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VETIGENICS ANNOUNCES SECOND DISCOVERY COLLABORATION WITH A MAJOR ANIMAL HEALTH PHARMA

New partnership established to explore multiple novel therapeutic antibodies for treating challenging pet diseases.

PHILADELPHIA, Nov. 8, 2022 /PRNewswire/ -- Vetigenics, an animal health biotechnology company, today announced a second discovery collaboration with a major animal health pharmaceutical company for use of the VETIGENICS CANIBODY™ Platform. The aim is to jointly discover and develop novel therapeutic antibodies to treat chronic diseases of companion animals.

The new collaboration provides further validation of the highly differentiated qualities of the Vetigenics platform, most notably its fully comprehensive and entirely canine antibody repertoire and speed of isolating high-value drug candidates.

"We are thrilled about the significant progress made by our growing team of superstars over the last two years," said Adriann Sax, Vetigenics CEO and co-founder. "We've entered two successful partnerships with major animal health companies, expanding our pipeline beyond cancer to include chronic conditions in both dogs and cats. We're confident that combining the power of our platform with our new partner's exceptional development and commercialization capabilities will lead to substantial market opportunities for superior therapeutic antibodies to treat companion animals."

Vetigenics' best-in-class entirely canine phage display platform offers distinct advantages over other approaches. Designed for dogs, by dogs, it's a proprietary technology that generates single chain variable fragments (scFvs) or CANIBODIES, which are isolated from canine genetic material and therefore 100 percent canine in origin and structure. Unique and precisely targeted, the technology eliminates the risk for immune response and allows for therapeutic versatility. And, unlike other technologies, validation of the target-specific binding for CANIBODIES occurs in the first step of development, which can help reduce overall R&D costs.

Earlier this year, Vetigenics completed a successful proof of concept study in dogs demonstrating the safety of VGS-001 (canine anti-CTLA4 mAb). Plans are also underway to launch a clinical trial in dogs with malignant melanoma.

"This new collaboration represents such an important milestone for us," said Vetigenics co-founder Nicola Mason, BVetMed, PhD, DACVIM. "We're delighted to have this new collaborative opportunity with leaders in the field of companion animal drug discovery and development, which aims to further advance our mission to effectively treat disease and improve the lives of companion animals."

About VETIGENICS, LLC

Vetigenics is a privately held animal health biopharmaceutical company committed to improving the health and well-being of companion animals through the discovery and development of species-specific, safe and effective antibody-based therapies to treat a wide range of the chronic diseases. The company's founders, Nicola Mason, BVetMed, PhD, DACVIM, and Don Siegel, MD, PhD, of the University of Pennsylvania, are internationally recognized leaders in veterinary medicine, immunotherapy, and phage display technology. Their complementary expertise naturally resulted in an unrivalled ability to generate best-in-class, antibody-based therapeutics for diagnostic purposes. For more information, visit www.vetigenics.com and connect with us on LinkedIn.

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VETIGENICS ANNOUNCES PUBLICATION OF COMPREHENSIVE PRECLINICAL DATA FOR ANTI-CANINE CTLA4 MONOCLONAL ANTIBODY

Published study confirms validity of the first entirely canine phage display technology to generate unique canine immunotherapy for treating canine cancer.

PHILADELPHIA, Jan. 5, 2022 /PRNewswire/ -- Vetigenics, an animal health biotechnology company, has announced preclinical data that paves the way for clinical evaluation of the first entirely canine, anti-CTLA4 antibody to promote anti-tumor immunity in dogs with immune-responsive cancers. Published in the current issue of mAbs,1 studies of Vetigenics' anti-CTLA4 antibody (A1mut2 mAb) demonstrated in vitro functionality as well as favorable in vivo safety and biodistribution properties in laboratory mice.

The manuscript, "Development of a Fully Canine Anti-Canine CTLA4 Monoclonal Antibody for Comparative Translational Research in Dogs with Spontaneous Tumors," describes the discovery, design and functional properties of this important immune checkpoint inhibitor. It also validates the use of Vetigenics' proprietary phage display libraries to rapidly isolate and evaluate novel, entirely canine antibodies.

"The results of this work are compelling," said Vetigenics co-founder Nicola Mason, BVetMD, PhD. "We've proven Vetigenics' unique platform and developed a novel veterinary checkpoint inhibitor that's specific for its target and promotes T cell responses. Now this antibody can move directly into canine clinical trials. Our ability to rapidly isolate, validate and evaluate our antibodies in vivo confirms Vetigenics can quickly bring promising new immune therapies to the clinic to support dogs with debilitating diseases."

Introduced in 2018, Vetigenics' technology is the first entirely canine phage display platform. Designed for dogs, by dogs, Vetigenics' proprietary technology consists of a large and comprehensive single chain variable fragment (scFvs) phage display library from which entirely canine scFvs or CANIBODIES™ can be rapidly isolated. CANIBODIES are derived from antibody sequences, which were created by and existed in dogs. They're not canonized, synthetic or generated from murine sources. This technology eliminates the risk for host anti-drug immune response, prolongs half-life, and allows for therapeutic versatility. Unlike other technologies, validation of the target-specificity of CANIBODIES occurs in the first step of development, which helps reduce overall R&D costs.

The first phase of the anti-CTLA4 study, led by Vetigenics co-founder Donald Siegel, MD, PhD, focused on selecting large arrays of canine anti-canine CTLA4 scFvs and identifying those with optimal functional properties. Then Dr. Mason and Vetigenics' scientists conducted preclinical studies evaluating the preliminary therapeutic potential of cCTLA4-specific scFvs based on their ability to block the interaction between cCTLA4 protein and its ligands, CD80 and CD86. Select clones were then chosen and reformatted into full length monoclonal antibodies for further testing. In vivo studies in mice were also conducted, which demonstrated safety and appropriate biodistribution.

"Immune checkpoint inhibitors and the ability to treat cancer by using the patient's own immune system has transformed cancer therapy for humans, but we have yet to be able to do that for our pets," Dr. Siegal said. "This new data is exciting because it suggests we will be able to offer this therapy to 'our best friends' to help improve the quality of their lives."

Full text of the manuscript and supplemental material are available for review and download at mAbs open access site: www.tandfonline.com/toc/kmab20/current.

1mAbs, Volume 13, Issue 1 (2021), www.tandfonline.com/toc/kmab20/current

About VETIGENICS, LLC

VETIGENICS is a privately held animal health biopharmaceutical company committed to improving canine health through the development of entirely canine, safe and effective antibody-based immunotherapies to treat chronic diseases of companion animals. The company’s founders, Nicola Mason, BVetMed, PhD, and Don Siegel MD, PhD, of the University of Pennsylvania are internationally recognized leaders in veterinary medicine, immunotherapy, and phage display technology. Their complementary expertise naturally resulted in an unrivalled ability to generate and validate entirely canine antibodies for therapeutic and diagnostic purposes. For more information, visit www.vetigenics.com and connect with us on LinkedIn.

About mAbs

mAbs is a multi-disciplinary journal dedicated to the art and science of antibody research and development. The journal has a strong scientific and medical focus, but also strives to serve a broader readership with articles of interest to scientists, clinical researchers, and physicians, as well as the wider mAb community, including technology transfer, legal issues, investment, strategic planning, and the regulation of therapeutics.

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VETIGENICS RECEIVES STARTUP OF THE YEAR AWARD FROM PENN CENTER FOR INNOVATION

Successful creation of the first entirely canine phage display platform for research and development of antibody immunotherapy spurs recognition for Vetigenics.

Vetigenics co-founders Don Siegel, MD, PhD; Nicola Mason, BVetMed, PhD; and Adriann Sax accept the Startup of the Year Award from the Penn Center for Innovation.

PHILADELPHIA, Dec. 3, 2021 /PRNewswire/ -- Vetigenics, a privately held animal health biotechnology company, has been chosen Startup of the Year 2021 by the University of Pennsylvania’s Penn Center for Innovation (PCI). Vetigenics received the award as part of PCI’s sixth annual Celebration of Innovation, an event where the Penn innovation community and its stakeholders issue a total of five awards, four going to faculty, researchers and partners, and one going to an outstanding startup.

Since its inception in 2017, Vetigenics has introduced the first entirely canine phage display technology, as well as a growing portfolio of CANIBODY™ immunomodulators in various stages of production and testing to treat cancer, infections and immune-mediated chronic diseases. The company has also been accepted into the competitive awards-based Small Business Innovation Research (SBIR) program and has entered into an extension of a collaborative discovery partnership with Merck Animal Health.

“All of us at Vetigenics are delighted by this honor and can’t thank the Penn Innovation community enough for the recognition,” said Adriann Sax, Vetigenics CEO and co-founder. “The award not only recognizes the breakthrough work of our co-founders, scientists and partners for safe and effective antibody immunotherapies, but it also affirms our commitment to improve the health and quality of life for companion animals. It inspires us to keep expanding the incredible potential of phage display technology and antibody immunotherapy for veterinary medicine.”

Vetigenics’ best-in-class entirely canine phage display platform offers distinct advantages over other approaches. Designed for dogs, by dogs, it’s a proprietary technology that generates single chain variable fragments (scFvs) or CANIBODIES, which are isolated from actual dog genetic material and 100 percent canine in structure. Unique and precisely targeted, the technology eliminates the risk for immune response and allows for therapeutic versatility. And, unlike other technologies, validation of the target-specific binding for CANIBODIES occurs in the first step of development, which can help reduce overall R&D costs.

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About VETIGENICS, LLC
VETIGENICS is a privately held animal health biopharmaceutical company committed to improving canine health through the development of entirely canine, safe and effective antibody-based immunotherapies to treat chronic diseases of companion animals. The company’s founders, Nicola Mason, BVetMed, PhD, and Don Siegel MD, PhD, of the University of Pennsylvania are internationally recognized leaders in veterinary medicine, immunotherapy, and phage display technology. Their complementary expertise naturally resulted in an unrivalled ability to generate and validate entirely canine antibodies for therapeutic and diagnostic purposes. For more information, visit www.vetigenics.com and connect with us on LinkedIn.

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VETIGENICS ANNOUNCES DISCOVERY COLLABORATION WITH MERCK ANIMAL HEALTH

Partnership extended to explore multiple novel therapeutic antibodies for treating challenging pet diseases

PHILADELPHIA, Nov. 2, 2021 /PRNewswire/ -- VETIGENICS, an animal health biotechnology company, today announced that it is extending its discovery collaboration with Merck Animal Health, a division of Merck & Co., Inc. for use of the VETIGENICS CANIBODY™ Platform to discover and develop novel therapeutic antibodies to treat chronic diseases of companion animals. The collaboration provides Merck Animal Health with multiple unique therapeutic candidates that could transform the way veterinarians treat a range of diseases in animals quickly and effectively.

“VETIGENICS is thrilled that Merck Animal Health has expressed confidence in VETIGENICS’ CANIBODY Platform for the discovery of novel, entirely canine, antibody-based therapeutics,” said Adriann Sax, CEO and Co-founder of VETIGENICS. “With our platform’s highly differentiated qualities, most notably the complete species-specific antibody repertoire as well as the speed in which we can isolate high-value drug candidates, we are confident that combining the power of our platform with Merck Animal Health’s exceptional development and commercialization capabilities will result in superior therapeutic antibodies to treat companion animals.”

VETIGENICS’ best-in-class entirely canine phage display platform offers distinct advantages over other approaches. Designed for dogs, by dogs, it’s a proprietary technology that generates single chain variable fragments (scFvs) or CANIBODIES which are isolated from actual dog genetic material and 100 percent canine in structure. Unique and precisely targeted, the technology eliminates the risk for immune response and allows for therapeutic versatility. And, unlike other technologies, validation of the target-specific binding for CANIBODIES occurs in the first step of development, which can help reduce overall R&D cost. VETIGENICS has built a portfolio of CANIBODY immunomodulators in various stages of production and testing to treat cancer, infections and immune-mediated chronic diseases.

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About VETIGENICS, LLC
VETIGENICS is a privately held animal health biopharmaceutical company committed to improving canine health through the development of entirely canine, safe and effective antibody-based immunotherapies to treat chronic diseases of companion animals. The company’s founders, Nicola Mason, BVetMed, PhD, and Don Siegel MD, PhD, of the University of Pennsylvania are internationally recognized leaders in veterinary medicine, immunotherapy, and phage display technology. Their complementary expertise naturally resulted in an unrivalled ability to generate and validate entirely canine antibodies for therapeutic and diagnostic purposes. For more information, visit www.vetigenics.com and connect with us on LinkedIn.

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An Interview with Adriann Sax, Biotech Executive & Entrepreneur

This week, Jason Colodne, Managing Partner at Colbeck, spoke with Adriann Sax, co-founder and CEO at Vetigenics, a prominent innovator in animal health that is one of the first companies to produce antibody-based immunotherapies for canines. She formerly served as CEO of Orsenix, a clinical stage biotech company focused on developing novel therapies to treat hematologic cancers.

With nearly three decades of pharmaceutical and biotech experience, Sax has overseen the global launch of leading oncology and immunotherapy drugs. She has held executive roles at Roche, BMS, Merck, King Pharmaceuticals, and Kadmon, and is continuously recognized for her commitment to the advancement and professional development of women within the pharmaceutical industry. Sax is a passionate advocate of the One Health movement, and believes it is our best hope for tackling animal and human disease challenges of the future.

Human and Animal Health are Converging

Colodne: Early on in your career, you started out with a background in animal science. How did you transition into pharmaceuticals?

Sax: I wanted to be a veterinarian since I was very young. I worked for a veterinarian starting at the age of twelve just cleaning out cages and doing all the grunt work. I really developed a passion for health, and animal health in particular, and so I went to undergrad for animal science with the hopes of going to vet school.

At the time, there were only 9 vet schools in the US and female vets from out of state were not a high priority, so it was difficult to get in. Instead, I pursued a job in veterinary pharmaceuticals and that's where I got a better understanding of the pharmaceutical industry and how drugs to treat animal diseases are developed. While in this job, I met a human pharmaceutical sales rep, and realized that there were tremendous opportunities on the human side of the business. As much as I enjoyed animal health, pharma was appealing because it seemed like I could really help people by treating disease.

I touched on most aspects of large pharma—sales, marketing, business development—before moving into startup biotech. I transitioned into biotech when the first antibodies to treat cancer hit the market and the science of antibody therapeutics was exciting to me. I also wanted to have more direct influence and hands-on experience with building companies and influencing the development path and commercialization of drugs. My primary expertise was in cancer, but I worked in other specialty therapeutic areas as well, predominantly with antibody therapeutics.

Over a year ago, I was recruited to transition Vetigenics from an academic startup to an independent animal health biotech. It was a wonderful full circle moment, because I could bring what I've learned in biotech to benefit pets suffering from cancer and other chronic diseases with very few treatment options.

Colodne: How has the distinction between human health and animal health changed over the course of your career?

Sax: Historically, most of the drugs that have been used to treat animals—with the exception of things like flea and tick treatments—were really repurposed drugs or generic drugs used in human medicine, and then used to treat those same diseases in animals. Now companies are much more focused on developing species-specific drugs. These drugs are clinically tested in the intended animal species with disease to ensure meaningful efficacy and safety of the drug for the animal patient. These drugs are specifically developed to address the individual needs of animals based on their underlying disease mechanisms versus trying to take human medicines and repurpose them.

Vetigenics actually started out as an initiative to develop fully canine antibody drugs for translational research using pet dogs with cancer as pre-clinical models of cancer. Humans and dogs have lived and evolved together over thousands of years with the same environmental exposures and genetic susceptibilities. So, it is not surprising that canine cancers occur spontaneously with similar presentation, molecular makeup, pathophysiology and natural progression of human cancers. By using pet dogs as parallel patient populations to accelerate human cancer drug development, we can reduce the high failure of drugs that may show efficacy when tested in a mouse but fail when tested in humans.

Vetigenics works very closely with the National Cancer Institute to ensure canine antibodies are available to advance human translational research. At the same time, we further develop these same antibodies as animal therapeutics to treat cancer and other chronic conditions. Thanks to the pandemic, the whole pet industry has seen a huge boost, so the timing is really optimal right now to introduce these types of therapies because the market is primed to consider them and to pay for them.

Is Pharma R&D in Decline?

Colodne: Since the 1990s, the return on investment in pharma R&D has steadily fallen, leading many to predict the industry’s “terminal decline.” Despite this, the past decade has seen a number of record-breaking years in terms of new drug approvals. Last year, the FDA approved 53 novel drugs. How are companies remaining productive?

Sax: I think that pharma is just as productive, but there is a change strategically. At one time there was a holistic focus on treating chronic diseases with millions of patients such as hypertension, diabetes and high cholesterol. These drugs enabled patients to live long, productive lives with chronic disease, but they were disease specific, not patient specific. There were a lot of “me too” drugs, or similar molecules offering incremental benefit compared to the innovator drug. Payers no longer reimburse patients for new drugs with minimal benefit when a cheaper generic alternative is available which can get the job done safely and effectively for MOST patients.

Now, pharma is really focused on meaningful innovation and patient-targeted therapies where new treatments cure disease, extend survival, substantially improve treatment outcomes, and reduce overall cost to the healthcare system. Although these innovations may treat smaller groups of patients, their impact is significant and pharmaceutical companies can recoup their investment in risk, time, and cost with higher prices. Payers have had the greatest effect on biopharma innovation. Despite the transformational role pharma and biotech have played on changing the course of lethal and rare disease, payers still make it exceedingly difficult for patients to receive these novel therapies and create obstacles for physicians to prescribe them. Payers have evolved to control drug pricing, making it much more difficult for pharmaceutical companies to bring to innovative products to market.

The decline in productivity is still high, but much of it occurs in early translation from animals to humans. There is a lot of work being done to validate the right target, to understand underlying disease mechanisms, and to select clinically relevant animal models of disease that can more accurately predict how different patients will respond to treatment. Identifying specific biomarkers of disease and response to treatment has also helped improve the productivity and cost of drug development, but for some disease areas the process is still very time consuming and costly.

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Animal Health Innovation USA Virtual Event

Animal Health Innovation USA | Virtual Event

Please join us on June 16 at 12:45pm to learn more about Vetigenics as a Innovation Showcase Finalist at the Animal Health Innovation USA virtual event.

Vetigenics aims to solve challenges in canine immunotherapy discovery and development

Adriann Sax has been appointed to advance Vetigenics from an academic start-up to an independent animal health biotech company.

Ms Sax was hired earlier this year as the firm's chief executive. While her undergraduate education and early career focused on animal health, Ms Sax has spent the last several decades in the human biopharma sector – working across large corporations and start-ups, with a particular focus on developing oncology and antibody-based therapeutics.

"Harnessing the power of the immune system to treat cancer and immune-related disorders in humans has resulted in improved survival, quality of life and reduced toxicity for people suffering from these devasting diseases," she told IHS Markit Animal Health. "There is now an increasing demand to develop safe, targeted immunotherapies for veterinary use so dogs may enjoy the same therapeutic benefits of this powerful approach."

Vetigenics is the brainchild of founders Nicola Mason and Don Siegel of the University of Pennsylvania. Dr Mason is a leader in veterinary medicine and immunotherapy with extensive experience in the performance of clinical trials in pet dogs using immunotherapy. She is a National Institutes of Health-funded researcher in the areas of comparative oncology and autoimmunity.

Dr Siegel is an internationally recognized authority in antibody phage display and has been a National Institutes of Healthfunded researcher in the areas of immunohematology, hemostasis, thrombosis, autoimmunity and oncology. Among his career accomplishments is participating in the development of CD19-directed chimeric antigen receptor T (CAR-T) therapy, which was the first FDA-approved genetically modified cellular therapy in human medicine licensed from UPenn and marketed under the brand name Kymriah by Novartis.

Founded in 2017, Vetigenics originally focused on development of immunotherapies for use in dogs with spontaneous diseases to accelerate the treatment of human cancers. However, Ms Sax is now helping the start-up look at the other end of the One Health spectrum and produce antibody therapeutics for the animal health market.

Vetigenics has exclusive access to canine single chain fragment variable (scFv) phage display libraries developed by Drs Mason and Siegel. This platform is estimated to contain over 40 billion independent scFv members.

In its vast discovery library, Vetigenics has the potential to pursue a wide variety of different therapeutic formats including full length monoclonal antibodies (mAbs), bi- and multi-specific antibodies, bi-specific T cell engagers (BiTEs), CAR-T and other cellular therapies.

Speaking at the recent Animal Health Investment One conference, Ms Sax stated: "Our proprietary phage display technology is derived from natural canine immunoglobulin gene rearrangements, and selection of antibodies from our phage display libraries is not subject to the tolerance mechanisms that plague other technologies that rely on animal immunization. We can rapidly generate multiple, fully canine antibody candidates against multiple epitopes of a specific target antigen with drug-like qualities ready for in vitro and in vivo validation.

"Currently marketed human immunotherapies that might cross-react with canine antigens would be rapidly rejected by the dog's immune system, rendering them ineffective. Development of entirely canine antibody therapies is needed to provide effective, target-specific, treatments for dogs with cancer and immune-related diseases.

"Existing competitive methodologies include chimeric or caninized murine antibodies, in silico design of canine-like antibodies, phage display of synthetic canine gene segments, and use of transgenic mice expressing a portion of the repertoire of canine antibody genes. These approaches are expensive, technically challenging, time consuming, require late-stage validation of binding affinity and specificity, and may induce anti-drug antibodies that limit their efficacy in vivo.

"Alternative approaches trying to generate canine antibodies through dog immunization are unlikely to yield high affinity antibodies to canine antigens because of natural immune tolerance mechanisms. Antibody-based immunotherapies have revolutionized the treatment of cancer and immune-related diseases in humans. However, this success has yet to be achieved for use in dogs due to the lack of validated, non-immunogenic, affordable and easily administered canine antibody-based medicines."

Vetigenics has "over four candidates" for the treatment of cancer and autoimmune disease that have passed the in vitro validation stage. The company is now moving its most advanced candidates to small-scale production for pilot studies in dogs by the year's end.

Commercial goals

Ms Sax stated: "Our goal is two-fold. One is to continue advancing our own product candidates and the second is to explore target antigen discovery collaborations with strategic partners. We think our value proposition is the power of our platform technology together with our ability to rapidly test novel therapies in dogs. These capabilities could be extraordinarily valuable for partners.

"If a company is interested in pursuing a research collaboration with us, we can very rapidly raise multiple candidates and move them through identification to lead candidate selection. In terms of the time from discovery to pre-clinical, clinical or pilot, we can reduce that significantly. We are able to generate multiple candidates to a target antigen for in vivo validation within weeks versus months.

"Other methods of developing antibodies can be time-consuming and have problems with affinity. I'm not saying all the other technologies are bad, but they are still plagued with problems because the antibodies are not native to the dog. Ours are completely natural."

Philadelphia-based Vetigenics has previously benefited from a $300,000 Small Business Innovation Research grant. While the firm has other grants pending, Ms Sax said it is eyeing supplementary funding to further advance additional candidates.

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TIAA 100th Anniversary Difference Makers

TIAA 100th Anniversary Difference Makers: Veterinarian Helping Dogs | TIAA

More than 10,000 dogs are diagnosed with bone cancer every year in the U.S. alone. They’re often given just a year to live. In this short film by Yoruba Richen, we meet Dr. Nicola Mason, a veterinarian who’s using a new dog cancer treatment to helps dogs’ immune systems fight back, adding years to their lives. Bone cancer in dogs is almost identical to cancer found in children. Listen to how Dr. Nicola Mason is discovering positive results and can potentially apply these findings to children in the future.