On November 29, 2018 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it has entered into an agreement with PharmaEssentia Corporation (Taipei Exchange:6446) to license the rights to develop and commercialize Athenex’s Oradoxel in Taiwan, Singapore and Vietnam (Press release, Athenex, NOV 29, 2018, View Source [SID1234531900]). The existing licensing agreement for Oraxol (oral paclitaxel) and Oratecan (oral irinotecan) with PharmaEssentia is being expanded to account for additional considerations, including milestone payments, for Oradoxel (oral docetaxel). In December 2013, Athenex and PharmaEssentia entered into a license agreement, pursuant to which PharmaEssentia was granted a license to develop and commercialize Oraxol and Oratecan in Taiwan and Singapore. The agreement was amended in December 2016 to also include Vietnam in the territories covered by the license.

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Under the terms of the expanded agreement, which includes Oradoxel, Athenex will receive a cash payment as well as the potential to receive additional milestone payments for certain development and regulatory milestones of Oradoxel in the territories. PharmaEssentia will be responsible for all activities and expenses relating to clinical development, regulatory approval, and commercialization of Oradoxel in the territories.

Docetaxel is an anti-cancer chemotherapeutic agent that is used widely in the treatment of breast, prostate, gastric, head and neck, and lung cancers. Oradoxel is an oral formulation of Docetaxel combined with HM30181A, a novel gastrointestinal tract specific P-glycoprotein pump inhibitor. Oradoxel is currently in Phase I clinical studies in the U.S. and New Zealand, and is ready to advance to Phase II with studies expected to begin in the first half of 2019.

Dr. Kochung Lin, Chief Executive Officer of PharmaEssentia, commented, "We are excited with the encouraging results so far from clinical trials of Athenex’s Orascovery drug candidates, particularly Oraxol. The potential of oral chemotherapy drugs to improve efficacy and safety, and improve patients’ quality of life, cannot be overstated. Athenex has generated promising Phase I data with both Oratecan and Oradoxel, and we are pleased to participate in the development of these exciting products in Taiwan, Singapore and Vietnam to help realize the full potential of this platform. We have been impressed by the Athenex team in their execution and are delighted to continue and expand our excellent partnership with the addition of Oradoxel."

Dr. Johnson Lau, Chief Executive Officer and Chairman of Athenex, stated, "This agreement builds on our longstanding relationship with PharmaEssentia. PharmaEssentia has demonstrated strong commitment to cancer drug research and development, and we are confident they have the capabilities for successfully delivering Oradoxel to patients in the licensed territories."

The Orascovery platform was initially developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi.

On November 29, 2018 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that Dr. Rita Laeufle, M.D., Ph.D., who has been working as a consultant for Oncolytics for the last four months, has been appointed as Chief Medical Officer (Press release, Oncolytics Biotech, NOV 29, 2018, View Source [SID1234531769]). Dr. Laeufle will oversee the clinical development plan for pelareorep as the company drives towards a registration study in breast cancer.

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"Dr. Laeufle brings a tremendous track record in clinical advancement to Oncolytics, including approval in the treatment of metastatic breast cancer," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech. "Her experience in establishing the processes, teams and external support needed to gain approval will be invaluable as we prepare for our phase three registration study in metastatic breast cancer. With Dr. Laeufle’s additional background in gastrointestinal cancer and under her guidance, our objective is to establish a second registration pathway in this area, such as colorectal cancer, anal cancer or pancreatic cancer."

Dr. Laeufle brings more than 15 years of experience in drug development in oncology, most recently serving as Vice President of Clinical Development & Medical Affairs at SFJ Pharmaceuticals where she developed a clinical program for a new drug substance class in colon cancer. Previously, Dr. Laeufle was Senior Vice President, Clinical Development of Oncology at Coherus Biosciences where she developed a biosimilar strategy for Avastin, prior to which she was Senior Medical Director, Global Medical Affairs at Clovis Oncology, where she led the Medical Affairs strategy for their PARP inhibitor, Rucaparib. Dr. Laeufle also served as Senior Medical Director, U.S. Medical Affairs, gastrointestinal (GI) cancers at Genentech where she led GI disease across molecules and indications, and as Senior PD Medical Director and Clinical Science Leader in Oncology at Roche, working with Avastin for the treatment of breast cancer where she successfully maintained approval for Avastin in first-line metastatic breast cancer in combination with paclitaxel in Europe and ROW (rest of world). She was Senior Medical Scientific Expert of Immunology and Infectious Diseases and Senior Pharmacovigilance Leader, Oncology at Novartis and began her pharmaceutical career as PD Medical Director and Medical Monitor (International Study Manager), Altana Pharma.

"Having had the chance to work with the Oncolytics team since July and evaluate the oncolytic virus space from an internal perspective, I couldn’t be more excited to join Oncolytics and look forward to being a part of the exciting and rapidly advancing oncolytic virus therapeutic arena," said Dr. Laeufle. "Pelareorep’s potential includes a very favorable safety profile and statistically significant efficacy data in metastatic breast cancer, as well as supporting data that it is a synergistic treatment option in other cancers, particularly in gastrointestinal cancer in combination with immunotherapy. I strongly believe that pelareorep has the potential to change the treatment landscape of a wide number of indications based on its synergy with a number of immunotherapy agents and targeted treatments in oncology."

Dr. Laeufle, a surgical oncologist, completed her general surgery residency at Buckland Hospital in Dover, England, Basel Switzerland, and Ueberlingen, Germany, and was trained as a surgical oncologist at Staedtisches Krankenhaus, Singen Germany, where she focused on gastroenterological, thyroid and breast cancer. Dr. Laeufle completed medical school at Medical School Albert Ludwig University Freiburg i.Br. Germany, where she received her Ph.D. in exploring Her2 oncogenes in brain cancer. Dr. Laeufle’s work has been published in The Lancet Oncology, the European Journal of Cancer, the Journal of Hepatology and Human Pathology and she has had multiple posters presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)

(ASCO), the World Congress on Gastrointestinal Cancer (WCGC) and the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper).

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

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.