CELL AND GENE THERAPY
Ginkgo Bioworks, mRNA Victoria | November 18, 2021
mRNA Victoria, the agency of the Australian State of Victoria Government charged with building the State's mRNA manufacturing and research capability, and Ginkgo Bioworks (NYSE: DNA), the leading horizontal platform for cell programming, announced a partnership to support vaccine development, biosecurity initiatives, and the application to Ginkgo's platform in the pharmaceutical and biotech, food and agriculture, and mining and bioremediation/recycling sectors in Australia. As the first step in the partnership, Ginkgo will establish an office in Melbourne in what is hoped to be a future long-term business expansion within Australia.
Ginkgo's synthetic biology platform infrastructure and expertise brings critical capability to Victoria's biotech sector, and adds significant momentum to the State's rapidly growing biotechnology ecosystem. Ginkgo's cell programming capabilities have supported innovations in diagnostics and vaccine design and manufacturing, as well as ongoing research and development of innovative products such as living medicines, therapeutic proteins, and gene and cell therapies. Further, the company has established one of the largest nationwide COVID testing platforms in the United States, helping communities across the country keep kids in classrooms and COVID out. The company has also established an Airport Biosurveillance Program in collaboration with XpresCheck and the Centers for Disease Control and Prevention (CDC).
"Melbourne is one of the leading biomedical research communities in the world. We have to forge international collaborations like this because, as we have all learned, biology doesn't respect borders. We are incredibly excited to work with mRNA Victoria and hope to expand further into the Australian market,"
said Matt McKnight, Chief Commercial Officer, Ginkgo Bioworks
Victoria is a leader in mRNA research and manufacturing in Australia, with the nation's most sophisticated and largest mRNA ecosystem and commercialization capability. Through mRNA Victoria, the Victorian Government will continue to attract world leading biotech innovators to invest in Victoria, creating new jobs and fostering innovation in novel RNA treatments.
"Victoria has a strong RNA ecosystem and is ideally placed to develop a sophisticated supply chain with critical capability from clinical development to the establishment of onshore mRNA manufacturing to the critical biosecurity technologies that enable us to reopen borders and get back to our lives," said Jaala Pulford, Victoria's Minister for Innovation, Medical Research and the Digital Economy.
About mRNA Victoria
The State of Victoria is the home of Australia's biotech community with a globally recognized research sector including the country's leading mRNA researchers and existing capabilities in medtech, biotech, pharmaceutical and advanced manufacturing. mRNA Victoria is the Australian State of Victoria Government agency charged with building a world-class mRNA manufacturing and research capability. It leads the engagement and partnership with domestic and international companies, researchers, and other stakeholders in the mRNA ecosystem, and its investments and programs accelerate the growth of mRNA technology's scientific, commercial, and life-saving potential.
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.
Forward-Looking Statements of Ginkgo Bioworks
This press release contains certain forward-looking statements within the meaning of the federal securities laws, including statements regarding the potential of Ginkgo's biosecurity capabilities and partnership with mRNA Victoria. These forward-looking statements generally are identified by the words "believe," "project," "potential," "expect," "anticipate," "estimate," "intend," "strategy," "future," "opportunity," "plan," "may," "should," "will," "would," "will be," "will continue," "will likely result," and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this document, including but not limited to: (i) the effect of the business combination with Soaring Eagle Acquisition Corp. ("Soaring Eagle") on Ginkgo's business relationships, performance, and business generally, (ii) risks that the business combination disrupts current plans of Ginkgo and potential difficulties in Ginkgo's employee retention, (iii) the outcome of any legal proceedings that may be instituted against Ginkgo related to its business combination with Soaring Eagle, (iv) volatility in the price of Ginkgo's securities now that it is a public company due to a variety of factors, including changes in the competitive and highly regulated industries in which Ginkgo plans to operate, variations in performance across competitors, changes in laws and regulations affecting Ginkgo's business and changes in the combined capital structure, (v) the ability to implement business plans, forecasts, and other expectations after the completion of the business combination, and identify and realize additional opportunities, and (vi) the risk of downturns in demand for products using synthetic biology. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" section of Ginkgo's quarterly report on Form 10-Q filed with the U.S. Securities and Exchange Commission (the "SEC") on November 15, 2021 and other documents filed by Ginkgo from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Ginkgo assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Ginkgo does not give any assurance that it will achieve its expectations.
CELL AND GENE THERAPY
Imara | November 22, 2021
Imara Inc. a clinical-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from rare inherited genetic disorders of hemoglobin and other serious diseases, today announced a change to the primary endpoint for the Ardent clinical trial, a Phase 2b study of tovinontrine (IMR-687) in patients with sickle cell disease (SCD), based on the recommendation of the U.S. Food and Drug Administration (FDA).
Imara requested feedback from the FDA on the draft statistical analysis plan (SAP) for the Ardent trial in which fetal hemoglobin (HbF) response was the primary endpoint and annualized rate of vaso-occlusive crises (VOCs) was the key secondary endpoint. In reviewing the Ardent draft SAP and prior to any database lock for analysis, the FDA recommended that Imara change the primary endpoint to be annualized rate of VOCs. HbF response will continue to be evaluated as a key secondary endpoint. The endpoint revisions do not affect the conduct of the trial or operational aspects of the study. As part of its recommendation, the FDA suggested further interactions regarding the revised SAP and engagement on the potential of the current program for regulatory decision-making.
“We welcome the FDA’s recommendations and are in the process of changing the primary endpoint of the Ardent trial to be annualized rate of VOCs and moving HbF response to be a key secondary endpoint. A reduction in VOC rate is an established approval endpoint, and we are engaging the FDA further on this and related topics, including possible streamlined paths to registration.”
Rahul Ballal, Ph.D., President and Chief Executive Officer of Imara
Dr. Ballal continued, “In light of this endpoint revision, the previously planned fourth quarter interim analysis will no longer occur. That interim analysis had been designed to have a focus on safety and pharmacodynamic biomarkers, including HbF, but did not include a review of VOCs. The first review of data from the Ardent trial, including annualized VOC rate, will be conducted when all subjects have completed assessment at Week 24 or terminated early, and is planned for the first quarter of 2022, subject to our upcoming discussions with the FDA. Final data analysis from the Ardent trial remains on track for the second half of 2022. In June 2021, we reported promising data from our Phase 2a and open label extension clinical trials in SCD that demonstrated reduced annualized rates of VOCs in patients treated with tovinontrine versus placebo. We expect to present updated 12-month VOC data from our ongoing Phase 2a open label extension clinical trial at the American Society of Hematology Annual Meeting in December 2021.”
About the Ardent Phase 2b Clinical Trial
The Ardent Phase 2b clinical trial is a fully-enrolled, global, randomized, double-blind, placebo-controlled, multicenter study with approximately 115 adult patients with sickle cell disease (SCD) enrolled. The planned primary efficacy objective will be to evaluate the annualized rate of vaso-occlusive crises (VOCs) in patients dosed with tovinontrine (IMR-687) as compared to placebo. A key secondary endpoint will be to evaluate the proportion of all patients with fetal hemoglobin (HbF) response, defined as an absolute increase from baseline of at least 3% in HbF, as compared to placebo. Additional endpoints include the evaluation of the effect of tovinontrine versus placebo on other VOC-related outcome measures, HbF-associated biomarkers, markers of red blood cell hemolysis, white blood cell adhesion markers and quality of life measures over the course of a one-year treatment period.
The FDA has granted Orphan Drug, Fast Track and Rare Pediatric Disease designations and the European Commission has granted Orphan Drug designation for tovinontrine for the treatment of SCD.
About Tovinontrine (IMR-687)
Tovinontrine is a highly selective and potent small molecule inhibitor of phosphodiesterase-9 (PDE9). PDE9 selectively degrades cyclic guanosine monophosphate (cGMP), an active signaling molecule that plays a role in vascular biology and hemoglobin production in red blood cells. Lower levels of cGMP are found in people with sickle cell disease (SCD) and beta-thalassemia and are associated with reduced blood flow, increased inflammation, greater cell adhesion and reduced nitric oxide mediated vasodilation. Blocking PDE9 acts to increase cGMP levels, which is associated with several benefits including the potential reactivation of fetal hemoglobin (HbF), a natural hemoglobin produced during fetal development. Increased levels of HbF in RBCs have been demonstrated to improve symptomology and substantially lower disease burden in both patients with SCD and patients with beta-thalassemia.
About Sickle Cell Disease
Sickle cell disease (SCD), a hemoglobinopathy, is a rare inherited red blood cell disorder. The disease causes structural abnormalities in hemoglobin that cause red blood cells to become inflexible and elongated, ultimately blocking blood flow to organs, which can lead to vaso-occlusive crises (VOCs). SCD is characterized by debilitating pain, progressive multi-organ damage and early death. The global prevalence of SCD is estimated to be approximately 4.4 million patients, including an estimated 100,000 patients in the United States and 134,000 patients in the European Union.
Imara Inc. is a clinical-stage biotechnology company dedicated to developing and commercializing novel therapeutics to treat patients suffering from rare inherited genetic disorders of hemoglobin and other serious diseases. Imara is advancing tovinontrine (IMR-687), a highly selective, potent small molecule inhibitor of PDE9 that is an oral, potentially disease-modifying treatment currently in clinical development for sickle cell disease and beta-thalassemia and preclinical development for heart failure with preserved ejection fraction, or HFpEF. Imara is also advancing IMR-261, an oral activator of nuclear factor erythroid 2–related factor 2, or Nrf2.
Cautionary Note Regarding Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to (i) the Company’s plans to change the primary and secondary endpoints for the Ardent Phase 2b clinical trial of tovinontrine (IMR-687), (ii) the timing for reporting of additional data from the Ardent Phase 2b and open label extension clinical trials of tovinontrine in patients with sickle cell disease and (iii) the Company’s planned discussions with the FDA regarding the regulatory pathway for tovinontrine. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the impact of extraordinary external events, such as the risks and uncertainties resulting from the impact of the COVID-19 pandemic on the Company’s business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities and ability to readout data from the Ardent Phase 2b and open label extension clinical trials of tovinontrine in sickle cell disease; the Company’s ability to advance the development of tovinontrine under the timelines it projects in current and future clinical trials, demonstrate in any current and future clinical trials the requisite safety and efficacy of tovinontrine; and other factors discussed in the “Risk Factors” section of the Company’s most recent Quarterly Report on Form 10-Q, which is on file with the Securities and Exchange Commission and in other filings that the Company makes with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Applied Microarrays Inc. | September 30, 2021
SCHOTT MINIFAB, a subsidiary of SCHOTT that develops and manufactures microfluidic devices for point-of-care and life sciences consumables, has had a long-standing close customer relationship with Applied Microarrays Inc. (AMI). Together, they develop biotech substrates for diagnostics applications. The expertise of AMI will further strengthen SCHOTT’s ability to offer a single-source contract manufacturing solution. The deal is expected to close in early October.
Through this acquisition, SCHOTT MINIFAB significantly expands its biosensor printing capabilities. This is of particular importance as demand is growing for the manufacturing of point-of-care microarray consumables, especially in applications such as infectious disease detection.
“We pride ourselves on being an end-to-end partner for the global diagnostics industry. Our expansive offering allows us to provide an integrated single-source collection of value-intensive services and products. With the added bioscience knowledge of AMI, we become an even stronger partner, enhancing our capability in surface modification, functionalization and deposition for both glass and polymer products.”
- Greg Wolters, Head of SCHOTT MINIFAB.
AMI will soon be moving to a larger facility in the Phoenix, Arizona area. Its new location will greatly increase SCHOTT’s manufacturing footprint in the United States to serve its global customer base.
Pioneering – responsibly – together
These attributes characterize SCHOTT as a manufacturer of high-tech materials based on specialty glass. Founder Otto Schott is considered its inventor and became the pioneer of an entire industry. Always opening up new markets and applications with a pioneering spirit and passion – this is what has driven the #glasslovers at SCHOTT for more than 130 years. Represented in 34 countries, the company is a highly skilled partner for high-tech industries: Healthcare, Home Appliances & Living, Consumer Electronics, Semiconductors & Datacom, Optics, Industry & Energy, Automotive, Astronomy & Aerospace. In the fiscal year 2020, its 16,500 employees generated sales of 2.24 billion euros. With the best teams, supported by the best digital tools, the group intends to continue to grow. SCHOTT AG is owned by the Carl Zeiss Foundation, one of the oldest foundations in Germany. It uses the Group's dividends to promote science. As a foundation company, SCHOTT has anchored responsibility for employees, society and the environment deeply in its DNA. The goal is to become a climate-neutral company by 2030.
About Applied Microarrays (AMI)
AMI is a company headquartered in Tempe, AZ, which designs, optimizes and manufactures DNA and protein biosensors, and other microarrays on glass, plastic and semiconductors. AMI operates under ISO 9001 and ISO 13485 certification. Since acquiring GE Healthcare’s microarray business in 2007, AMI has evolved to become a full service provider for RUO and Dx devices.