On September 26, 2016 Mateon Therapeutics, Inc. (Nasdaq:MATN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, reported a collaboration under which sites affiliated with US Oncology Research will participate in the FOCUS Study, Mateon’s recently initiated phase 2/3 clinical trial in platinum-resistant ovarian cancer (Press release, Mateon Therapeutics, SEP 26, 2016, View Source [SID:SID1234515403]). Schedule your 30 min Free 1stOncology Demo! "We are pleased to work with US Oncology Research, an outstanding organization that has had tremendous success in oncology-related clinical trials," stated William D. Schwieterman, M.D., President and Chief Executive Officer of Mateon. "US Oncology Research is selective regarding the studies in which it participates. So we are pleased they recognize the importance of developing CA4P for women with platinum-resistant ovarian cancer."
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US Oncology Research is a premier organization in the United States dedicated to bringing physicians, clinics and patients together for innovative cancer research in the community setting. One of the largest community-based oncology research programs in the U.S., US Oncology Research has nearly 150 affiliated locations as well as more than 900 affiliated investigators. The organization has played a role in the development of more than 60 FDA-approved cancer therapies, which represents about one-third of all cancer therapies approved by the FDA to date, and manages about 300 active clinical trials at any given time.
"Inhibition of tumor-related angiogenesis provides an important therapeutic option for women with recurrent ovarian cancer," stated Michael A. Bookman, M.D., Director, Gynecologic Oncology Research, US Oncology Research. "Strategies to combine Mateon’s CA4P, a novel vascular disrupting agent, with other agents, including bevacizumab, appear promising, and we are excited to offer our patients the opportunity to participate in this high-priority randomized trial."
About FOCUS
The FOCUS Study is a randomized, double-blind, 2-arm, parallel-group, phase 2/3 study to evaluate the efficacy and safety of physician’s choice chemotherapy (PCC) plus bevacizumab and CA4P versus PCC plus bevacizumab in patients with platinum-resistant ovarian cancer. The primary endpoint of the FOCUS Study is progression free survival (PFS). The Study will also evaluate CA4P’s effect on objective response rate (ORR), overall survival (OS) and other parameters. For additional information on the FOCUS Study, please visit www.clinicaltrials.gov, study identifier NCT02641639.
Array BioPharma and Pierre Fabre Announce COLUMBUS Phase 3 Study of Encorafenib plus Binimetinib For BRAF-Mutant Melanoma Met Primary Endpoint
On September 26, 2016 Array BioPharma (Nasdaq: ARRY) and Pierre Fabre jointly reported top-line results from Part 1 of the Phase 3 COLUMBUS (Combined LGX818 Used with MEK162 in BRAF Mutant Unresectable Skin Cancer) study evaluating LGX818 (encorafenib), a BRAF inhibitor, and MEK162 (binimetinib), a MEK inhibitor, in patients with BRAF-mutant advanced, unresectable or metastatic melanoma (Filing, 8-K, Array BioPharma, SEP 26, 2016, View Source [SID:SID1234515368]). The study met its primary endpoint, significantly improving progression free survival (PFS) compared with vemurafenib, a BRAF inhibitor, alone. Schedule your 30 min Free 1stOncology Demo! Array BioPharma.
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"The COLUMBUS Part 1 trial results demonstrate a robust PFS benefit associated with the combination of binimetinib plus encorafenib versus vemurafenib in patients with BRAF-mutant melanoma," said Ron Squarer, Chief Executive Officer, Array BioPharma. "We look forward to working with global regulatory authorities as they evaluate our planned submission."
In the analysis of the primary endpoint, the median PFS for patients treated with the combination of encorafenib plus binimetinib ("combination") was 14.9 months versus 7.3 months for patients treated with vemurafenib; HR (0.54), [95% CI 0.41-0.71], p<0.001. The combination was generally well-tolerated and reported adverse events were overall consistent with previous combination encorafenib plus binimetinib clinical trial results in BRAF-mutant melanoma patients.
"The preliminary results from Part 1 of COLUMBUS suggest that the combination of encorafenib plus binimetinib represents a potentially unique therapy for the BRAF-mutant melanoma population," said Keith T. Flaherty, M.D., Director of the Termeer Center for Targeted Therapy, Massachusetts General Hospital and Professor of Medicine, Harvard Medical School. "In addition to the robust activity observed in Part 1, the combination appeared to be generally well-tolerated."
Analysis of a secondary endpoint comparing the PFS of patients treated with combination to patients treated with encorafenib showed a median of 14.9 months versus 9.6 months with HR (0.75), [95% CI 0.56-1.00], p=0.051, which did not reach statistical significance. A complete analysis of these results will be provided to global regulatory authorities as part of planned submissions. In addition, data from Part 2 of the COLUMBUS trial are anticipated in mid 2017 and will also be provided to global health authorities as part of planned regulatory submissions for approval of these product candidates.
Further results from Part 1 of the COLUMBUS trial, including objective response rates, disease control rates, safety endpoints, exploratory analyses such as a Part 1 PFS comparison of encorafenib to vemurafenib and pre-specified subgroup analyses including outcomes in patients who received prior treatment with immunotherapy will be presented at an upcoming medical meeting. Analysis of the secondary endpoint of overall survival (OS) was not planned as part of these initial results.
Frédéric Duchesne, Chief Executive Officer Pharmaceutical Division, Pierre Fabre remarked, "We are very pleased with the COLUMBUS Part 1 results and look forward to the possibility that, if approved, the combination of encorafenib plus binimetinib could offer a new treatment option for patients suffering from this devastating disease."
About the Phase 3 COLUMBUS Study
The COLUMBUS trial, (NCT01909453), is a two-part, international, randomized, open label Phase 3 study evaluating the efficacy and safety of the combination of encorafenib plus binimetinib to vemurafenib and encorafenib monotherapy in 921 patients with locally advanced, unresectable or metastatic melanoma with BRAF V600 mutation. Prior immunotherapy treatment was allowed. Over 200 sites across North America, Europe, South America, Africa, Asia and Australia participated in the study. Patients were randomized into two parts:
In Part 1, 577 patients were randomized 1:1:1 to receive the combination of 450mg encorafenib plus 45mg binimetinib, 300mg encorafenib alone, or 960mg vemurafenib alone. The primary endpoint for the COLUMBUS trial was a PFS comparison of the combination versus vemurafenib. PFS is determined based on tumor assessment (RECIST version 1.1 criteria) by a Blinded Independent Review Committee. Secondary endpoints include a comparison of the PFS of encorafenib monotherapy to that of the combination and a comparison of OS for the combination to that of vemurafenib alone.
In Part 2, 344 patients were randomized 3:1 to receive 300mg encorafenib plus 45mg binimetinib or 300mg encorafenib alone. Part 2 is designed to provide additional data to help evaluate the contribution of binimetinib to the combination. While formal statistical analysis of Part 2 is only planned if both the comparison of PFS between combination versus vemurafenib and the combination versus encorafenib achieve statistical significance in Part 1, data from Part 2 are anticipated in mid 2017 and will be provided to global health authorities as part of planned regulatory submissions in 2017.
Binimetinib and encorafenib are investigational medicines and are not currently approved in any country.
About BRAF-Mutant Melanoma
Melanoma is the fifth most common cancer among men and the seventh most common cancer among women in the United States, with more than 76,000 new cases and over 10,000 deaths from the disease expected in 2016. Novel therapies that target the RAS/RAF/MEK/ERK pathway have a strong scientific rationale for activity in this disease, as up to 50 percent of patients with metastatic melanoma have activating BRAF mutations, the most common gene mutation in this patient population. Current marketed MEK/BRAF combination agents have a run rate forecasted to approach $1 billion in annual worldwide sales.
About Binimetinib & Encorafenib
MEK and BRAF are key protein kinases in the MAPK signaling pathway (RAS-RAF-MEK-ERK). Research has shown this pathway regulates several key cellular activities including proliferation, differentiation, survival and angiogenesis. Inappropriate activation of proteins in this pathway has been shown to occur in many cancers, such as melanoma, colorectal and thyroid cancers. Binimetinib is a late-stage small molecule MEK inhibitor and encorafenib is a late-stage small molecule BRAF inhibitor, both of which target key enzymes in this pathway.
Binimetinib and encorafenib are being studied in clinical trials in advanced cancer patients, including the recently initiated Phase 3 BEACON CRC trial that will study encorafenib in combination with cetuximab with or without binimetinib in patients with BRAF V600E-mutant colorectal cancer. Array submitted a New Drug Application (NDA) for binimetinib in NRAS-mutant melanoma to the FDA at the end of June 2016. The FDA accepted the NDA with a target action date under the Prescription Drug User Fee Act (PDUFA) of June 30, 2017.
Array BioPharma retains exclusive rights to binimetinib and encorafenib in key markets including the U.S. and Japan.
Onconova Announces Successful End-of-Phase 2 Meeting with FDA for Oral Rigosertib and Azacitidine Combination
On September 26, 2016 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3 clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, reported receipt of the End-of-Phase 2 meeting minutes from the U.S. Food and Drug Administration (FDA) for the combination of oral rigosertib with azacitidine for the treatment of patients with higher-risk myelodysplastic syndromes (HR-MDS) (Press release, Onconova, SEP 26, 2016, View Source [SID:SID1234515367]). Schedule your 30 min Free 1stOncology Demo! Based on these discussions, Onconova will design a randomized, controlled Phase 3 clinical trial comparing the combination of oral rigosertib plus azacitidine to azacitidine plus placebo in 1st-line HR-MDS patients. The primary endpoint of this pivotal trial will be overall response rate (ORR); ORR will be a composite of complete remission (CR) and partial remission (PR). Onconova could potentially pursue additional available paths from FDA for accelerated or enhanced review and further input on the development of a final trial protocol. Full details of the protocol will be available following completion of all regulatory discussions.
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As part of the End-of-Phase 2 meeting with FDA, Onconova presented updated results from its Phase 2 trial of oral rigosertib and azacitidine. These results are expected to be presented by study investigators at a scientific conference later this year.
"We are encouraged that our interactions with FDA resulted in agreement on the patient population to be evaluated and the selection of overall response as the primary endpoint in this pivotal trial," stated Steven Fruchtman, M.D., Chief Medical Officer of Onconova. "We will provide additional details on the design of this trial and the full Phase 2 data set supporting our pivotal study plans at upcoming meetings and scientific conferences later in 2016."
Onconova is developing rigosertib for patients with MDS where there is a paucity of therapeutic options. Two hypomethylating agents (HMAs), azacitidine and decitabine, the mainstays for eligible 1st-line patients, were approved by the FDA more than a decade ago. In addition to the oral rigosertib and azacitidine combination program, Onconova is currently enrolling patients in the global, pivotal Phase 3 INSPIRE trial of IV rigosertib for 2nd-line MDS patients, who have failed HMA therapy. This trial of 225 patients is now enrolling in the U.S., Europe, Japan and Australia.
About Oral Rigosertib
The oral form of rigosertib provides a more convenient dosing for use where the duration of treatment may extend to multiple years. To date, more than 350 patients have been treated with the oral formulation of rigosertib, either as a single agent or in combination with other drugs. Phase 1 studies with oral rigosertib were conducted in hematological malignancies, lower-risk MDS and solid tumors. Combination therapy of oral rigosertib with azacitidine and chemoradiotherapy has also been explored.
About Trial 09-08 (NCT01926587): Combination therapy with oral rigosertib and azacitidine
The current standard of care for higher-risk MDS patients is one of two approved hypomethylating agents (Azacitidine and Decitabine, approved by the FDA in 2004 and 2006). Although these drugs are currently the mainstays in HR-MDS therapy, their overall response rate and duration of benefit is limited to a subset of eligible patients and all responding patients ultimately progress. Therefore, there is an urgent need for developing therapeutic options for newly diagnosed MDS patients. The 09-08 Phase 1/2 trial tested oral rigosertib in combination with injectable azacitidine in a dose ranging study (Phase 1), followed by an expansion cohort (Phase 2) to evaluate the efficacy and safety of the combination. Interim results from this trial were presented at the 2015 ASH (Free ASH Whitepaper) conference indicating that the combination was generally well tolerated and that clinical responses were observed in 23 of 30 MDS patients evaluable for efficacy assessment.1 Both 1st-line and 2nd-line patients were included in this study.
Corvus Pharmaceuticals Announces Preclinical and Preliminary Clinical Biomarker Data of Lead Oral Checkpoint Inhibitor CPI-444 Presented at Second CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference
On September 25, 2016 Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immuno-oncology therapies, reported preclinical data as well as preliminary biomarker data from its ongoing Phase 1/1b study of CPI-444 as a single agent and in combination with Genentech’s TECENTRIQ (atezolizumab), a fully humanized monoclonal antibody targeting protein programmed cell death ligand 1 (PD-L1) (Filing, 8-K, Corvus Pharmaceuticals, SEP 26, 2016, View Source [SID:SID1234515364]). CPI-444 is a selective and potent inhibitor of the adenosine A2A receptor. The data were presented today in both oral and poster presentations by Stephen Willingham, Ph.D., Corvus senior scientist, at the Second CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper): Translating Science into Survival, which is taking place in New York at the Sheraton New York Times Square Hotel and the New York Hilton Midtown. Schedule your 30 min Free 1stOncology Demo!
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"We are very encouraged by the early data showing that CPI-444 is well tolerated and by the biomarker data indicating that treatment with CPI-444 as a single agent is associated with activation of T-cells detected in the blood. We believe this is the first demonstration of immune modulation in cancer patients receiving an adenosine antagonist," said Richard A. Miller, M.D., an oncologist and co-founder, president and chief executive officer of Corvus. "Patient enrollment in our CPI-444 Phase 1/1b study is on schedule, and we anticipate completing the dose-selection portion of the study and reporting interim safety and efficacy data at a scientific conference later this year. That data will enable us to choose the best dose for testing in disease-specific expansion cohorts, which we expect to initiate before year end."
According to preclinical study results presented at the Conference:
· CPI-444 has been shown to be active, both as a single agent and in combination with anti-PD-1 and anti-PD-L1 antibodies, in stimulating various immune cells, generating anti-tumor immunity, suppressing tumor growth, delaying tumor progression and generating complete tumor rejection in multiple animal models of cancer.
· Results from mechanism of action studies indicate that CD8+ cytotoxic T-lymphocytes are necessary for CPI-444’s activity in animal models.
· Long-term immunity was demonstrated upon tumor re-challenge in animals previously treated with CPI-444.
Preliminary biomarker data from ongoing analyses of patients with various solid tumors treated to date in the ongoing Phase 1/1b study presented at the Conference demonstrated:
· In the first 11 patients analyzed, 40-100 percent blockade of peripheral blood lymphocyte A2A receptors was achieved in a dose-dependent manner with CPI-444 treatment.
· All three patients receiving CPI-444 100 mg twice daily for 28 days achieved 90-100 percent continuous, sustained blockade of peripheral blood lymphocyte A2A receptors.
· Pharmacodynamic markers on peripheral blood lymphocytes showed evidence of activation of T-cell mediated immunity in all three patients treated with CPI-444 100 mg twice daily for 28 days. In these patients, increases in cytotoxic T-lymphocytes that were both PD-1-positive and CD8-positive (double positive) were seen in the blood following 28 days of treatment compared to baseline pretreatment. Previous research from others has shown that PD-1, CD8 double positive T-cells are associated with anti-tumor immune responses.
· CPI-444 has been well tolerated to date, with no drug-related dose limiting toxicities or serious adverse events observed.
· The trial is currently enrolling patients at 25 sites in the United States, Canada and Australia with 39 patients enrolled to date.
About the Phase 1/1b Trial
The Phase 1/1b trial is designed to examine the activity of CPI-444 as a single agent and in combination with Genentech’s TECENTRIQ (atezolizumab), an anti-PD-L1 antibody. The first part of the study (dose-selection) includes four cohorts of 12 patients each — three cohorts treated with single agent CPI-444 (100 mg twice daily for 14 days; 100 mg twice daily for 28 days; 200 mg once daily for 14 days) and one cohort treated with the combination (CPI-444 50 mg or 100 mg twice daily for 14 days combined with TECENTRIQ). A treatment cycle is 28 days. Patients with non-small cell lung cancer, melanoma, renal cell cancer, triple-negative breast cancer, colorectal cancer, head and neck cancer, bladder cancer and prostate cancer who have failed all standard therapies are eligible. Based on safety and biomarker analyses, an optimum single agent and combination dose will be selected. The second part of the study will evaluate CPI-444 as a single agent in five disease-specific cohorts, and CPI-444 in combination with TECENTRIQ in five additional matched disease-specific cohorts. Corvus expects that each of these 10 cohorts will initially enroll 14 patients, but each cohort may be expanded based on efficacy.
Idera Pharmaceuticals Reports Promising Data from Ongoing Phase 1 Dose Escalation in Clinical Trial of Intra-tumoral IMO-2125 in Combination with Ipilimumab in Patients with PD-1 Refractory Metastatic Melanoma
On September 26, 2016 Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage biopharmaceutical company developing Toll-like receptor and RNA therapeutics for patients with cancer and rare diseases, reported initial clinical data from its ongoing Phase 1/2 clinical trial of intra-tumoral IMO-2125, a Toll-like receptor (TLR) 9 agonist (Press release, Idera Pharmaceuticals, SEP 26, 2016, View Source [SID:SID1234515362]). In this arm of the Phase 1 portion of the trial, IMO-2125 is being evaluated in combination with ipilimumab for treatment of patients with metastatic melanoma who have failed prior PD-1 therapy. These early results indicate that IMO-2125 is demonstrating promising clinical activity and is being well tolerated in a patient population with minimal options and low expectation of clinical response with ipilimumab treatment alone. Further clinical information from the ongoing dose escalation portion of the trial, as well as detailed information on the translational results, will be presented during an oral session at the 2016 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting beginning November 9th in Maryland. Schedule your 30 min Free 1stOncology Demo! "We have completed extensive pre-clinical work in a broad scope of tumor types to test the hypothesis of intra-tumoral administration of IMO-2125 inducing a meaningful effect on the tumor microenvironment and potentiating local and systemic tumor regression in patients. This work gave us confidence to test the ability of IMO-2125, beginning with this current study in PD-1 refractory metastatic melanoma patients," stated Vincent Milano, Idera’s Chief Executive Officer.
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"We are energized by the early results from this ongoing trial and have been solidifying our plans to accelerate the program as we believe there is a clear path to bring IMO-2125 to melanoma patients who have not benefited from checkpoint inhibition alone and open an opportunity to establish IMO-2125 as the agent of choice to activate the tumor microenvironment and potentially improve outcomes for patients," Milano added. "Following a full strategic review, we have decided to prioritize the IMO-2125 program and explore strategic options for IMO-8400 in B-cell lymphoma."
Current Data Analysis
Safety
10 patients in 3 dosing cohorts (4mg, 8mg and 16mg) have been dosed and are assessable for safety, as of the September 19, 2016 cutoff date;
IMO-2125 in combination with ipilimumab is being generally well tolerated at all 3 dose levels studied to date;
Immune related adverse events have been observed in 3 subjects: 2 responding patients have experienced hypophysitis and 1 patient has discontinued the study due to a recurrence of immune related hepatitis previously observed on prior therapy with ipilimumab;
No dose limiting toxicities (DLTs) have been identified to date and the study is currently enrolling at the highest (32mg) dosing cohort in combination with ipilimumab.
Clinical activity
6 patients treated in the first 2 dosing cohorts (4mg and 8mg) are assessable for initial clinical activity, as of the September 19, 2016 cutoff date;
3 of the 4 patients with cutaneous melanoma are responders with one Complete Response (CR) and 2 Partial Responses (PR);
2 patients with mucosal melanoma experienced Progressive Disease (PD).
Translational observations
Translational data seen through the first two dosing cohorts is promising relative to the induction of immune responses;
Detailed information on the translational findings from biopsies taken in the first 2 dosing cohorts and the relationship of these to clinical response is the subject of an accepted oral presentation on November 11, 2016 at the 2016 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting by Cara Haymaker, Ph.D., University of Texas, MD Anderson Cancer Center.
"The degree of activity we’ve seen so far in this trial is very exciting as these patients are very unlikely to respond to other therapies. All three responses that we’ve seen are clinically meaningful, and these patients continue to do well following treatment," stated Adi Diab, M.D., Assistant Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine, University of Texas, MD Anderson Cancer Center.
These early results are from the Phase 1 portion of study IMO-2125-204 (NCT02644967) in which cohorts of patients with metastatic melanoma unresponsive to PD-1 inhibitor therapy are being administered escalating doses of IMO-2125 ranging from 4 mg/kg through 32 mg/kg. IMO-2125 is injected intra-tumorally into a designated tumor lesion together with a standard dosing regimen of ipilimumab given intravenously. Following determination of the recommended Phase 2 dose (RP2D) additional patients will be treated in an expansion Phase 2 portion of the study. The primary objective of the Phase 1 portion of the trial is to characterize the safety and determine a RP2D of IMO-2125 when administered intra-tumorally in combination with ipilimumab. The primary objective of the Phase 2 portion is to assess the clinical activity of IMO-2125 in combination with ipilimumab at the respective RP2D in patients. Assessment will be based on the immune-related response criteria (irRC) and additionally the traditional RECIST criteria. Serial biopsies are being taken of selected injected and non-injected tumor lesions to assess immune changes and correlate with clinical response assessments. The trial will enroll approximately 60 patients. The study is being conducted at The University of Texas MD Anderson Cancer Center and is being led by Adi Diab, M.D., Assistant Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine, MD Anderson as part of a strategic research alliance announced by Idera and MD Anderson in 2015.
Business Update
Idera is also reporting that the company has chosen to suspend the clinical development of IMO-8400 for B-cell lymphomas, including studies in Waldenstroms Macroglobulinemia (WM) and Diffuse Large B-Cell Lymphoma (DLBCL), and will explore strategic options in these indications. This decision was based upon the prioritization of the clinical development plans for IMO-2125 and our assessment that the level of clinical activity seen in the WM trial does not support monotherapy, the very slow enrollment rate in DLBCL and our commercial assessment. No safety concerns have been observed with IMO-8400 in the B-cell Lymphoma program. The development of IMO-8400 in dermatomyositis continues and is not impacted by this decision.
Investor Event and Webcast
Idera will host a conference call and live webcast on Monday, September 26 at 9:00 A.M. EST to review the data being presented along with a discussion of the next steps for the IMO-2125 development program in melanoma. To participate in the conference call, please dial (844) 882-7837 (domestic) and (574) 990-9824 (international). The webcast can be accessed live or in archived form in the "Investor’s" section of the company’s website at www.iderapharma.com. The company has also posted a slide presentation to the Idera corporate website in the "Investors" section which will be referenced during the conference call. Additionally the company has updated its corporate presentation which has also been posted to the Idera corporate website in the "Investors" section.
About Toll-like Receptors and Idera’s Immuno-Oncology Research Program
Toll-like receptors (TLRs) play a central role in the innate immune system, the body’s first line of defense against invading pathogens, as well as damaged or dysfunctional cells including cancer cells. The innate immune system is also involved in activating the adaptive immune system, which marshals highly specific immune responses to target pathogens or tissue. Cancer cells may exploit regulatory checkpoint pathways to avoid being recognized by the immune system, thereby shielding the tumor from immune attack. Checkpoint inhibitors such as agents targeting CTLA4 or programmed cell death protein 1 (PD1) are designed to enable the immune system to recognize tumor cells. In this setting, intra-tumoral TLR9 agonist administration may increase the tumor-infiltrating lymphocytes (TILs), and thereby potentiate anti-cancer activity of checkpoint inhibitors in the injected tumor as well as systemically.
Idera’s TLR9 agonist, IMO-2125 has been created using the company’s proprietary chemistry-based discovery platform. IMO-2125 has been shown to activate dendritic cells and induce interferon. Idera selected IMO-2125 to advance into clinical development in combination with checkpoint inhibitors based on this immunological profile. In previously completed clinical trials, subcutaneous administration of IMO-2125 was generally well tolerated in about 80 patients with hepatitis C. Idera has conducted further preclinical research evaluating the potential of IMO-2125 to enhance the anti-tumor activity of other checkpoint inhibitors in cancer immunotherapy with data being presented at several medical conferences during the past twelve months. The posters from these presentations can be found at View Source
About Metastatic Melanoma
Melanoma is a type of skin cancer that begins in a type of skin cell called melanocytes. As is the case in many forms of cancer, melanoma becomes more difficult to treat once the disease has spread beyond the skin to other parts of the body such as by through the lymphatic system (metastatic disease). Melanoma accounts for only one percent of skin cancer cases, but causes a large majority of skin cancer deaths. The American Cancer Society estimates that in 2016, there will be 76,380 new cases of melanoma in the U.S., and about 10,130 will die of this disease.