Starton Aims to Supercharge CAR-T with Novel Drug Delivery Tech

PARAMUS, NJ – March 05, 2026 – Starton Therapeutics has taken a significant step toward potentially revolutionizing blood cancer treatment, filing patent applications for a novel combination therapy. The approach pairs the potent, personalized power of CAR-T cell therapy with the company's proprietary continuous low-dose immunomodulatory drug, STAR-LLD, aiming to create a more durable, effective, and less toxic treatment for patients with diseases like multiple myeloma and chronic lymphocytic leukemia.

This move signals a strategic effort to solve some of the most persistent challenges in modern oncology by optimizing how proven drugs are delivered. By reimagining the administration of lenalidomide, a cornerstone of myeloma therapy, Starton believes it can unlock new synergies and improve the outcomes of cutting-edge treatments.

“We are delighted to announce the filing of these provisional patent applications that incorporate both in vivo and ex vivo CAR-T cell therapies in combination with our proprietary subcutaneous formulation,” said Pedro Lichtinger, Chairman and Chief Executive Officer of Starton. “We believe this combination has the potential to improve CAR-T cell expansion and persistence while minimizing the concomitant toxicity of the IMiD.”

The Twin Challenges of Modern Cancer Therapy

The treatment of hematologic malignancies has seen remarkable progress, yet significant hurdles remain. CAR-T (Chimeric Antigen Receptor T-cell) therapy, which engineers a patient's own immune cells to hunt and destroy cancer, has produced dramatic responses in patients who had exhausted all other options. However, its success is often tempered by severe toxicities, such as Cytokine Release Syndrome (CRS) and neurotoxicity. Furthermore, the durability of these responses can be a major concern, with many patients relapsing as the engineered T-cells lose their potency or persistence over time.

On the other side of the treatment spectrum is lenalidomide, an immunomodulatory imide drug (IMiD) that is a standard-of-care for multiple myeloma. Given as a daily oral pill, it is highly effective but comes with a heavy price in terms of side effects. The high peak drug concentrations from oral dosing often lead to dose-limiting toxicities, including severe neutropenia (low white blood cells), anemia, and fatigue, forcing dose reductions or treatment interruptions that can compromise efficacy and diminish a patient's quality of life.

The central problem is a delicate balancing act: how to maximize the cancer-killing power of these therapies while minimizing the collateral damage to the patient's body. Starton Therapeutics' strategy hinges on breaking this trade-off not with a new molecule, but with a new method of delivery.

Re-engineering Delivery for Superior Results

At the heart of Starton's innovation is STAR-LLD, a subcutaneous, continuous-delivery formulation of lenalidomide. Instead of the sharp peaks and troughs of daily oral dosing, STAR-LLD is designed to maintain a constant, low, and biologically active level of the drug in the body. The scientific rationale is that this steady-state exposure can provide sustained anti-tumor activity without the high peak concentrations that drive toxicity.

The clinical data, though early, is compelling. A Phase 1 study in healthy subjects showed that STAR-LLD's peak plasma concentration (Cmax) was over 90% lower than that of oral lenalidomide, with 57% less overall drug exposure. Despite this lower exposure, the results from patient studies are striking.

In a preclinical model of multiple myeloma, tumors treated with STAR-LLD shrank by an astonishing 80% over a 28-day cycle. By contrast, tumors treated with a higher daily dose of oral lenalidomide still grew five-fold, and untreated tumors grew 25-fold. The study yielded a 100% overall response rate for the STAR-LLD cohort, with 20% of the animals becoming tumor-free, compared to a 0% response rate for the oral drug group.

These results were further supported by a Phase 1b study in six heavily pre-treated, relapsed/refractory multiple myeloma patients. All six patients achieved an objective response, including one complete response. Critically, none of the patients experienced significant drug-related hematologic toxicity (greater than grade 2), a common and debilitating side effect of the oral formulation, even after up to 12 cycles of therapy. This suggests STAR-LLD can achieve meaningful efficacy with vastly improved tolerability.

A Synergistic Approach to Boost CAR-T

The potential of STAR-LLD extends beyond being a better version of lenalidomide. The company's recent patent filings highlight its ambition to use this optimized drug to solve the problems plaguing CAR-T therapy. The key lies in T-cell fitness.

CAR-T therapy's long-term success depends on the engineered T-cells remaining healthy, active, and persistent enough to patrol the body for any remaining cancer cells. The harsh toxicities of oral lenalidomide can be detrimental to these crucial immune cells. Starton's preclinical data suggests that the continuous, low-dose exposure from STAR-LLD not only avoids this toxicity but may actively support T-cell function without inducing T-cell exhaustion—a state where the cells become worn out and ineffective.

By combining STAR-LLD with CAR-T, the goal is to create a more supportive microenvironment for the engineered cells. The continuous immunomodulatory effect of STAR-LLD could help the CAR-T cells expand more robustly after infusion and persist longer in the body, potentially leading to deeper, more durable remissions and reducing the risk of relapse. This synergistic approach could transform CAR-T from a powerful but often transient therapy into a more reliable and lasting cure for blood cancers.

The company is now advancing STAR-LLD into a Phase 2a clinical study, which will directly compare three doses of the continuous subcutaneous therapy against the standard oral lenalidomide regimen in myeloma patients. The results of this trial will be closely watched, as they could validate this platform technology and pave the way for combination studies that could set a new standard of care in hematology. For patients battling relentless blood cancers, this focus on optimizing proven therapies offers a tangible new avenue of hope for living better, and for longer.