logo
Lifeist Wellness Expands Mikra's Mind-First Product Portfolio with Three New Performance-Focused Formulations

Lifeist Wellness Expands Mikra's Mind-First Product Portfolio with Three New Performance-Focused Formulations

Business Upturn21-07-2025
By GlobeNewswire Published on July 21, 2025, 16:35 IST
New products reflect Mikra's commitment to recently unveiled Mind-First Movement prioritizing mindset as the primary driver of peak performance
Mikra partners with leading nutritional supplement brand Designs for Health to introduce new product formulations
TORONTO, July 21, 2025 (GLOBE NEWSWIRE) — Lifeist Wellness Inc. ('Lifeist' or the 'Company') (TSX.V: LFST; OTCQB: LFSWF; FRANKFURT: M5B0), a health-tech wellness company curating and building innovation at the forefront of consumer health, announces the availability of three new Mikra performance-focused daily essentials on wearemikra.com. The new products — Magnesium Bis-Glycinate, Coenzymated B Complex, and Omega-3 with EPA & DHA — are foundational daily formulas designed to support core systems that contribute to cognitive performance and mental resilience. Each product is manufactured in partnership with Designs for Health, a leading provider of premium-grade, practitioner-trusted supplements known for their precision and purity.
'Offering a complete system of mind-first tools is key to our fundamental shift toward mental performance as the essential foundation of high performance,' said Andrea Judge, CEO of Lifeist Wellness. 'Mikra's Mind-First Movement is about pairing clinical precision with real-world performance. This approach prioritizes focus, cognitive endurance, and complete recovery as primary drivers of peak performance for athletic and for everyday life.'
'We are delighted to partner with Designs for Health, which has decades of formulation expertise and rigorous quality standards,' Judge added. 'This collaboration with Designs for Health has made it possible to bring premium, research-based cognitive support into everyday formulations that match the integrity of our more targeted cognitive solutions.'
The new Mikra formulations support key body systems that play vital roles in helping to unlock higher cognitive performance: Magnesium Bis-Glycinate is a highly absorbable and bioavailable form of magnesium that helps ease physical tension and supports the body's shift into a restorative, parasympathetic state. By calming the nervous system, it plays a critical role in post-exertion recovery — supporting not only muscle relaxation but the mental clarity and emotional balance needed for cognitive performance.
is a highly absorbable and bioavailable form of magnesium that helps ease physical tension and supports the body's shift into a restorative, parasympathetic state. By calming the nervous system, it plays a critical role in post-exertion recovery — supporting not only muscle relaxation but the mental clarity and emotional balance needed for cognitive performance. Coenzymated B Complex delivers B vitamins in their active methylated, bioavailable forms to help the body efficiently produce energy, regulate the stress response, and support nervous system resilience. These essential nutrients play a key role in cognitive stamina, mood balance, and mental recovery — especially under daily physical and psychological demands.
delivers B vitamins in their active methylated, bioavailable forms to help the body efficiently produce energy, regulate the stress response, and support nervous system resilience. These essential nutrients play a key role in cognitive stamina, mood balance, and mental recovery — especially under daily physical and psychological demands. Omega-3 with EPA & DHA provides a high concentration of essential fatty acids that nourish brain cell membranes, support mood regulation, and optimize communication between neurons. By reducing neuroinflammation and supporting structural brain health, omega-3s are foundational for cognitive clarity, emotional steadiness, and long-term brain performance.
The new products complement Mikra's mind-first supplements each designed to support the connection between mental and physical performance: CLARITY for preparing the mind for the demands ahead, HYDRATE to fuel focus during performance, and CALM to support recovery and nervous system repair afterward. Lifeist plans to unveil a reformulation of its flagship CellF later this summer.
About Designs for Health
Family-owned Designs for Health, Inc. offers high-quality nutritional supplements and functional foods to health care professionals and their patients. Guided by its founding philosophy of 'Science-First™,' the company holds an unwavering commitment to creating research-driven formulations with meaningful quantities of functional ingredients that maximize the potential for successful health outcomes. For over 35 years, Designs for Health has been many health-care professionals' trusted source for not only product innovation but also leadership in clinical education and practice development solutions. https://www.designsforhealth.com/our-story
About Mikra
Mikra is a performance-focused supplement brand built around a simple idea: the mind leads, and the body follows. Through targeted, science-backed formulations, Mikra is creating a new standard for what it means to support total human performance — starting with cognitive and emotional resilience.
About Lifeist Wellness Inc.
Lifeist is a health-tech wellness company that believes in building performance from within. Through its innovative portfolio of consumer brands — including Mikra — Lifeist is creating a new standard in mental and physical optimization. Learn more at: www.lifeist.com | www.wearemikra.com
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release or has in any way approved or disapproved of the contents of this press release.
Source: Lifeist Wellness Inc.
Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same.
Ahmedabad Plane Crash
GlobeNewswire provides press release distribution services globally, with substantial operations in North America and Europe.
Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

Booking Health Unveils New Study: Role of Immunotherapy in Extending Life Expectancy for Stage4 Cervical Cancer Patients
Booking Health Unveils New Study: Role of Immunotherapy in Extending Life Expectancy for Stage4 Cervical Cancer Patients

Business Upturn

time4 hours ago

  • Business Upturn

Booking Health Unveils New Study: Role of Immunotherapy in Extending Life Expectancy for Stage4 Cervical Cancer Patients

Langenfeld, Germany, Aug. 11, 2025 (GLOBE NEWSWIRE) — Booking Health , a global leader in medical treatment coordination, today unveiled a new study titled Role of Immunotherapy in Extending Life Expectancy for Stage 4 Cervical Cancer Patients . The report outlines how cutting-edge immunotherapy is reshaping care for women with advanced cervical cancer, offering new pathways to longer survival and improved quality of life, particularly in cases resistant to standard treatments. Cervical Cancer Immunotherapy is redefining how doctors treat women diagnosed with stage 4 cervical cancer – offering hope where traditional treatments often fall short. According to global cancer statistics provided by the World Health Organization, cervical cancer is still ranking as the fourth most frequently diagnosed cancer among women worldwide, with over 350,000 deaths reported in 2022 alone. Therefore, the need for more effective therapies is urgent. Chemotherapy and radiation therapy remain standard for locally advanced and metastatic cervical cancer. However, they often come with harsh side effects and limited long-term benefit – especially in recurrent or PD-L1-positive cases. This is where immunotherapy is beginning to transform the way we treat cervical cancer. By training the immune system to recognize and destroy cancer cells, this innovative approach is extending survival, improving quality of life, and reshaping the future of gynecologic oncology, according to the American Cancer Society. Leading the way in connecting patients with advanced treatment abroad is Booking Health, a global medical coordination platform that offers access to advanced cervical cancer treatment in the best European clinics. Why Is Stage 4 Cervical Cancer So Hard to Treat? Stage 4 cervical cancer is difficult to treat because it involves metastatic disease, where cancer has spread beyond the pelvis to distant organs, making it less responsive to traditional therapies such as chemotherapy and radiation. In many cases, the disease becomes persistent or recurrent, with fewer effective treatment options available, as reported by the National Cancer Institute. Types of Advanced Cervical Cancer Understanding the different stages helps clarify why some cases are more complex than others: Term Definition Treatment Challenge Locally advanced cervical cancer Cancer has spread beyond the cervix to nearby tissues (e.g., vagina, parametria) but not to distant organs Often treated with chemoradiation, but recurrence risk remains Recurrent cervical cancer Cancer returns after a period of remission May resist previously used therapies and require new approaches Metastatic cervical cancer Cancer spreads to distant organs like lungs, liver, or bones Hard to target; systemic therapies often have limited success Most Common Cervical Cancer Types Squamous cell carcinoma – accounts for 80-90% of cases; originates in the ectocervix Adenocarcinoma – about 10-20% of cases; arises from glandular cells in the endocervix Adenosquamous carcinoma – a rarer subtype with mixed features As reported by Cancer Research UK, each type may behave differently in terms of spread, immune response, and treatment sensitivity. Limitations of Traditional Treatments Standard treatments for advanced cervical cancer include: Chemotherapy: Often platinum-based; effectiveness diminishes over time; Radiation therapy: Can control local disease but may not impact distant metastases; Systemic therapies: Cause significant side effects, with limited survival benefit in persistent cervical cancer. Moreover, the American Cancer Society reports that patients with persistent or metastatic disease often experience poor outcomes, with 5-year survival rates below 20% in stage 4 cases. As such, gynecologic oncology experts have increasingly turned to immunotherapy to improve response rates and extend survival. What Is Immunotherapy and How Does It Work for Cervical Cancer? Immunotherapy for cervical cancer stimulates the body's own immune system to recognize and destroy cancer cells by targeting specific immune pathways. This approach is especially useful for patients with PD-L1–positive, recurrent, or metastatic cervical cancer who may not respond well to conventional treatments. Approach Description Relevance to Cervical Cancer Immune checkpoint inhibitors Block proteins (PD-1, PD-L1) that prevent immune cells from attacking cancer Reactivates exhausted T cells to fight cervical cancer cells Monoclonal antibodies Lab-made antibodies designed to target specific tumor markers Some bind PD-L1 or deliver cytotoxic agents directly to tumor cells Cancer vaccines Stimulate immune response to HPV or tumor-associated antigens Promote lasting T cell activation and memory Adoptive T cell therapy Infuse engineered T cells that can attack tumor cells Under investigation for recurrent cervical cancer The PD-1/PD-L1 Pathway PD-1 is a receptor on T cells that regulates immune response PD-L1 is often overexpressed on cervical cancer cells When PD-L1 binds to PD-1, it 'switches off' the immune attack Checkpoint inhibitors block this interaction – reactivating T cells to destroy cancer cells Why It Matters Many cervical tumors exhibit high PD-L1 expression, making them ideal candidates for immunotherapy. Successful treatment leads to greater T cell infiltration into tumors, enhancing immune surveillance. Patients often experience improved immune response and more durable control of the disease than with chemotherapy alone. This therapeutic shift reflects a broader move toward personalized medicine in gynecologic oncology, targeting tumor-infiltrating lymphocytes and immune checkpoints rather than relying solely on cytotoxic drugs. Findings from the Latest Clinical Trials Recent phase III clinical trials have shown that combining immunotherapy with standard chemotherapy – or using it as a second-line option – can significantly extend survival and delay disease progression in patients with recurrent or metastatic cervical cancer. These studies demonstrate that there has occurred a major shift in how advanced cervical cancer is treated, providing hope to patients who previously had limited options after conventional therapies failed. Highlights from the Trials Patients receiving immunotherapy lived significantly longer than those on chemotherapy alone. Survival benefit was observed regardless of PD-L1 status, especially in recurrent cases after platinum-based treatment. Delays in disease progression gave patients more time with better quality of life. Immune checkpoint inhibitors helped reactivate the immune system's ability to target and destroy cervical cancer cells. Clinical Trial Treatment Type Median Overall Survival (OS) Disease Control Outcome Notes Phase III Study Immunotherapy + Chemo Up to 28.6 months vs 16.5 months Longer survival in all groups Strongest benefit in PD-L1+ patients Randomized Phase III Trial Immunotherapy (2nd-line) 11.7 months vs 8.5 months Benefit seen in all PD-L1 levels Works even after chemo failure * Both studies confirmed survival advantages without significantly higher severe side effects compared to chemotherapy alone. What This Means for Patients For women with recurrent, persistent, or metastatic cervical cancer, these results signal a new standard of care. Immunotherapy is not only more targeted than traditional therapies but also better tolerated, offering: A longer window of disease control (median progression-free survival extended); Improved quality of life with fewer systemic side effects; Hope for those who did not respond to chemotherapy or radiation. This also opens the door for future therapies involving antibody drug conjugates, personalized immune profiling, and combination treatments that utilize both the immune system and conventional medicine. Today, cervical cancer cohorts worldwide are benefiting from a more individualized, immune-driven approach that redefines what is possible after recurrence or metastasis. Who Benefits Most from Immunotherapy in Cervical Cancer? Immunotherapy is most effective for patients with PD-L1-positive, recurrent, or metastatic cervical cancer, particularly when standard treatments like chemotherapy or radiation therapy have failed, as previously mentioned. These patients often have limited options, and immunotherapy provides a targeted approach that can activate the immune system to attack tumor cells more effectively. Common Eligibility Criteria for Immunotherapy Patients who may benefit from immunotherapy typically meet one or more of the following criteria: PD-L1 expression ≥1% (as determined by tumor biopsy); Recurrent or metastatic cervical cancer following standard treatment; Persistent squamous cell carcinoma that does not respond to initial therapies; Evidence of T cell infiltration or active immune cell presence within the tumor; No contraindications for immune checkpoint blockade (e.g., autoimmune diseases). Histology Type Prevalence Response to Immunotherapy Squamous Cell Carcinoma ~80-90% Better overall immune response; more PD-L1 expression; strong T cell infiltration Adenocarcinoma ~10-20% Slightly lower PD-L1 expression; emerging data still promising Adenosquamous/Mixed <5% Limited clinical data; under investigation While both subtypes may benefit, squamous cell carcinoma tends to respond more favorably due to its immunogenicity and higher prevalence of immune markers like PD-L1. Why This Is Important Understanding which patients are most likely to respond helps oncologists personalize therapy, avoid unnecessary toxicity, and improve overall outcomes in metastatic cervical cancer patients. As clinical trials continue to evolve, biomarkers like PD-L1, tumor-infiltrating lymphocytes, and even genomic profiling are playing a larger role in guiding treatment selection. What Are the Current Limitations and Side Effects of Immunotherapy? While immunotherapy is an innovative option in cervical cancer treatment, it is not without limitations. Not all patients experience a positive immune response, and treatment can lead to side effects caused by overstimulation of the immune system. Main Limitations of Immunotherapy for Cervical Cancer Variable response rates: Only patients with specific tumor profiles (e.g., PD-L1-positive tumors or high T cell infiltration) tend to respond. Delayed response: Unlike chemotherapy, benefits may take weeks or months to appear. Immune hyperactivation: Some patients may develop autoimmune-like reactions when the immune system attacks healthy tissue. High costs: Immunotherapy is expensive, and coverage varies widely by country and provider. Limited access: Not all regions offer advanced immune-based therapies or diagnostic testing. Side Effect Type Description Frequency Colitis Inflammation of the colon causing diarrhea Moderate Thyroiditis/Hypothyroidism Immune attack on the thyroid Common Dermatitis or skin rash Immune-related skin inflammation Common Fatigue and joint pain General inflammatory response Mild to moderate Pneumonitis Lung inflammation (rare but serious) Rare Cleveland Clinic highlights that these side effects are often immune-related and differ from those of chemotherapy, which typically causes nausea, hair loss, and bone marrow suppression. Most immune-related reactions are manageable with corticosteroids or immunosuppressive agents when diagnosed early. Importance of Tumor Profiling and Biomarker Testing Before initiating immunotherapy, tumor profiling is crucial. Tests that assess PD-L1 expression, tumor mutational burden, and immune cell markers help determine whether a patient is a good candidate. This ensures that patients treated are those most likely to benefit from therapy while minimizing unnecessary risks. Why Are More Patients Going Abroad for Cervical Cancer Immunotherapy? Many cervical cancer patients choose to go abroad for immunotherapy because of faster access, broader treatment options, and advanced clinical expertise – especially in countries known for innovation in gynecologic oncology. In many parts of the world, patients face long wait times, outdated systemic therapies, or limited access to next-generation immune system-based treatments. This is especially critical for women with advanced or recurrent cervical cancer, where timely intervention can directly affect survival and quality of life. In contrast, specialized cancer centers in countries like Germany offer accelerated treatment pathways, advanced diagnostics, and access to experimental options not yet widely available elsewhere. Primary Reasons Patients Travel Abroad for Treatment Limited access at home: In some countries, immune checkpoint inhibitors and personalized immunotherapy are not yet standard care – or are cost-prohibitive without insurance support. Delays in diagnosis or therapy: Long waitlists for oncology consultations or biopsy testing can result in treatment delays that worsen outcomes. Patients who choose to treat cervical cancer abroad often report improved outcomes, better coordination, and more comprehensive care – especially when guided by experienced facilitators like Booking Health. From Research to Results: How Immunotherapy Extends Life Expectancy Recent clinical advances highlight the growing role of immunotherapy in improving life expectancy for patients with stage 4 cervical cancer. Immune checkpoint inhibitors and other immune-based treatments are showing encouraging results, particularly for recurrent, metastatic, and PD‑L1‑positive cervical cancers, where traditional chemotherapy offers limited benefit. By stimulating the body's own immune system to recognize and attack tumor cells, these therapies have been linked to longer survival and improved progression-free outcomes in international studies. Access to such innovative care remains uneven, prompting patients to seek specialized oncology centers abroad. Through coordination platforms such as Booking Health, individuals are able to connect with leading hospitals in Germany and other countries that offer advanced cervical cancer immunotherapy programs. These multidisciplinary approaches combine personalized treatment planning, modern diagnostics, and targeted immune modulation to address late‑stage disease. As immunotherapy research continues to expand, it represents a significant shift in the management of advanced cervical cancer, giving more women a realistic chance at extended survival and an improved quality of life. Key Takeaways: Immunotherapy's Impact on Advanced Cervical Cancer Immunotherapy offers hope for women with stage 4 cervical cancer, especially when other treatments have failed. It works by strengthening the immune system to recognize and eliminate cancer cells more effectively. Most effective in patients with PD-L1-positive, recurrent, metastatic, or invasive cervical cancer. Recent phase III clinical trials show longer survival and improved median progression-free survival compared to chemotherapy alone. Booking Health connects international patients with leading European hospitals that specialize in cervical cancer immunotherapy and personalized care. These breakthroughs represent a major advancement in the treatment of metastatic cervical cancer – delivering not only longer survival, but also a significantly improved quality of life. To explore your personalized treatment options, contact Booking Health today and take the next step toward advanced cervical cancer care. Side_Effects About Booking Health Booking Health™ is the international platform for rapid access to innovative treatments in the world's leading certified clinics. Our network features over 250 top-tier hospitals across the globe, all distinguished by the exceptional levels of medical accreditation and expertise. By arranging care with the help of Booking Health company, you benefit from comprehensive medical support based on the latest innovations and personalized coordination. We offer cost saving up to 70% compared to direct booking via clinics — all without compromising on quality. Choosing Booking Health means more than just acquiring access to innovative world-class therapy – it means saving valuable time knowing that every detail is handled by professionals. Headquartered in Bad Hönningen, Germany and officially registered in Düsseldorf under HRB 106466, Booking Health proudly consults patients from over 75 countries for over a decade, offering services in 11 languages. Press inquiries Booking Health Lena Hanten [email protected]

Disarming a Hidden Killer: Predicting – and Preventing – C. diff Before It Strikes
Disarming a Hidden Killer: Predicting – and Preventing – C. diff Before It Strikes

Yahoo

time4 hours ago

  • Yahoo

Disarming a Hidden Killer: Predicting – and Preventing – C. diff Before It Strikes

Institute for Systems Biology researchers use personalized models to forecast gut colonization risk and test targeted probiotic therapies. SEATTLE, Aug. 06, 2025 (GLOBE NEWSWIRE) -- Clostridioides difficile (C. diff) is a stealthy threat. It infects more than 500,000 people in the United States each year, and kills up to 30,000. It is a leading cause of healthcare-associated infections, particularly in hospitals and long-term care facilities. But not everyone who harbors C. diff gets sick – as many as 30-40 percent of us are carrying this bug right now in our guts. C. diff is what scientists call an opportunistic pathogen – capable of causing life-threatening illness, but also capable of existing quietly as a commensal organism in the gut, waiting for the right moment – like after a round of antibiotics – to wreak havoc. What if we could identify the risk before infection takes hold? In a new study published in Cell Systems, researchers from the Institute for Systems Biology (ISB) have developed a powerful, personalized modeling framework to predict whether C. diff is likely to colonize an individual's gut, and to test whether specific probiotic therapies might prevent and/or reverse that colonization. 'C. diff is an opportunist. It can lie in wait in the gut, living benignly, ready to cause disease when conditions allow. If we remove the opportunity, we neutralize the threat,' said Dr. Sean Gibbons, senior author and associate professor at ISB. 'Instead of reacting to disease, this gives us a path to prevent it before it starts.' The team used microbial community-scale metabolic models, developed at ISB by co-senior author Dr. Christian Diener (now an assistant professor at the Medical University of Graz), to simulate how C. diff might behave in more than 15,000 human gut microbiome samples. The models identified three colonization states – high growth, moderate growth, and no growth – based on the unique microbial and metabolic composition of each individual's gut. Using C. diff invasion experiments in synthetic lab-based communities of human gut bacteria, the researchers found that they could accurately predict which communities were susceptible and which were resistant. In addition, they showed that they could accurately predict C. diff colonization in human time series with known C. diff colonization dynamics and in recurrent C. diff infection patients before and after receiving fecal transplants. To better understand the mechanisms of C. diff suppression, they showed that a defined probiotic cocktail (known to resolve recurrent C. diff infections) suppresses C. diff growth by outcompeting it for key metabolites – such as succinate (a dicarboxylic acid), trehalose (a sugar), and ornithine (an amino acid byproduct) – that fuel C. diff's expansion. They also found that the probiotic cocktail was better at suppressing model-predicted C. diff growth in the context of certain microbiota, but not in others – revealing responders and non-responders. By looking at model outputs from naturally resistant microbiota, the authors found that including dominant gram-negative anaerobic genera, like Phocaecola, in the simulated probiotic cocktail further improved model-predicted C. diff growth suppression. These results suggest that personalized, model-predicted probiotics could improve C. diff suppression and reduce the rate of non-responders. 'This work moves us closer to precision probiotics – tailored interventions that account for each person's gut ecosystem,' said Dr. Alex Carr, lead author of the paper and a postdoctoral fellow in ISB's Gibbons Lab. 'The ultimate goal is to decolonize opportunists like C. diff before they cause harm.' The findings have immediate implications for reducing C. diff infections and longer-term potential for proactively managing other opportunistic pathogens. They also offer a blueprint for designing smarter, more targeted probiotic therapies that are personalized to each patient's gut microbiome, although these model-guided interventions will need to be tested in human trials. 'Rather than just flooding the gut with microbes and hoping for the best, we can now use models to match the right probiotic to the right person,' Gibbons said. 'It's a systems biology approach to rationally engineering gut microbiome function, and we think that it has enormous promise for improving the efficacy of microbiome-mediated therapies.' About ISB Institute for Systems Biology (ISB) is a collaborative and cross-disciplinary non-profit biomedical research organization based in Seattle. We focus on some of the most pressing issues in human health, including aging, brain health, cancer, chronic illness, infectious disease, and more. Our science is translational, and we champion sound scientific research that results in real-world clinical impacts. ISB is an affiliate of Providence, one of the largest not-for-profit healthcare systems in the United States. Follow us online at and on YouTube, Facebook, LinkedIn, X, Bluesky, and Instagram. CONTACT: Joe Myxter Institute for Systems Biology jmyxter@

IO Biotech Announces Clinical Improvement in Progression Free Survival Demonstrated in Pivotal Phase 3 Trial of Cylembio® plus KEYTRUDA® (Pembrolizumab) for the Treatment of First-line Advanced Melanoma, but Statistical Significance Narrowly Missed
IO Biotech Announces Clinical Improvement in Progression Free Survival Demonstrated in Pivotal Phase 3 Trial of Cylembio® plus KEYTRUDA® (Pembrolizumab) for the Treatment of First-line Advanced Melanoma, but Statistical Significance Narrowly Missed

Yahoo

time6 hours ago

  • Yahoo

IO Biotech Announces Clinical Improvement in Progression Free Survival Demonstrated in Pivotal Phase 3 Trial of Cylembio® plus KEYTRUDA® (Pembrolizumab) for the Treatment of First-line Advanced Melanoma, but Statistical Significance Narrowly Missed

Patients treated with Cylembio (imsapepimut and etimupepimut, adjuvanted) plus pembrolizumab achieved improvement in progression free survival (PFS) compared to patients treated with pembrolizumab monotherapy, HR=0.77 (CI 0.58-1.00), (p=0.056), with median PFS (mPFS) of 19.4 months vs. 11.0 months, respectively; the results on the primary endpoint narrowly missed the study's statistical significance threshold of p≤0.045 In patients enrolled in this study without prior neo-adjuvant/adjuvant anti-PD-1 treatment (n=371), patients treated with Cylembio plus pembrolizumab achieved improvement in PFS, HR: 0.74 (CI 0.56-0.98) (nominal p=0.037), with mPFS of 24.8 months vs. 11.0 months for the control arm Improvement in PFS was achieved across virtually all subgroups, including those with poor prognostic factors A profound effect was observed in patients with PD-L1 negative tumors treated with Cylembio plus pembrolizumab, HR: 0.54 (CI 0.35-0.85) (nominal p=0.006), with mPFS of 16.6 months vs. 3.0 months for the control arm A trend towards improvement in overall survival (OS) was observed in patients treated with Cylembio plus pembrolizumab (OS not yet mature), HR=0.79 (CI 0.57-1.10) Cylembio plus pembrolizumab was well tolerated, with no new safety signals observed IO Biotech plans to meet with the FDA this fall to discuss the data and next steps for a potential regulatory submission Company to host conference call today at 8:30 a.m. ET to discuss these results NEW YORK, Aug. 11, 2025 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT) today announces topline results from the pivotal Phase 3 trial of its investigational, immune-modulatory, off-the-shelf therapeutic cancer vaccine, Cylembio® (imsapepimut and etimupepimut, adjuvanted). The trial evaluated Cylembio in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), vs. pembrolizumab alone as a first-line treatment in 407 patients with unresectable or metastatic (advanced) melanoma. In the study, Cylembio plus pembrolizumab demonstrated clinical improvement in progression free survival compared to pembrolizumab alone, but statistical significance was narrowly missed on the primary endpoint. 'In this study, we observed a highly encouraging improvement in progression free survival and consistent trend in overall survival in patients treated with Cylembio,' said Mai-Britt Zocca, PhD, president and chief executive officer of IO Biotech. 'The magnitude and durability of clinical effect observed consistently across subgroups supports our confidence in Cylembio and its potential as a treatment for advanced melanoma patients. We look forward to engaging with the FDA to determine a potential path to approval based on these data.' The randomized, open-label study enrolled 407 patients across more than 100 sites worldwide. Patients received either Cylembio in combination with pembrolizumab (n=203) or pembrolizumab alone (n=204). The primary endpoint was PFS as assessed by a blinded independent review committee per RECIST v1.1. The early and sustained separation of PFS curves demonstrated an improvement with a hazard ratio of 0.77 [95% CI: 0.58-1.00; p=0.056; threshold for significance p≤0.045]. Based on an intent-to-treat analysis, patients in the study treated with Cylembio in combination with pembrolizumab achieved 19.4 months of median progression free survival compared to 11.0 months in patients treated with pembrolizumab alone. Although not yet mature, a trend toward an improvement in overall survival was also observed [HR 0.79 (95% CI: 0.57-1.10)]; the company expects OS to mature over the next six to nine months. Improvement in PFS was achieved across virtually all subgroups, including those with poor prognostic factors, with a profound effect in patients with PD-L1 negative tumors treated with Cylembio plus pembrolizumab (n=67) compared to patients treated with pembrolizumab monotherapy (n=63), HR: 0.54 (CI 0.35-0.85) (nominal p=0.006), with mPFS of 16.6 months vs. 3.0 months, respectively. Additionally, in a post hoc analysis of patients enrolled in this study without prior anti-PD-1 treatment (n=371), patients treated with Cylembio plus pembrolizumab achieved improvement in PFS compared to patients treated with pembrolizumab monotherapy, HR: 0.74 (CI 0.56-0.98) (nominal p=0.037), with mPFS of 24.8 months vs. 11.0 months, respectively. The combination was well tolerated, with no new safety signals observed. Injection site reactions, which were transient and resolved on treatment, were the most commonly reported adverse events in the combination arm, with 56% of patients receiving Cylembio plus pembrolizumab reporting an event. 'In this study, patients treated with Cylembio in combination with pembrolizumab have achieved the longest median PFS ever observed in a Phase 3 clinical study in advanced melanoma, and in the PD-L1 negative population, patients achieved a remarkable 16.6 months of median PFS, compared to 3.0 months in patients treated with pembrolizumab alone,' said Omid Hamid, MD, Director, Clinical Research and Immunotherapy at The Angeles Clinic and Research Institute, A Cedars Sinai Affiliate. 'The significant benefit seen across patients with poor prognostic factors, including PD-L1 negative patients, cannot be overlooked. Given the notable safety profile and the strong clinical effect observed with Cylembio, as well as the unmet need in advanced melanoma patients, Cylembio, if approved, has the potential to become a new standard of care for patients with advanced melanoma.' 'These data show the potential of a therapeutic cancer vaccine in patients with metastatic melanoma,' said Jessica Hassel, MD, Professor at the Department of Dermatology and National Center for Tumor Diseases at the University Hospital Heidelberg, Germany, and lead enrolling investigator for the Phase 3 trial. 'We were thrilled to play such an important part in this study and to have had the ability to offer our patients an investigational therapy that potentially offers improvements in PFS while not adding significant systemic toxicity.' 'Delaying progression and improving survival is the ultimate treatment goal for patients and although overall survival is not yet mature, the trend we are seeing in OS with separation of the curves is encouraging, with a consistent PFS clinical improvement and OS trend favoring the combination arm across virtually all subgroups, with no new safety signals or significant additional systemic toxicity,' said Qasim Ahmad, MD, chief medical officer of IO Biotech. 'We are deeply grateful to the patients for their participation in this study, as well as to investigators and study coordinators whose dedication and collaboration brings us one step closer to delivering a new treatment option to patients in need.' 'Since reporting the positive outcome of our Phase 1/2 study (MM1636) in a similar patient population, we have been eagerly awaiting these results supporting the activity of Cylembio combined with an anti-PD-1 in patients with advanced melanoma,' said Inge Marie Svane, MD, PhD, Professor, Director of the National Center for Cancer Immune Therapy (CCIT) at the Copenhagen University Hospital, Herlev and Principal Investigator in the Phase 3 trial. 'These data provide evidence that a therapeutic cancer vaccine can improve progression free survival in patients with metastatic disease.' Based on these results, IO Biotech plans to meet with the United States (US) Food and Drug Administration (FDA) this fall to discuss the totality of data and determine next steps for submission of a Biologics License Application (BLA) for the treatment of advanced melanoma. Additionally, the company plans to present more detailed results from the IOB-013 study at an upcoming medical meeting. Conference Call and Webcast Information IO Biotech management will hold a conference call and webcast today at 8:30 a.m. ET to discuss these clinical data results. Participants can register for the live webcast here. The live webcast and replay will be available through IO Biotech's website here. About the IOB-013/KN-D18 Pivotal Phase 3 Clinical Trial IOB-013/KN-D18 ( NCT05155254) was an open label, randomized Phase 3 pivotal clinical trial evaluating Cylembio® in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma. Enrollment in the trial was completed by December 2023 with a total of 407 patients enrolled from more than 100 centers across the United States, Europe, Australia, Turkey, Israel and South Africa. The primary endpoint of the study was progression free survival. Secondary endpoints include overall response rate, overall survival, durable objective response rate, complete response rate, duration of response, time to complete response, disease control rate, and incidence of adverse events and serious adverse events (safety and tolerability). Biomarkers in the blood and tumor tissue will also be assessed as exploratory endpoints. The company reported topline results from this trial in the third quarter of 2025. IO Biotech is sponsoring the Phase 3 trial and Merck is supplying pembrolizumab. About Cylembio® Cylembio® (imsapepimut and etimupepimut, adjuvanted) is an investigational, immune-modulatory, off-the-shelf therapeutic cancer vaccine candidate 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 1 (IDO1) positive and/or programmed death-ligand 1 (PD-L1) positive cells. The company is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) investigating Cylembio in combination with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) versus pembrolizumab alone in patients with advanced melanoma, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) investigating Cylembio in combination with pembrolizumab as first line treatment in patients with advanced solid tumors, and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) investigating Cylembio in combination with pembrolizumab as neo-adjuvant/adjuvant treatment of patients with solid tumors. Enrollment in the Phase 3 trial was completed rapidly by December 2023 with topline results from this trial reported in the third quarter of 2025. Enrollment in the two ongoing company-sponsored Phase 2 clinical trials is now complete. The clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck, which is supplying pembrolizumab. IO Biotech maintains global commercial rights to Cylembio. Cylembio® is a registered trademark of IO Biotech ApS, a subsidiary of IO Biotech. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the US and Canada). About IO Biotech IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulatory, off-the-shelf 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 both tumor cells and the immune-suppressive cells in the tumor microenvironment. IO Biotech is advancing its lead cancer vaccine candidate, Cylembio®, in clinical trials, and additional pipeline candidates through preclinical development. 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 statements regarding the timing or outcome of communications with the FDA, submission of a BLA, the launch of Cylembio, and statements regarding other 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. Contacts: InvestorsMaryann Cimino, Director of Investor RelationsIO Biotech, Inc.617-710-7305mci@ MediaJulie beim Abrufen der Daten Melden Sie sich an, um Ihr Portfolio aufzurufen. Fehler beim Abrufen der Daten Fehler beim Abrufen der Daten Fehler beim Abrufen der Daten Fehler beim Abrufen der Daten

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into a world of global content with local flavor? Download Daily8 app today from your preferred app store and start exploring.
app-storeplay-store