FDA set to review Sanofi’s isatuximab for multiple myeloma

Pharmatimes | July 11, 2019

The US Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for isatuximab for a review, for the indication of relapsed/refractory multiple myeloma (RRMM). The drug’s maker Sanofi has announced that the target action date for the FDA decision is April 30, 2020. The drug is an investigational monoclonal antibody that targets a specific epitope on the CD38 receptor of a plasma cell and its BLA is based on positive results from ICARIA-MM, an open-label pivotal Phase III clinical trial of isatuximab in patients with RRMM. During the trial, isatuximab was administered through an intravenous infusion at a dose of 10mg/kg once weekly for four weeks, then every other week for 28-day cycles in combination with standard doses of pomalidomide and dexamethasone for the duration of treatment, and was found to prolong progression-free survival by five months versus Pomalyst and dexamethasone alone in patients. “We are excited by these results, which represent significant progress in our ambition to extend the lives of multiple myeloma patients,” said John Reed, head of Research and Development at Sanofi. “We look forward to engaging with regulatory authorities with the goal of bringing this potential new treatment to patients as quickly as possible.” The drug is currently being evaluated in multiple ongoing Phase III clinical trials in combination with current standard treatments for people with relapsed/refractory or newly diagnosed multiple myeloma, as well as being under investigation for the treatment of other hematologic malignancies and solid tumours.

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PHARMACY MARKET

DrFirst Pharmacy Solution Earns Edison Award for Excellence in Commercial Technology, Consumer Safety

DrFirst | April 26, 2022

DrFirst's SmartSuite for Pharmacy has earned a prestigious Bronze Edison Award in the Commercial Technology, Consumer Safety Category, honoring the solution's innovative use of artificial intelligence to improve safety for patients and efficiency for pharmacies. The Edison Awards is a global leader in recognizing and honoring the best in innovation and excellence in the development of new products and services to create a positive impact on the world. "Being recognized with an Edison Award is one of the highest accolades a company can receive for innovation in product development and business. We deeply appreciate this recognition for SmartSuite for Pharmacy, which also highlights the dangers posed by medication errors and the need to provide more accurate, efficient technology solutions to hard-working pharmacists." G. Cameron Deemer, president at DrFirs SmartSuite for Pharmacy cleans and accurately translates medication data between incompatible systems, which saves time and can help reduce adverse drug events—the cause of more than 100,000 deaths per year. "The Edison Awards is delighted to recognize DrFirst for its innovation and positive impact on patients and health systems throughout the U.S. with SmartSuite for Pharmacy," said Frank Bonafila, executive director of Edison Awards. This year's Edison Awards finalists were chosen by senior business executives and academics from across the globe, whose votes acknowledge excellence in meeting the award criteria. The awards are named for Thomas Alva Edison, whose extraordinary contributions garnered 1,093 U.S. patents, pioneered multiple industries, and made him a household name worldwide. The 2022 Edison Awards were celebrated April 20 to 22, 2022, in Fort Myers, Florida, at an event hosted by award-winning science and technology journalist Miles O'Brien of PBS NewsHour. SmartSuite for Pharmacy is an AI-powered solution that cross-links an electronic prescription from a provider's EHR to an actual product on the shelf at the receiving pharmacy. It also translates abbreviated medication directions from the electronic prescription into the specific "short codes" used by the receiving pharmacy. Finally, SmartSuite for Pharmacy codifies allergy data for safety checks within the pharmacy workflow. About The Edison Awards The Edison Awards is an annual competition designed to honor excellence in new product and service development, marketing, human-centered design and innovation. Winners represent "game changing" products, services and excellence and leadership in innovation around four criteria: Concept, Value, Delivery and Impact. Started in 1987, The Awards are named after inventor Thomas A. Edison and symbolize the persistence and excellence in innovation personified by him. About DrFirst Since 2000, DrFirst has pioneered healthcare technology solutions and consulting services that securely connect people at touchpoints of care to improve patient outcomes. We create unconventional solutions that solve care collaboration, medication management, price transparency, and adherence challenges faced in healthcare. We unite the Healthiverse—the interconnected healthcare universe—by providing our clients with real-time access to the information they need, exactly when and how they need it, so patients get the best care possible. DrFirst solutions are used by nearly 325,000 healthcare professionals, including more than 120,000 prescribers, 70,000 pharmacies, 280 HIS/EHRs, and 1,500 hospitals in the U.S. and Canada.

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PHARMACY MARKET

Titan Pharmaceuticals to Explore Strategic Alternatives

Titan Pharmaceuticals, Inc. | December 22, 2021

Titan Pharmaceuticals, Inc. announced that it has commenced a process to explore and evaluate strategic alternatives to enhance shareholder value. Titan has engaged Maxim Group LLC as its exclusive financial advisor to assist in this process. Potential strategic alternatives that may be explored or evaluated as part of this process include an acquisition, merger, reverse merger, other business combination, sales of assets, licensing or other strategic transactions involving the Company. There can be no assurance that the exploration of strategic alternatives will result in any agreements or transactions, or that, if completed, any agreements or transactions will be successful or on attractive terms. Titan does not expect to disclose developments with respect to this process unless and until the evaluation of strategic alternatives has been completed or the board of directors has concluded that disclosure is appropriate or legally required. About Titan Pharmaceuticals Titan Pharmaceuticals, Inc. based in South San Francisco, CA, is a development stage company developing proprietary therapeutics with its ProNeura® long-term, continuous drug delivery technology. The ProNeura technology has the potential to be used in developing products for treating a number of chronic conditions, where maintaining consistent, around-the-clock blood levels of medication may benefit the patient and improve medical outcomes. Ultimate validation of the ProNeura® delivery system has been exemplified by approval of Probuphine in the US, EU and Canada. Key ongoing ProNeura implant programs include IND-enabling, non-clinical assessment of TP-2021, a potent peptide kappa opioid agonist for the long-term treatment of severe, chronic pruritis, and nalmefene, a mu opioid receptor blocker designed to decrease relapse and potential death from overdose in detoxed patients with Opiate Use Disorder.

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BUSINESS INSIGHTS

AbCellera and Empirico Expand Strategic Multi-Target Antibody Discovery Collaboration

AbCellera | May 04, 2022

AbCellera and Empirico Inc. announced today that they have expanded their strategic multi-target discovery collaboration, which leverages Empirico’s Precision Insights PlatformTM to discover genetically validated drug targets and AbCellera’s technology to identify lead candidate antibodies against those targets. Following the rapid progress of their first collaborative program, which identified a lead candidate against an undisclosed G protein-coupled receptor target in less than 12 months, the companies have expanded their partnership to include seven targets. In addition, under the expanded agreement, AbCellera has a co-development option on a program-by-program basis. Empirico’s platform is designed to uncover causal relationships between genes, proteins, and clinical outcomes by integrating genetic data and health information from millions of individuals together with experimental validation. AbCellera integrates leading technologies to solve all steps in the antibody discovery process and delivers to partners diverse and developable lead candidates against drug targets. “We have been impressed by Empirico’s ability to discover and validate new drug targets and believe the combination of our respective technologies has great potential to bring new first-in-class treatments to patients. We are pleased to build on our productive collaboration with Empirico by expanding the number of targets and maximizing the opportunity for mutual success by having an option to co-invest on a program-by-program basis.” Carl Hansen, Ph.D., CEO and President of AbCellera “AbCellera’s technology enables us to extend our competitive advantage in target discovery and validation with best-in-class antibodies to rapidly advance our programs towards the clinic,” said Omri Gottesman, M.D., CEO and President of Empirico. “We are excited to expand our relationship with AbCellera and to translate many more genetically validated targets into potential new antibody-based therapies together.” Under the terms of the expanded agreement, Empirico will have the right to develop and commercialize therapeutic antibodies resulting from the collaboration, and AbCellera has the option to co-develop each therapeutic program to maintain up to a 50 percent ownership stake. Financial terms were not disclosed. About Empirico Inc. Empirico is a next-generation therapeutics company founded on utilizing human genetics, data science, and programmable biology to power novel target discovery and development. Empirico’s Precision Insights PlatformTM, a proprietary human genetics-focused discovery platform, leverages a world-leading dataset, hyperscale infrastructure and algorithmic approaches that encode and enhance human intuition to identify and prioritize therapeutic targets. All potential therapeutic targets are subjected to rigorous in vitro and in vivo experimental validation to elucidate the mechanism by which genetic variation impacts disease risk and provide insights about which therapeutic modality could be ‘programmed’ to mimic or interfere with that mechanism. Empirico is advancing multiple programs across a broad range of indications and therapeutic modalities, both independently and in collaboration with industry partners. Empirico is headquartered in San Diego, California with laboratories in Madison, Wisconsin. About AbCellera Biologics Inc. AbCellera is a technology company that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease. AbCellera partners with drug developers of all sizes, from large pharmaceutical to small biotechnology companies, empowering them to move quickly, reduce cost, and tackle the toughest problems in drug development.

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RESEARCH

Hemogenyx Pharmaceuticals and Selexis SA Will Advance Hemogenyx’s Acute Myeloid Leukemia (AML) CDX Bispecific Antibody to Human Trials

Hemogenyx Pharmaceuticals plc | January 13, 2022

Hemogenyx Pharmaceuticals plc the biopharmaceutical group developing new therapies and treatments for blood diseases, and Selexis SA, a JSR Life Sciences company, have signed a service agreement to develop the cell line for Hemogenyx’s CDX bispecific antibody for the treatment of acute myeloid leukemia (AML). Under the agreement, Hemogenyx will leverage Selexis’ proprietary SUREtechnology Platform™, a suite of cell line development tools and technologies that significantly reduces the time, effort, and costs associated with developing high-performance mammalian cell lines. The CDX bispecific is made using the Hemogenyx’s proprietary humanised monoclonal antibody against a target on the surface of AML cells. CDX was co-developed by Hemogenyx Pharmaceuticals and Eli Lilly and Company (“Lilly”). This cutting-edge application of immune therapy offers a potentially more benign and effective form of treatment that, if successful, could have a significant impact on treatment and survival rates for AML. CDX is planned to be the Company’s second therapeutic candidate to enter clinical trials. Following the completion of the co-development phase, Lilly granted the Company an exclusive worldwide license to certain intellectual property developed by Lilly related to the CDX bispecific antibody for all uses, including the treatment of AML and other blood cancers. “We are delighted to partner with Selexis, and access its proprietary protein expression tools and technologies, IP and know-how. The partnership is key to advancing our CDX programme into clinical trials and accelerating the timeline to deliver this innovative therapy to patients in need of a more benign and effective treatment for AML.” Dr. Vladislav Sandler, Chief Executive Officer and co-founder of Hemogenyx Pharmaceuticals Mr. Dirk Lange, CEO of Selexis, added, “There’s an urgent need for effective treatments for AML, and we at Selexis are pleased to apply our technologies to help Hemogenyx advance the CDX bispecific antibody to the clinic. We’ve built a reputation for delivering cell lines rapidly and cost-effectively, without compromising safety. This is an exciting milestone for Hemogenyx and we welcome the opportunity to join the company on its journey toward delivering a promising and effective therapy for patients with AML.” Selexis’ modular SUREtechnology Platform™ facilitates the rapid, stable, and cost-effective production of recombinant proteins and vaccines, providing seamless integration of the development continuum from discovery to commercialization. About Hemogenyx Pharmaceuticals plc Hemogenyx Pharmaceuticals is a publicly traded company headquartered in London, with its US operating subsidiaries, Hemogenyx Pharmaceuticals LLC and Immugenyx LLC, located in New York City at its state-of-the-art research facility. The Company is a pre-clinical stage biopharmaceutical group developing new medicines and treatments to treat blood and autoimmune disease and to bring the curative power of bone marrow transplantation to a greater number of patients suffering from otherwise incurable life-threatening diseases. Hemogenyx Pharmaceuticals is developing several distinct and complementary product candidates, as well as a platform technology that it uses as an engine for novel product development. For more than 50 years, bone marrow transplantation has been used to save the lives of patients suffering from blood diseases. The risks of toxicity and death that are associated with bone marrow transplantation, however, have meant that the procedure is restricted to use only as a last resort. The Company’s technology has the potential to enable many more patients suffering from devastating blood diseases such as leukemia and lymphoma, as well as severe autoimmune diseases such as multiple sclerosis, aplastic anemia and systemic lupus erythematosus (Lupus), to benefit from bone marrow transplantation. About Selexis SA Selexis SA, a JSR Life Sciences company, is the global leader in cell line development with best-in-class modular technology and highly specialized solutions that enable the life sciences industry to rapidly discover, develop and commercialize innovative medicines and vaccines. Our global partners are utilizing Selexis technologies to advance more than 146 drug candidates in preclinical and clinical development and the manufacture of eight commercial products. As part of a comprehensive drug development process, the Company’s technologies shorten development timelines and reduce manufacturing risks.

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