INDUSTRY OUTLOOK

Tantu and Ginkgo Bioworks Announce Partnership to Engineer a Living Biotherapeutic for Gastrointestinal Healing

Ginkgo Bioworks | September 07, 2021

Tantu, a company engineering living biotherapeutic products to treat gastrointestinal diseases, and Ginkgo Bioworks, which is building the leading horizontal platform for cell programming, today announced a partnership to accelerate the research and development of Tantu's therapeutic genes. Ginkgo, which recently announced a business combination with Soaring Eagle Acquisition Corp., serves customers across industries seeking to develop new and better products using biology.

Tantu is working to create an orally administered, living biotherapeutic that will produce and apply anti-inflammatory therapeutic proteins directly into diseased sites in the gut, resulting in improved gut barrier function and faster mucosal healing in patients where systemic anti-inflammatory therapies are not enough. Ginkgo plans to apply its automated foundry to accelerate the traditionally slow steps of candidate strain construction and genomic integration and validation with the aim of accelerating Tantu's first program and potentially helping them reach clinical proof of concept in patients faster.

"Each year, 62 million Americans are diagnosed with a digestive disorder and current treatments don't sufficiently promote gastrointestinal healing, meaning many patients need to undergo invasive surgeries to improve their quality of life," said Neel Joshi, co-founder of Tantu. "A therapeutic to aid intestinal mucosal healing could transform patient care for a significant patient population."

"We are excited to partner with a pre-seed company like Tantu with the goal of reducing their time-to-market because we view it as an opportunity to invest in the biotech industry through the startups that are driving forward so much innovation," said Jason Kelly, CEO and co-founder of Ginkgo Bioworks. "Working with Tantu provides Ginkgo with the opportunity to leverage its expertise in pharmaceuticals to support the development of a potentially transformative therapeutic for the millions struggling with digestive disorders."

Companies across numerous industries use Ginkgo's cell programming platform to find more effective, environmentally friendly ways to create products including food ingredients, fragrances, cosmetics, medicines, and more. By enabling the design of organisms that can produce valuable biological products, Ginkgo helps accelerate the development of innovative, bio-based solutions to the world's most pressing challenges.

About Tantu Therapeutics
Tantu is developing living biotherapeutic products to treat gastrointestinal diseases. Its lead therapeutic candidate is an engineered microbe that produces anti-inflammatory and healing agents from inside the gut lumen – something that no clinically approved therapeutic currently does. Tantu's local delivery strategy is designed to improve patient outcomes by reducing reliance solely on systemic anti-inflammatory drugs that can suppress the immune system.  Tantu's living biotherapeutic products are being designed to complement proven approaches to further improve patients' health and quality of life.

About Ginkgo Bioworks
Ginkgo is building a platform to enable customers to program cells as easily as we can program computers. The company's platform is enabling biotechnology applications across diverse markets, from food and agriculture to industrial chemicals to pharmaceuticals. Ginkgo has also actively supported a number of COVID-19 response efforts, including K-12 pooled testing, vaccine manufacturing optimization and therapeutics discovery. In May 2021, Ginkgo announced a business combination with Soaring Eagle Acquisition Corp. (Nasdaq: SRNG), which, if completed, will result in Ginkgo, through a parent entity, Ginkgo Bioworks Holdings, Inc., becoming a public company. The extraordinary general meeting of Soaring Eagle's shareholders in connection with the transaction has been scheduled for September 14, 2021 and the transaction is expected to close shortly thereafter, subject to customary closing conditions.

Spotlight

Molecular inclusion complexes using cyclodextrins have become a standard formulation strategy to improve the solubility or stability of active ingredients. Roquette has pioneered the development of betacyclodextrin technology, developing a full range of KLEPTOSE® betacyclodextrins

Spotlight

Molecular inclusion complexes using cyclodextrins have become a standard formulation strategy to improve the solubility or stability of active ingredients. Roquette has pioneered the development of betacyclodextrin technology, developing a full range of KLEPTOSE® betacyclodextrins

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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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MEDICAL

Moderna Announces Supply Agreement with UK Government for Additional 2 Million Doses of mRNA-1273, Moderna’s Vaccine Candidate Against Covid-19

Moderna | November 30, 2020

Moderna, Inc., a biotechnology organization pioneering messenger RNA (mRNA) therapeutics and vaccines to make new generation of transformative medicines for patients, today reported a supply agreement with the UK government for an extra 2 million doses of mRNA-1273, Moderna's vaccine candidate against COVID-19, to the United Kingdom starting in March 2021. The UK government has now made sure about 7 million dosages of mRNA-1273. This confirmation comes as the UK proceeds with its efforts to secure access to safe and effective COVID-19 vaccines by establishing a broad portfolio of the most promising vaccines. On November 16, Moderna reported that the autonomous, NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 investigation of mRNA-1273, its vaccine candidate against COVID-19, has informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%. This study, known as the COVE study, enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.

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MEDICAL

Absci Opens Door to New Biotechnology Campus

Absci | October 23, 2021

Absci Corporation the drug and target discovery company harnessing deep learning AI and synthetic biology to expand the therapeutic potential of proteins, today announced the opening of its new campus located in Vancouver, Washington, a few miles east of the downtown location that housed the company for the last four years. “Absci has been an incredibly positive force in the Vancouver community since establishing its headquarters here in 2016 I have followed Absci’s progress as it expanded within and has now outgrown that initial Vancouver facility. Absci is not only attracting investment and top talent to Washington, it is continuously innovating, creating exciting new possibilities for the future of medicine. I look forward to cutting the ribbon on Absci’s new campus early next month, and to continuing to support the development of our biotechnology ecosystem here in Washington. Washington Governor Jay Inslee The new Absci facility was concepted and constructed in a close collaboration between the company, Portland design firm Bora Architecture & Interiors, and local contractor Bremik Construction. Covering over 85,000 square feet of laboratory, office, and meeting spaces, it features regionally sourced, renewable, and natural building materials, custom finishes, and a vibrant aesthetic. The scalable laboratory space was designed to maximize flow, increase capacity, and readily reconfigure as needed. In addition to tripling capacity for program execution, the incorporation of in-house tissue culture capabilities, high throughput analytical instrumentation, advanced liquid handling and automation, and a dedicated clean air fermentation facility, in conjunction with a state-of-the-art offsite computational cluster, facilitate the expanded scope of Absci’s research and development activities. Additionally, integrated technologies for high volume data capture across Absci’s workflow generate the input for ongoing training of Absci’s Denovium EngineTM deep learning AI models for drug discovery and cell line design. “It’s inspiring to come to work each day in this exceptional building,” said Sean McClain, founder and CEO of Absci. “We designed the light-filled space around collaboration and the pursuit of scientific excellence, and we are thrilled with the pride our Unlimiters feel inhabiting this new campus. We strive every day to bring new insights to challenging problems, and this collaborative setting really encourages all of us to step beyond the impossible to create new possibilities for patients.” “When I visited Absci’s campus, I was impressed by the quality and productivity that imbues the space,” commented Bharat Dixit of ClearB Therapeutics. “The facility is designed with a modern look, yet with practical aspects in mind -- the futuristic gowning rooms, the bright, open lab spaces with lots of natural light and intuitive flow, as well as state-of-the-art robotic equipment, to name a few. And the friendly town hall full of people sharing ideas seems to be a sign of big success ahead.” About Absci Absci is the drug and target discovery company harnessing deep learning AI and synthetic biology to expand the therapeutic potential of proteins. We built our Integrated Drug Creation™ Platform to identify novel drug targets, discover optimal biotherapeutic candidates, and generate the cell lines to manufacture them in a single efficient process. Biotech and pharma innovators partner with us to create the next generation of protein-based drugs, including Bionic Proteins™ containing nonstandard amino acids, and other novel drug designs that may be impossible to make with other technologies. Our goal is to enable the development of better medicines by Translating Ideas into Drugs™. For more information visit www.absci.com. Availability of Other Information about Absci Investors and others should note that we routinely communicate with investors and the public using our website (www.absci.com) and our investor relations website (investors.absci.com), including without limitation, through the posting of investor presentations, SEC filings, press releases, public conference calls and webcasts on these websites. The information that we post on these websites could be deemed to be material information. As a result, investors, the media, and others interested in Absci are encouraged to review this information on a regular basis. The contents of our website, or any other website that may be accessed from our website, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended. Absci Forward-Looking Statements Certain statements in this press release that are not historical facts are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements containing the words “will,” “may,” "pursues," “anticipates,” “plans,” “believes,” “forecast,” “estimates,” “expects,” and “intends,” or similar expressions. We intend these forward-looking statements, including statements regarding drug development efforts, to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act, and we make this statement for purposes of complying with those safe harbor provisions. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies, and prospects, which are based on the information currently available to us and on assumptions we have made. We can give no assurance that the plans, intentions, expectations, or strategies will be attained or achieved, and, furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control, including, without limitation, risks and uncertainties relating to drug development efforts; along with those risks set forth in our Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission on September 7, 2021, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the U.S. Securities and Exchange Commission. Except as required by law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise.

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