AlgaEnergy | January 14, 2021
AlgaEnergy N.A. Inc., the U.S. subsidiary of Spain-based AlgaEnergy S.A. furthermore, a worldwide pioneer in microalgae biotechnology, has marked worldwide item conveyance and item improvement concurrences with Laboratoire M2 Inc., a Quebec-based biotechnology organization that creates normal and practical disinfectant items, including THYMOX CONTROL® fungicide and bactericide.
AlgaEnergy formulates and creates incredible, manageable, microalgae-based yield contributions for the world's producers. Laboratoire M2's THYMOX® items, gotten from the antimicrobial intensity of thyme oil and other regular oils, are utilized in harvest and indoor farming, just as in turf and nursery markets.
Under the arrangements, AlgaEnergy will acquire restrictive worldwide rights to disperse the THYMOX crop insurance product offering through AlgaEnergy's specialty units in key rural business sectors in Europe, the Americas, Africa and Asia-Pacific. The two organizations likewise marked a permit and collective item advancement understanding under which their logical groups will together attempt to make new, value-added biocontrol products.
Antheia | August 13, 2021
Antheia, a synthetic biology company enabling next-generation plant-inspired medicines, and Ginkgo Bioworks, which is building the leading horizontal platform for cell programming, today announced a partnership to accelerate the development and production of essential medicines. Ginkgo, which recently announced a business combination with Soaring Eagle Acquisition Corp. (NASDAQ: SRNG), serves customers across industries seeking to develop new and better products. Antheia plans to leverage Ginkgo's high throughput enzyme design and screening capabilities to broaden its pipeline of critical active pharmaceutical ingredients (APIs) and key starting materials (KSMs).
Nearly half of all medicines today are sourced from nature, and many of the most widely used essential medicines are sourced directly from medicinal plants. The World Health Organization classifies "essential medicines" as medicines "that satisfy the priority health care needs of the population." The supply chains for most critical plant-based medicines are fragile, and depend on a years-long process of growing, harvesting, transporting, and processing specialty plants. During times of extreme demand or constrained supply, many plant-based medicines, including widely used analgesics and sedatives, can be in shortage, as was recently the case during the COVID-19 pandemic.
"Antheia is committed to using synthetic biology to enable more equitable access to essential medicines," said Kristy Hawkins, CSO and co-founder at Antheia. "By partnering with Ginkgo Bioworks, a global leader in organism engineering, we are greatly increasing our ability to develop essential medicines at the speed and scale necessary to drive change in global pharma supply chains."
Synthetic biology platforms, such as those created by Antheia and Ginkgo Bioworks, make it possible for critical medicines to be produced on-demand in a much more efficient and environmentally friendly process compared to today's fragmented production systems. Additionally, when it comes to plant-based pharmaceuticals, biomanufacturing has significant advantages in supply chain resiliency and agility, cost, quality control, sustainability and efficiency compared to the conventional production methods, which are based on crop farming.
"We're proud to partner with Antheia, a leader in the application of synthetic biology, as they leverage our platform to produce essential medicines at scale," said Tom Knight, co-founder at Ginkgo Bioworks. "Antheia and Ginkgo are both committed to using biology to build a better future, and we look forward to a long lasting partnership that will drive substantial impact."
Antheia is focused on plant-inspired pharmaceuticals that are too complex to be produced through scalable synthetic chemistry processes. Antheia has managed to efficiently produce these highly-complex pharmaceuticals by pioneering whole-cell engineering, a technique that reconstructs multi-step biosynthetic pathways of unprecedented complexity in yeast cells. As Antheia brings its engineered microbes to commercial scale, it continually invests in strain optimization to ensure highly efficient production of the pharmaceutical compound of interest. Through this partnership, Antheia plans to leverage Ginkgo's extensive and rapid cell programming platform and biological codebase to greatly expand and accelerate its strain and enzyme engineering work.
"Antheia is at the cutting edge of synthetic biology innovation, and its whole-cell engineering platform is capable of producing entire classes of medicines that were previously inaccessible," said Barry Canton, co-founder and Chief Technology Officer at Ginkgo Bioworks. "We are thrilled that Ginkgo's platform can support innovators like Antheia as they create next generation manufacturing technologies for essential medicines."
Antheia is unlocking the medicinal power of nature with synthetic biology. Through a novel whole-cell engineering approach to reconstruct complex molecules in yeast, Antheia's platform enables the discovery and manufacturing of plant-inspired drugs of unprecedented complexity and diversity. Antheia's team of scientists and technologists is headquartered in Menlo Park, California.
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.