On November 29, 2018 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, is reported the grant of patent number 2601961 entitled "Compositions comprising LAG-3 and therapeutic antibodies and their uses in treating cancer" by the European Patent Office (Press release, Immutep, NOV 29, 2018, View Source [SID1234531768]).

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This European patent was filed as a divisional application, and follows the grant of the parent application and another divisional application in Europe in 2013 and 2017, respectively.

The claims of this new patent are geared toward the use of Immutep’s lead product candidate eftilagimod alpha ("efti" or "IMP321") in combination with a therapeutic antibody, such as rituximab, cetuximab, or trastuzumab, that kills tumor cells through antibody dependent cell-mediated cytotoxicity (ADCC) for the treatment of cancer. According to the claims, efti elicits a monocyte-mediated immune response, therefore enhancing ADCC, and is administered before, with, or subsequent to administration of the therapeutic antibody.

The new patent points to the broad potential of efti as an immunostimulant and provides patent protection in Europe for an additional range of combination therapies.

The patent expiry date is 3 October 2028.

On November 29, 2018 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported the appointment of Michael Rosol, PhD as Chief Medical Officer of Navidea, effective December 17, 2018 (Press release, Navidea Biopharmaceuticals, NOV 29, 2018, View Source [SID1234531746]). Dr. Rosol brings to this position over 10 years of experience in biomedical imaging and commercialization.

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"We are pleased for Dr. Rosol to join Navidea and bring his deep insights into the needs of the industry for the development, validation and implementation of imaging biomarkers in clinical trials," said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "He brings a wealth of knowledge and extensive experience to Navidea as we move forward with advancing our novel pipeline of imaging products and bringing products to market."

"I am excited to join Navidea as Chief Medical Officer at a key stage in the advancement of Navidea’s business," commented Dr. Rosol. "I look forward to working with the leadership team to develop innovative immunodiagnostic agents and immunotherapeutics that can meaningfully improve the lives of patients living with devastating conditions."

Prior to joining Navidea, Dr. Rosol served as Associate Director in the Clinical and Translational Imaging Group at Novartis Institutes for BioMedical Research from November 2016 to December 2018. Before that, he held positions as Senior Director of Business Development at Elucid Bioimaging, Inc. where he drove adoption of its Computer-Aided Phenotyping applications from May 2016 to November 2016, and as Chief Scientific Officer of MediLumine, Inc. from October 2015 to May 2016. Prior to those roles, he was the Head of the Translational Imaging Group at Novartis Pharmaceuticals Group from October 2012 to March 2015. His training and experience lie in the fields of biophysics, physiology, and biological/medical imaging, and his work has focused on cardiovascular imaging, preclinical and clinical imaging instrumentation and applications, animal models of human disease, pathophysiology, biomarkers, and imaging in toxicological and clinical trials. He has also served as faculty in Radiology and Director of two academic research imaging facilities. Dr. Rosol holds a PhD from Boston University School of Medicine.

On November 29, 2018 Sierra Oncology, Inc. (Nasdaq: SRRA), a clinical stage drug development company focused on advancing targeted therapeutics for the treatment of patients with significant unmet needs in hematology and oncology, reported preclinical data for its novel oral Chk1 inhibitor, SRA737, in a poster presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Conference on Tumor Immunology and Immunotherapy in Miami Beach, Florida (Press release, Sierra Oncology, NOV 29, 2018, View Source [SID1234531745]).

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"In this study we found that the potent, selective oral Chk1 inhibitor, SRA737, activated the innate immune signaling STING pathway and demonstrated significant anti-tumor activity in an immunocompetent preclinical model of small cell lung cancer (SCLC)," said Dr. Lauren Byers, Associate Professor at the University of Texas MD Anderson Cancer Center, Houston, Texas. "Remarkably, the combination of SRA737 with an anti-PD-L1 immune checkpoint inhibitor induced tumor regression in this model, providing strong rationale for combining these agents to treat this immunotherapy refractory indication."

"SCLC remains a significant unmet need and one where immunotherapies have yielded limited efficacy. These tumors frequently harbor defects in cell cycle checkpoint and DNA damage repair (DDR) genes, with a coincident dependence on regulators of replication stress such as Checkpoint Kinase 1 (Chk1) as a compensatory mechanism," said Dr. Christian Hassig, Chief Scientific Officer, Sierra Oncology. "These encouraging preclinical results highlight an additional potential application for SRA737 that warrants further evaluation beyond our current clinical development programs for the drug as a monotherapy and in combination with replication stress-inducing low dose gemcitabine."

The poster will be presented on Thursday, November 29th from 5:00 to 7:00 pm (ET).

Title: The oral Chk1 inhibitor, SRA737, synergizes with immune checkpoint blockade in small cell lung cancer (SCLC).

Authors: Triparna Sen, Snezana Milutinovic, Robert J. Cardnell, Lixia Diao, Youhong Fan, Ryan J. Hansen, Bryan Strouse, Michael Hedrick, Christian Hassig, Jing Wang, Lauren A. Byers.

Location: Poster Session: B; Board Number: B15; Session Location: Americana 3 and 4

STING: Stimulator of Interferon Genes

About SRA737
SRA737 is a potent, highly selective, orally bioavailable small molecule inhibitor of Checkpoint kinase 1 (Chk1), a key regulator of cell cycle progression and the DNA Damage Response (DDR). In cancer cells, intrinsic replication stress is induced by factors such as oncogenes (e.g., CCNE1 or MYC), genetic mutations in DNA repair machinery (e.g., BRCA1 or FANCA), genetic mutations leading to a dysregulated cell cycle (e.g., TP53 or RAD50) or other genomic alterations. This replication stress results in persistent DNA damage and genomic instability leading to an increased dependency on Chk1 for survival. Targeted inhibition of Chk1 by SRA737 may therefore be synthetically lethal to cancer cells with elevated intrinsic replication stress and have utility as a monotherapy in a range of tumor indications. The combination of SRA737 with other modalities, such as other agents that target the DDR network and certain chemotherapeutics, may also provide synergistic anti-tumor activity via a variety of potential biological mechanisms. Importantly, the oral bioavailability of SRA737 may afford greater dosing flexibility for both monotherapy and combination therapy settings than is possible with intravenously administered agents.

SRA737 is currently being investigated in two Phase 1/2 clinical trials primarily focused on patients with ovarian cancer: SRA737-01, a monotherapy study, and SRA737-02, a drug combination study evaluating SRA737 potentiated by low dose gemcitabine. Sierra has also prepared for a potential clinical study of SRA737 in combination with a PARP inhibitor.

On November 29, 2018 Constellation Pharmaceuticals, Inc. (Nasdaq: CNST), a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported that Jigar Raythatha, CEO, will present at the BMO 2018 Prescriptions for Success Healthcare Conference at the Mandarin Oriental Hotel in New York at 10:40 AM on Wednesday, December 12 (Press release, Constellation Pharmaceuticals, NOV 29, 2018, View Source [SID1234531744]). A live audio webcast of the presentation and an archive for replay will be available on the Investor Relations section of Constellation’s website at View Source The audio webcast replay will be available for 90 days following the live presentation.

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On November 29, 2018 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported details of the Company’s next-generation chimeric antigen receptor T cell (CAR T) technologies and pipeline in conjunction with hosting a CAR T Breakfast Teach-In event in New York, NY (Press release, Atara Biotherapeutics, NOV 29, 2018, View Source [SID1234531739]).

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"Atara is building a leading next-generation and off-the-shelf, allogeneic CAR T pipeline," said Isaac Ciechanover M.D., Chief Executive Officer and President of Atara Biotherapeutics. "Although the current generation autologous CAR T immunotherapies have transformed outcomes for patients with B cell malignancies, we believe many opportunities exist to improve outcomes, expand to earlier lines of therapy and address areas of high unmet need, including acute myelogenous leukemia (AML) and solid tumors. We are collaborating with academic leaders to advance programs using technologies at the forefront of CAR T immunotherapy innovation."

The event featured next generation CAR T experts:

Michel Sadelain, M.D., Ph.D., Director, Center for Cell Engineering, and Head, Gene Expression and Gene Transfer Laboratory, Memorial Sloan Kettering Cancer Center (MSK)
Marco Davila, M.D., Ph.D., Associate Attending Physician, Department of Blood & Marrow Transplantation and Cellular Immunotherapy Medical Director, Cell Therapy Facility, Moffitt Cancer Center
Dr. Sadelain described CAR T technologies including novel co-stimulatory domains modified to generate more physiologic signaling, reduce exhaustion, improve persistence and unlock the solid tumor microenvironment. Atara and MSK are collaborating to develop next-generation CAR T immunotherapies using several of these innovative CAR T technologies.

Dr. Davila’s presentation focused on developing promising CAR T immunotherapies for patients with AML and B cell malignancies in collaboration with Atara using modified co-stimulatory subdomains designed to improve persistence and reduce T cell exhaustion.

Dietmar Berger, M.D., Ph.D., Global Head of Research & Development of Atara Biotherapeutics introduced the Company’s strategy to leverage these innovative licensed technologies with Atara’s EBV-specific T cell expertise to advance next-generation, off-the-shelf CAR T programs.

Dr. Berger presented results for an EBV.CD19.28z CAR T that demonstrated high CAR transduction, increased frequency of central memory T cell phenotype, specific and selective CD19 activity, low levels of off-target alloreactivity and strong antigen-specific proliferation and persistence. These findings establish feasibility for engineering EBV-specific T cells by leveraging next-generation CAR technologies, and support further development as an off-the-shelf, allogeneic, CAR T platform to generate IND clinical candidates. He concluded by describing Atara’s CAR T preclinical pipeline, including four oncology programs progressing toward IND.

A webcast replay of the Atara CAR T Breakfast Teach-In can be accessed on the Investors and Media section of Atarabio.com for 30 days following today’s live event.