Cytoki Pharma Highlights Data Reinforcing Therapeutic Potential of Lipidated IL-22 for IBD in Digestive Diseases and Sciences Publication
Findings support lipidated IL-22 as a differentiated treatment option to address the significant unmet need in IBD
Results strongly support continued development of Cytoki's oral IL-22 program for UC which is part of its growing preclinical pipeline of IL-22-based assets
SØBORG, Denmark, May 8, 2025 /PRNewswire/ -- Cytoki Pharma ApS (Cytoki), a clinical-stage biotechnology company pioneering a new class of medicines that harness interleukin-22 (IL-22) biology to drive improved metabolic and other health outcomes, today announced the publication of preclinical data demonstrating the efficacy of its novel lipidated IL-22 analogue in a model of inflammatory bowel disease (IBD) in Digestive Diseases and Sciences.
The publication, titled 'Lipidated IL-22 Alone or Combined with Immunomodulatory Agents Improves Disease Endpoints and Promotes Mucosal Healing in a Mouse Model of Chronic Dextran Sodium Sulfate-Induced Colitis,' includes findings demonstrating the therapeutic potential of a novel lipidated IL-22 analogue in a widely used preclinical IBD model. Findings indicated lipidated IL-22's ability to significantly improve all aspects of chronic colitis, with a clear dose-dependent response in reducing clinical, endoscopic, and histological signs of the disease. Preclinical results also highlighted lipidated IL-22's ability to directly induce mucosal healing and reduce inflammation, further demonstrating IL-22's unique ability when compared to existing IBD treatments. Notably, the combination of lipidated IL-22 with immunomodulatory agents resulted in additive therapeutic benefits, signaling potential for even greater improvements when used in combination.
The translatability of these findings is supported by human data demonstrating increased expression of genes associated with epithelial repair and host defense in colonic biopsies from patients with ulcerative colitis after IL-22 administration. Together, these results suggest a promising new therapeutic strategy for managing IBD and increasing long-term remission rates.
'These compelling findings underscore the significant potential of IL-22's powerful biology to fuel novel therapeutics capable of addressing IBD via a differentiated mode of action,' said Martijn van de Bunt, M.D., D.Phil, CSO at Cytoki and publication co-author. 'Given IL-22's unique potential to overcome the current therapeutic ceiling in IBD management, we are excited about the preclinical oral IL-22 program we are pursuing alongside our metabolic disease-focused clinical and preclinical IL-22 pipeline.'
Additional key takeaways from the paper are as follows:
About Cytoki Pharma
Cytoki Pharma is a clinical-stage biotechnology company pioneering a new class of medicines that harness IL-22 biology to drive improved outcomes for cardiometabolic disease and inflammatory conditions. Cytoki's lead program, CK-0045, a lipidated IL-22 analogue, is currently being evaluated in a Phase 2 clinical study in individuals with obesity and type 2 diabetes. The company is also advancing a broader portfolio of preclinical IL-22-based assets. Cytoki was founded in 2019 and is led by a team of pharma industry veterans with deep expertise in the discovery and clinical development of novel drugs. Please visit www.cytokipharma.com or follow us on LinkedIn for additional details.
Media Contact
Lia Dangelico
[email protected]
+1 540-303-0180
View original content to download multimedia: https://www.prnewswire.com/news-releases/cytoki-pharma-highlights-data-reinforcing-therapeutic-potential-of-lipidated-il-22-for-ibd-in-digestive-diseases-and-sciences-publication-302447688.html
SOURCE Cytoki Pharma
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
2 hours ago
- Yahoo
The British Medical Journal Publishes Study Results on Sacituzumab Tirumotecan for Previously Treated EGFR-Mutant Advanced NSCLC
CHENGDU, China, June 6, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech", today announced that results from its registrational study (OptiTROP-Lung03) evaluating sacituzumab tirumotecan (sac-TMT) versus docetaxel in patients with previously treated advanced EGFR-mutant non-small cell lung cancer (NSCLC) have been published in The British Medical Journal (impact factor: 93.6). These data were also presented as an oral presentation in the Lung Cancer—Non–Small Cell Metastatic session (Abstract #8507) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Based on the encouraging data from this study, sac-TMT was approved for marketing by the National Medical Products Administration (NMPA) for the treatment of adult patients with epidermal growth factor receptor (EGFR) mutant-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-tyrosine kinase inhibitor (TKI) therapy and platinum-based chemotherapy in March 2025. This marks the first global approval of a TROP2 ADC for a lung cancer indication. The published results are based on OptiTROP-Lung03, an open-label, randomized, multicenter registrational study evaluating the efficacy and safety profile of sac-TMT monotherapy versus docetaxel for the treatment of patients with locally advanced or metastatic EGFR-mutant NSCLC who have failed after treatment with an EGFR-TKI and platinum-based chemotherapy. A total of 137 patients with advanced EGFR-mutant NSCLC who had progressed after EGFR-TKI and platinum-based chemotherapy were randomized (2:1) to receive sac-TMT (5 mg/kg once every 2 weeks) or docetaxel (75 mg/m2 once every 3 weeks) until disease progression, intolerable toxicity or other reason for discontinuation, with a median follow-up time of 12.2 months (Data cutoff date: December 31, 2024). Sac-TMT achieved statistically significant and clinically meaningful outcomes compared to docetaxel: Confirmed objective response rate (ORR) (As assessed by blinded independent review committee (BIRC): 45% (95% CI, 35-56) vs 16% (95% CI, 7-30). Median progression-free survival (PFS) (As assessed by BIRC: 6.9 months [sac-TMT; 95% CI, 5.4-8.2] vs 2.8 months [docetaxel; 95% CI, 1.6-4.1], hazard ratio (HR)= 0.30 [range, 0.20 -0.46], one-sided p<0.0001; as assessed by investigator (INV): 7.9 months [sac-TMT; 95% CI, 6.2-9.5] vs 2.8 months [docetaxel; 95% CI, 1.5-3.8], HR=0.23 [95% CI, 0.15-0.36], one-sided p<0.0001). With 36.4% of patients in docetaxel group crossing over to receive sac-TMT, median overall survival (OS) was not reached (NR) for both groups (HR=0.49; 95% CI, 0.27-0.88; one-sided p=0.007). The median OS analysed by pre-specified rank-preserving structural failure time (RPSFT) model adjusted for crossover was 9.3 months for docetaxel and NR for sac-TMT (HR=0.36; 95% CI, 0.20-0.66). Efficacy benefit favored patients with sac-TMT over docetaxel across all pre-specified subgroups, including prior EGFR-TKI therapy, brain metastases, EGFR mutation type, etc. Grade ≥ 3 treatment-related adverse events (TRAEs) occurred in 56.0% of patients in sac-TMT group vs 71.7% in docetaxel group. The results demonstrated that sac-TMT monotherapy achieved statistically significant and clinically meaningful improvements in objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) compared to docetaxel, with a manageable safety profile. Sac-TMT is being extensively studied in the NSCLC field. Covering treatment settings from later-line therapy to early-stage postoperative adjuvant therapy, including both monotherapy and combination regimens. Currently, five company-led registrational clinical studies for sac-TMT in NSCLC are underway in China. Meanwhile, Merck Sharp & Dohme（the tradename of Merck & Co., Inc., Rahway, NJ, USA）is also conducting five global Phase III clinical trials of sac-TMT for NSCLC in regions where it has exclusive rights. Professor Li Zhang, National Lead Principal Investigator, Medical Oncologist and Deputy Director of the Lung Cancer Research Centre at Sun Yat-Sen University, stated: "EGFR mutation is the most common driver alteration in NSCLC. The prevalence of EGFR mutations reaches 28.2% among NSCLC patients in China. Although third-generation EGFR-TKIs have become the standard of care for advanced EGFR-mutant NSCLC and may significantly improve PFS, acquired resistance remains inevitable. Combining EGFR-TKIs with chemotherapy can offer additional survival benefits to some patients, but this approach is limited by safety concerns and may compromise future treatment options, posing significant clinical challenges. The publication of the OptiTROP-Lung03 study in the British Medical Journal marks a major milestone—not only highlighting international recognition of this study outcomes in lung cancer, but also demonstrating the global competitiveness of sac-TMT as a novel TROP2 ADC." Dr. Michael Ge, CEO of Kelun-Biotech, commented: "We are thrilled to see the OptiTROP-Lung03 study published in a top-tier journal. Currently, EGFR-TKIs and chemotherapy remain the standard of care for patients with EGFR-mutant advanced NSCLC, but the challenge of increasing efficacy with manageable tolerability. The results from OptiTROP-Lung03 highlight significant survival benefits with manageable safety profile and suggest that sac-TMT could emerge as a new standard of care for this population. We remain committed to working with our partners to establish sac-TMT as a new standard of care for this patient population and improve outcomes for lung cancer patients worldwide." Registrational Study Led by Kelun-Biotech OptiTROP-Lung03: Sac-TMT monotherapy versus docetaxel for locally advanced or metastatic EGFR-mutant NSCLC after treatment failure with EGFR-TKI and platinum-containing chemotherapy； OptiTROP-Lung04: Sac-TMT monotherapy versus pemetrexed in combination with platinum for locally advanced or metastatic non-squamous NSCLC with EGFR mutations that have failed EGFR-TKI therapy； OptiTROP-Lung05: Sac-TMT combined with pembrolizumab versus chemotherapy combined with pembrolizumab for first-line treatment of PD-L1-positive locally advanced or metastatic NSCLC; OptiTROP-Lung06: Sac-TMT combined with pembrolizumab versus chemotherapy combined with pembrolizumab for the first-line treatment of PD-L1-negative locally advanced or metastatic non-squamous NSCLC; OptiTROP-Lung07: First-line treatment of locally advanced or metastatic NSCLC with EGFR mutations by sac-TMT in combination with ositinib. Registrational Study Led by MSD NSCLC not achieving a pCR after neoadjuvant therapy followed by surgery. NSCLC expressing PD-L1 >50% pre-treated NSCLC with EGFR mutations or other genomic alterations EGFR-mutated, advanced non-squ NSCLC progressed on prior EGFR-TK metastatic sg NSCLC About sac-TMT Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as NSCLC, BC, gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells. In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (includes Mainland China, Hong Kong, Macao, and Taiwan). To date, two indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) based on the OptiTROP-Breast01 study and EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy based on the OptiTROP-Lung03 study. Sac-TMT became the first domestic ADC with global intellectual property rights to be fully approved for marketing. It is also the world's first TROP2 ADC to be approved for marketing in a lung cancer indication. In addition, two new indication applications for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy and with unresectable locally advanced, metastatic hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) BC who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting were accepted by the National Medical Products Administration (NMPA), and were reviewed via the priority review and approval process. As of today, the Company has initiated 8 registrational clinical studies in China. MSD has initiated 14 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other agents for several types of cancer. These studies are sponsored and led by MSD. About Kelun-Biotech Kelun-Biotech（ a holding subsidiary of Kelun Pharmaceutical ( which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 3 projects have been approved for marketing, 1 project is in the NDA stage, and more than 10 projects are in the clinical stage. The company has established one of the world's leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC and novel coupled drug products in clinical or preclinical research stage. For more information, please visit Media: klbio_pr@ View original content to download multimedia: SOURCE Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Yahoo
5 hours ago
- Yahoo
Zero Gravity Lifts off on Documentary Showcase
LOS ANGELES, June 6, 2025 /PRNewswire/ -- Scientology Network's DOCUMENTARY SHOWCASE, the weekly series providing a platform for Independent filmmakers to air films on important social, cultural and environmental issues, presents the celestial documentary Zero Gravity on June 6, 2025. DOCUMENTARY SHOWCASE airs Fridays at 8 p.m. ET/PT on Scientology Network. In Zero Gravity, middle school students from San Jose, California, enter a nationwide NASA tournament to code satellites aboard the International Space Station (ISS). Led by an inspiring first-time coach, the team rises from budding digital dreamers to ultimately represent California in the ISS finals tournament—where astronauts execute the young coders' algorithms in orbit, 250 miles above Earth. Directed by Thomas Verrette, the film follows the kids' transformation and serves as a powerful reminder: the future begins with those bold enough to imagine it. An official selection at over 70 film festivals—including DOC NYC, Cinequest and the Cleveland International Film Festival—Zero Gravity has won 18 documentary awards from Audience Choice to Best Editing. Endorsed by scientists and educators, the film has reached more than 10,000 students nationwide through classroom and community screenings. ABOUT THOMAS VERRETTE Thomas Verrette is an award-winning director, producer and editor. A more than 15-year veteran of the film industry, Verrette is a former FOX and Disney creative and post-production executive. He is most known for producing the 20-episode World Cup docu-series Phenoms for FOX Sports. Verrette began his career upon graduating from the Savannah College of Art and Design. Zero Gravity is his first feature documentary as a director. ABOUT DOCUMENTARY SHOWCASE Fundamental to Scientology is a humanitarian mission that extends to some 200 nations with programs for human rights, human decency, literacy, morality, drug prevention and disaster relief. For this reason, the Scientology Network provides a platform for Independent filmmakers who embrace a vision of building a better world. DOCUMENTARY SHOWCASE debuts films weekly from award-winning Independent filmmakers whose goal is to improve society by raising awareness of social, cultural and environmental issues. For more information, visit Scientology Network debuted on March 12, 2018, launched by David Miscavige, ecclesiastical leader of the Scientology religion. Since then, Scientology Network has been viewed in over 240 countries and territories worldwide in 17 languages. Satisfying the curiosity of people about Scientology, the network takes viewers across six continents, spotlighting the everyday lives of Scientologists, showing the Church as a global organization and presenting its Social Betterment programs that have touched the lives of millions worldwide. The network also showcases documentaries by Independent filmmakers who represent a cross section of cultures and faiths, but share a common purpose of uplifting communities. Scientology Network's innovative content has been recognized with more than 125 industry awards, including Tellys, Communitas and Hermes Creative Awards. Broadcast from Scientology Media Productions, the Church's global media center in Los Angeles, Scientology Network is available on DIRECTV Channel 320, DIRECTV STREAM and AT&T U-verse and can be streamed at on mobile apps and via the Roku, Amazon Fire and Apple TV platforms. View original content to download multimedia: SOURCE Church of Scientology International
Yahoo
6 hours ago
- Yahoo
46 State Medical Associations Urge Senate to Reject Medicaid Cuts in H.R. 1
The House Budget Reconciliation bill will cause at least 7.8 million Medicaid enrollees to lose their health care coverage. SACRAMENTO, Calif., June 6, 2025 /PRNewswire/ -- Just days ahead of an expected Senate vote on H.R. 1, 46 state medical associations, as part of Physicians for Medicaid have sent a letter to the United States Senate urging them to reject the dangerous cuts to Medicaid proposed in H.R. 1 that will cause millions of patients to lose coverage and even more to lose access to care - children, pregnant women, seniors, veterans, the disabled and working families. Statewide hospital associations have also weighed in, as proposed cuts impact all providers, including physicians and hospitals. The bill, which includes $200 billion in cuts to the existing and longstanding provider taxes, would have a catastrophic effect on state budgets and the country's entire health care delivery system and would impact 49 state Medicaid programs. Provider taxes have been authorized under federal law, approved by both Republican and Democratic administrations, and affirmed by state legislatures in 49 states for decades. They are a legitimate financing mechanism used by states in partnership with the federal government to fund essential health services and have kept rural hospitals, maternity wards, nursing homes, and physician practices open. The bill also imposes damaging changes to federal student loan programs making it harder for students to pursue medical careers at a time of critical physician shortages. We urge the Senate to pursue more balanced solutions that expand the physician workforce and preserve Medicaid for our patients. "If these provider tax cuts are enacted, it will create significant gaps in State budgets, forcing states to raise taxes, or reduce benefits, coverage, and provider payments. These reductions will lead to even more crowding of emergency departments and as the uncompensated care burdens grow from patients losing coverage, many rural hospitals, nursing homes, and community physician practices will be forced to close to all patients," the letter says. There are three main provisions in H.R. 1 (as passed by the House of Representatives on May 22, 2025) that will drastically limit or eliminate existing provider taxes nationwide. These provisions below apply to all provider taxes, including hospitals, nursing homes, managed care organizations, and other provider categories. Moratorium on New or Increased Provider Taxes (SEC. 44132) – Under the provisions of H.R. 1, none of these taxes could be increased after the passage and enactment of the law nor can any new taxes be adopted by the state Legislatures (there are 19 categories of provider taxes). This provision would freeze taxes and not keep pace with increasing health care costs over time. It is also not equitable between states. Revising Payments for Certain State Directed Payments (SEC. 44133) – Once a provider tax is established, state Medicaid programs can fund supplemental or enhanced payments to providers using a variety of rate methodologies. Under H.R. 1, any future directed payments would be limited to the Medicare payment rate. Medicare physician payment rates are already 33% behind the costs to provide health care. These rates will not keep pace for public hospitals and physician specialists that care for the sickest patients nationwide. Requirements Regarding Waiver of Uniform Tax Requirement for Medicaid Provider Tax (SEC. 44134) – The language in H.R. 1 requires provider taxes in multiple states to uniformly tax hospitals, nursing homes, and managed care organizations within each category of provider tax. The uniformity requirement will be extremely difficult for most states to meet and therefore, it eliminates multiple provider taxes in many states. The HHS Secretary has discretion to allow for a transition period, which is not something upon which states can rely. "These provisions will destabilize state health systems, reduce access to care, and worsen physician shortages. Instead, we encourage you to protect Medicaid – a proven, cost-effective safety net that serves 80 million vulnerable Americans," the letter concluded. View original content to download multimedia: SOURCE California Medical Association; Physicians for Medicaid Sign in to access your portfolio
