On May 17, 2017 Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, reported new clinical and biomarker data today from CMB305 and G100 monotherapy studies (Press release, Immune Design, MAY 17, 2017, View Source [SID1234519200]). The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) is publishing three abstracts today relating to these new data. A broader set of data will be presented at the ASCO (Free ASCO Whitepaper) 2017 Annual Meeting, providing further clinical validation of the company’s lead product candidates and discovery platforms. Schedule your 30 min Free 1stOncology Demo! CMB305 Monotherapy in Patients with Soft Tissue Sarcoma
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Most recent patient survival data meaningfully exceed published survival outcomes for standard of care therapy in comparable soft tissue sarcoma (STS) patients with recurrent metastatic disease.
With a median follow up exceeding 18 and 11 months for LV305 and CMB305, respectively, median overall survival (mOS) has not yet been reached in recurrent metastatic STS patients.
Durable disease control was observed in more than half of STS patients, including durable tumor growth arrest in patients who had evidence of disease progression prior to CMB305 therapy.
CMB305’s safety profile consisted mostly of mild to moderate adverse events, with therapy being well tolerated by patients.
Anti-NY-ESO-1 immune biomarkers identify cancer patients who may be more likely to have prolonged survival following therapy with CMB305
Anti-NY-ESO-1 immune responses were observed in more than half of the patients who received CMB305 therapy.
Induction of anti-NY-ESO-1 immunity in patients treated with CMB305 or LV305 was associated with better clinical outcomes, including survival.
Immune biomarkers pre-treatment may guide regulatory strategy via the selection of patients more likely to respond to CMB305 therapy.
G100 Intratumoral Monotherapy with Radiation in Patients with Low-grade Follicular NHL (FL)
More than 40% of the FL patients experienced objective responses based on WHO criteria (at least a 50% tumor reduction), including substantial tumor shrinkage in untreated, unirradiated distal (abscopal) lesions.
Safety profile remains favorable at higher doses than those previously reported in Merkel cell carcinoma patients.
G100 resulted in favorable tumor microenvironment changes.
An increased intratumoral expression of inflammatory cytokines/chemokines, T cell infiltration, and an increased frequency of clonal tumor infiltrating lymphocytes, were observed.
"The ability to identify patients who are likely to benefit from antigen-targeted immunotherapy has been an elusive goal. We believe the results highlighted here should be considered as we aim to maximize the chance of success of these novel modalities, including CMB305 and future product candidates from our ZVex platform." said Carlos Paya, M.D., Ph.D., President and Chief Executive Officer of Immune Design. "During the second half of the year, we hope to have the opportunity to build on these positive clinical and biomarker data for CMB305 and G100 monotherapy with the results from ongoing trials evaluating each agent in combination with anti-PD-1/PD-L1 inhibitors."
Presentations at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting
Data underlying the topline releases above were published online today by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in abstracts accepted for presentation at ASCO (Free ASCO Whitepaper)’s 2017 Annual Meeting in June (presentation information set forth below). The abstracts reflect an analysis performed on or before February 2017; additional data will be presented at the Annual Meeting.
ORAL PRESENTATION
Immune response, safety, and survival impact from CMB305 in NY-ESO-1+ recurrent soft tissue sarcomas (STS)
Abstract # 11006
Session Title: Sarcoma
Date: Friday, June 2, 2017
Time: 3 p.m. — 6 p.m. CT (oral session)
Location: S100bc
Presenter: Neeta Somaiah, M.D., Department of Sarcoma Medical Oncology, The University of Texas MD Anderson Cancer Center
POSTER PRESENTATIONS
The Association of CMB305 or LV305-induced and baseline anti-NY-ESO-1 immunity with survival in recurrent cancer patients
Abstract # 3090
Session Title: Developmental Therapeutics—Immunotherapy
Date: Monday, June 5, 2017
Time: 8 a.m. — 11:30 a.m. CT
Location: Hall A
Presenter: Seth M. Pollack, M.D., Fred Hutchinson Cancer Research Center
Intratumoral G100 to induce systemic immune responses and abscopal tumor regression in patients with follicular lymphoma
Abstract # 7537
Session Title: Hematologic Malignancies — Lymphoma and Chronic Lymphocytic Leukemia
Date: Monday, June 5, 2017
Time: 8 a.m. — 11:30 a.m. CT
Location: Hall A
Presenter: Christopher Flowers, M.D., Department of Hematology and Medical Oncology, Emory University School of Medicine
About CMB305
CMB305 is a prime-boost vaccine approach against NY-ESO-1-expressing tumors, designed to generate an integrated, anti-NY-ESO-1 immune response in vivo via a targeted, specific interaction with dendritic cells, a mechanism of action Immune Design believes differs from traditional cancer vaccines. CMB305 is being evaluated in STS patients in ongoing Phase 1 monotherapy and 2 combination studies with the anti-PD-L1 antibody, Tecentriq (atezolizumab), pursuant to a collaboration with Genentech. Immune Design has received Orphan Drug Designation for CMB305 from the U.S. Food and Drug Administration (FDA) for the treatment of soft tissue sarcoma, as well as from the FDA and European Medicines Agency for each of the components of CMB305 for the treatment of soft tissue sarcoma.
About G100
G100 contains a potent synthetic small molecule toll-like receptor-4 (TLR-4) agonist, Glucopyranosyl Lipid A (GLA), and is the lead product candidate in Immune Design’s Antigen Agnostic approach. It leverages the activation of both innate and adaptive immunity, including dendritic cells, in the tumor microenvironment to create an immune response against the tumor’s preexisting diverse set of antigens. G100 is being evaluated as both a monotherapy (with XRT) and in combination with Merck’s anti-PD-1 agent, Keytruda (pembrolizumab), pursuant to a clinical collaboration with Merck, in a randomized Phase 1/2 trial in patients with follicular non-Hodgkin’s lymphoma. The FDA has granted Orphan Drug Designation for G100 for the treatment of follicular non-Hodgkin’s lymphoma.