Industry Articles| Discovering Biotech Startups
Welcome to another edition of our Sponsor Atlas series, which focuses on startups and young pharmaceutical and biotechnology companies that are in early stages or stealth mode. In the next edition of Sponsor Atlas: Discovering Biotech Startups, we’re looking at Geneos Therapeutics, Inc., and exploring the current affairs and future orientation of this emerging Pennsylvania - based stealth biotech startup. To accomplish this, we will give a business overview of their current operations, summarize their outsourcing needs, map out their development goals and decision-makers, and highlight their current strategies for capturing innovation. If you haven’t already read our other blogs on new biotech startups, be sure to check them out here.
Geneos Therapeutics is developing a neo-antigen based personalized immunotherapy designed to offer novel cancer treatments. The company's technology is designed to identify relevant neoantigen targets from individual patient tumors to develop innovative treatments for cancer, providing patients with tumor targeted immunotherapies to cure their specific diseases.
Geneos Therapeutics is a registered trademark of Inovio Pharmaceuticals. They also have a thoroughly developed website, full of information about their executive team, product development, key publications and R&D pipeline. The company was established in Delaware as a C-Corp on 12/26/2017, and they are currently categorized as doing work under Biotechnology & Drug Discovery. Geneos’s principal place of business, as noted on their website, is located at 660 West Germantown Pike, LL 100, Plymouth Meeting, PA, as well as having a registered agent address. Data also shows that Geneos has an annual revenue of <$1M, and employs a staff of approximately 10. 
Geneos Therapeutics announced in February of 2019 that they closed a Series A round of $10.5M in financing. This funding launched their operations as a standalone entity to develop the next generation of neoantigen-targeting cancer immunotherapies. Geneos, created as a spinout of Inovio Pharmaceuticals, Inc. was able to leverage a proven immunotherapy platform, coined as the Geneos Platform, under an exclusive license from Inovio in the field of personalized treatments for cancer. The Series A Financing included a committed initial investment and a milestone driven option. The financing will allow the company to establish its operations and complete Investigational New Drug (IND) activities toward the initiation of first-in-human clinical trials. 
Geneos Therapeutics’s Series A financing was led by Santé Ventures and joined by Inovio in order to enable the company to establish its operations and complete IND enabling activities towards proof-of-concept studies and first-in-human clinical trials. As part of the new financing, Geneos will no longer be a wholly-owned subsidiary of Inovio Pharmaceuticals.
In 2019, Geneos entered into a strategic long-term master supply agreement with plasmid CMO VGXI, Inc. The agreement will leverage VGXI’s highly experienced management team and decades of plasmid manufacturing proficiency to establish small-scale and rapid turn-around production services ideally suited for personalized therapy platforms. VGXI’s proprietary plasmid manufacturing process is recognized for providing the highest purity and supercoil fraction for DNA-based pharmaceuticals, and in particular DNA vaccines. To meet urgent patient needs, their process is optimized to enable turnaround times 1/10 of that for standard GMP grade products without compromising product quality. Completion of all process development, qualification, and validation activities at VGXI was projected by end of 2019, with clinical grade production of patient-specific DNA-plasmid based products for human clinical use by 1Q 2020. 
In lieu of the recent VGXI master supply agreement, there will be many other avenues for Geneos to outsource some of their clinical manufacturing and product development work. We think business development teams in the realms of back-up production facilities and commercial upscale, preclinical CROs with animal model development for multiple types of cancer, bioanalytical CROs, and CMOs with experience in DNA vaccines should definitely have Geneos Therapeutics on their radar for the next few years.
Geneos Therapeutics’s Pipeline and R&D Focus
The research team at Geneos Therapeutics is developing personalized immunotherapies against tumor specific neoantigens which arise from gene mutations in cancerous cells. These mutations form during the development and progression of cancer. Data has shown that the immune system can recognize these mutated proteins as being foreign bodies as opposed to normal proteins and produce a neoantigen-targeted immune response. Furthermore, clinical studies with immune checkpoint inhibitors, such as anti-PD1/PDL1 molecules in marketed immunotherapy drugs like Keytruda®, Opdivo®, Tecentriq®, Imfinzi™, and Bavencio® all have shown that these treatments appear to work better in tumors that have a higher mutational burden suggesting that neoantigen directed immune responses are important. Thus, the accumulating clinical evidence strongly points to the idea that developing tumor specific neoantigen-targeted immunotherapies are an attractive approach for treating cancer.
Cancer neoantigens are the mutations and genomic changes that accumulate as tumors develop, and they have been recognized as important targets in the development of immune mediated treatments for cancer. As mentioned before, these neoantigens are recognized by the immune system as being foreign and generate immune responses directed at the cancer. The GT-EPIC Platform, or Geneos Platform, is based on a DNA vaccine platform which Geneos exclusively licensed from Inovio Pharmaceuticals, and allows the company to develop exquisitely personalized therapies tailored to each patient's unique tumor mutations. Geneos, along with its collaborators at The Wistar Institute, recently published preclinical, proof-of-concept animal model data in the prestigious journal, Cancer Immunology Research, demonstrating the functional advantages of the Geneos Platform. 
The Geneos Platform drives T cells, and in particular, antigen-specific CD8 + T cells with a killing function. Tumor targeted T cells are the key effectors of tumor cell death. The Geneos Platform has demonstrated in multiple human clinical trials, animal models, and peer-reviewed publications the ability to elicit a potent and tumor-specific CD8/CD4+ T cell response, tumor infiltration (TILs), and impact on lesion regression/tumor challenge. Geneos has exclusively licensed this DNA-based immunotherapy platform from Inovio Pharmaceuticals to develop and commercialize TSNA-targeted personalized immunotherapies. Geneos has extended the Inovio technology platform to deliver multiple neoantigen sequences simultaneously. In pre-clinical (mice and non-human primates) animal studies, Geneos has shown that multiple antigenic sequences delivered simultaneously can elicit strong CD8+ and CD4+ T cell responses against the target antigens. 
- Niranjan Y. Sardesai, Ph.D. - Founder, President & CEO for Geneos Therapeutics has broad development and consulting experience in biotechnology and pharmaceuticals, and in particular vaccine product development. He served as Sr. Vice President, Research & Development at Inovio Pharmaceuticals before being promoted to his current position as Inovio’s Chief Operating Officer. Dr. Sardesai is responsible for leading the company's corporate development function and product development programs in infectious disease and cancer vaccines and vaccine delivery systems. He has authored over 75 peer-reviewed manuscripts and book chapters, delivered over 100 invited talks and lectures, and filed several field patents. Dr. Sardesai received a Ph.D. in Chemistry from the California Institute of Technology and an MBA from the Wharton School of the University of Pennsylvania, where he was the recipient of the Shils-Zeidman Award in Entrepreneurship. He completed fellowships at Scripps Research Institute and Massachusetts Institute of Technology. Dr. Sardesai received his bachelors and masters in Chemistry from the Indian Institute of Technology, Mumbai. 
- James A. Barlow Jr., MBA - VP of Operations and Business Development for Geneos Therapeutics joined the Company after leading the development of Inovio’s Immuno-Oncology (IO) product strategy. In this effort, he led a cross-functional team across Commercial, Clinical, Product Development, R&D and Business Development to establish a set of key strategic principles guiding Inovio’s IO development. Prior to Inovio, Jim was at Bristol-Myers Squibb where he was the Payer Marketing Lead for YERVOY®, the pioneering cancer immunotherapy whose approval set off the current wave of immunotherapy development in Oncology. While at BMS, Jim also worked on the overall Immuno-Oncology franchise commercial strategy including the development of communication planning for the groundbreaking immunotherapy drug, OPDIVO®. Prior to BMS, Jim spent 8 years at Merck working in commercial leadership roles with increasing responsibility for the Oncology franchise. Jim received a MBA (strategy and marketing) with honors from the Tepper School of Business at Carnegie Mellon University. He was awarded the Dean’s Scholarship from Tepper. Jim received the Alumni Memorial Scholarship from Colgate University where he graduated Summa Cum Laude with a Bachelor of Arts in Math and Economics. 
- Joann Peters, MHA - VP of Clinical Operations for Geneos Therapeutics joined Geneos after a successful 19-year career working in the Contract Research Organization (CRO) industry where she strategically supported the growth of companies and effectively led oncology focused study teams. She is bringing this strong oncology clinical operations experience to Geneos and plays a pivotal role in the company’s expansion by leading the execution of the clinical development strategy. She leads all facets of Geneos Clinical Operations, providing oversight to clinical trials, including site management, human protections, IRB oversight, patient safety and interactions with regulatory authorities. Prior to joining Geneos, Joann was the VP of Clinical Operations and Project Delivery for Linical Accelovance. During her time at Linical Accelovance, she held a variety of leadership roles gaining global, operational and investigative site relationship experience with a focus in immuno-oncology, solid tumor and hematology. She was successful in developing and driving processes to strategically align growth based on operational needs. Joann received her B.S. from Iowa State University in Dietetics and a Master’s in Health Care Administration at Webster University. 
- Alfredo Perales-Puchalt, M.D., Ph.D. - joined as VP of Director of Research & Development bringing his experience in Immuno-Oncology and DNA-based therapeutics in both the scientific and the clinical development space. He led, in collaboration with Geneos, the preclinical development of DNA-encoded neoantigen-targeting vaccines at the Wistar Institute. Prior to joining Geneos, Dr. Perales-Puchalt was leading clinical development of DNA-encoded CD3 bispecific antibodies for oncology, of which he is also co-inventor. His extensive preclinical training, focused on the research of novel immunotherapies, along with his clinical work as physician and director of clinical development in pharmaceutical industry has equipped Dr. Perales-Puchalt to become a translational scientist in the field of tumor immunology and specifically in the development and implementation of immunotherapies for cancer. Dr. Perales-Puchalt received his M.D. with honors from the University of Valencia and completed residency in Obstetrics & Gynecology at La Fe University Hospital (Spain). He received his Ph.D. with honors from the University of Valencia, developing at the Wistar Institute a novel adoptive T cell transfer immunotherapy for the treatment of ovarian cancer. Three of the immunotherapies that he has invented have been licensed and are currently in clinical development, including chimeric antigen receptor T cells, bispecific antibodies, and cancer vaccines. Dr. Perales-Puchalt has authored over 42 peer-reviewed manuscripts and has received grants and awards from funding bodies such as the Department of Defense, the Ovarian Cancer Research Fund, and Fundación Alonso Martín Escudero. He also holds a Bachelor's Degree in Statistics in Health Sciences, a Masters Degree in Methodology in Research in Health Sciences, and a Masters Degree in Human Reproduction. He also served as Clinical Research Fellow at the PennState Health Milton S. Hershey Medical Center. 
With a substantial amount of investment backing, significant progress in scientific benchwork, a large amount of available outsourcing work, and deep technical backgrounds from their executives, we believe that Geneos Therapeutics will do very well in their early-stage developments, clinical trial studies, and beyond. Geneos Therapeutics’s innovative approach to mass production of personalized cancer therapeutics is something this field really needs for potentially curing patients moving forward. Backed by an extensive portfolio of globally issued patents and 120+ peer reviewed publications, Geneos is prepared to become the leader in the development of personalized cancer immunotherapies to provide patients the potential for a cure. At this point in time, the Geneos platform potency, capacity to target multiple antigens simultaneously, and speed of product manufacturing are key differentiating attributes to their unique approach for neoantigen targeting.
Dr. Joseph Kim, CEO, Inovio Pharmaceuticals, said, "Establishing Geneos with a patient-specific direction allows Inovio to focus on executing our strategies to develop and commercialize DNA-based vaccines and immunotherapies to attack the major cancer types and challenging infectious diseases affecting global populations. Geneos will build on Inovio's technology offering patient-specific, tumor-targeted immunotherapies to the world, one patient at a time."
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