La Jolla Institute for Allergy & Immunology

All patients in the treatment arm remain disease-free after a minimum of 2-year follow-up in the randomized Phase I trial in resected HPV-negative locally advanced head and neck cancer – Demonstrating clinical proof of principle for TG4050 Single agent TG4050 induced long-lasting neoantigen-specific CD8+ T cell responses Treatment was well-tolerated with no unexpected safety signals Data presented during rapid oral session at ASCO 2025 Conference call scheduled on Friday June 6, 2025 at 3:00 p.m. CET (in English). See details below Strasbourg, France & Tokyo, Japan, June 1st, 2025, 7:15 p.m. CET – Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, and NEC Corporation (NEC; TSE: 6701), a leader in IT, network and AI technologies, have presented new positive data on TG4050 in a rapid oral presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting. These positive data confirm that individualized neoantigen therapeutic vaccine TG4050 is safe and feasible in the adjuvant setting of resectable HPV-negative locally advanced head and neck squamous cell carcinoma (HNSCC). TG4050 induces, as monotherapy, long-lasting immune responses to vaccine neoantigens sustained for up to 2 years, and these results met all trial endpoints (NCT04183166) including safety, feasibility, immune activation and disease-free survival (defined as survival without recurrence or death for any cause). TG4050 is based on Transgene’s myvac® platform and powered by NEC’s cutting-edge AI capabilities designed to optimize antigen selection. Positive data from Phase I, confirming proof of principleof Transgene’s viral vector based individualized cancer vaccine TG4050in HPV-negative locally advanced head and neck cancer 100% disease free survival at a minimum of 2-year follow-up of treated patients (median follow-up: 30 months) in the Phase I part of the trial: all patients in the TG4050 treatment arm remain disease free while 3 patients in the observational arm have relapsed.Persistenceof neoantigen-specific CD8+ T cell responses over 2 years after the start of TG4050 has been observed. Dr. Alessandro Riva, CEO of Transgene, commented: “The sustained clinical and immunogenicity outcomes observed over two years of TG4050 monotherapy, along with the positive safety profile, mark an important milestone for Transgene. These results reinforce both the clinical promise of TG4050 and our commitment to accelerate the development of this individualized immunotherapy in adjuvant setting for patients with HPV-negative, locally advanced head and neck cancer.” Motoo Nishihara, Corporate EVP, and CTO, at NEC, commented: “This positive readout, combined with the durability of the efficacy data at two years, underscore the clinical potential of individualized cancer vaccine programs. It is a strong validation of our innovative AI platform and our dedication to advancing solutions that deliver meaningful, long-term value to patients and healthcare systems alike.” Ongoing Phase II part of Phase I/II clinical trial of individualized neoantigen therapeutic cancer vaccine TG4050 TG4050 is being evaluated in a randomized multicenter Phase I/II trial as a single agent in the adjuvant treatment of HPV-negative head and neck cancers (NCT04183166). Based on the promising data obtained in the Phase I part of the trial, Transgene and NEC extended the joint development of TG4050 in this indication with a Phase II extension of the trial. The Phase II part of the trial, aimed at confirming the encouraging results in a larger patient population and evaluating both immunological and clinical outcomes, is currently underway. All patients are expected to be randomized by Q4 2025. Altogether, the Phase I/II study will comprise approximately 80 patients. Dr Christian Ottensmeier, MD, PhD, FRCP (University of Liverpool, La Jolla Institute for Immunology), will discuss the data presented at ASCO 2025, the unmet medical need and current treatment landscape for patients suffering from head and neck cancers in a live virtual event taking place on June 6, 2025 (9:00 p.m. ET; 3:00 p.m. CET).

PRINCETON, N.J. and TOKYO, July 29, 2025 /PRNewswire/ -- Kyowa Kirin Co., Ltd. (TSE: 4151) today announced that results of the Phase 3 ROCKET IGNITE trial of rocatinlimab, an investigational therapy targeting the OX40 receptor (OX40R) in patients with moderate-to-severe atopic dermatitis (AD), will be presented at the European Academy of Dermatology and Venereology (EADV) 2025 Annual Meeting to be held in Paris, France from September 17-20, 2025. AD, a chronic, heterogeneous, inflammatory disease characterized by skin redness, pruritus, and pain, is driven by skin barrier disruption and T-cell-dependent inflammatory pathways. Expansion of OX40R+ pathogenic T cells leads to T-cell imbalance, a root cause of inflammatory diseases including AD. Title: Efficacy & Safety of OX-40 Receptor Targeting with Rocatinlimab in Moderate-to-Severe Atopic Dermatitis: Results from the Phase 3 ROCKET-IGNITE Trial Presenter: Emma Guttman-Yassky, MD, PhD Date: Friday, September 19th Time: 4:40 – 4:50 pm CEST Session: FC 08 Atopic Dermatitis Location: Paris Convention Centre, Pavillon 7.3, Room W05-W06 About the ROCKET Phase 3 Program ROCKET is a comprehensive, global Phase 3 clinical trial program comprised of eight studies intended to establish the safety and efficacy profile of rocatinlimab in adults and adolescents with moderate to severe atopic dermatitis (AD) as well as multiple dosing regimens. About Moderate to Severe Atopic Dermatitis Atopic dermatitis, the most common form of eczema, is a chronic inflammatory disease that causes excessively dry, itchy skin that can be painful. People with moderate to severe atopic dermatitis experience chronic symptoms, intensified by unpredictable flare-ups that can be painful and disruptive to everyday life. More than half of these patients report severe itching, leading to repeated scratching which can cause the skin to thicken and become vulnerable to infection. Atopic dermatitis (all severities) affects 15-20% of children and up to 10% of adults. T-cell imbalance is a root cause of atopic dermatitis, contributing to clinical manifestations including the disease's recurring, unpredictable symptoms. About Rocatinlimab Rocatinlimab is an anti-OX40 human monoclonal antibody being investigated for the treatment of moderate to severe atopic dermatitis. Rocatinlimab has the potential to be the first and only T-cell rebalancing therapy that inhibits and reduces pathogenic T cells by targeting the OX40 receptor. OX40 is a co-stimulatory receptor responsible for driving systemic and local inflammatory responses in atopic dermatitis and other conditions. It has been reported that effector T cells expressing OX40 are present in the lesions of patients with atopic dermatitis and are critical in the disease pathophysiology. Rocatinlimab is also being studied for prurigo nodularis, moderate to severe uncontrolled asthma and potentially other conditions where T-cell imbalance is a root cause of inflammation. The initial antibody was discovered in collaboration between Kyowa Kirin and La Jolla Institute for Immunology. Rocatinlimab is currently under clinical investigation, and its safety and efficacy have not been evaluated by the U.S. FDA or any other regulatory authority. About Kyowa Kirin Kyowa Kirin aims to discover and deliver novel medicines and treatments with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company, we have invested in drug discovery and biotechnology innovation for more than 70 years and are currently working to engineer the next generation of antibodies and cell and gene therapies with the potential to help patients with high unmet medical needs, such as bone & mineral, intractable hematological diseases/hemato oncology, and rare diseases. A shared commitment to our values, to sustainable growth, and to making people smile unites us across the globe. You can learn more about the business of Kyowa Kirin at: . Amgen and Kyowa Kirin Collaboration On June 1, 2021, Kyowa Kirin and Amgen entered into an agreement to jointly develop and commercialize rocatinlimab. Under the terms of the agreement, Amgen will lead the development, manufacturing, and commercialization for KHK4083/AMG 451 for all markets globally, except Japan, where Kyowa Kirin will retain all rights. If approved, the companies will co-promote the asset in the United States and Kyowa Kirin has opt-in rights to co-promote in certain other markets including Europe and Asia. CONTACT: Kyowa Kirin Hiroki Nakamura: Japan Corporate Communications Department [email protected] Subrenie Thomas-Smith: North America Sr. Director, R&D Patient Engagement & Communications [email protected] Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SAN DIEGO, May 28, 2025 /PRNewswire/ -- As federal funding for medical and life sciences research faces deep and destabilizing cuts, Prebys Foundation is stepping in with a rapid response package totaling $7 million to defend San Diego's biomedical research sector—one of the world's leading innovation hubs. Federal grants have historically provided nearly half of all medical research funding in the United States. This support has enabled transformative advances in drug discovery, fueled job growth, and secured America's position as a global leader in the life sciences. In San Diego, the impact has been profound, home to internationally renowned research institutes, universities, and biotech startups that together make up a biomedical ecosystem unlike any other in the country. But that ecosystem is now under severe strain. In confidential conversations with the Prebys Foundation, leaders across the medical research field shared frank and urgent concerns about the future of their work. These quotes are presented without attribution to protect the identities of those who spoke candidly under an agreement of anonymity: "The suction of talent is real. People need to understand that the NIH and U.S. taxpayers have invested billions in training scientists, and now we're losing them—often for pennies on the dollar—to countries like Sweden and China that have the infrastructure to support robust research programs." "As of now, few grants have been awarded in 2025 - the pipeline is dry and constricted. Most research spans five years and is funded on a rolling basis each quarter—but this year, even renewals that should have been routine are disappearing." Executive orders and steep reductions in federal research investment are threatening critical local initiatives, halting active projects, and forcing early- and mid-career scientists to look abroad or leave the field altogether. Without swift and targeted action, the region risks an exodus of talent and a slowdown in the medical breakthroughs that improve lives and drive the economy. "San Diego's biomedical research institutions aren't just world-class in reputation—they deliver real impact by tackling urgent problems and advancing the treatments and cures the world needs," said Grant Oliphant, CEO of the Prebys Foundation. "While we can't match the scale of federal investment, we can respond with urgency to help prevent the loss of extraordinary talent and critical momentum. This is a defining moment, and philanthropy must rise to meet it." To address the immediate need, Prebys Foundation is awarding grants to seven anchor institutions: La Jolla Institute for Immunology – $1,000,000 Rady Children's Hospital Foundation – $1,000,000 Salk Institute for Biological Studies – $1,000,000 San Diego State University – $1,000,000 Sanford Burnham Prebys Medical Discovery Institute – $1,000,000 Scripps Research – $1,000,000 University of California San Diego – $1,000,000 The grants will provide general operating support aimed at retaining early and mid-career scientists at risk of being lost to the field, as well as supporting key research programs. "This is not just about science—it's about our economy, our global leadership, and the health of future generations," said Oliphant. "This funding was an emergency allocation above and beyond our planned giving for the year. We urge other funders and stakeholders to join us in going above traditional spending allocations to help preserve the excellence and impact of San Diego's life sciences community." About Prebys Foundation The Prebys Foundation—pronounced Preh-Biss—is a charitable foundation based in San Diego County. We are dedicated to advancing a vibrant, equitable, and resilient future for all San Diegans by investing in four key areas: health and well-being, medical research, arts and culture, and youth success. While we operate under both Prebys Foundation and The Conrad Prebys Foundation as our DBAs, we use "Prebys Foundation" in our branding to keep things concise, accessible, and aligned with our forward-facing identity. SOURCE The Conrad Prebys Foundation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED