Merck's Keytruda, passing Opdivo, bags double head and neck cancer OK

fiercepharma | June 11, 2019

Tuesday was a twofer for Merck & Co., which notched two new FDA approvals for blockbuster Keytruda in previously untreated head and neck cancer patients. Regulators green-lighted the immuno-oncology star as monotherapy in patients whose tumors bear the biomarker PD-L1 and in combination with a commonly used chemo regimen in patients regardless of PD-L1 status. The regulatory wins follow a quick review from the agency, which bestowed its priority designation on Keytruda back in February. FDA staffers based the speed-up on data showing that that, when facing off against a standard-of-care regimen commonly referred to by the name “Extreme,” Keytruda could lower the risk of death by 22% in PD-L1 positive patients. And when paired with chemo, Keytruda slashed the risk of death by 23% regardless of patients’ PD-L1 status.

Spotlight

With complex development processes and stringent regulatory requirements, the path to developing a combination product can seem uncertain and fraught with risk. All elements of the delivery system must comply with the highest quality and regulatory standards.

Spotlight

With complex development processes and stringent regulatory requirements, the path to developing a combination product can seem uncertain and fraught with risk. All elements of the delivery system must comply with the highest quality and regulatory standards.

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PHARMACY MARKET

Exscientia Highlights "The Future of AI-enabled Drug Discovery" at SLAS Europe

Businesswire | May 23, 2023

Exscientia plc announced two abstracts for oral and poster presentation, as well as the closing keynote to be delivered at the Society for Laboratory Automation and Screening (SLAS) Europe Conference and Exhibition being held May 22-26, 2023, in Brussels, Belgium. These presentations highlight Exscientia’s recent advancements in technology, including the development of computer-aided biology (CAB) approaches, encompassing design of experiments (DoE) and automation for biochemical assay optimisation. The SLAS Conference is Europe’s premiere venue for industry, government and academic researchers, developers and providers of laboratory automation technology innovation. “At Exscientia, our mission is to encode and automate drug discovery. We believe that within this decade the design of all new drug candidates will be augmented with AI. I am delighted to showcase at SLAS Europe how our recent technology advances enable and drive our projects,” said Dr Garry Pairaudeau, Chief Technology Officer at Exscientia. Integrating laboratory automation of synthesis and screening with its AI-driven computational design platform is the logical next step for the company. “This will facilitate the next transformation in speed and productivity, as we aim to bring better medicines to patients faster. We’re looking forward to opening our purpose-built automation studio in Oxfordshire, U.K., later in 2023.” The company’s presentation at SLAS will demonstrate how far along Exscientia is in automating the drug discovery processes. “We believe automation has the potential to radically improve the timely creation of high-quality drug candidates, so that future patients may benefit from innovative science faster,” Pairaudeau stated. Closing Keynote Presentation Title: The future of AI-enabled drug discovery Room/Location: Plenary Theater Date/Time: Thursday, May 25 / 16:30 – 17:30 PM CET This presentation will highlight Exscientia’s distinct approach to molecular design, using an end-to-end patient centric, AI-enabled platform, which has led the way in the precision design of AI-generated molecules resulting in the first AI-designed compounds to enter clinical trials. To reach Exscientia's goal of fully encoding and automating drug discovery, the company is assembling an automated physical laboratory alongside its suite of sophisticated computational design tools, methods and scalable engineering platform. This presentation will highlight Exscientia's current progress in the automation field and the critical steps needed in the implementation of automated, digital laboratories. Abstracts Accepted for Presentation Oral Presentation Title: Computer-aided biology: DoE solutions Track: Frontiers in Technology Room/Location: 231 Date/Time: Thursday, May 25 / 15:30 – 16:00 PM CET Exscientia is building an automated ecosystem of chemistry, biology and compound management, including developing a pipeline of fully automated biochemical assays from assay development onwards. This presentation highlights how CAB has been leveraged to achieve this pipeline, combining DoE (a statistical methodology) with automation to rapidly determine optimum conditions to run assays efficiently through analysis of multi-factorial experimental results. Utilising CAB also allows Exscientia to increase capacity and efficiency across FTEs, time and reagents required to run assays, increase assay robustness and investigate areas of biology not normally studied. Poster Title: Improving assay optimisation and pharmacological sensitivity of a nuclease by employing a computer-aided biology approach Session/Track: Session A; Frontiers in Technology Abstract Number: 1034-A Date/Time: Wednesday, May 24 / 13:30 – 14:30 PM Exscientia researchers demonstrated the practical use of CAB to simultaneously improve an assay’s performance and reduce the reagent requirement, cost and labour for assay development. This presentation highlights the application of CAB to optimise the buffer of a nuclease assay, resulting in a 15-fold enhanced assay signal in low salt buffer conditions, alongside over a three-fold decrease in protein requirement​ and reduced assay development cycle times. The low salt requirement is a previously unforeseen result from CAB use which would have not been predicted from the literature. This highlights the potential for technology to improve assay performance in ways a human alone would not have been able to predict. About Exscientia Exscientia is an AI-driven precision medicine company committed to discovering, designing and developing the best possible drugs in the fastest and most effective manner. Exscientia developed the first-ever functional precision oncology platform to successfully guide treatment selection and improve patient outcomes in a prospective interventional clinical study, as well as to progress AI-designed small molecules into the clinical setting. Our internal pipeline is focused on leveraging our precision medicine platform in oncology, while our partnered pipeline broadens our approach to other therapeutic areas. By pioneering a new approach to medicine creation, we believe the best ideas of science can rapidly become the best medicines for patients.

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PHARMACY MARKET

Xeris Biopharma Announces Research Evaluation Collaboration and Option Agreement With Regeneron for XeriJect™

businesswire | April 03, 2023

Xeris Biopharma Holdings, Inc. a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapeutic areas, today announced that it has entered into a platform research evaluation collaboration and option agreement with Regeneron Pharmaceuticals, Inc. Under the terms of the agreement, Xeris will use its proprietary drug-formulation platform, XeriJect™, to develop ultra-highly concentrated, ready-to-use, small volume subcutaneous injections of two undisclosed monoclonal antibodies developed by Regeneron. Xeris will receive an upfront payment and potential milestone payments for preclinical achievements. Regeneron has an option to commercially license the Xeris technology for such molecules and nominate additional molecules for reformulation and potential commercialization. Specific financial terms of the agreement were not disclosed. “We are excited to be working with Regeneron on a platform collaboration basis, which builds on our prior feasibility studies and reflects the significant progress and investment we have been making into the development of XeriJect™,” said Paul R. Edick, Chairman and CEO of Xeris Biopharma. “Through our novel drug-formulation platform, we aim to provide our biologic development collaborators with the competitive advantage of delivering a significantly improved patient and provider experience through stable, ready-to-use, ultra-highly concentrated, small-volume subcutaneous injection formulations. This agreement with Regeneron is another in a series of collaborations Xeris has recently undertaken with top pharmaceutical and biotechnology companies.” About XeriJect™ Xeris’ drug-delivery system, XeriJect, provides innovative, ready-to-use, viscoelastic pharmaceutical suspensions that have the potential to improve drug delivery, lower treatment burden and improve patients' lives across a broad range of therapeutic categories. XeriJect suspensions maximize drug loadings at >450mg/mL, enable small volume subcutaneous injections, do not settle on storage and are ready-to-use. The suspensions use FDA-approved excipients and leverage known manufacturing processes. XeriJect formulation technology is well suited for drugs and biologics including large molecules such as proteins, monoclonal antibodies, and vaccines. The technology is protected by an extensive patent estate, trade secrets and know-how, and it is available for licensing. About Xeris Xeris is a growth-oriented biopharmaceutical company committed to improving patients’ lives by developing and commercializing differentiated and innovative products across a range of therapies. Xeris has three commercially available products: Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia; Keveyis®, a proven therapy for primary periodic paralysis; and Recorlev® for the treatment of endogenous Cushing’s syndrome. Xeris has a diverse pipeline of development and partnered programs using its formulation sciences, XeriSol™ and XeriJect™, to support long-term product development and commercial success.

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BUSINESS INSIGHTS, PHARMA TECH

Indivior Announces Its Successful Acquisition of Opiant Pharmaceuticals

Indivior | March 06, 2023

Indivior PLC, a global pharmaceutical company, recently announced its successful acquisition of Opiant Pharmaceuticals, Inc. The acquisition strengthens Indivior's addiction treatment and science portfolio by adding Opiant's late-stage assets. In particular, OPNT003, an investigational opioid overdose treatment, aims to provide an effective treatment option to address the current wave of opioid overdose caused by powerful synthetic opioids such as fentanyl. Indivior acquired Opiant for an upfront consideration of $20.00 per share in cash, summing to approximately $145 million and up to $8.00 per share in contingent value rights (CVRs). The CVRs will become payable if OPNT003 meets certain net revenue milestones within seven years after approval and launch. The acquisition was completed after meeting customary conditions, and Indivior funded the upfront consideration with its existing cash. It expects OPNT003 to generate net revenue of 150 million to 250 million dollars and the acquisition to be earnings accretive after the second year of launch. The company plans to provide updated guidance for FY 2023 with its Q1 results announcement on April 27, 2023. OPNT003 is a patent-protected intranasal formulation of nalmefene. It employs an absorption-enhancing technology to improve its pharmacokinetic and pharmacodynamic profile, resulting in a fast-acting and long-lasting duration of action that helps OPNT003 as a possible new treatment option for opioid overdose. On December 22, 2022, Opiant completed its rolling NDA for OPNT003. OPNT003's FDA PDUFA date is May 22, 2023. One formulation patent (expiry 2038) and five other patent applications cover various aspects of OPNT003, including treatment methods. National Institutes of Health, National Institute on Drug Abuse (NIDA) is funding the development of the program, as well as an agreement from Biological Advanced Research and Development Authority (BARDA). About Indivior A global pharmaceutical company, Indivior, is working to support patients in changing their lives by developing medicines that help in coming out of addiction and severe mental illnesses. The company aims to provide access to evidence-based treatment to all patients globally for chronic conditions and co-occurring disorders of substance use disorder (SUD). It is committed to transforming substance use disorder from a worldwide human crisis to a recognized and treated chronic illness. In addition, it has a pipeline of product candidates designed to build on its global portfolio of OUD treatments and potentially address other chronic conditions and co-occurring disorders of SUD, such as alcohol use disorder and cannabis use disorder.

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