Twenty-four pts with stage IIIB-IV melanoma and with at least two accessible lesions received one treatment cycle of pIL-12 EP administered on days 1, 5 and 8. Dose escalation with increasing plasmid concentrations was performed in cohorts 1 through 5. Plasmid was dispensed at concentrations of 0.1, 0.25, 0.5, 1.0 and 1.6 mg/mL, and plasmid volume was calculated based on tumor volume. Two additional cohorts were enrolled (cohorts 6 and 7) and received a total dose of 3.8 or 5.8 mg/treatment respectively, divided among two to four tumor sites, irrespective of tumor volume. Tumor responses were evaluated by modified RECIST. Biopsies were obtained for tumor histology, including evaluation of lymphocytic infiltrate, and tissue intratumoral IL-12 concentration.
In this phase 1 study, 53% (10/19) pts with metastatic disease had a systemic response to the local pIL-12 EP treatment as evidenced by stable disease or objective regression of non-injected lesions. Additionally, 11% (2/19) experienced complete regression of all distant lesions without concurrent or subsequent systemic therapy. The most frequent adverse event (AE) related to treatment was transient pain during the EP procedure, with 54% (13/24) pts reporting grade 1 and 46% (11/24) pts reporting grade 2 pain. No DLT was noted within any of the treatment cohorts. The median OS (n=24, ITT) was 24.2 mos. In pts who experienced SD or better with pIL-12 EP (n=9), OS of 46.4 mos was observed, a 32.9 mos increase compared to non-responders (OS 13.5 mos; n=15).
Results from this phase 1 study demonstrate that local treatment with pIL-12 EP successfully induces systemic anti-tumor immune-mediated effects without severe local or systemic toxicity. Moreover, long-term follow-up data suggest that systemic disease stabilization with pIL-12 EP is correlated with improved survival. Based on this evidence, intratumoral EP of pIL-12 is an effective tool for gene transfer of DNA plasmid with potential applications as both a monotherapy and in combination with other agents that promote anti-tumor immunity.
In its third year, The Life Sciences Report's 2015 Small-Cap Biotech Watchlist currently includes 12 drug development companies selected by leading analysts in the sector. With catalysts on the horizon and pipelines that encompass a variety of indications and innovative platforms, these biotechs are primed to return multiples on investment.
At January 31, 2015, OncoSec had $30.7 million in cash and cash equivalents, as compared to $37.9 million of cash and cash equivalents at July 31, 2014. OncoSec expects these funds will be sufficient to allow the company to continue to operate our business for at least the next 12 months.
"Under the agreement, OncoSec and Heat will jointly evaluate the preclinical efficacy of OncoSec’s core technology, ImmunoPulse, an investigational stage intratumoral DNA delivery platform, with Heat’s proprietary gp-96-Ig based ImPACT immunotherapy platform."
"OncoSec and Heat are exploring this combination as part of their ongoing strategy to expand the application of their technologies to benefit cancer patients with unmet medical needs. OncoSec’s core platform, ImmunoPulse, which is based on the intratumoral delivery of DNA IL-12, is currently in Phase 2 clinical trials, investigating the approach for treatment of metastatic melanoma, head and neck cancer, triple negative breast cancer, and cutaneous T-cell lymphoma. Heat has two clinical stage programs based on the ImPACT platform, viagenpumatucel-L (HS-110) in a Phase 2 clinical trial in patients with non-small cell lung cancer and vesigenurtacel-L (HS-410) in a Phase 2 clinical trial in patients with non-muscle invasive bladder cancer."
Heat Biologics, Inc.
announced that it has received fast track designation from the FDA for its oncology candidate, HS-410 (vesigenurtacel-L), for the treatment of non-muscle invasive bladder cancer (NMIBC).
Read more: http://www.nasdaq.com/article/heat-biologics-bladder-cancer-drug-gets-fast-track-status-analyst-blog-cm453354#ixzz3U1pT53ZB