LyGenesis Announces Four Peer-reviewed Papers Are Published on Its Organ Regeneration Technology

LyGenesis | August 28, 2020

LyGenesis, Inc., a biotechnology company focused on regenerative medicine, announced today that four peer-reviewed papers have been published on its organ regeneration technology. LyGenesis' lead development asset is liver regeneration, which was the focus of the first two papers. Development of Ectopic Livers by Hepatocyte Transplantation into Swine Lymph Nodes by Fontes et al. was published this month in Liver Transplantation, demonstrating that functional mini-livers could be grown using the lymph node as a bioreactor. In this swine model using surgically-induced liver injuries, liver cells were isolated from the animals and then transplanted into lymph nodes in the abdominal region of the animal. In 100% of the animals the transplanted liver cells engrafted into the lymph nodes, proliferated, and formed ectopic mini-livers, which had the same structure and function as native liver tissue. The cell transplant procedure was safe, well tolerated, and as expected, the amount of liver mass generated by the ectopic livers was proportional to the degree of the native liver's damage.

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MEDICAL

Thermo Fisher Scientific Opens Bioprocessing Manufacturing Site in Ogden, Utah

Thermo Fisher Scientific | April 21, 2022

Thermo Fisher Scientific today celebrated the opening of its new single-use technology manufacturing site in Ogden, Utah. The state-of-the-art facility creates additional capacity to produce the high-quality technology and materials needed for the development of new vaccines and breakthrough therapies. The $44 million facility is part of Thermo Fisher’s $650 million multi-year investment, announced last year, to help ensure flexible, scalable and reliable bioprocessing production capacity exists for critical materials used in developing new and existing biologics and vaccines, including for COVID-19. The Ogden site is a 55,000-square-foot facility that will manufacture highly customizable bioprocess container (BPC) systems. These BPCs are used for the delivery, processing, separation, storage and transportation of critical liquids and readily integrate into systems across all steps in the production of life-saving biologics, vaccines and cell and gene therapies. The Ogden facility further strengthens our global manufacturing network, which has been growing to meet increasing demand for single-use consumables and critical raw materials, This new facility expands our presence in Utah and locating here gives us the ability to work closely with our Logan site, providing access to a talented workforce that is ideal for manufacturing the highly complex and customized solutions we provide our customers.” Mitch Kennedy, president, single-use technologies, Thermo Fisher Scientific. The Ogden site has hired more than 300 employees and has the potential to employ up to 450 people across safety, quality, manufacturing, HR, engineering and warehousing. Thermo Fisher currently employs more than 2,000 colleagues across the state of Utah, establishing a critical hub for bioprocessing. Thermo Fisher’s new facility in Ogden is not only an investment in Utah’s bio-tech infrastructure, but also an investment in the thriving communities of our state, Utah is a high-tech hub for businesses seeking an educated, dedicated workforce within communities and an economy that is thriving. I welcome Thermo Fisher’s investment in Utah and congratulate them on this next step on the cutting edge of biotechnology.” Senator Mike Lee. An integral part of Utah’s biotech community, Thermo Fisher has had a positive impact on Utah’s economy, providing several thousand jobs to Utahns around the state, They also have played a critical role in our country’s fight against the COVID-19 pandemic by helping pharmaceutical companies produce therapeutics and vaccines. I look forward to joining the opening of their new manufacturing site in Ogden, which shows how our state continues to be a place where companies can grow and thrive.” Senator Mitt Romney. We’re pleased to welcome a new Thermo Fisher Scientific facility to Ogden, This facility, along with campuses in Logan and South Jordan, will bring more than 400 new jobs and expand the company’s employee base to 2,000 statewide. We are grateful to have Thermo Fisher Scientific as part of Utah’s growing biotech economy." Governor Spencer Cox. About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

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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

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

Genetic Leap and Astellas Establish Research Collaboration to Develop RNA-targeted Small Molecules for Oncology Target

Genetic Leap | March 11, 2022

Genetic Leap today announced a research collaboration agreement with Astellas Pharma, Inc. to develop novel RNA-targeted small molecule therapeutic candidates against an undisclosed oncology target. Under the terms of the agreement, Genetic Leap will deploy its platform to discover and validate RNA-targeted small molecules against an undisclosed oncology target selected by Astellas. The agreement provides Astellas with certain rights to intellectual property on candidates discovered and developed under the collaboration that are directed against the program target. Further details of the collaboration were not disclosed. About Genetic Leap Genetic Leap's vision is to lead the next giant leap in human healthcare by developing today the incredible therapeutics of the future. To accomplish this, Genetic Leap built paradigm-shifting AI technologies that find the causal factors in disease and correct these factors with precision RNA therapy that is safe, convenient, and reversible. The company is leveraging its platform to advance a pipeline that spans internal as well as partnered programs, across both novel and known (but traditionally undruggable) targets.

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Medication History for Populations from Cureatr Meds 360º provides timely and accurate dispensed medication data for at-risk patient populations. This enables healthcare providers to better manage high-risk groups to reduce readmissions and CMS penalties, maximize reimbursements and ultimately improve care.

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