On November 4, 2015 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported its revenues and cash position for the first nine months of 2015 (Press release, Innate Pharma, NOV 4, 2015, View Source [SID:1234507967]). Cash, cash equivalents and financial instruments of the Company amounted to €269.6 million at September 30, 2015. At the same date, its financial liabilities amounted to €3.9 million (lease-financing of its premises).

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Revenues for the first nine months of 2015 amounted to €13.1 million (€1.0 million for the same period in 2014).

This revenue results from Innate Pharma’s collaboration and licensing agreement with Bristol-Myers Squibb and co-development and commercialization agreement with AstraZeneca:

€5.5 million from the agreement with Bristol-Myers Squibb including a €4.4 million milestone payment as well as €0.7 million from the recognition over the period of the upfront payment received in July 2011;
€7.6 million resulting from the agreement with AstraZeneca, corresponding to the recognition over the period of the initial payment received in April 2015.

Revenue for the first nine months of 2014 mainly resulted from the recognition over the period of the upfront payment received in 2011 from Bristol-Myers Squibb (€0.6 million).

Business update:

During the period, clinical and research discovery activities moved forward as anticipated. Regarding Innate’s three most advanced programs:

Lirilumab: a first patient was dosed in the Phase II trial of lirilumab in combination with rituximab in patients with relapsed/refractory or high-risk untreated Chronic Lymphocytic Leukemia, triggering a milestone payment from Bristol-Myers Squibb;

IPH2201: a first patient was treated in the Phase I/II trial in ovarian cancer and the Phase I/II trial in combination with ibrutinib in patients with relapsed or refractory chronic lymphocytic leukemia started;

IPH4102: the rationale of the program and the Phase I design were presented at the cutaneous lymphoma task force meeting of the EORTC as well as during a KOL event organized in New-York. The enrolment of the first patient is expected in the coming weeks.

(Filing, 10-Q, Regeneron, NOV 4, 2015, View Source [SID:1234507952])

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On November 4, 2015 ChemoCentryx, Inc., (Nasdaq:CCXI), a clinical-stage biopharmaceutical company focused on autoimmune diseases, inflammatory disorders and cancer, reported that two abstracts from the Company’s immuno-oncology programs have been selected for presentation at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) being held November 5-9, 2015 in Boston, Massachusetts (Press release, ChemoCentryx, NOV 4, 2015, View Source [SID:1234507942]). The abstracts highlight clinical stage results in a pancreatic cancer trial with CCX872, the Company’s second inhibitor of the chemokine receptor known as CCR2, and, separately, preclinical results in a model of triple negative breast cancer using combination therapy employing an antibody against the checkpoint inhibitor PD-L1 in conjunction with CCX9588, an inhibitor of the chemokine receptor known as CCR1.

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"Tumors have devised ways to suppress anti-tumor immune responses in part by importing immune suppressor cells into the tumor microenvironment. One goal of our chemoattractant based immuno-oncology program is to develop treatments that specifically reduce the content of immune suppressive elements in the tumor mass, thus enabling the body’s effector immune response to predominate," said Thomas J. Schall, Ph.D., President and Chief Executive Officer. "Towards this end, in our pancreatic cancer trial we are encouraged by observations to date of excellent coverage of the receptor CCR2, which guides suppressor cells to the tumor, by our drug CCX872, and we except to see greater than 90 percent receptor coverage continuously in the ongoing multi-dose portion of the study. Patient recruitment in the trial is ramping up, having reached 20 percent of the target enrollment, and we look forward to efficacy data from this trial in 2016. Also, our preclinical model work using a combination of checkpoint inhibitor antibody therapy in combination with an orally administered chemokine receptor inhibitor may pave the way for new treatment options in such important areas as triple negative breast cancer."

Part A Results of Pancreatic Cancer Clinical Trial for CCX872

Pharmacokinetic and pharmacodynamic profile of the novel, oral and selective CCR2 inhibitor CCX872-B in a Phase Ib pancreatic cancer trial, Hezel et al, (Abstract #B24, poster presentation November 7 from 12:30-3:30 p.m. ET, Session B, Hall C-D)

In the ongoing clinical trial in patients with pancreatic cancer with the Company’s CCR2 inhibitor, CCX872, all patients are receiving FOLFIRINOX and CCX872. The two-part trial includes Part A, in which patients receive a single dose of CCX872, and Part B, in which patients receive once or twice daily doses of CCX872 initially for 12 weeks with the ability to continue treatment unless disease progression or unacceptable intolerability occurs. In the trial, the Company plans to evaluate CCX872 in up to 54 patients. The primary efficacy measurement is progression-free survival when patients have completed at least 24 weeks of treatment.

From the abstract, after a single dose of CCX872, across four patients in Part A, the pharmacokinetic profile was favorable and pharmacodynamic assays demonstrated excellent receptor coverage after 12 hours. With 4 to 5-fold accumulation of plasma concentrations with twice daily dosing in Part B, the authors expect to see greater than 90 percent coverage of the receptor throughout the day.

Preclinical Data of Combination Therapy of Chemokine Receptor and Checkpoint Inhibitors

Combination therapy of chemokine receptor inhibition plus PD-L1 blockade potentiates anti-tumor effects in a murine model of breast cancer, Jung et al, (Abstract #A90, poster presentation November 6 from 12:15-3:15 p.m. ET, Session A, Hall C-D)

The Company’s immuno-oncology program is pursuing a better understanding of the body’s immune response to tumors and is therefore conducting studies with various chemokine receptor inhibitors in combination with checkpoint inhibitors that may result in beneficial anti-tumor effects. Results from a study of one of the Company’s inhibitors of the chemokine receptor known as CCR1, CCX9588, demonstrated the ability to act synergistically with a PD-L1 inhibitor to reduce tumor burden in a preclinical model of triple negative breast cancer.

From the abstract, CCX9588, when delivered in combination with an anti-PDL1 antibody, resulted in significantly reduced primary tumor growth and lung metastasis, as compared to either agent alone. In addition, an analysis of tumor-infiltrating cells revealed that the addition of CCX9588 to the anti-PD-L1 antibody significantly reduced the number of myeloid derived suppressor cells (MDSCs) in primary tumors, potentially contributing to the overall reduction of tumor burden. These preclinical results were also accepted for presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting being held from November 4-8, in National Harbor, MD.

"One of the most exciting advances in oncology in decades is the recent observation that modifiers of the activity of the body’s own immune system can profoundly enhance the response to chemotherapy," said Israel F. Charo, M.D., Ph.D., Senior Vice President, Research, ChemoCentryx. "We believe that chemokine receptor inhibitors such as CCX9588, combined with immunotherapy or traditional chemotherapy, may result in greater efficacy and fewer systemic side effects."

About the ChemoCentryx Immuno-Oncology Program

CCR1- and CCR2-bearing cells, such as myeloid derived suppressor cells (MDSCs), are thought to possess an immunosuppressive behavior. MDSCs effectively help tumors hide from the body’s natural cytotoxic immune response to tumor cells. Inhibiting CCR1 and CCR2, may lead to the liberation of the cytotoxic immune response against tumor cells, reduced tumor burden and potentially lead to improved patient survival.

The Company currently has an ongoing clinical trial of CCX872, an inhibitor of the chemokine receptor known as CCR2, in patients with non-resectable pancreatic cancer. In addition, the Company is conducting preclinical research with various chemokine receptor inhibitors in combination with checkpoint inhibitors, such as those inhibiting the PD-L1 pathway, which may result in a greater anti-tumor effect than with checkpoint inhibition alone. CCX9588 is a small molecule inhibitor of CCR1 and is currently in preclinical development for certain oncology indications targeting both solid and liquid tumors.

(Filing, 10-Q, TetraLogic Pharmaceuticals, NOV 4, 2015, View Source [SID:1234507958])

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On November 4, 2015 Epizyme, Inc. (NASDAQ: EPZM), a clinical stage biopharmaceutical company creating novel epigenetic therapies for cancer patients, reported that it will present data from 11 accepted abstracts on the role of histone methyltransferase (HMT) inhibition in human cancers at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) taking place in Boston, Mass., November 5 – 9, 2015 (Press release, Epizyme, NOV 4, 2015, View Source [SID:1234507944]). Among the presentations are important new data on the critical role played by EZH2 in Non-Hodgkin Lymphoma (NHL). Epizyme’s lead compound, tazemetostat, is a first-in-class EZH2 inhibitor currently being studied in relapsed or refractory B-cell NHL and advanced solid tumors.

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"Epizyme is leading the field of epigenetic drug discovery with our focused approach to development of small molecule therapeutics against HMTs and other chromatin modifiers," said Robert A. Copeland, Ph.D., President of Research and Chief Scientific Officer. "Our presentations at the AACR (Free AACR Whitepaper)-NCI-EORTC meeting demonstrate the breadth of our drug discovery efforts and preclinical target identification in this space and our continued commitment to understanding the role of EZH2 and EZH2 inhibition across a spectrum of cancer indications."

Presentations on the role of EZH2 include:

EZH2 Plays a Critical Role in B-cell Maturation and in Non-Hodgkin Lymphoma: Interplay between EZH2 Function and B-cell Activation
Abstract number: B85
Speaker: Danielle Johnston, Epizyme, Inc.
Session title: Poster Session B, Epigenetic Targets
Presentation time: Saturday, November 7, 12:30 – 3:30

Advanced Image Analysis of H3K27 Trimethylation in Skin from Subjects Dosed with the EZH2 Inhibitor Tazemetostat
Abstract number: B6
Speaker: Alice McDonald, Epizyme, Inc.
Session title: Poster Session B, Biomarkers
Presentation time: Saturday, November 7, 12:30 – 3:30

EZH2 Inhibition Leads to Decreased Proliferation in SMARCA4-deleted Ovarian Cancer Cell Lines
Abstract number: C87
Speaker: Elayne Penebre, Epizyme, Inc.
Session title: Poster Session C, Epigenetic Targets
Presentation time: Sunday, November 8, 12:30 – 3:30

Initial Testing (Stage 1) of EPZ-6438 (tazemetostat), a Novel EZH2 Inhibitor, by the Pediatric Preclinical Testing Program (PPTP)
Abstract number: A137
Speaker: Raushan Kurmasheva, Greehey Children’s Cancer Research Institute
Session title: Poster Session A, Pediatric Early Drug Development
Presentation time: Friday, November 6, 12:15 – 3:15

Physiologically-based pharmacokinetic modeling to support clinical investigation of the EZH2 inhibitor, tazemetostat (EPZ-6438) in INI1-deficient pediatric tumors
Abstract number: A135
Speaker: Nigel Waters, Epizyme, Inc.
Session title: Poster Session A, Pediatric Early Drug Development
Presentation time: Friday, November 6, 12:15 – 3:15

Chromatin Flow Cytometry Based Quantification of Cell Type Specific Alterations in Histone Methylation States Resulting from in vitro and in vivo EZH2 Inhibitor Treatment
Abstract number: B133
Speaker: Christopher Plescia, Epizyme, Inc.
Session title: Poster Session B, Novel Assay Technology
Presentation time: Saturday, November 7, 12:30 – 3:30

In addition to these presentations on the role of EZH2, Epizyme will present additional data on the company’s ongoing work to elucidate the potential of HMT inhibitors as treatments for human cancers. These additional presentations include:

CRISPR Pooled Screening Identifies Differential Dependencies on Epigenetic Pathways
Abstract number: B78
Speaker: Alexandra R. Grassian, Epizyme, Inc.
Session title: Poster Session B, Epigenetic Targets
Presentation time: Saturday, November 7, 12:30 – 3:30

Pinometostat (EPZ-5676) Enhances the Anti-proliferative Activity of MAP Kinase Pathway Inhibitors in MLL-r Leukemia Cell Lines
Abstract number: B82
Speaker: Alejandra Raimondi, Epizyme, Inc.
Session title: Poster Session B, Epigenetic Targets
Presentation time: Saturday, November 7, 12:30 – 3:30

Identification of a Novel Potent Selective SMYD3 Inhibitor with Oral Bioavailability
Abstract number: C85
Speaker: Lorna Mitchell, Epizyme, Inc.
Session title: Poster Session C, Epigenetic Targets
Presentation time: Sunday, November 8, 12:30 – 3:30

Identification of Biomarkers and Pathways Associated with Response to the DOT1L Inhibitor Pinometostat (EPZ-5676) in MLL-r Leukemia
Abstract number: C12
Speaker: Scott Daigle, Epizyme, Inc.
Session title: Poster Session C, Biomarkers
Presentation time: Sunday, November 8, 12:30 – 3:30

A Medium-Throughput Single Cell CRISPR CAS9 Assay to Assess Gene Essentiality
Abstract number: C162
Speaker: Alexandra Grassian, Epizyme, Inc.
Session title: Poster Session C, Target Identification and Validation
Presentation time: Sunday, November 8, 12:30 – 3:30

About EZH2 in Cancer

EZH2 is a histone methyltransferase (HMT) that is increasingly understood to play a potentially oncogenic role in a number of cancers. These include Non-Hodgkin Lymphoma, INI1-deficient cancers such as malignant rhabdoid tumors, epithelioid sarcomas and synovial sarcoma, and a range of other solid tumors.

About Tazemetostat

Epizyme is developing tazemetostat for the treatment of patients with Non-Hodgkin Lymphoma and for patients with INI1-deficient solid tumors. Tazemetostat is a first-in-class small molecule inhibitor of EZH2 created by Epizyme using its proprietary product platform. In some human cancers, aberrant EZH2 enzyme activity results in misregulation of genes that control cell proliferation resulting in the rapid and unconstrained growth of tumor cells. Tazemetostat is the WHO International Non-Proprietary Name (INN) for compound EPZ-6438.

Additional information about this program, including clinical trial information, may be found here: View Source