Ascend Announces Patients with Nodular Basal Cell Carcinoma Receives First Dose of ASN-002 in Phase 1/2a Study

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Oct 07, 2015, 09:00 ET

MELBOURNE, Australia, Oct. 7, 2015 /PRNewswire/ -- Ascend Biopharmaceuticals, a Melbourne-based immunotherapy company focused on developing innovative cancer therapeutics, today announced the first nodular Basal Cell Carcinoma patient (nBCC) dosed with ASN-002 (an injectable immunotherapy) in a Phase 1/2a clinical study. BCC is a type of non-melanoma skin cancer diagnosed in an estimated two million people worldwide every year. It is the most prevalent form of cancer in Australia, the United States and Europe. Surgery is currently the primary treatment for BCC, however for many patients it can be a poor treatment option for both clinical and cosmetic reasons.

ASN-002 is a biologic therapeutic based on an adenovirus (a type of cold-virus) that has been engineered to produce the immunostimulatory anti-cancer protein Interferon-g. Ascend has an exclusive worldwide license to develop ASN-002 (formerly TG1042) from the French biopharmaceutical company Transgene SA (Euronext: TNG). Three clinical studies have already been completed in 64 patients with Cutaneous Lymphomas and Advanced Melanomas. These studies demonstrated that ASN-002 was safe, well tolerated and conferred favourable clinical outcomes.

"We are excited about evaluating ASN-002 in nodular BCC patients. We believe this product has been de-risked by the previous clinical studies and there is a strong biological rationale for its use in the treatment of BCC," Ascend CEO Clement Leong said. "In addition, we also believe there is a strong scientific rationale for the use of ASN-002 in a number of other cancers with important unmet medical needs, such as cutaneous lymphomas, bladder cancer and ovarian cancer."

The multi-centre Phase 1/2a study (ASN-002-001) will be conducted in up to 36 patients with an initial 3 cohorts of 6 patients each (total of 18 patients). The dose and schedule of ASN-002 for the remaining 18 patients (expansion cohort) will be based on the interim results. The primary objective of the study is to evaluate the safety of ASN-002, in addition to the secondary objectives of evaluating the histological clearance and clinical responses of the nodular BCC over time. Interim results from the trial are expected by H1, 2016 and study completion expected to occur in H2, 2016.

Details on the trial: (https://clinicaltrials.gov/ct2/show/NCT02550678?term=ascend+asn-002&rank=2).

About Ascend Biopharmaceuticals

Ascend is a clinical-stage company developing innovative cancer treatments. The company focuses on identifying disease settings where targeting the disease microenvironment or key cell types can bring about meaningful improvements in clinical outcomes.

Ascend has two clinical stage immunotherapy programs that have undergone previous clinical evaluation. The first product, ASN-002, will be assessed in basal cell carcinoma patients while the second product, ASN-004, is a pan-cancer therapeutic vaccine that will be studied in early stage breast cancer.

For more information, please visit www.ascendbiopharma.com or call +61-3-8606-3488.

SOURCE Ascend Biopharmaceuticals Ltd