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messenger RNA

GreenLight Biosciences and EpiVax Therapeutics Sign Exclusive Collaboration Agreement to Develop Personalized Cancer Vaccines

  • The effort will combine GreenLight’s mRNA design and manufacturing expertise with EpiVax’s advanced Ancer® pipeline for personalized cancer vaccine design
  • EpiVax Therapeutics, Inc. will contribute a proprietary set of immunoinformatics tools for rapidly identifying and differentiating highly immunogenic neo-antigens from epitopes that induce immune tolerance
  • GreenLight will contribute proprietary RNA technology allowing mRNA design, formulation, and manufacturing

BOSTON and PROVIDENCE January 9, 2022: GreenLight Biosciences Holdings, PBC (Nasdaq:GRNA), and EpiVax Therapeutics Inc, today announced that they have signed an exclusive collaboration agreement to jointly develop and commercialize personalized mRNA-based vaccine candidates for cancers.

GreenLight Biosciences is a public benefit corporation striving to bring effective and safe RNA-based solutions to make food clean and affordable for everyone and dedicated to developing health solutions for every person on our planet. EpiVax Theraeutics Inc. is a biotechnology company with extensive experience in immune-engineering more effective vaccines that recently completed an end-to-end computational pipeline for the design of precision cancer immunotherapies, Ancer®.

Under this collaboration, the companies will design and develop new personalized mRNA cancer vaccine candidates using GreenLight and EpiVax Therapeutics technology platforms. EpiVax Therapeutics has developed a proprietary computational tool for precision immunotherapy, Ancer®, an end-to-end, automated platform that integrates multiple advanced algorithms into a single pipeline to rapidly design custom therapies for individual cancer patients using each patient’s own tumor genome sequence as the starting point for the vaccine design. The Ancer® algorithms include two extensively validated tools, EpiMatrix® and JanusMatrix™, which, when used together, identify the most immunogenic CD8 and CD4 neoepitopes while excluding potentially tolerogenic epitopes that may reduce vaccine efficacy. EpiVax Therapeutics was the first personalized vaccine company to use computational tools to identify tolerogenic epitopes in neoantigens and to exclude these from cancer vaccine designs. EpiVax Therapeutics’ pipeline currently includes vaccine design capacity for bladder cancers and other solid tumors.

GreenLight’s mRNA design, formulation and manufacturing expertise is currently applied to research and develop mRNA vaccine candidates, including a collaboration with the NIH to develop a next generation Covid vaccine, and a multi-target license agreement with Serum Institute of India, which includes developing a shingles vaccine candidate. GreenLight has also completed two commercial-scale engineering runs manufacturing mRNA at scale, in partnership with Samsung Biologics. This includes production of drug substance and lipid nanoparticle formulation to produce bulk drug product in a single facility, producing 650g of mRNA.

Together, GreenLight and EpiVax Therapeutics will leverage their respective expertise and jointly develop and commercialize potential novel personalized mRNA-based vaccine candidates for a wide range of oncology indications.

“We are delighted to partner with EpiVax Therapeutics, to expedite development of personalized cancer vaccine candidates using GreenLight’s RNA platform.” said Andrey Zarur, CEO of GreenLight. “We are excited to combine our mRNA design and manufacturing expertise with EpiVax Therapeutics’ neoantigen discovery platform and oncology expertise to build towards a future of accessible and timely oncology vaccines”

EpiVax Therapeutics CEO, Nicole Ruggiero, added, “I am excited by what lies ahead. We have found the ideal partner for our personalized vaccine program in GreenLight Biosciences. Combining our advanced Ancer pipeline for personalized cancer vaccine design with GreenLight’s expertise in mRNA production is a win-win for the companies and for cancer patients.”

About EpiVax Therapeutics:

EpiVax Therapeutics, Inc. is a privately-held biotechnology company focusing on developing precision cancer immunotherapies. Incorporated in 2017, EpiVax Therapeutics spun-out of EpiVax Inc., a privately held immunoinformatics and vaccine design company founded by Dr. Annie De Groot and Mr. Bill Martin in 1998. EpiVax Therapeutics’ personalized vaccine design platform, Ancer®, incorporates the world-class EpiMatrix® system and the innovative JanusMatrix™ tool, which were exclusively licensed to EpiVax Therapeutics for use in Ancer, by EpiVax. The Ancer® platform is an end-to-end, biopsy-to-vaccine design platform that reduces the time required to develop personalized vaccines to hours rather than days while uncovering the most immunogenic neoantigens for precision cancer immunotherapy. More information about EpiVax Therapeutics is available at www.epivaxtx.com/

About GreenLight:

Founded in 2008, GreenLight aims to address some of the world’s biggest problems by delivering on the full potential of RNA for human health and agriculture. In human health, this includes messenger RNA vaccines and therapeutics. In agriculture, this includes RNA to protect honeybees and a range of crops. The company’s breakthrough cell-free RNA platform, which is protected by numerous patents, allows for cost-effective production of RNA. GreenLight’s human health product candidates are in the pre-clinical stage, and its product candidates for the agriculture market are in the early stages of development or regulatory review. GreenLight is a public benefit corporation that trades under the ticker GRNA on Nasdaq. For more information, including our latest investor presentation and other materials, please visit https://www.greenlightbiosciences.com/.

Availability of Other Information About GreenLight Biosciences

Investors and others should note that we communicate with our investors and the public using our website (www.greenlightbiosciences.com), the investor relations website (https://investors.greenlightbio.com/), and on social media (Twitter and LinkedIn), including but not limited to investor presentations and investor fact sheets, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that GreenLight posts on these channels and websites could be deemed to be material information. As a result, GreenLight encourages investors, the media, and others interested in GreenLight to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on GreenLight’s investor relations website and may include additional social media channels. The contents of GreenLight’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.

Forward Looking Statements 

Certain statements in this press release may constitute “forward-looking statements” for purposes of the federal securities laws. Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, including those relating to the success, timing of and costs associated with the strategic collaboration, the success, cost and timing of our research and development activities in our plant and human health programs, the acceptance of RNA-based technologies by regulators and the public, our ability to raise and productively deploy capital and the rate at which we can successfully bring products to market, our projected cash runway and our ability to obtain funding for our operations when needed. Forward-looking statements include statements relating to our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting us will be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described under the heading “Risk Factors” in the Company’s most recent Annual Report on Form 10-K filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors included in our Quarterly Reports on Form 10-Q, periodic filings on Form 8-K, and any of our future filings with the SEC. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Some of these risks and uncertainties may in the future be amplified by current macroeconomic conditions and the ongoing COVID-19 pandemic and there may be additional risks that we consider immaterial, or which are unknown. It is not possible to predict or identify all such risks. Our forward-looking statements only speak as of the date they are made, and we do not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. For additional information on GreenLight and potential risks associated with investing, please see our public filings at: https://investors.greenlightbio.com/financial-information/sec-filings.

Contacts (GreenLight):

Media Contact:

Thomas Crampton

SVP Corporate Affairs

GreenLight Biosciences

[email protected]

Investor Contact: 

Ingrid Fung

Director, Enterprise Operations and Strategy & Head of Investor Relations

GreenLight Biosciences

[email protected] 

Financial tables and further information, including regulatory filings, can be found on our website at https://investors.greenlightbio.com/

Contacts (Epivax Therapeutics):

Guilhem Richard

CTO, EpiVax Therapeutics, Inc.

[email protected]

Nicole Ruggiero

CEO, EpiVax Therapeutics, Inc.

[email protected]

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Nature: mRNA printers kick-start personalized medicines for all

GreenLight Biosciences has been profiled in Nature Biotechnology magazine as a pioneer of mRNA printers, which can produce low-cost vaccines and made-to-order treatments for a range of different diseases.

Greenlight Biosciences uses cell-free microbial lysates to manufacture mRNA. The company has adapted its inexpensive small interfering RNA production technology for insect and fungal pathogen control in agriculture and apiculture to human health applications. “We use microbial strains to produce the building blocks of RNA,” says cofounder and CEO Andrey Zarur.

Read the full article here.

Find out more about how GreenLight manufactures RNA.

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EndPoints: GreenLight Biosciences celebrates manufacturing milestone

GreenLight Biosciences first commercial-scale engineering run of its Covid-19 vaccine booster candidate with Samsung was reported in EndPoints News as a manufacturing milestone. In an interview with the publication, GreenLight CEO Andrey Zarur said:

“The beauty of our platform is that once we have that we have ensured that whatever the leading candidate is that we liked at that microscopic scale is fully scalable to produce hundreds of millions of doses very rapidly,” he aid. “So, the value of the manufacturing platform itself gets amplified, if you will, by the fact that we have this upstream discovery engine.”

Read the full article here.

Find out more about how GreenLight manufactures RNA.

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GreenLight Biosciences and Samsung Biologics complete first commercial-scale engineering run for mRNA Covid-19 vaccine

●  GreenLight’s messenger RNA production process is transferable to large-scale equipment and CMO facilities​

●  Technology transfer and scale-up from lab bench to Samsung’s commercial facility was completed in seven months

●  GreenLight’s mRNA synthesis reaction had a titer of 12g/L at a commercial scale and produced 650g of mRNA

●  The mRNA synthesis reaction was achieved without the need for customization, using standard equipment for Contract Development and Manufacturing Companies (CDMO)

●  Commercial-scale run has demonstrated production—in a single facility—of both Drug Substance and LNP formulation, allowing the production of bulk Drug Product

Boston and Incheon, S. Korea, August 1, 2022—GreenLight Biosciences (Nasdaq: GRNA), a biotechnology company dedicated to making ribonucleic acid (RNA) products affordable and accessible for human health and agriculture, and Samsung Biologics (KRX: 207940.KS), a leading global CDMO providing fully integrated end-to-end contract development and manufacturing services, announced the successful completion of the first commercial-scale engineering run for the companies’ mRNA production partnership.

Since the announcement of the strategic partnership between GreenLight Biosciences and Samsung Biologics in late 2021, technology transfer and scale-up from the lab bench to Samsung’s commercial facility was completed in seven months, demonstrating platform adaptability and scalability.

GreenLight’s process—from drug substance and lipid nanoparticle formulation to bulk drug product—can be completed in the same facility, an important capability. GreenLight’s mRNA synthesis reaction had a titer of 12g/L at commercial scale and produced 650g of mRNA.

The company’s RNA platform allowed GreenLight to move from conceptualizing an mRNA vaccine to delivering released clinical trial material in less than two years. With the demonstration at Samsung, and with GreenLight’s Covid booster vaccine clinical trial expected to start in 2022, GreenLight would be capable of supplying mRNA vaccine at a commercial scale.

“This demonstrates a major achievement in our continuing goal to offer one-stop end-to-end mRNA production from Drug Substance to Aseptic Fill Finish to commercial release, all from a single site, as we strive across our biomanufacturing network to fight the pandemic,” said John Rim, CEO and President at Samsung Biologics.

Earlier this year, Samsung Biologics completed the expansion of its mRNA drug substance manufacturing suite at its Songdo headquarters, where the company is now fully equipped to provide end-to-end mRNA production for clients.

“One of the greatest challenges when producing quality pharmaceuticals is advancing from a small lab to large-scale commercial production,” said GreenLight CEO Andrey Zarur. “We are grateful for the help and support of Samsung in demonstrating that our small mRNA process can scale in a linear fashion to the industrial scale that will be needed to help satisfy the vaccine needs of humanity.”

To date, all comparability data conforms with expected outcomes, indicating successful scale up and fit of GreenLight’s process to Samsung Biologics’ Songdo facility. A second engineering run will start in August, to implement improvements indicated by the first run and to demonstrate repeatability at scale​.

About GreenLight Biosciences

GreenLight Biosciences aims to address some of the world’s biggest problems by delivering on the full potential of RNA for human health and agriculture. Our RNA platform allows us to research, design, and manufacture for human, animal, and plant health. In human health, this includes messenger RNA vaccines and therapeutics. In agriculture, this includes RNA to protect honeybees and a range of crops. The company’s platform is protected by numerous patents. GreenLight’s human health product candidates are in the pre-clinical stage, and its product candidates for the agriculture market are in the early stages of development or regulatory review. GreenLight is a public benefit corporation that trades under the ticker GRNA on Nasdaq. For more information, visit https://www.greenlightbiosciences.com/

GreenLight Biosciences contact:

David Pesci

Head of Media Relations

[email protected]

For press, email: [email protected]

For investors, email: [email protected]

About Samsung Biologics Co., Ltd.

Samsung Biologics (KRX: 207940.KS) is a fully integrated CDMO offering state-of-the-art contract development and manufacturing services. With proven regulatory approvals, the largest capacity, and the fastest throughput, Samsung Biologics is an award-winning partner of choice and is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide. For more information, visit samsungbiologics.com.

Samsung Biologics contact:

Claire Kim

Senior Director of Global Marketing Communications

[email protected]

Notes to editors

  1. GreenLight and Samsung Biologics announced their partnership in December 2021:
    https://greenlightbiosciences.com/greenlight-biosciences-and-samsung-biologics-announce-collaboration/
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Bloomberg: Honeybees Find Lifeline in Covid Tech

GreenLight Biosciences features in Bloomberg for its use of Covid RNA technology to target parasites partly blamed for the honeybee crisis. Extracts from the article are below:

Technology used to develop Covid-19 vaccines may also help combat a honeybee-killing pest.

GreenLight Biosciences is developing an RNA-based syrup to attack varroa mites, a parasite that attaches itself to honeybees and feeds off them while spreading diseases. The RNA acts as an “off switch” that interferes with the mites, disrupting their ability to lay offspring that attach to bees, said Mark Singleton, chief commercial officer and general manager of plant health at the Boston-based firm.

Read the full article here.

Find out more about how GreenLight manufactures RNA.

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Scientific American: Lessons for a Plant Pandemic

GreenLight Biosciences is referred to in Scientific American in its piece asking “What Did COVID Teach Us about Preparing for a Plant Pandemic?”.

GreenLight Biosciences is a part of the effort to address the plant pandemic by tackling diseases and mutations faster than is possible with conventional pesticides or processes. An extract from the article is below:

Establish libraries for rapid screening and optimization: Genetic libraries have been fundamental to synthetic biology innovation because they permit the rapid construction and evaluation of diverse populations of genetic variants. The same framework applies to biofungicides; we can screen thousands to millions of variants to identify and optimize those that selectively interfere with a given pathogen. Once we know that a specific agent can disrupt a disease, we can develop the means to deliver the solution, whether it’s through an engineered microbe (as we are doing at Joyn Bio) or biomolecules like RNA (pursued by GreenLight Biosciences) and proteins (such as Biotalys’ antibody technology).

Read the full article here.

Find out more about how GreenLight manufactures RNA.

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YonHap: GreenLight in mRNA deal with Samsung Biologics

Greenlight Biosciences’ deal with Samsung Biologics to establish a one-stop production capability for manufacturing messenger RNA (mRNA) vaccines was reported by Yonhap News Agency.

Samsung has completed the addition of the new mRNA vaccine substance production capability at its plant in Songdo, Incheon, 40 kilometers west of Seoul, and began producing drug substances for COVID-19 vaccines of GreenLight Biosciences Inc. of the United States late last month.

Samsung Biologics, a leading contract development and manufacturing organization (CDMO), signed a drug substance supply agreement with the American biotech company last year

Read the full article here.

You can read more about our deal with Samsung Biologics in this article by BioProcess.

Find out more about how GreenLight manufactures RNA.

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Co-developer of COVID-19 Vaccine Joins GreenLight Advisory Board

Dr. Graham is an author on more than 500 scientific publications and a thought leader on emerging viral diseases and pandemic preparedness. He was involved in the advanced evaluation of vaccines and monoclonal antibodies for HIV, Ebola, and Chikungunya. He also developed novel vaccines for RSV, influenza, Zika, paramyxoviruses, and coronaviruses including the first COVID-19 vaccine and monoclonal antibody to enter clinical testing and that subsequently achieved Emergency Use Authorization and licensure.

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EndPoints: Q&A with GreenLight CEO Andrey Zarur

GreenLight Biosciences CEO, Andrey Zarur, is interviewed by Endpoints News.

He outlines how he is determined not to repeat the mistakes from the last pandemic and speaks about GreenLight’s latest deal with the Serum Institute.

Can you talk to me about how you’ve identified the shingles vaccine as a key area of focus?

[Shingles] can be dangerous and is extraordinary painful. [A shingles vaccine] is a huge unmet need, there are billions of people who are at risk of shingles who don’t have a solution, and of course there is no established business model. So we’re focused on a major need that’s likely to affect everybody over the age of 60.

Read the full article here.

Find out more about how GreenLight manufactures RNA.

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