Bench2Bedside:
What are the key challenges that your team at Tikva Allocell is dedicated to solving?

Dr. Ivan Horak:
We’ve all seen the promise of CAR-T therapies, which have been revolutionary for some blood cancers. But like many new medical advances, they face significant limitations. First and foremost, the limitations of autologous therapies have been clear from their inception. Treatments that are made from a patient’s own cells necessitate bespoke, lengthy, and expensive manufacturing processes, not to mention variable cell quality, and the risk of manufacturing failure. This limits scalability and affordability.

Vitally, safety continues to be a concern for many CAR-T therapies. While generally safe, there are still concerns about potential side effects like cytokine release syndrome (CRS) and neurotoxicity, as well as the long-term risk of secondary malignancies.

And solid tumors continue to be a major limitation for CAR-T that is important to our work at Tikva. This is due to several factors, including the difficulty in finding appropriate tumor-associated antigens without causing “on-target, off-tumor” toxicities, poor CAR-T cell persistence in the body, and the immunosuppressive microenvironment within solid tumors.

Bench2Bedside:
What are the core technologies behind Tikva Allocell’s approach?

Dr. Horak:
Our platform is based on a second-generation empowered allogeneic Epstein-Barr Virus (EBV)-specific T cell (ALLO EBVST) platform. We use T cells from the blood of EBV-positive healthy individuals. The intrinsic properties of these virus-specific T cells, combined with our proprietary technologies, allow us to enhance the performance of these cells to safely target difficult-to-treat solid tumors.

Our lead program, TAVST01, is a bi-specific allogeneic B7-H3-CAR EBVST technology targeting B7-H3 positive solid tumors, which include lung, breast, prostate and pancreatic cancers. We are confident that B7-H3 is a very promising target as it’s expressed in multiple solid tumors but has a very low expression in a normal tissue.

As we designed our technology, we looked at the challenges for allogeneic therapies. Not only are there concerns around CRS, neurotoxicity, and graft versus host disease, but we also need to improve the performance of the cells. As we work on targeting solid tumors, persistence is clearly an important factor. We’ve designed CAR-T cells that are protected from allogenic rejection by host using various pathways to improve persistence of the infused CAR-T cells (survival after infusion) and ensure durable response. Our team is utilizing an engineered SerpinB9 armoring strategy to resist rejection—this is part of the cascade of the innate immunity, and the modification of this protein has shown evidence of improved cell performance.

Bench2Bedside:
Why is the “off-the-shelf” aspect of your technology so important?

Dr. Horak:
The “off-the-shelf” approach is critical for global accessibility and affordability. It means that we can create therapies that are readily available to patients without the need for a personalized, patient-specific manufacturing process, which is often time-consuming and expensive. This makes the therapy much more scalable and accessible to a wider patient population. As we look at these major and underserved cancers, bringing cell therapies to the clinic with the potential to fight and kill solid tumor cells would be a revolutionary development for countless patients. And importantly, we believe these off-the-shelf treatments could offer a new sense of hope for these patients where these novel technologies have not yet been able to make an impact.

Bench2Bedside:
What is the current status of your research and development pipeline?

Dr. Horak:
Our TAVST01 program targeting B7-H3 positive solid tumors has shown promise in its ability to target both tumor cells and the immunosuppressive tumor microenvironment in preclinical studies, and we have several high-profile publications that have provided validation for our approach. We believe our platform has the potential to enable multiple dosing or combination therapies without the need for lymphodepletion. We are currently in the late preclinical stage and anticipate filing INDs in the US and Singapore, as well as initiating a Phase 1 trial in 2026.