On November 29, 2018 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical stage targeted oncology company, reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new drug (IND) application for MRTX849, a small molecule inhibitor of KRAS G12C. Mirati is developing MRTX849 for the treatment of cancers driven by KRAS G12C mutations (Press release, Mirati, NOV 29, 2018, View Source [SID1234531731]).

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"KRAS mutations, like the G12C mutation, are recognized as drivers of multiple tumor types, including non-small cell lung cancer and colorectal cancers. Efforts over the last 25 years to develop drugs to inhibit mutant KRAS have been largely unsuccessful," said James Christensen, Ph.D., Chief Scientific Officer, Mirati Therapeutics. "MRTX849 represents the culmination of significant scientific effort by our research team to design a potent and highly selective inhibitor of KRAS G12C. We believe that this scientific breakthrough has the potential to result in meaningful and lasting clinical benefit for patients with G12C mutation-positive cancers. We look forward to working with patients and physicians to evaluate the potential of MRTX849."

FDA clearance of the IND enables Mirati to initiate its planned Phase 1/2 clinical trial in patients with advanced solid tumors that harbor KRAS G12C mutations. The Phase 1 dose escalation phase of the trial will assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of MRTX849 in patients with molecularly-identified KRAS G12C-positive cancers. A dose expansion phase is planned to follow the selection of a recommended Phase 2 dose. Mirati expects the first patient to be enrolled in the trial by January 2019.

About MRTX849
MRTX849 is an orally-available small molecule that potently and selectively inhibits a form of KRAS which harbors a substitution mutation (G12C). KRAS G12C mutations are present in approximately 14% of NSCLC adenocarcinoma patients and 5% of colorectal cancer patients. Tumors characterized by KRAS G12C mutations are commonly associated with poor prognosis and resistance to therapy, and patients with these mutations have few treatment options. MTRX849 has demonstrated broad-spectrum tumor regression in a large cohort of KRAS G12C-positive pre-clinical in-vivo human tumor models. MRTX849 demonstrated complete regression of tumors in a subset of models at well-tolerated dose levels. Early proof-of-concept clinical data is anticipated in 2019.

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 OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a company developing intratumoral cancer immunotherapies, reported the presentation of new data from the company’s Phase 2 study of TAVO (tavokinogene telseplasmid) for the treatment of metastatic melanoma (Press release, OncoSec Medical, NOV 29, 2018, View Source [SID1234531716]). The newly presented data reports abscopal responses with TAVO monotherapy, finding that treatment with TAVO monotherapy resulted in 47 percent of patients experiencing tumor regression in at least one untreated lesion. These data were selected for an oral presentation at Melanoma Bridge 2018, taking place November 30 to December 1, Naples, Italy.

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"These findings are significant because they clearly demonstrate that intratumoral treatment with TAVO is having a systemic effect that goes beyond the treated tumor, and to see that effect in nearly half of treated patients is remarkable, particularly with such a well-tolerated therapy," said Alain Algazi, M.D., Lead Trial Investigator, Associate Professor, Department of Medicine (Hematology/Oncology), at the University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center and Strategic Clinical Advisor to OncoSec. "These findings build upon our previous report from this study showing an approximate 30 percent overall response rate with monotherapy TAVO and further support the potential value of TAVO therapy for this patient population."

OMS-100 is a Phase 2 study of monotherapy TAVO for the treatment of patients with metastatic melanoma. In all, 51 subjects were enrolled in three treatment arms. Reponses data from the study were previously reported, with approximately 30 percent of subjects achieving a best overall response based on RECIST criteria. In addition, 47 percent of patients had stable disease, resulting in a DCR (Disease Control Rate) of 77 percent. Among patients who responded to monotherapy, investigators noted upregulation of innate immune mediators in the periphery of responding patients after treatment. TAVO was well tolerated, with predominantly grade 1 procedural related adverse events.

Slides from the Melanoma Bridge will be available following the conference on www.oncosec.com

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 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.