Locally Advanced Recurrent Ovarian Cancer

The Clinical Need

Worldwide in 2008, approximately 225,000 women were diagnosed with ovarian cancer and 140,000 died from this disease. In the United States, it is the second most common gynaecologic malignancy, but the most lethal.   Although most patients are initially responsive to chemotherapy, many will develop recurrent disease which are frequently confined to the peritoneal cavity and become unresponsive to standard chemotherapy agents.  More recently, clinical evidence that ovarian cancer can respond to immunotherapy with anti-PD1 immunotherapy, has provided renewed hope in treating chemotherapy resistant recurrent cancer patients.  However, responsiveness to immune check point agents such as anti-PD1 appear to be still limited to only a subset of patients and as such there is still an urgent clinical need for new treatment options.

Rationale

Ascend is developing ASN-002, in combination with chemotherapy to be administered intraperitoneally as a novel treatment option for patients with locally advanced recurrent ovarian cancer.  ASN-002 is based on a replication deficient adenovirus type 5 (Ad5 is a type of common cold virus) engineered to express IFNγ – a potent protein that can stimulate the immune system to destroy cancers.   Previous clinical trials with recombinant Interferon-γ have provided encouraging results in advance ovarian cancer patients.  Ascend will adopt a chemo-immunotherapy approach for  recurrent forms of Ovarian cancer.  In recent preclinical studies, Ascend has shown that the combination of ASN-002 plus select chemotherapy agents could trigger multiple forms of programmed cell death and was superior over ASN-002 alone.  The combination treatment will be evaluated in chemotherapy resistant and refractory patients.