CELL AND GENE THERAPY

IndyGeneUS AI Secures Pathogen Sequencing for COVID-19 Genomic Surveillance Initiatives

IndyGeneUS AI | May 20, 2021

Through collaborations, IndyGeneUS AI has acquired genomic analysis and testing capabilities. This pathogen sequencing capacity has emerged at a critical moment in efforts to improve genomic surveillance and monitor COVID-19 variant strains across the continent.

IndyGeneUS founder and CEO Yusuf Henriques emphasized the importance of this work. "COVID-19 and its variants pose a danger to the entire African continent, so we must act quickly. Our partners understand the urgency of this mission and are united with their cooperation."

Next-generation sequencing (NGS)-based genotyping, targeted sequencing, and comprehensive bioinformatics analysis are among the capabilities. Comparative genomic analysis, disease genetics, epigenomics, and genome mapping are some of the applications of our capabilities.

Bradford Wilson, Ph.D., Chief Scientific Officer at IndyGeneUS AI, said, "These capabilities are pivotal for the Continent and the future of precision medicine." "We are currently in talks with several large pharmaceutical firms that see the value of what we are developing to combat infectious and non-communicable diseases alike," he said.

In less than a year, IndyGeneUS AI has partnered with Kenyan organizations such as the KAVI Institute of Clinical Research at the University of Nairobi and Afya Rekod. We've also teamed up with Encrypgen, which has created a blockchain-encrypted marketplace for commercializing insights gleaned from our repository and compensating participants who contribute data.

IndyGeneUS has certainly understood the increasing need for infrastructure to sustain genomic surveillance activities by developing sequencing capabilities. Following the introduction of COVID-19 variant strains, the World Health Organization (WHO) and the African Centres for Disease Control (Africa CDC) established a network of laboratories last year to improve the continent's capacity to identify emerging variants of concern. More funding and infrastructure are needed for these initiatives. IndyGeneUS intends to accelerate sequencing capabilities across Africa by using public and private partnerships.

About IndyGeneUS AI
IndyGeneUS AI is a genomics company based in Nairobi is also developing the world's largest block-chain encrypted repository of African clinical and multi-omics data for disease prevention and diagnosis, drug discovery and development, clinical disease management, and the promotion of precision health equity. Mr. Yusuf Henriques, COO Dr. Wilmot Allen, and CSO Dr. Bradford Wilson formed IndyGeneUS. The company, which is owned by African Americans and Africans, has offices in Washington, DC, and a presence in South Africa through the Founder Institute. The Founder Institute is the world's largest pre-seed startup accelerator.

Spotlight

Biomaterials are engineered materials that have been designed to interact with biological systems, for example, when implementing a medical implant or other
devices.

Spotlight

Biomaterials are engineered materials that have been designed to interact with biological systems, for example, when implementing a medical implant or other
devices.

Related News

MEDTECH, INDUSTRIAL IMPACT

QIAGEN and Helix Partner to Advance Companion Diagnostics for Hereditary Diseases

QIAGEN | January 06, 2023

QIAGEN recently announced an exclusive strategic partnership with Helix, a California population genomics leader, to advance companion diagnostics for hereditary diseases. The requirement for companion diagnostic devices and tests capable of detecting clinically relevant genetic abnormalities grows along with the accelerated development of precision medicines. These tests helps in making decisions by showing patients that are most likely to benefit from a specific therapeutic product or be at risk. Although companion diagnostics that use whole exome sequencing have primarily been used in oncology so far, they are widely believed to have a great deal of potential in hereditary disease areas like cardiovascular, metabolic, neurodegenerative, and auto-immune diseases. According to the agreement, QIAGEN will be Helix’s exclusive marketing and contracting partner in the United States. This partnership will use the Helix® Laboratory Platform, the first whole exome sequencing platform, to get a de novo class II authorization from the U.S. Food and Drug Administration. As a leader in precision medicine, QIAGEN has more than 30 master partnership agreements with multinational pharma and biotech firms to develop and commercialize companion diagnostic tests for their drug candidates. Its companion diagnostic offerings include next-generation sequencing (NGS), polymerase chain reaction (PCR), and digital polymerase chain reaction (dPCR), sample types ranging from liquid biopsy to tissue, and disease areas such as cancer and Parkinson's, including 11 FDA-approved PCR-based companion diagnostics. Helix has developed an end-to-end platform that enables health systems, life sciences firms, and payers to enhance genomic research and expedite the integration of genomic data into clinical care. It has teamed with major health systems to enable population genomics programs across the United States. These programs significantly improve the identification and recruitment of patients for clinical trials in hereditary diseases such as Parkinson's and cardiovascular or inflammatory diseases such as non-alcoholic steatohepatitis (NASH). About QIAGEN QIAGEN is a leading provider of sample-to-insight solutions, enabling clients to get significant molecular insights from samples containing life's building elements. Its sample technologies are used to isolate and process DNA, RNA, and proteins from blood, tissue, and other materials. The company serves over 500,000 customers worldwide in molecular diagnostics (human healthcare) and life sciences (academia, pharma R&D, and industrial applications, primarily forensics).

Read More

INDUSTRIAL IMPACT, MEDICAL

Celularity and CH Trading Group Declares Territory Distribution Agreement

Celularity | January 17, 2023

Celularity Inc., a biotechnology firm based in the United States that develops placental-derived allogenic cell treatments and biomaterials, and CH Trading Group LLC, an international import, export, and trading corporation, have agreed to an exclusive territorial distribution agreement. CH Trading Group will serve as the exclusive territorial distributor for halal-certified products previously announced by Celularity in over 100 countries. The product distribution agreement for halal-certified products by Celularity provides a five-year minimum accumulated purchase commitment of US $225 million. CEO of CH Trading Group, Sayed Zayan, said, “Based on market demand for Celularity’s commercial biomaterial products, we believe there is a billion-dollar commercial opportunity across the Middle East and North Africa Islamic markets.” He also added, “We are excited to be in a position to expand access to these important medicines and wellness products to more people across the region through our exclusive territories distributor agreement with Celularity.” (Source – Business Wire) “According to Emergent Research's most recent analysis, the global regenerative medicine market was valued at $9.80 billion in 2021 and is predicted to expand at a CAGR of 15.9%, reaching $37.10 billion in 2030.” Under the agreement, CH Trading Group will distribute products to more than 100 countries that are members of or affiliated with the following intergovernmental organizations (‘Islamic Markets’) The Gulf Cooperation Council: Consists of Bahrain, Oman, Kuwait, Qatar, Saudi Arabia, and the UAE. The Organization of Islamic Cooperation: It spans four continents and includes 57 member nations The African Union: Includes 55 member countries Robert J. Hariri, M.D., Ph.D., Celularity’s CEO, Chairman and Founder, said, “Our partnership with the CH Group represents another critical milestone towards bringing our innovative halal-certified—under globally recognized Circle H International Inc. standards – regenerative biomaterial products to treat degenerative disease across Islamic Markets.” (Source – Business Wire) About Celularity Headquartered in Florham Park, N.J., Celularity is a clinical-stage biotechnology firm paving the way for the future of cellular medicine by offering off-the-shelf allogeneic placenta-derived cellular therapeutics with unmatched scale, quality, and affordability. With its novel approach to cell therapy, the company can unlock the unique therapeutic potential of the postpartum placenta. In addition, through the placenta, nature’s immunotherapy engine, the firm is driving the next generation of cellular medicine using placenta-derived T cells, NK cells, and pluripotent stem cells to address unmet and underserved clinical needs in cancer, infectious, and degenerative diseases.

Read More

INDUSTRIAL IMPACT, MEDICAL

Emulate Publishes Landmark Study Validating Organ-on-a-Chip Technology for Predictive Toxicology in Preclinical Development

Emulate, Inc. | December 07, 2022

Emulate, Inc., the leading provider of next-generation in vitro models announced the publication of a landmark study, “Performance assessment and economic analysis of a human Liver-Chip for predictive toxicology,” in Nature Communications Medicine demonstrating that the Emulate human Liver-Chip could improve patient safety and reduce small-molecule clinical trial failures due to liver toxicity by up to 87%. These findings conclude the single largest Organ-Chip study to date, in which researchers compared the performance of human Liver-Chips in predicting drug-induced liver injury (DILI) to those of animal in vivo models—the current industry standard—and primary human 3D hepatic spheroids. In addition to assessing and quantifying model performance, this study effectively qualifies the Emulate human Liver-Chip model against the guidelines defined by IQ MPS, an affiliate of the International Consortium for Innovation and Quality in Pharmaceutical Development. “This first-of-its-kind study demonstrates the Emulate human Liver-Chip can better predict drug safety than other methods for modeling liver toxicity. In light of these findings, the pharmaceutical industry and government agencies have a responsibility to both patients and researchers to bring efficient, accurate, and safe preclinical testing models—like Organ-Chips—into the drug development process.” Jim Corbett, Chief Executive Officer of Emulate Researchers assessed the performance of 870 Emulate human Liver-Chips across a blinded set of 27 known hepatotoxic and non-toxic drugs. In line with the IQ MPS guidelines, the tested drugs included seven matched pairs that demonstrate the chip’s ability to distinguish toxic drugs from their less toxic structural analogs. Furthermore, the study demonstrated that the Emulate human Liver-Chip was able to correctly identify 87% of the tested drugs that caused drug-induced liver injury in patients despite passing animal testing evaluations. At the same time, the Emulate human Liver-Chip did not falsely identify any drugs as toxic leading to a 100% specificity and supporting its use in toxicology screening workflows. Pharmaceutical companies can encounter many challenges in developing human drugs. Often, compounds showing promise in preclinical efforts face high attrition during human trials due to poor predictive validity of preclinical models, especially for biologics. Therefore, the researchers also modeled the potential economic impact that routine use of the Emulate human Liver-Chip could have on drug development productivity. By simply improving the ability to detect hepatotoxicity with 87% sensitivity, they estimated that broad adoption of the Emulate human Liver-Chip could increase research and development productivity by $3 billion dollars on an annual basis for the small molecule drug development industry. Additionally, their computational economic value analysis estimated that routine use of Organ-Chips to assess cardiovascular, neurological, immunological, and gastrointestinal small molecule toxicities could similarly generate approximately $24 billion dollars per year due to increased research and development productivity. With 40% of current drugs in the pipeline being biologics, this value is expected to increase even more as Organ-Chips are further incorporated into the biopharmaceutical drug development pipeline. “The predictive validity of a model is the rate limiting step in drug research and development,” said Jack Scannell, PhD, CEO of Etheros Pharma Corp, Author of Eroom’s Law. “These models are under-evaluated, and the financial value of good models remains opaque; consequently, model innovation is poorly incentivized. Two outcomes from the Emulate study have implications that extend well beyond toxicity. First, it sets the benchmark for model evaluation, and secondly it shows how to map from model validity to decision quality to dollar value. After all, if we want the scientific community to invest in better models, we need to work out how much they are worth.” The authors suggest that researchers could employ the Emulate human Liver-Chip in the lead optimization phase of their drug development pipeline, where projects have identified three to five chemical compounds that have the potential to become a candidate drug. By doing so, a chemical compound that produced a toxic signal in the Emulate human Liver-Chip could be deprioritized from early in vivo studies, thus reducing animal testing, and permitting safer candidates to progress through the development pipeline. “This study is one of the most critical developments in the field of Organ-on-a-Chip technology,” said Zaher Nahle, PhD, MPA, Chief Science Officer at the Center for Contemporary Sciences. “It shows the primacy and utility of the technology in predictive toxicology. It also demonstrates the immediate readiness of such technology to transform critical phases of the drug development process, in particular lead optimization and preclinical assessment, making the entire process safer, cheaper, faster, and more effective.” Full study: Performance assessment and economic analysis of a human Liver-Chip for predictive toxicology, Nature Communications Medicine, December 6, 2022 Co-authors include: Lorna Ewart, Athanasia Apostolou, Skyler A. Briggs, Christopher V. Carman, Jake T. Chaff, Anthony R. Heng, Sushma Jadalannagari, Jeshina Janardhanan, Kyung-Jin Jang, Sannidhi R. Joshipura, Mahika Kadam, Marianne Kanellias, Ville J. Kujala, Gauri Kulkarni, Christopher Y. Le, Carolina Lucchesi, Dimitris V. Manatakis, Kairav K. Maniar, Meaghan E. Quinn, Joseph S. Ravan, Ann Catherine Rizos, John F.K. Sauld, Josiah Sliz, William Tien-Street, Dennis Ramos Trinidad, James Velez, Max Wendell, Prathap Kumar Mahalingaiah, Donald E. Ingber, Jack Scannell, Daniel Levner About Emulate, Inc. Emulate is igniting a new era in human health with industry-leading Organ-on-a-Chip technology. The Human Emulation System provides a window into the inner workings of human biology and disease, offering researchers an innovative technology designed to predict human response with greater precision and detail than conventional cell culture or animal-based experimental testing. Pioneered at the Wyss Institute for Biologically Inspired Engineering at Harvard University and backed by Northpond Ventures, Founders Fund, and Perceptive Advisors, Organ-on-a-Chip technology is assisting researchers across academia, pharma, and government industries through its predictive power and ability to recreate true-to-life human biology.

Read More