La Jolla Institute for Allergy & Immunology

Kyowa Kirin affirms commitment to developing rocatinlimab as a life-changing differentiated asset with significant market potential.Rocatinlimab’s novel approach as an investigational T-cell rebalancing therapy directly targeting the OX40 receptor expressed on pathogenic T-cells shows potential to deliver long-term disease control in patients with moderate-to-severe atopic dermatitis (msAD).Regulatory submission is planned in the first half of 2026. TOKYO and PRINCETON, N.J., Jan. 30, 2026 (GLOBE NEWSWIRE) -- Kyowa Kirin Co., Ltd. (TSE:4151, Kyowa Kirin), a Japan-based global specialty pharmaceutical company, today announced the termination of the current rocatinlimab development and commercialization collaboration with Amgen. Kyowa Kirin will regain control of the global rocatinlimab program, including regulatory filings and future commercialization. This business decision is the result of a strategic portfolio prioritization by Amgen. The companies are initiating a smooth and orderly transition of the program, with a focus on ensuring continuity for participants currently enrolled in clinical trial programs. Amgen, who has partnered with Kyowa Kirin on numerous investigational therapies over 41 years, will continue to manufacture rocatinlimab. “Kyowa Kirin is confident in the potential of rocatinlimab to address critical unmet needs for patients with moderate-to-severe atopic dermatitis who are looking for new, long-lasting options that may address the chronic nature of unpredictable flares,” said Abdul Mullick, Ph.D., President and Chief Operating Officer of Kyowa Kirin. “Rocatinlimab’s science and its highly differentiated mechanism of action targeting the OX40 receptor make it a potentially unique treatment option. We are excited to build on the strong clinical program we have established and apply our extensive clinical and commercial expertise to help make patients smile with what is a key strategic priority for Kyowa Kirin going forward.” In November 2025, landmark findings from the Phase 3 ROCKET-IGNITE and ROCKET-HORIZON studies in nearly 1,500 adults with msAD were published in The Lancet. Both studies evaluated rocatinlimab monotherapy and met all co-primary and key secondary endpoints, including the US regulatory submission requirement, the revised Investigator’s Global Assessment (rIGA) score of 0/1 (defined as achieving a vIGA-AD score of 0 [clear skin] or 1 [almost clear skin] with only presence of barely perceptible erythema and ≥2-point reduction from baseline). For the more stringent rIGA score of 0 or 1 endpoint, patients with a score of 1 could not have any induration, papulation, or lichenification. Previously announced topline results from the primary analysis of the long-term safety extension study ROCKET-ASCEND demonstrated the potential for long-term therapeutic effect and extended dosing. The most frequent treatment-emergent adverse events (AEs) in adults (≥ 5 per 100 patient-years in any of the rocatinlimab groups and greater than placebo), included upper respiratory infections (including nasopharyngitis and pharyngitis), aphthous ulcers, headache, influenza, cough and rhinitis, which were observed in previous ROCKET trials. Results from this trial will be presented at an upcoming medical conference. Rocatinlimab was discovered and advanced by Kyowa Kirin, drawing on the company’s deep expertise in immunology and antibody engineering. It reflects the strength of the company’s internal R&D capabilities and long-term investment in science that targets the underlying drivers of chronic inflammatory disease, not just its symptoms. The Phase 3 ROCKET program is a comprehensive clinical development program in atopic dermatitis, which consists of eight pivotal studies evaluating both long-term efficacy and safety. The program includes diverse patient populations including adults and adolescents, systemic treatment–naïve patients, as well as those previously treated with biologics and JAK inhibitors, underscoring its potential as a meaningful treatment option for people living with atopic dermatitis across a broad range of clinical scenarios. “Based on the data available to-date, rocatinlimab has demonstrated a generally favorable benefit–risk profile across its Phase 3 clinical program, in which more than 3,300 patients with moderate to severe atopic dermatitis have been enrolled,” said Takeyoshi Yamashita, Ph.D., Executive Vice President and Chief Medical Officer of Kyowa Kirin. “The potential to provide a meaningful and sustained clinical response may be important, particularly for patients who continue to experience symptoms despite existing therapies. We will continue to evaluate rocatinlimab’s clinical profile as development progresses and look forward to presenting additional data from the program at future medical congresses.” The company plans to file for regulatory approval in the U.S. first, followed by Japan, before expanding to other markets across the world as appropriate. About Rocatinlimab Rocatinlimab is an anti-OX40 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 effector and memory 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 moderate to severe uncontrolled asthma, prurigo nodularis 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/haemato-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: www.KyowaKirin.com CONTACT: Kyowa Kirin Hiroki Nakamura, hiroki.nakamura.fp@kyowakirin.com (Media, Global) Marah Oberfield, marah.oberfield.3c@kyowakirin.com (Media, U.S.) Ryohei Kawai, ryouhei.kawai.jh@kyowakirin.com (Investors)

$100 Million Initiative by Colorectal Cancer Alliance Aims to Accelerate Progress The discoveries emerging from Project Cure CRC represent the most exciting advances we’ve seen in colorectal cancer research in decades.” — John Marshall, M.D., Chief Medical Consultant, Colorectal Cancer Alliance WASHINGTON, DC, UNITED STATES, November 12, 2025 / EINPresswire.com / -- Project Cure CRC, a $100 million initiative by the Colorectal Cancer Alliance (Alliance), continues to revolutionize colorectal cancer research by announcing three new groundbreaking grants aimed at transforming patient care. To date, Project Cure CRC has reviewed more than 500 research proposals and invested nearly $13 million to fuel 32 innovative studies. Several grantees have already published progress from their work in prestigious scientific journals, reflecting the program’s impact on advancing the field. As the largest nonprofit dedicated to ending colorectal cancer, the Alliance is prioritizing Project Cure CRC to accelerate the development of cutting-edge treatments that improve outcomes for patients worldwide. “The discoveries emerging from Project Cure CRC represent the most exciting advances we’ve seen in colorectal cancer research in decades,” said John Marshall, M.D., Chief Medical Consultant, Colorectal Cancer Alliance, and Director, Ruesch Center for the Cure of Gastrointestinal Cancers at Georgetown University. “By strategically investing in bold ideas and brilliant scientists, we’re accelerating the pace of progress toward treatments that patients urgently need.” Recent Funding from Project Cure CRC The most recent Project Cure CRC grants support innovative research at leading institutions, including La Jolla, Virginia Tech, and the University of Arizona. These new projects focus on areas with high potential to change the landscape of colorectal cancer treatment: - Miguel Reina-Campos, Ph.D., La Jolla Institute for Immunology – TRM-Reactivation Immunotherapy: A New Approach Against Metastatic Colorectal Cancer ($210,000) - DaeYong Lee, Ph.D., Fralin Biomedical Research Institute at Virginia Tech Carilion – Rational Design of Bispecific Conjugates for Immunotherapy of Colorectal Cancers ($100,000) - Kelvin Pond, Ph.D., University of Arizona – Dissection of PI3K and MAPK Dynamics in Patient-Derived Colorectal Cancer Organoids for Accelerating Therapeutic Development ($188,000) Project Cure CRC Researchers with Published Articles Several Project Cure CRC scientists have already published articles about their preliminary work in peer-reviewed journals, advancing scientific understanding and citing the Alliance for funding support: - Ekaterina Dadachova, Ph.D., University of Saskatchewan – Actinium-armed antibody targeting CCR8+ regulatory T cells synergizes with immunotherapy to promote tumor rejection in syngeneic colorectal cancer models - DaeYong Lee, Ph.D., Virginia Tech – Cancer researchers shape new strategies for immunotherapy - Lisa Mielke, Ph.D., Olivia Newton-John Cancer Research Institute and La Trobe University – Key nervous system components shown to influence gastrointestinal tumour growth “Colorectal cancer is the leading cancer killer among men under 50 and is predicted to be the leading cause of cancer-related deaths among people aged 20–49 by 2030, yet it remains less known and less funded than other less deadly cancers,” said Michael Sapienza, CEO of the Colorectal Cancer Alliance. “Without research, there is no progress, so we are prioritizing Project Cure CRC to end this disease.” Past Alliance-funded research has been instrumental in revolutionary advancements. In 2018, Alliance support for Josh Smith, M.D., Ph.D., now Chair of Colon and Rectal Surgery at MD Anderson Cancer Center, was critical to his team’s groundbreaking work as they created and developed the first viable rectal cancer organoid models, which have since transformed options for patients with rectal cancer and the discovery of novel treatments. Every breakthrough begins with research, and every discovery brings us closer to a cure. The Alliance invites the public, corporations, foundations, and philanthropists to help fuel this progress by contributing to Project Cure CRC. For more information on Project Cure CRC, view our recent Curecast, get involved, donate, or learn about submitting a research proposal, visit colorectalcancer.org/curecrc. About the Colorectal Cancer Alliance The Colorectal Cancer Alliance empowers a nation of passionate and determined allies to prevent, treat, and overcome colorectal cancer in their lives and communities. Founded in 1999 and headquartered in Washington, D.C., the Alliance advocates for prevention through initiatives like LEAD FROM BEHIND, magnifies support with BlueHQ, and accelerates research through Project Cure CRC. We are the largest national nonprofit dedicated to colorectal cancer, and we exist to end this disease in our lifetime. For more information, visit colorectalcancer.org. Emily Blasi Colorectal Cancer Alliance +1 202-971-9964 email us here Visit us on social media: LinkedIn Bluesky Instagram Facebook YouTube TikTok X Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Continued uncertainty in the US has many of the world's top scientists considering the Basel area. BASEL, Switzerland, Nov. 11, 2025 /PRNewswire/ -- Between the government shutdown, crippling international tariffs, debilitating funding cuts to critical research, and the general policy whiplash in Washington DC, it's little wonder many US-based life sciences companies are opting to expand in a more stable environment. Basel Area Business & Innovation says the Basel area in Switzerland is poised to welcome them. Continue Reading Photo credit: Basel Area Business & Innovation. Photography by AviaticFilms Often considered a world leading life sciences supercluster, the Basel region is already the global headquarters for some of the world's top pharmaceutical and biotech companies. Given its strategic location in the centre of Europe with direct access to the biggest European markets, close proximity to several top-tier universities, one of the fastest drug registration processes in the world, and a government committed to funding innovation, it's little wonder the region is attracting notable names. Immunologist and California transplant, Dr. Stephen Wilson, who spent 24 years at the La Jolla Institute for Immunology, is one of them. He recently left the US to lead the Botnar Institute of Immune Engineering (BIIE). Headquartered at the Switzerland Innovation Park Basel Area, BIIE is a life sciences research institute focused on developing immune-based diagnostics and therapeutics for children. Dr. Wilson is concerned that American innovation will suffer long-term impacts if funding cuts to research and a dismissive mindset towards science continue. "It has long been that if you were a top scientist in your field, you were drawn to the United States to further your research; no questions," he explained. "In particular, grants from the National Institutes of Health was a global attractor of talent, funding work in the US that has led to medical breakthroughs and acting as a catalyst to private investment and economic rewards unmatched anywhere. When research funding is abruptly cut for non-scientific reasons, it sends a signal this administration is skeptical of researchers or the importance of America's world-leader status in biomedical science." NIH budget cuts are unnerving enough, but given they're happening in conjunction with other policy changes that evoke feelings of hostility and uncertainty, it's not surprising many top scientists are looking to practice elsewhere. After a global survey of locations, and a commitment of over $1 billion (USD) from the Swiss philanthropic foundation, Fondation Botnar, the BIIE began its operations in Basel. Pioneering research requires the institute to assemble a critical mass of elite researchers from around the world. After first visiting Basel in 2022, Dr. Wilson and his family moved full-time in 2024 to take on the role as CEO of BIIE, and to recruit others to make the move as well. "Moving your research and your family are both long-term decisions. Scientists accept that innovation requires perseverance and risk-tolerance, but the ecosystem around you should not bring additional chaos." Dr. Wilson added. "Here in Basel, it's palpable that the Swiss are committed to bold science and global impact. Having confidence that your organization's mission will not be undermined by shifting policies each election cycle means the research community can invest with confidence and take on the necessary level of risks." Christof Klöpper, CEO of Basel Area Business & Innovation, the agency that promotes investment in the area, agreed. "US pharma and biotech companies used to acquire Basel-based startups, but now, they're setting up shop here," he said. "They recognize we have a science-sympathetic regional government, excellent tax rates, and offer an exceptional quality of life. But more than that, they know ambitious research and development needs policies that will not flip in a two-year cycle. Switzerland provides that certainty." About Basel Area Business & Innovation: Basel Area Business & Innovation is the investment and innovation promotion agency dedicated to helping companies, institutions and startups find business success in the Basel area. The organization targets and attracts companies to settle, supports founders of innovative ventures, and drives high growth initiatives in order to establish the region as the Swiss business and innovation hub of the future. The non-profit agency focuses on promoting the Basel Area Life Sciences Supercluster as Europe's most concentrated destination for biotech, pharma, health tech and MedTech innovation — and home to the highest density of life sciences professionals anywhere in the world. Spanning Switzerland, France, and Germany, its borderless location delivers triple the talent and triple the market access, uniting 800+ companies, 1,000 research groups and nearly 35,000 industry experts into a single end-to-end ecosystem accelerating innovation from lab to launch. Learn more at: and Media contact: Amy Roberts [email protected] SOURCE Basel Area Business & Innovation 21% more press release views with Request a Demo