FDA Allows WIN Consortium to Proceed with Targeted Tri-Therapy Clinical Trial in First Line Treatment of Metastatic Non Small Cell Lung Cancer
VILLEJUIF, France--(EON: Enhanced Online News)--WIN Consortium (WIN) received the US Food and Drug Administration (FDA)’s approval to start the clinical investigation of a novel therapeutic approach using a combination of three targeted therapies for the first line treatment of patients with advanced Non Small Cell Lung Cancer (NSCLC). The Survival Prolongation by Rationale Innovative Genomics (SPRING) trial will aim to enroll patients who are usually offered first line platinum-based chemotherapy. Patients with documented targetable driver alterations (EGFR mutations, ALK rearrangements, ROS1 and MET exon 14 skipping mutations) will be excluded. The population of NSCLC patients without actionable oncogenic driver mutations, envisioned for the enrollment in SPRING trial, represents the vast majority of patients with metastatic NSCLC (~80% in the Caucasian population).“WIN’s trial, entitled SPRING, is therefore a first proof of concept of this novel approach in the treatment of lung cancer, and will test as a first combination three drugs from WIN’s big pharma members, Merck’s Avelumab combined with Pfizer’s Palbociclib and Axitinib.’’ added Dr. Mendelsohn.” With over 60% of NSCLC detected in an advanced or metastatic stage, and less than 5% of patients alive at 5 years, a paradigm changing strategy for treating the deadliest cancer is needed. WIN’s novel approach is based on the utilization of the tri-therapy combination of targeted drugs, following the historical success of this approach in AIDS and tuberculosis. Similarly, our concept relies on the association of three targeted drugs that used in combination are expected to be highly potent, whereas used alone in monotherapy they produce only modest clinical outcome.‘’Nevertheless, it is important to acknowledge a significant difference between cancer and AIDS which lies in the higher biological complexity and heterogeneity of cancer compared to AIDS. In AIDS, one tri-therapy combination is effective for a majority of patients, whereas in cancer it is expected that many combinations will be needed to treat all patients effectively. WIN Consortium has developed new technologies for tailoring combinations for each individual patient.’’ said Dr. John Mendelsohn, Chairman of WIN. "WIN’s trial, entitled SPRING, is therefore a first proof of concept of this novel approach in the treatment of lung cancer, and will test as a first combination three drugs from WIN’s big pharma members, Merck’s Avelumab combined with Pfizer’s Palbociclib and Axitinib.’’ added Dr. Mendelsohn.SPRING’s investigator initiated research will be led by Dr. Razelle Kurzrock (University of California San Diego, Moores Cancer Center) and co-led by Dr. Enriqueta Felip (Vall d'Hebron Institute of Oncology) and is planned to be launched in 5 countries and 8 WIN member sites: University of California San Diego Moores Cancer Center and Avera Cancer Institute (Dr. Benjamin Solomon), USA; Institut Curie (Dr. Nicolas Girard), Centre Léon Bérard (Dr. Pierre Saintigny) and Hôpital Paris Saint-Joseph (Dr. Eric Raymond), France; Vall d'Hebron Institute of Oncology, Spain; Centre Hospitalier de Luxembourg (Dr. Guy Berchem); and Chaim Sheba Medical Center (Dr. Jair Bar), Israel.The SPRING trial will start with a Phase I portion to explore the safety of the combination and determine the optimal doses for the Phase II that will explore the efficacy of this tri-therapy regimen in first line treatment of metastatic NSCLC. The trial will also aim to validate a novel algorithm SIMS (Simplified Interventional Mapping System) developed by WIN and designed to match each patient’s tumor biology to a specific drug combination. For this purpose, both tumor and normal lung tissue biopsies will be obtained and explored in the SPRING trial. DNA and RNA analysis will be performed by Dr. Brandon Young at Avera WIN Precision Oncology Laboratory in San Marcos, California on biopsies using, respectively, Illumina NGS (next generation sequencing) and HTG Molecular’s expression (mRNA and microRNA) EdgeSeq technology used in conjuction with Illumina (NGS). Data integration for the SIMS algorithm will be performed by Ben-Gurion University of the Negev (Dr. Eitan Rubin), Israel.‘’It is an unprecedented cooperation between our WIN members from academia, industry and research organizations.“ said Dr. Vladimir Lazar, WIN Chief Scientific and Operating Officer. ‘’Eight clinical sites will activate the study, drugs will be provided by Pfizer Inc., DNA and RNA analysis technologies by Illumina and HTG Molecular and pharmacovigilance by Covance. In particular, we are grateful to Foundation ARC on cancer research in France for financial support to initiate the SPRING trial. We are welcoming the support of any other organization or private donors, wishing to join this unique global effort dedicated to lung cancer patients.’’ added Dr. Lazar.‘’It is very exciting to see this endeavor becoming more concrete and this unprecedented cooperation materializing. We are looking forward to the activation of our clinical sites. We will need more combinations to be launched rapidly and other pharma companies to join us in this effort.’’, said Dr. Razelle Kurzrock, trial global coordinator, and Head of WIN Clinical Trials Committee. ‘’WIN has the potential and expertise to test other combinations and has the technologies needed to match patients’ tumor biology profile with the appropriate combination”.About WIN Consortium WIN Consortium is a French based non-profit network of 41 world-class academic medical centers, industries (pharmaceutical and diagnostic companies), health payer, research organizations and foundation and patient advocates spanning 17 countries and 4 continents, aligned to deliver now the progress in cancer treatment that is awaited by so many patients and families around the world.For further information, please visit www.winconsortium.org.
InDex Pharmaceuticals Holding AB (publ) today announced that the US Food and Drug Administration (FDA) has granted orphan-drug designation for the drug candidate cobitolimod for treatment of ulcerative colitis in pediatric patients.“ We are pleased that the FDA has granted orphan-drug designation for cobitolimod for treatment of ulcerative colitis in children, which may provide seven years of market exclusivity in this indication on the US market,” said Peter Zerhouni, CEO of InDex Pharmaceuticals. "The decision shows the medical need for new therapeutic options for this patient population and gives InDex additional opportunities to interact with the FDA." Cobitolimod in briefCobitolimod is a new type of drug that can help patients with moderate to severe ulcerative colitis back to a normal life. It is a so-called Toll-like receptor 9 (TLR9) agonist, that can provide an anti ‐ inflammatory effect locally in the large intestine, which may induce mucosal healing and relief of the clinical symptoms in u lcerative colitis. Cobitolimod has achieved clinical proof-of-concept in moderate to severe active ulcerative colitis, with a very favorable safety profile. Data from four placebo-controlled clinical trials indicate that cobitolimod has statistically significant effects on those endpoints that are most relevant in this disease, both from a regulatory and clinical perspective. These endpoints include the key clinical symptoms such as blood in stool, number of stools, and mucosal healing, respectively. Cobitolimod is also known as Kappaproct® and DIMS0150.InDex Pharmaceuticals in briefInDex is a pharmaceutical development company focusing on immunological diseases where there is a high unmet medical need for new treatment options. The company’s foremost asset is the drug candidate cobitolimod, which is in late stage clinical development for the treatment of moderate to severe active ulcerative colitis - a debilitating, chronic inflammation of the large intestine. InDex has also developed a platform of patent protected discovery stage substances, so called DNA based ImmunoModulatory Sequences (DIMS), with the potential to be used in treatment of various immunological diseases.InDex is based in Stockholm, Sweden. The company’s shares are traded on Nasdaq First North Stockholm. Redeye AB is the company’s Certified Adviser. For more information, please visit www.indexpharma.com
Klaria signs exclusive development, license and supply agreement with Purdue Pharma (Canada) for acute treatment of opioid overdose (KL-00514)
Klaria AB and Purdue Pharma (Canada) today announce they have entered into exclusive development and license and supply agreements for KL-00514 (Naloxone Buccal Film). KL-00514 is a developmental stage formulation of naloxone intended for acute treatment of intentional or accidental opioid overdose designed to give a rapid and reliable response in patients while providing a compact dosage form that could be distributed widely to patients, caregivers and emergency personnel. KL-00514 will be co-developed by Klaria and Purdue Pharma (Canada). The development program will include formulation selection and optimization, pre-clinical studies and clinical trials. The development agreement includes exclusive global license options for the independently associated Purdue/Napp/Mundipharma network of companies upon achievement of defined milestones. Purdue Pharma (Canada) will pay Klaria a combination of upfront, milestone, success-based payments plus a royalty on sales. Further terms of agreements give Klaria exclusive manufacturing rights to supply the global market with KL-00514. Staged, success-based payments during the development phase and registration and approval process will total approximately 2.3 million USD. Klaria will also receive income from the resulting sales of KL-00514 as a combination of royalties on sales and possible income from the exclusive supply of the product. These payments are currently estimated, as a percentage of sales, to be in the mid- to high-single digit range. Payments, upfront and royalty amounts for other markets for KL-00514 will be agreed separately for each market. “We are very excited to enter into this collaboration with a development partner with such broad experience and expertise in the field as well as direct market knowledge and legacy,”says Dr. Scott Boyer, CEO, Klaria. “Wider patient access to naloxone is one of the goals of many health authorities throughout the world and we believe KL-00514 can provide broad access and relative ease of use for a very competitive cost.” “Collaborating on the development of KL-00514, a product designed to specifically address opioid overdose, is another concrete step we are taking to address a serious public health issue crisis Canadians are facing,” says Dr. Craig Landau, President and CEO, Purdue Pharma (Canada). “Prescription opioid medicines remain a safe and effective treatment option for patients who are appropriately selected and monitored; however, these medicines have risks. It is our goal to provide access to life-saving treatments that support the combined efforts of regulators and governments of all levels to make treatments for intentional or accidental overdose as broadly available as possible.” Landau added: “Investing in drug development to bring value to patients has always been an integral part of Purdue Canada’s contributions to the healthcare system and to Canadian patients. In the case of KL-00514, subject to successful clinical development and subsequent approval by Health Canada, those who use diverted medications and suffer from accidental or intentional overdose may also benefit.” Both Purdue Pharma (Canada) and Klaria look forward to seeing the results of the development program at which time we will determine our ability to submit the product for approval with regulators in Canada.
Medtronic Hits Illinois with Job Cuts
Medtronic said it will lay off 185 people as it closes a distribution center in Joliet, IL. The company plans to close the facility by December in order to leverage other U.S.-based facilities and service providers, according to a Chicago Tribune report.The company said it told employees about the mass layoff in May and is offering severance and benefits, in addition to helping them find job leads in the area. The Joliet facility opened in 1998, and primarily receives and ships products related to minimally invasive therapies.Medtronic spokesperson Fernando Vivanco said the closing is intended to keep the company’s operations flexible and scalable in a cost-efficient way.The company is also eliminating jobs at a facility in Columbia Heights, MN, and in Memphis, TN.original post by Amanda Pedersen is Qmed's news editor. Contact her at email@example.com.
und, Sweden – Alligator Bioscience AB (Nasdaq Stockholm; ATORX), a biotechnology company developing tumor-directed immunotherapies for cancer treatment, today announced that it has expanded its collaboration with Stanford University to support its biomarker strategy.The collaboration’s objective is to enable the early prediction of clinical efficacy of Alligator´s pipeline candidates through the analysis of potential systemic biomarkers. In the longer-term, this may benefit patients through appropriate treatment selection based on biomarker analysis. Biomarker selection is critical to the success of this strategy, and Stanford´s expertise, including RNA sequencing and proteomic analysis, will be instrumental in this.Alligator has worked with Stanford since 2014, drawing on its pioneering work in immuno-oncology. The principal investigator at Stanford, Prof Dean Felsher, is an expert in the field of oncogene-induced cancer immune evasion and the relationship between oncogenes and cancer immunotherapy. The next step in the biomarker program will be to evaluate Alligator´s compounds in Stanford´s pre-clinical models.“The expanded collaboration with Stanford University will accelerate the pre-clinical development of our pipeline projects and strengthen the biomarker discovery program by drawing on their world-leading expertise in this area”, says Per Norlén, CEO of Alligator Bioscience. “Tumor-directed immunotherapy has the potential to add efficacy without adding dose-limiting toxicity, and the biomarker strategy will be essential to fully deliver on this.”
Survey of Payers and Gastroenterologists Finds Excitement Over the Prospect of JAK Inhibitors to Treat Inflammatory Bowel Disease
BURLINGTON, Mass., Aug. 8, 2017 /PRNewswire/ -- Decision Resources Group finds that surveyed health insurance medical and pharmacy directors as well as gastroenterologists look favorably on Janus kinase (JAK) inhibitors for use in Inflammatory Bowel Disease (IBD). A majority of surveyed payers regarded Pfizer's Xeljanz (tofacitinib) and Gilead/Galapagos' filgotinib as the emerging therapies that will have the greatest impact in ulcerative colitis and Crohn's disease, respectively, and a sizable majority of gastroenterologists expect to prescribe these agents within their first year on the market. An additional finding was that Johnsons and Johnson's Remicade (infliximab) continues to enjoy favorable market access despite the launch of the infliximab biosimilar, Pfizer's Inflectra. Indeed, at the time the survey was fielded, Inflectra had experienced little uptake according to surveyed gastroenterologists. Still, physicians expect that over time, payers will push them to use the biosimilar, and some payers report that they implement utilization management approaches to encourage its use. SOURCE Decision Resources GroupRelated Linkshttp://www.decisionresourcesgroup.com
Mylan Receives Tentative Approval for "TLD" Under PEPFAR for HIV/AIDS
Mylan's TLD is the first fixed-dose combination of its kind to be offered to patients being treated for HIV/AIDSTLD is comprised of Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 50 mg/300 mg/300 mgMylan (PRNewsfoto/Mylan N.V.) NEWS PROVIDED BY Mylan N.V. Aug 07, 2017, 08:00 ET SHARE THIS ARTICLE HERTFORDSHIRE, England and PITTSBURGH, Aug. 7, 2017 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL), a leading global pharmaceutical company, today announced receipt of tentative approval from the U.S. Food and Drug Administration under the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application for Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate Tablets, 50 mg/300 mg/300 mg (TDF-3TC-DTG or "TLD"). TLD, an antiretroviral (ARV) fixed-dose combination, will be available in developing countries as a first-line regimen for people being treated for HIV/AIDS. Mylan's TLD combines molecules from three originator medicines - ViiV Healthcare's Tivicay® (via a license through the Medicines Patent Pool) and Epivir® and Gilead Science's Viread®.Mylan President Rajiv Malik commented, "Our innovative TLD is a new medicine that will be available specifically to patients in the developing world being treated for HIV/AIDS. We know the challenges they face accessing high quality, affordable ARVs. That's why our scientists worked diligently to develop a medicine that combines three of the leading first-line regimens into a new, smaller tablet that patients have to take only once each day."In July 2017, the WHO recommended national programs evaluate using DTG as a first-line therapy. The recommendation is based on the medicine's improved tolerability, higher antiretroviral efficacy, lower rates of treatment discontinuation, a higher genetic barrier to resistance and fewer drug interactions than other ARV drugs. Additionally, both the U.S. Department of Health and Human Services and the European AIDS Clinical Society include DTG as a preferred medicine on their HIV/AIDS treatment guidelines.Globally, Mylan supplies life-saving ARVs to nearly 50% of patients being treated for HIV/AIDS in more than 100 developing countries. The company's comprehensive ARV portfolio includes 14 APIs and 50 finished dosage forms in first-line, second-line and pediatric formulations.Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which approximately 50% of people being treated for HIV/AIDS in the developing world depend. We market our products in more than 165 countries and territories. We are one of the world's largest producers of active pharmaceutical ingredients. Every member of our more than 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com.SOURCE Mylan N.V.
MilliporeSigma and Baylor College of Medicine Advance Vaccine Development and Manufacturing for Neglected Diseases
Collaboration furthers both parties’ commitment to advance research and development for neglected diseases Agreement focuses on optimizing vaccine process development and formulation and exchanging know-how Billerica, Massachusetts, August 8, 2017 – MilliporeSigma today announced that it has formed a strategic alliance with Baylor College of Medicine, Houston, Texas, and its vaccine product development partnership (PDP), Texas Children’s Hospital Center for Vaccine Development (Texas Children’s CVD), to advance vaccine research and development for neglected and emerging infections. The collaboration focuses on bringing vaccines through development to efficiently deliver them to societies in need. MilliporeSigma’s experts in process development and formulation are working with Texas Children’s CVD scientists at Baylor to optimize the vaccine manufacturing process to increase vaccine stability and yield. Initially, these activities are targeting schistosomiasis, a deadly parasitic disease that affects millions of people a year in tropical and subtropical regions. “Our purpose is to solve the toughest problems in life science by collaborating with the global scientific community,” said Udit Batra, CEO, MilliporeSigma. “The alliance with Baylor College of Medicine, one of the premier research universities in the world, is the ideal partnership to advance vaccine development and manufacturing. Together, we will support the fight against infectious diseases.” News Release Page 2 of 3 The collaboration includes training and exchange of technical know-how in process development and formulation, filling knowledge gaps that exist from research and development to manufacturing, with a focus on neglected and emerging diseases. Dr. Peter Hotez, founding Dean of the National School of Tropical Medicine at Baylor College of Medicine and co-director of the PDP, recently presented on the topic at an Access to Medicine event earlier this year in Darmstadt, Germany. “We are excited to partner with MilliporeSigma in order to advance this important vaccine. Today, schistosomiasis is considered one of the world’s most devastating neglected tropical diseases, affecting hundreds of millions of the world’s poorest people. We are excited about our new collaboration with MilliporeSigma to advance this lifesaving vaccine,” said Dr. Hotez. Dr. Maria-Elena Bottazzi, Deputy Director of Texas Children’s Hospital Center for Vaccine Development, said, “The scientific knowledge exchange from this partnership will catalyze and accelerate the product development of much-needed vaccines against the diseases of poverty. It will serve as a framework for capacity building and will establish self-reliance in vaccine development and manufacturing around the globe.” This collaboration, together with the recently announced public-private partnership with the Australian Institute of Tropical Health and Medicine (James Cook University, Queensland), the Australian Government’s investment promotion agency, and Baylor College of Medicine, furthers both parties’ commitment to advancing research in neglected diseases globally.