Posts tagged:

messenger RNA

GreenLight Biosciences Outlines Development Strategy and Highlights Portfolio Updates at Human Health R&D Day

  • Progressing human health pipeline conferring mRNA platform advantages for infectious disease and personalized oncology medicines; pursuing capital efficient strategy targeting unmet medical needs, in both the developed and lower- and middle-income countries (LMICs), pairing focused R&D spend with partnerships.
  • Accelerating development of next-generation COVID vaccine candidate; decision to advance universal pan-sarbecovirus vaccine candidate in place of mono-valent Wuhan based antigen.
  • Preclinical data on shingles vaccine candidate(s) showing high and durable antibody response, strong cellular T-cell response, and durable memory response.
  • Collaboration with EpiVax therapeutics to develop personalized mRNA cancer vaccine candidates.
  • R&D Day webcast to begin at 10:30 am ET today.

BOSTON, March 9, 2023 —GreenLight Biosciences (Nasdaq: GRNA), a public benefit corporation striving to deliver on the full potential of RNA to address some of the world’s toughest problems in human health and agriculture, will today outline its pipeline strategy and R&D progress for mRNA-based solutions during its Human Health R&D Day being held today, March 9, 2023 at 10:30 a.m. ET in Lexington, MA.

GreenLight today is sharing the key pillars of its human health strategy:

  • Developing vaccines for infectious diseases, especially those addressing unmet medical needs in lower- and middle-income countries.  Consistent with its public benefit corporation status, Greenlight is striving to support global, sustainable vaccine access and pandemic response readiness. 
  • Developing innovative products to address unmet medical needs in oncology and autoimmune diseases.  This work has begun with the collaboration with EpiVax Therapeutics to co-develop personalized cancer vaccines.
  • Continued advancement of GreenLight’s mRNA technology platform through innovations and to seek potential partnerships with pharmaceutical and biotechnology companies.

As previously announced, GreenLight received approval from the Rwanda Food and Drugs Authority (Rwanda FDA) to initiate a Phase I/II study of its GLB-COV2-043 vaccine booster candidate.  However, given the global shift in the standard of care for COVID vaccination to the Wuhan/Omicron bivalent vaccine, and new availability of the bivalent vaccine in Rwanda, GreenLight has decided to proceed with its pan-sarbecovirus vaccine candidate instead of the GLB-COV2-043 (monovalent) vaccine candidate as originally planned.  GreenLight is accelerating the development of its pan-sarbecovirus vaccine candidate that is potentially capable of broader coverage and predictive protection and plans to make a follow-up filing on this candidate to the Rwanda FDA and the Rwanda National Ethics Committee (RNEC).  GreenLight will be working expeditiously and closely with its Rwandan partners to advance these efforts over the coming months and are starting conversations with potential partners in other countries that have expressed interest in supporting its development and clinical path for a broader pan-sarbecovirus vaccine. “We are excited to advance our pan-sarbecovirus vaccine candidate that may allow us to bring a next generation, innovative Covid-19 vaccine to market in Rwanda, and the rest of the world, earlier than we anticipated,” Andrey Zarur, CEO of GreenLight.

Regarding its shingles program, GreenLight is excited to share promising new pre-clinical data.  GreenLight has selected a lead candidate to progress towards clinical development after evaluation of multiple antigen designs and formulations.  Based on pre-clinical data, our lead pre-clinical candidate induced antibody levels and memory B and T cell responses in mouse in vivo studies similar to the current standard of care.  In addition, the pre-clinical data showed that the lead candidate induced T cell responses in mouse in vivo studies stronger than the current standard of care.  This pre-clinical candidate is advancing towards development candidate nomination.  Serum Institute of India Private Limited will be responsible for the clinical development, manufacturing, and commercialization of the vaccine candidate in lower- and middle- income countries under its license agreement with GreenLight Biosciences.  GreenLight retains the clinical development, manufacturing, and commercial rights in the developed world.

GreenLight and EpiVax Therapeutics are partnering to create a proprietary personalized cancer vaccine platform which combines GreenLight’s mRNA design and manufacturing expertise with EpiVax Therapeutic’s neoantigen discovery platform. “We continue to be excited about expediting the development of personalized cancer vaccines in collaboration with EpiVax Therapeutics.” said Kimberly Warren, Chief Business Officer of GreenLight Biosciences. “While our initial focus will be on bladder cancer, the 4th most common cancer in men, we plan on working to shape a pipeline of compelling personalized cancer vaccine candidates that will help build a future of more timely and accessible treatments.”

The human health R&D Day is the second in a series providing comprehensive updates on GreenLight’s R&D strategy and progress. The previous session, which focused on GreenLight’s Plant Health pipeline, was held on Tuesday, March 7, 2023.

A live webcast of the event will be available live and can be accessed via the Investors section of the Company’s website at www.greenlightbiosciences.com. Registration is available here: https://www.greenlightbiosciences.com/rdshowcase/ and a replay of both events will be available at https://investors.greenlightbio.com for approximately 30 days.

About GreenLight Biosciences 

GreenLight Biosciences (Nasdaq: GRNA) 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.

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, cost and timing of our research and development activities in our plant and human health programs, the timing of regulatory submissions and approvals, our ability to commercialize our products, the acceptance of RNA-based technologies by regulators and the public, including the timing it takes to receive regulatory approval, the success, cost and timing of our clinical trials, including estimates regarding when patients will be enrolled, our ability to progress our candidates into the clinic, if at all, the timing to commence future clinical trials, 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://www.sec.gov/edgar/browse/?CIK=1822691&owner=exclude

Contacts:

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] 

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GreenLight Biosciences to Host R&D Day Series on Plant and Human Health Development Strategy

BOSTON, March 1, 2023 —GreenLight Biosciences (Nasdaq: GRNA), a public benefit corporation striving to deliver on the full potential of RNA to address some of the world’s toughest problems in human health and agriculture, today announced it will host a two-part R&D Day Series for analysts and investors.

Session One: Plant Health

  • Date: Tuesday, March 7th, 2023
  • Time: 10:30 a.m. – 1:30 p.m. ET
  • Location: GreenLight Biosciences North Carolina Biotech Center in Research Triangle Park, NC

Session Two: Human Health

  • Date: Thursday, March 9th, 2023
  • Time: 10:30 a.m. – 1:30 p.m. ET
  • Location: GreenLight Biosciences Headquarters in Lexington, MA

The event will provide a comprehensive update on GreenLight’s R&D strategy and progress.

A webcast of both events will be available live and can be accessed via the Investors section of the Company’s website at www.greenlightbiosciences.com. Registration is available here: https://www.greenlightbiosciences.com/rdshowcase/ and a replay of the webcasts will be available at https://investors.greenlightbio.com for approximately 30 days.

About GreenLight Biosciences

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.

Contacts:

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]

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GreenLight Biosciences receives approval to initiate Phase I/II clinical trial of Covid-19 mRNA vaccine candidate 

  • The Rwanda FDA has given regulatory approval to GreenLight to start a Phase I/II clinical trial of its Covid-19 vaccine candidate in Rwanda. 
  • This phase I/II clinical trial is the first step in GreenLight’s integrated strategy of bringing a universal Covid-19 mRNA vaccine to market globally. 
  • By initiating this first-in-human clinical study in Rwanda, GreenLight is demonstrating its commitment to partner with the people of Africa in bringing advanced health technologies to the continent. 

Kigali, Rwanda, and Lexington, MA February 1, 2023—GreenLight Biosciences (Nasdaq: GRNA), a public benefit corporation striving to deliver on the full potential of RNA to address some of the world’s toughest problems in human health and agriculture, today announced that it has received regulatory approval from the Rwanda Food and Drugs Authority (Rwanda FDA) to start a Phase I/II clinical trial of its vaccine candidate against Covid-19, as a booster to previously vaccinated individuals. Preparations for the trial are underway. 

Mark Dybul, chair of GreenLight’s Human Health Scientific Advisory Board, and former executive director of the Global Fund to Fight AIDS, Tuberculosis and Malaria, said: 

 
“Covid-19 continues to be a significant global health issue. Efforts to develop novel vaccines that are longer-lasting and effective against a broad spectrum of variants are necessary to minimize the risk of disease resurgence or dangerous mutations of the SARS-CoV-2 virus.  It is especially important to develop vaccines that are globally affordable and scalable. GreenLight’s efforts to initiate this clinical study in Rwanda show the company’s commitment to support Africa’s goal of affordable vaccine self-sufficiency. 

Andrey Zarur, GreenLight’s CEO, said: 

“This clinical trial marks the necessary first step toward developing an integrated, universal strategy against Covid-19. Our previously announced collaboration with the U.S. National Institutes of Health to develop a universal Covid-19 vaccine, and our previously reported scalable mRNA manufacturing process, will enable us to address this disease in a more effective manner.” 

“We are delighted to receive approval from the Rwanda Food and Drugs Authority to start our Covid-19 mRNA vaccine candidate trial. Approval to begin clinical trials in humans, from a national regulatory authority, is a significant milestone for GreenLight’s human health business. This demonstrates our commitment of supporting vaccine and therapeutics accessibility for low- and middle-income countries.”  

We share the Rwandan government’s vision that everybody should have access to the best healthcare. A Phase I/II trial of our Covid-19 vaccine candidate is just the start. Rwanda is at the forefront of bringing end-to-end research and development to Africa. We look forward to deepening our partnership so that we can play our part, and help Africa become self-sufficient in vaccines.” 

In addition to its mRNA Covid-19 vaccine candidate, GreenLight is developing mRNA vaccines against other infectious diseases, such as shingles (in collaboration with Serum Institute of India Pvt. Ltd.), and cancer (in collaboration with EpiVax Therapeutics), as well as RNA-based therapies against genetic disorders, such as sickle-cell disease.  Further details of the Covid-19 vaccine candidate study can be found at: https://www.clinicaltrials.gov/ct2/show/NCT05602961

Notes to editors 

  1. GreenLight’s mRNA vaccine candidate, GLB-COV2-043, contains mRNA, encoding the SARS-CoV-2 full-length spike protein from the Wuhan strain, formulated in a lipid nanoparticle. This vaccine candidate is part of GreenLight’s broader Covid-19 strategy, which includes the development of a universal Covid-19 vaccine with broader and more durable protection. Pending positive safety and immunogenicity results from this Phase I/II clinical trial, GreenLight will look to continue development in Africa on potential next-generation Covid-19 vaccine candidates. 
  2. The Phase I/II study is designed to assess safety and immunogenicity as measured by humoral and cellular immune-response endpoints. Enrollment will be open to eligible adults who have received a 2-dose priming course of the mRNA BNT162b2/Comirnaty vaccine or a 2-dose priming and a third injection (i.e. as a booster) of the same mRNA vaccine. Participants will be evaluated in four cohorts, with the GreenLight vaccine candidate being administered in 15 microgram, 30 microgram, 60 microgram and 90 microgram doses, respectively. Each cohort will include 10 participants receiving the GreenLight vaccine candidate. 
  3. Further details on GreenLight’s pipeline and plans can be found at investors.greenlightbio.com. 
  4. Platform Life Sciences, in collaboration with GreenLight and leading clinical investigators in Rwanda, will conduct the trial. 

About GreenLight Biosciences  

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, 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, the success, cost and timing of our clinical trials, including estimates regarding when patients will be enrolled, when data will be reported for our ongoing clinical trials and timing to commence future clinical trials, 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.

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]  

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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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