Ipsen Biopharm Ltd.

NEW YORK, April 05, 2024 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win® platform, today announced that Faiçal Miyara, Ph.D., has been appointed as the company’s chief business officer. Dr. Miyara, who has more than 17 years of experience in the pharmaceutical industry, will be responsible for global business development activities including strategic partnerships. Dr. Miyara will be based in the United States, report to IO Biotech’s CEO, Mai-Britt Zocca, Ph.D., and be a member of the company’s executive team, effective immediately. “We are very excited to welcome Faiçal to IO Biotech,” said Dr. Zocca. “His deep experience in business development with proven ability to execute strategic transactions will be invaluable as we look at opportunities to advance our wholly owned proprietary T-Win platform. The coming months will be a critical period for the development of our company with the outcome of the pivotal Phase 3 interim analysis of our lead therapeutic cancer vaccine, IO102-IO103, expected in the third quarter of this year, as well as the readout of the primary endpoint of progression free survival estimated to follow in the second half of 2025.” Dr. Miyara added, “I am thrilled to join the IO Biotech team at this important time in the company’s development. I believe the novel dual-mechanism approach of the vaccines being developed is very promising and has the potential to significantly improve the current treatment paradigm for people living with cancer. I look forward to developing new partnerships to further progress the company’s growing portfolio.” Dr. Miyara is a seasoned executive with nearly two decades of experience in the pharmaceutical and biotechnology industry with a track record of successful deals and partnerships across several key therapeutic areas. Most recently, he served as Vice President, Head of Business Development Oncology, then Head of External Innovation Oncology, Lead on Venture Capital Activities at Ipsen Biosciences. Prior to this role, he was Senior Vice President, Head of Business Development and External Research at Kadmon Corporation. Earlier in his career, Dr. Miyara served in leadership roles at Pfizer and Eli Lilly and Company. Dr. Miyara holds a Ph.D. in reproductive, molecular, and cellular biology from the Université Pierre & Marie Curie Paris, and a Master of Engineering of Medical Biology degree from Université Joseph Fourier Grenoble. Inducement Equity Awards In connection with Dr. Miyara’s acceptance of employment with the company, Dr. Miyara will, as of the close of business on April 5, 2024, be granted a non-statutory option to purchase 310,000 shares of the company’s common stock. The option will vest over four years, with 25 percent of the shares vesting on the first anniversary of Dr. Miyara’s hire date and the remainder vesting in equal monthly installments over the following three years. The option will have an exercise price per share equal to the closing price of the company’s common stock on the grant date, have a ten-year term, be granted outside of outside of the company’s 2021 Equity and Incentive Plan, but be governed by the company’s 2023 Inducement Award Plan, and be subject to the terms and conditions of stock option agreement covering the grant. The stock option was granted as an inducement material to the employee entering into employment with the company in accordance with Nasdaq Listing Rule 5635(c)(4). About IO102-IO103 IO102-IO103 is an investigational off-the-shelf therapeutic cancer vaccine designed to kill both tumor cells and immune-suppressive cells in the tumor microenvironment (TME) by stimulating activation and expansion of T cells against indoleamine 2,3-dioxygenase (IDO) and/or programmed death-ligand 1 (PD-L1) cells. The company is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) investigating IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with advanced melanoma, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) investigating IO102-IO103 in combination with pembrolizumab as first line treatment in patients with solid tumors, and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) investigating IO102-IO103 in combination with pembrolizumab as neo-adjuvant/adjuvant treatment of patients with solid tumors. The clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck, and Merck is supplying pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About IO Biotech IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win® platform. The T-win platform is based on a novel approach to cancer vaccines designed to activate T cells to target the immunosuppressive cells in the tumor microenvironment. IO Biotech is advancing its lead cancer vaccine candidate, IO102-IO103, in clinical trials, and additional pipeline candidates through preclinical development. Based on positive Phase 1/2 first line metastatic melanoma data, IO102-IO103, in combination with pembrolizumab, has been granted a breakthrough therapy designation for the treatment of advanced melanoma by the US Food and Drug Administration. IO Biotech is headquartered in Copenhagen, Denmark and has US headquarters in New York, New York. For further information, please visit . Follow us on our social media channels on LinkedIn and X (@IOBiotech). Forward-Looking Statement This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including regarding the timing of the interim and primary analyses of the company’s Phase 3 trial, current or future clinical trials, their progress, enrollment or results, or the company’s financial position or cash runway, are based on IO Biotech’s current assumptions and expectations of future events and trends, which affect or may affect its business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Except to the extent required by law, IO Biotech undertakes no obligation to update these statements, whether as a result of any new information, future developments or otherwise. Contact: Maryann Cimino, Director of Investor Relations IO Biotech, Inc. 617-710-7305 mci@iobiotech.com

WATERTOWN, Mass., March 04, 2024 (GLOBE NEWSWIRE) -- Tome Biosciences, Inc., the programmable genomic integration (PGI) company, announces the formation of its Science and Technology Advisory Committee (STAC) comprised of four leaders in the delivery, development and manufacturing of genomic medicines: David T. Curiel, MD, PhD, Sadik Kassim, PhD, Cynthia Pussinen and Daniel Siegwart, PhD. “David’s and Daniel’s pioneering work in novel delivery systems has the potential to enable broad applications for genomic medicines. These breakthroughs will be invaluable to us as we develop PGI technologies capable of inserting any DNA sequence of any size into user-defined genomic locations,” said John Finn, PhD, Chief Scientific Officer. Added Matt Barrows, Chief of Quality and Technical Operations, “Sadik and Cynthia have the drug development and manufacturing expertise needed to bring innovative medicines to the patients in need, and we look forward to working closely with them.” The founding members of Tome’s STAC: David T. Curiel, MD, PhD, is a tenured professor in the Cancer Biology Division of the Department of Radiation Oncology at the Washington University School of Medicine in St. Louis. His research is focused on gene transfer vectors to advance the human application of gene therapy, virotherapy, and vaccinology. Dr. Curiel’s scientific training includes tenureship at the National Institutes of Health in Bethesda, Maryland at the Pulmonary Branch of the Heart and Lung, and Blood Institute (NHLBI) and a fellowship in biotechnology at the National Cancer Institute, Navy Medical Oncology Branch. He serves as editor for Adenoviral Vectors for Gene Therapy and is a funded member of the NIH Common Fund’s Somatic Cell Genome Editing (SCGE) program. Dr. Curiel received his MD from Emory University, where he also completed his internship and residency in Internal Medicine, and his PhD in virology from University of Groningen in The Netherlands. Sadik Kassim, PhD, serves as Chief Technology Officer of Genomic Medicines for the Life Sciences companies at Danaher Corporation. He has extensive experience in the biotechnology industry with a specific focus on cell and gene therapy bioprocessing and translational research. In his prior roles, Dr. Kassim and his teams have contributed to the successful BLA and MAA applications for three of the commercially available CAR-T therapies: Kymriah®, Yescarta®, and Tecartus®. Prior to Danaher, Dr. Kassim was Chief Technology Officer at Vor Bio where he built the technical operations team responsible for process development, analytical development, supply chain and manufacturing support of a CRISPR gene-edited HSPC product and oversaw the company’s CAR-T efforts. Previously, Dr. Kassim served as Executive Director at Kite Pharma and led the development of manufacturing processes for autologous CAR-T and TCR-based cell therapies. As the Chief Scientific Officer at MustangBio, Dr. Kassim managed the foundational build-out of the company’s preclinical and manufacturing activities. Earlier in his career, he was Head of Early Analytical Development for Novartis’ Cell and Gene Therapies Unit and worked on research teams at the National Cancer Institute with Dr. Steven Rosenberg, the University of Pennsylvania Gene Therapy Program with Dr. Jim Wilson, and Johnson and Johnson’s Immunology Discovery group. He received his PhD in microbiology and immunology from Louisiana State University and his BS in cellular and molecular biology from Tulane University. Cynthia Pussinen serves as CEO and a Director of the Board of Sernova. Her expertise spans the drug development continuum from research through commercialization. She has led the development, licensure, commercialization and/or subsequent delivery to patients of more than fifteen new medical therapies for patients globally, including Obizur® (Antihemophilic Factor (Recombinant), Porcine Sequence), Eraxis® (anidulafungin), Zmax® (azithromycin extended-release) and LUXTURNA® (voretigene neparvovec-rzyl), the first gene therapy approved in both the United States and the European Union. Most recently, Ms. Pussinen was the Chief Technical Officer for Spark Therapeutics, Inc., a fully integrated, commercial gene therapy company, and a member of the Roche Group; she also served as a Board Director for Spark Therapeutics Ltd in the United Kingdom and Ireland. Prior to joining Spark, Ms. Pussinen’s leadership roles include 6 years with Ipsen Biomeasure and Ipsen Biosciences, US R&D focused subsidiaries of Ipsen, where she served as President and CEO. Ms. Pussinen was also the Executive Vice President, Technical Development, Operations & Supply Chain for Actinium Pharmaceuticals, Inc. and the Global Vice President and General Manager, Life Sciences and Specialty Chemicals for Honeywell International. Early in her career Ms. Pussinen spent more than 18 years at Pfizer in a variety of increasingly responsible leadership roles across various functional areas. Ms. Pussinen received her MS in R&D management from Rensselaer Polytechnic Institute and BS in chemistry, with a minor in engineering from the University of Connecticut. Daniel Siegwart, PhD, a Professor in the Department of Biomedical Engineering and Department of Biochemistry at the University of Texas Southwestern Medical Center. He holds the W. Ray Wallace Distinguished Chair in Molecular Oncology Research and serves as the Director of the Program in Genetic Drug Engineering, Director of the Drug Delivery Program in Biomedical Engineering, and Co-leader of the Chemistry and Cancer Program in the NCI-designated Simmons Comprehensive Cancer Center. His research focuses on the development of new materials that can deliver genetic medicines to treat cancer and genetic diseases. In particular, he was the first to report in vivo CRISPR/Cas gene editing using non-viral carriers. He has designed synthetic carriers for various genome editors and applied these technologies for correction of genetic diseases, focusing on hepatic and extrahepatic delivery for organ and cell specific protein delivery, gene delivery, and gene editing. Dr. Siegwart developed Selective Organ Targeting (SORT) lipid nanoparticles (LNPs), which was named in Nature's "Seven technologies to watch in 2022." He received a BS in biochemistry from Lehigh University and a PhD in chemistry from Carnegie Mellon University, studying with Professor Krzysztof Matyjaszewski. He also studied as an NSF EAPSI Research Fellow at the University of Tokyo with Professor Kazunori Kataoka. He completed an NIH NSRA Postdoctoral Fellowship at MIT with Professor Robert Langer. He has received awards including a CPRIT Scholar Award, an American Cancer Society Research Scholar Award, the Young Innovator Award in Nanobiotechnology, Biomaterials Science Emerging Investigator Award, and election to the Controlled Release Society (CRS) College of Fellows and the American Institute for Medical and Biological Engineering (AIMBE) College of Fellows. About TomeTome Biosciences, Inc., is the programmable genomic integration (PGI) company. Our technologies allow us to insert any genetic sequence of any size at any location in the genome with site-specific precision. We are writing the final chapter in genomic medicines, delivering cures to patients through cell and integrative gene therapies. Follow us on X @Tome_Bio and on LinkedIn. www.tome.bio. PGI is a brand name and technology of Tome Biosciences, Inc. Contacts: For media:CG LifeCGL.TomeBio@cglife.com For investors:Michelle Avery, PhD, SVP, Corporate Affairsinvestors@tome.bio

Industry veteran with deep commercial experience joins to lead the next stage of growth and development Dr. Philip Toleikis will serve as Chief Technology Officer Sernova to host investor calls LONDON, Ontario and WINDHAM COUNTY, Conn., Sept. 05, 2023 (GLOBE NEWSWIRE) -- Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in cell therapeutics, today announced that its Board of Directors has appointed Cynthia Pussinen as Chief Executive Officer and a member of the Board of Directors. Dr. Philip Toleikis, who has led the company since 2009 as President and CEO will serve as Chief Technology Officer. Ms. Pussinen’s expertise spans the drug development continuum from research through commercialization. She has led the development, licensure, commercialization and/or subsequent delivery to patients, of more than fifteen new medical therapies for patients globally, including Obizur® (Antihemophilic Factor (Recombinant), Porcine Sequence), Eraxis® (anidulafungin), Zmax® (azithromycin extended-release) and LUXTURNA® (voretigene neparvovec-rzyl), the first gene therapy approved in both the United States and the European Union. Most recently, Ms. Pussinen was the Chief Technical Officer for Spark Therapeutics, Inc., a fully integrated, commercial gene therapy company, and a member of the Roche Group. Prior to joining Spark in 2021, Ms. Pussinen’s leadership roles include 6 years with Ipsen Biomeasure and Ipsen Biosciences, U.S. R&D focused subsidiaries of Ipsen, where she served as President and CEO. She was instrumental in leading and executing the divestiture of Obizur® and its associated manufacturing physical infrastructure to Baxter. Ms. Pussinen was also the Executive Vice President, Technical Development, Operations & Supply Chain for Actinium Pharmaceuticals, Inc. and the Global Vice President and General Manager, Life Sciences and Specialty Chemicals for Honeywell International. Early in her career Ms. Pussinen spent more than 18 years at Pfizer in a variety of increasingly responsible leadership roles across various functional areas. Ms. Pussinen also served on the Drexel University Solutions Advisory Board, as a Board Director for Spark Therapeutics UK Ltd. and Spark Therapeutics Ireland Ltd. and is a member of an early-stage biotech company’s scientific and technical advisory board. Ms. Pussinen earned a Master of Science in R&D management from Rensselaer Polytechnic Institute and a Bachelor of Science in chemistry, with a minor in engineering from the University of Connecticut. She is lean six sigma certified, is recognized as a mentor through the Healthcare Businesswomen’s Association (HBA) and was honored by WEST (Women in the Enterprise of Science and Technology) as a recipient of their Giving Back award. “Sernova has demonstrated tremendous growth over the past several years as it has transitioned from a research company to one that is moving towards commercialization of a product for the treatment of multiple chronic diseases including our flagship program for Type 1 Diabetes (T1D). As a united Board, we feel now is the time to bring in an industry leader with extensive experience with large pharmaceutical companies as well as entrepreneurial biotech and advanced therapeutics focused companies,” commented Brett Whalen, Chair of the Board of Directors of Sernova. “The skills that Ms. Pussinen brings to our company include over 25 years of global experience shepherding new therapies from development through commercialization across multiple conditions with sales measured in the billions.” Mr. Whalen continued, “the Board would like to thank Dr. Toleikis for his significant contributions to Sernova and his passionate commitment to our mission, and for continuing in his new role as Chief Technology Officer. Under his leadership, Sernova has solidified the strong scientific and technical foundations for future success and created significant market value driven by the strong positive clinical data outcomes in T1D. The Board is convinced that Ms. Pussinen and Dr. Toleikis bring the right combination of experience and talent to optimize this unique opportunity for all stakeholders.” Ms. Pussinen added, “It is an honor and a privilege to join Sernova at this pivotal stage in the company’s evolution. Sernova has developed novel technology, and I am very excited by the positive pre-clinical and clinical results thus far. The company is a pioneer in creating new ways to address some of the most challenging chronic diseases, providing the possibility of a life-changing ‘functional cure’ for conditions including Type 1 Diabetes. I am inspired by the mission to improve human health and look forward to working with the passionate Sernova team to boldly advance the company’s mission for the benefit of all patients, stakeholders and investors.” Dr. Toleikis said, “I am grateful to have led Sernova’s dedicated team over the past years. I am proud of all that we have accomplished together over the past years, including establishing a strong technology and scientific foundation along with introducing new treatments options to patients with chronic conditions. I am very pleased to welcome Ms. Pussinen to the Sernova team as the new CEO and look forward to working together. I look forward to my continued involvement with the Company to see through the realization of Sernova’s mission to bring a functional cure to patients around the world suffering from chronic diseases. Sernova’s management will host investor calls, firstly to introduce Ms. Pussinen, and later, in approximately 30 days, to provide an overview of Sernova as well as a question-and-answer session. Investors will be informed of the details once finalized. ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY Sernova Corp. is a clinical-stage biotechnology company that is developing therapeutic cell technologies for chronic diseases, including insulin-dependent diabetes, thyroid disease, and blood disorders that include hemophilia A. Sernova is currently focused on developing a ‘functional cure’ for insulin-dependent diabetes with its lead asset, the Cell Pouch System, a novel implantable and scalable medical device with immune protected therapeutic cells. On implantation, The Cell Pouch forms a natural vascularized tissue environment in the body for long-term survival and function of therapeutic cells that release essential factors that are absent or deficient in the bodies of patients with certain chronic diseases. Sernova’s Cell Pouch System has demonstrated its potential to be a ‘functional cure’ for people with T1D in an ongoing Phase 1/2 clinical study at the University of Chicago. Sernova is also advancing a proprietary technology in collaboration with the University of Miami to shield therapeutic cells from immune system attack with the goal to eliminate the need for chronic, systemic immunosuppression. In May 2022, Sernova and Evotec entered into a global strategic partnership to develop an implantable off-the-shelf iPSC (induced pluripotent stem cells) based islet replacement therapy. This partnership provides Sernova a potentially unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova continues to progress two additional development programs that utilize its Cell Pouch System: a cell therapy for hypothyroid disease resulting from thyroid gland removal and an ex vivo lentiviral Factor VIII gene therapy for hemophilia A. FOR FURTHER INFORMATION, PLEASE CONTACT: Corporate: Investors: Media: Christopher Barnes VP, Investor Relations Sernova Corp. christopher.barnes@sernova.com Tel: 519-902-7923 www.sernova.comCorey Davis, Ph.D. LifeSci Advisors, LLC cdavis@lifesciadvisors.com Tel: 212-915-2577Hannah HolmquistLifeSci Communications hholmquist@lifescicomms.com Tel: 619-723-4326 FORWARD-LOOKING INFORMATION This release contains statements that, to the extent they are not recitations of historical facts, may constitute “forward-looking statements” that involve various risks, uncertainties, and assumptions, including, without limitation, statements regarding the prospects, plans, and objectives of the company. Wherever possible, but not always, words such as "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential for" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur are used to identify forward-looking statements. These statements reflect management’s beliefs with respect to future events and are based on information currently available to management on the date such statements were made. Many factors could cause Sernova’s actual results, performances or achievements to not be as anticipated, estimated or intended or to differ materially from those expressed or implied by the forward-looking statements contained in this news release. Such factors could include, but are not limited to, the company’s ability to secure additional financing and licensing arrangements on reasonable terms, or at all; ability to conduct all required preclinical and clinical studies for the company’s Cell Pouch System and or related technologies, including the timing and results of those trials; ability to obtain all necessary regulatory approvals, or on a timely basis; ability to in-license additional complementary technologies; ability to execute its business strategy and successfully compete in the market; and the inherent risks associated with the development of biotechnology combination products generally. Many of the factors are beyond our control, including those caused by, related to, or impacted by the novel coronavirus pandemic. Investors should consult the company’s quarterly and annual filings available on www.sedar.com for additional information on risks and uncertainties relating to the forward-looking statements. Sernova expressly disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.