CELL AND GENE THERAPY

Xylyx Bio partners with Inventia Life Science to develop tissue-specific, digitally-printed bioinks for drug discovery

Xylyx Bio, Inc. | September 02, 2021

Xylyx Bio, a New York-based leader in advanced biomaterials, and Inventia Life Science, a Sydney-based biotechnology company, today announced their strategic partnership following promising results developing more realistic, scalable, and reproducible 3D cell cultures for drug discovery and biomedical research.

As researchers seek to develop more physiologically relevant in vitro models, 3D bioprinting provides promising tools to quickly and more precisely culture cells to develop more effective drugs.

Inventia Life Science differentiates from other bioprinting solutions with their RASTRUM™ 3D cell culture platform, which empowers biologists with easy access to reproducible and tunable tissue models at scale. By incorporating liver-specific extracellular matrix (ECM) components developed by Xylyx Bio, the partners are developing robust 3D bioprinted liver tissue models. Inventia will complete product development and offer these solutions for research and drug discovery applications, with plans to expand offerings to other tissue types.

Dr. John O'Neill, Xylyx Bio Co-Founder and Chief Scientific Officer, stated: "Xylyx is collaborating with groundbreaking companies like Inventia to lead the industry transition to physiologically relevant disease modeling and compound testing 'in matrico'."

Dr. Julio Ribeiro, Co-Founder and Chief Executive Officer of Inventia Life Science, is very enthusiastic about this partnership. He stated, "At Inventia Life Science we strive to provide an automated 3D cell culture solution to accelerate drug discovery and biomedical research. This partnership with Xylyx is a significant step in the right direction in further expanding our matrix portfolio to enable the generation of complex tissue models in a reproducible and tissue specific manner."

About Xylyx Bio
Xylyx Bio is a pioneer in advanced biomaterials, serving customers across research, clinical and commercial applications. The Company's products provide the full suite of components from the natural cell microenvironment essential for the most accurate and actionable results for scientists working in pharmaceutical development, cell biology research, and regenerative medicine.

About Inventia Life Science
Inventia Life Science is a fast-growing biotech start-up based in Sydney, Australia, that is revolutionizing biomedical research, drug discovery and regenerative medicine. The award-winning RASTRUM™ 3D cell culture platform has already been adopted in leading medical research institutes and biotechnology and pharmaceutical companies worldwide, which are creating bioprinted tissue models that mimic real human biology.

Spotlight

Genetically modified organisms (more commonly referred to as GMOs) are organisms that have been created through the application of transgenic, gene-splicing techniques that are part of biotechnology. These methods for moving genes are also referred to as genetic engineering (GE).


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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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MEDICAL

ILC Dover Announces Liquid Single-Use Bioprocessing Bags for Rapidly Growing Biotherapeutics and Cell & Gene Therapy Markets

ILC Dover | March 30, 2022

ILC Dover LP ("ILC Dover" or the "Company"), specializing in innovative single-use solutions for biotherapeutics and pharmaceutical processing, announced its launch of liquid single-use bioprocessing bags, representing the first of many new products for handling and supply of sterile liquids for the biotherapeutics market. This expansion is a continuation of ILC Dover's solution set across the entire biotherapeutic and pharmaceutical manufacturing workflow, from powder containment and handling, through sterile liquid handling and pre-filled liquid and powder bags. ILC Dover manufactures its high-quality, single-use bioprocessing bags in Frederica DE, but ultimately will utilize its growing cGMP global footprint to support its customers and partners worldwide. The Company maintains manufacturing for its pharmaceutical and biotherapeutic customers in Frederica DE, Durham NC, Stockport UK, Rossens Switzerland, and Blarney Ireland, with a large, planned expansion in Juarez, Mexico coming online later in 2022. ILC Dover's differentiated value proposition comes during a time of unprecedented disruption in the life science supply chain amidst significant industry growth. ILC Dover is committed to providing comprehensive solutions customized to our customers unique needs. Additionally, the Company's overall global footprint, quality, and supply reputation ensure that it can meet customer needs at scale with speed. In addition to the launch of ILC Dover's single-use bioprocessing bags, the Company is also rapidly expanding its offering of sterile liquids and (pre-filled and non pre-filled) powder offerings. ILC Dover will be providing updates throughout the year on these launches. In the past two weeks, we've made two large investments in our customers' success: our Juarez capacity expansion and transformation, and the official launch of our exciting single-use bioprocessing bags, We will continue to innovate to serve our pharmaceutical, biotherapeutic, and cell & gene therapy customers across the entire processing and manufacturing workflow." Corey Walker, CEO of ILC Dover. About ILC Dover ILC Dover is a world-leader in the innovative design and production of solutions for biopharmaceutical, pharmaceutical, medical device markets as well as a leading supplier for the (aero)space industries. Our customers will attest to our relentless dedication to high value products, advanced technology, and responsive service, as our visionary solutions have improved efficiency while safeguarding people, product, and infrastructure in hazardous conditions through flexible protective solutions since 1947.

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INDUSTRY OUTLOOK

Curocell, Breaks Ground on 'CAR-T Manufacturing GMP Facility'

Curocell, Inc. | December 24, 2021

Curocell, currently on PhaseⅠCAR-T Therapy clinical trial with CRC01 has recently broken ground for the new CAR-T Center in Dungok Residential & Industrial Area in Daejeon International Science & Business Belt. The GMP Facility for commercial manufacturing CAR-T Cell therapy and R&D Center for further pipeline development are constituting the 17,325 square-meter site of CAR-T Center. By the first half of 2023, construction is expected to be completed and in 2024, when the CAR-T Center is fully operational, supply of advanced cure should be possible for patients in pain. Also, Curocell is expecting to expand their business to global market by in-housing all processes of CAR-T therapy development and production. About CRC01 (anbalcabtagene autoleucel) CRC01, recognized CD19 and is based on OVIS™, a first-in-class CAR-T platform. OVIS™ technology downregulates PD1 and TIGIT expression on CAR-T cells. Through overcoming the immune suppression by PD-1 and TIGIT ligands, OVIS™ CAR-T has superior cytotoxicity to tumor cells in the tumor microenvironment. Phase II clinical trial of CRC01 will start in South Korea in the first half of 2022. About Curocell Curocell, based in Daejeon, South Korea, is clinical-stage biotech innovating CAR-T therapies. Curocell is developing OVIS™ technology with the goal of improving clinical efficacy of CAR-T therapies.

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RESEARCH

BigHat Biosciences Completes First Stage of Research Collaboration with Amgen

BigHat Biosciences, Inc. | January 12, 2022

BigHat Biosciences, Inc., a biotechnology company with an artificial intelligence/machine learning-guided antibody discovery and development platform, announced the successful completion of the first stage of a previously undisclosed research collaboration and licensing agreement with Amgen applying BigHat’s platform for multi-objective optimization of a next-generation antibody. BigHat’s antibody design platform integrates a high-speed characterization with AI/ML technologies to engineer antibodies with more complex functions and better biophysical properties. This approach reduces the difficulty of designing antibodies and other therapeutic proteins to tackle conditions ranging from chronic illness to life-threatening disease. BigHat’s experimental platform massively speeds up candidate discovery and validation. “This is an important milestone for BigHat, and the AI/ML biologics drug discovery field more broadly, as it demonstrates the ability of their platform to quickly and significantly optimize next-generation antibodies,” said Steve Doberstein, BigHat Independent Board Member and former Chief R&D Officer at Nektar Therapeutics, Inc. Achievement of this first milestone shows that BigHat’s platform has the potential to design high-quality therapeutic antibodies effectively and efficiently. Its platform can synthesize, express, purify, and characterize antibodies in a fraction of the time compared to traditional labs to guide the search for better molecules. “BigHat's platform for data-driven antibody design generated several antibodies significantly better than the starter molecules found using traditional technologies. Now that Amgen has validated the capabilities of BigHat's unique approach to antibody development, we're excited to continue working with them towards a lead antibody for their discovery research.” Vineeta Agarwala, MD, PhD, General Partner at Andreessen Horowitz and BigHat Board Director This successful milestone triggers the initiation of work to create a lead panel of VHH antibodies for patients in need. “We are excited to show the power of our platform to rapidly improve biophysical characteristics and function by directing and learning from each cycle of our AI/ML-enabled experimental platform. We are looking forward to continuing our productive collaboration,” said Peyton Greenside, BigHat’s CSO and Co-Founder. About BigHat Biosciences, Inc. BigHat Biosciences is reimagining antibody discovery and engineering with an AI-first experimental platform that integrates a high-speed wet lab with machine learning to create better antibodies faster and undertake novel designs far beyond what’s possible today. BigHat applies these design capabilities to develop new generations of safer and more effective treatments for patients suffering from today’s most challenging diseases. BigHat is a Series A stage biotechnology company based in the San Francisco Bay Area with a team-oriented, inclusive, and family-friendly culture. BigHat is backed by a16z, 8VC, AME Cloud Ventures, and Innovation Endeavors and counts among its employees and advisors a Nobel Laureate, a serial life-science entrepreneur, and leaders in fields from antibody development to machine learning.

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