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Inovio Announces Clinical Trial Collaboration to Evaluate a Novel T-cell Immunotherapy in Combination with a PD-L1 Checkpoint Inhibitor

On June 1, 2017 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported a clinical collaboration with Genentech, a member of the Roche Group, for advanced bladder cancer (Press release, Inovio, JUN 1, 2017, View Source [SID1234519333]). The phase 1b/2 immuno-oncology trial will evaluate Genentech’s atezolizumab (TECENTRIQ) in combination with Inovio’s INO-5401, a T cell activating immunotherapy encoding multiple antigens, and INO-9012, an immune activator encoding IL-12.

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The multi-center open-label trial will be managed by Inovio, and Genentech will supply atezolizumab. It is anticipated to start in 2017 and designed to evaluate the safety, immune response and clinical efficacy of the combination therapy in approximately 80 patients with advanced bladder cancer, specifically advanced unresectable or metastatic urothelial carcinoma (UC), the most common type of bladder cancer. The majority of the patients to be enrolled in the trial will have previously received and failed to demonstrate meaningful response to a checkpoint inhibitor alone. Thus the study will evaluate potential benefit of a checkpoint inhibitor combined with a DNA-based immunotherapeutic and T-cell activator within a bladder cancer patient population with very limited treatment options and poor outcomes. The immunologic analyses accompanying the study will provide further insight into mechanisms of checkpoint inhibition and T-cell activation in bladder cancer.

Nearly 430,000 new cases of urinary bladder cancer are diagnosed each year worldwide; it accounts for about 165,000 deaths worldwide annually. Advanced unresectable or metastatic UC remains a high unmet medical need as survival remains poor for most patients who experience disease progression or intolerance to treatment during or after platinum-containing chemotherapy. The approval of several checkpoint inhibitors for advanced unresectable or metastatic UC has improved response and survival rates for some patients, however, the majority of patients do not experience meaningful clinical responses to checkpoint inhibitor monotherapy.

Inovio’s INO-5401, an immunotherapy encoding multiple cancer antigens, is designed to generate and activate T-cells to many cancer types including bladder cancer. INO-9012, an immune activator encoding IL-12, is designed to amplify and accelerate T cell immune responses to INO-5401. Combining INO-5401/INO-9012 with atezolizumab may provide a synergistic therapeutic effect as a result of generating higher levels of activated T cells and simultaneously inhibiting PD-L1. Atezolizumab is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, atezolizumab may enable the activation of T cells.

Dr. Joaquim Bellmunt, MD, PhD, Dana-Farber/Brigham and Women’s Cancer Center Associate Professor, Harvard Medical School, said, "Urothelial carcinoma represents an area of high unmet need. Checkpoint inhibitors offer significant potential, however, only a proportion of patients respond to these therapies alone. Increasing evidence suggests that combinatorial approaches are needed and a combination of a checkpoint inhibitor with an immunotherapy that generates antigen-specific T cells may offer the potential for significantly increased benefit."

Dr. J. Joseph Kim, Inovio’s President and Chief Executive Officer, said, "We are excited to collaborate with Genentech, a leader in the development of transformative products to treat cancer. I am a strong believer in combination immuno-oncology regimens employing an immunotherapy to generate significant antigen-specific killer T cells then blocking T cell suppression via checkpoint inhibition. We believe INO-5401 has significant potential as a cancer immunotherapeutic in combination with a checkpoint inhibitor to address the high unmet medical need for advanced bladder cancer patients and to provide meaningful benefit for checkpoint inhibitor refractory patients."

About Metastatic Urothelial Carcinoma (UC)

The prognosis for patients with advanced unresectable or metastatic UC is poor, with limited treatment options. It is a disease that has seen no major advances for more than 30 years until the approvals of checkpoint inhibitors. Expected survival is generally less than 12 months; in the U.S., five-year survival of patients with distant metastasis is 5%. In the US, an estimated 79,000 new cases of urinary bladder cancer are expected in 2017.

About INO-5401

INO-5401 includes Inovio’s SynCon antigens for WT1, hTERT and PSMA and has the potential to be a powerful cancer immunotherapy in combination with checkpoint inhibitors. The National Cancer Institute previously highlighted WT1, hTERT and PSMA among a list of attractive cancer antigens, designating them as high priorities for cancer immunotherapy development and placing WT1 at the top of the antigen list. The hTERT antigen is expressed in 85% of cancers; the WT1 and PSMA antigens are also widely prevalent in many cancers. In addition, INO-5401 is being evaluated for the treatment of GBM in combination with a checkpoint inhibitor.

Immunocore Highlights IMCgp100 clinical data in Uveal Melanoma at ASCO 2017 Annual Meeting

On June 1, 2017 Immunocore Limited, the world’s leading TCR company developing biological drugs to treat cancer, infectious diseases and autoimmune diseases, reported that new clinical data from a second Phase I study of its lead programme, IMCgp100, will be presented in a poster session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago on 3 June 2017 (Press release, Immunocore, JUN 1, 2017, View Source [SID1234519332]).

The abstract will be presented by Dr Takami Sato, MD, PhD, Department of Medical Oncology, Kimmel Cancer Center, Thomas Jefferson University, in the poster session Melanoma/Skin Cancers on Saturday 3 June, 13:15-16:45. The title of the abstract (number 9531, found at Poster Board number 139) is: Intra-patient escalation dosing strategy with IMCgp100 results in mitigation of T-cell based toxicity and preliminary efficacy in advanced uveal melanoma.

Chris Coughlin, Chief Medical Officer of Immunocore commented: "We continue to be excited by the compelling clinical data we are observing with IMCgp100 in patients uveal melanoma and are advancing our lead programme into a pivotal study. There are no treatments that have shown any survival benefit in this disease so the unmet need is high."

Atreca, Inc., and Dana-Farber Cancer Institute Establish Broad Cancer Immunotherapy R&D Collaboration

On May 31, 2017 Atreca, Inc., a biotechnology company focused on developing novel therapeutics based on a deep understanding of the human immune response, and the Dana-Farber Cancer Institute reported that they have entered into a collaborative research agreement to focus Atreca’s IRC technology on the active immune responses of cancer patients whose disease is responding well to immunotherapy and other treatments (Press release, Atreca, MAY 31, 2017, View Source [SID1234522953]). The research will apply Atreca’s Immune Repertoire Capture (IRC) technology, which identifies and generates sequences of functional, native antibodies and T cell receptors (TCRs) from active human immune responses.

A team of scientists led by F. Stephen Hodi, M.D., Director of the Melanoma Center and Center for Immuno-Oncology at Dana-Farber Cancer Institute/Brigham and Women’s Cancer Center and Professor of Medicine at Harvard Medical School, will collaborate with Atreca to study how different immunotherapies generate an active immune response, to understand why only a subset of patients benefit from therapy, and to identify anti-tumor antibodies generated in these responses. The study will focus on patients with melanoma, non-small cell lung cancer (NSCLC), and renal cell cancer, with the potential to expand into other cancer types.

"We are excited to collaborate with the accomplished team at Atreca. Through this unique collaboration, we believe we can work together to accelerate the discovery and development of novel therapeutic agents and treatment paradigms with the potential to improve patient outcomes in diverse cancer indications," stated Dr. Hodi.

"It is a thrilling opportunity for us to partner with one of the world’s leading institutions advancing cancer treatment," said Tito A. Serafini, Ph.D., Atreca’s President, Chief Executive Officer, and Co-Founder. "Previous peer-reviewed findings have demonstrated that our IRC technology delivers valuable data from the active immune responses of patients. We believe the collaboration with Dana-Farber, focused on generating such actionable data, will make an important contribution to our immuno- oncology therapeutics programs."

Atreca applies IRC to generate sequences of native antibodies and TCRs from cancer patients, patients with autoimmune disease, vaccinated subjects, and patients who resolve infections. Analyses of the resulting essentially unbiased and error-free repertoires yield valuable insights, as well as potent antibodies targeting tumors, pathogens, and autoimmune epitopes.

GlycoMimetics Completes Enrollment of Relapsed/Refractory AML Patient Cohort in Phase 2 Portion of Clinical Trial of GMI-1271

On May 31, 2017 GlycoMimetics, Inc. (NASDAQ:GLYC) reported that the second of two patient cohorts in the Phase 2 portion of its ongoing Phase 1/2 clinical trial of GMI-1271 in patients with acute myeloid leukemia (AML) has completed enrollment (Press release, GlycoMimetics, MAY 31, 2017, View Source [SID1234519338]). This second cohort is comprised of 66 participants with relapsed/refractory AML. The study is designed to evaluate the potential of GMI-1271, an E-selectin antagonist drug candidate, in combination with chemotherapy, as a treatment for individuals with either newly diagnosed or relapsed/refractory AML. Enrollment in the study’s first arm in newly diagnosed elderly AML patients was completed in the first quarter of this year. GlycoMimetics expects to submit interim study data for presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2017.

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"Across the two cohorts of this Phase 1/2 clinical trial, we have a strong sample size of 91 patients and experienced brisk enrollment, which we feel is indicative of the strong interest that our clinical investigators have for this novel agent," said Helen Thackray, M.D., Chief Medical Officer of GlycoMimetics. "We are further encouraged by GMI-1271’s achievement of European Orphan Designation as well as the recent granting of Breakthrough Therapy designation by the U.S. Food & Drug Administration (FDA) for the treatment of adults with relapsed/refractory AML. We believe GMI-1271, when combined with chemotherapy, has the potential to address an unmet therapeutic need for individuals living with AML, and we are encouraged by both our clinical results to date and the acknowledgement of the U.S. and European regulatory agencies."

Interim clinical data from the ongoing trial of GMI-1271 will be presented at the 2017 meetings of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the European Hematology Association (EHA) (Free EHA Whitepaper). To date, GMI-1271 has been consistently well tolerated, with no obvious incremental toxicity when added to chemotherapy. In addition, patients with AML treated with GMI-1271 have experienced higher than expected remission rates and lower than expected 30- and 60-day mortality rates.

"The consistency of our data readouts is great news in and of itself, and the emerging biomarker data is especially encouraging," said Rachel King, CEO of GlycoMimetics. "AML has long been a difficult indication for the developers of new therapeutics, and we continue to feel more confident that our investigational drug, GMI-1271, may play a role in addressing key unmet needs in this deadly cancer."

In addition to the ongoing Phase 1/2 trial, clinical investigators are currently evaluating GMI-1271 in an ongoing Phase 1 clinical trial in multiple myeloma. Preclinical data supporting the multiple myeloma study was recently published in an online preview of the journal Leukemia on April 25, 2017. Specifically, the newly published preclinical results indicate that myeloma with higher levels of E-selectin ligands is a more aggressive disease that is more likely to be resistant to bortezomib, which is currently the front-line standard of care The publication reported that in preclinical studies, the combination treatment of GMI-1271 to bortezomib was able to break this chemoresistance and restore sensitivity to bortezomib which led to significant improvement in survival. This preclinical multiple myeloma conclusion supports the clinical findings on the potential biomarker that the Company is presenting at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) next month.

About AML

AML is a cancer of the blood and bone marrow. AML is the most common type of acute leukemia in adults. The National Cancer Institute estimates that there will be over 21,000 new cases of AML diagnosed in 2017 in the United States, and over 10,000 people will die from all forms of the disease in 2017. AML is more commonly present in elderly patients. Unlike other cancers that start in an organ and spread to the bone marrow, AML is known for rapid growth of abnormal white blood cells that gather in the bone marrow, getting in the way of normal blood cell production. The lack of normal blood cells can cause some of the symptoms of AML, including anemia (shortage of red blood cells resulting in tiredness and weakness), neutropenia (shortage of white blood cells that may lead to increased infections), and thrombocytopenia (shortage of platelets in the blood that may lead to excessive bleeding). Current treatment options for AML consist of reducing and eliminating cancer cells mainly through chemotherapy, radiation therapy, and stem cell transplantation.

2X ONCOLOGY TO PRESENT AT JEFFERIES GLOBAL HEALTHCARE CONFERENCE

On May 31, 2017 2X Oncology, Inc. ("2X" or the "Company"), a company focused on developing targeted therapeutics to address significant unmet needs in women’s cancer, reported that its chief executive officer, George O. Elston, will present at the Jefferies 2017 Global Healthcare Conference on Friday, June 9 at 10:00 am EDT (Press release, 2X Oncology, MAY 31, 2017, View Source [SID1234526105]).

The 2X presentation will be webcast live and archived for 90 days on the Company’s website under the ‘News’ tab.

Mr. Elston will be joined by other members of the executive team for a breakout session immediately after the presentation, and for one-on-one meetings throughout the conference. Please contact your Jefferies representative or Amy Raskopf to schedule a meeting with 2X.