human trial results indicate that mda-7 is a promising immunotherapy therapeutic that can generate direct tumor growth inhibition and can act at distal tumor sites through a bystander anti-tumor effect.

MBFT is adapting this potent, broad-spectrum solid tumor therapy to canines.

Reference

Lebedeva I., et al. mda-7/IL-24, novel anticancer cytokine: Focus on bystander antitumor, radiosensitization and antiangiogenic properties and overview of the phase I clinical experience (Review) Int J. Oncology 31: 985-1007, 2007

For Pet Owners

2009-11-04T05:00:00.001-08:00

MBF Therapeutics Inc. (MBFT) is a veterinary oncology company dedicated to advancing the standard of cancer care for companion animals. We are working with cancer researchers and veterinary clinicians to develop new, innovative and humane therapies for the treatment of dogs and cats with cancer. We are taking advantage of many significant advances that have been made in human cancer treatment to adapt therapies proven safe and effective in human clinical studies for use in companion animals.

Our products are not yet commercially available. We are planning and conducting clinical evaluations of our products in collaboration with professional veterinary organizations throughout the United States.

We are planning and conducting clinical evaluations of our products

MBFT-101 is currently being evaluated as a treatment for cats with nonresectable oral squamous cell carcinoma. This clinical study, being conducted at the University of Pennsylvania, is now recruiting feline patients.

For more information about this study in cats, please visit the official clinical trials site at: http://research.vet.upenn.edu/CurrentClinicalTrials/DentistryOralSurgery/FelineOralSqumousCellCarcinoma/tabid/3459/Default.aspx

If you have a feline patient that may qualify for this study, please contact the University of Pennsylvania Veterinary Clinical Investigation Center for more information at: 215-573-0302 or via email at vcic@vet.upenn.edu.

News

2009-09-15T10:28:00.000-07:00

October 1, 2009: MBF Therapeutics Named as one of the Top 50 Emerging Companies in Funding Posts’s 6th annual Pitch Across America Competition

October 1, 2009: LANKENAU PARTNERSHIP HOPES TO FIGHT CANCER IN PETS

September 28, 2009: MBF THERAPEUTICS & LANKENAU INSTITUTE FOR MEDICAL RESEARCH PARTNER TO DEVELOP NOVEL DRUG TREATMENT FOR COMPANION ANIMAL CANCERS Pilot Clinical Study Underway at University of Pennsylvania’s School of Veterinary Medicine

September 25, 2009: VETERINARY DRUG COMPANY IS TARGETING CANCER IN PETS

September 1, 2009: MBF THERAPEUTICS SHOWCASES VETERINARY ONCOLOGY PORTFOLIO AT ANIMAL HEALTH INVESTMENT FORUM Company Presents Plans for Rapid Commercialization of Companion Animal Therapeutics at Kansas City Meeting

Management Team and Boards

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Thomas Tillett – President & CEO.

Chairman - BioIndustrial Liaison Committee, American Society of Gene and Cell Therapy; Executive Director - Sustained Acts
Former positions: Founder/CEO, RheoGene Inc. (merged with Intrexon Inc.); President, Quadrant Biosystems Inc., a division of Intrexon; Management positions in fine chemicals manufacture, formulations, sales and marketing at Rohm and Haas Company.

Lorraine H. Keller, Ph.D. – Executive Vice President of Technology.

Senior Advisor/Development Strategist, Rondaxe Pharma LLC; Portfolio Manager, BioStrategy Partners
Former positions: Founder/VP of Marketing and Communications RheoGene Inc. (merged with Intrexon Corporation); Senior technical, toxicology and regulatory positions at Rohm and Haas Company

Travis Meredith, DVM, MBA, Diplomate ACT – Founding Partner

Vice President of Commercial Operations for PetWatch Animal Hospitals, Inc.
Former positions: Marketing Manager, Schering Plough Animal Health; Market Development Manager for Companion Animal Portfolio, Intervet Inc; Owner, VRS Partners.

Board of Directors

Thomas Tillett – President & CEO, MBF Therapeutics

Christopher Cashman – CEO, Protez Pharmaceuticals; former senior executive at Pfizer Animal Health.

Christopher Ragland – Managing Principal, Axxiom LLC; former President, Intervet; former Vice Chairman of the Animal Health Institute

Corporate Counsel

Kathleen Shay, Partner – Duane Morris LLP

Clinical Advisory Board

Carl Johnson, A.M. DVM – Senior Director Research, Baxter Healthcare Corporation; former Director, Product Development and Regulatory Affairs – Intervet; Director, Global Veterinary Medical Group Pfizer Animal Health

Thomas O’Brien, Ph.D. Professor, Lankenau Institute for Medical Research; Professor, Department of Dermatology and Cutaneous Biology, Thomas Jefferson University

Products

2009-04-05T08:49:00.001-07:00

MBFT is developing products for the treatment of multiple types of solid tumor and blood cancers. Our lead products are:

MBFT-101, a combination therapy for sarcomas and lymphoma. MBFT-101 combines MBF-1569, a proprietary polyamine transport inhibitor, and DFMO (difluoromethylornithine), a potent inhibitor of Ornithine DeCarboxylase (ODC) the key enzyme that regulates cellular polyamine metabolism and that becomes dysregulated in forms of cancer. A clinical study with MBFT-101 in cats with nonresectable oral squamous cell carcinoma is underway at the University of Pennsylvania’s School of Veterinary Medicine. The study is partially supported by a Ben Franklin Technology Partners Technology Concept Network grant to MBF Therapeutics and Dr. Thomas O’Brien, a leading expert on the role of polyamines in cancer, at the Lankenau Institute for Medical Research (Wynnewood, PA).

MBFT 102, a potent immunotherapy product based on the tumor suppressor/cytokine mda-7/IL24, a DNA-based therapy that has demonstrated safety and efficacy in human patients with a variety of advanced cancers including melanoma, breast, colon, head and neck, lymphoma, hepatoma and adrenal carcinoma. MBFT is working with Dr. Paul Fisher, the inventor and leading expert on mda7/IL24, to adapt this therapy for use in dogs.

Under Construction

2009-04-04T11:47:00.000-07:00

Under construction. Check back tomorrow!

Contact Us

2009-03-30T13:35:00.000-07:00

MBF Therapeutics
640 Woodbrook Dr.
Ambler, PA 19002

email: info@mbftherapeutics.com

About Us

2009-03-30T13:34:00.000-07:00

MBF Therapeutics is privately owned and headquartered in Ambler PA, in the heart of the southeastern Pennsylvania life sciences community.

The company consists of a core management team, consultants and boards that bring extensive experience in cancer treatment, veterinary medicine, veterinary product regulation, licensing, business development, marketing and commercialization.

Therapeutics

2009-03-30T07:35:00.000-07:00

MBFT is in the process of in-licensing a lead product for cancer that has demonstrated efficacy in canines and a lead anti-arthritis product.

This is a quote about how wonderful the therapeutics are.

In addition, MBFT has developed an extensive portfolio of second generation products that will be either developed internally or in-licensed.

Pitching Across America: 2009 Regional Winner

2009-02-21T19:34:00.000-08:00

MBF Therapeutics is a winner of the Pitching Across America Venture Capital competition.

For more information visit www.FundingPost.com

Awards-and-Recognitions

2008-02-22T09:04:00.000-08:00

Pitching Across America: 2009 Regional Winner

MBF Therapeutics is a winner of the Pitching Across AmericaVenture Capital competition.
For more information, visit www.FundingPost.com

Small Business Commerce Association: 2009 Category Winner

MBF Therapeutics is a winner of SBCA's Best of Business Award in the Pharmaceutical Preparations category.
For more information, visit SmallBusinessCommerceAssociation.org

Eastern Technology Council: 2009 Life Science Startup of the Year Finalist

MBF Therapeutics was nominated for the 2009 Life Science Startup of the Year.
For more information, visit EasternTechnologyCouncil.org