Two pilot studies initiated to explore clinical applications for this convenient, one-time injectable treatment

Positions Scout Bio as the first company to advance novel GLP-1 constructs for gene therapy in companion animals

PHILADELPHIA, October 28, 2020 – 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 it has initiated two pilot clinical studies to demonstrate effectiveness of an AAV expressing a GLP-1 analog (SB-009) in treating diabetic felines.

Scout Bio envisions two potential therapeutic applications for SB-009. First, to replace daily insulin injections with a single injection of SB-009 to treat feline diabetes and second to significantly increase the percentage of cats entering remission when SB-009 is given with insulin.

The two initiated pilot clinical studies will investigate each of these two potential treatment paradigms.

• The initial pilot study will recruit a minimum of 20 cats and evaluate if SB-009 is safe and efficacious in the management of the clinical signs and high blood sugar levels of feline diabetes.
• A separate clinical study enrolling approximately 60 cats, followed for six months, will determine if adding SB-009 to insulin can significantly increase the percentage of cats entering remission.

Mark Heffernan, Ph.D., Chief Executive Officer of Scout Bio remarked, “This one-time injectable therapy for feline diabetes has the potential to provide a convenient single treatment that is an alternative to the burden of twice daily insulin injections. We believe SB-009 has the potential to be a blockbuster product for animal health and that our pipeline of gene therapy products for pets will disrupt and grow major markets.”

SB-009 was developed under a collaboration between scientists at Scout Bio and the University of Pennsylvania’s Gene Therapy Program, where the protein was engineered to improve potency, circulating accumulation kinetics and manufacturability. The design of SB-009 makes the clinical dose both affordable and commercially attractive.

Matthew Wilson, VP Product Discovery and External Innovation said, “This is a further example of our strong collaborative relationship with UPenn’s Gene Therapy Program and Scout’s internal capabilities of executing preclinical research to rapidly identify highly potent AAV gene therapies. In less than 12 months after initiating a discovery program, we are now in a position to transition into patients.”

Scout Bio has conducted robust preclinical studies with various GLP-1 constructs in rodents and healthy cats. Key findings include:

• Sustained dose-related GLP-1 analog expression in cats, over the targeted therapeutic concentration, lasted out to five months after a single intramuscular injection in an ongoing study
• A clear dose-related pharmacokinetic profile, with the highest dose of SB-009 showing no adverse effects and expressing the GLP-1 analogue significantly above the expected therapeutic levels
• Ex vivo potency verification against known effective molecules demonstrating active products secreted from transduced muscle cells of cats
• Blood glucose correction and weight reduction in representative mouse diabetes models versus controls and dose dependent biologic activity demonstrated in healthy cats

Dr. Anne Traas, Scout Bio’s Chief Development Officer reflected, “Owners can be devastated to learn their pet has this life-threatening disease and unfortunately, many are unable to give twice daily insulin injections and have to make the difficult choice to euthanize their beloved pet. A one-time safe and efficacious therapy, given by a veterinarian, that eliminates the need for insulin and worry of hypoglycemia, would greatly improve the current treatment paradigm and result in an improved quality of life for diabetic cats and their owners.”

Feline diabetes, a severe disease lacking recent innovation, remains a major challenge for veterinarians and owners to safely and effectively manage. Diabetes in most cats is similar to type 2 diabetes in people. Insulin resistance, caused by factors such as obesity, leads to Beta-cell disfunction (the cells that produce insulin). Cats become insulin dependent when blood sugar levels rise, commonly 3-10 times normal, leading to the development of clinical signs which can seriously and negatively impact both the owner and the cat. The most common signs are increased drinking, increased urination and weight loss despite ravenous appetite.

About SB-009
SB-009 is a recombinant AAV gene therapy viral vector utilizing a novel capsid expressing an engineered feline GLP-1 agonist for the treatment of feline diabetes. GLP-1 has been shown to be a safe and highly efficacious molecule in the treatment of humans with type 2 diabetes and SB-009 is the first gene-therapy delivered GLP-1 to be studied in clinical studies in cats with a view to treat the disease.

The expressed feline GLP-1 analog protein functions by stimulating the beta-cells in the pancreas to produce more insulin and may also have an effect in decreasing insulin resistance. GLP-1 receptor agonists do not decrease glucose levels in animals with normal blood glucose, so there is expected to be a very low, or no risk of hypoglycemia.

About Feline Diabetes
Most diabetic cats appear to have disease similar to human type 2 diabetes, which is primarily defined as a combined problem with insulin production by the beta-cells in the pancreas, as well as a decrease in the sensitivity to the normal action of insulin (insulin resistance). In cats, one of the most common factors contributing to insulin resistance is obesity which reduces insulin sensitivity.

Lack of insulin production and decreased sensitivity to insulin causes the glucose (sugar) in the blood to become very high leading to the clinical signs. Very high levels of blood glucose also hurt the beta-cells in the pancreas, leading to further reductions in insulin production.

Substantial progress has been made in the treatment of human type 2 diabetes, even in the early stages of the disease. However, insulin therapy remains the only FDA-approved treatment for diabetes in cats.

About Current Treatment | Feline Diabetes
Current therapy aims to replace the insulin that the cat’s body no longer makes by injecting insulin twice daily. Giving insulin in the right amounts may bring the blood sugar levels down. If the blood glucose can be brought under control for the majority of a 24-hour period each day, then the clinical signs will be reduced to manageable levels. Too much insulin can cause the blood sugar to drop to dangerous levels (hypoglycemia), so there has to be a careful balance made between maintaining ideal blood glucose levels and administering too much insulin which may result in life threatening low blood sugar levels.

Often owners find the prospect of administering injections to their cats daunting and the strict regimen of twice daily injections and feedings can be difficult to fit into a busy lifestyle. Unfortunately, not treating the cats is simply not a viable option and usually results in a rapid decline in physical health. Even with insulin treatment, some cats’ diabetes is not well controlled, resulting in the continuation of clinical signs and/or euthanasia.

About Diabetic Remission
Good control of blood glucose may also allow the beta-cells to ‘rest’. That rest may increase their capacity to regain some of their insulin-secreting ability. Insulin administration helps to decrease and control the excess blood glucose levels and complement whatever insulin producing ability the cat has left. In some cases, cats regain enough function to allow the insulin injections to stop. This is called diabetic remission. A cat is determined to be in remission when blood sugar is normal and there is complete correction of clinical signs once insulin has been discontinued.

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 Bio’s therapeutics are designed to induce long-term expression of therapeutic proteins in pet patients using AAV vector technology. Scout Bio 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. For more information, see 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

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.

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