Latest news with #CRISPR-Cas
Yahoo
6 days ago
- Business
- Yahoo
GenEditBio Announces First Patient Dosed in Investigator-Initiated Trial of GEB‑101, World's First In Vivo CRISPR-Cas Ribonucleoprotein-Based Genome Editing Investigational Therapy for TGFBI Corneal Dystrophy
HONG KONG, BEIJING and BOSTON, June 6, 2025 /PRNewswire/ -- GenEditBio Limited ("GenEditBio"), a clinical-stage biotechnology start-up company focusing on genome editing therapeutic solutions through the discovery of novel and precise Cas nucleases and the development of safe and efficient cargo delivery platforms, today announced a key milestone in the development of its pipeline: First patient has been dosed in an investigator-initiated trial (IIT) of GEB-101, the Company's leading in vivo genome editing program for TGFBI corneal dystrophy. The ongoing IIT is in collaboration with Prof Xingtao ZHOU, MD, PhD, Professor and President, and his team at the Eye & ENT Hospital of Fudan University in Shanghai, China. GEB-101 is a wholly owned program of GenEditBio. Preclinical assessment in non-human primates demonstrated that GEB-101 was well-tolerated after local intrastromal injection and had high safety profile with virtually undetectable off-target effect ( The preclinical research recently received the Excellence in Research Award at the 28th Annual Meeting of the American Society of Gene and Cell Therapy in May 2025 ( The IIT of GEB-101 is an open-label and dose-escalation clinical study to investigate the tolerability of GEB-101 when combined with standard treatment phototherapeutic keratectomy in adults with corneal dystrophy. The first patient, who received GEB-101 in May 2025, has been discharged from the collaborating hospital with no observable adverse event. This trial marks the world's first clinical study of an in vivo CRISPR-Cas ribonucleoprotein (RNP)-based genome editing investigational therapy for TGFBI corneal dystrophy. "Today, on National Sight Day, we are proud and honored to announce that we have initiated the world's first clinical study of an in vivo genome editing investigational therapy for corneal dystrophy. This key milestone represents years of effort in technology platform development and dedication from our world-class research team and clinical partners," said Zongli ZHENG, PhD, Chairman and Co-Founder of GenEditBio, "We stand at the frontier of a new era and recognize the transformative potential of this moment is not just for the Company but for the entire field of genetic medicine because the technology has the potential to extend far beyond corneal dystrophy. Our company is committed to developing fundamentally safe, efficacious and affordable in vivo genome editing therapies for genetic diseases with unmet medical needs". "This investigator-initiated trial marks a defining moment for our award-winning research team and clinical partners. Remarkably, in just one year since initiating our proof-of-concept and preclinical studies, we have successfully integrated our genome editing and delivery technologies to advance this pipeline program from the laboratory to clinical stage, showcasing our competence and dedication to rapidly translate basic research into clinical program to ultimately benefit patients," said Tian ZHU, PhD, CEO and Co-Founder of GenEditBio, "We also express our deepest gratitude to the participant who volunteers in this early stage trial to support medical innovation. As clinical data accumulate, we are positive that GEB-101 has the potential to become a new treatment option for patients with corneal dystrophy". About TGFBI Corneal Dystrophy TGFBI corneal dystrophy is a group of genetic eye disorders caused by mutations in the TGFBI gene, resulting in abnormal protein buildup in the stromal layer of cornea. Symptoms include photophobia, gradual vision loss and recurrent corneal erosions. Current treatment options include phototherapeutic keratectomy and corneal transplantation. These procedures, however, have known limitations such as recurrence and carry risks of sight-threatening complications, underscoring the need for novel therapies. About GEB-101 GEB-101, a wholly owned program of GenEditBio, is a genome editing drug candidate designed as a once-and-done treatment for TGFBI corneal dystrophy. GEB-101 is based on the CRISPR-Cas genome editing technology that targets a particular locus in the mutated TGFBI gene. GEB-101 is encapsulated in the form of RNP in engineered protein delivery vehicle (PDV), a proprietary in vivo delivery system developed by GenEditBio. GEB-101 is to be administered by intrastromal injection and is being investigated for tolerability in the IIT. About GenEditBio Established in 2021 and headquartered in Hong Kong, China, GenEditBio is a gene therapy start-up company with an overarching strategic goal of providing potentially curative, once-and-done and programmable in vivo genome editing-based therapeutic solutions (dubbed "DNA surgery") with high safety profile, unmatched precision, and affordable access for genetic diseases with unmet needs. The Company's core areas of focus include novel Cas nuclease discovery and safe and efficient cargo delivery utilizing lipid nanoparticle (LNP) and engineered protein delivery vehicle (PDV). We have research laboratories and supporting offices in Hong Kong, Beijing, and Boston. GenEditBio is financially backed by top-tier life science investors, including Qiming Venture Partners, Fangyuan Capital, Center Biotherapeutics, Lumosa Therapeutics, HKSTP Venture Fund, and others. For more information, please visit Related Previous Press Releases GenEditBio Scientist Receives Excellence in Research Award at the 28th Annual Meeting of the American Society of Gene and Cell Therapy 2025 GenEditBio to Present Preclinical Data on its Delivery Technology Platform and Drug Pipeline at the 28th Annual Meeting of the American Society of Gene and Cell Therapy Media Contact: Investors Contact: bd@ View original content: SOURCE GenEditBio Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Mint
12-05-2025
- Science
- Mint
This rice is set to make your meal climate-friendly
Earlier this month, India released the world's first genome-edited rice, a breakthrough that promises to retune its farm R&D space. The new varieties yield more using less water and are resilient to climate shocks. Mint explains why you must hold your plate and take note. Tell us more about these new varieties... These were released on 4 May by the Indian Council of Agricultural Research (ICAR), which used genome editing (GE) to improve two rice cultivars—Samba Mahsuri and MTU1010. The project began in 2018. These advanced varieties can improve yields by up to 19% and are shorter-duration—they use less water and fertilizers. They emit less methane, a potent greenhouse gas, and overall have a lower carbon footprint. As per ICAR, the GE variants are more tolerant to drought, salinity and climate stresses. They can be grown across South, central and East India, as a sustainable choice for farmers in the era of climate crisis. Also Read | Can soil-less farming revive a Kashmiri rice variety on the verge of extinction? In what way is it designer rice? GE technology uses CRISPR-Cas, a protein that acts as molecular scissors to edit the DNA sequence of a genome. Editing a genome, which carries the genetic code of an organism, changes its character—a bit like rewriting the code of life. Using CRISPR-Cas, scientists can design or incorporate traits like increasing the number of grains on a plant. GE crops are different from genetically modified (GM) ones. In GM technology, a foreign DNA is inserted into plant genes. For example, genes from a soil bacterium were used to make Bt Cotton, the only GM crop allowed in India, to make it pest resistant. Also Read | Rice fortification can help tackle our problem of hidden hunger Can this technology be used for other crops? Yes. GE technology, it is hoped, will help India find a way out of its import dependency in pulses and oilseeds. ICAR is working on GE enhancement of these crops, for which the government has set aside ₹500 crore. Currently, India spends more than $20 billion every year to import pulses and oilseeds. By contrast, it is the world's largest exporter of rice. Also Read | Subsidies and MSP:It makes most sense for farmers to keep growing rice and wheat Are GE crops safe to consume? Scientists say GE crops pose only a marginal risk to human health and environment, and are as good as normally bred crops, which involve crossing plants. GE is more precise and a faster way to achieve results. The Coalition for GM-Free India has criticised the government's deregulation of GE techniques (compared with GM, which is tightly regulated), and alleged that the new varieties were released without any safety assessment. Experts say activists oppose gene technologies on the basis of speculative risks. Is the CRISPR tool globally accepted? Scientists Emmanuelle Charpentier and Jennifer Doudna received the 2020 Nobel Prize in chemistry for developing CRISPR-Cas. The Nobel committee said GE can be used for cancer therapies, hereditary diseases and develop innovative crops. GE has been used to create soy oil that can be stored for longer, reducing the use of chemical preservatives. GE was also used to make high-GABA tomato, which claims to lower blood pressure and improve sleep. But repurposing food as medicine may not be to everybody's taste.
Time of India
09-05-2025
- Science
- Time of India
Agri revolution or regulatory blind spot? Genome-edited rice crops stir debate
Tired of too many ads? Remove Ads Tired of too many ads? Remove Ads According to ICAR, genome editing technology (CRISPR-Cas), serves as a precision mutagenesis tool designed to create novel and desirable variants of a native gene(s) found in a living organism. Tired of too many ads? Remove Ads Without regulations, consumers can't easily distinguish between gene-edited crops and non-edited ones, say experts. In 2018, ICAR launched a genome editing research project in rice under the National Agricultural Science Fund. On May 4, 2025, India made history. The country introduced the first genome-edited rice to the world. At a grand event in the national capital, Union Agriculture Minister Shivraj Singh Chouhan unveiled two new genome-edited rice varieties—DRR Dhan 100 and Pusa DST Rice 1 The Indian Council of Agricultural Research ( ICAR ), the government's apex agriculture research organisation, has developed these innovative varieties; these crops could boost rice yields by up to 30% while also improving drought tolerance and decreasing water is 'a historic milestone' in the field of scientific research. 'These new varieties will play a leading role in heralding the second Green Revolution,' says Chouhan, noting that these new crops will not only enhance production but will also produce beneficial outcomes for the environment by saving water and reducing greenhouse gas is the second-largest producer and consumer of rice in the world, behind only China, accounting for nearly 27% of the global production. The country uses nearly 40% of its total arable land for rice cultivation. Thanks to the advanced technologies and farming practices, the country's rice output has grown substantially over the years. In 2023-24, India produced 137 million tonnes of rice, while the projection for 2024-25 suggests a total production of 147 million country's rice output could even swell further in the coming years with the introduction of these new rice varieties. Some experts, however, criticised the development, raising concerns about safety testing. They insist that gene editing should undergo rigorous regulations, even as ICAR asserts that the existing regulations are adequate. There is no need for 'a separate framework for genome-edited crops,' it Ministry officials indicate that these varieties are expected to take at least four to five years to reach farmers, following completion of the seed development cycle, which includes breeder, foundation, and certified the controversy surrounding genome-edited rice varieties, let's understand the regulatory framework in this to ICAR, genome editing technology (CRISPR-Cas), serves as a precision mutagenesis tool designed to create novel and desirable variants of a native gene(s) found in a living organism. However, the products made using certain genome editing techniques, such as Site-Directed Nuclease 1 ( SDN-1 ) and Site-Directed Nuclease 2 ( SDN-2 ), are exempt from regulations because of their resemblance to naturally occurring mutations.'In SDN-1 and SDN-2 types of genome editing, a native gene is mutated in its native location to create an alternative form known as an allele, which exhibits a desirable altered expression and function. The mutants created by the SDN-1 and SDN-2 approaches are free of exogenously introduced DNA. These mutants are alike and indistinguishable from spontaneous or induced mutants. Hence, exempted from biosafety regulation of Rules 7-11 of Rules 1989 under Environment (Protection) Act 1986,' ICAR clarifies in a is important to note that under this regulatory framework for SDN-1 and SDN-2 genome edits, DRR Dhan 100 and Pusa DST Rice 1 received clearance on May 31, 2023, for to Devinder Sharma, a Mohali-based agriculture expert, corporate influence led to regulatory exemptions for these two varieties. He says, 'The GM industry is promoting genome-edited crops to stay afloat, as they have faced criticism for lacking tangible outputs and are under pressure.'In India, GM crops are subject to regulation; however, there is currently no comprehensive regulatory framework for genome-edited crops, Sharma points out. 'Why can't India have regulation for gene-edited crops, just like the EU?' Sharma regulations for genome-edited crops vary across the globe. The EU regulates genetically modified organisms (GMOs), including gene-edited crops, under a stringent framework that mandates rigorous testing, approval, and labelling, while the US and Japan offer some exemptions. Devendra Kumar Yadava , Deputy Director General (Crop Science), ICAR, countered the criticism, asserting that the existing regulatory framework is sufficient and that a separate regulation is not required.'In India, all activities related to genetically engineered organisms (GE organisms) or cells and hazardous microorganisms and products are regulated as per the 'Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells, Rules, 1989' (Rules, 1989) notified by the Government of India under the Environment (Protection) Act, 1986 (EPA 1986). A draft guideline for genome-edited organisms was published by the Department of Biotechnology, Government of India, in 2020 for public consultation. Based on the consultation, scientific results, and inputs from the National Science Academies, the Ministry of Environment, Forest, and Climate Change brought an office memorandum,' says Yadava.'All provisions under Rules, 1989, shall be applicable on genome-edited plants except the rules 7 -11 (both inclusive) on which exemption from regulation has been granted under Rule 20 by the Ministry of Environment, Forests and Climate Change vide Office Memorandum F. No. C -12013/3/2020-CS-III dated 30.03.2022. The GMO regulation rules are applicable to the initial stages of genome editing of plants. The genome-edited plants in later generations are exempted from Rules 7-11 of Rules 1989 once it is proved that the mutant is developed by the SDN-1/SDN-2 approach and it is proved that the mutant does not contain exogenously introduced DNA. As per the 'Standard Operating Procedures (SOPs) for regulatory review of genome-edited plants under SDN-1 and SDN-2 categories, 2022', notified by RCGM, DBT, Govt of India, on October 4, 2022,' explains Pareek, an agriculture economist and convener of the Global Grains and Pulses Council, commended India's genome-edited rice varieties; however,he noted that the widespread adoption of these varieties faced significant challenges. 'A four-to-five-year timeline for commercial rollout underscores the urgency for streamlined regulatory and seed distribution frameworks.''Long-term ecological impacts, particularly on soil and biodiversity across five million hectares, demand rigorous scrutiny, as do intellectual property complexities surrounding CRISPR tools. While water savings and early maturity are compelling, extensive field trials across diverse agroclimatic zones are critical to validate performance,' says to Pareek, the success of these genome-edited rice varieties depends on strategic implementation, farmer-centric education, and ongoing scientific oversight to achieve sustainable outcomes. India is currently implementing gene editing techniques on 24 food crops and 15 horticulture crops, according to government officials. As several new genome-edited varieties are expected to be released in the coming days, experts are urging for a comprehensive guideline specifically for these crops to tackle regulations, consumers can't easily distinguish between gene-edited crops and non-edited ones. This necessitates 'the need for labelling and stricter oversight' for these crops, says a similar vein, The Coalition for a GM-Free India, an advocate for a GM-free world, highlights safety concerns surrounding gene-editing techniques, raising doubts about their safety. 'Gene editing is also genetic modification, as is apparent from the statutory definition in India of genetic engineering. However, the Government of India has deregulated two kinds of SDN-1 and SDN-2, giving specious unscientific rationale. Under a smokescreen of higher yield/drought resistance, etc., it has now released two gene-edited rice varieties without safety testing,' states The Coalition for a GM-Free India in a release, a day after the launch of these crops.'Given the lack of public acceptance of transgenic r-DNA technology—one kind of modern biotechnology—the biotech industry and lobbies have resorted to falsely portraying gene editing as a precise and safe technology, whereas published scientific papers show that this is untrue. India's deregulation of two kinds of gene editing (SDN-1 and SDN-2) is outright illegal,' the Coalition Ashok Kumar, Director of Farm Prosperity at Transform Rural India (TRI), hailed the innovation while emphasising the need to conduct thorough biosafety testing of gene-edited and transgenic crops prior to their release for 2022 document titled 'The Regulatory Authority for Gene-edited Organisms' issued by the Department of Biotechnology (DBT) states that SDN-1 and SDN-2 are not classified as GMOs. 'But since this is the first time the genome of rice is edited using CRISPR technology, and the product is a staple food, its biosafety for human and animal health must be thoroughly tested and assured before releasing for consumption,' Kumar labelling, Yadava says, 'Genome editing is a precision mutagenesis tool. Mutations are created in the native genes, similar to the conventional mutagenesis approach, and since no foreign gene is presented in the gene-edited crop, labelling is not necessary.'In 2018, ICAR launched a genome editing research project in rice under the National Agricultural Science Fund. The project focused on two popular rice varieties: Samba Mahsuri (BPT5204) and MTU1010 (Cottondora Sannalu), which are cultivated across nine million hectares in the country. The genome-edited rice line, officially designated IET 32072, underwent multi-location field trials in 2023 and 2024 under the All India Coordinated Research Project on Rice (AICRPR) to assess its varieties promise to increase rice yields by 20-30%. According to ICAR, cultivating these rice varieties on nearly 5 million hectares can yield an additional 4.5 million tonnes of paddy while reducing greenhouse gas emissions by 20% (32,000 tonnes). The shorter duration (reduction by 20 days) of these varieties can also save around 7,500 million cubic metres of irrigation water by reducing three experts find it confusing to promise unverified yield increases for crops such as rice, considering India's current surplus production. There are also concerns that introducing gene-edited rice varieties could threaten India's rich rice genetic diversity, jeopardise its native rice heritage, and impact trade opportunities for non-GM there are concerns, some experts also view this development as a notable step forward, potentially paving the way for further advancements in this field. Ajay Kakra, Leader-Food and Agriculture, GIDAS, Forvis Mazars, India—a global consultancy—states that pioneering genome-edited rice without foreign DNA insertion has the potential to position India as a biotechnology leader. 'However, their long-term credibility hinges on transparent and timely progression through field validation and regulatory processes, he says, noting that the early announcements can increase awareness among stakeholders, enabling them to prepare for Agriscience, a global agriculture and seed company, too, welcomed the development but declined to comment on regulatory aspects. 'Gene editing offers a way to grow more food on less land while strengthening crops against pests and climate stressors. Its widespread adoption could redefine how we farm and, more importantly, offer a powerful tool in the global effort to ensure food security,' says the spokesperson of the ongoing debate regarding the regulation of genome-edited crops, agri experts like Pareek and Kakra assert that the announcement isn't premature, given its scientific significance and global implications. They suggest ICAR should emphasise the timeline of 4-5 years for seed development and execute rigorous testing and transparency to manage expectations. If concerns are addressed before their commercial launch, these crops hold the potential to redefine farming in the coming days.
The Hindu
04-05-2025
- Politics
- The Hindu
Genome-edited seeds to mark beginning of second green revolution: Chouhan
Union Agriculture Minister Shivraj Singh Chouhan, on Sunday (May 4, 2025), announced the development of two genome-edited rice varieties and said the technological advancement would lead to a second green revolution in the country. The new varieties would be made available to farmers within four to five years, he said. 'After the laboratory cultivation, breeder seeds will be developed, and after multiplying breeder seeds, certified seeds will be given to farmers. The process generally takes four to five years. We are trying to reduce this time,' he said, speaking to reporters after an event at the Indian Council of Agricultural Research (ICAR) to felicitate the scientists involved in the development of the new seeds. He said the country's vision for a developed nation was being realised, and farmers were moving towards prosperity. 'Today's achievement will be written in golden letters. During the Azadi Ka Amrit Mahotsav, Prime Minister Narendra Modi had called upon farmers to adopt modern techniques to overcome agricultural challenges. Inspired by his words, ICAR scientists have made exceptional achievements in the field of agriculture with the creation of these new varieties,' he said and added that the development of these new crops would not only enhance production but also yield positive results in environmental terms. 'It will save irrigation water and reduce greenhouse gas emissions, thereby lowering environmental pressure. This is a classic example of getting both benefits – increased production and environmental conservation,' the Union Agriculture Minister said. He told the reporters that the innovative approach would mark the beginning of the second green revolution. Mr. Chouhan added that the coming years would see the need for ensuring food security, increasing nutritious production, and providing food for both India and the world, while making India the food basket of the world. ICAR Director-General M.L. Jat said demand-driven research should be promoted, adding that there was a need to gather feedback from farmers about their specific requirements. 'This approach will ensure that research outcomes are tailored to meet the needs of farmers and effectively reach them with the right solutions,' he said. About 13 scientists, including Vishwanathan C, Gopal Krishnan S, Santosh Kumar, Shivani Nagar, Archana Vats, Satyendra Kumar Mangruthia, R.M. Sundaram, R. Abdul Fiyaz and C.N. Neerja, were honoured for their contribution to the development of the rice varieties. 'These new varieties were developed using genome-editing technology based on CRISPR-Cas, which makes precise changes in the organism's genetic material without adding foreign DNA. Genome editing of SDN 1 and SDN 2 types of genes has been approved under India's biosafety regulations for general crops. In 2018, ICAR initiated genome-editing research to improve two major rice varieties – Samba Mahsuri and MTU 1010 – under the National Agricultural Science Fund. The outcome of this research is the two advanced varieties that offer the following benefits such as 19% increase in yield, 20% reduction in greenhouse gas emissions, saving of 7,500 million cubic meters of irrigation water and improved tolerance to drought, salinity, and climate stresses,' the ICAR said in a statement.
Time of India
03-05-2025
- Science
- Time of India
India's first genome-edited climate-resilient rice varieties developed to boost yields and conserve water
AI generated image NEW DELHI: In a first of its kind initiative, the Indian Council of Agricultural Research ( ICAR ) - India's premier agri research organisation - has developed the country's first genome-edited climate-resilient varieties of rice to boost yields and conserve water. The ICAR claimed that the cultivation of these improved rice varieties -- ' DRR Dhan 100 (Kamala)' and ' Pusa DST Rice 1 ' -- in about 5 million hectares of the recommended area will produce 4.5 million tons of additional paddy and save a minimum 7,500 million cubic meters of irrigation water. Besides, it will also reduce the greenhouse gas emissions by 20% (32,000 tons). Genome-editing, particularly the CRISPR-Cas technology , is being recognised as a breakthrough in precision breeding. It enables scientists to make targeted changes in the native genes of living organisms, creating new and desirable traits without introducing foreign DNA. "Development of these two varieties using genome editing technology has paved the way for using this innovative method in other crops too for higher yields, climate resilience and improved quality to achieve the targets of Viksit Bharat," said an official note, released by the ICAR, on late Saturday. Union agriculture minister Shivraj Singh Chouhan will formally release these two varieties on Sunday. Recognizing the transformative potential of new technology, the ICAR initiated a genome-editing research project in rice in 2018 and selected two widely cultivated mega rice varieties -- 'Samba Mahsuri (BPT5204)' and 'MTU1010 (Cottondora Sannalu)' -- to further enhance their qualities through technological interventions. The ICAR scientists eventually enhanced these varieties with better stress tolerance, improved yield, and climate adaptability without compromising their existing strengths, and developed two new genome-edited varieties 'Kamala' and 'Pusa DST Rice 1'. "The initiative marks a significant step forward in India's efforts to ensure food security and sustainable agriculture in the face of mounting environmental challenges. There are few concerns about the Intellectual Property Rights of the technology which are being looked after and will be resolved in times to come," said the ICAR. The genome-edited 'DRR Dhan 100 (Kamala)' is recommended for cultivation across major rice-growing states, including Andhra Pradesh, Telangana, Karnataka, Tamil Nadu, Puducherry, Kerala, Chhattisgarh, Maharashtra, Madhya Pradesh, Odisha, Jharkhand, Bihar, Uttar Pradesh, and West Bengal. The other new variety - 'Pusa DST Rice 1' - is also recommended for cultivation in most of these states. Currently, genome-editing programmes have also been initiated by the ICAR in many crops including oilseeds and pulses.
