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- BioFocus | Life Science News
Hello. Welcome to BioFocus, a life science news and insights platform bringing you updates across biotech, pharma, bioprocessing, health, and sustainability. Hello. Welcome to BioFocus. Explore the latest updates from the life science industry. Read more Popular Content. Breakthrough "Armoured" CAR T-Cell Therapy Shows Promising Results in Tough-to-Treat Lymphomas In a phase 1 study, 81% of patients responded to IL18-boosted therapy, with over half achieving complete remission. Featured Articles. BIOTECH One Million New Species Discovered Read More BIOTECH SolasCure Receives FDA Fast Track Designation for Aurase Wound Gel in Treatment of Calciphylaxis Ulcers Read More PHARMA Women’s Health Therapeutics Market Enters Transformative Growth Phase Read More BIOTECH Using Jumping Genes for Safer, More Accurate DNA Editing Read More PHARMA Compass Pathways' Phase 3 Psilocybin Readout Raises Efficacy Questions Despite Meeting Primary Endpoint Read More HEALTH The Applications of Wearable Biosensors Read More SPONSORED Accelerating cell therapy development and manufacturing Read More BIOPROCESSING Fujifilm Rebrands Life Sciences Units to Strengthen Unified Market Presence Under ‘Partners for Life’ Strategy Read More SPONSORED Preparing your cell culture workflow to scale for success Read More Latest News. 11th July, 2025 01. SPT Labtech and Semarion Join Forces to Advance Automated Cell-Based Assays SPT Labtech and Semarion have partnered to create flexible, automated, and miniaturized workflows for advanced cell-based assays. Read More 6th July, 2025 02. Shift Bioscience Unveils Improved Virtual Cell Model Ranking to Accelerate Gene Target Discovery Shift Bioscience has unveiled an improved ranking system for virtual cell models, enhancing gene target discovery through better performance metrics in rejuvenation research. Read More 4th July, 2025 03. ProBio Opens Cell and Gene Therapy Center of Excellence in New Jersey. The 128,000-sq-ft GMP cell and gene therapy facility in New Jersey, expands the CDMOs U.S. capabilities in plasmid, AAV, and LVV manufacturing. Read More 3rd July, 2025 04. Optibrium Joins Forces with TalTech to Develop Sustainable AI-Driven Drug Discovery EU-funded PhD research program focuses on improving methods for predicting drug metabolism. Read More Editor's Selects. Weighing the Cost of Semaglutide 01. Read more Essential Strategies for Scaling Up Biologics 02. Read more Biotechnology in Agriculture - Feeding the World’s Growing Population 03. Read more Top Trends in Pharmaceutical Sustainability for 2025 04. Read more Event Spotlight. Explore the key upcoming industry events. Discover more. Stay up-to-date. Connect with BioFocus on LinkedIn or subscribe to our mailing list. Mail
- Biotechnology | BioFocus
Biotech SPT Labtech and Semarion Join Forces to Advance Automated Cell-Based Assays SPT Labtech and Semarion have partnered to create flexible, automated, and miniaturized workflows for advanced cell-based assays. Read More Shift Bioscience Unveils Improved Virtual Cell Model Ranking to Accelerate Gene Target Discovery Shift Bioscience has unveiled an improved ranking system for virtual cell models, enhancing gene target discovery through better performance metrics in rejuvenation research. Read More Optibrium Joins Forces with TalTech to Develop Sustainable AI-Driven Drug Discovery EU-funded PhD research program focuses on improving methods for predicting drug metabolism. Read More Enhanced Genomics and ALBORADA Drug Discovery Institute Accelerate Alzheimer’s Drug Discovery Revolutionary 3D multi-omics platform reveals new therapeutic targets, promising faster, more successful drug development. Read More SolasCure Receives FDA Fast Track Designation for Aurase Wound Gel in Treatment of Calciphylaxis Ulcers Designation underscores potential to address critical unmet need in rare and life-threatening wound condition. Read More One Million New Species Discovered Basecamp Research has announced the discovery of over one million previously unknown species as part of their new BaseData™ dataset. Read More Load more
- SPT Labtech and Semarion Join Forces to Advance Automated Cell-Based Assays
SPT Labtech and Semarion have partnered to create flexible, automated, and miniaturized workflows for advanced cell-based assays. < Back SPT Labtech and Semarion Join Forces to Advance Automated Cell-Based Assays SPT Labtech and Semarion have partnered to create flexible, automated, and miniaturized workflows for advanced cell-based assays. SPT Labtech, a global leader in laboratory automation, has announced a new collaboration with Semarion, a University of Cambridge spin-out focused on microcarrier technology for cell biology. The partnership will combine SPT Labtech’s firefly® liquid handling platform with Semarion’s SemaCyte® microcarriers to develop flexible, miniaturized, and automated workflows for cell-based assays. Cell-based assays play a critical role in drug discovery and biological research, but their automation and miniaturization have remained challenging. By integrating SPT Labtech’s adaptable liquid handling system with Semarion’s microcarrier technology, the two companies aim to simplify and speed up key steps in adherent cell assay development, including applications like high-content imaging and cell painting. Maryia Karpiyevich, Product Development Scientist at SPT Labtech, said, “This collaboration gives us the chance to bring together innovative microcarrier technology and flexible automation in one platform. Our goal is to provide scientists with better tools to advance cellular research.” Jeroen Verheyen, CEO and Co-Founder of Semarion, added, “Partnering with SPT Labtech allows us to combine our microcarrier technology with their automation expertise. This opens the door to new, streamlined workflows that are both miniaturized and scalable, helping researchers develop assays more efficiently.” Morten Frost, Chief Commercial Officer at SPT Labtech, commented, “We’re committed to supporting technologies that make lab work easier and more adaptable. This partnership reflects that commitment, offering solutions that can scale and adjust as research demands change.” The companies will work together on application protocols, proof-of-concept studies, and workflow optimization to deliver practical, automated solutions for cell-based research. Author BioFocus Newsroom Previous Next
- Verve Therapeutics Halts Gene Editing Trial After Side Effects
Verve halts enrollment in lead trial following grade 3 side effects and prioritizes next steps for PCSK9 editing therapy. < Back Verve Therapeutics Halts Gene Editing Trial After Side Effects Verve halts enrollment in lead trial following grade 3 side effects and prioritizes next steps for PCSK9 editing therapy. Verve Therapeutics , a pioneering biotech company focused on developing gene-editing therapies for cardiovascular diseases, recently announced a temporary halt in enrollment for its lead clinical trial. The decision comes in response to the occurrence of Grade 3 elevations in liver enzymes observed in participants receiving its investigational PCSK9 editing therapy. The trial, which aims to evaluate the safety and efficacy of Verve's gene-editing technology targeting PCSK9, a gene linked to high cholesterol and cardiovascular risk, has encountered a setback due to safety concerns. Grade 3 elevations in liver enzymes represent a significant adverse event, prompting the company to prioritize a thorough investigation before proceeding with further enrollment. Verve's decision to pause enrollment aligns with its commitment to patient safety and rigorous clinical evaluation. By taking this precautionary measure, the company demonstrates its dedication to ensuring the integrity and safety of its therapeutic approach. The temporary halt in enrollment follows a series of promising advancements in the field of gene editing, particularly in the context of cardiovascular disease management. Verve's innovative approach leverages cutting-edge technology to target specific genes associated with heightened cardiovascular risk, offering the potential for more precise and effective treatment strategies. Despite this setback, Verve remains steadfast in its mission to advance gene-editing therapies for cardiovascular diseases. The company has outlined plans to thoroughly investigate the observed adverse events and implement appropriate measures to address safety concerns before resuming enrollment in the trial. The decision underscores the inherent challenges and complexities involved in the development of novel therapeutic modalities, particularly in the realm of gene editing. While setbacks are not uncommon in the biopharmaceutical industry, Verve's proactive response highlights its commitment to upholding the highest standards of patient care and scientific rigor. Moving forward, Verve will continue to collaborate with regulatory authorities, healthcare professionals, and patients to navigate the clinical development process effectively. By prioritizing safety and transparency, the company aims to overcome challenges and ultimately deliver innovative therapies that have the potential to transform the landscape of cardiovascular disease treatment. Learn more about Verve Therapeutics here . Author BioFocus Newsroom Previous Next
- Cerevance Reports Phase 2 Results for Solengepras in Early-Stage Parkinson’s Disease
Cerevance has announced topline results from its Phase 2 ASCEND trial of solengepras, showing a small but non-significant improvement in motor symptoms and potential benefits for non-motor symptoms, with a strong safety profile. < Back Cerevance Reports Phase 2 Results for Solengepras in Early-Stage Parkinson’s Disease Cerevance has announced topline results from its Phase 2 ASCEND trial of solengepras, showing a small but non-significant improvement in motor symptoms and potential benefits for non-motor symptoms, with a strong safety profile. Cerevance , a clinical-stage biopharmaceutical company, has announced topline results from its Phase 2 ASCEND trial evaluating solengepras as a monotherapy for early-stage Parkinson's disease. The findings were presented at the AD/PD™ 2025 International Conference in Vienna. Solengepras is an oral, non-dopaminergic therapy designed to modulate brain circuits responsible for motor and non-motor functions without directly affecting dopaminergic pathways. This approach aims to reduce motor complications such as dyskinesia and minimize "OFF" periods. In the ASCEND trial, solengepras demonstrated a small, non-statistically significant improvement in motor symptoms from baseline to week 12 compared to placebo, as measured by the Movement Disorder Society – Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Parts II and III. While the primary endpoint was not met, trends toward improvement were observed in several patient-reported measures, including: MDS-UPDRS Part I (-1.38, p=0.12) MDS-UPDRS Part II (-0.4, p=0.62) Non-Motor Symptoms Scale (-1.7, p=0.59) Epworth Sleepiness Scale (-0.3, p=0.62) These results suggest potential benefits in functional and non-motor aspects of Parkinson's disease. Solengepras was generally well tolerated, with all patients in the treatment arm completing the 12-week trial and no discontinuations due to treatment-related adverse events. No serious adverse events related to solengepras were reported, and most were mild and transient. Notably, fewer non-motor symptom-related adverse events occurred in the treatment arm compared to placebo. Dr. Aaron L. Ellenbogen, primary investigator of the ASCEND trial, emphasized the need for therapies addressing both motor and non-motor symptoms in Parkinson's disease. He noted that solengepras' novel mechanism offers promise in this area. Cerevance is continuing its pivotal Phase 3 ARISE trial to evaluate solengepras as an adjunctive therapy in Parkinson's disease, with topline data expected in the first half of 2026. Author BioFocus Newsroom Previous Next
- ECB2024 | BioFocus
< Back ECB2024 30th June – 3rd July, 2024 The Dutch Biotechnology Association (NBV) is pleased to host the World’s two longest running biotechnology Congresses, ECB2024 and IBS2024, at their annual meeting, NBC-24, in the Netherlands. Previous Next
- Spotlight on Constructive Bio
The UK-based biotech company, specialising in synthetic genomics, recently obtained $58 million in Series A financing. < Back Spotlight on Constructive Bio The UK-based biotech company, specialising in synthetic genomics, recently obtained $58 million in Series A financing. Constructive Bio’s recent $58 million Series A financing (bringing the total amount raised by the company to date to $75 million) signals a major milestone in synthetic biology and biomanufacturing. Based in the historic city of Cambridge, Constructive Bio is very much future-focused, operating in the burgeoning realm of creating new biomolecules. By advancing the capacity to "write genomes from scratch," Constructive Bio is pushing synthetic genomics to unprecedented levels, going beyond traditional genetic engineering, with platforms that can design and synthesize entire genomes and precisely tailor protein translation systems. This allows for the creation of entirely novel biomolecules with specific and programmable properties. This holds vast potential for industries reliant on complex molecules, such as pharmaceuticals, consumer goods, and advanced materials. CEO Ola Wlodek had this to say about Constructive Bio’s position, and the impact this financing will provide to them. "Synthetic genomics is redefining how we harness biology. Our suite of proprietary technologies and incomparable team allows us to build novel materials and products that will revolutionise drug manufacturing and discovery. This financing will enable us to accelerate bringing breakthrough products and platforms to market, which will grow our revenue through existing and new paths, ranging from exciting therapeutics to sustainable biomaterials. We see the future of biology, and we're leading the charge." Notably, Constructive Bio’s foundational technology originates from groundbreaking research by founder Professor Jason Chin at the UK’s Medical Research Council’s Laboratory of Molecular Biology. Chin’s landmark achievement—synthesizing the genome of E. coli —laid the groundwork for developing synthetic organisms capable of incorporating non-standard amino acids, an innovation that can create proteins and biopolymers with novel functionalities. This expansion of the genetic code represents a key advancement, enabling Constructive Bio to engineer proteins with enhanced features that are difficult, if not impossible, to produce via natural biological pathways. This funding infusion, led by prominent investors such as Ahren, OMX Ventures, and Paladin Capital Group, reflects strong confidence in Constructive Bio’s ability to commercialize its synthetic biology platforms. The addition of Nobel Laureate Sir Gregory Winter to the board adds extra depth of expertise, as Winter’s background in developing therapeutic monoclonal antibodies complements Constructive Bio’s vision for pioneering therapeutic proteins and enzymes. As Winter noted, "With this investment, we aim to develop Constructive Bio's technology to deliver biomanufacturing at scale. By providing a biological, cost-effective production process, we can help overcome shortfalls in global supplies of therapeutic peptides and proteins such as semaglutide ." Constructive Bio is unique in combining three core technologies—recoded genomes, engineered cell machinery, and expanded molecular chemistry—enabling rapid genome synthesis and versatile biomolecular engineering. This trifecta has allowed Constructive Bio to reduce genome synthesis timelines from years to days, fast-tracking their ability to produce commercial-scale biomaterials. Furthermore, by developing new routes to sustainability in molecule synthesis, Constructive Bio aligns with broader industry goals of sustainable production, reducing dependency on resource-intensive manufacturing processes. The company’s technology represents a remarkable synthesis of computational biology, protein engineering, and molecular chemistry, making it an innovator capable of transforming not just healthcare, but global supply chains for a range of high-demand biological products. The future of synthetic genomics, as Constructive Bio’s rapid growth suggests, is one where the boundaries of natural biology are expanded and applied across industries, making novel therapeutics, sustainable materials, and highly engineered biomolecules a tangible reality. Author BioFocus Newsroom Previous Next
- The Future of Gene Editing Beyond CRISPR
Emerging gene editing technologies including base editing, prime editing, ZFNs, and TALENs show promising therapeutic applications treating genetic diseases. < Back The Future of Gene Editing Beyond CRISPR Emerging gene editing technologies including base editing, prime editing, ZFNs, and TALENs show promising therapeutic applications treating genetic diseases. Exploration into gene therapy techniques dates back to 1987 when researchers discovered an intriguing repetitive DNA sequence while studying genes involved in phosphate metabolism in the Escherichia coli genome . This sequence was later recognised as CRISPR, which stands for ‘clustered regularly interspaced short palindromic repeats’. The scientific community has since been invested in gene therapies because they can potentially be utilised to treat a broad spectrum of diseases, such as cancer, infectious diseases, and genetic disorders that were previously considered untreatable, positioning them as a powerful class of therapeutics. In 2023, CRISPR took the world by storm following the FDA approval of Casgevy, the first gene therapy approved for sickle cell disease. This sparked significant interest in CRISPR from the media and the public. While CRISPR is undeniably captivating, there are a variety of other gene editing techniques that could potentially pave the way for new therapeutic solutions, which we’ll explore in this article. Gene editing, also known as genome editing, can be used to amend a faulty gene or replace it with a healthy one or to add, delete, or introduce a specific base or sequence in the genome. Other types of gene editing techniques include base editing, prime editing, Zinc Finger Nuclease (ZFNs), and Transcriptor Activator-like Effector Nuclease (TALENs). Base editing – one nucleotide at a time This technique goes down to the nucleotide level. Unlike CRISPR, which involves cutting the DNA to insert or delete sequences, base editing allows scientists to precisely replace one DNA base with another without making double-strand breaks. Since only a single nucleotide is replaced, this makes it a favourable technique due to the lower risk of introducing errors in the DNA strand. It has the potential to correct harmful mutations responsible for conditions like sickle cell disease and Tay-Sachs disease. Several promising therapies using base editing are in development. This includes Verve-101 by Verve Therapeutics, which targets the PCSK9 gene to treat familial hypercholesterolemia, and Beam Therapeutics' BEAM-101 and BEAM-102, designed to treat sickle cell disease and beta-thalassemia. Prime editing – a new technique on the horizon Prime editing is one of the newest genome editing techniques, allowing for more precise DNA modifications than CRISPR or base editing. Compared to other techniques, prime editing does not cut both strands of DNA; it instead uses a "prime editor” protein to make targeted changes, such as inserting, deleting, or swapping DNA bases. This unique approach offers more versatility, allowing for a wider range of edits with reduced risks of unintended, off-target effects. However, more research is needed to measure the long-term effects of therapies designed using this technique. Prime editing has a significant potential to correct genetic mutations that cause diseases like cystic fibrosis or Huntington's disease. This technique is relatively new and still in the early stages of development. However, a couple of promising therapies are being developed, mainly by Beam Therapeutics , who are using prime editing to develop treatments for sickle cell anaemia and beta-thalassemia. As this technology advances, we expect to see more applications in rare genetic conditions and other therapeutic areas. Zinc Finger Nucleases (ZFNs) – binding to a specific site ZFNs are DNA-binding proteins that can create targeted double-strand breaks in DNA, enabling the precise insertion, deletion, or modification of specific genes. They consist of a zinc finger “DNA-binding domain” and a “DNA-cleavage domain” that cuts DNA at a desired location. While ZFNs target specific sites, it cannot be ruled out that ZFNs cut DNA at off-target sites, and the proteins can induce an immune response, leading to side effects in patients receiving the therapy. Furthermore, this technique is more complex to design in comparison to CRISPR, therefore becoming more costly and time-consuming. Despite these challenges, ZFNs are being studied for numerous applications, such as the treatment of HIV , where this method has been used to modify immune cells to resist the virus. Sangamo Therapeutics is developing several therapies using ZFNs, including a treatment for haemophilia and sickle cell disease. Transcription Activator-Like Effector Nucleases (TALENs) – more precision and flexibility TALENs are used for more targeted and efficient gene editing in live cells, enabling precise edits to be made to the genome. TALENs can be built from a simple “protein-DNA-code” that can be customised to “ specifically recognise a unique DNA sequence” to make specific modifications to the genome, including insertion, deletion, repair, and replacement. This method is less prone to off-target effects. Cellectis has used this method to develop several CAR-T therapies for treating blood cancers by editing immune cells to target tumours. Looking forward, what is next? More than 4,000 gene, cell, and RNA therapies are currently in development. The biotech industry is constantly looking for innovative solutions to treat diseases that have been difficult to target with traditional therapies. The field is exponentially growing, with constant developments in gene-editing technologies such as CRISPR, TALENs, base editing, prime editing and ZFNs, as well as breakthroughs in delivery methods such as lipid nanoparticles and viral vectors . These scientific and technological advancements offer hope for curing genetic disorders, some cancers, and rare diseases that previously had no prior treatment options. As we anticipate the growth and future success of genome editing therapies, it is also important to note the ethical considerations of this field. For example, concerns over germline editing, equitable access to treatments, and ensuring patient safety must be responsibly managed to ensure that gene-editing technologies are used for the benefit of society as a whole. Author Mariam Zaki , freelance contributor Previous Next
- Verdiva Bio Launches with $411M Funding to Revolutionize Obesity and Cardiometabolic Care
Biotech Startup Unveils Next-Generation Therapies, Including a Promising Once-Weekly Oral GLP-1 Peptide, Backed by Leading Global Investors. < Back Verdiva Bio Launches with $411M Funding to Revolutionize Obesity and Cardiometabolic Care Biotech Startup Unveils Next-Generation Therapies, Including a Promising Once-Weekly Oral GLP-1 Peptide, Backed by Leading Global Investors. Verdiva Bio , a newly established clinical-stage biopharmaceutical company, has launched with an impressive $411 million in Series A financing. The funding round was co-led by Forbion and General Atlantic, with additional participation from RA Capital Management, OrbiMed, Logos Capital, Lilly Asia Ventures, and LYFE Capital. The company is dedicated to developing innovative therapies targeting obesity, cardiometabolic disorders, and related complications. Its pipeline includes both oral and injectable treatments with the potential to be first-in-class or best-in-class. Notably, Verdiva's lead asset is a once-weekly oral GLP-1 peptide, VRB-101, which has demonstrated compelling efficacy potential in a Phase 1 study, confirming the viability of once-weekly dosing. Khurem Farooq, formerly the CEO of Aiolos Bio and Gyroscope Therapeutics, will lead Verdiva Bio as Chief Executive Officer. He is joined by a team of experienced drug developers and biotech professionals, including Chief Scientific Officer Jane Hughes and Chief Medical Officer Dr. Mohamed Eid. "People living with obesity and its complications deserve better options at each stage of their treatment journey," said Farooq. "We created Verdiva Bio to accelerate the development of differentiated medicines that address these significant unmet medical needs." Verdiva Bio's proprietary oral delivery technology is designed to enable patient-friendly dosing, greater scalability, and broader patient access. The company's portfolio also includes multiple amylin molecules (oral and subcutaneous agonists) and other undisclosed programs aimed at enhancing efficacy, improving tolerability, and promoting healthier weight loss. With this substantial financial backing and a robust pipeline, Verdiva Bio is poised to make significant strides in the treatment of obesity and cardiometabolic disorders, offering new hope to millions affected by these conditions worldwide. Author BioFocus Newsroom Previous Next
- FDA Approves NGS-Based Companion Diagnostic for Targeted Therapy in Grade 2 IDH-Mutant Glioma Patients
FDA approves Thermo Fisher's NGS-based companion diagnostic for targeted therapy in patients with grade 2 IDH-mutant glioma < Back FDA Approves NGS-Based Companion Diagnostic for Targeted Therapy in Grade 2 IDH-Mutant Glioma Patients FDA approves Thermo Fisher's NGS-based companion diagnostic for targeted therapy in patients with grade 2 IDH-mutant glioma Thermo Fisher Scientific has announced that the U.S. Food and Drug Administration (FDA) has approved its next-generation sequencing (NGS)-based companion diagnostic for the first targeted therapy aimed at patients with Grade 2 IDH-mutant glioma, a rare and challenging form of brain cancer. This milestone approval marks a significant step forward in the treatment of this patient population, offering new hope for personalized and more effective therapy options. The FDA approval pertains to Thermo Fisher’s Oncomine Dx Target Test, which is designed to identify patients with Grade 2 glioma who have mutations in the isocitrate dehydrogenase (IDH) gene. These patients can now be matched with a targeted treatment specifically designed for their genetic profile. This companion diagnostic is the first of its kind for this particular subtype of glioma, which is typically difficult to treat due to its aggressive nature and location in the brain. In a statement, Dr. Marc Tremblay, Vice President of Clinical Research at Thermo Fisher Scientific, emphasized the importance of the approval, noting, “The approval of the Oncomine Dx Target Test represents a major advancement in personalized cancer care, enabling oncologists to more effectively identify patients who are eligible for a targeted therapy. This is a step toward transforming the way we approach glioma treatment by focusing on genetic drivers rather than traditional treatment regimens.” IDH-mutant gliomas are a genetically distinct subgroup of gliomas, a type of brain tumor, and are characterized by mutations in the IDH gene. These tumors are generally slower-growing than other forms of glioma but can still be challenging to treat due to their location and the difficulty in achieving complete surgical resection. The approval of a targeted therapy for this condition represents a significant advancement in precision medicine, allowing for a more individualized treatment approach that may improve patient outcomes. The Oncomine Dx Target Test leverages Thermo Fisher’s expertise in NGS technology to analyze tumor DNA and identify genetic mutations that can guide treatment decisions. By detecting IDH mutations in glioma patients, the diagnostic test ensures that only those most likely to benefit from the targeted therapy are selected, thus optimizing treatment effectiveness and reducing unnecessary side effects. The targeted therapy, which was developed in conjunction with the companion diagnostic, is designed to block the oncogenic effects of the IDH mutation, potentially slowing tumor growth and improving survival in patients with this specific genetic alteration. The approval of this diagnostic test provides a critical tool for oncologists in selecting appropriate treatments and personalizing care for glioma patients. Thermo Fisher Scientific’s NGS-based diagnostic is part of a broader trend in oncology toward more precise, gene-targeted treatments. The company continues to expand its portfolio of companion diagnostics, supporting the growing field of precision medicine and helping to bridge the gap between genetic insights and effective clinical therapies. The approval of the Oncomine Dx Target Test is expected to significantly impact the treatment landscape for Grade 2 IDH-mutant glioma, improving the quality of care and offering new treatment options for patients who previously had limited therapeutic choices. Author BioFocus Newsroom Previous Next
- A Millennia-Old Mutation with Modern Implications | BioFocus
< Back A Millennia-Old Mutation with Modern Implications A genetic mutation known as CCR5Δ32, originating between 6,700 and 9,000 years ago near the Black Sea, provided ancient humans with a controlled immune response to emerging pathogens and now plays a crucial role in modern HIV resistance and gene-editing therapies. A recent study conducted at the University of Copenhagen has uncovered the origins of a genetic mutation that provides resistance to HIV—a mutation that first appeared in a single individual near the Black Sea between 6,700 and 9,000 years ago. Today, this same mutation, known as CCR5Δ32, is carried by 18-25% of the Danish population and has played a crucial role in developing modern HIV treatments. The CCR5Δ32 mutation deletes a small segment of the CCR5 gene, which encodes a protein on the surface of immune cells. HIV typically uses this protein as an entry point to infect the body, but the mutation disrupts the receptor, making it harder for the virus to take hold. While this protective effect against HIV was discovered decades ago, its ancient origins remained a mystery. By analyzing DNA from over 2,000 modern individuals and 900 ancient skeletons, researchers traced the mutation’s emergence to a single ancestor in the Black Sea region during the Neolithic period. Using AI-powered genetic analysis, they determined that the mutation spread rapidly, suggesting it provided a significant survival advantage long before HIV existed. Why did this mutation spread so widely? HIV has only been around for about a century, so why would a mutation that blocks it have been beneficial thousands of years ago? The researchers propose that CCR5Δ32 may have helped balance the immune system during a time of increasing infectious disease threats. As humans transitioned from hunter-gatherer lifestyles to settled farming communities, population density rose, and so did exposure to new pathogens. An overactive immune response could be deadly—much like the cytokine storms seen in severe COVID-19 cases. The mutation may have tempered excessive inflammation, giving carriers a better chance of survival during outbreaks. "This wasn’t about making the immune system stronger—it was about making it more controlled," explained Professor Simon Rasmussen, senior author of the study. "In an era of emerging diseases, a less aggressive immune response could have been the difference between life and death." The discovery not only solves a long-standing evolutionary puzzle but also reinforces the importance of studying ancient DNA. The same mutation that once helped Neolithic farmers survive is now the basis for HIV therapies, including the controversial (but groundbreaking) CCR5 gene-editing approach used in the "Berlin Patient," the first person cured of HIV. "This is evolution in action—a genetic fluke from the past turning out to be vital in the present," said Kirstine Ravn, lead researcher on the study. "It shows how much we can learn from our ancestors’ DNA." The study , published in Cell, marks a major step in understanding how human genetics and ancient diseases have shaped our biology. Future research could explore whether similar mutations exist for other modern viruses, hidden in the genomes of our distant ancestors. For now, the CCR5Δ32 mutation stands as a remarkable example of how the past continues to influence medicine today—one ancient gene at a time. Author BioFocus Newsroom Previous Next
- Merck's Keytruda Receives Landmark 30th EU Approval for Two New Indications in Gynecologic Cancers
This latest approval expands Keytruda’s reach to include the treatment of patients with advanced endometrial carcinoma and those with cervical cancer, bolstering options for patients with these hard-to-treat cancers. < Back Merck's Keytruda Receives Landmark 30th EU Approval for Two New Indications in Gynecologic Cancers This latest approval expands Keytruda’s reach to include the treatment of patients with advanced endometrial carcinoma and those with cervical cancer, bolstering options for patients with these hard-to-treat cancers. Merck’s groundbreaking immunotherapy drug, Keytruda (pembrolizumab), has reached a significant milestone, securing its 30th approval from the European Commission with two new indications for treating gynecologic cancers. This latest approval expands Keytruda’s reach to include the treatment of patients with advanced endometrial carcinoma and those with cervical cancer, expanding options for patients with these hard-to-treat cancers. In collaboration with chemotherapy, Keytruda is now approved for adults with persistent, recurrent, or metastatic cervical cancer where PD-L1 expression is present. The European Commission also approved Keytruda, when used in combination with lenvatinib, for the treatment of adult patients with advanced endometrial carcinoma who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. These approvals mark a notable step forward in gynecologic oncology, providing essential new options for patients facing limited treatments and poor outcomes. Impact and Efficacy in Gynecologic Cancer Keytruda, a monoclonal antibody that boosts the immune system’s response to cancer cells, has demonstrated robust results in clinical trials for both cervical and endometrial cancers. Studies revealed that patients treated with Keytruda, in combination with either chemotherapy or lenvatinib, showed significant improvements in progression-free survival and overall response rates. These advances are critical in the treatment of gynecologic cancers, where current options remain limited. Dr. Gregory Lubiniecki, Vice President, Global Clinical Development at Merck Research Laboratories, expressed optimism about Keytruda’s expanding role in cancer care: “These approvals in cervical and endometrial cancers mark important progress for patients with advanced cancers who face a poor prognosis and have historically had limited treatment options. We are excited to build on our ongoing commitment to addressing these significant unmet needs.” A Legacy of Innovation in Immunotherapy With its 30th European approval, Keytruda continues to set new benchmarks in oncology care. It is already approved in Europe for a wide range of cancers, including lung, melanoma, and head and neck cancers, among others. This milestone further solidifies Merck’s position as a leader in immuno-oncology and its commitment to expanding therapeutic options for complex and often underserved patient populations. The latest approvals underscore Merck’s dedication to pioneering life-saving treatments, bringing new hope to patients throughout Europe. The company is committed to ensuring widespread access to Keytruda and supporting physicians and healthcare systems in deploying this innovative therapy. Author BioFocus Newsroom Previous Next