Allogene Therapeutics has revised its ALPHA3 CAR T trial to use only standard lymphodepletion after a patient death linked to its investigational antibody. < Back Allogene Pivoting Lymphodepletion Strategy in ALPHA3 CAR‑T Trial Following Patient Death Allogene Therapeutics has revised its ALPHA3 CAR T trial to use only standard lymphodepletion after a patient death linked to its investigational antibody. Allogene Therapeutics (Nasdaq: ALLO), a pioneer in off-the-shelf CAR T cell therapy, has announced a significant update to its ALPHA3 Phase 2 clinical trial of cemacabtagene ansegedleucel (cema-cel) in first-line consolidation for large B-cell lymphoma (LBCL). In response to an adverse event, the company will now use the standard fludarabine and cyclophosphamide (FC) lymphodepletion regimen exclusively. The move comes after the trial’s FCA arm—which combined FC with ALLO‑647, an anti-CD52 monoclonal antibody—was halted following a Grade 5 adverse event involving liver failure due to a disseminated adenovirus infection. This fatality, occurring on Day 54 post-infusion, was attributed to ALLO‑647 rather than cema-cel, prompting an immediate safety review. Allogene will discontinue use of ALLO‑647 in all future protocols. Per CEO David Chang, the decision was made in coordination with the ALPHA3 Data and Safety Monitoring Board (DSMB), Steering Committee, and the U.S. Food and Drug Administration. Chang emphasized that no cases of severe viral infection or hepatic failure have occurred with FC-only lymphodepletion in any trial participants. Under the revised protocol, ALPHA3 will now proceed as a two‑arm randomized study: cema-cel following standard FC lymphodepletion versus observation alone (current standard of care). The study’s statistical design remains unaltered, with a futility analysis—focused on minimal residual disease (MRD) conversion—expected in the first half of 2026. Over 50 clinical sites across the U.S. and Canada remain active in the study. Chang commented: “The loss of a patient is always deeply saddening, […] administering cema-cel following standard FC lymphodepletion in an outpatient setting will simplify treatment, accelerate enrollment, and streamline regulatory pathways.” Analysts say this adjustment reinforces Allogene’s strategic pivot toward its Dagger® Platform, which aims to reduce reliance on antibodies like ALLO‑647 and minimize lymphodepletion altogether. All trials and pipeline programs will now focus on Dagger‑enabled candidates such as ALLO‑316 and ALLO‑329, which are being developed for renal cancer and autoimmune diseases, respectively. This protocol change closely follows a Fierce Biotech report revealing the patient death and Allogene’s swift decision to discontinue its investigational antibody use. The article confirmed that this was the only active trial still utilizing ALLO‑647. About Allogene Therapeutics Allogene Therapeutics is a clinical-stage biotechnology company at the forefront of developing allogeneic (“off-the-shelf”) chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer and autoimmune diseases. Headquartered in South San Francisco, Allogene is led by a team of industry pioneers with deep expertise in cell therapy and immuno-oncology. The company’s proprietary technology platform is designed to deliver CAR T cell therapies that are readily available, scalable, and do not require patient-specific cell collection, aiming to make advanced cell therapies more accessible to patients around the world. Allogene’s pipeline includes multiple product candidates, such as cemacabtagene ansegedleucel (cema-cel) for large B-cell lymphoma, as well as innovative programs in solid tumors and autoimmune disorders. Author BioFocus Newsroom Previous Next

Revolutionary 3D multi-omics platform reveals new therapeutic targets, promising faster, more successful drug development. < Back 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. A pioneering collaboration between biotech innovator Enhanced Genomics and The ALBORADA Drug Discovery Institute at the University of Cambridge has delivered a major breakthrough in Alzheimer’s research. The partnership, supported by Alzheimer’s Research UK, is already generating multiple novel drug targets that were previously undetectable using traditional genomic methods. By harnessing Enhanced Genomics’ proprietary 3D multi-omics platform, scientists have been able to map complex gene-regulatory interactions at an unprecedented scale and resolution. This has revealed critical new insights into the underlying biology of Alzheimer’s disease and accelerated the discovery of high-confidence, genetically validated drug targets. “This collaboration marks a turning point in how we discover drugs for complex diseases like Alzheimer’s,” said Dr. Dan Turner, Chief Scientific Officer at Enhanced Genomics. “Our platform doesn’t just look at the genome—it interprets how different regions of DNA interact in 3D space across specific human cell types. This gives us the power to uncover therapeutic targets hidden in the non-coding genome, something conventional tools simply can’t do.” The ALBORADA Drug Discovery Institute, based at the University of Cambridge, has used these findings to open new research pathways into drug development. “The insights provided by Enhanced’s technology have already led us to previously unknown targets with real therapeutic potential,” said Dr. John Skidmore, CSO at The ALBORADA Drug Discovery Institute. “This could significantly advance our ability to develop effective treatments for Alzheimer’s disease.” Alzheimer’s Research UK, the UK’s leading dementia research charity, sees this partnership as a model for future industry-academic collaborations. “This is the kind of ambitious, high-impact science we need to bring hope to the millions affected by dementia,” said Dr. Julia Dudley, Head of Strategic Programmes. “By combining cutting-edge technology with deep disease expertise, we’re accelerating progress toward the next generation of treatments.” The collaboration not only delivers immediate value in Alzheimer’s research, but also underscores the wider potential of Enhanced’s 3D multi-omics platform. By defining causal biology from disease-associated genetic variants, the technology dramatically improves both the speed and likelihood of success in early drug discovery. Looking ahead, Enhanced Genomics and The ALBORADA Drug Discovery Institute are exploring ways to expand their work into other neurodegenerative diseases. The company is also actively seeking new partnerships with pharmaceutical and biotech organizations interested in incorporating 3D multi-omics into their own drug discovery pipelines. About Enhanced Genomics: Enhanced Genomics is a biotechnology company revolutionizing drug discovery through its proprietary 3D multi-omics platform, capable of identifying high-confidence therapeutic targets from disease-associated variants across the entire genome. The platform enables faster, more efficient, and more successful drug development for common diseases with high unmet need. About The ALBORADA Drug Discovery Institute: Established by Alzheimer’s Research UK, The ALBORADA Drug Discovery Institute focuses on developing treatments that tackle the biological mechanisms driving neurodegenerative diseases, including Alzheimer’s. About Alzheimer’s Research UK: Alzheimer’s Research UK is the UK’s leading dementia research charity, dedicated to accelerating the discovery of new treatments and, ultimately, a cure for dementia. Author BioFocus Newsroom Previous Next

< Back 15th – 17th April, 2025 Rome, Italy The Cell & Gene Meeting on the Med The Cell & Gene Meeting on the Mediterranean is the leading conference bringing together the ATMP community from Europe and beyond. Covering a wide range of commercialization topics from market access and regulatory issues to manufacturing and financing the sector, this program features expert-led panels, extensive one-on-one partnering capabilities, exclusive networking opportunities, and 60+ dedicated presentations by leading publicly traded and privately held companies in the space. Join ARM for Europe’s premier conference for advanced therapies. Previous Register now Next

Reach out to the BioFocus team for publishing enquiries, new story ideas, advertising with us, and anything else you may be curious about. Contact us. The BioFocus team are a group of scientists, communicators, and marketeers dedicated to delivering up-to-date news to the public, industry professionals, and everyone in-between. We welcome you to reach out to us about publishing enquiries, new story ideas, advertising with us, and anything else you may be curious about. You can also find us on LinkedIn. Reach out to the BioFocus team Fill out the form below or contact us directly via email or social media and we will be in touch soon. Email info@bio-focus.co.uk Social Media First name Last name Email Country Questions? I acknowledge and agree to the use of my contact information to receive messages about offerings by BioFocus, its brands, affiliates and/or third-party partners, consistent with the BioFocus Privacy Policy View privacy policy. Submit Thanks for submitting!

Shift Bioscience has unveiled an improved ranking system for virtual cell models, enhancing gene target discovery through better performance metrics in rejuvenation research. < Back 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. Shift Bioscience, a biotechnology company at the forefront of cell rejuvenation research, has announced the release of a new study that proposes a significantly improved approach to ranking virtual cell models used in gene discovery. The findings promise to accelerate the company’s therapeutic pipeline aimed at combating age-related diseases by enhancing the accuracy and reliability of virtual cell modelling. The study, led by Lucas Paulo de Lima Camillo, Head of Machine Learning at Shift Bioscience, introduces novel metrics and calibration techniques designed to better assess the performance of virtual cell models trained on single-cell RNA sequencing (scRNA-seq) data. These models are critical tools for simulating how cells respond to gene perturbations, offering a virtual alternative to laborious and time-intensive wet lab experiments. "By focusing on the development of new metrics and baselines, we can more easily identify models that demonstrate strong predictability," said Camillo. “The paper provides foundational data which will enable us to develop more powerful, biologically useful perturbation models, ultimately accelerating our therapeutic pipeline and helping us to uncover new targets for rejuvenation therapeutics.” Despite the promise of virtual cell models in high-throughput gene screening, past benchmarking efforts using standard performance metrics have revealed a surprising limitation: even top models often underperform compared to the simple average of all cells in a dataset. Shift’s new study attributes this issue to misleading signals from weak perturbations and control biases in experimental data. To overcome these challenges, the team at Shift developed a suite of enhancements that allow for more meaningful evaluations. These include: DEG-weighted scoring to emphasize biologically significant gene changes, Positive and negative baseline calibrations for clearer performance comparisons, and DEG-aware optimization objectives to focus model training on relevant cellular shifts. Together, these refinements enable researchers to better identify models that truly capture the biological effects of gene perturbations, paving the way for faster and more accurate target discovery. The company believes this innovation marks a critical step toward the future of drug discovery in aging-related diseases. With improved virtual models, Shift Bioscience can streamline the identification of gene targets with rejuvenation potential, significantly reducing the time and cost associated with bringing new therapies to the clinic. This latest advancement builds on Shift Bioscience’s growing momentum in the field of cellular rejuvenation. Earlier this year, BioFocus covered the company’s landmark discovery of a breakthrough single-gene target capable of driving safe cellular rejuvenation, a major milestone in age-related therapeutic research. To learn more about this, read the full article here . Author BioFocus Newsroom Previous Next

< Back 11th January, 2026 San Francisco, CA ACCESS China Biotech Forum Effective partnering and China market assessment platform – ACCESS CHINA is the most effective deal-making platform for Western pharma and biotech leaders looking to enter or expand in the Chinese market. ACCESS CHINA creates invaluable BD opportunities by directly connecting and meeting with the right partners for development, licensing or commercial collaborations. Celebrate the 15th Advancing Women’s Leadership in Pharma and Healthcare and gain the confidence to lead and influence change across your organisation and the wider industry. This highly regarded three-day event offers a powerful platform to learn from inspiring leaders, overcome roadblocks to advancement, and elevate your professional impact. Connect with peers, share experiences, problem-solve collaboratively, and chart your path toward sustainable, successful leadership. Previous Register now Next

< Back BD Hit With Antitrust Lawsuit Over Hernia Mesh Market Power Rival Tela Bio claims pricing and contracting tactics shut out lower-cost alternatives, raising costs in a $12B surgical market. Becton Dickinson (BD) is facing a new legal challenge, this time from a competitor rather than patients. Tela Bio has filed an antitrust lawsuit in federal court in Philadelphia alleging that BD used its dominance in the U.S. hernia mesh market to stifle competition and block adoption of Tela’s OviTex reinforced biologic mesh. According to the complaint, BD leveraged conditional pricing, long-term bundling contracts and purchasing agreements with group purchasing organisations, integrated delivery networks and hospitals to penalise providers that stocked Tela’s products. Tela argues these tactics effectively excluded OviTex from the market despite its lower price point, about $3,000 per unit compared with roughly $4,500 for BD’s Phasix mesh, and limited its U.S. resorbable mesh share to under 8% in 2024. OviTex, cleared by the FDA in 2016, combines a sheep-derived extracellular matrix with synthetic fibres and is designed for open, robotic and laparoscopic hernia repairs. Tela claims its performance has been stronger in markets such as the UK, where BD does not hold similar contracting arrangements. BD’s mesh portfolio accounts for an estimated 65% of spending on permanent hernia mesh and 77% of the resorbable segment, according to the lawsuit. Tela says the alleged conduct has not only harmed its business but also driven up costs for hospitals and patients in a market that sees roughly 1.5 million procedures annually, representing about $12 billion in U.S. healthcare spending. “BD operates fairly in a complex, highly competitive industry, complying with all laws and regulations governing our commercial activities,” the company said in a statement to Fierce Medtech through a company spokesperson. “The allegations in this matter are without merit and BD will vigorously defend against these claims.” The case comes against the backdrop of extensive prior litigation over BD’s hernia mesh products. Last year, the company agreed to settle about 38,000 personal injury lawsuits, with Reuters reporting the deal covered a “large majority” of the $1.7 billion BD had set aside for mesh-related liability, without admitting wrongdoing. Author BioFocus Newsroom Previous Next

< Back 11th – 13th October, 2026 Berlin, Germany World Health Summit From Crisis to Resilience: Innovating for Health. The annual World Health Summit brings together global health stakeholders from all sectors and regions to find solutions for the most pressing health challenges. In 2025, it took place under the theme "Taking Responsibility for Health in a Fragmenting World." Across three conference days, the World Health Summit sparked exchange, generated insights, and catalyzed science-based and interdisciplinary solutions. The World Health Summit 2026 will take place on 11–13 October 2026. Previous Register now Next

GATHER2 extension data show sustained efficacy and no new safety concerns after 3.5 years of treatment. < Back Astellas Reports Long-Term Benefits and Strong Safety Profile for IZERVAY™ in Geographic Atrophy GATHER2 extension data show sustained efficacy and no new safety concerns after 3.5 years of treatment. Astellas Pharma Inc. (TSE: 4503) announced promising long-term data for its therapy IZERVAY™ (avacincaptad pegol intravitreal solution), demonstrating continued benefit in slowing the progression of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Results from the open-label extension of the Phase 3 GATHER2 study, presented at the American Academy of Ophthalmology (AAO) 2025 Annual Meeting in Orlando, showed that IZERVAY reduced GA lesion growth by up to 40.5% versus projected sham over 3.5 years of treatment. Importantly, the findings revealed that earlier initiation of IZERVAY therapy resulted in greater protection of retinal tissue, underscoring the importance of early intervention in GA management. IZERVAY continued to demonstrate a strong safety profile, with no new safety signals and no cases of retinal vasculitis or occlusive vasculitis reported during the 18-month open-label extension period. “These findings corroborate the favorable efficacy and safety outcomes previously observed in the two-year GATHER2 trial,” said Dr. Arshad M. Khanani, Director of Clinical Research at Sierra Eye Associates. “IZERVAY maintains a consistent safety profile and offers meaningful long-term reductions in disease progression, particularly when started earlier.” In parallel, real-world data from more than 10,000 GA patients in the American Academy of Ophthalmology IRIS® Registry supported the drug’s safety and tolerability. The analysis found low discontinuation rates, low incidence of adverse events (3.6%), and an average treatment interval of seven weeks between injections, confirming that IZERVAY’s benefits in clinical studies are reflected in everyday clinical practice. “IZERVAY continues to be a trusted treatment option for countless patients living with GA and the fear of vision loss,” said Marci English, Senior Vice President, Biopharma and Ophthalmology Development at Astellas. “Our ongoing research underscores the need for early detection and intervention to preserve vision for as long as possible.” Additional findings presented at AAO 2025 linked structural changes in the retina to functional outcomes in GA patients treated with IZERVAY. Astellas researchers demonstrated that treatment slowed photoreceptor loss, reinforcing the structure-function relationship between ellipsoid zone (EZ) integrity and visual function, as measured by low luminance deficit (LLD). These biomarkers could help clinicians track disease progression and treatment impact more precisely. IZERVAY is approved for the treatment of geographic atrophy in the United States, Australia, and conditionally in Japan, with Astellas continuing to work with regulatory agencies worldwide to expand access to patients globally. About IZERVAY™ (avacincaptad pegol intravitreal solution) IZERVAY is an intravitreal therapy designed to slow the progression of geographic atrophy, the advanced form of dry AMD. It is administered by eye injection and works by targeting complement protein C5, a key component in the inflammatory pathway implicated in GA progression. Author BioFocus Newsroom Previous Next

Scientists are proposing a lunar biobank to preserve the world's endangered species. < Back A Modern Day Noah's Ark? Scientists are proposing a lunar biobank to preserve the world's endangered species. As many of us are aware, the effects of climate change are becoming more and more apparent. From the melting of the polar ice caps to powerful life-threatening hurricanes to blazing hot summers, all have a huge impact on people, wildlife and the environment. Scientists are now gathering plans to send plant and animal cells to the moon , in attempts to safeguard Earth’s biodiversity! Within the moon’s south pole there is a permanently shaded area which typically remains around -196 degrees Celsius, which would allow these endangered cells to be protected long term through a method known as cryopreservation. Usually when cells are being collected, they are stored within biorepositories , essentially a huge library keeping the biospecimens safe. The idea is to have a biorepository within this shadowy region of the moon. This idea brings hope that soon to be extinct creatures can continue to exist through the protection of their cells. What species would go on the moon first? Mary Hagedorn and her colleagues of the Smithsonian National Zoo and Conservation Biology Institute in Washing DC wrote about this lunar Noah’s Ark proposition in the summer of 2024 in a published article for BioScience. She explained how the species to be stored on the moon would be prioritised, starting with endangered species, species with a large impact on habitats, also known as ecosystem engineers, and species with the potential to help humans with space exploration. Why on the moon? So, why does this biorepository need to be on the moon. Ironically, as well as protecting these species from climate change, the biorepository also needs to be protected from the impacts of changing climates on Earth. Something that the Svalbard Global Seed Vault in Norway know all too well about. The Svalbard Global Seed Vault utilises the freezing temperatures of the Arctic Circle to give home to hundreds of thousands of seeds in a “doomsday” style storage facility. The collection is the largest in the world and “contains 13,000 years of agricultural history” claims Brian Lainoff, who is the lead partnership coordinator of the company (Crop Trust) who manage the vault. In 2017, melting permafrost due to climate change resulting in unseasonably warm temperatures led to the vault being flooded putting the seed collection at risk. Thankfully, the global seed vault is still operating today, working hard to collect and preserve the world’s crops. Researchers explain how this event highlights the need for an alternative plan to protecting our biorepositories. What issues are involved with this plan? As exciting as this plan for a lunar Noah’s Ark sounds, there are plenty of questions still left unanswered such as, how would the different levels of radiation and gravity on the moon affect the samples? What about the dust on the moon, could this contaminate the samples and get into storage containers? Not to mention the fluctuating temperatures which still occur despite the region of the moon’s south pole being consistently dark. Moreover, another big challenge would be coordinating and getting stakeholders and nations invested into the project. To conclude, this idea is still in its early stages and would require a lot of hard work and collaboration for it to come to fruition. However, this is still an incredibly cool concept to think about as well as its potential to protect Earth’s precious biodiversity. Author Mia Butterworth-Brooks Previous Next

A BioFocus educational piece discussing important considerations when implementig perfusion and traditional bioprocessing workflows. < Back Comparing Perfusion Bioprocessing and Traditional Bioprocessing Methods A BioFocus educational piece discussing important considerations when implementig perfusion and traditional bioprocessing workflows. Bioprocessing is fundamental to the production of biologics, such as vaccines, monoclonal antibodies, and other therapeutic proteins. Traditional bioprocessing methods, including batch and fed-batch processes, have been the industry standard for decades. However, perfusion bioprocessing is gaining attention as a more efficient and productive alternative. This article compares perfusion bioprocessing with traditional methods, highlighting the key differences and advantages of each. Traditional bioprocessing methods Batch bioprocessing In batch bioprocessing, cells are grown in a fixed volume of nutrient medium, and the process runs until the nutrients are depleted or inhibitory waste products accumulate. The product is then harvested at the end of the cycle. Advantages: Simplicity: Easy to set up and manage. Lower initial investment: Requires simpler infrastructure and equipment. Disadvantages: Lower productivity: Limited by the volume of the initial nutrient medium. Variability: Greater batch-to-batch variability in product quality. Downtime: Requires time for setup, sterilization, and cleaning between batches. Fed-Batch bioprocessing Fed-batch bioprocessing improves upon batch processing by periodically adding fresh nutrients to the culture, which extends the growth phase and increases product yield. Advantages: Improved productivity: Extending the growth phase leads to higher product yields. Better control: Allows for more precise control over nutrient levels and growth conditions. Disadvantages: Intermediate complexity: More complex than batch processing. Still limited: While better than batch, it still experiences downtime and variability. Perfusion bioprocessing Perfusion bioprocessing is a continuous culture system where cells are constantly supplied with fresh nutrient medium while waste products and spent medium are simultaneously removed. This creates a steady-state environment conducive to optimal cell growth and consistent product production. Advantages: High Productivity: Continuous operation supports high cell densities, resulting in significantly higher yields. Consistent Product Quality: The steady-state environment minimizes batch-to-batch variability, ensuring consistent product quality. Efficiency: Smaller bioreactors can achieve the same production levels as larger batch systems, reducing costs. Real-Time Control: Advanced monitoring systems enable real-time adjustments to maintain optimal conditions. Scalability: Easily scalable from laboratory to commercial production. Sustainability: More efficient use of resources and reduced waste generation. Disadvantages: Complexity: Requires sophisticated equipment and control systems. Initial Investment: Higher initial capital investment for setup and equipment. Comparison Productivity and Yield Traditional Methods: Limited by the nutrient medium's initial volume and the growth phase's duration. Productivity is inherently lower. Perfusion: Continuous nutrient supply and waste removal support higher cell densities and extended production periods, significantly increasing overall yield. Product Quality Traditional Methods: Batch and fed-batch processes can lead to variability in product quality due to fluctuating growth conditions and nutrient levels. Perfusion: The steady-state environment ensures consistent conditions, leading to more uniform product quality. Operational Efficiency Traditional Methods: Require downtime for cleaning, sterilization, and setup between batches, reducing overall efficiency. Perfusion: Continuous operation eliminates downtime, maximizing bioreactor usage and operational efficiency. Resource Utilization Traditional Methods: Generally involve higher consumption of raw materials and generation of waste due to less efficient use of nutrients. Perfusion: More efficient nutrient use and continuous waste removal reduce raw material consumption and waste production. Scalability Traditional Methods: Scaling up involves larger bioreactors and more complex nutrient management, which can be challenging and costly. Perfusion: Easier to scale, as the process is continuous and can be maintained in smaller, more efficient bioreactors. Cost Implications Traditional Methods: Lower initial setup costs but higher operational costs due to inefficiencies and downtime. Perfusion: Higher initial capital investment but lower operational costs and higher long-term savings due to increased efficiency and productivity. Both traditional and perfusion bioprocessing methods have their respective advantages and disadvantages. Traditional methods offer simplicity and lower initial costs, making them suitable for smaller-scale operations or processes where high yield and consistency are less critical. However, for large-scale production and applications requiring high productivity and consistent product quality, perfusion bioprocessing presents a compelling alternative. As the biotechnology industry continues to evolve, the adoption of perfusion bioprocessing is likely to increase, driven by its superior efficiency, scalability, and sustainability. Author BioFocus Newsroom Previous Next

< Back LIVX 2026 8th – 10th December, 2026 Dubai, UAE Hosting the most powerful global ecosystem for longevity, biotech, and investment. ! Widget Didn’t Load Check your internet and refresh this page. If that doesn’t work, contact us. Previous Next