IND Candidates Nominated for the Treatment of Liver Disease and Inflammatory Bowel Disease
SOUTH SAN FRANCISCO, Calif., June 19, 2020 (GLOBE NEWSWIRE) — Surrozen Inc., a biotechnology company pioneering a new class of targeted regenerative antibodies, today announced the successful completion of a $50 million Series C financing. Investors from the Series B financing participated in the Series C round, including The Column Group, Hartford Healthcare Trust, and Horizons Ventures. Four new investors also participated in this recent financing round, including Euclidean Capital. Surrozen is focused on engaging the body’s own biological repair mechanisms through tissue-specific modulation of the Wnt pathway to discover and develop a broad pipeline of first-in-class, targeted regenerative antibodies.
Proceeds from the financing will be used to advance the Company’s two IND candidates to the clinic, one for the for the treatment of liver disease and a second novel antibody for inflammatory bowel disease. The company will also continue its discovery efforts to expand its pipeline to include novel Wnt-modulating regenerative antibodies for additional tissues and disease areas.
“The nomination of our first two candidates marks the culmination of preclinical proof-of-concept work achieved in multiple disease models demonstrating cell proliferation, tissue regeneration, and functional improvement — which suggests an ability to repair damaged tissue and restore function,” said Craig Parker, president and chief executive officer of Surrozen. “Our goal is to file IND applications in 2021 and 2022 for novel antibodies targeting severe liver disease and moderate to severe inflammatory bowel disease, respectively. We believe that these two candidate molecules have the potential to play a critical role in tissue regeneration in these diseases.”
“While it has long been known that the Wnt signaling pathway plays a crucial role in the maintenance and self-renewal of stem cells in a variety of tissues, scientists had been unable to overcome the technical challenges inherent in developing a therapeutic based on Wnt signaling,” said Roeland Nusse, Ph.D., Virginia and Daniel K. Ludwig Professor of Cancer Research and Professor of Developmental Biology at Stanford University School of Medicine. “I am hopeful that Surrozen’s approach to modulating the Wnt pathway, with the flexibility to address insufficient endogenous Wnt or insufficient receptors, may someday lead to therapeutics that have the potential to repair damaged tissue.”
SZN-043: Liver-Specific R-spondin-mimetic
SZN-043 is the first development candidate designed using Surrozen’s SWEETS (Surrozen Wnt signal enhancers engineered for tissue specificity) platform. SWEETS stabilize Frizzled receptors to enhance the body’s response to endogenous Wnt proteins. In preclinical animal models of liver injury and fibrosis, SZN-043 has been shown to selectively activate Wnt signaling in the liver, stimulate hepatocyte proliferation, improve synthetic function, and reduce fibrosis. The Company’s goal is to clinically evaluate the candidate in settings of drastic hepatocyte loss, such as severe acute alcoholic hepatitis (AAH), where SZN-043 may have a rapid impact on hepatocyte regeneration, as well as settings of advanced chronic disease conditions of cirrhosis. Liver cirrhosis is characterized by a decline in liver synthetic function and an increase in liver fibrosis, culminating in various complications such as portal hypertension, ascites, varices, and hepatic encephalopathy.
Severe liver diseases, including severe acute alcoholic hepatitis, and advanced liver cirrhosis from NASH, hepatitis, alcohol, and other etiologies, represent a significant area of high unmet need for patients and medical providers. There are no effective drug treatments available for these patients, who often require, and frequently do not get, a liver transplant. Furthermore, there are no effective treatments to reverse the course of the disease in patients with advanced cirrhosis who are at risk of decompensation and end-stage liver failure. In the United States, annual hospitalizations attributable to severe alcoholic hepatitis and decompensated liver disease are estimated to reach nearly 100,000 and 200,000 per year, respectively, and the number of patients with advanced cirrhosis and at risk of decompensation is estimated to reach over 750,000.
SZN-1326: Intestine-Specific Wnt-mimetic
SZN-1326 is the first development candidate designed using Surrozen’s SWAP (Surrozen Wnt signal activating proteins) platform. Designed to mimic the activity of Wnt proteins, SWAP directly activate Wnt-signaling pathways by binding to Frizzled receptors and co-receptors. SZN-1326 targets the Wnt-signaling pathway in the intestinal epithelium. In preclinical animal models of acute and chronic colitis, SZN-1326 has been shown to activate Wnt signaling in the intestine, stimulate intestinal epithelial regeneration, and reduce disease activity. Anti-inflammatory effects were also observed.
Inflammatory Bowel Disease (IBD), including Crohn’s disease and ulcerative colitis, remains a significant unmet medical need. In the United States alone, it is estimated that there are approximately 800,000 adults diagnosed with moderate-to-severe IBD. Immune suppressants and anti-inflammatory biologics can be effective treatment options for people with IBD, however many do not achieve adequate long-lasting disease control nor mucosal healing.
About Wnt Signaling
Wnt signaling plays key roles in the control of development, homeostasis, and regeneration of many essential organs and tissues, including liver, intestine, lung, kidney, central nervous system, cochlea, bone, and others. Modulation of Wnt signaling pathways has potential for treatment of degenerative diseases and tissue injuries. There are 19 Wnt ligands (Wnts) in mammals, and they signal through Frizzled receptors 1-10 and co-receptors LRP5 or 6, two families of receptors. Endogenous Wnts bind to multiple Frizzled receptors and are heavily modified post-translationally, making them difficult to manufacture consistently. R-spondin stabilizes Frizzled receptors, enhancing the body’s response to endogenous Wnts.
About Surrozen’s Proprietary Antibody Platforms and Harnessing Wnt Signaling
Since its founding in 2016, Surrozen has developed two proprietary platforms to selectively modulate the Wnt pathway for the potential treatment of injury and disease. Surrozen Wnt-mimetics, also referred to as SWAP (Surrozen Wnt signal activating proteins), are bi-specific full-length human (IgG) antibodies that directly activate the canonical Wnt signaling pathway in target tissue. Surrozen R-spondin-mimetics, also referred to as SWEETS (Surrozen Wnt signal enhancers engineered for tissue specificity), are antibody-based molecules that enhance Wnt signaling by stabilizing Frizzled receptors on targeted cells.
Surrozen is a biotechnology company pioneering a new class of targeted regenerative antibodies to repair a broad range of tissues and organs damaged by serious disease. Surrozen is designing tissue-specific antibodies that engage the body’s own biological repair mechanisms resulting in a broad pipeline of disease-specific therapies to help patients across multiple disease areas, including severe liver diseases, inflammatory bowel disease, retinopathies, hearing loss, lung and airway diseases, and certain neurological disorders. For more information, please visit surrozen.com.
CONTACT: Investors/Partners/Media: Reza Afkhami VP, Corporate Development and Strategy Surrozen, Inc. [email protected]