Today’s therapies for treating advanced prostate cancer, particularly castration therapies, are rendered useless once the cancer becomes resistant to those treatments. Seventy-five percent of men with prostate cancer-resistant disease die within the first five years of diagnosis.
Newzen Pharma is developing Newzen-138, a targeted drug therapy that can dramatically improve the treatment of resistant prostate cancer. The drug is designed to specifically block the DNA repair machinery of prostate cancer cells, preventing them from becoming resistant to current treatments. Newzen-138 is designed to enhance the efficacy of existing treatments, particularly for androgen-dependent cancers, without harming normal cells.
Newzen-138 promises to improve the outcomes for hundreds of thousands of men worldwide, where today’s treatments are simply failing men who are battling late stage prostate cancer.
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Prostate cancer is one of the most commonly diagnosed cancers among men, with millions of new cases each year worldwide. While significant progress has been made in treatment, particularly in early-stage prostate cancer, the standard of care for advanced prostate cancer remains problematic, leaving these patients with limited and often ineffective options.
When a man is diagnosed with late stage prostate cancer, he typically undergoes androgen deprivation therapy (ADT), commonly referred to as castration therapy. Since prostate cancer cells rely on androgens (male hormones) to grow, these therapies aim to reduce androgen levels or block androgen receptors to slow cancer progression. When ADT fails to control the disease, chemotherapy (e.g., docetaxel) or androgen receptor signaling inhibitors (e.g., abiraterone or enzalutamide) are introduced. In advanced stages, radiopharmaceuticals such as Lutetium-177 or Radium-223 may also be used.
The big problem is resistance. In time, prostate cancers no longer respond to therapies because they find ways to bypass androgen deprivation or repair the damage caused by treatments, leading to disease progression and treatment failure. In the US, 34,000 men will die of prostate cancer this year, simply because we do not have treatments that work.
Newzen Pharma, a clinical-stage biotech, is changing this. Newzen Phamra has developed Newzen-138, a drug that is selective in preventing prostate cancer cells from repairing themselves after treatments have damaged them.
Newzen-138 blocks a key DNA repair mechanism, enhancing the potency of existing therapies and potentially preventing prostate cancers from developing resistance. This approach is aimed at overcoming the limitations of current therapies so that more men battling late-stage prostate cancer will survive, without enduring the harsh side effects or current treatments.
Newzen Pharma’s next step is to test the safety, tolerability, and effectiveness of Newzen-138 in men with advanced prostate cancer. This critical step involves securing regulatory approvals, conducting clinical studies, and gathering essential data to validate the “mechanism of action” of how Newzen-138 works to prevent DNA repair of prostate cancer cells. Achieving this milestone will pave the way for further development, eventual market approval, and expanded use in prostate cancer treatments.
Funds raised will help accelerate Newzen-138’s journey through clinical development addressing the current limitations that men are facing in prostate cancer treatment.
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To facilitate the advancement of Newzen-138 through clinical trials, Newzen Pharma will leverage strategic partnerships, including a collaboration with Florida International University, to provide access to research expertise. Additionally, the company will acquire top talent in clinical operations and regulatory affairs while utilizing existing infrastructure for efficient project management and execution.
If successful in raising funds, Newzen Pharma would utilize this initial capital as a validation tool to attract additional funding from other sources, such as venture capital firms and strategic investors.
Demonstrating early-stage progress with Newzen-138 will enhance credibility and increase interest from potential partners. This initial funding could also be leveraged to apply for matching grants and research funding from government agencies and non-profit organizations dedicated to cancer research, thereby maximizing financial support and accelerating clinical development efforts.
Once prostate cancer has spread beyond the prostate to distant organs in the body such as the bone, lungs, survival beyond 5 years is almost impossible. If we are to save 34,000 men in the US and hundreds of thousands worldwide each year from late-stage prostate cancer, the standard of care must change.
Newzen Pharma’s prostate drug candidate is a real opportunity to save, extend and improve the lives of men whose prostate cancers are not curable by today’s medicine. If Newzen-138 disappears in the “Valley of Death” funding bottleneck, this would be an unbearable consequence for society. This setback would leave thousands of men without effective options, particularly those who have become resistant to existing prostate cancer therapies.
So too, the loss of Newzen-138 would stifle innovation in cancer treatment, delaying advancements in targeting the DNA repair mechanisms that are crucial for improving patient outcomes. Ultimately, loss of this promising drug would also be a loss to opportunities for future breakthroughs in cancer research. We cannot accept this.
Inhibition of base excision repair by natamycin suppresses prostate cancer cell proliferation
Founder & CEO
Vishwas Bhatia is a visionary leader and the driving force behind Newzen Pharma, a pioneering biotech company dedicated to transforming prostate cancer treatment through cutting-edge, targeted therapies. With over a decade of experience in drug development, Vishwas has led innovations from conception through clinical trials, establishing Newzen Pharma as a trusted partner in patient-centered cancer care. Under his leadership, Newzen Pharma harnesses proprietary technologies, breakthrough science, and strategic global partnerships to improve outcomes and quality of life for patients worldwide.
Chief Technology Officer
Dr. Nirmal Paliwal, CTO of Newzen Pharma, brings over 12 years of specialized experience in CMC, Analytical, and Formulation Development within the biopharmaceutical industry. A proven leader in analytical method development and formulation science, Dr. Paliwal has expertly led teams to develop and scale processes for biologics and vaccines, ensuring high standards of quality and compliance. His comprehensive expertise spans analytical and stability testing, method qualifications, and technology transfers, optimizing resources and meeting rigorous clinical and regulatory milestones. As CTO, Dr. Paliwal directs Newzen Pharma’s technology strategy, driving advancements in drug formulation and analytical innovations to improve patient outcomes.
Head of Program Management
Head of Analytical Research and Development
The Head of Analytical Research and Development at Newzen Pharma is responsible for advancing our innovative pipeline through rigorous analytical strategies, from discovery to commercialization. This role ensures the development and validation of cutting-edge bioanalytical methods to support CMC processes, encompassing potency and binding assays, protein characterization, and phase-appropriate regulatory alignment. With a focus on method development, sample testing, data interpretation, and technology transfer, the team leads a full-spectrum approach to ensure the highest quality and regulatory standards in drug development.
