Some of the key messages from the report include the following:
- Reminiscent of monoclonal antibodies in the late 1990’s, the field of active immunotherapy is poised for dramatic growth in the coming years
- Nearly 50 clinical programs involving active immunotherapies for the treatment of cancer are currently underway, including nearly a dozen that are in pivotal Phase III development with several biologic license application [BLA] submissions planned in 2010
- Using the history of passive immunotherapy [monoclonal antibodies] as a guide, we expect five active cancer immunotherapies approved within the next five years that will revolutionize the treatment of cancer
- Beyond Dendreon Corporation’s (DNDN) Provenge®, there are a number of additional catalysts in 2010 that could ignite further interest in the field of cancer immunotherapy
A list of potential catalysts for cancer vaccine companies in 2010 was included in our initial report, such as the presentation of new clinical data during the American Society for Clinical Oncology [ASCO] annual meeting being held June 4-8, 2010. However, following a review of the abstracts published online, we identified three additional vaccine companies worth watching at ASCO.
Interestingly, the three companies span the largest segments of cancer vaccine development – allogeneic peptides [17 programs in development], gene transfer [15 programs in development], and autologous dendritic cell approaches [9 programs in development]. The first two approaches represent “off the shelf” cancer vaccines, while the latter is a “personalized” approach. To date, the only active immunotherapy approved for the treatment of cancer in the US is Dendreon’s Provenge, which is an autologous approach.
Bavarian Nordic A/S (BAVA.CO)
Bavarian Nordic, who’s stock price reached a multi-year high following approval of Dendreon’s Provenge, is developing Prostvac™ [also known as PSA-TRICOM], under a license from the National Cancer Institute [NCI]. Prostvac is a vector-based vaccine that targets prostate-specific antigen [PSA] and includes the transgenes for three human costimulatory molecules to enhance T-cell activation. Following the recent publication of encouraging Phase II results and receipt of Fast Track designation from the FDA, Bavarian Nordic is planning to initiate a pivotal Phase III prostate cancer trial in 2010.
At ASCO, Bavarian Nordic is scheduled to present “Overall survival [OS] analysis of a phase l trial of a vector-based vaccine [PSA-TRICOM] and ipilimumab [Ipi] in the treatment of metastatic castration-resistant prostate cancer [mCRPC]” during the Developmental Therapeutics – Clinical Pharmacology and Immunotherapy General Poster Session held Monday, June 7, 8:00am to 12:00pm in S Hall A2. Separately, the company announced an investor and analyst briefing to be held in conjunction with ASCO on Saturday, June 5, 2010, in Chicago, IL.
Generex Biotechnology Corporation (GNBT)
While Canada’s Generex is perhaps better known for its $250 million lawsuit against TheStreet.com and senior columnist Adam Feuerstein regarding two articles expressing doubts about the company’s oral insulin spray for the treatment of diabetes, its wholly owned subsidiary [Antigen Express, Inc.] is scheduled to present “Effect of a novel II-key hybrid HER2/neu peptide (AE37) vaccine with GM-CSF as compared to GM-CSF alone on levels of regulatory T-cell (Treg) populations” during the Developmental Therapeutics – Clinical Pharmacology and Immunotherapy General Poster Session held Monday June 7, 8:00am to 12:00pm in S Hall A2.
HER-2 is a growth factor receptor that is over-expressed by approximately 20-30% of patients with localized breast cancer and is the target for Herceptin® [trastuzumab] by the Roche Group (RHHBY). However, Generex isn’t the only company targeting HER-2/neu for the treatment of breast cancer. Other cancer vaccine developers working with the target include Dendreon, Bavarian Nordic, Apthera, Inc., and others.
Prima Biomed Ltd. (PRR.AX)
Similar to the concept behind Dendreon’s Provenge, Prima Biomed is developing an autologous dendritic cell vaccine for the treatment of cancer. The company’s lead product candidate is called CVac™, which incorporates the MUC-1 antigen that is overexpressed in cancer, including epithelial ovarian carcinoma. According to the company, prior phase I and II studies conducted in Australia in heavily pretreated, advanced disease patients showed minimal toxicities and prolonged disease stabilization.
Prima Biomed is scheduled to present “A randomized, open-label phase IIb study of maintenance therapy with a MUC-1 dendritic cell vaccine in patients with epithelial ovarian cancer in first or second remission” during the Trials in Progress Poster Session held Monday, June 7, from 8:00am to 12:00pm in S Hall A2.
Consistent with ASCO’s policies, we won’t report on research information represented by the aforementioned abstracts until the information is publicly released in conjunction with the annual meeting. Suffice it to say that we believe active immunotherapy for the treatment of cancer will take center stage at this year’s meeting.