MEDTECH

Entos and BioMarin Enter into Agreement for Product Candidates Incorporating Entos' Fusogenix Drug Delivery Platform

Entos Pharmaceuticals, Inc., BioMarin | November 16, 2021

entos-and-biomarin-enter-into-agreement-for-product-candidates-incorporating entos fusogenix drug delivery platform 301423783.html
Entos Pharmaceuticals, Inc. (Entos), a clinical-stage biotechnology company developing genetic medicines with its Fusogenix proteolipid vehicle (PLV) nucleic acid delivery platform, and BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that they have entered into an agreement that will see Entos apply its Fusogenix nucleic acid delivery technology to promising gene therapy candidates in the BioMarin pipeline. Under the agreement, Entos will create specially formulated product candidates for BioMarin, a world leader in developing and commercializing innovative biopharmaceuticals for genetic diseases driven by genetic causes.

Entos' Fusogenix platform utilizes a PLV formulation with a novel mechanism of action to deliver molecular payloads, intact and unmodified, directly into target cells. By combining well-tolerated neutral lipids with proprietary fusion-associated small transmembrane (FAST) proteins, the Fusogenix platform efficiently delivers mRNA or DNA to target tissue with excellent tolerability. Fusogenix technology has been applied to a wide range of therapeutic approaches, including vaccines, gene therapy, and gene editing.

"As a company committed to addressing the unmet therapeutic needs of patients living with genetic diseases, BioMarin values novel technologies that enable the development of transformative therapies," said Brinda Balakrishnan, M.D., Ph.D., Group Vice President, Corporate and Business Development at BioMarin. "We believe that Entos' Fusogenix platform offers potentially unique benefits for safe and effective tissue targeting compared with other lipid-based delivery systems. The Fusogenix PLV formulations generated under this agreement are a critical first step in determining how we may incorporate this promising platform into our drug development efforts."

"With a 20-year track record of successfully discovering, developing, and commercializing first- or best-in-class therapies for diverse rare diseases, the BioMarin team has extensive expertise in harnessing the potential of breakthrough technologies. We believe this licensing agreement helps validate the potential of our Fusogenix platform. It also provides additional opportunities for incorporating our technology into cutting-edge treatments that may have significant clinical and commercial value."


John Lewis, Ph.D., Founder and Chief Executive Officer of Entos
 
Under the terms of the agreement, Entos will use its Fusogenix nucleic acid delivery system to specially formulate BioMarin products directed at multiple undisclosed genetic disease indications. BioMarin will conduct preclinical studies of the Fusogenix-formulated candidates to evaluate their potential as therapies to prevent or treat these conditions.
 
 
Entos' most advanced clinical program is Covigenix VAX-001, a COVID-19 DNA vaccine encoding SARS-CoV-2 Spike protein and two genetic adjuvants engineered to stimulate host adaptive and innate immune systems. Formulated using the Fusogenix platform, Covigenix VAX-001 is the subject of an ongoing phase 2 clinical trial in South Africa, with additional trials planned in other regions. Licensees of the Fusogenix platform include Oisín Biotechnologies and OncoSenX, which are using the technology for age-related diseases and oncology applications, respectively.

pH Partners, LLC served as financial advisor to Entos.

About BioMarin
BioMarin is a global biotechnology company that develops and commercializes innovative therapies for patients with serious and life-threatening rare genetic diseases. The company's portfolio consists of seven commercialized products and multiple clinical and preclinical product candidates.

About Entos Pharmaceuticals, Inc.
Entos develops next generation nucleic acid-based therapies using its proprietary Fusogenix proteolipid vehicle (PLV) drug delivery system. Fusogenix is formulated with FAST proteins to deliver mRNA or DNA directly into the cytosol of target cells for translation into protective and therapeutic vaccines and medicines.

Spotlight

Biopharmaceutical drug development has been experiencing one of its most productive periods in recent history. During the past decade, the total number of new chemical and biologic entities in the R&D pipeline has been rising 6% each year and now exceeds 10,000 active drug candidates targeting unmet and under-served medical needs .

Spotlight

Biopharmaceutical drug development has been experiencing one of its most productive periods in recent history. During the past decade, the total number of new chemical and biologic entities in the R&D pipeline has been rising 6% each year and now exceeds 10,000 active drug candidates targeting unmet and under-served medical needs .

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MEDICAL

SOPHiA GENETICS Launches New Solution to Advance Chronic Lymphocytic Leukemia Care, in Collaboration with IDIBAPS

biotech, biotechnology, cell, gene, tissue | June 10, 2022

SOPHiA GENETICS (Nasdaq: SOPH), the Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) of Barcelona, and the Spanish Diagnóstica Longwood today announced from the European Hematology Association Congress in Vienna that they have combined their expertise to develop a new Chronic Lymphocytic Leukemia (CLL) solution to advance CLL care. This collaboration will unify the wide variety of current guideline recommendations into one single application aiming to improve CLL characterization and CLL research practices in Iberia. SOPHiA GENETICS has already facilitated the analysis of one million genomic profiles through the SOPHiA DDM™ Platform, including a significant amount of onco-hematological-related diseases such as acute myeloid leukemia and lymphomas. The Platform computes a wide array of genomic variants needed to continually hone machine learning algorithms designed to accurately detect rare and challenging cases. The growing number of users of the SOPHiA DDM™ community can share and access insights by pulling the relevant signals detected from the noise, ultimately saving time and helping to make better-informed decisions. The new CLL solution allows for progress of Chronic Lymphocytic Leukemia research using genomic analysis. This could lead to better detection of the disease, which accounts for 25-30% of all leukemia cases in Western countries and affects yearly more than 100,000 people globally[1], and ultimately improve patient care. Thanks to the SOPHiA DDM™ Platform and IDIBAPS, hematopathologists can now access guidelines for the mutational status of TP53, immunoglobulin (IG) gene rearrangements and their somatic hypermutation status, while benefitting from the identification of 23 CLL-specific genes for SNVs, InDels and CNVs including NOTCH1, SF3B1, ATM, IGLV3-21, BTK, PLCG2, BCL2, del13q14, and trisomy 12, all in one single NGS workflow. The new CLL solution has already been used in routine in Spain, with further opportunities throughout the country, and in Latin America through Diagnóstica Longwood's distribution channels. We are proud to work together with some of the most renowned experts in the field of Chronic Lymphocytic Leukemia research around the world. This partnership is a great example of how combining advanced data analytics with emerging CLL strategies can move the possibilities of data-driven medicine forward." Lara Hashimoto, Chief Business Officer at SOPHiA GENETICS. It is a great satisfaction to see how thanks to the partnership with SOPHiA GENETICS and Diagnóstica Longwood we will be able to transfer into clinical practice the relevant information generated for so many years in the research of CLL using a simple and robust assay." Elías Campo, principal investigator and director of IDIBAPS. About SOPHiA GENETICS SOPHiA GENETICS (Nasdaq: SOPH) is a healthcare technology company dedicated to establishing the practice of data-driven medicine as the standard of care and for life sciences research. It is the creator of the SOPHiA DDM™ Platform, a cloud-based SaaS platform capable of analyzing data and generating insights from complex multimodal data sets and different diagnostic modalities. The SOPHiA DDM™ Platform and related solutions, products and services are currently used by more than 790 hospital, laboratory, and biopharma institutions globally. About IDIBAPS The August Pi i Sunyer Biomedical Research Institute (IDIBAPS) is a biomedical research center of excellence that addresses the most common diseases in our environment. It is a public consortium comprising the Catalan Government (Generalitat de Catalunya), the Hospital Clínic Barcelona, the Faculty of Medicine and Health Sciences at the University of Barcelona and the CSIC Institute of Biomedical Research of Barcelona. About 1,500 professionals are organized in a hundred research groups. IDIBAPS undertakes translational research. It focuses on ensuring that the questions that arise at the patient's bedside have a response in the laboratory, and that advances made in the laboratory are promptly applied to patients. With over 1,200 articles published annually, it is the leading biomedical research center in Spain.

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INDUSTRIAL IMPACT

Anthos Therapeutics Announces that Abelacimab has Received FDA Fast Track Designation for the Treatment of Thrombosis Associated with Cancer

Anthos Therapeutics | July 11, 2022

Anthos Therapeutics, a clinical-stage biotechnology company developing innovative therapies for cardiovascular and metabolic diseases, announced that the U.S. Food and Drug Administration has granted Fast Track Designation to its investigational Factor XI inhibitor, abelacimab, for the treatment of thrombosis associated with cancer. The company will also be announcing this important milestone today at a session of the ongoing 2022 Congress of the International Society on Thrombosis and Haemostasis Congress in London, UK. The Fast Track Designation process is designed to facilitate the development and expedite the review of treatments for serious medical conditions, thereby, addressing unmet medical needs. Drugs that are included in this program may be eligible for more frequent interactions with the FDA to discuss the development path, and if the program criteria are met, eligibility for a potential Rolling Review, Accelerated Approval, and Priority Review. Venous Thromboembolism including both deep vein thrombosis and pulmonary embolism, is the second most prevalent cause of death in patients with cancer, second only to the disease itself.1 However, treatment of Cancer Associated Thrombosis (CAT) can be challenging because the currently available anticoagulants used to treat VTE can have an increased risk of bleeding.2,3 "We believe that abelacimab has the potential to provide patients with cancer associated thrombosis an enhanced safety profile and overall low risk of bleeding, without sacrificing any efficacy of currently available agents. This unmet need is particularly true in patients with gastrointestinal / genitourinary (GI/GU) cancers who are at an even higher risk of bleeding and can be further burdened by the inconvenience of daily injections. Fast track designation by the FDA is a significant milestone for abelacimab and Anthos Therapeutics, but more importantly represents another hopeful step forward for patients. We look forward to working closely with the FDA on our clinical trial program to bring once-monthly abelacimab to patients in need." Dan Bloomfield, Chief Medical Officer at Anthos Therapeutics "Caring for cancer patients is a delicate and complex process, requiring a fine balance between the risks and benefits of their anticoagulant treatments. Managing thrombosis episodes is of the utmost importance for physicians, patients, and their caregivers, as untreated blood clots or bleeding episodes associated with currently available anticoagulants, can have dire consequences," said Jean Marie Connors, M.D., Associate Professor of Hematology at Harvard Medical School. "The hemostasis sparing potential of FXI inhibitors, such as abelacimab, may represent an important treatment advance in how we manage patients moving forward." About the Abelacimab Phase 3 Program in Cancer Associated Thrombosis (CAT) The abelacimab phase 3 CAT program comprises two complementary studies targeting to enroll approximately 2700 patients across 220 sites in more than 20 countries -- the largest program of any anticoagulant performed in Cancer-Associated Thrombosis. ASTER is an international multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 study comparing the effect of abelacimab relative to apixaban on venous thromboembolism recurrence and bleeding in patients with cancer associated VTE in whom DOAC treatment is recommended. Abelacimab 150 mg will be administered intravenously (IV) on Day 1 and subcutaneously (SC) monthly thereafter for up to 6 months; Apixaban 10 mg will be administered orally, twice daily (bid) for the first 7 days, followed by 5 mg bid up to 6 months. Enrollment in this trial began in May 2022. MAGNOLIA is an international multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 study in patients with gastrointestinal (GI) / genitourinary (GU) cancer in whom DOAC treatment is not recommended. The study will compare the effect of abelacimab relative to dalteparin on VTE recurrence and bleeding in patients with cancer associated VTE who are at a high bleeding risk with non-resectable, locally or regionally invasive GI / GU tumors. Abelacimab 150 mg will be administered intravenously (IV) on Day 1 and subcutaneously (SC) monthly thereafter for up to 6 months; dalteparin administered subcutaneously will be given daily, 200 IU/kg/day for the first month, and then 150 IU/kg/day up to 6 months. About the AZALEA-TIMI 71 Phase 2 Trial The AZALEA-TIMI 71 trial is an event-driven, randomized, active-controlled, blinded endpoint, parallel-group study to evaluate the effect of two blinded doses of abelacimab relative to open label rivaroxaban on the rate of major or clinically relevant non-major (CRNM) bleeding events in patients with atrial fibrillation (AF) who are at moderate-to-high risk of stroke. The trial completed enrollment in December 2021, with 1287 patients across 95 global study sites including the U.S., Canada, as well as from parts of Europe, and Asia. About Abelacimab Abelacimab is a novel, highly selective, fully human monoclonal antibody designed to induce effective hemostasis-sparing anticoagulation through Factor XI inhibition. Abelacimab targets the active domain of Factor XI, demonstrating dual inhibitory activity against both Factor XI and its activated form, Factor XIa. Abelacimab can be administered intravenously (IV) to achieve rapid inhibition of Factor XI activity and then used subcutaneously (SC) monthly to maintain nearly complete inhibition in a chronic setting. In a PK/PD study, abelacimab administered IV provided profound suppression of Factor XI within one hour after the start of therapy and maintained near maximal inhibition for up to 30 days. 4,5 In a Phase 2 study whose results were published in the New England Journal of Medicine in 2021, a single intravenous dose of abelacimab after knee surgery reduced the rate of venous thromboembolism by 80%, measured 10 days after surgery, compared to enoxaparin.4 Factor XI inhibition offers the promise of hemostasis-sparing anticoagulation for the prevention and treatment of arterial and venous thromboembolic events.6 Abelacimab is an investigational agent and has not been approved for any indication. About Anthos Therapeutics Anthos Therapeutics is a clinical-stage biopharmaceutical company focused on the development and commercialization of genetically and pharmacologically validated innovative therapies to advance care for people living with cardiovascular and metabolic diseases. Anthos Therapeutics aims to combine the agility of a biotech with the rigor of a large pharmaceutical company.

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MEDTECH

BiOWiSH Technologies and SABIC Agri-Nutrients Company Announce Bio-Enhanced Mineral Fertilizer Collaboration

BiOWiSH Technologies, Inc. | July 22, 2022

BiOWiSH Technologies, Inc. and SABIC Agri-Nutrients Company announced the successful completion of a year-long technical evaluation of BiOWiSH® Crop Liquid technology coated on SABIC’s urea in nine countries across five continents and nine different crop types. BiOWiSH® Crop Liquid is a blend of proprietary microbial cultures that can be coated onto dry fertilizer or mixed with liquid fertilizers to create an enhanced efficiency fertilizer specifically designed to optimize yield potential and improve soil productivity. Featuring the company’s proprietary HoloGene 3™ technology, BiOWiSH® Crop Liquid creates a high-performance partnership between the plant and BiOWiSH microorganisms. The new alliance has a combined genetic profilethat enhances native microbial activity in the soil, promotes soil quality, and supports the plant’s natural ability to resist environmental stress. This optimizes crop yield potential by increasing nutrient availability and improving soil productivity and plant vigor. This unique mode of action, combined with the product’s industry-leading shelf life, is proven to achieve consistent desired results across a broad range of operating conditions, climates and environments – all at a low cost to farmers. “We are thrilled to confirm that SABIC AN Bio-Enhanced Urea powered by BiOWiSH® has performed extremely well in the field,” Munif Al-Munif, General Manager Agri-Nutrients Technology at SABIC AN “Our uniform, high-crushing strength urea combined with the superior technology of BiOWiSH® Crop Liquid delivers extended stability and consistent performance at a price per acre farmers can afford. In an industry challenged with high regulatory pressures and global food demand, we are excited to offer a sustainable product that safely increases crop production and generates higher profits for growers,” he added. The market launch of SABIC AN Enhanced Urea will initially be fulfilled through SABIC AN partners in select target countries while the teams work together to expand in other regions around the world. The launch follows extensive successful testing of the product across multiple international markets, including the United States. The Bio-Enhanced Urea, powered by BiOWiSH®, will be available at the same price as standard urea through the Archer-Daniels-Midland Company (ADM) and American Plant Food (APF) for a limited time in select areas. Customers can contact their ADM or APF representative for more details. In addition, SABIC AN and BiOWiSH have constructed a joint development platform designed to advance further customizations across a range of SABIC AN’s high-efficiency fertilizers. This partnership is the foundation for future products and other agronomic innovations. “We appreciate the close collaboration with SABIC AN’s team,” said BiOWiSH CEO Ian Edwards. “It is very exciting that a market-leading fertilizer company such as SABIC AN recognizes the importance of biologicals and is placing such high focus and energy on bringing Bio-Enhanced Mineral Fertilizer to customers across the globe. Together, we will work toward our shared goal of developing agricultural solutions that help farmers maximize productivity and increase income – while at the same time, improving environmental outcomes.” SABIC AN Bio-Enhanced Urea will be available to farmers in additional locations in the future, enabling growers to experience the benefits of BiOWiSH®-powered fertilizer. About BiOWiSH Technologies Headquartered in Cincinnati, Ohio, BiOWiSH Technologies, Inc. is a global provider of biotechnology solutions for the agriculture, aquaculture, and environmental management industries. As a leader in the agricultural market, we help farmers increase crop production sustainably, safely and cost effectively. Our revolutionary BiOWiSH® Crop Liquid can be coated onto dry fertilizer or mixed with liquid fertilizer to create an enhanced efficiency fertilizer that optimizes yield potential, expresses plant vigor and improves soil productivity across a broad range of operating conditions, climates and environments. By unifying nature and science, BiOWiSH reinvents the way food is grown. About SABIC Agri-Nutrients Company SABIC AN is a public joint stock company listed on the Saudi Stock Exchange where SABIC owns 50.1% with the remaining 49.9% being held by the private sector and the public. It is one of the leading global fertilizer producers. SABIC AN portfolio includes urea, ammonia, phosphate and other specialized products.

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