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Re: None

Tuesday, 10/21/2014 2:40:03 PM

Tuesday, October 21, 2014 2:40:03 PM

Post# of 48316
Well, I found the abstracts to be presented at WCMC:

They are available at the following link. You have to create a profile.

http://personalizedmedonc.com/issues/october-2014-vol-3-no-7/970-the-third-annual-world-cutaneous-malignancies-congress

The only thing that was even remotely related is the following abstract regarding MCC. However, this is not ONCS. It is a company called Immune Designs. Here is the Phase 1 link: https://clinicaltrials.gov/ct2/show/NCT02035657?term=NCT02035657&rank=1

"Preliminary Results of a Proof-of-Concept Trial of Intratumoral (IT) Administration of Glucopyranosyl Lipid Adjuvant (GLA), a Toll-Like Receptor-4 (TLR-4) Agonist, in Patients With Merkel Cell Carcinoma (MCC)
Shailender Bhatia,1 Dafina Ibrani,1 Olga Afanasiev,1 Natalie Vandeven,1 David Byrd,1 Upendra Parvathaneni,1 Michael Donahue,1 Frank J. Hsu,2 Barry Storer,1 David Koelle,1 Paul Nghiem1
1University of Washington/Fred Hutchinson Cancer Research Center, Seattle, WA; 2Immune Design, Seattle, WA

Background: MCC is an aggressive skin cancer with limited therapeutic options. Despite persistent expression of the non-self Merkel cell polyomavirus (MCPyV) proteins, MCC tumors are able to evade the immune surveillance mechanisms through multiple interrelated mechanisms: down-regulation of MHC class I expression, strikingly sparse IT infiltrates of T cells, and immune exhaustion of infiltrating T-lymphocytes (TIL). Therapeutic immune modulation of the MCC tumor microenvironment using IT injections of GLA, a synthetic TLR-4 agonist, may overcome these evasion mechanisms via immune responses against the tumor antigens. Objectives: This proof-of-concept trial (NCT02035657) is a single center study to test the safety, clinical efficacy and immunologic effects of IT administration of GLA in MCC patients (pts). Methods: 10 MCC pts will be enrolled to receive multiple IT injections into a superficial injectable tumor. Pts with localized MCC (cohort A) may receive 1 cycle of GLA injections (on days 1, 8) followed by definitive surgery and/or radiation therapy (RT) starting during week 4; pts with distant metastatic disease (cohort B) may receive multiple cycles of GLA injections (days 1, 8, 22) every 6 weeks (up to 4 cycles, may be in conjunction with RT). Serial tumor biopsies and peripheral blood samples will be collected in all pts at baseline and posttreatment. Results: Four pts have been enrolled to date (2 in each cohort). Treatment has been tolerated well with no grade 3/4 or serious adverse events (AEs). Treatment-related AEs have all been grade 1 (inflammation, pain and bruising at the injection site), except transient grade 2 inflammation at the injected inguinal lymph node in patient 002 (in cohort A), who interestingly also had a pathologic complete remission of the involved node after only 2 GLA injections. Both pts in cohort A successfully completed definitive therapy without any delays. Both pts in cohort B successfully completed cycle 1 but had progressive disease at the first restaging evaluation. We identified MCPyV-specific CD8 T cells isolated from TIL and peripheral blood, and correlative immune studies tracking these cells in terms of frequency and functional status are in progress. Conclusion: Preliminary results indicate that IT immunotherapy with GLA injections in MCC patients is tolerated well and may induce antitumor responses. Updated clinical and correlative results will be presented at the meeting."