Unmet Needs

Starting with hematologic cancers

The FDA defines unmet medical need for cancer as a serious condition that is not adequately treated by current therapies. This could include conditions that are rare, have few treatment options, or have poor survival rates. 

We evaluated over 80,000 potential drug compounds to identify where we believed our continuous delivery technology would bring the most benefit to patients. Based on the results of that evaluation, we are focused initially on the treatment of hematologic malignancies (blood cancers).  

Multiple Myeloma (MM)

Multiple myeloma is a cancer of abnormal plasma cells, a type of white blood cell that is normally responsible for producing antibodies. It is the second most common hematological malignancy in the US.

For patients who are newly diagnosed or experiencing their first relapse, progression-free survival (PFS) typically ranges from 5 – 6 years, with overall survival (OS) averaging between 8 -10 years. However, data from a previous EU study showed that around 40% of patients do not make it to second line (2L) treatments. In cases of relapsed refractory multiple myeloma, PFS is generally around 18 to 24 months. For patients who are primary refractory at the time of their initial diagnosis, meaning they do not respond to the first line of treatment, OS is approximately 2.5 years.

Although patients live for many years with the disease under control, ultimately, all patients will relapse.

Chronic lymphocytic leukemia (CLL) 

CLL is a type of blood cancer of a white cell called lymphocyte that affects bone marrow, spleen and the lymphatic system. With a prevalence of roughly 200,000 patients, CLL represents the most common form of leukemia in the U.S. The majority of CLL patients are asymptomatic at diagnosis and require no treatment. These patients are assigned a ‘watch-and-wait’ approach to monitor for disease progression.  

For symptomatic patients, Bruton’s Tyrosine Kinase inhibitors (BTKi) are a class of targeted therapies that have become a standard part of early treatment. Although they are highly effective, nearly all patients progress following or during their treatment. The standard of care usually follows BTKi failure with a BCL2i. When a patient progresses on a BCL-2i and a BTKi there is a limited armamentarium available that provides a meaningful response and survival.

Lenalidomide for the treatment of MM and CLL

REVLIMID® (lenalidomide) is a prescription medicine owned by Bristol Myers Squibb, currently used to treat adults with multiple myeloma in combination with dexamethasone as well as with other drug classes.  In many cases, despite a good response to lenalidomide, drug-related toxicities remain a challenge and lead to treatment discontinuations.

Lenalidomide has been studied extensively in CLL due to its unique mechanism of action. This immunomodulatory drug (IMiD) targets both the tumor cells and the tumor microenvironment. It enhances immune surveillance by stimulating T-cell and natural killer (NK) cell activity, while also directly inducing tumor cell apoptosis through cereblon-mediated degradation of key survival proteins like IKZF1 and IKZF3. Additionally, lenalidomide inhibits angiogenesis and disrupts stromal support in the tumor microenvironment, further impairing CLL progression. This dual targeting of malignant cells and their supportive niche makes lenalidomide a distinctive therapeutic option in CLL, however despite being widely studied lenalidomide has not gained formal regulatory approval in CLL.  

Celgene, now part of Bristol Myers Squibb, conducted two randomized Phase 3 clinical studies in CLL. The first pivotal study met its primary endpoints and Revlimid® was well tolerated. In the second pivotal study, neutropenia related deaths occurred. This resulted in the FDA imposing a clinical hold that led Celgene to discontinue seeking an indication in the disease. The FDA included an on-label warning against the use of REVLIMID® in CLL patients except for clinical research.

STAR-LLD

Our lead candidate STAR-LLD, is a continuous delivery of lenalidomide which enables better tolerability, thus longer drug exposure at effective doses which may potentially improve PFS, OS, as well as quality of life. 

Starton is seeking the approval of STAR-LLD-OCR as superior in tolerability and/or efficacy, replacing Revlimid® in the treatment of high-risk relapsed refractory multiple myeloma. 

Starton is also seeking approval of STAR-LLD-OCR as the first IMiD approved in CLL, potentially becoming a novel treatment for BTKi and BCL2i refractory patients, addressing a significant unmet medical need.

In addition, Starton is exploring the use of STAR-LLD in combination with CAR-T cell therapies in lymphoma and solid cancers.