AbbVie axes multi-billion cancer flop Rova-T after another trial fails

pharmaphorum | August 29, 2019

AbbVie has axed its troubled lung cancer drug Rova-T, after another trial failure from the drug that is turning out to be an expensive flop, costing almost $10 billion so far. As it searched for new drugs to replace revenues lost from the patent expiry of its mega-blockbuster Humira, AbbVie snapped up Rova-T’s developer Stemcentrx in 2016 for $5.8 billion. But the gamble has not paid off after yet another trial disaster from the antibody-drug conjugate, full name rovalpituzumab tesirine. AbbVie already took an impairment charge of $4 billion earlier this year following a previous Rova-T trial failure, and there are doubts about the other compounds that AbbVie added to its pipeline following the Stemcentrx deal. The idea behind Rova-T is to use the antibody to target delta-like protein 3 (DLL3), an antigen expressed in more than 80% of small cell lung cancer tumours, prevalent in tumour cells and cancer stem cells but not healthy tissue. Then the cytotoxic agent tesirine could be delivered directly to the DLL-3 expressing cancer cells. It sounds great in theory but in practice it’s not working – AbbVie announced that it has ended the phase 3 MERU trial of Rova-T as first line maintenance therapy in advanced small-cell lung cancer (SCLC) after it demonstrated no survival benefit in a pre-planned interim analysis comparing it with placebo. The company made the decision based on a recommendation from the trial’s Independent Data Monitoring Committee, which cited a lack of survival benefit compared with placebo.

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This brief video shows a detailed overview of the Manufacturing module's functional specifications, design specs , process flow and the overall product architecture based on USFDA guidelines.

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This brief video shows a detailed overview of the Manufacturing module's functional specifications, design specs , process flow and the overall product architecture based on USFDA guidelines.

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BUSINESS INSIGHTS

ERS Genomics and Lepton Pharmaceuticals LTD Enter CRISPR/Cas9 License Agreement

ERS Genomics | July 27, 2022

ERS Genomics Limited is pleased to announce a new license agreement with Lepton Pharmaceuticals LTD. This is a non-exclusive licensing agreement granting Lepton access to the ERS CRISPR/Cas9 patent portfolio for certain applications. ERS, co-founded by Dr. Emmanuelle Charpentier, 2020 Nobel Prize winner for gene-editing, provides access to the foundational CRISPR/Cas9 intellectual property. Over 90 patents are held in over eighty countries. Lepton Pharmaceutical LTD is a biotechnology company developing a proprietary, breakthrough technology to substantially improve adaptive cell-mediated immune response. "We are very pleased to establish this relationship and license agreement with ERS Genomics. It will greatly assist us to develop our innovative Castling technology to significantly improve immune cells efficiency and longevity to fight cancer." Dr. Daniel Zurr, CEO of Lepton Eric Rhodes, CEO at ERS Genomics added: "Lepton's Castling technology has great potential to impact the field of immunotherapies and we are pleased to help enable Lepton in pursuing this exciting approach." The Castling technology is a proprietary, miRNA-based general technology platform, essentially consisting of the manipulation of miRNA expression to achieve enhanced efficacy and longevity (reduced exhaustion) of cell-based therapies. miRNAs are noncoding RNAs that each affects the expression of hundreds of coding genes. The Castling technology allows, in a single gene editing event in the immune cell (either allogeneic or autologous), to impact the expression of a multitude of genes in the immune cells, once such miRNAs penetrate the microenvironment of cancer cells. This technology aims to revolutionize the immune cell cancer therapy field. About ERS Genomics ERS Genomics is a biotechnology company based in Dublin, Ireland. The company was formed to provide broad access to the foundational CRISPR/Cas9 intellectual property held by Dr. Emmanuelle Charpentier. Non-exclusive licenses are available for research and sale of products and services across multiple fields including: research tools, kits, reagents; discovery of novel targets for therapeutic intervention; cell lines for discovery and screening of novel drug candidates; GMP production of healthcare products; companion animal and livestock health; production of industrial materials such as enzymes, biofuels and chemicals; and synthetic biology. About Lepton Pharmaceuticals Lepton Pharmaceuticals LTD. is based in Israel. Lepton focuses on subtle and precise silencing of coding RNA expression by small non-coding RNA molecules, working via the DROSHA/DICER/RISC pathways, small interfering RNA and microRNA (miRNA), to develop products and services to, ultimately, improve therapies for underserved diseases and improve and change patients' lives.

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PHARMACY MARKET

Jubilant HollisterStier LLC enters into cooperative agreement of $149.6 Mn with US Government to expand critical vaccine manufacturing capacity

Jubilant Pharmova Limited | May 31, 2022

Jubilant Pharmova Limited has announced today that Jubilant Pharma Limited, a wholly owned subsidiary of the Company, through one of its wholly owned subsidiaries, Jubilant HollisterStier LLC, (JHS) a leading US-based pharmaceutical contract manufacturer has entered into a cooperative agreement for $149.6 million (USD) with the Army Contracting Command, in coordination with the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) on behalf of the Biomedical Advanced Research and Development Authority (BARDA), within the US Department of Health and Human Services. The effort was funded under the American Rescue Plan, this agreement will enable the Company to double its injectable filling production capacity at a total cost of $193 million, at its Spokane, Washington manufacturing facility. This will be completed by 2025. This agreement is in addition to the $92 million filling line expansion announced in November 2021, which will be commercially available by the end of 2024. "Jubilant HollisterStier LLC is committed to making the US pharmaceutical supply chain more resilient with domestic manufacturing facilities and less reliant on foreign suppliers. Jubilant HollisterStier has a long history of supporting the US Department of Health and Human Services (HHS) and Department of Defense (DOD) biodefense and medical countermeasure programs, including production for national preparedness efforts. We are proud to support the US government in their efforts of making the US more prepared and ready for future pandemics." Speaking on the announcement, Pramod Yadav, CEO, Jubilant Pharma Limited "Jubilant HollisterStier LLC's expansion will target large Pharmaceuticals and Biotech companies for parenteral products as well as feature a flexible manufacturing platform able to produce several types of vaccines (live, mRNA and inactivated/subunit). We are committed to investing in capability and capacity. This investment will ensure our ability and flexibility to speedily produce quality vaccines and treatments for our customers and be better prepared for any future threats to the country," shared Amit Arora, President, Contract Manufacturing Organization (CMO), Jubilant HollisterStier LLC. About Jubilant HollisterStier LLC Jubilant HollisterStier LLC, a subsidiary of Jubilant Pharma Limited, is a leading integrated contract manufacturer of sterile injectables, ophthalmics, optics, sterile and non-sterile topicals and liquids. With facilities in North America, Jubilant HollisterStier LLC provides specialized manufacturing for the pharmaceutical and biopharmaceutical industries. Services include a full range of support to streamline manufacturing, from process qualifications through commercial release. About Jubilant Pharma Limited Jubilant Pharma Limited, a Company incorporated under the laws of Singapore and a wholly-owned subsidiary of Jubilant Pharmova Limited, is an integrated global pharmaceutical company engaged in manufacturing and supply of Radiopharmaceuticals with a network of radio-pharmacies in the US, Allergy Immunotherapy, Contract Manufacturing of Sterile Injectables and Non-sterile products, APIs and Solid Dosage Formulations through six manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies. The Company has a team of over 4,600 multicultural people across the globe and is committed to delivering value to its customers spread across over 75 countries. It is well recognized as a 'Partner of Choice' by leading pharmaceutical companies globally. About Jubilant Pharmova Limited Jubilant Pharmova Limited is a company engaged in Pharmaceuticals, Contract Research and Development Services and Proprietary Novel Drugs businesses. Pharmaceuticals business through Jubilant Pharma Limited Singapore (JPL) is engaged in manufacturing and supply of Radiopharmaceuticals with a network of 48 radio-pharmacies in the US, Allergy Immunotherapy, Contract Manufacturing of Sterile Injectables and Non-sterile products, APIs and Solid Dosage Formulations through six manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies. Jubilant Biosys Limited provides contract research and development services through two world class research centers in Bangalore and Noida in India. Jubilant Therapeutics is involved in Proprietary Novel Drugs business and is an innovative biopharmaceutical company developing breakthrough therapies in the area of oncology and auto-immune disorders. Jubilant Pharmova Limited has a team of over 6,000 multicultural people across the globe. The Company is well recognized as a 'Partner of Choice' by leading pharmaceuticals companies globally.

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BUSINESS INSIGHTS

C-Path and Replica Analytics Collaboration Aims to Accelerate Rare Disease Research

Replica Analytics | June 30, 2022

Critical Path Institute and Replica Analytics, an Aetion company, announced a new partnership that involves leveraging synthetic data to further catalyze the generation of actionable solutions to accelerate drug development for rare diseases. Replica Analytics will help generate synthetic datasets across rare and orphan indications in which patient-level datasets are often quite small, which heightens considerations regarding data privacy and accessibility. Together with real data, these synthetic data will help maximize the utility of C-Path's Rare Disease Cures Accelerator-Data and Analytics Platform which provides a centralized and standardized infrastructure to support and accelerate rare disease characterization targeted to accelerate drug development. Additionally, the platform includes a framework that supports the rigorous conduct of natural history studies, with attention to established data quality standards, to be most useful to clinical trial design and regulatory review. It includes a robust, integrated database and analytics hub that allows for the aggregation of rare disease data from various sources and the efficient and effective interrogation of that data. Once added to RDCA-DAP, the synthetic data will also represent valuable real-world, electronic health record (EHR) based data available on the platform, opening doors to modeling and research based on longitudinal focused analyses. "Our collaboration with Replica Analytics is important because synthetic data can add value to real-world data while observing data privacy considerations, which will help accelerate overall rare disease drug development. The goal of RDCA-DAP is to provide a centralized and standardized infrastructure to support and accelerate rare disease characterization and therapy development, this collaboration is in line with our efforts." RDCA-DAP Scientific Director Alexandre Betourne, Pharm.D., Ph.D Synthetic data generation is a privacy enhancing technology that has been gaining rapid adoption, particularly in the life sciences sector. SDG uses AI to create machine learning models that learn the statistical patterns and properties of real datasets to generate data that retain the same characteristics as the original dataset, but with no one-to-one mapping back to an identifiable person. SDG can help amplify small datasets, simulate virtual patients to augment patients in existing datasets, and optimize the design of small sample clinical trials. "We are certainly seeing a growing opportunity to partner with organizations like C-Path for generating datasets that are fit-for-purpose," says Khaled El Emam, Ph.D., SVP and GM of Replica Analytics. "Synthetic data, which preserves the integrity and utility of source data, as well as being privacy-protective, can be a very valuable tool to enable this collaboration." In May 2022, C-Path hosted a webinar in which the Replica Analytics team introduced SDG and discussed the role the technology can play in researching and treating rare diseases. The event was recorded and can be viewed on C-Path's YouTube channel. About C-Path Critical Path Institute is an independent, non-profit organization established in 2005 as a public and private partnership. C-Path's mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established numerous global consortia that currently include more than 1,600 scientists from government and regulatory agencies, academia, patient organizations, disease foundations, and hundreds of pharmaceutical and biotech companies. C-Path U.S. is headquartered in Tucson, Arizona, C-Path in Europe is headquartered in Amsterdam, Netherlands and C-Path Ltd. operates from Dublin, Ireland with additional staff in multiple other locations. Critical Path Institute is supported by the Food and Drug Administration of the U.S. Department of Health and Human Services and is 54.2% funded by the FDA/HHS, totaling $13,239,950, and 45.8% funded by non-government sources, totaling $11,196,634. The contents are those by the author(s) and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. Government. About Replica Analytics, an Aetion company Replica Analytics is the premier science-based SDG technology provider to the healthcare industry. The company a pioneer in the development of unique technologies for generating privacy-protective synthetic data that maintain the statistical properties of real-world data. The company was acquired in late 2021 by Aetion, the leading regulatory-grade real-world evidence technology provider. Replica Synthesis software provides a full suite of synthetic data generation and evaluation capabilities that can solve multiple grand challenges facing the life sciences industry, and health research in general. About Aetion Aetion is a healthcare analytics company that delivers real-world evidence for the manufacturers, purchasers, and regulators of medical treatments and technologies. The Aetion Evidence Platform® analyzes data from the real world to produce transparent, rapid, and scientifically validated answers on safety, effectiveness, and value. Founded by Harvard Medical School faculty members with decades of experience in epidemiology and health outcomes research, Aetion informs healthcare's most critical decisions—what works best, for whom, and when—to guide product development, commercialization, and payment innovation.

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