RESEARCH

Evelo Biosciences Presents Data on EDP1815 Mechanism of Action and Supporting Ongoing Clinical Development for Inflammatory Diseases

Evelo Biosciences, Inc. | January 18, 2022

Evelo Biosciences, Inc. a clinical stage biotechnology company developing SINTAX™ medicines as a new modality of orally delivered treatments for inflammatory disease, today announced data for EDP1815, the Company’s lead product in inflammation, detailing its mechanism of action and supporting further clinical development in patients with psoriasis and atopic dermatitis. The data were presented in two posters on Saturday, January 15, 2022, at the 2022 Winter Clinical Dermatology Congress in Koloa, Hawaii.

The data presented today build on the substantial evidence accumulated through our clinical and preclinical work, deepening our understanding of the mechanism by which EDP1815 drives its clinical effects. They explain how an oral, gut-restricted SINTAX medicine can interact with the immune system in the gut, leading to systemic inflammation resolution without immunosuppression or concerning side-effects. We are particularly pleased to share these results with the clinical community as we progress EDP1815 into later stages of development for the treatment of psoriasis and atopic dermatitis, two inflammatory diseases that affect millions of people worldwide.”

 Douglas Maslin, M.Phil, M.B. B.Chir, Dermatology and Pharmacology Physician at Addenbrooke’s Hospital and Immunology Clinical Lead of Evelo

Preclinical data from the studies presented at the Winter Clinical Dermatology Congress confirm that EDP1815 modulates systemic inflammation through its initial interaction with innate immune receptors, including TLR2, leading to downstream changes in circulating immune-cell phenotypes. In addition, the data demonstrate that preclinical effects in Th17 models translate into signs of clinical benefit in psoriasis, and that preclinical effects in Th2 models translate into signs of clinical benefit in atopic dermatitis, supporting further clinical development of EDP1815 in these indications. A Phase 2 study of EDP1815 in patients with mild to moderate psoriasis is ongoing, and a Phase 2 study of EDP1815 in patients with mild, moderate, and severe atopic dermatitis is expected to initiate dosing in the first quarter of 2022.

About EDP1815
EDP1815 is an investigational oral medicine being developed for the treatment of inflammatory diseases. It is a non-live pharmaceutical preparation of a strain of Prevotella histicola, selected for its potential to provide systemic pharmacological effects after oral administration with gut-restricted distribution. Being non-live, it has not been observed to colonize the gut or modify the microbiome. Preclinically, EDP1815 had anti-inflammatory effects in models that cover multiple pathways of inflammation, Th1, Th2, and Th17. Clinical results from multiple independent cohorts provide evidence supporting EDP1815’s potential to address Th1, Th2 and Th17-mediated inflammation.

About Evelo Biosciences
Evelo Biosciences is a clinical stage biotechnology company developing orally delivered product candidates that are designed to act on the small intestinal axis, SINTAX™, with systemic therapeutic effects. SINTAX plays a central role in governing the immune, metabolic, and neurological systems. The Company’s first product candidates are pharmaceutical preparations of single strains of microbes selected for their potential to offer defined pharmacological properties. Evelo’s therapies have the potential to be effective, safe, and affordable medicines to improve the lives of people with inflammatory diseases.

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DIAGNOSTICS

Exothera announces industrial scale AAV manufacturing collaboration with LogicBio Therapeutics and Polyplus

Exothera | June 15, 2022

Exothera SA today announced a collaboration with LogicBio® Therapeutics and Polyplus-transfection® SA. for the development of a highly scalable AAV manufacturing platform with a capacity from 200 L to 2,000 L. Adeno-associated viruses (AAV) are non-enveloped, non-pathogenic viruses largely used as drug delivery vectors for biotherapeutics, like gene therapies and vaccines. Although the application of AAV is spreading rapidly, the industry is struggling to find cost-effective manufacturing strategies to reach clinical and commercial scales. The collaboration among Exothera, LogicBio, and Polyplus aims to focus on the scale-up of a transient transfection-based AAV serotype 8 (AAV8) manufactured in suspension cell culture. The consortium selected the Allegro™ stirred tank Single-Use Bioreactor (from Pall) as a suspension culture device due to its scalability and single-use features. The project aims to assess reproducibility and comparability between the different scales of suspension bioreactors, up to 2,000 L bioreactor scale. Exothera will provide state-of-the-art production space, process development expertise and access to the latest enabling technologies. LogicBio will support the initiative with its mAAVRx™ plasmid technology and its AAV expertise. Polyplus will provide transfection reagent expertise with FectoVIR®-AAV for a smooth scaled-up GMP-eligible process development. Exothera's team is proud to work with the experienced teams at biotech companies like LogicBio and Polyplus. The success of AAV-based therapeutics requires a change in the manufacturing paradigm and through this collaboration, we aim to enable a new approach to consistently scale AAV manufacturing." Hanna Lesch, Chief Technology Officer at Exothera: " We are excited to collaborate with Exothera, an emerging leader in the CDMO industry and with Polyplus, a long-time transfection partner, for implementing an AAV manufacturing process at 200L scale and above. We believe our proprietary mAAVRx™ plasmid technology could dramatically help to improve manufacturing yields and consequently reduce AAV manufacturing costs. We are hopeful that the work done under this collaboration will be an important step forward in making gene therapy products accessible for a greater number of patients.". Matthias Hebben, Global Vice President, Technology Development at LogicBio. We are delighted to scale up AAV Viral vector Manufacturing processes to larger bioreactor volumes with innovators in the industry like Exothera and LogicBio. At Polyplus we aim to improve gene-therapy viral vector manufacturing economics by increasing titers in the upstream processes using novel transfection reagents like FectoVIR®-AAV. The collaboration will use a combination of state-of-the-art manufacturing technologies, innovative plasmid technologies and scalable transfection reagents which will make gene-therapy viral vector therapies affordable". Roel Gordijn, Chief commercial Officer at Polyplus. Exothera specializes in the industrialization of vaccine and gene therapy processes. It has recently performed successful viral vector manufacturing scale-up studies in adherent and suspension cell systems helping its clients to reach the clinical trial scale. Additionally, the team is operating and continuously improving its own GMP manufacturing platform, exoREADY, for viral vector-based gene therapies and vaccine production. About Exothera SA Exothera is a viral vector CDMO (contract manufacturing and development organization) using standard and innovative bioproduction platforms to rapidly deliver affordable viral vector-based vaccines and cell and gene therapies. As a Univercells company, Exothera capitalizes on novel manufacturing technologies and best-in-class bioprocessing expertise to provide custom-made process optimization and GMP clinical and commercial production of viral vectors. Based on its extensive technology expertise, Exothera selects technologies to optimally answer customer needs for cost-effective and agile viral vector manufacturing and provides QC services and analytical development. About LogicBio® Therapeutics LogicBio® Therapeutics is a clinical-stage genetic medicine company pioneering genome editing and gene delivery platforms to address rare and serious diseases from infancy through adulthood. The company's genome editing platform, GeneRide®, is a new approach to precise gene insertion harnessing a cell's natural DNA repair process potentially leading to durable therapeutic protein expression levels. The company's gene delivery platform, sAAVy™, is an adeno-associated virus (AAV) capsid engineering platform designed to optimize gene delivery for treatments in a broad range of indications and tissues. The company's proprietary system, mAAVRx™, aims to overcome some of the current limitations of AAV manufacturing by optimizing the transfection process to improve yields and product quality. The company is based in Lexington, MA.

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OPKO Health Acquires ModeX Therapeutics, Gains Proprietary Immunotherapy Technology with a Focus on Oncology and Infectious Diseases

OPKO Health | May 10, 2022

OPKO Health, Inc. (NASDAQ: OPK), a multinational biopharmaceutical and diagnostics company, today announced the acquisition of ModeX Therapeutics, Inc. a privately held biotechnology company focused on developing innovative multi-specific immune therapies for cancer and infectious diseases. OPKO acquired ModeX for $300 million in OPKO common stock. Founded in October 2020 with headquarters in Natick, Mass., ModeX Therapeutics has developed highly flexible multi-specific antibody technology platforms with broad targeting and functional capabilities, simpler manufacturing and potentially better specificity and safety, providing significant differentiation from competing platforms. The design of these multi-specifics is amenable to gene-based delivery by mRNA or DNA vectors. The ModeX product portfolio includes cancer immunotherapies that combine four specificities into one protein to improve targeting and immune killing, as well as masking or “stealth” technology to improve tumor-specific killing and reduce side effects. For viral diseases, the lead targets of a broad and potent multi-specific antibody portfolio include HIV and SARS-CoV-2. A vaccine for Epstein-Barr virus is also in development. The acquisition of ModeX Therapeutics significantly broadens our technology foundation and expands our product pipeline to include multi-specific multi-functional antibodies focused on a range of cancers and infectious diseases, with applicability to other therapeutic areas. We believe the promise of better outcomes for patients treated with these multi-specific antibodies represents a next generation of large molecule therapeutics and the next chapter of OPKO, We welcome ModeX’s co-founders Dr. Zerhouni and Dr. Nabel, as well as Alexis Borisy to our Board of Directors, and Dr. Zerhouni and Dr. Nabel to OPKO’s executive management team. The ModeX executive team brings to OPKO a wealth of experience, knowledge and industry contacts, which we expect will have a tremendous long-term positive impact on OPKO as we advance their technology and product pipeline and leverage potential synergies with our current portfolio in diagnostics and therapeutics.” Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO. Elias Zerhouni, M.D., Co-Founder and Chairman of the Board of ModeX, has been appointed President and Vice Chairman of the Board of Directors of OPKO. Dr. Zerhouni brings extensive experience in academia, government and industry as a leading authority on emerging trends and issues in medical care and biomedical research and development. A physician scientist with an academic background in imaging and biomedical engineering, Dr. Zerhouni most recently served as President of Global Research & Development and Executive Vice President of Sanofi. Dr. Zerhouni also served as Director of the National Institutes of Health (NIH), Senior Fellow for Global Health Research at the Bill and Melinda Gates Foundation, Presidential U.S. Envoy for Science and Technology, and Professor and Chair of the Russell H. Morgan Department of Radiology and Biomedical Engineering, Executive Vice Dean and Dean for Research at the Johns Hopkins School of Medicine. Dr. Zerhouni was elected to the National Academy of Medicine and to the National Academy of Engineering. He serves on the Board of the Lasker Foundation, the Foundation for NIH, the Davos Alzheimer’s Collaborative and Research!America. He received the 2017 Scripps Executive of the Year Award for the pharmaceutical industry and the French Legion of Honor in 2008. He has been a director of Danaher Corporation since 2009. Being part of OPKO represents a transformative opportunity for both companies. We anticipate it will accelerate ModeX’s product pipeline focused on unmet needs in oncology and infectious diseases and the development of our innovative technologies, and also will take advantage of synergies with OPKO’s programs, ModeX has operated quietly since we were founded 18 months ago on the basis of over 10 years of prior foundational work. We have assembled a world-class executive team with outstanding public and private sector leadership experience to advance our programs. Our lead drug candidate is already in the clinic while several others in late preclinical stages are expected to enter clinical development in 2023. We were enticed to join OPKO by its leadership’s vision and enthusiasm for strengthening our mutual potential for breakthrough innovation.” Dr. Zerhouni. Gary Nabel, M.D., Ph.D., Co-Founder, President and Chief Executive Officer of ModeX, has been appointed Chief Innovation Officer of OPKO and joins OPKO’s Board of Directors. Dr. Nabel, a renowned virologist and immunologist, served as Chief Scientific Officer and Senior Vice President of Sanofi where he directed the breakthrough laboratory that developed tri-specific products now in early clinical development. He is the founding director of the NIH’s Vaccine Research Center, working on vaccines and broadly neutralizing antibodies against HIV, influenza, SARS, Ebola, Chikungunya and Epstein-Barr virus. He was previously an investigator at the Howard Hughes Medical Institute at the University of Michigan. In recognition of his expertise at the forefront of virology, immunology, gene therapy and molecular biology, Dr. Nabel was elected to the National Academy of Medicine, is a fellow of the American Association of Physicians and the American Academy of Arts Sciences, and was awarded the Geoffrey Beene Builders of Science Award from Research!America. Alexis Borisy, the Lead Independent Director of ModeX, also joins OPKO’s Board of Directors. Mr. Borisy is a leading biotechnology entrepreneur and investor with more than 25 years of experience, including founding, serving as Chief Executive Officer and/or Chairman of nine NASDAQ-listed companies. He co-founded and served as either the Chief Executive Officer or Chairman of Blueprint Medicines, Foundation Medicine, Relay Therapeutics, Tango Therapeutics, Celsius Therapeutics and CombinatoRx. With the additions of Dr. Zerhouni, Dr. Nabel and Mr. Borisy to OPKO’s Board, the number of Directors expands to 13. About OPKO Health, Inc. OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies.

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CELL AND GENE THERAPY

Enzychem Lifesciences Announces Formation of Corporate Advisory Committee

Enzychem Lifesciences | March 03, 2022

Enzychem Lifesciences a clinical-stage biotechnology company, announced today the formation of its Corporate Advisory Committee. Composed of four eminent physicians, its mission is to support and guide corporate activities including technology transfer for its lead compound, EC-18, seeking strategic partnerships, and preparing U.S. phase 3 clinical trials to successfully commercialize EC-18. After the completion of its phase 2 U.S. clinical trial with EC-18 in Chemoradiation–induced Oral Mucositis (CRIOM), Enzychem is actively negotiating licensing deals with several partnering candidates while also preparing a phase 3 trial under a US FDA IND. To reinforce such corporate initiatives, and to start supporting the company’s next stage activities, Enzychem has formed the Corporate Advisory Committee. Enzychem Lifesciences recognizes the need for engagement of key opinion leaders at an earlier stage in the process of developing new therapeutics for a large population with high unmet needs such as Chemoradiation-induced Oral Mucositis (CRIOM). Enzychem is proactively bringing more experts to the company to strengthen its new drug development capabilities. The newly appointed corporate advisors will actively influence the development of strong business strategies to successfully meet corporate objectives. The four physicians appointed are Dr. Alexander Fleming, a former FDA reviewer and supervisory medical officer, as head of the metabolic group, Dr. Frank Castellana, a market value assessment expert, Dr. Joe McMenamin, a health lawyer, and Dr. Richard Hamrick, a former healthcare provider executive. Based on their extensive experience, the corporate advisors will assist Enzychem in accomplishing its business milestones. For two years, until 2018, Dr. Fleming served as Enzychem’s Chief Technology Officer (CTO). During his term, Dr. Fleming had recommended CRIOM as the lead indication for EC-18 and introduced Dr. Steve Sonis of Harvard School of Dental Medicine as Enzychem’s key advisor for the U.S. phase 2 CRIOM Study. Enzychem Lifesciences is a clinical-stage biopharmaceutical company focused on developing oral small molecule therapies for patients with unmet medical needs in oncology, metabolic, and inflammatory diseases. Founded in 1999, the company’s lead compound, EC-18, acts as an immunomodulator, facilitating the resolution of inflammation and the early return to immune homeostasis. Enzychem is headquartered in South Korea, with an office in the United States.

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CELL AND GENE THERAPY

c-LEcta Continues Its Growth in 2021 and Sees Itself Excellently Positioned for the Future With the ENESYZ Technology Platform

c-LEcta | December 20, 2021

c-LEcta, a global biotechnology company with technology leadership in enzyme engineering and bioprocess development, continued its growth in 2021. The high expectations for the fiscal year have been fully met and were even significantly exceeded. Thus, the management expects annual revenue in the range of EUR 20 million, which equates to a doubling of last year’s result. With an expanded team, further investments in the product range and the ENESYZ technology platform are expected to keep up the pace of growth in the coming year. The continued growth confirms the Leipzig-based company’s strategy of placing its development on a solid foundation with a broad range of specialized enzymes for the pharmaceutical and food industries. With average revenue growth of 56% from 2018 to 2020 and further growth expected to reach around EUR 20 million in 2021, even during the Covid-19 pandemic, the business performance illustrates the strength and resilience of this strategy. “We are very proud of our performance in recent years. Our products provide good growth momentum and also great resilience due to the diverse application fields and this has supported us over the last two years. To continue to drive this growth in the long term, we have continued to build our team again this year and now employ 108 people. Moving forward, we plan to continue to invest in additional staff and equipment,” Thomas Pfaadt, CFO of c-LEcta GmbH c-LEcta managed to launch its new product NuCLEANase in October 2021. NuCLEANase is an enzyme that is used to remove unwanted DNA residues, in the food industry, for example, but also helps to dissolve deposits on machines and manufacturing equipment. The high demand from customers already at its launch confirms the high market potential for this product. “NuCLEANnase is an incredibly versatile product that holds great potential. However, the development also demonstrates the versatility of our ENESYZ technology platform, which allows enzyme developments based on different production systems for a wide range of applications. ENESYZ is constantly being further developed. For example, this year we were able to integrate an additional expression host, Bacillus, into our enzyme engineering platform,” explained Dr. Marc Struhalla, founder and CEO of c-LEcta. The company also made significant progress in the area of machine learning and artificial intelligence in 2021. “We were recently able to achieve some very promising results in this innovative area. The topic is a very important building block for future product developments and we are extremely motivated to rapidly expand our expertise in this area,” Dr. Struhalla added. Many new customers were once again acquired over the course of 2021. There was strong demand for the products from the DENARASE family, which also address the gene and cell therapy market. A total of more than 500 mailings were sent out to more than 200 customers from nearly 30 countries. The largest sales market was the USA. The ELISA kit launched in 2020 was also a particular success, with very significant growth in demand in 2021. c-LEcta’s most important markets, the food and pharmaceutical industries, are subject to strict regulations worldwide. An enzyme dossier submitted by c-LEcta facilitates the approval of its products for customers from the food industry. With the filing of a master file with the FDA, c-LEcta supports its customers in terms of regulatory compliance and demonstrates the quality of its manufacturing processes and products. In October, c-LEcta secured itself its own building complex with more than 10,000 m2 of space in the new biotechnology campus that spans a total area of 27,000m2 and is to be built at the “Alte Messe” site in Leipzig starting in the second quarter of 2022. “We want to and will indeed continue to grow. Great new space is being built at Alte Messe, which will allow us to set up state-of-the-art office and laboratory areas for our growing team. This will provide us with the space to continue our growth,” Dr. Struhalla concluded. About c-LEcta c-LEcta is a world-leading biotechnology company with a focus on enzyme engineering and application in regulated markets like the food and pharma industries. The company is based in Leipzig, Germany, and has established itself as a leading player in the realization of high-value biotech products, either in the form of in-house developments or in close cooperation with industry. The company currently employs more than 100 people.

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Sample preparation and processing are often crucial components in immuno-oncology and cell and gene therapy studies. Obtaining timely and high-quality processing services is an industrywwide challenge, particularly within the context of global trials.

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