On September 4, 2018 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), reported that MediciNova will attend the Morgan Stanley Global Healthcare Conference which will be held at the Grand Hyatt New York in New York City from September 12 – 14, 2018 (Press release, MediciNova, SEPT 4, 2018, View Source;p=irol-newsArticle&ID=2366038 [SID1234529265]). Yuichi Iwaki, MD, PhD, President and Chief Executive Officer, and Geoffrey O’Brien, JD/MBA, Vice President and Executive Officer, will be available for one-on-one meetings at this conference and investors may request a one-on-one meeting through Morgan Stanley

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On September 4, 2018 Advaxis, Inc. (NASDAQ: ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, and OS Therapies LLC, a clinical-stage therapeutic company focused on the identification, development and commercialization of treatments for osteosarcoma, reported that Advaxis has granted a license to OS Therapies for the use of ADXS31-164, also known as ADXS-HER2, for evaluation in the treatment of osteosarcoma in humans (Press release, Advaxis, SEP 4, 2018, View Source [SID1234529250]).

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Osteosarcoma is an aggressive cancerous tumor that forms in bone. Although it is rare, osteosarcoma is the most common type of bone cancer, and is most frequently found in children and young adults. Current treatment options are limited and there have been no new treatment options in more than thirty years.

Under the terms of the license agreement, OS Therapies, in collaboration with the Children’s Oncology Group (COG)1, will be responsible for the conduct and funding of a clinical study evaluating ADXS-HER2 in recurrent, completely resected osteosarcoma. Advaxis will receive an upfront payment, reimbursement for product supply and other support, clinical, regulatory, and sales-based milestone payments, and royalties on future product sales. Additional details of the financial terms have not been disclosed.

"Advaxis is pleased to license ADXS-HER2 to OS Therapies for human clinical trials in osteosarcoma. ADXS-HER2, which is already approved in the U.S. for the adjuvant treatment of osteosarcoma in canines, has the potential to provide a new treatment option for human osteosarcoma patients," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "As Advaxis is primarily focused on developing neoantigen-directed therapeutics, this license agreement will allow for the clinical potential of ADXS-HER2 to be explored in osteosarcoma without financial support from Advaxis, building on earlier work performed by us with ADXS-HER2 in a Phase 1 clinical trial."

"The OS Therapies mission is to develop and commercialize new therapeutics for the treatment of osteosarcoma, a deadly and extremely underserved pediatric cancer. We are excited about the opportunity to evaluate ADXS-HER2 in this indication, as its clinical profile has shown promise to date," said Paul Romness, Chief Executive Officer of OS Therapies. "Our initial focus is on the most common genetic mutation found in osteosarcoma, and we believe that HER2, and more specifically ADXS-HER2, holds potential to impact the treatment paradigm."

1 The Children’s Oncology Group (www.childrensoncologygroup.org), a member of the NCI National Clinical Trials Network (NCTN), is the world’s largest organization devoted exclusively to childhood and adolescent cancer research with over 10,000 experts worldwide working in over 200 COG member institutions. COG’s mission is to improve the cure rate and outcome for all children with cancer.

On September 4, 2018 Turnstone Biologics, a clinical-stage immuno-oncology company developing the next generation of oncolytic viral therapies, and the La Jolla Institute for Allergy and Immunology reported that they have entered into a collaboration and licensing agreement whereby Turnstone will utilize La Jolla Institute’s proprietary neoantigen identification methodology to select personalized neoantigens to target with its proprietary viral technologies for the development of new cancer immunotherapies (Press release, Turnstone Biologics, SEPT 4, 2018, View Source [SID1234529266]).

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Under the terms of the agreement, Turnstone will license the neoantigen identification methods developed by La Jolla Institute professors Dr. Stephen Schoenberger, Division of Developmental Immunology, and Dr. Bjoern Peters, Division of Vaccine Discovery, for use in cancer immunotherapies. Turnstone will fund collaborative research to further develop antigen identification methods for use in a Phase I/II clinical trial using its proprietary MG1 viral platform, expected to commence in 2019. Turnstone will also make development and regulatory milestone payments for therapies that utilize La Jolla Institute’s technology.

"Neoantigen-based treatments have the potential to transform cancer patient care by targeting specific genetic mutations in cancer malignancies," said Dr. Mike Burgess, MBChB, Ph.D., President of Research and Development of Turnstone. "Neoantigens identified using the highly-predictive functional-based approach developed at La Jolla Institute will be incorporated into our MG1 viral platform to form powerful immunotherapies. We are excited to be collaborating with the La Jolla Institute with the goal of developing best-in-class personalized cancer medicines."

"The field of neoantigens has evolved tremendously, and we are diligently working to more accurately predict patient-specific cancer mutations that can be targeted to drive more effective cancer treatments," says Dr. Stephen Schoenberger. "Turnstone has exciting proprietory technologies for eliciting strong anti-tumor immune responses and we are looking forward to capitalizing on their novel approach to bring personalized neoantigen therapies to patients."

On September 4, 2018 Tempest Therapeutics Inc., a development-stage biotechnology company advancing small molecules that modulate anti-tumor immunity pathways, reported that Ginna Laport, M.D., joined the company as Chief Medical Officer (Press release, Tempest Therapeutics, SEPT 4, 2018, View Source [SID1234529267]). Dr. Laport brings significant expertise in hematology, oncology and clinical drug development, and will lead the evaluation and clinical development of Tempest’s portfolio of novel first-in-class drug candidates in patients with advanced malignancies.

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"We are very excited to welcome Ginna to the Tempest team. She has an impressive academic and biotech pedigree together with a track record of advancing multiple modalities of cancer therapeutics. Ginna will be integral in the transition of Tempest into a clinical-stage biotechnology company in 2019," said CEO Tom Dubensky, Ph.D.

Prior to joining Tempest, Dr. Laport served as vice president of clinical development at Corvus Pharmaceuticals, where she led the clinical development of small molecules and antibodies targeting the adenosine pathway to treat advanced solid tumors. Additionally, Dr. Laport was a member of the Executive Committee and oversaw clinical development and operations.

Before Corvus, Dr. Laport was faculty in the Stanford University School of Medicine, most recently as professor of medicine in the Division of Blood and Marrow Transplantation (BMT). Her research focused on adoptive immunotherapies for malignant diseases and she served as director of clinical research in the BMT Division and as an associate director of the Stanford Cancer Institute. Prior to Stanford, Dr. Laport was an assistant professor in hematology/oncology at the University of Pennsylvania. Dr. Laport served on the FDA’s Oncologic Drugs Advisory Committee (ODAC), was national chair of the NIH-sponsored BMT Clinical Trials Network that directs multicenter clinical trials, and has co-authored over 80 publications.

Dr. Laport received her M.D. from the University of Texas-Houston and a B.A. from Baylor University. She completed her internal medicine residency and fellowship in hematology/oncology at The University of Chicago.

In addition, Tempest has promoted Dr. Alicia Levey to Chief Business Officer. Dr. Levey previously was Tempest’s VP of business development and strategy. Prior to Tempest, she was VP of business development at Inception Sciences, a small molecule drug discovery company formed in collaboration with Versant Ventures, a global venture capital firm focused primarily on early stage investing and biotechnology company creation.

Dr. Levey is an operating principal at Versant where she has led the diligence on multiple deals including several that have been acquired or are now public. She holds a Ph.D. from the Stanford University School of Medicine.

"We are delighted to have Alicia in the CBO role," said Dr. Dubensky. "She has been a critical component in establishing Tempest and has a deep track record of successful business development."

On September 4, 2018 IntegraGen (FR0010908723: ALINT – PEA-SME Eligible), a company specializing in the transformation of data from biological samples into genomic information and diagnostic tools for oncology, reported the publication of the results of a definitive study reporting on the analysis of the expression of miR-31-3p in tumors from 370 RAS wild-type (WT) metastatic colorectal cancer (mCRC) patients enrolled in the FIRE-3 clinical trial (AIO KRK-0306) (Press release, Integragen, SEP 4, 2018, View Source [SID1234529334]). The paper, entitled "Validation of miR-31-3p Expression Level to Predict Cetuximab Efficacy When Used as First-Line Treatment in RAS Wild-Type Metastatic Colorectal Cancer" was published online in Clinical Cancer Research, a leading oncology journal which focuses on innovative clinical and translational cancer research studies that bridge the laboratory and the clinic.

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The study found that a low expression of the miR-31-3p biomarker predicts both improved survival and treatment response in patients receiving anti-EGFR therapy. In addition to confirming miR-31-3p is predictive of outcomes for RAS WT mCRC patients treated with anti-EGFR therapy, the study also found that patients with a miR-31-3p expression below a pre-defined threshold have a one year longer median overall survival, a 40% reduction in mortality risk, and a better treatment response when they are treated with FOLFIRI plus cetuximab compared to FOLFIRI plus bevacizumab. Conversely, no difference in outcomes was seen between the two treatment groups in patients with miR-31-3p expression above the pre-defined threshold. These results support the use of miR-31-3p expression testing in primary tumors from RAS WT mCRC patients to assist clinicians to identify the most appropriate first line biologic therapy may be most beneficial.

"The results of our study demonstrate the ability for miR-31-3p to predict which patients with RAS wild-type metastatic colorectal cancer will have improved outcomes when treated in first line with cetuximab compared to bevacizumab when combined with FOLFIRI therapy," explained Prof. Dr. Sebastian Stintzing, an oncologist from University Hospital, LMU Munich in Munich, Germany and lead author on the paper. "These findings are particularly significant since nearly two-thirds of the patients with RAS wild-type tumors in our study had low miR-31-3p expression levels and would therefore benefit from being treated with cetuximab versus bevacizumab as first line therapy for mCRC."

"The results from this study confirm the ability of the miR-31-3p biomarker to predict anti-EGFR therapy response, and in turn, demonstrates the clinical utility of this biomarker for patients with metastatic colorectal cancer," stated Dr. Bernard Courtieu, IntegraGen’s CEO. "This data demonstrates that the use of miR-31-3p expression testing can guide the choice of first line biologic therapy in RAS wild-type patients and enable oncologists to better select a personalized therapeutic approach, resulting in an improved opportunity for positive patient outcomes and decreased cost of care."

IntegraGen will presenting new data reporting positive results from an analysis of miR-31-3p expression in over 1,400 resected stage III colon cancer patients enrolled in the PETACC-8 trial during the upcoming 2018 Annual Meeting of the European Society for Medical Oncology October 19-23 in Munich, Germany.

IntegraGen has commercialized the miRpredX 31-3p kit, a proprietary IVD CE Marked kit and has also licensed its intellectual property associated with miR-31-3p to GoPath Laboratories for the North American market. GoPath Labs recently announced the commercial launch of miR-31now, a laboratory developed test which measures miR-31-3p expression in FFPE specimens.

ABOUT THE FIRE-3 CLINICAL TRIAL

The FIRE-3 (AIO KRK-0306) clinical trial is an independent, randomized, controlled Phase III trial conducted in Europe and led by University Hospital, LMU Munich, Germany. The study compares outcomes of KRAS Exon 2 wild-type (WT) stage IV colorectal cancer patients randomized to receive FOLFIRI therapy (5-FU, folinic acid and irinotecan) in combination with either cetuximab or bevacizumab.