Bavarian Nordic, a vaccine-focused biotechnology company has announced promising data from phase II clinical study of its CV-301 cancer immunotherapy candidate in patients with resected metastatic colorectal cancer. The study was published in Annals of Surgery.
This clinical study was conducted at Duke University, wherein, 74 patients who were disease free after surgical resection of metastatic colon cancer received chemotherapy followed by immunotherapy with CV-301 (formerly designated as PANVAC-VF) either as CV-301 modified dendritic cells or in combination with GM-CSF. Compared to a group of contemporary control patients who were matched for key clinical features and had similar surgery and chemotherapy, the overall survival of the CV-301 treated patients was significantly longer (p < 0.0001).
Treatment with CV-301 was well tolerated, with injection site reactions, fever, fatigue and muscle soreness as the most common side effects.
Michael Morse, MD, an oncologist with the Duke University Medical Centre and lead author on the study, said, "With few treatment options available for patients with advanced colon cancer following complete surgical resection of metastases, there is a clear unmet medical need for better treatments. We believe that the encouraging data from this phase II study support a late stage pivotal clinical trial of CV-301 in this patient population."
Bavarian Nordic has expanded its license with the National Cancer Institute (NCI) for CV-301 to include colon cancer. The original collaboration agreement was executed in 2011, and involved multiple cancers including breast, lung, ovarian and other cancers. Colorectal cancer is the most frequently diagnosed cancer and second leading cause of cancer death in developed countries, according to the American Cancer Society.
"We are excited about exploring the potential of our cancer immunotherapy platform in colorectal cancer," said James Breitmeyer, EVP of Bavarian Nordic and president of the Cancer Vaccine Division. "We are optimistic that CV-301 offers patients with colon cancer the same promise of extended survival with a favorable side effect profile that our other product candidate, PROSTVAC offers patients with advanced prostate cancer. This provides an excellent opportunity to broaden our cancer immunotherapy clinical pipeline with yet another late-stage product candidate. We now look forward to assessing the complete CV-301 portfolio and expect to present the future development strategy later this year."
This announcement does not affect the company's expectations for the financial results for 2013.
CV-301 (CEA-MUC-1-TRICOM) is an off-the-shelf immunotherapy product candidate for the treatment of multiple cancers. It originates from the same poxvirus technology platform as PROSTVAC.
Both PROSTVAC and CV-301 are prime-boost vaccines sequentially combining two different poxviruses (vaccinia and fowlpox). Collectively, these two product candidates, along with earlier generations of these vaccines, have been the subject of over 30 clinical trials with more than 1,100 patients actively treated for prostate, breast, lung, colorectal, gastric, pancreatic, ovarian and other cancers. These extensive clinical studies suggest that the product candidates are well-tolerated with the ability to induce specific immune responses directed against the relevant tumour-associated antigens.
While PROSTVAC incorporates a single antigen over-expressed in prostate cancer (PSA), CV-301 incorporates two antigens (CEA and MUC-1) that are over-expressed in other major cancers, including breast, colon and other cancers, which makes CV-301 potentially applicable in various cancers.
Bavarian Nordic is developing and producing novel vaccines for the treatment and prevention of life-threatening diseases with a large unmet medical need.