SB-001, a gene therapy expressing feline erythropoietin (fEPO), demonstrates clinically relevant hematocrit improvements in end-stage anemia patients and improved quality of life scores

PHILADELPHIA, Sept. 30, 2020 (GLOBE NEWSWIRE) — Scout Bio, a biotechnology company focused on revolutionizing pet medicine by delivering a pipeline of one-time therapeutics for major chronic pet health conditions, today announced preliminary results from a pilot study of SB-001 demonstrating statistically significant clinical outcomes for SB-001, a novel AAV gene therapy expressing feline erythropoietin (fEPO), indicated for chronic kidney disease (CKD)-associated anemia.

“This data presents a game-changing opportunity for the animal health industry, and to our knowledge, is the first multi-center AAV gene therapy study conducted in the U.S. in client owned animals,” says Mark Heffernan, Ph.D., CEO of Scout Bio. “Not only is this a major milestone for Scout Bio, but it also shifts the paradigm in the animal health industry for the delivery of therapeutic peptides and proteins that are effective and safe long-term. These results reinforce gene therapy’s potential for the treatment of acquired chronic disease and paves the way for Scout Bio’s evolving gene therapy pipeline to advance into other major chronic diseases, such as diabetes, chronic pain and atopic dermatitis.”

The study compared the change in Packed Cell Volume (PCV), an indicator of increased hematocrit or red blood cell (RBC) number, from baseline in sixteen client owned cats with end-stage kidney disease. The study was designed to identify an optimized dose and to run a minimum of 70 days and maximum of 126 days for each animal. All cats received the therapy and two dosing protocols were evaluated, with success defined as an increase in PCV into the normal range or ≥5 percentage points above baseline.

Protocol A and B combined resulted in a 71% success rate and a significant increase in mean PCV (p<0.05). The success rate in protocol B alone, which allowed an optional second dose, was 87%. The increase in PCV resulted in improved clinical signs and quality of life scores. A few cats were followed beyond Day 70 and maintained an increased PCV for up to 152 days. No cat had adverse clinical signs attributed to SB-001 treatment. The study is ongoing and a protocol C (optimized single dose) is being tested, with results expected in early 2021.

This interim study data strongly validates that SB-001’s expressed feline erythropoietin (fEPO) results in a prolonged therapeutic effect after a single treatment protocol, rather than the peaks and troughs of multiple injections with off-label human EPO treatment.

Anne Traas, DVM, MS, DACT, Chief Development Officer for Scout Bio and head of the clinical team leading the study, explains, “When a cat develops anemia associated with CKD, it can be life-disrupting for the cat and the entire family. With no approved treatments available, owners are limited in helping their beloved pets overcome the symptoms of anemia which include extreme lethargy, weakness, increased respiratory effort, which often leads to euthanasia. This data demonstrates that SB-001 has the ability to increase PVC into the normal range, resulting in an improved quality of life for the cat by reducing, or eliminating, the clinical effects of the anemia and presents an enormous advantage in convenience and improved compliance.”

James Wilson, M.D., Ph.D. Director of the Gene Therapy Program at the University of Pennsylvania and a co-founder of Scout Bio commented, “I am thrilled that our work in animal models of human diseases is being used to inform the development of one-time treatments for disorders that commonly affect dogs and cats. I got into this field 35 years ago to help patients with chronic and disabling diseases, which is exactly what Scout Bio hopes to do in companion animal populations.”

About SB-001
SB-001 has a unique and innovative adeno-associated viral (AAV) vector, containing the gene for feline EPO, for delivery into the muscle cell nucleus which will continually produce therapeutic levels of the hormone. The expressed feline EPO stimulates erythropoiesis, or red blood cell production. The U.S. Food and Drug Administration (FDA) CVM has confirmed that SB-001 is eligible for expanded conditional approval, potentially shortening the time until this product could be approved and made available.

About Chronic Kidney Disease (CKD)-Associated Anemia
Anemia associated with chronic kidney disease (CKD) in cats is a disease of high unmet medical need, with no FDA-approved therapies currently available. CKD is one of the most common diseases in senior cats and is an end-of-life disease that creates quality of life issues for cats and their owners. Up to 21% of cats with CKD have anemia and the only currently available therapeutic options are multiple blood transfusions or repeated injections of off-label human drugs. Compared to the use of human EPO drugs, SB-001 is expected to have a superior safety profile with respect to immune reactions and incidence of pure red cell aplasia (PRCA), a serious life-threatening condition.

About Scout Bio
Scout Bio is a biotechnology company focused on revolutionizing pet medicine by delivering a pipeline of one-time therapeutics for major chronic pet health conditions. Scout’s therapeutics are designed to induce long-term expression of therapeutic proteins in pet patients using AAV vector technology. Scout has an exclusive research and development collaboration with the University of Pennsylvania’s Gene Therapy Program. Scout Bio’s innovative partnerships build on a 20-year history with AAV leaders and is complemented by Scout Bio’s global leaders in gene therapy research and development. Scout Bio is ​a private company headquartered in Philadelphia, Pennsylvania.

Penn Financial Disclosure
Dr. Wilson is a Penn faculty member and also a scientific collaborator, consultant and co-founder of Scout Bio. As such, he holds an equity stake in the Company, receives sponsored research funding from Scout Bio, and as an inventor of the licensed technology he may receive additional financial benefits under the license in the future. The University of Pennsylvania also holds equity and licensing interests in Scout Bio.

For further information, please contact:

Investors:
Sarah McCabe
Stern Investor Relations, Inc.
212-362-1200
sarah.mccabe@sternir.com

Media:
Fran Gaconnier
214-417-4142
fran.gaconnier@scoutbio.co

PHILADELPHIA, September 28, 2020 – Scout Bio, a biotechnology company focused on revolutionizing pet medicine by delivering a pipeline of one-time AAV gene therapies for major chronic pet health conditions, today announced that Mark Heffernan, Chief Executive Officer, will present at two upcoming investor conferences.

• Jefferies Virtual Gene Therapy/Editing Summit on Thursday, October 1, 2020 at 4:00 p.m. ET
• Chardan Virtual 4th Annual Genetic Medicines Conference on Monday, October 5, 2020 at 2:00 p.m. ET

About Scout Bio

Scout Bio is a biotechnology company focused on revolutionizing pet medicine by delivering a pipeline of one-time AAV gene therapies for major chronic pet health conditions. Scout has an exclusive research and development collaboration with the University of Pennsylvania’s Gene Therapy Program, which is a global leader in gene therapy research and development for nearly three decades. Scout’s therapeutics are designed to induce long-term expression of therapeutic proteins in pet patients using AAV vector technology. Scout Bio is ​a private company headquartered in Philadelphia, Pennsylvania. For more information, please visit www.scoutbio.co.

For further information, please contact:

 Investors:

Sarah McCabe
Stern Investor Relations, Inc.
212.362.1200
sarah.mccabe@sternir.com

Media:

Fran Gaconnier
Scout Bio
214.417.4142
fran.gaconnier@scoutbio.co

PHILADELPHIA, October 28, 2019 – Scout Bio, a biotechnology company focused on revolutionizing pet medicine by delivering a pipeline of one-time therapeutics for major chronic pet health conditions, today announced the appointment of Anne Traas, DVM, as Chief Development Officer. Dr. Traas brings to Scout Bio nearly 20 years of experience as a clinical research leader and veterinarian, including over a decade at Boehringer Ingelheim (BI) Animal Health.

“After a career focused on advancing new animal therapeutics, it is thrilling to join a team delivering an entirely new paradigm to veterinary medicine that could transform the care of conditions with pressing unmet medical need,” said Dr. Traas. “Scout’s gene therapy approach of AAV-mediated gene transfer is designed to deliver a simply administered, single dose treatment for conditions where long-lasting expression of a therapeutic protein can alter the course of the disease. This is an exciting concept that builds on decades of basic and clinical research now validated by the emergence of FDA-approved products for humans. I look forward to pioneering this approach in veterinary medicine as part of the Scout team.”

Dr. Traas most recently served as Head of Saint Joseph Pharma Clinical R&D at Boehringer Ingelheim (BI) Animal Health, the U.S.-based animal health subsidiary of BI. In that role, she led a team of scientists and clinical operations specialists responsible for target animal safety and efficacy studies for the development of new therapeutics. In prior roles at BI, Dr. Traas served as Associate Director of U.S. Biological Clinical Development and Associate Director of Pharmaceutical Clinical Development, driving clinical development of novel veterinary pharmaceuticals while guiding study design, implementation and regulatory compliance.

“Anne is a proven research leader with deep experience in clinical program execution and regulatory engagement,” said Mark Heffernan, PhD, Chief Executive Officer of Scout Bio. “With Scout’s advancing pipeline of novel biotherapeutic approaches in development for major chronic pet health conditions, we are thrilled to welcome Anne’s specialist expertise to the oversight of our portfolio.”

Earlier in her career, Dr. Traas was involved in gene therapy research as a resident in medical genetics and a clinical trials veterinarian at the University of Pennsylvania, with a focus on translational medicine. She began her career as a practicing veterinarian in general companion animal care. Dr. Traas earned her Master of Science in translational research from the University of Pennsylvania School of Medicine, and her DVM and Bachelor of Science from the University of Minnesota.

About Scout Bio

Scout Bio is a biotechnology company focused on revolutionizing pet medicine by delivering a pipeline of one-time therapeutics for major chronic pet health conditions. Scout has an exclusive research and development collaboration with the University of Pennsylvania’s Gene Therapy Program, which has been a global leader in gene therapy research and development for nearly three decades. Scout’s therapeutics are designed to induce long-term expression of therapeutic proteins in pet patients using AAV vector technology. Scout Bio is ​a private company headquartered in Philadelphia, Pennsylvania. For more information, please visit www.scoutbio.co.

Media Contact

Tom Donovan, Ten Bridge Communications
tom@tenbridgecommunications.com
+1 857-559-3397

Financing to drive leadership in AAV vector-delivered one-time therapies for major chronic pet health conditions

Company supported by leading life sciences investors and an R&D collaboration with the Gene Therapy Program in the Perelman School of Medicine at the University of Pennsylvania

Recent executive appointments provide global expertise in animal biologics clinical R&D, regulatory affairs, AAV manufacturing, and gene therapy research

PHILADELPHIA, April. 10, 2019 – Scout Bio, a biotechnology company focused on revolutionizing pet medicine by delivering a pipeline of one-time therapeutics for major chronic pet health conditions, today announced a $20 million Series B financing to advance its pipeline and expand clinical and other operations. The financing was co-led by Digitalis Ventures’ Companion Fund and RiverVest Venture Partners, and was joined by new investor GreenSpring Associates as well as existing investors Frazier Healthcare Partners, Adage Capital Management and Correlation Ventures. In conjunction with the financing, Nancy Hong of RiverVest Ventures, Cindy Cole of Digitalis Ventures, and Aditya Kohli of Frazier Healthcare Partners will join the board alongside existing directors Mark Heffernan, Tachi Yamada, and Patrick Heron.

Scout was founded to harness the same genetic revolution transforming human medicine to deliver the future of veterinary medicine. Scout is advancing a number of programs across chronic kidney disease, chronic pain and the inflammatory skin condition atopic dermatitis. The company’s approach is to deliver long-term expression of therapeutic proteins in pet patients using adeno-associated viral (AAV) vector technology, administered through a single intramuscular injection.

Scout Bio has entered into an AAV animal health research and development collaboration with the Gene Therapy Program (GTP) at the Perelman School of Medicine at the University of Pennsylvania (Penn), led by Jim Wilson, M.D., Ph.D, a Scout scientific advisor and co-founder. The GTP has been a global leader in gene therapy research and vector discovery and development for nearly three decades. Through a separate license agreement between Scout and Penn, Scout is granted exclusive worldwide rights to multiple AAV-based veterinary product candidates and associated AAV technologies for animal health.

“Scout’s mission is to leverage advances in gene therapy to dramatically elevate the standard of care for multiple areas of veterinary medicine that currently rely on chronically administered medicines,” said Mark Heffernan, Ph.D., Chief Executive Officer of Scout Bio. “Our approach is designed to provide improved patient outcomes via therapies that have a sustained duration of effect from a one-time dose, aligning with the significant market need for longer-lasting pet medications that improve compliance and convenience.”

“In the United States alone, there are 90 million dogs and 94 million cats, underscoring the opportunity in a new generation of medicines that dramatically improve standards of care for major chronic conditions. We are impressed with Scout’s strategy for meeting this need and look forward to supporting them into clinical development,” said Cindy Cole, DVM, Ph.D., Technical Partner at Digitalis Ventures.

“Scout has assembled an executive team which unites experts in animal biologics development with world-leading AAV research and manufacturing capabilities, a combination uniquely suited to deliver on the promise of the company’s technology platform for innovative veterinary medicines,” said Nancy Hong, Ph.D., Managing Director of RiverVest Ventures.

Scout’s most advanced therapeutic candidate is designed to deliver long-term expression of feline erythropoietin (EPO) in cats with anemia associated with chronic kidney disease. This condition leads to a progressive deterioration in quality-of-life, has no FDA-approved therapy, and current standards of care have severe drawbacks. Scout has recently demonstrated statistically significant increased red blood cell counts (an EPO biomarker) in cats for months after a single intramuscular injection, and has initiated a clinical pilot field study (the stage immediately prior to pivotal studies in animal health) for this program. A proprietary survey of 424 veterinarians indicated that over 90% of veterinarians would use a product with Scout’s target profile over all other treatments for feline anemia, citing life-long efficacy as its most attractive feature.

“The GTP is looking forward to extending its long-term leadership in AAV research and development into companion animal health to address the compliance challenges associated with frequent administration and provide new modalities for tackling chronic disease,” said Dr. Jim Wilson of Penn’s GTP. “There is now a confluence between matured gene therapy technologies and medical need in animal health, and we believe Scout is positioned very strongly at that intersection and opportunity.”

About Scout Bio

Scout Bio is a biotechnology company focused on revolutionizing pet medicine by delivering a pipeline of one-time therapeutics for major chronic pet health conditions. Scout has an exclusive research and development collaboration with the University of Pennsylvania’s Gene Therapy Program, which has been a global leader in gene therapy research and development for nearly three decades. Scout’s therapeutics are designed to induce long-term expression of therapeutic proteins in pet patients using AAV vector technology. Scout Bio is ​a private company headquartered in Philadelphia, Pennsylvania. For more information, please visit www.scoutbio.co.

Penn Financial Disclosure

Dr. Wilson is a Penn faculty member and also a scientific collaborator, consultant and co-founder of Scout Bio. As such, he holds an equity stake in the Company, receives sponsored research funding from Scout Bio, and as an inventor of the licensed technology he may receive additional financial benefits under the license in the future. The University of Pennsylvania also holds equity and licensing interests in Scout Bio.

About Digitalis

Digitalis is a venture capital firm that invests in solutions to complex problems in human and animal health. The firm partners with entrepreneurs, inventors, and scientists across all stages of venture investing, and its investments span the full continuum of the healthcare ecosystem. In addition to its healthcare activities, Digitalis manages the Companion Fund, the first venture capital fund to focus exclusively on innovations in pet care. Digitalis has offices in New York City, Boston, San Francisco, and Los Angeles. To learn more, please visit: www.digitalisventures.com.

About RiverVest Venture Partners

RiverVest Venture Partners is a venture capital firm focused on identifying and shaping early stage life science companies to create significant shareholder value. With hands-on, high-level expertise and financial resources, RiverVest supports entrepreneurs by helping them achieve near-term objectives that position their companies for exit. Visit www.rivervest.com and follow on Twitter @Rivervest.

Media Contact

Tom Donovan, Ten Bridge Communications
tom@tenbridgecommunications.com
+1 857-559-3397