In this Q&A, we sit down with David Schaffer from SciTech Development to discuss the progress of their Phase 1 trial for ST-001 nanoFenretinide, the impact of recent funding, site selection for clinical trials, and future plans for their nanoparticle delivery platform. Schaffer also shares insights into key partnerships and strategic goals for the coming year.
Moe Alsumidaie: How is your Phase 1 trial for ST-001 nanoFenretinide progressing, and what challenges have you encountered?
David Schaffer: Reaching the clinical study stage is a significant milestone for any early-stage biotech company, but it comes with its own set of complexities. We are currently in the Phase 1A accelerated portion of our study, which has a unique structure approved by the FDA. This trial builds on over 40 previous clinical studies, focusing on demonstrating the safe delivery of fenretinide and the ability to dose escalate. Historically, challenges included limited absorption and toxicities from previous delivery mechanisms. For instance, Johnson & Johnson faced issues where the body couldn’t absorb additional doses, and emulsions used in other trials caused toxicities like increased triglyceride levels. We are now at dose level 7, where we had expected to see drug related activity, and the
clinicians are observing encouraging signs of drug activity with minimal side effects. In fact, we now have two confirmed responses at that level, and we are now dosing at levels 8 and 9. The drug continues to be well tolerated in patients. We are close to concluding the accelerated portion and transitioning to a more traditional arm, which will allow us to set the dose level for our next study on small-cell lung cancer.
Moe Alsumidaie: Why did you choose Columbia, USC, and UPMC for trial sites, and how have they aided recruitment?
David Schaffer: Patient recruitment has been our biggest challenge, so we chose sites like Pittsburgh, Columbia, MD Anderson, and USC due to their high patient counts and comprehensive cancer centers. These sites have been instrumental in dosing more patients and generating interest from other clinicians. For example, Pittsburgh has been our lead site, dosing more patients than any other. Our network has expanded to include eight active sites, such as the City of Hope and the University of Colorado, with more in the pipeline. The enthusiasm from clinicians and their efforts in recruiting both patients and additional sites have been invaluable. This is exemplified by the growing interest from clinicians wanting to join our study, as seen by the increased attendance at our upcoming dinner at the American Society of Hematology meetings. This kind of organic growth and interest is something you can’t put a value on, and it significantly boosts our recruitment efforts.
Moe Alsumidaie: What impact has the recent $3.2 million funding had on your clinical trials?
David Schaffer: The $3.2 million from our second convertible note has been crucial in maintaining our study’s momentum. It has enabled us to reach our current stage and continue building momentum. We are now oversubscribed in commitments for our third note, which will help us raise an additional $20 million needed to file the NDA for T cell lymphoma within 18 months. Despite the typical billion-dollar costs associated with advancing oncology therapeutics, we’ve managed to progress with a modest budget, thanks to strategic planning and partnerships. For instance, we’ve raised about $12 million through convertible notes and grants, and we’ve received drug supplies from the National Cancer Institute, allowing us to execute our plan efficiently. This funding strategy has been pivotal in allowing us to advance our trials without the massive financial burdens typically associated with drug development.
Moe Alsumidaie: Are there plans to use your nanoparticle delivery platform with other drugs or conditions?
David Schaffer: Yes, our platform has potential applications with other water-insoluble drugs. While each construct requires specific development, the foundational technology of our nanoparticles can be adapted for other molecules, and we have intellectual property protection in place. The basic premise of using nanoparticles, as demonstrated with ST-001, can be applied to other drugs, potentially expanding our platform’s utility across various therapeutic areas. This adaptability opens up numerous possibilities for treating different conditions, and we are actively exploring these opportunities. Our goal is to leverage this technology to address a broader range of medical needs, thereby maximizing the impact of our innovations.
Moe Alsumidaie: Are there key partnerships that are crucial to advancing your pipeline?
David Schaffer: We have several key partnerships, including a reliable lipid supplier in Germany and the Plough Center for Sterile Drug Delivery for manufacturing. Our clinical sites and advisors, like Larissa Gaskin at Columbia, are also crucial. Additionally, our internal team, with experts like Tony Polverino, who has extensive experience in commercializing specialty oncology drug delivery technologies, and Ken Massey, who has led clinical trials for Pfizer, provides invaluable experience in advancing our pipeline. These partnerships and our team’s expertise have been instrumental in overcoming challenges and driving our progress. They provide the support and resources necessary to navigate the complexities of drug development, ensuring that we remain on track to achieve our goals.
Moe Alsumidaie: What major milestones do you aim to achieve in the next year or so?
David Schaffer: We aim to demonstrate the durability of responses in both T-cell and small-cell lung studies, showcasing the drug’s effectiveness in solid tumors and blood disorders. This is significant because few oncology therapeutics target both types of cancers. Scaling manufacturing and attracting pharmaceutical partnerships for companion therapeutics are also key. We anticipate expanding our studies to at least 15 other cancers, including breast and pancreatic cancer, and exploring the drug’s potential in non-cancerous conditions like diabetes and macular degeneration. The partner side is expected to grow, as evidenced by the 23 meetings we had at a recent pharma partnering conference, indicating strong interest from pharmaceutical companies in collaborating with us. These milestones are crucial for validating our approach and setting the stage for broader applications of our technology.
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.
