Thermo Fisher Scientific Highlights Growing Capacity for Biologics, Cell and Gene Therapy Production During BIO 2020

PR Newswire | June 08, 2020

For biopharma companies seeking increased development and manufacturing capacity for vaccines and therapies, including new COVID-19-related programs, Thermo Fisher Scientific provided highlights of its new capabilities during the BIO International Convention, June 8-12, now a virtual event at www.bio.org/events/bio-digital. "We can now provide an uninterrupted path from development to commercialization for biopharma companies, small to large, in geographies worldwide and across vaccines, antivirals and other therapies," said Mike Shafer, senior vice president and president, pharma services, Thermo Fisher Scientific. "Through our recent strategic initiatives, we are delivering to our customers a powerful combination of expertise, flexibility and scale that allows us to be the partner they start with and stay with." Earlier this year, the company announced plans to invest in new capabilities and capacity for biologics, cell and gene therapies and drug product development and commercialization. For example, to support demand for gene therapies, Thermo Fisher will be doubling its viral vector manufacturing capacity with a new manufacturing site in Plainville, Mass. Construction of the 290,000-square-foot facility will be complete in 2022 and complements the company's recent expansions in Lexington and Cambridge, Mass., and Alachua, Fla. This week, STAT News will feature, "The STAT Guide to viral vectors, the linchpin of gene therapy," which covers the issues and considerations in engineering and manufacturing viral vectors.

Spotlight

Vaccination is generally considered as one of the greatest public health achievements in industrialized countries during the 20th century, reducing morbidity and mortality from a broad range of vaccine-preventable diseases. Globally, over 5.9 million deaths are prevented annually through vaccination against nine major infectious diseases, including varicella, diphtheria, tetanus, pertussis, Haemophilus influenzae type b (childhood), hepatitis B, measles, polio, and tuberculosis.


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INDUSTRIAL IMPACT

Angel Yeast Partners with PhaBuilder to Open PHA Factory

Angel Yeast | July 27, 2022

Angel Yeast a globally listed yeast and yeast extract manufacturer, has inked an agreement with Bejing PhaBuilder Biotechnology Co., Ltd in Yichang, Hubei province to build a large manufacturing base for polyhydroxyalkanoates (PHA) in the city. The pair will set up a joint venture company to drive the application of synthetic biology in the biotechnology industry. PHA is a polyester produced naturally by microorganisms. The biodegradable and biocompatible properties of PHA make it highly sought-after in fields such as biomedical material and biodegradable packaging material. "This collaboration with PhaBuilder marks a milestone and a significant step forward for Angel Yeast in synthetic biology. At Angel Yeast, we are very keen on innovation and exploration of new landscapes in the industry. This project is also part of our efforts to be an international and professional biotechnology company," Tao Xiong, chairman of Angel Yeast He added that the partnership is expected to forge a new venture in bioeconomy, fuel innovation in synthetic biology, and drive the expansion of the global market. Guoqiang Chen, the founder of PhaBuilder, added that by working with Angel Yeast on the initiative, major inroads have been made in converting technology breakthroughs into industrial programs for synthetic biology. "The new production line of PHA with the capacity of 30,000 tons will certainly bring more advanced technologies, new services and products for the industry and consumers. It will also create a 'greener' lifestyle. We are thrilled to see it happen," said Chen. In addition to synthetic biology, Angel Yeast has also been exploring cutting-edge development in biological agriculture. According to the company, it will be engaged in a project to produce animal feed through biological fermentation. Angel Yeast will invest some 120 million yuan to build the manufacturing center with an annual capacity of 50,000 tons. The project is estimated to start in August 2022 and to be completed in September the next year. One highlight of the project is that it uses Distillers' Dried Grains with Solubles (DDGS) as one raw material to produce yeast culture products. As a new category, yeast culture products will diversify the company's animal nutrition products lineup. About Angel Yeast Founded in 1986, Angel Yeast Co., Ltd specializes in the production of yeast and yeast derivatives. Its product range includes baker's yeast and ingredients, Chinese dim sum and seasoning, savory yeast extract, human health, animal nutrition, plant nutrition, distilled spirits and biofuels, microbial nutrition, and enzymes.

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MEDICAL

Ratio Therapeutics Launches to Discover and Drive Early Clinical Development of Best-in-Class Targeted Radiopharmaceuticals for Treatment of Cancers

Ratio Therapeutics | June 13, 2022

Ratio Therapeutics Inc. today announced its launch with a mission to develop best-in-class targeted radiopharmaceuticals for the treatment of cancers. Founded by entrepreneurial scientists Jack Hoppin, Ph.D., and John Babich, Ph.D., Ratio emerges from stealth mode with more than $20 million in seed funding, fully funded development alliances with Bayer AG and Lantheus Holdings Inc., a robust portfolio of assets developed with two proprietary technologies, and a growing team of world-class experts in radiopharmaceuticals discovery and development. The company's near-term plans call for the submission of its first investigational new drug (IND) applications, which are expected this quarter, and the initiation of clinical trials later this year. Based in Boston, Ratio is set to move to a new 19,000-square-foot headquarters and research facility in the Seaport District in January. Ratio's radiopharmaceuticals strategy is focused on optimizing tumor localization while minimizing uptake by normal tissues. To achieve this, the company uses its proprietary technology platform called Trillium™ that is based on Dr. Babich's prior research at Weill-Cornell Medical College and first developed and validated by the founders in a previous venture. Trillium is a trifunctional small molecule scaffold that can be fine-tuned to alter its plasma clearance, target affinity and therapeutic payload. Each component of the scaffolding can be independently optimized to boost tumor uptake over normal tissue uptake, thereby maximizing therapeutic index. Ratio has successfully applied this framework to several tumor targets and multiple therapeutic payloads. In addition, Ratio is developing a technology platform to take advantage of the tumor killing power of the alpha emitter, Actinium-225. This proprietary technology is called the Macropa™ chelate platform. Ratio's scientists have already successfully incorporated Macropa into the Trillium platform as well as several peptides and antibodies. Macropa's unique chemistry enables ease of manufacture and robust in vitro and in vivo stability of the resulting radiotherapeutic compound. The ability to fine-tune our targeted radiotherapeutics using Trillium and Macropa enables us to address head-on the trifecta of typical challenges we see with most radiopharmaceuticals: delivery, safety and efficacy, Over the past year, we have generated significant preclinical data that demonstrate our ability to create excellent performing drug candidates that now are advancing into the clinic. Our goal is to become the partner of choice for pharmaceutical companies committed to this area of cancer therapy by enabling the optimization of a broad array of targeting compounds. We will shepherd these therapies through early clinical studies on our own or in collaboration." Dr. Babich, Ratio's President and Chief Scientific Officer. Targeted radiotherapy is an exciting and emerging field where chemistry meets physics meets medicine. We have assembled and will continue to build a world-class interdisciplinary team of researchers and developers with a singular focus on delivering these treatments to cancer patients. It isn't often that a start-up company has in place the early financial backing and industry support to advance entirely new drug discoveries to clinical development at this pace. It is with great pride that we announce our formal launch and exit from stealth mode." Dr. Hoppin, Ratio's Chairman and Chief Executive Officer. In collaboration with Bayer, Ratio has leveraged its Trillium platform for the identification of lead prostate-specific membrane antigen (PSMA)-targeted therapeutic compounds for prostate cancer. At the same time, Ratio is working with Lantheus to develop a lead fibroblast activation protein (FAP)-targeted PET diagnostic compound for a broad array of epithelial-derived cancers, such as breast, pancreatic, lung and stomach cancer. Both collaborations are fully funded and reflect the types of partnerships that Ratio is currently pursuing with other companies. About Ratio Therapeutics Ratio Therapeutics Inc. is a Boston-based pharmaceutical company with the mission to accelerate the development of next-generation precision radiopharmaceuticals for solid tumors and transform oncology treatment paradigms. Founded by John Babich, Ph.D., and Jack Hoppin, Ph.D., the company currently employs a growing team of radiopharmaceuticals discovery and development experts with backgrounds in the life science industry. Ratio's fully integrated proprietary R&D platforms, Trillium™ and Macropa™, enable the imaging, discovery and advancement of novel radiopharmaceuticals that have first/best-in-class delivery, safety and efficacy properties. The tunable nature of the company's platforms enables the efficient and timely generation of numerous novel radiopharmaceuticals for a broad range of high unmet need in solid tumors. Built to be the radiopharmaceuticals discovery and development partner of choice, Ratio currently collaborates with Bayer and Lantheus.

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MEDICAL

Alterity Therapeutics Launches ATH434 Phase 2 Clinical Trial for the Treatment of Patients with Multiple System Atrophy

Alterity Therapeutics | June 03, 2022

Alterity Therapeutics (ASX: ATH,NASDAQ: ATHE) ("Alterity" or "the Company"), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced the Company's Phase 2 clinical trial of ATH434 for the treatment of patients with Multiple System Atrophy (MSA) is now open for enrolment in New Zealand. MSA is a rare neurodegenerative disease. While it is similar to Parkinson's disease, MSA progresses more rapidly and causes profound disability. In addition to the motor symptoms characteristic of Parkinson's disease, MSA manifests with more severe autonomic nervous system impairment resulting in bladder dysfunction and the inability to maintain normal blood pressure, as well as uncoordinated or clumsy movements that contribute to falling. Currently available treatments only address certain symptoms of MSA. There are no therapies that slow disease progression and there is no cure. ATH434 is designed to reduce the toxic accumulation of α-synuclein, a pathological hallmark of MSA, and preserve nerve cells by restoring normal iron balance in the brain. Therefore, ATH434 has the potential to address the underlying pathology of the disease and preserve function in individuals with MSA. The advancement of our ATH434 program underscores our commitment to bring a much needed treatment to individuals with MSA, The opening of enrolment for our Phase 2 in New Zealand is an important first step for this clinical program, and I am grateful to our team and our investigators who supported the launch of the trial. Over the course of this year, we will expand the trial into other regions globally." David Stamler, M.D., Chief Executive Officer, Alterity. About ATH434 Phase 2 Clinical Trial The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled investigation of TH434 in patients with early-stage MSA. The study will explore the effect of ATH434 treatment on imaging and protein biomarkers, such as aggregating α-synuclein and excess iron, which are important contributors to MSA pathology. Clinical and biomarker endpoints, including use of wearable sensors, will permit comprehensive assessment of ATH434 efficacy along with characterization of safety and pharmacokinetics. The use of wearable sensors will allow evaluation of motor parameters that are important in patients with MSA. The study is expected to enroll approximately 60 adult patients to receive one of two doses of ATH434 or placebo. About ATH434 Alterity's lead candidate, ATH434, is the first of a new generation of small molecules designed to inhibit the aggregation of pathological proteins implicated in neurodegeneration. ATH434 has been shown preclinically to reduce α-synuclein pathology and preserve nerve cells by restoring normal iron balance in the brain. In this way, it has excellent potential to treat Parkinson's disease as well as various forms of atypical Parkinsonism such as Multiple System Atrophy (MSA). ATH434 has successfully completed a Phase 1 clinical trial demonstrating the agent is well tolerated, orally bioavailable, and achieved brain levels comparable to efficacious levels in animal models of MSA, with the objective of restoring function in patients with MSA and other Parkinsonian disorders. About Multiple System Atrophy Multiple System Atrophy (MSA) is a rare, neurodegenerative disease characterized by failure of the autonomic nervous system and impaired movement. The symptoms reflect the progressive loss of function and death of different types of nerve cells in the brain and spinal cord. It is a rapidly progressive disease and causes profound disability. MSA is a Parkinsonian disorder characterized by a variable combination of slowed movement and/or rigidity, autonomic instability that affects involuntary functions such as blood pressure maintenance and bladder control, and impaired balance and/or coordination that predisposes to falls. A pathological hallmark of MSA is the accumulation of the protein α-synuclein within glia, the support cells of the central nervous system, and neuron loss in multiple brain regions. MSA affects approximately 15,000 individuals in the U.S., and while some of the symptoms of MSA can be treated with medications, currently there are no drugs that are able to slow disease progression and there is no cure1.

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INDUSTRIAL IMPACT

Lygos and Flexible Solutions International Announce Registration Statement on Form S-4 Related to Proposed Merger

Lygos Inc | July 26, 2022

Lygos Inc., a vertically integrated biotechnology provider of sustainable specialty ingredients, and Flexible Solutions International Inc. a developer and manufacturer of biodegradable products, today announced that FSI has filed a registration statement on Form S-4 with the U.S. Securities and Exchange Commission on July 25, 2022 in connection with its proposed merger with Lygos. On April 18, 2022, Lygos and FSI announced a definitive merger agreement in an all-stock transaction to form a leading sustainable specialty ingredient company for agricultural, industrial, and consumer applications. The merger transaction followed a fully funded $160 million of growth capital investment in Lygos. The agreement has been unanimously approved by the boards of directors of both companies and is subject to, among other things, the approval of Lygos and FSI stockholders and the satisfaction or waiver of other customary closing conditions. FSI is an environmental technology company involved in research, development, and manufacturing of supplies that are designed to increase crop yield, conserve energy, and reduce environmental impact. Lygos’ proprietary fermentation technology platform, which utilizes the latest advances in bioengineering and data science to convert sustainable sugars into multi-functional organic acids, helps improve the performance of FSI’s biodegradable, water-soluble cleaning and water treatment solutions. These bio-based ingredients are designed to make existing products more sustainable, while also offering performance, supply chain, and environmental advantages over traditional industrial chemicals. The registration statement on form S-4, which contains a preliminary proxy statement/prospectus, is available on the SEC’s website at www.sec.gov. These documents contain important information about Lygos, FSI, and the proposed acquisition. The registration statement has not yet become effective and the information contained therein and in the preliminary proxy statement/prospectus is subject to change. About Lygos Lygos has created a biological engineering platform focused on sustainable production of organic acid bio-monomers. Lygos’ bio-based ingredients offer alternatives to traditional industrial suppliers, enabling customers to create better, environmentally safer products. Participants in the Solicitation FSI and its directors and executive officers and Lygos and its directors and executive officers may be deemed to be participants in the solicitation of proxies from the shareholders of FSI in connection with the proposed transaction. Information regarding the special interests of these directors and executive officers in the proposed merger will be included in the joint proxy statement/prospectus referred to above. Additional information regarding the directors and executive officers of FSI is also included in FSI’s Annual Report on Form 10-K for the year ended December 31, 2021.

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Spotlight

Vaccination is generally considered as one of the greatest public health achievements in industrialized countries during the 20th century, reducing morbidity and mortality from a broad range of vaccine-preventable diseases. Globally, over 5.9 million deaths are prevented annually through vaccination against nine major infectious diseases, including varicella, diphtheria, tetanus, pertussis, Haemophilus influenzae type b (childhood), hepatitis B, measles, polio, and tuberculosis.

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