–IND Accepted by the FDA for Lead Development Program addressing HTLV-1 Associated Myelopathy (HAM) and T-cell Leukemia–
— Phase 1 Trial to be Commenced in Partnership with the NIH–
Irvine, CA, August 1, 2016 — Bioniz Therapeutics, Inc., a biopharmaceutical company leading the discovery and development of first-in-class peptide therapeutics that selectively and simultaneously inhibit multiple cytokines to treat immuno-inflammatory diseases and cancer, announced today that it has raised $13 million in its Series A funding. The investment syndicate was co-led by Takeda, via its corporate venture arm Takeda Ventures Inc., and Dr. David Pyott, and also includes investments from Mr. Joe Kiani, and Cota Capital. The Company also announced that it has appointed Dr. David Pyott as Chairman of the Board of Directors, effective immediately. Dr. Pyott is the past Chairman and Chief Executive Officer of Allergan Inc. (AGN). In connection with the financing, Ilan Zipkin Ph.D., Senior Investment Director, Takeda Ventures, and Joe Kiani, Chairman and CEO of medical device company Masimo Corporation (MASI), have also joined the Company’s Board of Directors.
The Series A funding will allow Bioniz to further advance its peptide platform technology focused on selective blockade of key cytokines that modulate serious diseases. The lead programs are BNZ-1 and BNZ-2. BNZ-1, a selective inhibitor of cytokines IL2/IL9/IL15, is intended for the treatment of HTLV-1 Associated Myelopathy (HAM) and for certain T-cell Leukemias. HAM is a progressive neuroinflammatory and immune-mediated orphan disease associated with serious, chronic morbidity. BNZ-2, a selective inhibitor of cytokines IL15/IL21, is in pre-clinical development for the treatment of Celiac Disease and other immuno-inflammatory disorders for the gastro-intestinal tract.
Additionally, the Company announced that an Investigational New Drug Application (IND) for BNZ-1 has been accepted by the Food and Drug Administration (FDA) and a Phase 1 clinical trial in healthy volunteers is expected to commence shortly in close partnership with the National Institutes of Health (NIH).
“This financing is an important step needed to drive the development of new potential treatments for patients affected by very serious cytokine-driven diseases. The acceptance of the BNZ-1 IND is a great accomplishment by our team and we are excited to collaborate with the NIH on the clinical advancement of this program. I’m very pleased to have the opportunity to work with such a dedicated group of people and organizations who share our vision for success in bringing these therapies to patients,” said Dr. Nazli Azimi, Founder, President and Chief Executive Officer. “We are also delighted to welcome David as the Chairman of the Company’s Board of Directors. His well-known industry accomplishments, business acumen, and executive leadership will be of great value to our rapidly emerging organization” added Dr. Azimi.
Dr. Pyott commented, “Bioniz is an exciting, emerging biotechnology company with a truly novel approach to addressing autoimmune diseases and cancer. I look forward to working with the Company and its leadership, and together, realize our vision to create the next generation of selective immune therapies.”
From 1998 to 2015, Dr. Pyott served as CEO of Allergan Inc., where he was recognized by the Harvard Business Review as one of “The 100 Best Performing CEO’s in the World.” Under his leadership, Allergan was transformed from a small eye care business with approximately $1 billion in sales to a global specialty pharmaceutical and medical device company, with sales over $7 billion in 2014 and more than 10,000 employees.
Prior to Allergan, Dr. Pyott served as the Head of the Novartis Nutrition Division and as a member of the Executive Committee of Switzerland-based Novartis AG. Dr. Pyott is a member of the Board of Directors of Avery Dennison Corporation, a member of the Board of Directors of BioMarin Pharmaceutical, Alnylam Pharmaceuticals, and a member of the Supervisory Board of Royal Philips in the Netherlands. He is a member of the Governing Board of the London Business School, President of the International Council of Ophthalmology Foundation, and a member of the Advisory Board of the Foundation of the American Academy of Ophthalmology. Dr. Pyott holds a Diploma in International and European Law from the Europa Institute at the University of Amsterdam, a Master of Arts degree and an Honorary Degree in Medicine from the University of Edinburgh, and a Master of Business Administration degree from the London Business School.
Bioniz is a biopharmaceutical company leading the discovery and development of first-in-class multi-cytokine inhibitory peptide therapeutics to address immuno-inflammatory diseases and cancer, with an initial focus on orphan diseases that have an immune component. Bioniz leverages its world class expertise in cytokine biology, originating in research conducted at the National Institutes of Health (NIH), to develop a novel approach to selectively inhibit functionally redundant cytokines while leaving the rest of the cytokine network intact. Bioniz’ innovative platform has resulted in multiple peer-reviewed publications in notable scientific journals. For more information, please visit www.bioniz.com.
Human T-cell lymphotropic virus type-1 (HTLV), is a virus that infects T-cells. A subset of patients infected with HTLV-1 develop a disease called HTLV-I Associated Myelopathy (HAM). HAM is a progressive orphan neuroinflammatory and immune-mediated disease with similar clinical manifestations to Primary Progressive Multiple Sclerosis. HAM is a devastating disease where patients suffer from neurological damage to their spinal cord that ultimately results in paralysis of their lower limbs, wheelchair dependency, and a shortened life expectancy. The Company’s product candidate BNZ-1 is a selective inhibitor of three interleukin cytokines (IL2/IL9/IL15) which are known to be major disease drivers in HAM. There is no FDA approved therapy for HAM.
About T-Cell Leukemia
“Leukemia” refers to cancer of white blood cells or lymphocytes, which are key components of the immune system. T lymphocyte malignancies (T-cell Leukemia), include a group of rare and often aggressive leukemias with limited treatment options and poor prognosis. Bioniz’ product candidate BNZ-1 is a selective inhibitor of two cytokines IL2 and IL15 that are potent T-lymphocyte growth factors and key disease drivers in these T-cell malignancies. With a dual mechanism of action, BNZ-1 blocks tumor proliferation and mobilizes patient’s internal immune response by eliminating regulatory T-cells to fight the cancer.