• Partnership agreement includes exclusive rights in animal health to novel viral vector capsid and expands additional option rights to novel capsids
• Next-generation novel adeno-associated viral (AAV) vector capsid promises enhanced manufacturability
• Expanded partnership with Penn’s Gene Therapy Program continues to strengthen Scout Bio’s long-term leadership position in companion animal gene therapy

Philadelphia, PA December 7, 2021 – Scout Bio, a biotechnology company focused on one-time AAV gene therapies for major chronic pet health conditions, today announced the expansion of their foundational collaboration agreement with the Gene Therapy Program (GTP) at the University of Pennsylvania (Penn) to grant Scout Bio exclusive rights in the field of animal health to an emerging viral vector capsid technology for use in animal gene therapy, as well as extended option terms to other next-generation AAV vector technologies.

Scout Bio has undertaken a thorough evaluation of this new capsid, which is now the basis of several of Scout Bio’s programs undergoing in-species veterinary clinical trials. This capsid has been optimized for enhanced manufacturability to significantly increase yield per production batch. The next generation capsid may also deliver enhanced targeting of muscle cells, further supporting Scout Bio’s focus on gene therapy treatments that emphasize convenience for owners and ease of administration and integration into veterinary practice.

The collaboration expansion, which includes additional rights to novel capsids, leverages world leading AAV capsid discovery, development, and engineering programs under the direction of James M. Wilson, Director of the Gene Therapy Program at Penn and a co-founder of Scout Bio.

“This expanded collaboration supports Scout Bio’s continued scientific leadership in pet gene therapy and supports the manufacturing and commercial planning for our portfolio – which is already delivering meaningful clinical outcomes. We are proud to leverage the world’s leading AAV technologies to complement our in-house expertise in preclinical R&D, manufacturing, and clinical execution,” said Mark Heffernan, Ph.D., Chief Executive Officer at Scout Bio.

“Scout Bio’s complementary expertise means our partnership is ideally suited to deliver an entirely new paradigm to veterinary medicine and see transformational benefits in complex chronic diseases in companion animals,” Wilson said. “Scout Bio’s progress in veterinary patients is now showing significant potential of the AAV gene therapy platform for more expanded applications across multiple species.”

With three AAV product candidates in clinical development and the ability to move from concept to the clinic rapidly, Dr Heffernan said, “Scout Bio has built a discovery and development engine designed to meet the major needs in pet chronic disease with affordable, convenient, and durable one-time gene therapies.”

About AAV Vector-Based Gene Therapies For Pets
Scout Bio is the leading developer of gene therapies for pets. Each gene therapy candidate is a single injection designed to induce long-term expression of a therapeutic protein to treat a particular serious chronic veterinary disease or condition. Scout Bio uses a highly validated technology for the delivery of therapeutic genes called adeno-associated viral (AAV) vectors.

A ‘vector’ is a transporter for genetic material. AAV vectors are the most commonly used and studied delivery technology in gene therapy today. The exclusive rights covered in the collaboration agreement with Penn cover animal health applications of a new type of AAV vector capsid, which is the protein shell that mediates delivery of a vector’s payload to target cells. Capsid engineering can bring a range of additional benefits. For example, Scout Bio’s novel AAV vector capsids have delivered dramatic improvements in the manufacturability of the vector.

Scout Bio focuses on intramuscular delivery of gene therapies for pets to maximize convenience and integration into veterinary practice. The company’s data suggests that intramuscular delivery may deliver superior durability of therapeutic effect and mitigate any dampening effect of natural antibodies against AAV vectors. Scout Bio’s candidates are therefore optimized to specifically deliver therapeutic genes to muscle cells.

About Scout Bio
Scout Bio is a biotechnology company revolutionizing pet medicine by delivering a pipeline of one-time gene therapies 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 a research and development collaboration with the University of Pennsylvania’s Gene Therapy Program, a leader in the field of genetic medicine research. Scout Bio is a private company headquartered in Philadelphia, Pennsylvania. For more information, see www.scoutbio.co

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

For further information, please contact:
Fran Gaconnier
Scout Bio
214.417.4142
fran.gaconnier@scoutbio.co

IHS Markit recognizes Scout Bio for pioneering therapies in companion animal medicine

PHILADELPHIA, November 08, 2021 — Scout Bio, a biotechnology company focused on one-time AAV gene therapies for major chronic pet health conditions, received top honors as the Best Start-up 2021 from the IHS Markit Animal Health Awards. Judged by an independent panel of industry experts, the awards honor a firm’s ability to innovate, attract investment, and execute exciting R&D achievements within the animal health sector during a calendar year.

Joseph Harvey, Head of Animal Health at IHS Markit, said: “Scout Bio’s progress has really stood out in 2021. It has a team of proven innovators that are again showing momentum in the companion animal therapeutics segment. This year, the start-up has shown significant development with both clinical trials and fundraising. The judging panel believe Scout Bio will be a key innovator of the future.”

Over the last twelve months, Scout Bio has accomplished a number of animal health industry firsts including the:

• First gene therapy in clinical development to successfully treat feline patients with an acquired non-monogenic disease (chronic kidney disease associated anemia)
• First to clinically advance a novel GLP-1 analog expressed via adeno-associated virus (AAV) gene therapy for feline diabetes in companion animal patients
• First vectorized monoclonal antibody to be studied in feline chronic pain when delivered by AAV gene therapy

“This award is welcomed recognition acknowledging our team’s innovative work in achieving a number of industry firsts amidst a year of COVID-related challenges,” said Mark Heffernan, Ph.D., Chief Executive Officer at Scout Bio. “I couldn’t be more proud of our team and key collaborators for their commitment to advancing gene therapy innovation in pet patients in a number of chronic diseases over this past year. In addition to these groundbreaking pipeline milestones, we are strongly positioned to continue to advance Scout Bio’s portfolio of AAV delivered therapeutic proteins for companion animal diseases thanks to the recent closing of additional financing.”

A spin-out company from the University of Pennsylvania (Penn) and the laboratory of Dr. Jim Wilson at Penn’s Gene Therapy Program (GTP), Scout Bio is uniquely able to leverage the expertise of GTP to accelerate discovery and development efforts in this exciting new field of companion animal medicine. “Scout Bio is on target to significantly disrupt the field by showing that AAV gene therapy can deliver therapeutic proteins as a single-injection alternative to weekly or monthly injectable proteins,” Wilson said. “Scout Bio’s progress in veterinary patients is now showing significant potential of the AAV gene therapy platform for more expanded applications in a multitude of species.”

About Scout Bio
Scout Bio is a biotechnology company revolutionizing pet medicine by delivering a pipeline of one-time gene therapies 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 a research and development collaboration with the University of Pennsylvania’s Gene Therapy Program, a leader in the field of genetic medicine research. Scout Bio is a private company headquartered in Philadelphia, Pennsylvania. For more information, see www.scoutbio.co

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

For further information, please contact:
Fran Gaconnier
Scout Bio
214.417.4142
Fran.gaconnier@scoutbio.co

– First vectorized antibody gene therapy to be studied in pets

– Strong initial in-species data support therapeutic profile of one-time gene therapy designed for long-term pain management

– Novel monthly pain management antibody therapy also assessed as part of study design

– Topline data expected in Q3 2022

PHILADELPHIA, October 28, 2021 – 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 initiation of a clinical study to evaluate the safety and efficacy of SB-007, the company’s one-time AAV gene therapy for chronic arthritis pain in cats. After a single injection, SB-007 is designed to trigger consistent long-term production of an antibody that inhibits a pain-promoting protein called nerve growth factor (NGF) in cats. The study will also assess SB-011, which is the anti-NGF antibody encoded by SB-007, in parallel development as a monthly injection.

“Pet owners and veterinarians are looking for ways to relieve chronic pain and restore quality of life in the most convenient, long-lasting way, which is the promise of one-time gene therapies like SB-007,” said Mark Heffernan, Ph.D., Chief Executive Officer of Scout Bio. “Emerging anti-NGF antibody therapies have validated the potential of this approach, and as the leaders in pet gene therapy Scout Bio has a clear opportunity to significantly improve treatment options in this major therapeutic area, as we are also doing in anemia, diabetes and atopic dermatitis.”

The study is a multi-center placebo-controlled pilot clinical study that will target enrollment of 132 client-owned (pet) cats in veterinary clinics throughout the United States. The study will include an evaluation of the SB-011 antibody given monthly; or two combination groups where one dose of SB-011 is followed two weeks later by one of two dosages of the SB-007 gene therapy. The transition enables the direct assessment of anti-NGF activity and clinical outcomes delivered by a monthly antibody versus a one-time gene therapy. Endpoints will include validated owner-assessment tools for pain and mobility in cats. Topline data from the study is expected in the third quarter of 2022.

Both SB-007 and SB-011 target feline NGF which has been shown to play an important role in the production of pain signals and inflammation in diseases like degenerative joint disease (DJD). Inhibition of NGF is intended to dramatically reduce or eliminate pain, improving a cat’s quality of life and mobility.

“Our anti-NGF candidates represent another major innovation to emerge from our proprietary research and AAV development platform. This study expands our work in vectorized antibodies, a gene therapy approach that allows patients to produce their own therapeutic antibodies after a single, intramuscular dose of gene therapy,” said Matt Wilson, Scout Bio’s VP of Product Discovery and External Innovation. “Anti-NGF antibodies are only the first of many antibodies that may be vectorized through a design process where we have specialist expertise based on our foundational partnership with the University of Pennsylvania’s Gene Therapy Program. In addition to feline anti-NGF vectorized antibodies, we are also advancing a canine anti-NGF and an anti-IL-31 antibody program for the major area of atopic dermatitis.”

Data highlights from completed studies of SB-011 and SB-007 to-date include:

• SB-011: This monoclonal antibody (mAb) candidate has demonstrated potent neutralizing activity and repeat dosing in healthy cats has been shown to achieve a serum concentration with potential for therapeutic effect. SB-011 has also demonstrated favorable safety following multiple repeated subcutaneous injections. No immunogenicity has been observed.
• SB-007: Our gene therapy program to express our SB-011 monoclonal antibody has demonstrated the ability to produce sustained plasma levels of the monoclonal antibody within a target therapeutic concentration for over a year after a single injection. The animals in this pre-clinical study continue to be followed long-term.
• No drug related adverse events have been observed with either product.

About Feline Chronic Pain and Degenerative Joint Disease (DJD)
Degenerative joint disease, also known as osteoarthritis or degenerative arthritis, is one of the most significant and under-diagnosed diseases of cats. It involves the destruction of cartilage and supportive tissue which causes pain. 90% of cats over age 12 have radiographic evidence of joint disease. It is difficult for owners to recognize clinical symptoms of arthritis in a cat, as they often conceal their pain. Nearly 40% of all cats have clinical signs of DJD which are often mistaken for normal signs of aging. They include limping, difficulty with stairs, stiffness upon rising, pain when petted, and inability to jump.

Veterinarians spend considerable time educating their clients about chronic diseases such as DJD. Clients and patients – particularly cats – struggle with the need for regular treatments to manage chronic disease or pain. A pet’s limited ability to clearly communicate when they are experiencing early symptoms of their chronic conditions can prevent early intervention. These factors often result in both poor compliance and patient outcomes for chronic diseases. Scout Bio’s proprietary market data strongly supports the eagerness of veterinarians for one-time therapies that can effectively answer these challenges.

About Scout Bio
Scout Bio is a biotechnology company revolutionizing pet medicine by delivering a pipeline of one-time gene therapies 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 a research and development collaboration with the University of Pennsylvania’s Gene Therapy Program, a leader in the field of genetic medicine research. Scout Bio is a private company headquartered in Philadelphia, Pennsylvania. For more information, see www.scoutbio.co.

For further information, please contact:

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

– Proceeds to support advancing single injection Adeno-Associated Viral (AAV) vector therapeutics targeting chronic companion animal diseases including diabetes, pain, and anemia associated with chronic kidney disease (CKD)

– New investors to the syndicate include leading healthcare investment firm OrbiMed

Philadelphia, PA – October 19, 2021 – 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 the closing of a Series B2 financing, which raised a total of $33.0 million. This financing round included new investors, including OrbiMed and a major animal health company, along with existing Series B1 investors: Digitalis Ventures, Frazier Healthcare Partners, RiverVest Venture Partners, Greenspring Associates, Adage Capital Management and Correlation Ventures. Proceeds from the financing will advance the clinical development of Scout Bio’s lead product candidates targeting diabetes, feline pain associated with osteoarthritis and CKD-associated anemia, in addition to research efforts in further indications.

“We are pleased to welcome the validating support of world-class investors who share our excitement for innovation in veterinary medicine.  The financial commitment from our broadened investor base will enable us to further deliver on the clinical development of our programs in a number of conditions, such as diabetes and chronic pain,” said Mark Heffernan Ph.D., Chief Executive Officer at Scout Bio. “We are very excited to have recently generated meaningful clinical data in patients with CKD-associated anemia, proving that AAV gene therapy can be efficacious in client owned animals with chronic diseases. Scout Bio is on target to deliver on our platform over the next twelve months, making single-shot therapies expressing validated protein therapeutics a reality in veterinary medicine.”

About Scout Bio
Scout Bio is a biotechnology company revolutionizing pet medicine by delivering a pipeline of one-time gene therapies 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 a research and development collaboration with the University of Pennsylvania’s Gene Therapy Program, a leader in the field of genetic medicine research. Scout Bio is a private company headquartered in Philadelphia, Pennsylvania. For more information, see www.scoutbio.co

About OrbiMed
OrbiMed is a leading healthcare investment firm, with $19 billion in assets under management. OrbiMed invests globally across the healthcare industry, from start-ups to large multinational corporations, utilizing a range of private equity funds, public equity funds, and royalty/credit funds. OrbiMed maintains offices in New York City, San Francisco, Shanghai, Hong Kong, Mumbai and Herzliya. OrbiMed seeks to be a capital provider of choice, providing tailored financing solutions and global team resources and support to help build world-class healthcare companies.

For further information, please contact:
Fran Gaconnier
Scout Bio
214.417.4142
fran.gaconnier@scoutbio.co

PHILADELPHIA, Oct. 04, 2021 (GLOBE NEWSWIRE) — 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.

• Chardan 5th Annual Genetic Medicines Conference (Virtual) on Monday, October 4, 2021 at 5:00 p.m. ET
• Jefferies Gene Therapy/Editing Summit (Virtual) on Thursday, October 28, 2021 at 2:00 p.m. ET

About Scout Bio
Scout Bio is a biotechnology company revolutionizing pet medicine by delivering a pipeline of one-time gene therapies 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 a research and development collaboration with the University of Pennsylvania’s Gene Therapy Program, a leader in the field of genetic medicine research. Scout Bio is a private company headquartered in Philadelphia, Pennsylvania. For more information, see www.scoutbio.co

For further information, please contact:
Fran Gaconnier
Scout Bio
214.417.4142
Fran.gaconnier@scoutbio.co

PHILADELPHIA, September 9, 2021 — Scout Bio today announced the successful completion of a CKD-associated anemia study in client owned cats treated with SB-001, an AAV expressing feline erythropoietin (fEPO). The study demonstrated a prolonged therapeutic effect with statistically significant increases in red blood cells after a single injection. SB-001 is the first gene therapy to successfully treat feline patients with an acquired non-monogenic disease. These results pave the way for Scout Bio’s portfolio of AAV delivered therapeutic proteins for companion animal diseases.

Clinical Study Highlights:

• Studies compared the change in Packed Cell Volume (PCV), an indicator of increased hematocrit or red blood cell number, from baseline in twenty-three client owned cats with kidney disease;
• All cats received therapy and success was defined as an increase in PCV into the normal range or ≥5 percentage points above their pre-treatment PCV;
• A single dose has now been selected that significantly increased PCV (p<0.05), 87% of cats met success criteria by showing clinically relevant increases in PCV;
• A study published by Boyd in 2008 determined that 95% of Stage 4 CKD cats will die by 99 days after diagnosis. In the Scout Bio study, 44% of treated Stage 4 cats lived longer than 99 days, with one cat living to 339 days post-treatment;
• The single injection AAV treatment is expected to last the rest of the cat’s life, therefore offering a significant compliance and convenience advantage over current intervention (i.e., off-label human EPO or blood transfusions) or future approaches; and
• No immune response to fEPO was observed with SB-001 treatment in any feline patient. In contrast, off-label use of human drugs in cats is reported to carry a high risk of a life-threatening immune reaction to the drug.

“In this study we have successfully shown that SB-001 has the ability to increase PCV into the normal range, thereby reducing or eliminating the clinical effects of anemia associated with CKD.” said Mark Heffernan, Ph.D., CEO of Scout Bio. “These exciting results reinforce the potential for Scout Bio’s gene therapy platform to advance treatments for other acquired chronic diseases such as diabetes, chronic pain and atopic dermatitis.”

There are no FDA-approved treatments available for CKD-associated anemia in cats. The single injection treatment of SB-001 presents an enormous advantage in convenience, improved compliance, and potentially allows owners more quality time with their pets. “A new option for cats with kidney disease and anemia is urgently needed. These cats come into the veterinary clinic with weakness, lethargy, breathing difficulties, and overall feeling very unwell. SB-001’s ability to increase the PCV can make a huge difference for many of these cats that would otherwise face euthanasia,” said Anne Traas, DVM, MS, DACT, Chief Development Officer for Scout Bio and head of the clinical team leading the study. “It was very rewarding to hear from owners participating in the study, who expressed their deep gratitude for the additional time SB-001 was able to provide their beloved pets.”

James M. Wilson, MD, PhD, Director of the Gene Therapy Program at the University of Pennsylvania and a co-founder of Scout Bio, commented, “Scout Bio’s focus in companion animals with chronic diseases has resulted in this successful demonstration that AAV gene therapy can be an effective alternative to frequent injections with therapeutic proteins and result in the improvement of feline patient lives. These results provide validation that Scout Bio’s platform can be used to successfully deliver therapeutic proteins to treat chronic diseases in companion animals.”

Scout Bio intends to progress key manufacturing activities and safety studies that will be necessary to apply for Expanded Conditional Approval under FDA guidelines.

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 off-label 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 revolutionizing pet medicine by delivering a pipeline of one-time gene therapies 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 a research and development collaboration with the University of Pennsylvania’s Gene Therapy Program, a leader in the field of genetic medicine research. Scout Bio is a private company headquartered in Philadelphia, Pennsylvania. For more information, see www.scoutbio.co

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

For further information, please contact:
Fran Gaconnier
Scout Bio
214.417.4142
Fran.gaconnier@scoutbio.co

PHILADELPHIA, May 27, 2021 (GLOBE NEWSWIRE) — Scout Bio today announced that Mark Heffernan, Chief Executive Officer, will present at the upcoming Stifel 2021 Virtual Jaws & Paws Conference on Thursday, June 3, 2021 at 3:00 p.m. ET.

About Scout Bio
Scout Bio is a biotechnology company revolutionizing pet medicine by delivering a deep pipeline of one-time gene therapies 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 a research and development collaboration with the University of Pennsylvania’s Gene Therapy Program, a leader in the field of genetic medicine research. 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

PHILADELPHIA, Feb. 18, 2021 (GLOBE NEWSWIRE) – Scout Bio, a biotechnology company revolutionizing pet medicine by delivering a pipeline of one-time gene therapies for major chronic pet health conditions, today announced that Mark Heffernan, Scout Bio’s Chief Executive Officer, will present at the upcoming BofA Securities 2021 Animal Health Summit on Thursday, February 25, 2021 at 2:35 p.m. ET.

About Scout Bio
Scout Bio is a biotechnology company revolutionizing pet medicine by delivering a pipeline of one-time gene therapies 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 a research and development collaboration with the University of Pennsylvania’s Gene Therapy Program, a leader in the field of genetic medicine research. 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

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 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.

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