TASQ

With the TASQ project, Active Biotech is developing a small molecule compound, tasquinimod, that attacks the tumor microenvironment and inhibits the establishment and growth of metastases. The development of tasquinimod is mainly focused on the treatment of prostate cancer. Proof of concept has been established by the results from a Phase II trial with slightly more than 200 patients where tasquinimod significantly slowed disease progression and showed an acceptable safety profile in men with metastatic castrate resistant prostate cancer. Enrollment of patients to a pivotal Phase III trial, 10TASQ10, is ongoing. The study is a global, randomized, double-blind, placebo-controlled trial in patients with metastatic castrate-resistent prostate cancer (mCRPC). The study is planned to include about 1,200 patients.

Read more about the history of TASQ here >>

Prostate cancer – The most common form of cancer among men

Prostate cancer is the most common cancer form among men. Its occurrence is strongly age-related and it is very rare before the age of 50. Prostate cancer has highly varying degrees of severity. Despite a relatively good prognosis, prostate cancer is the second most common cause of cancer death among men.

Suspicion of prostate cancer arises when a man has an elevated level of blood prostate specific antigen (“PSA”) or a hard and/or uneven prostate. A diagnosis is verified by a prostate biopsy. In the early stages, prostate tumors can be surgically removed, through a prostatectomy, or treated with radiation. In over half of the cases, however, the disease spreads to other locations in the body, whereupon surgery is no longer a viable alternative. Instead, treatment then focuses on removing the growth promoting effect of testosterone. This, however, produces a number of undesirable effects, such as sterility and impotence. At a later stage of the disease, the cancer becomes resistant to hormonal therapy. The metastases are often located to the skeleton which often leads to severe pain. At this stage, the tumor is treated with chemotherapy and median survival is approximately 20-25 months.

Every year about 220,000 new cases are diagnosed in the US alone (American Cancer Society 2010). The global market for drugs used in the treatment of prostate cancer was estimated at USD 3.3 billion for 2010 (Evaluate Pharma June 2011).

TASQ clinical trials

Complete results from the randomized, placebo-controlled, double-blind clinical Phase II trial in approximately 200 men with metastatic castrate resistant prostate cancer (mCRPC) were published in the Journal of Clinical Oncology in October 2011 (please see publication list for full reference). The primary endpoint, to show a difference in the number of patients with disease progression at six months was reached. Results showed that the fraction of patients who were disease progression-free after six months was 69% for patients treated with tasquinimod compared with 37% for placebo-treated patients (p<0.001). The median progression-free survival was 7.6 months for the tasquinimod group compared to 3.3 months for the placebo group (p=0.0042). Tasquinimod thus delayed disease progression by a median of 4.3 months. Tasquinimod treatment also had an effect on biomarkers relevant for prostate cancer progression and was generally well tolerated. Collection of data on overall survival is ongoing under a separate protocol.

The pivotal Phase III trial 10TASQ10 is currently open for recruitment. The study is a global, randomized, double-blind, placebo-controlled trial in about 1,200 patients with asymptomatic to mildly symptomatic mCRPC. Criteria for study participation include diagnosed CRPC, presence of bone metastasis, evidence of progression after hormonal treatment, and no prior cytotoxic therapy for prostate cancer within 2 years. If the significant delay of disease progression reported in Phase II is confirmed in this Phase III trial, tasquinimod could further defer the use of more toxic chemotherapeutic treatments.

For further info about the study and participating hospitals please visit ClinicalTrials.gov.

Tasquinimod mode of action

In order to grow and metastasize, tumors are dependent on successful interaction with the microenvironment at sites of growth. This includes formation and maintenance of a metastatic niche for tumor localization, blood vessels for nutrient and oxygen supply, as well as suppression of the local immune defence. 

Preclinical studies have shown that tasquinimod’s anti-prostate cancer efficacy involves its ability to interfere with all of these requirements. Tasquinimod has been shown to bind to the protein S100A9 which is present in tumor cells as well as different immune cells. This is binding is believed to effect the composition of populations of different immune cells which in turn will decrease immune suppression and angiogenesis.

Preclinical studies has concluded that tasquinimod exhibits anti-tumor activity via inhibition of tumor metastasis, angiogenesis, as well as modulation of immune cell populations.

Click here for a list of scientific publications related to tasquinimod.