Nventa Biopharmaceuticals Corporation said the company has completed enrolment and initiated dosing of the fourth and final cohort of patients in its phase 1 dose escalation trial. This study examines the safety of its lead candidate, new HspE7 (HspE7 + Poly-ICLC, a toll-like receptor-3, or TLR3 agonist), in patients with cervical intraepithelial neoplasia, or CIN, a precursor to cervical cancer. New HspE7 is an investigational therapeutic vaccine targeting human papillomavirus (HPV)-related diseases.
"Conclusion of enrolment in this study is a significant milestone for Nventa," said Gregory M. McKee, president and chief executive officer, Nventa. "We have spent considerable time analyzing the need for a fifth cohort in this study, and have determined that the fourth cohort dose level is likely optimal for future clinical trials. Following completion of this phase I study, we anticipate launching a comprehensive phase II programme studying the safety and efficacy of new HspE7 in patients with CIN."
When complete, the phase I trial will have dosed four cohorts totalling seventeen patients with a fixed dose of 500 mcg of HspE7 and either 50, 500, 1,000 or 2,000 mcg of the adjuvant, Poly-ICLC. In addition to safety data, immunological data are being collected pre-treatment, following each dose of new HspE7, and at the end of the study from all patients, which could provide an early indication of potential activity of new HspE7. All patients are also being typed for class I and II human leukocyte antigen (HLA) subtypes, and are being evaluated for cytokine responses, anti-HspE7 antibodies and cellular (T-cell) immunology.
Affiliations and investigators in this trial currently have included the Montefiore Medical Centre; William D. Kolton, M.D. of San Diego, California; Linda Roman, M.D. of the University of Southern California (USC); Michael L. Twede, M.D. of the Salt Lake Women's Centre in Sandy, Utah; and Mark T. Saunders, M.D. at the Mt. Timpanogos Women's Healthcare/Physician's Research in Pleasant Grove, Utah.
The company's lead candidate, new HspE7 (HspE7 + Poly-ICLC), is a novel therapeutic candidate intended for the treatment of precancerous and cancerous lesions caused by the human papillomavirus (HPV), one of the most common sexually transmitted diseases in the world. New HspE7 contains the novel CoVal fusion protein, HspE7 co-administered with the adjuvant, Poly-ICLC, a toll-like receptor-3 (TLR3) agonist adjuvant. An adjuvant is a substance added to vaccines to improve immune responses against target antigens. HspE7 is derived from Nventa's proprietary CoVal™ fusion platform, which uses recombinant DNA technology to covalently fuse stress proteins to target antigens, thereby stimulating cellular immune system responses. Nventa is developing new HspE7 for multiple indications.