Novartis collaborates with DNDi for visceral leishmaniasis drug

Pharmaceutical Technology | February 25, 2020

Swiss pharma giant Novartis and non-profit research and development organisation Drugs for Neglected Diseases initiative (DNDi) have signed a collaboration and license agreement to jointly develop LXE408 for visceral leishmaniasis. LXE408 is an oral treatment for this parasitic disease, which is transmitted by the bite of a sand fly, and can be life-threatening if left untreated. The drug was initially discovered by Novartis with the financial backing of the Wellcome Trust. DNDi executive director Dr Bernard Pécoul said: “Existing treatments for visceral leishmaniasis are simply not good enough. They are too long, increasingly ineffective, and can be toxic, painful, and costly. “Our hope is to radically transform this by developing new oral drugs that are affordable, safe, effective, easy to take, and can also be adapted to meet the treatment needs of patients in different countries.”

Spotlight

Lung Cancer is the leading cause of cancer death. It claims more lives each year than do colon, prostate, ovarian and breast cancers combined. ISR explores risk factors, treatment, and drug development in this infographic.

Spotlight

Lung Cancer is the leading cause of cancer death. It claims more lives each year than do colon, prostate, ovarian and breast cancers combined. ISR explores risk factors, treatment, and drug development in this infographic.

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BUSINESS INSIGHTS

Corval™ Launches New Biopharma Commercialization Planning Platform

Corval | September 22, 2021

Corval LLC announced the launch of its cloud-based commercialization planning platform designed for early- to mid-stage biopharma companies. Created by industry veterans with deep experience in biopharma commercialization, the platform provides a technology-based approach that expedites the commercialization planning process and helps teams align on strategic decisions, timing, and future resourcing needs. I have spent my entire career in this space and been exposed to the many challenges facing early- to mid-stage biopharma companies, particularly, how the lack of in-house expertise and constrained resources can threaten the ability to know what to do when. - Sue Nemetz, founder and CEO of Corval and CEO of The NemetzGroup LLC, a strategic consultancy that has supported the progression of more than 100 companies with assets at every phase of development. As a biotech CEO and investor, I have seen many companies get mired in the commercialization planning process. Corval, built upon the wealth of knowledge and experience from The NemetzGroup, will help ensure biotech executive teams don't miss any critical steps on their path to market. - Abbie Celniker, Ph.D., a Partner at Third Rock Ventures. Corval's platform is built upon decades of biopharma commercialization experience and more than 75,000 data points that drive recommendations throughout the entire development timeline and accommodate the unique circumstances of each asset's commercial strategy. Corval contains foundational tools for commercialization success, including: Custom Commercialization Map: a detailed and adaptable roadmap of the objectives and activities necessary to commercialize an asset Budget and Resource Plan: a customized schedule of the resources and investments required to support these activities and achieve organizational objectives Commercialization Center: a single workspace to collaborate on the roadmap and access a trove of commercialization knowledge About Corval Corval develops technology solutions to empower biopharma leaders to navigate the commercialization process with confidence. Built on decades of commercialization expertise, its innovative cloud-based platform assesses each asset's unique situation and creates a customized, detailed map to illustrate every step on the journey from clinic to market. Corval reduces the commercialization planning process from three to six months to three to six days, dramatically streamlining efforts to set commercialization plans in motion.

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RESEARCH

Ascentage Pharma Enters into an Agreement with University of Michigan to obtain an exclusive license for Degrader

Ascentage Pharma | November 30, 2020

Ascentage Pharma (6855.HK), an internationally engaged, clinical-stage biotechnology organization occupied with creating novel treatments for malignant growths, ongoing hepatitis B (CHB), and age-related infections, today reported it has gone into a concurrence with the University of Michigan, through which the organization may acquire the selective worldwide rights to a MDM2 protein degrader created utilizing the Proteolysis-Targeting Chimeras (PROTACs) innovation. The medication competitor is as of now entering IND-empowering considers. MDM2 is a critical controller of the tumor silencer p53 and one of the most powerful inhibitors of apoptosis found hitherto. It has high articulation in tumors and assumes a critical part in the event and advancement of tumors. Official to the MDM2 protein with high proclivity, MDM2 inhibitor hinders the MDM2-p53 connections and reestablish the tumor-stifling action of p53.1 Meanwhile, these MDM2 inhibitors present a few difficulties, including portion restricting hematological poison levels, in this manner the pressing need to grow new age of MDM2-focusing on treatments in the therapy of disease. The PROTAC innovation has arisen as another and promising methodology that initiates the corruption of focused proteins through the ubiquitin-proteasome framework (UPS), and it has gotten boundless interest from both mainstream researchers and enterprises since its presentation. Contrasted with ordinary "inhabitance driven" pharmacological methodology, the "occasion driven" PROTAC innovation has numerous focal points, for example, high intensity, high selectivity, with reactant method of activity, and the capacity to target undruggable proteins.2 Prof. Shaomeng Wang, Ph.D., Co-Founder of Ascentage Pharma and Chairman of its Scientific Advisory Board, and Warner-Lambert/Parke-Davis Professor in Medicine, Professor of Internal Medicine, Pharmacology and Medicinal Chemistry, Director of Michigan Center for Therapeutic Innovation, University of Michigan, is a main specialist in the field. Through structure-work investigations of their recently found MDM2 inhibitors utilizing the PROTAC innovation, Dr. Wang's exploration group has gotten intense and viable MDM2 degraders that could adequately actuate fast debasement of MDM2. The lead MDM2 degrader has accomplished total and tough tumor relapse in a xenograft tumor model in mice3. "As a new strategy to induce protein degradation, PROTAC has emerged as a novel modality in drug discovery," said Dr. Wang. "Studies showed, PROTAC-induced MDM2 degradation can not only enhance the potency of MDM2 inhibitors, but also maintain a long-lasting suppression of MDM2 protein levels, providing a new strategy to the treatment of MDM2-driven tumors such as leukemia. We look forward to the further development of the asset by Ascentage Pharma." "The emergence of the PROTAC technology represents another breakthrough in the identification of small molecule drugs. The technology has received tremendous interest for its ability to target undruggable proteins," said Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma. "We are very pleased to reach this agreement with the University of Michigan, to begin the assessment of this PROTAC-based MDM2 degrader and potentially bring this important addition to our existing pipeline. Through the assessment and potential development of the MDM2 degrader, we hope soon that it will offer an effective therapy for serious unmet medical needs."

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BUSINESS INSIGHTS

InDex Pharmaceuticals strengthens the clinical development organization in preparation of the start of the phase III study CONCLUDE with cobitolimod

InDex Pharmaceuticals | August 23, 2021

InDex Pharmaceuticals Holding AB today announced that two new employees have been appointed in the clinical development organisation in preparation of the start of the phase III study CONCLUDE with cobitolimod. Anders Bröijersén is joining InDex as Senior Medical Director Clinical Operations and Johan Levin as Project Manager Clinical Operations. Anders Bröijersén is a medical doctor and PhD with 15 years of experience in Clinical Development, Medical Affairs and Drug Safety at leading pharmaceutical companies such as Boehringer Ingelheim and MSD. Anders joins InDex from Sobi where he currently serves as Medical Director, Global Pharmacovigilance & Patient Safety. Johan Levin is a trained nurse and has more than 20 years of experience in Clinical Development at leading pharmaceutical companies and clinical research organizations (CROs) such as MSD and Covance. He currently works as senior Clinical Research Associate (CRA) at PRA Health Sciences. "I am pleased that InDex has been able to attract two highly qualified new employees and welcome Anders and Johan to the team," said Peter Zerhouni, CEO of InDex Pharmaceuticals. "We are expanding the organisation in preparation of the start of our global phase III study CONCLUDE with cobitolimod to be able to be active towards the study sites in collaboration with our CRO. This was a successful model for patient recruitment in our previous study CONDUCT." The phase III study CONCLUDE with cobitolimod will include 440 patients and be conducted at several hundred clinics in over 30 countries. It is a randomised, double-blind, placebo-controlled, clinical study to evaluate cobitolimod as a novel treatment for patients with moderate to severe left-sided ulcerative colitis. Cobitolimod Cobitolimod is a first-in-class 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 ulcerative colitis. Cobitolimod met the primary endpoint in the phase IIb study CONDUCT and demonstrated an outstanding combination of efficacy and safety. The results have been published in the reputable medical journal, The Lancet Gastroenterology & Hepatology. Data from four previous completed placebo-controlled clinical trials support the efficacy and safety demonstrated in the CONDUCT study. InDex Pharmaceuticals InDex is a pharmaceutical development company focusing on immunological diseases where there is a high unmet medical need for new treatment options. The company's lead asset is the drug candidate cobitolimod, which is in late stage clinical development for the treatment of moderate to severe 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 the treatment of various immunological diseases.

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