rMB - Recombinant Mycobacteria/Bladder Cancer

Bacilligen is developing an improved superficial bladder cancer therapy using recombinant Mycobacteria, rMB. Bacilligen’s proprietary mycobacterial strains will improve upon an existing, marketed therapy called BCG (bacille Calmette-Guérin). BCG is a strain of Mycobacterium bovis that is used outside the US as a vaccine for tuberculosis and has been used for more than thirty years as a treatment for bladder cancer (1-3). While BCG therapy for bladder cancer is reasonably efficacious (reviewed in 4), its reactogenicity lowers patient compliance, resulting in failures to complete the rigorous, multiple-dose treatment regimen; the long-term effects of BCG on cancer progression and patient survival are controversial. Further, some patients are unresponsive to BCG therapy which might be caused by pre-existing immunity in the patient. Bacilligen’s proprietary rMB technology equips the Mycobacteria to more actively fight cancer cells, be safer, resist interfering (pre-existing) immunity and prove useful in immunocompromised patients. Leveraging Bacilligen Chief Science Officer Dr. David Hone’s vast experience with Mycobacteria while CSO at Aeras Global TB Vaccine Foundation, Bacilligen has created rMB product candidates based on these proprietary genetic manipulations it has introduced into strains of Mycobacteria.

• Future Plans
• Intellectual Property
• Partnering Opportunities

Future Plans

Bacilligen scientists have completed the establishment of master seeds of two candidate rMB strains, each with regulatory pedigree. The best candidate based on preclinical studies due to be completed Q3 2008 will be moved to clinical studies in the coming months.

Intellectual Property

Bacilligen has protected its intellectual property through a patent filing covering the underlying technology and use of rMB.

Partnering Opportunities

Bacilligen is interested in exploring partnership and licensing opportunities for rMB for bladder cancer immunotherapy, or for use as vectors for vaccine delivery, including TB. Interested parties should contact Dr. Steve Bende, President and CEO of Bacilligen via email at sbende@bacilligen.com or by phone at 301-217-9525.

References

1.	Lamm, D. L., B. A. Blumenstein, E. D. Crawford, J. E. Montie, P. Scardino, H. B. Grossman, T. H. Stanisic, J. A. Smith, Jr., J. Sullivan, M. F. Sarosdy, and et al. 1991. A randomized trial of intravesical doxorubicin and immunotherapy with bacille Calmette-Guerin for transitional-cell carcinoma of the bladder. N Engl J Med 325:1205.
2.	Herr, H. W., D. M. Schwalb, Z. F. Zhang, P. C. Sogani, W. R. Fair, W. F. Whitmore, Jr., and H. F. Oettgen. 1995. Intravesical bacillus Calmette-Guerin therapy prevents tumor progression and death from superficial bladder cancer: ten-year follow-up of a prospective randomized trial. J Clin Oncol 13:1404.
3.	Patard, J. J., B. Muscatelli-Groux, F. Saint, Z. Popov, P. Maille, C. Abbou, and D. Chopin. 1996. Evaluation of local immune response after intravesical bacille Calmette-Guerin treatment for superficial bladder cancer. Br J Urol 78:709.
4.	Patard, J. J., A. Rodriguez, and B. Lobel. 2003. The current status of intravesical therapy for superficial bladder cancer. Curr Opin Urol 13:357.