Eye-Opening Advanced Therapy for Cancer Offers New Hope

We are excited to bring you an insightful conversation with Robert Towarnicki, Co-Founder and CEO of Sirpant Immunotherapeutics. In this interview, Robert shares the unique approach of Sirpant Immunotherapeutics in cancer treatment, detailing the promising potential of their innovative platform. Join us as we explore the intricacies of this advanced therapy, uncovering what sets it apart from existing oncological treatments, its current clinical trials, and the prospects for this pioneering technology.

Moe: Robert, can you tell me a bit about the uniqueness of your platform with Sirpant Immunotherapeutics? How is this different from other oncological platforms out there?

Robert: I’m glad you highlighted the uniqueness of our platform. Our advanced therapy for treating cancer is distinct from anything currently available, including other macrophage-based therapies in development—our technology platform results from years of rigorous research conducted by Emory University and Georgia State University. We utilize the patient’s cells, specifically monocytes, which we harvest through leukapheresis. This outpatient process takes about three hours and is relatively straightforward for the patient.

What sets our advanced therapy apart is how we transform these harvested monocytes into macrophages in the laboratory. Our approach is highly personalized, unlike other therapies relying on external agents or generic cells. We mature and activate these macrophages through a proprietary process that significantly enhances their ability to interact with and direct the patient’s immune system. These activated macrophages attack cancer cells directly and serve as commanders, orchestrating a broad and coordinated immune response. This method ensures that the patient’s immune system can target both the primary tumor and metastatic sites, providing a comprehensive and adaptable treatment strategy uniquely tailored to each individual’s cancer profile.

doing so, our activated macrophages essentially reprogram the patient’s entire immune system to recognize and eliminate cancer cells, much like how a vaccine works to prevent infections.

This comprehensive approach offers several advantages. Firstly, it allows for targeting both the primary tumor and metastatic sites, providing a more holistic treatment solution. While CAR T cell therapies are highly effective against specific types of blood cancers, they often struggle with solid tumors. They may lead to issues like antigen escape, where cancer cells mutate and evade detection. Our macrophage-based therapy addresses these limitations by generating a broad and sustained immune response that can adapt to the evolving nature of cancer. This enhances the likelihood of initial success and helps prevent recurrence, offering a more robust and durable treatment outcome for patients across various cancer types.

Moe: What evidence do you have to support the efficacy of advanced therapy?

Robert: In our animal studies, we have observed remarkable results that strongly support the efficacy of our therapy. For example, in mice with established tumors, a single injection of our modified macrophages into one tumor site has wholly eradicated all tumors in the body within just two weeks. This outcome is particularly significant as it demonstrates the therapy’s ability to not only target and eliminate the injected tumor but also to address metastatic tumors throughout the body. The treated mice exhibited no signs of cancer recurrence, indicating that our advanced therapy effectively establishes immune memory. This immune memory acts like a vaccine, enabling the body to recognize and attack the cancer if it reappears.

Furthermore, the efficacy of our therapy is reinforced by the observed immune response in these animal models. Our modified macrophages enhance the body’s natural defenses by activating other immune cells, such as T and B cells, to recognize and attack cancer cells. This broad immune activation is crucial for achieving comprehensive cancer eradication. The fact that a single treatment can lead to such extensive and lasting results is promising and underscores the potential of our therapy to be a game-changer in cancer treatment. These preclinical findings provide a strong foundation as we transition into human trials, where we hope to replicate and build upon these encouraging results to bring effective cancer treatment to patients in need.

Moe: What criteria are you using to select patients for your Phase 1 trial?

Robert: Our therapy is cancer-agnostic, meaning it has the potential to target a wide variety of cancers. We obtained separate IND applications for our Phase 1 trial to address hematologic and solid tumor cancers. Currently, we are focusing on hematologic cancers, particularly non-Hodgkin’s lymphoma (NHL). The selection criteria for patients in this phase are stringent, as we aim to recruit individuals who have exhausted all available approved therapies. This ensures that our trial participants are those who have no remaining standard treatment options, which is typical for Phase 1 studies.

Patients must also meet specific performance criteria to be eligible for our trial. Despite being in advanced stages of cancer, they need to be relatively healthy to withstand the trial’s demands and potential side effects. This includes having a certain level of organ function and overall physical condition assessed through various medical tests and evaluations. By selecting stable patients to participate, we can more accurately evaluate our therapy’s safety and initial efficacy without the confounding factors of severe comorbidities or imminent health deterioration. This careful selection process helps us ensure that the data we collect will be robust and meaningful, setting the stage for subsequent trial phases and potentially more comprehensive application of our therapy.

Moe: Can you explain the trial’s design and what you are monitoring?

Robert: The trial is designed with a focus on dose escalation to ensure the safety of our therapy, as mandated by the FDA. We began with a low dose to establish a baseline for safety and are currently completing the first cohort of three patients at this initial dose. This cautious approach allows us to carefully monitor adverse effects and determine the safest and most effective dosing regimen. Additionally, we are exploring the addition of focal radiation to the injected tumor site. This strategy is based on the understanding that radiation can create an inflammatory environment, enhancing our activated macrophages’ efficacy in targeting and destroying cancer cells.

We are monitoring a range of endpoints throughout the trial. Primary endpoints include observing for dose-limiting toxicities (DLTs) to ensure that the treatment is safe for patients. Secondary endpoints measure tumor response and immune activation, critical indicators of the therapy’s effectiveness. We are looking for signs of tumor shrinkage, improvements in metastatic lesions, and biomarkers that indicate an activated immune response. The early signs of tumor shrinkage and immune activation in our initial patients are encouraging, suggesting that our therapy has a positive impact even at low doses. These findings provide a solid foundation as we move forward with higher doses and the potential addition of radiation, aiming to enhance therapeutic responses and ultimately improve patient outcomes.

Moe: How does Sirpant Immunotherapeutics ensure the reproducibility and scalability of advanced therapy as you grow and scale into further studies?

Robert: With early success and the necessary funding, we plan to enhance our relationships with contract manufacturers and potentially bring production in-house. Each patient’s therapy is unique, involving their cells, but we have designed the process to be scalable. Our immediate focus is automating the system to minimize human interaction, ensuring safety, sterility, and consistency across treatments. Automation will streamline the manufacturing process and reduce the risk of contamination and variability, which are crucial for maintaining high standards as we scale up.

Additionally, although each patient’s therapy is essentially a custom batch, we are leveraging existing technologies from CAR T programs to provide a robust foundation for scalability. This involves adapting proven techniques for cell isolation, modification, and expansion to suit our macrophage-based advanced therapy. By incorporating these advanced methodologies, we can ensure that our processes are reproducible and efficient across multiple production sites. Moreover, our long-term strategy includes developing proprietary automated systems and potentially building dedicated manufacturing facilities to enhance further control over the production process. This integrated approach will enable us to meet the growing demand and expand our reach to a broader patient population while maintaining our advanced therapy’s high quality and efficacy.

Moe: Are you seeing any early response rates in the impact of this medical product on patients in your current study?

Robert: While we have not yet observed technical responses like partial or complete ones at this low dose, we have seen promising tumor shrinkage and improvement in metastatic lesions. These early indicators are particularly encouraging given that we are using a low dose, which we initially did not expect to produce significant therapeutic effects. The fact that we are already observing these positive changes suggests that our approach is fundamentally sound and has the potential to be highly effective once we optimize the dosing and treatment protocols.

Looking ahead, we are optimistic that higher doses, especially when combined with focal radiation to enhance the inflammatory environment around the tumors, will yield even more significant therapeutic responses. The addition of radiation is expected to activate the macrophages further, making them more effective in targeting and eliminating cancer cells. We anticipate these adjustments will lead to more pronounced tumor regression and possibly complete responses, providing robust proof-of-concept for our innovative therapy. This could pave the way for advancing to later-phase trials and ultimately bringing this promising treatment to a broader patient population.