Merck's Keytruda gives BMS' Opdivo some company with small cell lung cancer nod

fiercepharma | June 18, 2019

Bristol-Myers Squibb's FDA approval for Opdivo in patients with previously treated small cell lung cancer (SCLC) already has looked shaky since the drug failed to extend patients' lives in a phase 3 trial. Now, Opdivo will have to make some room for its archrival, Merck & Co.’s Keytruda, in the same indication. The FDA has approved Keytruda as a monotherapy for SCLC patients who have failed platinum-based chemo and at least one other line of therapy, Merck said Tuesday. Same as Opdivo’s third-line nod doled out last August, the new Keytruda go-ahead was granted under the accelerated approval program based on tumor response rate and duration of response data. In pooled data from the Keynote-158 and Keynote-028 non-randomized trials, which enlisted 83 metastatic SCLC patients who had failed two or more lines of treatment, Keytruda provoked a response in 19% of participants. Among the 16 who responded, 63% of their tumors continued to respond to Keytruda for a year or longer, according to Merck. “Small cell lung cancer, which accounts for 10% to 15% of all lung cancers, is often diagnosed at an advanced stage where the prognosis is very poor and there have historically been limited treatment options,” Patrick Ott of the Dana-Farber Cancer Institute said in a statement.

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By 2023, the monoclonal antibodies market is expected to reach a staggering $130B. The potential of monoclonal antibodies and other biologic drugs is huge. They are promising treatments for severe diseases and can improve or save patients’ lives. Check out our shiny new infographic on why these biologics need to be characterized properly!


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Glaukos Licenses Iveena’s Investigational Keratoconus Therapy

iVeena and Glaukos | August 25, 2022

iVeena Delivery Systems Inc. a clinical stage biopharmaceutical company with developmental products in keratoconus and pediatric myopia, has entered into a strategic licensing agreement with Glaukos Corporation that grants Glaukos an exclusive global license to develop and commercialize IVMED-80, a pharmacologic treatment for keratoconus. Keratoconus, a rare corneal disorder, is the leading cause of primary full-thickness corneal transplantation in the United States. IVMED-80 is a proprietary disease modifying topical eye drop with orphan drug designation that upregulates lysyl oxidase and induces pharmacologic corneal crosslinking to strengthen the cornea and treat keratoconus. In a 6-month phase 1/2a clinical study, IVMED-80 met its primary endpoint of a statistically significant reduction in baseline-adjusted Kmax of 1.0 D relative to placebo. “We are pleased to complete this agreement with Glaukos. This deal validates the technology we have developed at iVeena to induce corneal crosslinking pharmacologically via eyedrops. Glaukos is a strong partner to complete development of this product where, if approved, patients will have an additional keratoconus treatment option.” iVeena CEO Jerry Simmons As part of the agreement Glaukos paid $10 Million upfront and will assume all costs associated with development and regulatory activities on IVMED-80. In addition, deal terms include the potential for both development and sales milestone payments as well as royalties on sales to iVeena. About iVeena iVeena Delivery Systems, Inc. is a privately held, clinical stage ophthalmology company developing disease-modifying pharmacologic innovations for refractive diseases. iVeena has licensed its lead asset to Glaukos Corporation, IVMED-80, an Orphan Drug Designated eye drop for keratoconus. iVeena is developing IVMED-85, a first in class, investigational eyedrop formulation for pediatric myopia where it plans to initiate a first in human clinical trial early 2023. About Glaukos Glaukos is an ophthalmic medical technology and pharmaceutical company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. Glaukos first developed Micro-Invasive Glaucoma Surgery (MIGS) as an alternative to the traditional glaucoma treatment paradigm, launching its first MIGS device commercially in 2012, and has since developed a portfolio of technologically distinct and leverageable platforms to support ongoing pharmaceutical and medical device innovations. Products or product candidates for each of these platforms are designed to advance the standard of care through better treatment options across the areas of glaucoma, corneal disorders and retinal diseases.

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Asahi Kasei Bioprocess to Showcase Award-winning MOTIV™ Buffer Management Technology for Pharmaceutical Manufacturing at ACHEMA 2022

Asahi Kasei Bioprocess | August 01, 2022

Asahi Kasei Bioprocess America, subsidiary of diversified Japanese multinational company Asahi Kasei, will be featuring their MOTIV™ Buffer Management Technology at ACHEMA 2022 in Frankfurt this August. Winner of “Best in Show” at Interphex in 2017, “Technology of the Decade” from Bioprocess international in 2012 and originator of the concept for inline buffer formulation (IBF™), Asahi Kasei Bioprocess is a market leader that keeps pharmaceutical production moving efficiently and precisely through solutions like MOTIV with built-in automation software so that medicine can get to patients sooner and safer. Buffers are used for the vast majority of processes in pharmaceutical development, which has traditionally required storage in extremely large tank farms to be utilized as necessary. MOTIV can blend buffers from concentrates in small, single-use bags and is controlled with sensors to maintain and assure precision. It is also able to blend buffers to exact specifications as needed during a downstream development process and can handle a wide variety of buffer formulations. In addition, it is automated by the integrated OCELOT™1 System Control software to be repeatable and also helps to reduce waste created in the development process, so it is a more sustainable means of pharmaceutical manufacturing. “We have been working to ‘standardize’ system designs as much as we can, to make them more readily available with shorter lead times; but are also very capable at building custom systems to meet the specific needs of customers,” says Chris Rombach, Vice President of Sales and Marketing at Asahi Kasei Bioprocess America. “One of our strengths is not only having an innovative product, but also an extensive family of MOTIV systems to choose from. Buffer is the lifeblood of pharma manufacturing and with the R&D opportunities of being a part of the Asahi Kasei Group we have been able to develop MOTIV to be the most reliable and efficient IBF technology in the market today. Not to mention, Operation Warp Speed helped push capacity to expand globally and billions of dollars are being invested by manufacturers to ramp up production as quickly as possible. This drives a new sense of value for systems like our MOTIV family that can streamline processes.” 1 The OCELOT System Control is an Asahi Kasei Bioprocess proprietary technology that integrates and/or interfaces with plant-wide control systems in a universally compatible format, allowing for far-reaching data collection and analysis. About Asahi Kasei Bioprocess The Fluid Management Business Unit of Asahi Kasei Bioprocess is devoted to solving therapeutic product safety, efficiency and purity challenges within the pharmaceutical and bioprocessing industries. With technology platforms for virus filtration, chromatography, inline buffer formulation and oligonucleotide synthesis, our bioprocessing systems, columns, and automation solutions advance GMP manufacturing of critical drug substances around the world. Built with pride, built with quality, built to exceed your high expectations. “Built for You.” About Asahi Kasei The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber businesses, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 46,000 employees around the world, the company contributes to a sustainable society by providing solutions to the world's challenges through its three business sectors of Material, Homes, and Health Care. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents.

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Enable Injections Enhances Board with Addition of John DeFord, Ph.D.

Enable Injections, Inc. | August 12, 2022

Enable Injections, Inc. a company developing and manufacturing the enFuse® platform of investigational wearable drug delivery systems, is pleased to announce the appointment of John DeFord, Ph.D. to the company's Board of Directors, effective July 29, 2022. Enable Injections' enFuse is an innovative drug delivery technology designed to subcutaneously (SC) deliver large volumes of up to 50mL for a wide range of therapies and diseases, dedicated to improving the patient experience. Dr. DeFord brings over three decades of expertise as a global medical technology executive, most recently the executive vice president and chief technology officer for Becton, Dickinson and Company (BD) (BDX), a global medical technology company. Prior to BD, Dr. DeFord served in senior science, technology and leadership roles of increasing responsibility at organizations such as C.R. Bard and Cook Incorporated, with additional experience in venture capital as managing director of Early Stage Partners venture capital fund. He is currently also a member of the board of directors at Nordson Corporation (NDSN), NuVasive (NUVA), and Blue Spark, Inc. DeFord graduated from Purdue University with a bachelor's degree and master's degree in electrical engineering, and a Ph.D. in electrical/biomedical engineering, dedicating his career to innovative medical technologies to save lives, enhance quality of life and improve the patient experience. "Enable Injections is at the forefront of both simplifying the therapeutic delivery of critical medications and enhancing quality of life for the patient. I am excited to join the Board of Directors at this important time in the company's growth and development; and I look forward to working with the management team and Board to help accelerate translation of this important technology to the clinical setting." Dr. DeFord "We are pleased to welcome Dr. DeFord as a new director to Enable's Board," said Mike Hooven, President and CEO of Enable Injections. "We believe adding depth of experience in the global medical technology space such as Dr. DeFord's is key to the strong growth of our business." About Enable Injections Cincinnati-based Enable Injections is a global healthcare innovation company developing and manufacturing drug delivery systems designed to improve the patient experience. Enable's body-worn enFuse® delivers high-volume pharmaceutical and biologic therapeutics via subcutaneous administration, with the aim of improving convenience, supporting superior outcomes, and advancing healthcare system economics.

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Prime Medicine Expands Leadership Team with Key Appointments to Support Continued Growth and Advancement of Prime Editing Technology and Portfolio

Prime Medicine | July 29, 2022

Prime Medicine, Inc. a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, Prime Editors, to address the widest spectrum of diseases by deploying Prime Editing technology “Prime Medicine is advancing a first-of-its-kind technology intended to expand the number of patients who may benefit from genetic medicines. We are thrilled to welcome Richard, Niamh and Fubao to the team. Together, they bring strong business acumen, extensive clinical and regulatory experience and leadership of successful teams that position us well to achieve our mission. These esteemed leaders have deep expertise across their respective focus areas, each of which is key to the advancement of our novel Prime Editing technology.” Keith Gottesdiener, M.D., Chief Executive Officer of Prime Medicine Richard Brudnick, Chief Business Officer, brings extensive industry experience, including leading successful business development transactions, across multiple stages of development and an array of therapeutic areas. Mr. Brudnick was previously Chief Business Officer and Head of Strategy at Codiak BioSciences and, before that, was Executive Vice President of Business Development and Alliance Management at Bioverativ, Inc., a company he helped found in 2016. Mr. Brudnick joined Bioverativ at the time of its spinoff from Biogen where, over the course of nearly 15 years, he initiated, led and completed numerous transactions, including for several of the company's marketed products and late-stage pipeline, including Tecfidera, Spinraza and its biosimilars joint venture with Samsung. Previously, Mr. Brudnick was the Chief Executive Officer of a regional pharmaceutical distribution business that he sold to a strategic buyer, co-founded two companies, and was a strategy consultant at Bain & Company. Mr. Brudnick earned his undergraduate degree in management science from MIT and his M.S. in management from the Sloan School of Management at MIT. Niamh Alix, Chief Human Resources (HR) Officer, is a human resources leader who brings nearly 20 years of experience helping to grow teams from small, early-stage organizations to global enterprises. She joins Prime from Orchard Therapeutics, where she was Vice President, Global Talent and HR Business Partner. Prior to that, Ms. Alix held multiple global and regional roles at Lonza, including HR Business Partner for Americas, Mexico, and Canada where she led the HR team and people strategy for a 5,000+ employee population across corporate and manufacturing clients, and across multiple scientific platforms including cell and gene therapy. Prior to that, she held senior HR roles of increasing responsibility at Novartis and Bristol Myers Squibb. She holds a master’s degree in HR strategies from Dublin City University and a B.Sc. in management from the Technological University of Dublin. Fubao Wang, Ph.D., SVP, Head of Regulatory, has substantial experience leading product development of genomic medicine products, as well as regulatory strategies and execution for both clinical and commercial-stage products. Before Prime, Dr. Wang served as Senior Vice President, Head of Regulatory Affairs at Asklepios BioPharmaceutical where he built and led the regulatory team to support the development of clinical-stage AAV-based gene therapy products. Earlier, he was Vice President, Head of Regulatory CMC at Sarepta Therapeutics, where he supported the development of AAV gene therapy and RNA products, including the FDA approvals of Vyondys and Amondys. He also served as Associate Vice President, U.S. Site Head, CMC Dossiers at Sanofi to support the BLA approval of Dupixent, a monoclonal antibody product. Prior to that, he held a 16-year tenure at Merck serving in research, development and regulatory roles of increasing responsibility, most recently as director, global and emerging markets regulatory affairs, led and contributed to the discovery and development of a variety of vaccine and biologics products. Dr. Wang holds a Ph.D. in molecular biology from Heidelberg University and completed his postdoctoral work in molecular biology at Stanford University. About Prime Medicine Prime Medicine, Inc. is a biotechnology company committed to delivering a new class of differentiated, one-time, curative genetic therapies to address the widest spectrum of diseases. The company is deploying Prime Editing technology, a versatile, precise, efficient and broad gene editing technology, which is designed to make only the right edit at the right position within a gene. With the theoretical potential to repair approximately 90 percent of known disease-causing genetic mutations across many organs and cell types, medicines based on Prime Editing, if approved, could offer a one-time curative genetic therapeutic option to a broad set of patients.

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By 2023, the monoclonal antibodies market is expected to reach a staggering $130B. The potential of monoclonal antibodies and other biologic drugs is huge. They are promising treatments for severe diseases and can improve or save patients’ lives. Check out our shiny new infographic on why these biologics need to be characterized properly!

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