Acticor Biotech Announces the Success of the First Phase of its ACTIMIS study with Glenzocimab In Patients with Acute Ischemic Stroke

Acticor Biotech | October 05, 2020

Acticor Biotech, a clinical stage biotechnology company involved in the acute phase of thrombotic diseases, including acute ischemic stroke, today announced the completion of its ACTIMIS Dose Escalation Phase of Glenzocimab Study as add-on to standard of care in Patients with acute ischemic stroke. This Dose Escalation Phase was successfully completed with 60 patients enrolled from 6 European countries (France, Belgium, Germany, Spain, Switzerland and Italy). 5 cohorts of patients presenting with an acute ischemic stroke episode of moderate to severe intensity were enrolled in this study and randomly received glenzocimab at one of 4 ascending doses or a placebo, in a blind fashion as a 6-hour single-dose infusion. Patients were evaluated continuously for 24 hours, then 7 and 90 days after the episode. Approximately 50% were also treated with the thrombolytic agent rtPA (ACTILYSE®), and the other 50% received rtPA and underwent a mechanical thrombectomy. The DSMB met on 5 occasions in between each cohort and at the end of the last administration, and they analyzed the safety data with a particular focus on the advent of intra-cerebral hemorrhages and other bleeding related events. The last analysis performed after the target dose of 1000mg had been administered to 12 patients confirmed both the absence of increased bleeding when glenzocimab is added to rtPA and to rtPA and thrombectomy, and the absence of any dose-related trend in the number and nature of adverse events recorded.

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INDUSTRIAL IMPACT

Riverside Partners' Portfolio Company Syner-G Acquires IMPACT

Riverside Partners | February 02, 2022

Syner-G BioPharma Group a leading provider of Chemistry, Manufacturing, and Controls technical, regulatory, and compliance consulting services to pharmaceutical and biotechnology clients, today announced the acquisition of Impact Pharmaceutical Services. Based in Research Triangle Park, NC, IMPACT supports the outsourced medical writing, regulatory strategy, and regulatory publishing and submission needs of biotech and pharma companies from pre-IND through post-marketing of drugs and biologics. Syner-G is a portfolio company of Riverside Partners, a Boston-based private equity firm. Both Syner-G and IMPACT have demonstrated strong track records of consistent growth and success in providing customized and highly complementary solutions to support the development of quality of life enhancing and lifesaving therapeutics. The combination will allow the companies to provide an even greater depth and breadth of expertise while delivering the highest levels of scientific rigor and customer service. "We are thrilled to support the combination of Syner-G and IMPACT. Similar to Syner-G, IMPACT has a stellar reputation in the marketplace, a diverse list of clients, and an outstanding team of highly qualified, experienced, and dedicated employees. Together, Syner-G and IMPACT will be able to not only better serve existing clients but also expand their reach and support new customers." Craig Stern, a General Partner at Riverside Partners "This combination is an important milestone for both companies," said David Belluck, a General Partner at Riverside Partners. "By adding IMPACT's complementary service offering and outstanding team, Syner-G is building on its long-standing commitment to provide unparalleled expertise and service to biotech and pharma customers." "This acquisition adds medical writing, overall drug development and regulatory strategy, and regulatory publishing and submission services to Syner-G's capabilities which will allow us to better support our customers as they develop lifesaving and breakthrough therapeutics," added Prabu Nambiar, Founder and CEO of Syner-G. "The combination brings together two excellent companies with very similar organizational histories, operating philosophies, and corporate cultures." "IMPACT's expertise and experience, gained over more than a decade of serving its clients, is a perfect extension of Syner-G's best-in-class CMC capabilities," said Mark Cierpial, Founder and CEO of IMPACT. "We are excited to form this strong partnership and work together to build a leading biopharma services organization." Financial terms of the transaction, which closed in late December, were not disclosed. About Syner-G BioPharma Group Based in Boston, MA, Syner-G is a leading provider of customized science and risk-based CMC and regulatory solutions and services, supporting pharmaceutical and biotechnology companies across small molecule, large molecule, and cell and gene therapy products. With its high customer retention, Syner-G oversees all aspects of CMC and regulatory services throughout the drug development process and post-commercialization. About Impact Pharmaceutical Services Based in Research Triangle Park, NC, IMPACT specializes in medical writing and quality control, drug development consulting, regulatory affairs, regulatory operations, and project and program management for the pharmaceutical and biotech sector. About Riverside Partners Founded in 1989, Riverside Partners is a middle market private equity firm with total capital commitments of $1.6 billion raised since inception. The firm focuses on growth-oriented companies in the technology and healthcare industries. Riverside Partners is particularly experienced at partnering with founders, owners and management teams, and it brings substantial domain expertise and operating experience to its portfolio companies.

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CELL AND GENE THERAPY

Takeda to Acquire Adaptate Biotherapeutics to Develop Novel Gamma Delta (γδ) T Cell Engager Therapies Targeting Solid Tumors

Takeda | January 11, 2022

Takeda Pharmaceutical Company Limited announced the exercise of its option to acquire Adaptate Biotherapeutics a UK company focused on developing antibody-based therapeutics for the modulation of variable delta 1 (Vδ1) gamma delta (γδ) T cells. Through the acquisition, Takeda will obtain Adaptate’s antibody-based γδ T cell engager platform, including pre-clinical candidate and discovery pipeline programs. Adaptate’s γδ T cell engagers are designed to specifically modulate γδ T cell-mediated immune responses at tumor sites while sparing damage to healthy cells. The planned acquisition of Adaptate follows Takeda’s recently exercised option to acquire GammaDelta Therapeutics and is intended to further accelerate the development of innovative γδ T cell-based therapies. Combining GammaDelta’s cell therapy-based platform and Adaptate’s antibody-based γδ T cell engager platform with Takeda’s strong research and development organization positions Takeda to be at the leading edge in deploying the full potential of γδ T cells in the fight against cancer. The planned acquisition complements Takeda’s ongoing efforts to research and develop cell engagers for solid tumor applications, bolstered by the novel T cell engager COBRA platform, which was acquired from Maverick Therapeutics in another successful build-to-buy collaboration. “Partnering with early-stage innovators to access cutting-edge platforms in the fight against cancer is at the center of our R&D strategy. Adaptate’s γδ T cell engager platform and the team’s deep understanding of γδ T cell biology gives us an opportunity to develop a new class of therapeutics that tap into powerful innate immune mechanisms. The planned acquisition will strengthen our immuno-oncology R&D efforts as part of our ongoing pursuit of life-transforming medicines for patients with cancer.” Christopher Arendt, Ph.D., Head of Oncology Cell Therapy and Therapeutic Area Unit of Takeda Adaptate was formed in 2019 as a spin-out company from GammaDelta with investment from Abingworth LLP and Takeda, in which Takeda received an exclusive right to purchase Adaptate for a pre-negotiated upfront payment. The acquisitions of Adaptate and GammaDelta are expected to be finalized in Q1 of Takeda’s fiscal year 2022, pending completion of review under applicable antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the U.S. “Our acquisition by Takeda recognizes the tremendous work put in over the last two years by Adaptate’s incredibly talented team,” said Dr. Natalie Mount, CEO of Adaptate. “We have rapidly demonstrated, in preclinical models, the therapeutic potential of our novel Vδ1-targeting antibodies, and this move brings us an exciting step closer to realizing the full potential for Vδ1 T cell targeted therapies to improve treatment outcomes for cancer patients.” In addition, Tim Haines, Chair & Managing Partner at Abingworth noted, “Having played an instrumental role in creating Adaptate, we are delighted to see the impressive developments of its γδ T cell therapeutic antibody portfolio to date, under the leadership of Natalie Mount. We look forward to seeing Takeda progress Adaptate’s very promising therapeutic antibodies into the clinic.” Takeda’s oncology pipeline focuses on novel strategies that leverage the power of the immune system, with a focus on innate immunity. Innate immune responses serve as the body’s first defense mechanism against disease and involve the orchestration of a broad arsenal of mechanisms and cell types, including γδ T cells and natural killer (NK) cells, that may help to overcome cancer’s ability to evade immune recognition. Adaptate has discovered a unique set of antibodies that selectively modulate γδ T cell activity in the tumor microenvironment. The antibodies provide a precisely targeted signal to the immune system, thereby offering the opportunity for superior efficacy and safety compared to conventional immuno-oncology approaches in solid tumors. Takeda’s Commitment to Oncology Our core R&D mission is to deliver novel medicines to patients with cancer worldwide through our commitment to science, breakthrough innovation and passion for improving the lives of patients. Whether it’s with our hematology therapies, our robust pipeline, or solid tumor medicines, we aim to stay both innovative and competitive to bring patients the treatments they need. About Takeda Pharmaceutical Company Limited Takeda Pharmaceutical Company Limited is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in healthcare in approximately 80 countries and regions. About Adaptate Biotherapeutics Adaptate Biotherapeutics is an immunotherapy company developing an innovative portfolio of therapeutic antibodies designed to modulate the activity of a patient’s own cytotoxic gamma delta T cells in situ. Our exquisitely targeted approach offers the potential to safely and effectively address the challenges often encountered by current cancer immunotherapies.

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MEDICAL

PacBio transforms access to the epigenome and streamlines workflows

PacBio | April 23, 2022

PacBio (NASDAQ: PACB), a leading developer of high-quality, highly accurate sequencing solutions, today announced the release of a transformative capability to detect DNA methylation using the Sequel IIe and Sequel II Systems. This extends PacBio’s unique and highly capable HiFi sequencing technology to now include access to the epigenome, a second layer of genomic information often left unexplored due to fundamental limitations of common sequencing technologies. PacBio’s single-molecule approach provides a much more holistic view of molecular behavior during sequencing. Subtle patterns in this rich information allow detection of modified bases in native DNA during standard HiFi sequencing. As a result, scientists gain access to the epigenome with zero additional cost, effort, or complexity. This advance will unlock important new opportunities across a broad range of applications in fundamental and applied biological science. This update also includes a wide range of workflow improvements to enhance customer experience, such as simplified, unified, and accelerated library preparation workflows and consumables, live instrument performance monitoring, and on-instrument analysis support for recombinant adeno-associated virus (rAAV) genome sequencing, a rapidly growing biopharmaceutical application relevant to gene therapy and vaccine development research. With each product release we continue to improve the utility and value of the Sequel II and IIe platform, providing researchers with unique capabilities that differentiate PacBio HiFi sequencing from all other sequencing technologies, Our latest enhancements to the Sequel II and IIe platform, including 5-base sequencing and improved workflows are expected to both simplify the ability to generate high quality data and enable deeper insights into the complexity of the genome.” Christian Henry, President and Chief Executive Officer of PacBio. Multiple tests are currently required to evaluate rare disease cases for sequencing and methylation variation. HiFi sequencing has the potential to change that by measuring both genetic and epigenetic variation across the full genome in a single experiment. We have had success using 5-base HiFi sequencing at Children’s Mercy Kansas City to identify abnormal methylation in repeat expansion cases, and we plan to apply it to all the future genomes we sequence. It is exciting to access another aspect of the genome without needing to change sample handling or sequencing procedures.” Emily Farrow, PhD, CGC, Director of Laboratory Operations at Children’s Mercy Kansas City and Associate Professor of Pediatrics at University of Missouri Kansas City School of Medicine. We found that the CpG methylation patterns detected in tomato and maize genomes using HiFi sequencing are highly concordant to standard bisulfite sequencing but bring power to resolve transposable elements and other sequences that are out of reach with short reads. When combined with the incredible capabilities of HiFi sequencing for genome assembly and variation analysis, this creates an unmatched opportunity for ultra-high-quality genome and epigenome analysis of plant and vertebrate genomes from a single datatype.” Michael Schatz, PhD, Bloomberg Distinguished Professor of Computer Science and Biology at Johns Hopkins University. PacBio’s HiFi sequencing technology offers a comprehensive view of genomes and transcriptomes. But DNA contains much more information subtly encoded as “epigenetic” modifications to DNA bases. This epigenome influences how genes are expressed and plays a major role in determining biological function in both health and disease. Historically, access to the epigenome has been difficult and required sacrifices in read lengths, accuracy, and completeness while adding workflow complexity. By including automatic detection of the key modified base in humans and many other species (5mC in CpG motifs) PacBio sequencing technology provides access to the combined genome and epigenome without sacrificing read lengths, accuracy, or completeness, and without requiring additional workflow steps. Streamlining workflows is a key focus for PacBio, and this latest update makes it easier to perform HiFi sequencing. The company’s new SMRTbell prep kit 3.0 is capable of reducing workflow time for whole-genome sequencing applications by 50 percent or more and reducing required DNA inputs by 40 percent (to three micrograms per human genome). SMRTbell prep kit 3.0 is suitable for a wide range of applications and supports automation and batch processing of samples. PacBio also introduced a new single-reaction sequencing plate and SMRT Cell 8M tray that better enables customers to run samples at their convenience. About PacBio Pacific Biosciences of California, Inc. (NASDAQ: PACB) is empowering life scientists with highly accurate sequencing platforms. The company’s innovative instruments are based on Single Molecule, Real-Time (SMRT®) Sequencing technology, which delivers a comprehensive view of genomes, transcriptomes, and epigenomes, enabling access to the full spectrum of genetic variation in any organism. Cited in thousands of peer-reviewed publications, PacBio® sequencing systems are in use by scientists around the world to drive discovery in human biomedical research, plant and animal sciences, and microbiology.

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CELL AND GENE THERAPY

Brazil’s SENAI CIMATEC Doses First Healthy Volunteers in Phase 1 trial of HDT Bio’s RNA COVID-19 Vaccine

HDT Bio Corp. | January 17, 2022

HDT Bio Corp., a U.S. developer of immunotherapies for oncology and infectious diseases and SENAI CIMATEC, an important Brazilian education, research, and innovation institute, have dosed the first healthy volunteers in Brazil in a Phase 1 trial of HDT Bio’s RNA COVID-19 vaccine, HDT-301. SENAI CIMATEC will conduct the clinical trial under the name Vaccine RNA MCTI-CIMATEC-HDT. The vaccine uses HDT Bio’s proprietary lipid nanoparticle RNA-delivery technology. “This clinical trial in Brazil is the second international study to get under way in our efforts to help partners in historically underserved nations fight this pandemic by transferring our unique technology to provide them local control over development, manufacturing and distribution of a COVID-19 RNA vaccine. The first was in India with our partner Gennova Biopharmaceuticals which has moved the vaccine into Phase 2 and Phase 3 trials.” HDT Bio CEO Steve Reed HDT Bio has other partnerships for its RNA COVID-19 vaccine, including in South Korea and China. “These partnerships are part of our company’s mission and business strategy aimed at bringing our advanced immunotherapies to underserved nations to help address global health inequities,” Reed explained. "Through the partnership with HDT Bio Corp., SENAI CIMATEC is incorporating in Brazil the development and qualification for a state-of-the-art technology in an exclusive way, as well as the first clinical study involving an RNA self-amplifying vaccine. This moment can be considered as an important demonstration of the potential of Brazilian science, represented in this study by SENAI CIMATEC,” said President of Federation of Industries of the State of Bahia Ricardo Alban “We also highlight the important funding received through the Ministry of Science, Technology and Innovations which has supported the execution of the initial clinical phases, “Alban added. “From the clinical studies of the Vaccine RNA MCTI CIMATEC HDT we expect to obtain sufficient data to demonstrate the efficacy and safety of this product to the population. In this way, the development of the Vaccine RNA MCTI CIMATEC HDT represents a crucial milestone for the modernization of the national health system, since it can later be produced in the country itself,” said infectious disease doctor and Principal Investigator of the clinical studies in Brazil Roberto Badaró. SENAI CIMATEC’s double-blind, placebo-controlled, dose-ranging Phase 1 clinical trial will enroll 90 healthy adult volunteers. The trial will assess the safety, tolerability, and immunogenicity of the vaccine at three dose levels, 1 µg, 5 µg and 25 µg. Safety and tolerability will be the primary endpoints assessed by incidence of adverse events for each dose through 12 months after the vaccination. Scheduled interim evaluations to measure immunogenicity also will be conducted. HDT Bio’s innovative vaccine, which also will undergo a Phase 1 trial in the U.S., uses its proprietary lipid nanoparticle carrier system for delivery of RNA. The vaccine is significantly different from existing commercially available RNA vaccines in two ways. First, its RNA payload is designed to amplify itself inside the body. As a result, the vaccine activates the immune system at a much lower dose than commercially available vaccines, enhancing safety and reducing manufacturing costs. Second, the RNA attaches to the outside of the nanoparticle delivery system rather than being encapsulated within it, providing for enhanced stability. ABOUT HDT BIO CORP. HDT Bio is a biopharmaceutical company dedicated to providing immunotherapies to people around the world, including those in historically underserved areas. The company seeks to harness the body’s immune system to deliver therapies that narrowly target the specific areas of the body where they are needed. HDT Bio’s work focuses on oncological and infectious disease applications. HDT Bio’s founders are world leaders in the development of immune stimulants, including both therapeutics and therapy-enhancing adjuvants. One of the company’s core technologies, RNA/LION™, combines formulation and adjuvant ingredients to stabilize and deliver RNA to the immune system to stimulate responses for therapy or vaccination. ABOUT SENAI CIMATEC SENAI CIMATEC focuses on higher education, research and innovation for the development of industry. Its manufacturing and technology integrated campus is one of the most advanced centers for education specialized services, applied research and innovation projects in Brazil. CIMATEC operates in more than 40 different areas of competence, with emphasis on computer technology, engineering, health and biotechnology, with the main objective to support industries, including the Brazilian Industrial Health Complex.

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Spotlight

This white paper series is our way of explaining the biotechnology revolution to our investors and supporters. We wanted to take subject matter that is manifestly complex, and reassemble it into a clear and accessible form. As a team of Healthcare sector specialists, on a daily basis we parse through reams of data, dissect clinical literature, attend medical conferences alongside leading scientists, and analyze biotechnology companies with an eye for precise, narrow details. It is an exacting effort.

Resources