Onco Preventer

Category: Uncategorized

  • Leading Bladder Cancer Drug Developer CG Oncology Takes Stage at Major RBC Healthcare Conference

    CG Oncology, Inc., a trailblazer in the biopharmaceutical sector, is gearing up for a noteworthy showcase at the 2025 RBC Capital Markets Global Healthcare Conference, set for May 20 in the bustling heart of New York City. This promising late-stage clinical company has carved a niche for itself by focusing on a bladder-sparing therapeutic tailored for patients grappling with bladder cancer. Unlike conventional treatments that often lead to invasive surgeries such as cystectomy, CG Oncology’s approach centers on preserving the bladder, significantly enhancing patients’ quality of life. This pioneering direction reflects not only CG Oncology’s cutting-edge innovation but also underscores a broader industry trend towards specialized immunotherapies, which leverage the body’s own defense systems to combat cancer with greater precision and fewer side effects.

    The upcoming conference is poised to be an illuminating experience, especially as CG Oncology’s management team prepares for a fireside chat—an intimate, in-depth conversation designed to provide investors, healthcare professionals, and other stakeholders with valuable insights into the company’s developmental pipeline. Scheduled for 11:30 am Eastern Time, this session will be streamed live via audio webcast on the company’s official Investor Relations webpage, allowing a diverse global audience to participate effortlessly from wherever they are. The webcast’s accessibility fosters transparency and inclusiveness, crucial elements in today’s connected world where stakeholders seek clarity and engagement. Additionally, for those tied up with prior commitments, the discussion will be recorded and made available for replay for about 90 days, giving ample time to absorb and reflect on CG Oncology’s promising progress and strategic vision.

    Delving into CG Oncology’s mission reveals a company striving not only for medical innovation but for transformative patient care. Bladder cancer’s treatment has historically involved aggressive procedures, often compromising patients’ quality of life by necessitating bladder removal, which can profoundly impact a person’s physical and emotional wellbeing. By advancing bladder-sparing immunotherapies, CG Oncology offers a revolutionary alternative that could lessen the trauma of cancer treatment. This patient-centric focus aligns with a broader movement in medicine towards personalization—where therapies are tailored to individual biological profiles, improving effectiveness and minimizing adverse effects. Indeed, bladder-sparing treatments don’t just aim to control or eradicate cancer; they strive to maintain the dignity and life experience of those affected, marking a hopeful shift in oncology practice.

    Beyond CG Oncology’s own advancements, their work epitomizes the rapidly evolving landscape of immunotherapy, a cancer treatment modality that has made remarkable strides in recent years. Immunotherapy harnesses the patient’s immune system to detect and destroy cancer cells more selectively than traditional chemotherapy or radiation, which often harm healthy tissues. Originally demonstrating success in cancers such as melanoma and lung cancer, immunotherapy is now equally promising in treating urologic cancers—a field where CG Oncology is actively innovating. This evolution signifies a paradigm shift in cancer therapeutics, emphasizing targeted, patient-friendly approaches that improve survival rates and reduce debilitating side effects. Companies like CG Oncology actively participating in prominent healthcare conferences underscore a commitment to collaboration and the dissemination of new knowledge, fueling a larger wave of scientific progress.

    For those eager to track CG Oncology’s ongoing journey, the company maintains a vibrant and informative online platform at www.cgoncology.com. This resource-rich website houses updated information on their research initiatives, ongoing clinical trials, and corporate announcements. The leadership team’s proactive communication strategy further ensures timely updates for investors and media, spearheaded by figures such as Sarah Connors, Vice President of Communications and Patient Advocacy, and Chau Cheng, Vice President of Investor Relations. These dedicated roles facilitate open dialogue with the public and the professional community, reinforcing CG Oncology’s reputation as a transparent and forward-thinking organization. In an era where patient advocacy and investor trust are paramount, such openness not only inspires confidence but truly positions CG Oncology as a beacon of hope in the relentless battle against bladder cancer.

    #HealthcareInnovation #BladderCancer #ImmunotherapyAdvances #CGOncology #RBCCapitalMarkets #BiopharmaceuticalNews #CancerResearch

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  • RyboDyn Expands Strategic Cancer Immunotherapy Collaboration with Moffitt Cancer Center

    Dark genome biotech RyboDyn deepens partnership with world-leading cancer immunotherapy center to validate novel oncology targets and advance first-in-class therapies

    SAN DIEGO, May 15, 2025 /PRNewswire/ — RyboDyn, Inc., a biotechnology company pioneering first-in-class immunotherapies targeting the dark proteome, today announced the expansion of its strategic collaboration with Moffitt Cancer Center, a global leader in cancer care and research. The partnership aims to accelerate the development of immunotherapies targeting novel, cancer-specific proteins identified through RyboDyn's proprietary sequencing and AI-driven target discovery platform, RyboCypher™.

    Earlier this year, RyboDyn reported the identification of a cryptic class of proteins derived from overlooked RNA species—called Dark Targets™. These novel antigens, invisible to standard detection methods, represent a new and largely untapped frontier for oncology drug development. Through its expanded collaboration with Moffitt, RyboDyn will validate the presence and therapeutic potential of these Dark Targets™ across a wide array of tumor types, leveraging Moffitt's uniquely annotated tumor repository—one of the largest and most comprehensive in the world. "Moffitt's tumor bank is a critical resource in validating novel targets across a diverse set of cancer patients," said Dr. Alex Jaeger, PhD, assistant member of the Molecular Oncology Department at Moffitt Cancer Center. "The ability to correlate molecular signals with deep clinical metadata significantly accelerates both discovery and translational development."

    Initial studies from the collaboration have confirmed that select Dark Targets™ are consistently presented on tumors—but not in healthy tissues—de-risking this novel class of antigens and providing a path toward scalable, tumor-specific therapies. "The fact that our lead targets are consistently presented across patient samples—yet absent in healthy tissues, gives us high confidence in their relevance," said Corey Dambacher, PhD, President, CTO, and Co-founder of RyboDyn.

    These data support RyboDyn's core hypothesis: while not all Dark Targets™ are cancer-specific, a distinct subset is uniquely and consistently presented on tumor cells—making them highly compelling candidates for therapeutic development. "We're not building a personalized medicine platform—we're designing therapies that combine precision with broad reach," said Imad Ajjawi, PhD, MBA, CEO and Co-founder of RyboDyn. "By focusing on conserved targets with tumor-specific presentation, we're unlocking new opportunities for scalable, off-the-shelf therapies in oncology."

    "This collaboration reflects our shared commitment to advancing the next generation of cancer immunotherapies," said Dr. Jaeger. "By combining Moffitt's clinical and translational expertise with RyboDyn's novel discovery platform, we're accelerating progress toward more precise and effective treatments."

    About RyboDyn

    RyboDyn, Inc., based in San Diego, CA, is a biotechnology company pioneering the development of first-in-class immunotherapies targeting the dark genome. By leveraging RyboCypher™—a proprietary sequencing method and AI-driven bioinformatics platform—RyboDyn is uncovering and validating previously unknown proteins and disease-specific targets. With proprietary IP licensed from Oregon Health & Science University, the company is driving a unique "targets-to-assets" approach to therapeutic development. RyboDyn collaborates with leading clinical institutions, academic researchers, and biopharma partners to validate and advance its drug pipeline, with a focus on transformative solutions for cancer and other diseases with unmet medical needs.

    For more information, contact [email protected] or visit www.rybodyn.com.

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    SOURCE RyboDyn

  • FDA Approves Tislelizumab Combo for Advanced ESCC

    The U.S. Food and Drug Administration (FDA) has recently granted approval for the use of tislelizumab-jsgr, marketed under the brand name Tevimbra, in combination with platinum-based chemotherapy as a first-line treatment for adult patients diagnosed with PD-L1-positive, unresectable, or metastatic esophageal squamous cell carcinoma (ESCC). This approval marks a significant advancement in combating one of the most aggressive forms of esophageal cancer, offering renewed hope to patients who previously faced limited treatment options. Esophageal squamous cell carcinoma is notorious for its poor prognosis, largely due to its tendency to be diagnosed at an advanced, often inoperable stage. Traditionally managed with chemotherapy regimens based on platinum compounds, the survival outcomes have been far from satisfactory. The FDA’s decision to endorse Tevimbra signals not only progress in therapeutic strategy but also an embrace of the power of immunotherapy in oncology, paving the way for improved patient survival and quality of life.

    Esophageal squamous cell carcinoma arises from malignant transformations in the squamous epithelium lining the esophagus, one of the two primary histological subtypes of esophageal cancer, the other being adenocarcinoma. These squamous tumors tend to occur more frequently in certain regions such as East Asia and parts of Africa, linked to risk factors including tobacco use, alcohol consumption, and dietary influences. Unfortunately, the silent and progressive nature of ESCC often means symptoms emerge late, resulting in advanced disease at diagnosis where surgical options are limited or impossible. Standard treatment for unresectable or metastatic cases has long relied on chemotherapy, often combining platinum compounds like cisplatin with fluoropyrimidines to attempt tumor control. However, the overall survival rates with these regimens have remained discouraging, underscoring an urgent need for better, more effective treatment modalities. In this context, the approval of Tevimbra is a game changer because it introduces a biologically targeted approach that harnesses the body's own immune ability to fight cancer.

    Tevimbra’s active ingredient, tislelizumab-jsgr, is a programmed death-1 (PD-1) immune checkpoint inhibitor. This class of drugs has revolutionized oncology by disrupting the immune escape mechanisms that tumors employ. Normally, PD-1 receptors on immune T-cells engage with PD-L1 ligands expressed on cells (including cancer cells), which effectively “switches off” the immune response to avoid attacking normal tissues. Tumors cunningly exploit this pathway by overexpressing PD-L1 to evade immune detection. Tislelizumab blocks this PD-1/PD-L1 interaction, thereby reactivating the immune system’s capacity to recognize and destroy cancer cells. Immune checkpoint inhibition represents a sophisticated strategy to outsmart cancer’s defenses, turning the patient’s immune system into an ally rather than a bystander. This combination with platinum chemotherapy acts synergistically—while chemotherapy attacks rapidly dividing cancer cells, Tevimbra ensures the immune system stays alert and aggressive against any residual disease.

    Clinical trials evaluating the efficacy and safety of Tevimbra combined with platinum chemotherapy have delivered promising results, showing significantly improved response rates and extended progression-free and overall survival in patients with PD-L1-positive ESCC compared to chemotherapy alone. The designation “first-line treatment” highlights the therapy’s role as the initial intervention after diagnosis of unresectable or metastatic disease, aiming to maximize benefit from the outset. The improved outcomes are particularly encouraging given the historically grim statistics associated with ESCC. Moreover, while immune checkpoint inhibitors can cause immune-related side effects—ranging from mild rashes to more serious inflammation of organs—Tevimbra’s safety profile in combination with chemotherapy was reported to be manageable and consistent with known toxicities. This balance of efficacy and safety endorses its use as a new standard of care in appropriate patients and underscores the importance of careful monitoring during treatment.

    The recent FDA approval of Tevimbra alongside platinum chemotherapy exemplifies the ongoing evolution toward personalized medicine in oncology. Testing tumors for PD-L1 expression has become a critical step in treatment selection, helping clinicians tailor therapy to tumor biology to improve outcomes. The introduction of immunotherapy for esophageal squamous cell carcinoma is especially significant for patients and caregivers, expanding the therapeutic arsenal and providing new hope where few options had existed previously. This advancement also highlights the value of continued research into immune-modulating therapies and their combinations, with the potential to transform rather than merely manage cancer. The endorsement by regulatory authorities like the FDA confirms the promise of these innovations and encourages ongoing studies to explore long-term benefits, optimal treatment strategies, and broader indications—ultimately aiming to enhance survival and quality of life for patients worldwide.

    Interestingly, while esophageal cancer might not be as widely discussed as breast or lung cancer, it remains the seventh most common cancer worldwide and the sixth leading cause of cancer-related deaths. This places it firmly among the major global health challenges. The fact that Tevimbra harnesses the immune system strikes a fascinating chord with recent scientific advances revealing great complexity in how tumors interact with immunity. For instance, it’s not just about the presence of immune cells but also their functional state, affected by intricate cellular signals like PD-1 and PD-L1. This approval reflects a broader trend seen in other cancers, such as melanoma and non-small cell lung cancer, where immune checkpoint inhibitors have transformed the prognosis. Combining immunotherapy with chemotherapy in esophageal cancer is a reflection of how the field is moving toward multi-modal treatments that attack cancer from multiple angles. The future looks hopeful as novel drugs and combinations continue to emerge, potentially offering even more personalized and effective approaches.

    #Tevimbra #EsophagealCancer #Immunotherapy #FDAApproval #CancerTreatment #PrecisionMedicine #OncologyInnovation

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  • FDA Approves Remestemcel-L-Rknd for Steroid-Refractory Acute Graft-Versus-Host Disease in Pediatric Patients

    The U.S. Food and Drug Administration (FDA) has granted approval for remestemcel-L-rknd, marketed under the brand name Ryoncil®, marking a significant advancement in the treatment of acute graft-versus-host disease (GVHD) in pediatric patients. This innovative therapy is an allogeneic bone marrow-derived mesenchymal stromal cell treatment designed specifically for cases where the disease has shown resistance to steroid treatments, which traditionally have been the cornerstone of GVHD management. Ryoncil® is now approved for use in pediatric patients aged two months and older, providing a much-needed therapeutic option for a vulnerable patient population dealing with this serious and often life-threatening condition. Acute graft-versus-host disease is a complex and severe complication that can arise after allogeneic hematopoietic stem cell transplantation (HSCT), a procedure commonly used to treat various hematologic malignancies and disorders. In GVHD, the transplanted donor immune cells mistakenly attack the recipient's tissues and organs, triggering a cascade of immune responses that can result in significant morbidity and mortality. Steroids have been the mainstay of acute GVHD treatment; however, a substantial number of pediatric patients show steroid-refractory disease, highlighting the critical unmet need for alternative therapies. Remestemcel-L-rknd utilizes the unique immunomodulatory properties of mesenchymal stromal cells (MSCs), which are known for their ability to regulate immune responses and promote tissue repair. Derived from bone marrow donors, these MSCs are cultured and expanded under controlled conditions before being administered to patients. The therapy aims to mitigate the destructive immune attacks characteristic of acute GVHD while supporting the recovery of damaged tissues. Clinical trials leading up to FDA approval demonstrated that Ryoncil® not only provides a better-targeted approach for steroid-refractory acute GVHD but also offers a promising safety profile for young patients. The approval decision underscores the FDA's commitment to advancing treatments that address critical needs in pediatric healthcare, particularly for conditions as challenging as acute GVHD. The availability of remestemcel-L-rknd offers hope for improved outcomes in children as young as two months who face the daunting diagnosis of steroid-refractory acute GVHD. Medical professionals specializing in pediatric oncology and hematology now have an additional therapeutic tool to combat the adverse effects of this disease more effectively. As more clinics and hospitals begin integrating Ryoncil® into their treatment protocols, it is anticipated that patient monitoring and post-approval studies will continue to illuminate the long-term benefits and potential applications of mesenchymal stromal cell therapies in immune-mediated disorders. This breakthrough approval paves the way for further research and development in cell-based therapies, potentially transforming the landscape of treatment for a range of immune complications following stem cell transplantation. In summary, the FDA's approval of remestemcel-L-rknd (Ryoncil®) marks a milestone in pediatric medicine, introducing a new, efficacious treatment option for steroid-refractory acute graft-versus-host disease in very young patients. This advancement not only addresses a significant gap in current therapeutic strategies but also exemplifies the ongoing evolution of regenerative medicine and cellular therapies in managing complex immune conditions. The medical community and families affected by acute GVHD can now look toward a future of improved care and hope for better survival and quality of life for affected children.

  • exercises for cancer prevention

    Exercises for Cancer Prevention: A Vital Approach to Proactive Health

    Cancer remains one of the leading causes of morbidity and mortality worldwide, but proactive health measures can significantly reduce the risk. Among these measures, regular physical activity has emerged as a powerful tool in cancer prevention. Research consistently shows that exercise not only helps maintain a healthy weight but also improves immune function, hormone regulation, and overall cellular health – all crucial factors in reducing cancer risk.

    Understanding Exercise and Cancer Prevention

    Physical activity helps lower the risk of several types of cancer including breast, colon, endometrial, and lung cancer. The mechanisms behind this protective effect include reducing inflammation, improving hormone balance (such as lowering estrogen and insulin levels), strengthening the immune system, and enhancing digestion and metabolism. Exercise also minimizes obesity, which is a known risk factor for many cancers.

    Recommended Exercises for Cancer Prevention

    1. Aerobic Exercises: Activities such as walking, jogging, cycling, swimming, and dancing help improve cardiovascular health and maintain healthy body weight. The American Cancer Society recommends at least 150 minutes of moderate-intensity or 75 minutes of vigorous-intensity aerobic exercise each week.

    2. Strength Training: Building muscle mass through resistance exercises like weight lifting or bodyweight exercises (push-ups, squats) helps boost metabolism and improve insulin sensitivity.

    3. Flexibility and Balance Training: Yoga and stretching exercises contribute to overall fitness and stress reduction, which indirectly supports cancer prevention by improving mental health and hormone regulation.

    Tips for Staying Consistent

    – Set realistic goals and gradually increase your activity level.
    – Incorporate physical activity into daily routines like walking or cycling instead of driving.
    – Find enjoyable activities or group classes for motivation.
    – Track your progress with apps or journals to stay accountable.

    Introducing OncoPreventer: Your AI-Powered Ally in Cancer Prevention

    While exercise and lifestyle adjustments are crucial, personalized and consistent care is key to early cancer prevention. OncoPreventer is an innovative AI-powered assistant designed to empower you with personalized screening plans, timely reminders, and expert-backed health recommendations for cancer prevention and early detection.

    Why Choose OncoPreventer?

    – Tailored Screening Schedules: OncoPreventer creates a customized screening plan based on your age, gender, family history, and lifestyle, ensuring you receive the most relevant and timely health checks.

    – Smart Reminders: Never miss your check-ups, lab tests, or annual visits with intelligent reminders, helping you stay on top of your health effortlessly.

    – Expert-Backed Guidance: Get clear, trusted answers to your health-related questions without the medical jargon, reducing stress and confusion.

    – Progress Tracking: Monitor your health journey with interactive timelines and summaries, empowering you to maintain and improve your well-being.

    – Seamless Accessibility: Whether on the web, Telegram, or WhatsApp, OncoPreventer fits into your life smoothly without disrupting your routine.

    Conclusion

    Adopting regular exercise as part of a cancer prevention strategy is a scientifically supported approach to reduce your cancer risk and enhance overall health. Combining this lifestyle change with the intelligent, personalized support of OncoPreventer can further optimize your proactive health efforts. By staying informed, engaged, and consistent, you can empower yourself to minimize cancer risk and take charge of your health journey confidently with OncoPreventer by your side.

  • stress and cancer risk

    Stress is an inherent part of human life, arising from various factors such as work pressures, family responsibilities, and financial concerns. While stress is a natural response to challenges, its chronic presence can have significant implications for overall health, including potential effects on cancer risk.

    **Understanding Stress and Its Impact on Health**

    Stress triggers the body's 'fight-or-flight' response, leading to the release of hormones like epinephrine and norepinephrine. These hormones prepare the body to face immediate threats by increasing heart rate, blood pressure, and energy supplies. However, when stress becomes chronic, it can lead to adverse health outcomes, including digestive issues, heart disease, high blood pressure, and a weakened immune system. ([cancer.gov](https://www.cancer.gov/about-cancer/coping/feelings/stress-fact-sheet?utm_source=openai))

    **The Link Between Stress and Cancer Risk**

    The relationship between stress and cancer risk has been a subject of extensive research. While some studies suggest a potential link, the evidence remains inconclusive. For instance, a large study involving over 100,000 women in the UK found no association between perceived stress levels and breast cancer risk. ([cancerresearchuk.org](https://www.cancerresearchuk.org/about-cancer/causes-of-cancer/cancer-myths-question/can-stress-cause-cancer/index.html?utm_source=openai))

    However, chronic stress may influence cancer risk indirectly by promoting behaviors that are known to increase cancer risk, such as smoking, overeating, and alcohol consumption. Additionally, stress can lead to physiological changes, including hormonal fluctuations and immune system suppression, which may create an environment conducive to cancer development. ([wcrf.org](https://www.wcrf.org/preventing-cancer/topics/stress-and-cancer/?utm_source=openai))

    **Mechanisms Linking Stress to Cancer Development**

    Chronic stress can affect the body through several mechanisms:

    – **Hormonal Changes**: Stress activates the hypothalamic-pituitary-adrenal (HPA) axis and the sympathetic nervous system (SNS), leading to the release of stress hormones like cortisol and catecholamines. These hormones can influence tumor growth and progression by affecting various cellular processes. ([pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/32974180/?utm_source=openai))

    – **Immune System Suppression**: Chronic stress can impair immune function, reducing the body's ability to detect and destroy cancer cells. This immune suppression may facilitate tumor growth and metastasis. ([pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/32974180/?utm_source=openai))

    – **Inflammation**: Stress-induced hormonal changes can lead to increased inflammation, which is associated with cancer development. Elevated levels of pro-inflammatory cytokines can create a tumor-promoting environment. ([frontiersin.org](https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2021.738252/full?utm_source=openai))

    **Managing Stress to Support Overall Health**

    While the direct link between stress and cancer risk remains uncertain, managing stress is crucial for overall health and well-being. Effective stress management strategies include:

    – **Mindfulness and Meditation**: Practices such as mindfulness meditation can help reduce stress levels and improve emotional well-being. ([wcrf.org](https://www.wcrf.org/preventing-cancer/topics/stress-and-cancer/?utm_source=openai))

    – **Regular Physical Activity**: Engaging in regular exercise can alleviate stress and promote overall health.

    – **Social Support**: Maintaining strong social connections can provide emotional support and reduce stress.

    – **Professional Help**: Seeking guidance from mental health professionals can be beneficial in managing chronic stress.

    **OncoPreventer: Your AI-Powered Health Companion**

    In the context of health management, OncoPreventer offers a comprehensive solution for proactive cancer prevention and early detection. This AI-powered assistant provides personalized screening plans, timely reminders, and expert-backed recommendations, all accessible through a user-friendly app or messenger service.

    **Key Features of OncoPreventer**

    – **Personalized Screening Schedules**: OncoPreventer creates custom screening plans based on individual factors such as age, gender, family history, and lifestyle, ensuring that users receive appropriate and timely health assessments.

    – **Smart Reminders**: The app sends timely reminders for check-ups, lab tests, and annual visits, helping users stay on top of their health without the stress of remembering appointments.

    – **Expert-Backed Recommendations**: Users have access to clear, trusted answers to health-related questions, empowering them to make informed decisions about their health.

    – **Progress Tracking**: Interactive timelines and health summaries allow users to monitor their health journey, providing motivation and clarity.

    – **Seamless Integration**: OncoPreventer works seamlessly across web platforms, Telegram, and WhatsApp, offering flexibility and convenience.

    By integrating OncoPreventer into your health routine, you can take proactive steps toward cancer prevention and early detection, reducing the stress associated with managing your health. The app's personalized approach ensures that your health care is tailored to your unique needs, promoting overall well-being and peace of mind.

  • Medical Oncology

    Immunotherapy has revolutionized the fight against cancer by fundamentally shifting the way we approach treatment. Traditional cancer therapies, such as chemotherapy and radiation, often bluntly target rapidly dividing cells, unwittingly damaging healthy tissue in the process. Immunotherapy, however, uses a more elegant strategy: it leverages the body’s own immune system to recognize and destroy cancerous cells. This sophisticated approach not only aims to attack tumors more precisely but also minimizes many of the debilitating side effects commonly associated with older treatments. Imagine equipping the body’s natural defenses with advanced tools, turning the immune system into a highly specialized, cancer-sniffing army. This is exactly what immunotherapy seeks to accomplish, making it a beacon of hope for many patients worldwide.

    Delving deeper, the immune system is one of the most intricate and finely tuned defense networks in the human body. It’s continuously at work, identifying and neutralizing threats ranging from viral infections to bacterial invasions. Cancer cells, however, can be notoriously sneaky, often camouflaging themselves or even suppressing immune responses to survive undetected. Here’s where immunotherapy steps in—by reinvigorating immune cells or introducing agents that amplify their cancer-fighting abilities. For instance, biological molecules known as cytokines, which normally help coordinate immune responses, can be synthetically produced and administered to patients. This process allows the immune system to regain its vigilance and mount a stronger offensive. Think of it as replacing tired soldiers with energized reinforcements, ready to reclaim lost ground. Additionally, immunotherapy can help the body remember cancer cells long-term, reducing the risk of relapse.

    At renowned medical centers like the Helen F. Graham Cancer Center & Research Institute, these therapies are not just theories but living realities improving countless lives. IL-2 therapy serves as a prime example. Interleukin-2 (IL-2) is a protein naturally secreted by immune cells that functions as a crucial communication signal, encouraging immune cells to multiply and heighten their activity against invaders. By injecting patients with a lab-created IL-2, doctors stimulate this response deliberately, especially in cancers such as melanoma and renal cell carcinoma, where a vigorous immune attack can make a significant difference. Such targeted immunotherapy is a testament to medical innovation, as it transforms what once was a grim prognosis into a more manageable condition, enhancing survival and quality of life alike.

    Beyond the realms of IL-2 therapy, the Helen F. Graham Cancer Center embraces other groundbreaking techniques like bone marrow and stem cell transplants to further empower the immune system. Aggressive cancers or their treatments can sometimes decimate the body's ability to regenerate vital blood cells, leaving patients vulnerable to infections and unable to fight disease effectively. Stem cell transplants replenish this depleted reserve by introducing healthy cells that grow into new immune cells, essentially rebooting the body's defense mechanisms. This remarkable fusion of immunology and regenerative medicine signals how far cancer treatment has come, harnessing the body’s natural healing prowess in tandem with advanced science. The procedure can feel like pressing the reset button on the immune system, equipping patients with renewed strength to overcome their journey.

    The landscape of immunotherapy continues to evolve rapidly, fueled by ongoing research and personalized medicine’s promising potential. Today, we’re edging closer to therapies tailored precisely to an individual’s unique cancer profile and immune system makeup. This personalized immunotherapy could drastically reduce side effects and increase treatment efficacy – a true game-changer in oncology. What’s more, it illuminates a larger truth: the immune system is not merely a static shield but a dynamic ally capable of extraordinary adaptability. As science unveils new ways to empower this biological marvel, patients can look forward to cancer treatments that not only eradicate disease more efficiently but also enable fuller, healthier lives beyond the disease. The future of cancer care is undeniably bright, rooted in the elegant alliance between immune defenses and cutting-edge medical breakthroughs.

    #Immunotherapy #CancerTreatment #MedicalInnovation #StemCellTransplant #IL2Therapy #CancerResearch #HealthCareAdvancements

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  • Natural history research is powering more effective decision-making in oncology clinical trials

    In the US alone, over 7,000 different rare diseases affect more than 30 million people[i]. Many of these conditions are life-threatening, and most do not have viable treatments. To address this, the pharma industry develops “orphan drugs” tailored for rare diseases, which do not attract the same level of research and development investment as more common conditions due to their small patient population size.

    The US Orphan Drug Act[ii] (1983) defines a rare disease as a disease or condition that affects less than 200,000 people. To fill the treatment gap, the Orphan Drug Designation programme in the US and EU grants orphan status to rare drugs and biologics, offering incentives such as tax credits, user fee exemptions, and potential seven-year market exclusivity post-approval. However, drug development in rare diseases is often challenging, with complex biology and a lack of understanding of the natural history of many of these diseases making conducting clinical trials especially difficult.

    The untapped potential of real-world data

    With this information deficit driving the need for more research into such diseases, in 2019 the US Food and Drug Administration (FDA) published draft guidelines[iii] on the growing importance of natural history (NHx) research in helping drug development organisations react to unmet health needs, particularly in the context of rare diseases. Worldwide, the European Medicines Agency[iv] (EMA) and Japanese PMDA[v] have issued their own guidance, while the Australian TGA adopted the US FDA version in February 2023[vi].

    Natural history studies use retrospective patient data from registries, medical records and prospective observational studies to better understand the course of the disease, its clinical outcomes, patient burden, and responses to current management.

    These studies help drug developers understand diseases, their progression and responses to current therapies and identify both the available market for drug therapies and the most suitable patients for clinical trials. This enables developers to design and execute more efficient, adaptive trials with better dose selections and participant allocation.

    The consequence is better trial outcomes, including increased participant engagement, more equitable socioeconomic access, and smaller and more efficient trials with fewer placebos and a greater proportion of participants accessing active drugs. Ultimately, natural history studies can lead to more accurate data, more successful outcomes and faster regulatory review. But how does this work in practice?

    More accurate trials

    Real-world studies can improve clinical trials by filling in the gaps with evidence that predict drug performance outside of a controlled environment. This data can be included at any point in the trial, supplementing participant and practitioner-generated data. Prospective and retrospective studies can draw meaningful conclusions about biomarkers, genetics and disease subtypes that might alter treatment performance. This is especially critical in oncology, where biomarker stratification drives precision medicine approaches and informs targeted therapy selection.

    Diagnostics and prognostics can work together to inform trial course and participant responses to individual drugs. By accessing real-world data, developers can create robust clinical development plans that utilise confirmed epidemiological assumptions and clearly defined success criteria, essential for expedited regulatory submission and improved approval rates. In oncology trials, this approach can also reduce patient burden by minimising unnecessary procedures, streamlining monitoring, and increasing access to investigational treatments, ultimately improving the patient experience and retention.

    Reducing placebo use of control arms in oncology trials with synthetic external control arms

    Despite being the gold standard for drug testing and market safety, randomised clinical trials (RCTs) can pose challenges in patient recruitment and retention, especially for rare diseases, where population sizes are often too small to use an active control arm such as a placebo or even the current standard of care (SOC). Furthermore, patients may be more hesitant to participate if they know they may not receive the investigational therapy. This is particularly relevant in oncology where the treatment could potentially be lifesaving and as such introduces an important ethical dilemma for sponsors.

    Data from NHx studies can be used to create an external control arm, allowing for comparison of the treated trial arm against pre-existing evidence for a placebo or SOC. The FDA guidance provides recommendations to sponsors and investigators considering the use of externally controlled clinical trials to provide evidence of the safety and effectiveness of a drug product, provided the external control group is similar to the testing group and valid epidemiology approaches are taken to reduce selection bias[vii].

    For example, in the pivotal trial for tazemetostat, an EZH2 inhibitor for patients with histologically confirmed, metastatic or locally advanced epithelioid sarcoma (ES), an external control arm was established to study the natural history of ES patients who were taking standard therapies for the disease. This helped to understand unmet needs in the space and demonstrate the potential benefit of tazemetostat in a hard-to-study cancer population. A rare and aggressive cancer, epithelioid sarcoma is thought to account for approximately 1% of all soft tissue sarcomas in the US, while soft tissue sarcomas themselves make up just 1% of all adult cancers.[viii] In January 2020, based on the success of this Phase II trial, the FDA granted accelerated approval for tazemetostat in adults and paediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete surgical resection.

    While RCTs remain the gold standard, the use of synthetic control arms in rare oncological disease research is growing.[ix] As of March 2025, there are 214 ongoing rare cancer trials with a historical control recorded in GlobalData’s Clinical Trials database. The majority of these (69%) are Phase II trials, followed by Phase I/II at 13%.[x]

    Conclusion

    The landscape of rare diseases is complex, with a significant number of individuals affected and a pressing need for improved diagnosis and treatment options. While advancements are being made, the challenges remain substantial, and continued efforts are necessary to address the unmet medical needs of patients with rare disorders.

    Using the synthetic control arm method reduces the number of patients allocated to SOC and placebos, ensuring more patients have access to a potential lifesaving drug and allowing for faster trials and reduced time to market.

    To learn more about the growing potential of real-world data in oncology, download the whitepaper below.

  • Citius Oncology, Inc. Reports Fiscal Second Quarter 2025 Financial Results and Provides Business Update

    CRANFORD, N.J., May 14, 2025 /PRNewswire/ — Citius Oncology, Inc. ("Citius Oncology" or the "Company") (Nasdaq: CTOR), a specialty biopharmaceutical company focused on the development and commercialization of novel targeted oncology therapies, today reported business and financial results for the fiscal second quarter ended March 31, 2025.

    "In Q2 2025, Citius Oncology advanced its transformation from a development-stage company to a commercial-stage organization. Following FDA approval of LYMPHIR, we intensified our focus on disciplined capital deployment and operational execution to support the success of our planned U.S. launch," said Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Pharmaceuticals.

    "This quarter's progress underscores our commitment to creating long-term value by ensuring LYMPHIR reaches patients with cutaneous T-cell lymphoma. Discussions with prospective commercial and strategic partners are underway as we concurrently pursue opportunities to secure additional capital to enhance our financial flexibility. These efforts are critical as we lay the foundation for sustained commercial success. With disciplined execution and a focused strategic vision, we believe Citius Oncology is poised to deliver meaningful near-term impact and durable shareholder value," concluded Mazur.

    FISCAL SECOND QUARTER 2025 FINANCIAL RESULTS:

    Liquidity

    Citius Oncology is a subsidiary of Citius Pharma. Citius Pharma plans to continue to fund Citius Oncology until Citius Oncology raises adequate capital through equity financings from outside investors and/or generates revenue from the future sales of LYMPHIR. Citius Oncology has also retained Jefferies LLC as exclusive financial advisor to evaluate strategic alternatives aimed at maximizing stockholder value.

    As of March 31, 2025, the Company had $112 in cash and cash equivalents and 71,552,402 common shares outstanding. Citius Oncology will need to secure additional capital to support operations beyond May 2025.

    Research and Development (R&D) Expenses

    R&D expenses were $3.1 million for the quarter ended March 31, 2025, as compared to $1.3 million for the quarter ended March 31, 2024. For the six months ended March 31, 2025, R&D expenses were $4.4 million, as compared to $2.5 million for the six months ended March 31, 2024. The increase is primarily related to costs associated with the expense of a drug substance batch needed for the pre-license inspection of the manufacturer.

    General and Administrative (G&A) Expenses

    G&A expenses were $2.2 million for the quarter ended March 31, 2025, as compared to $1.4 million for the quarter ended March 31, 2024. For the six months ended March 31, 2025, G&A expenses were $5.5 million, as compared to $2.9 million for the six months ended March 31, 2024. The increase was primarily due to costs associated with pre-commercial and commercial launch activities of LYMPHIR including market research, marketing, distribution and drug product reimbursement from health plans and payers.

    Stock-based Compensation Expense

    For the quarter ended March 31, 2025, stock-based compensation expense was $2.1 million, as compared to $2.0 million for the quarter ended March 31, 2024. For the six months ended March 31, 2025, stock-based compensation expense was $3.9 million, as compared to $3.9 million for the six months ended March 31, 2024. The increase was primarily due to new options granted in December 2024.

    Net loss

    Net loss was $7.7 million, or ($0.11) per share, for the quarter ended March 31, 2025, as compared to a net loss of $4.8 million, or ($0.07) per share, for the quarter ended March 31, 2024. Net loss for the six months ended March 31, 2025 was $14.4 million, as compared to a net loss of $9.6 million for the six months ended March 31, 2024. The increase in net loss was primarily due to the increase in our operating expenses.

    About Citius Oncology, Inc.

    Citius Oncology specialty is a biopharmaceutical company focused on developing and commercializing novel targeted oncology therapies. In August 2024, its primary asset, LYMPHIR, was approved by the FDA for the treatment of adults with relapsed or refractory CTCL who had had at least one prior systemic therapy. Management estimates the initial market for LYMPHIR currently exceeds $400 million, is growing, and is underserved by existing therapies. Robust intellectual property protections that span orphan drug designation, complex technology, trade secrets and pending patents for immuno-oncology use as a combination therapy with checkpoint inhibitors would further support Citius Oncology's competitive positioning. Citius Oncology is a publicly traded subsidiary of Citius Pharmaceuticals. For more information, please visit www.citiusonc.com

    Forward-Looking Statements

    This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius Oncology. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated, and, unless noted otherwise, that apply to Citius Oncology are: our need for substantial additional funds and our ability to raise additional money to fund our operations beyond May 2025 and for at least the next 12 months as a going concern; our ability to commercialize LYMPHIR, including covering the costs of licensing payments, product manufacturing and other third-party goods and services, and any of our other product candidates that may be approved by the FDA; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; the estimated markets for our product candidates and the acceptance thereof by any market; our ability to regain compliance with Nasdaq's continued listing standards; the ability of our product candidates to impact the quality of life of our target patient populations; our dependence on third-party suppliers; our ability to procure cGMP commercial-scale supply; risks related to research using our assets but conducted by third parties; uncertainties relating to preclinical and clinical testing; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; government regulation; competition; as well as other risks described in our Securities and Exchange Commission ("SEC") filings. These risks have been and may be further impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our SEC filings which are available on the SEC's website at www.sec.gov, including in Citius Oncology's Annual Report on Form 10-K for the year ended September 30, 2024, filed with the SEC on December 27, 2024, as amended on January 27, 2025, Citius Oncology's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 14, 2025, and as updated by our subsequent filings with the SEC. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

    Investor Contact:

    Ilanit Allen

    [email protected]

    908-967-6677 x113

    Media Contact:

    STiR-communications

    Greg Salsburg

    [email protected]

    — Financial Tables Follow –

    SOURCE Citius Oncology, Inc.

  • Citius Oncology, Inc. Reports Fiscal Second Quarter 2025 Financial Results and Provides Business Update

    Citius Oncology, Inc., a specialty biopharmaceutical company focused on pioneering targeted oncology therapies, recently unveiled its fiscal second quarter results for 2025, marking a pivotal moment in its evolution from a development-stage enterprise to a commercial-stage company. Headquartered in Cranford, New Jersey, Citius Oncology has been steadily making strides, especially after receiving FDA approval for its flagship drug, LYMPHIR, designed to treat cutaneous T-cell lymphoma (CTCL), a rare and challenging form of cancer. The successful approval and impending U.S. launch of LYMPHIR signals a new chapter for the company, setting the stage for broader patient access and stronger market presence.

    Leonard Mazur, Chairman and CEO of Citius Oncology, emphasized the company’s transformation and commitment to disciplined capital management. Following LYMPHIR’s regulatory approval, the company has intensified efforts around operational execution and strategic partnerships. "This quarter's progress underscores our commitment to creating long-term value by ensuring LYMPHIR reaches patients with cutaneous T-cell lymphoma," Mazur shared. Discussions are underway not only with commercial and strategic partners but also to secure additional capital, aiming to boost the financial flexibility necessary for sustained growth. This approach highlights the company’s balanced strategy: carefully managing resources while driving innovation and market penetration.

    On the financial front, Citius Oncology reported having $112 million in cash and cash equivalents as of March 31, 2025, alongside approximately 71.5 million common shares outstanding. Despite this robust cash position, the company acknowledges the need to raise additional funds to support operations past May 2025. With Jefferies LLC appointed as the exclusive financial advisor, Citius Oncology is exploring strategic alternatives to maximize stockholder value and set the company on a course for financial health and commercial success. This financial roadmap is crucial given the company’s increased expenses recorded during the quarter, which reflect the costs associated with commercial launch preparations and ramped-up research and development efforts.

    Research and development (R&D) expenses rose significantly year-over-year, reaching $3.1 million for the quarter ending March 31, 2025, compared to $1.3 million in the same quarter the previous year. This increase was primarily driven by costs related to drug manufacturing batches necessary for pre-license inspections—a critical step ensuring high-quality production standards before entering the market. Additionally, general and administrative (G&A) expenses nearly doubled to $2.2 million in Q2 2025 compared to the prior year’s quarter, mainly due to activities surrounding LYMPHIR’s commercial launch including market research, marketing initiatives, distribution logistics, and reimbursement negotiations with health plans. Notably, stock-based compensation expenses remained stable, reflecting the company’s continued investment in employee incentives and retention, particularly through options granted in late 2024.

    Although the quarter concluded with a net loss of $7.7 million ($0.11 per share), higher than the previous year’s net loss, Citius Oncology views these expenditures as necessary investments catalyzing its transition to a commercially viable entity. The company’s proactive approach, underscored by its robust intellectual property portfolio—protecting LYMPHIR with orphan drug designation, trade secrets, and pending patents for combination immuno-oncology therapies—positions it well in an estimated market exceeding $400 million. This market is largely underserved by current therapies, opening the door for Citius Oncology to make a meaningful impact on the treatment landscape for adults with relapsed or refractory CTCL, who often have limited options after prior systemic therapies.

    Overall, Citius Oncology’s second-quarter results underscore the challenges and opportunities inherent in launching a novel oncology therapy. The company’s strategic focus on disciplined capital deployment, operational execution, and forging strategic partnerships points to a promising near-term outlook. As the biopharmaceutical industry continues to evolve rapidly, Citius Oncology’s dedication to innovation, patient access, and shareholder value aligns with broader trends emphasizing precision medicine and targeted therapies. The launch of LYMPHIR could not only transform patient outcomes in cutaneous T-cell lymphoma but also serve as a beacon of progress in the oncology space. Watch for further developments as Citius Oncology navigates market demands, regulatory environments, and the quest for commercial success.

    #CitiusOncology #LYMPHIR #OncologyInnovation #CutaneousTCellLymphoma #BiopharmaceuticalNews #CancerTherapies #MarketLaunch

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