Scientists develop methods to validate gene regulation networks

phys | April 05, 2019

A team of biologists and computer scientists has mapped out a network of interactions for how plant genes coordinate their response to nitrogen, a crucial nutrient and the main component of fertilizer. The work, published in the journal Nature Communications, offers a potential framework and more efficient methods that can be used to investigate a wide-range of vital pathways in any organism. The sequencing of whole genomes has transformed life sciences, leading to breakthroughs in medicine, agriculture, and basic research," explains Matthew Brooks, an NIH-postdoctoral fellow in New York University's Department of Biology and the paper's lead author. "The challenge now is to determine how the genes that are encoded by an organism are regulated and work together in networks that allow plants and animals to respond to their environment.

Spotlight

The overall strategy of 12th Five-Year Plan is to aaccelerate the pace of research, innovation and development.The government plans to strengthen regulatory science and infrastructure, which involves setting up the Biotechnology Regulatory Authority of India (BRAI) and a central agency for regulatory testing and certification of laboratoriesThe plan also entails expanding and commissioning new bioclusters at Faridabad, Mohali, Kalyani and Hyderabad

Spotlight

The overall strategy of 12th Five-Year Plan is to aaccelerate the pace of research, innovation and development.The government plans to strengthen regulatory science and infrastructure, which involves setting up the Biotechnology Regulatory Authority of India (BRAI) and a central agency for regulatory testing and certification of laboratoriesThe plan also entails expanding and commissioning new bioclusters at Faridabad, Mohali, Kalyani and Hyderabad

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CELL AND GENE THERAPY

Eiger BioPharmaceuticals Provides Update on Plans for Emergency Use Authorization Application Following FDA Feedback

Eiger BioPharmaceuticals, Inc. | October 06, 2022

Eiger BioPharmaceuticals, Inc. a commercial-stage biopharmaceutical company focused on the development of innovative therapies for hepatitis delta virus and other serious diseases, today announced that, following feedback from the U.S. Food and Drug Administration the company will not submit an emergency use authorization application of peginterferon lambda for the treatment of patients with mild-to-moderate COVID-19. Following Eiger's press release on September 6, 2022, the company submitted a pre-EUA meeting request to FDA, as well as additional morbidity and mortality outcomes data and analyses from the investigator-sponsored TOGETHER study. This included further statistical modeling and efficacy analyses of the study's primary and secondary endpoints and long-term follow-up data that the company believes continue to support the initial positive topline outcomes reported in March. In response, FDA denied the request for a pre-EUA meeting. Citing its concerns about the conduct of the TOGETHER study, FDA concluded that any authorization request based on these data is unlikely to meet the statutory criteria for issuance of an EUA in the current context of the pandemic. FDA suggested that, given peginterferon lambda's mechanism of action and the ongoing need for improved COVID-19 therapeutics, Eiger consider requesting an end-of-Phase 2 meeting to discuss a company-sponsored pivotal trial that could support an eventual Biologics License Application. Eiger is evaluating next steps for this program, in the U.S., as well as ex-U.S. emergency use authorization pathways and strategic options for continued development of peginterferon lambda for COVID-19 and other respiratory viral infections. "While we are disappointed that FDA will not consider an EUA application based on results generated from the TOGETHER study, we continue to have strong conviction in the potential of peginterferon lambda to confer a meaningful benefit for patients with COVID-19 and other respiratory viral infections. COVID-19 related deaths remain alarmingly high around the globe, including in the U.S. where, according to recent data from the Centers for Disease Control and Prevention, approximately 400 people die every day from this disease." David Cory, President and CEO, Eiger Eiger is advancing a late-stage pipeline of multiple FDA Breakthrough Therapy designated programs in Phase 3, including lonafarnib and peginterferon lambda for hepatitis delta virus (HDV) infection, and avexitide for congenital hyperinsulinism. The company expects to report topline data from D-LIVR, Eiger's landmark Phase 3 study of lonafarnib-based regimens for HDV, by year end. About TOGETHER Study TOGETHER is an independent multi-center, investigator-sponsored, randomized, placebo-controlled adaptive platform Phase 3 study evaluating therapeutics in newly diagnosed, high-risk, non-hospitalized patients with mild-to-moderate COVID-19. TOGETHER is the largest placebo-controlled study in COVID-19 and has evaluated 11 different therapeutic agents for non-hospitalized COVID-19 patients. The study was ongoing at the time the peginterferon lambda arm was added. The evaluation of peginterferon lambda versus placebo was the second largest study to date of a COVID-19 therapeutic of > 1,900 patients. Eligibility criteria required that all patients had laboratory-confirmed mild or moderate COVID-19 and were randomized within seven days of symptom onset. The study enrolled patients regardless of vaccination status or variant strain of SARS-CoV-2. The primary endpoint was a reduction in risk of clinical outcome comparing hospitalizations or emergency room visits greater than six hours after a single subcutaneous injection of peginterferon lambda versus placebo through Day 28. A key secondary endpoint was reduction in risk of hospitalizations or death in patients when dosed within three days of symptom onset. The TOGETHER study recruited from 12 sites in Brazil and 5 sites in Canada. About Peginterferon Lambda Peginterferon lambda is an investigational late-stage, first-in-class, type III interferon that stimulates immune responses that are critical for the development of host protection during viral infections and has been well-tolerated in clinical studies. Eiger is developing peginterferon lambda for the treatment of HDV infection. Peginterferon lambda has been administered to over 4,000 subjects in 28 clinical trials of HBV, HCV, HDV and COVID-19. Peginterferon lambda is an investigational agent and not yet approved for any indication. Eiger has received Orphan Designation by the U.S. Food and Drug Administration and European Medicines Agency, and Fast Track and Breakthrough Therapy Designation by FDA for peginterferon lambda in HDV. About Eiger Eiger is a commercial-stage biopharmaceutical company focused on the development of innovative therapies for hepatitis delta virus (HDV) and other serious diseases. The Eiger HDV platform includes two first-in-class therapies in Phase 3 that target critical host processes involved in viral replication.

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INDUSTRIAL IMPACT

Ginkgo Bioworks Completes Acquisition of Zymergen

Ginkgo Bioworks | October 20, 2022

Today, Ginkgo Bioworks the leading horizontal platform for cell programming, and Zymergen announced that Ginkgo has completed its previously announced acquisition of Zymergen. The acquisition is expected to significantly enhance Ginkgo's platform by integrating strong automation and software capabilities as well as a wealth of experience across diverse biological engineering approaches. "Today marks an important step in our long-term growth as we complete the Zymergen acquisition and welcome their world-class team to Ginkgo. We are excited to integrate Zymergen's capabilities into our platform and explore new and expanded partnerships and opportunities for their diverse array of product concepts currently under development." Jason Kelly, CEO and co-founder of Ginkgo Bioworks Under the terms of the merger agreement entered into on July 24, 2022, Zymergen stockholders received, for each share of Zymergen common stock, 0.9179 shares of Ginkgo Class A common stock. Zymergen shares will no longer be traded on Nasdaq. Ginkgo Class A common stock will continue to trade on NYSE under the ticker symbol DNA. 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. About Zymergen Zymergen is a biotech company that designs and produces molecules, microbes and materials for diverse end markets. Zymergen partners with nature to make better products, a better way, for a better world.

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MEDTECH

Neumora Therapeutics Announces $112 Million Series B Financing

Neumora | October 12, 2022

Neumora Therapeutics, Inc. a clinical-stage biotechnology company pioneering precision medicines for brain diseases through the integration of data science and neuroscience, today announced the close of a $112 million Series B financing. The Series B syndicate includes both new and existing investors, such as Abu Dhabi Growth Fund Altitude Life Science Ventures, Amgen, ARCH Venture Partners, Exor Ventures, F-Prime Capital, Invus, Mubadala Capital, Newpath Partners, Polaris Partners and other undisclosed investors. The funding will support the advancement of a broad clinical and preclinical pipeline of novel precision medicine candidates for neuropsychiatric disorders and neurodegenerative diseases and the development of the company's precision neuroscience platform. “This Series B financing reflects Neumora’s continued progress in building a best-in-class neuroscience company, including assembling a world-class team, scaling up an industry-leading data science and translational neuroscience platform, and advancing a broad and growing pipeline of seven development programs, including our internal discovery efforts and business development activities. This considerable amount of progress in such a short period of time reflects our urgency to address the relative lack of progress and innovation in neuroscience with our data-driven, precision medicine approach.” Paul L. Berns, co-founder, chairman and chief executive officer of Neumora Neumora continues to advance a broad and growing pipeline of clinical and preclinical programs, including a balance of both clinically validated and novel approaches targeting a broad range of underserved neuropsychiatric disorders and neurodegenerative diseases. The company recently completed enrollment in a Phase 2a clinical trial for its most advanced product candidate, NMRA-140, a kappa opioid receptor antagonist in development for the treatment of major depressive disorder. Neumora is also progressing NMRA-511, a clinical-stage vasopressin 1a receptor antagonist in development for neuropsychiatric disorders, and NMRA-266, an M4 muscarinic receptor positive allosteric modulator being advanced toward initiation of Phase 1 development for schizophrenia in 2023. The company’s earlier-stage pipeline includes multiple first-in-class opportunities in preclinical development, including neurodegeneration programs focused on Parkinson’s disease and amyotrophic lateral sclerosis (ALS). “We are pleased to have the support of this leading group of both new and existing investors that share our vision and excitement with our progress to date,” said Joshua Pinto, Ph.D., chief financial officer of Neumora. “With this Series B financing, we have successfully raised approximately $650 million in capital, resulting in a very strong financial position to continue advancing our broad pipeline through multiple near-term value-creating milestones.” Neumora was founded to pioneer a new era of precision neuroscience medicines by using patient enrichment strategies to help potentially improve clinical development success rates. The company’s proprietary approach leverages recent advances in data science and translational neuroscience to cut through the heterogeneity inherent in brain disease. By approaching patient enrichment and clinical development strategies through this lens, Neumora aims to match the right patient populations to the right targeted therapeutics, thereby driving innovation and the potential for clinical development success in this field and, ultimately, providing better therapies to patients. In connection with the completion of the Series B financing, Alaa Halawa, partner and head of U.S. Ventures at Mubadala Capital, joined Neumora’s board of directors. Mr. Halawa said, “We are proud to partner with Neumora in helping advance the company’s efforts to build the precision neuroscience company of the future. The integration of technology, namely AI/ML, and proprietary clinical data is helping us develop a deeper understanding of the complex drivers of brain disease to develop novel treatments for neuropsychiatric disorders and neurodegenerative diseases - we are humbled to be part of their journey.” About Neumora Neumora Therapeutics, Inc. is a clinical-stage biotechnology company pioneering precision medicines for brain diseases through the integration of data science and neuroscience. Neumora is redefining neuroscience research and development with a data-driven precision neuroscience platform to cut through brain disease heterogeneity to match the right patient populations to targeted therapeutics. Neumora is relentless in its commitment to discovering, developing and commercializing targeted therapies for people living with brain diseases.

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