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None\n Bispecific antibodies (BsAbs) have emerged as a transformative class of biologics, offering dual-targeting mechanisms that enhance therapeutic efficacy across oncology, autoimmune disorders, and rare diseases. According to Research and Markets, the bispecific antibody market is experiencing rapid growth, projected to rise from $12 billion in 2024 to $50 billion by 2030, driven by over 600 ongoing clinical trials.With the increasing demand for fast-tracked drug development, researchers and biopharmaceutical companies require high-quality bispecific antibodies delivered at high speed and scale. Biointron’s bispecific antibody production service addresses this need, providing customized, scalable solutions with a 2–3 week turnaround time.The Rise of Bispecific Antibodies: A New Era in Targeted TherapiesTraditional monoclonal antibodies (mAbs), primarily immunoglobulin G (IgG), are monospecific, recognizing and binding a single antigen. In contrast, bispecific antibodies are engineered to engage two distinct targets, enabling enhanced therapeutic mechanisms such as dual inhibition, immune cell redirection, and payload delivery. These properties make BsAbs highly effective in oncology, autoimmune diseases, and infectious disease therapies.Market Expansion and Clinical AdvancementsThe bispecific antibody sector has witnessed exponential growth, with 19 bispecific antibodies approved globally and total sales surpassing $35 billion as of March 2025. The expansion is fueled by breakthrough therapies such as:Hemlibra (emicizumab, Roche) – Approved in 2018, Emicizumab is a humanized, asymmetric bispecific IgG4 antibody that binds to blood clotting factor IXa and factor X. Emicizumab is used for the treatment of patients with hemophilia A, a hereditary bleeding disorder resulting from a deficiency of blood clotting factor VIII. This BsAb replicates the function of coagulation factor VIII by promoting the formation of the prothrombinase complex and subsequent clot formation.Vabysmo (faricimab, Roche) – Approved in 2022, Faricimab is a humanized bispecific immunoglobulin G1 (IgG1) antibody that inhibits both Ang-2 and vascular endothelial growth factor A (VEGF-A). Through VEGF-A inhibition, Faricimab reduces endothelial cell proliferation, neovascularization, and vascular permeability. It was first approved to treat neovascular age-related macular degeneration, diabetic macular edema.One example of an emerging candidate under review is Regeneron’s Linvoseltamab, an investigational, fully human, BCMAxCD3 bispecific antibody designed to bridge B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.The US Leads in R&D and InnovationThe United States remains the global leader in bispecific antibody R&D and commercialization, with key players such as Roche, Amgen, Pfizer, and Johnson & Johnson having strong pipelines. Since 2015, the number of bispecific antibody clinical trials has surged from fewer than 100 to over 650 in 2025, highlighting the growing significance of BsAbs in modern medicine.Speed, Scale, and Success: Why Rapid Bispecific Antibody Development MattersThe Need for Speed in Drug DevelopmentWith bispecific antibody innovation accelerating, speed has become a critical factor in drug development. Pharmaceutical companies are under pressure to advance novel therapeutics through preclinical and clinical stages before competitors. Rapid antibody production allows researchers to:Optimize lead candidates efficiently through high-throughput screening.Accelerate preclinical studies to secure early-stage funding and partnerships.Meet IND application requirements with high-purity, functionally validated BsAbs.The Role of CROs in Expediting Bispecific Antibody DevelopmentAs bispecific antibody pipelines expand, biotech and pharmaceutical companies are increasingly outsourcing development to specialized contract research organizations (CROs). CRO partnerships provide:Rapid turnaround times that internal teams may struggle to achieve.Scalable production capabilities for large-scale research programs.Access to advanced antibody engineering technologies without in-house infrastructure constraints.Biointron’s Fast-Track Bispecific Antibody Production: A Game Changer2–3 Week Turnaround: Enabling Rapid Drug DiscoveryBiointron’s streamlined bispecific antibody production service provides high-quality BsAbs in just 2–3 weeks, significantly reducing preclinical development timelines. The optimized workflow includes:Gene Synthesis & Plasmid Preparation (1 week)Codon optimization for enhanced expression.Subcloning into proprietary high-expression vectors.Plasmid amplification and purification.Transient Expression & Purification (1–2 weeks)Mammalian cell-based expression for high-yield production.Affinity purification with stringent QC (SDS-PAGE purity >95%, endotoxin <1 EU/mg).Size-exclusion chromatography (SEC-HPLC) to confirm antibody integrity.Scalability and Customization for Any Research NeedsTo support the growing demand for bispecific antibodies, Biointron offers scalable solutions tailored to diverse research needs, including:Support for all bispecific formats – IgG-like, BiTE, DVD-Ig, and more.Automated production platforms for high-throughput antibody expression.Multiple purification methods ensuring consistent quality and reproducibility.Conclusion: The Future of Bispecific Therapies Requires Speed and ScaleBiointron’s fast-track bispecific antibody production service enables researchers to accelerate preclinical research, optimize therapeutic candidates, and bring life-changing therapies to market faster. Biointron has delivered over 10,000 bispecific antibodies to global biotech and pharmaceutical companies, offering industry-leading expertise in bispecific antibody engineering, consistent, high-purity production with rapid turnaround, and end-to-end support for researchers and drug developers.Would you like to find out more about antibody production?Visit Biointron’s Learning Center or contact our expert team at info@biointron.com or +1 (732) 790 - 8340.

62.7% relative reduction in mortality at day 30, which persisted through day 60, for patients treated with Auxora versus placebo in subset of patients in CARDEA with AKI LA JOLLA, Calif., March 4, 2025 /PRNewswire/ -- CalciMedica Inc. ("CalciMedica" or the "Company") (Nasdaq: CALC), a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic illnesses, today announced that Sudarshan Hebbar, M.D., Chief Medical Officer of CalciMedica, delivered a plenary presentation at the 30th International Acute Kidney Injury and Continuous Renal Replacement Therapy Conference (AKI & CRRT) on March 3, 2025 in San Diego, CA. The presentation outlined the role of CRAC channels in acute kidney injury (AKI) pathophysiology and included new data highlighting the potential of CalciMedica's lead product candidate, Auxora™, in AKI. CalciMedica is currently conducting a Phase 2 trial of Auxora in patients with Stage 2 or Stage 3 AKI and acute hypoxemic respiratory failure, which is expected to read out in 2025. The new data presented were based on a post-hoc analysis from the previously completed Phase 2 CARDEA trial of Auxora in severe COVID-19 pneumonia. The study included 38 patients who enrolled with AKI, defined as an estimated glomerular filtration rate (eGFR) ≤ 60 ml/min/1.73 m², in addition to moderate or severe respiratory failure, which was an inclusion criterion. Within this subset: Patients treated with Auxora showed a 62.7% relative reduction versus placebo in mortality at day 30 which persisted through day 60. 7 out of 15 (46.7%) patients on placebo died by day 30 and day 60 as compared to 4 out of 23 (17.4%) patients on Auxora. Auxora exhibited an absolute reduction in mortality of 29.3%. This reduction in mortality in the patient subset with AKI exceeded that of the entire study population. In the entire population (n = 261), a 56.3% (p = 0.017) relative reduction versus placebo in mortality at day 30 was observed, with an absolute reduction of 9.9% versus placebo. In his presentation, Dr. Hebbar also summarized previously disclosed data supporting the role of CRAC channel inhibition as a potential therapeutic mechanism in AKI. Key data include: In preclinical biomarker studies, rats with AKI following ischemic reperfusion injury had decreased Th17 cells in their kidneys when receiving a CRAC inhibitor versus control, highlighting immunomodulatory effects. In in-vitro experiments, CRAC channel inhibition ameliorated injury to podocyte cells (kidney cells involved in filtration) caused by high glucose or angiotensin II, highlighting tissue-protective effects. In preclinical outcome studies, GFRs recovered more quickly and mortality was reduced in rats with severe or moderately severe AKI that received Auxora versus placebo. In clinical trial biomarker studies, CARDEA patients who received Auxora versus placebo had changes in cardiorenal biomarkers—increases in angiopoietin-1 and decreases in angiopoietin-2 and D-dimers—which have been linked to the prevention of endothelial damage in prior studies and were correlated with improved outcomes in CARDEA. At doses used experimentally and clinically, Auxora potentially provides a therapeutic window to treat acute critical illnesses without increasing risk of infection. "As illustrated by these data, the biological rationale for CRAC channel inhibition as a potential therapeutic mechanism for AKI is compelling," said Sudarshan Hebbar, M.D., Chief Medical Officer of CalciMedica. "The post-hoc analysis from CARDEA is especially relevant given that the 62.7% relative reduction in mortality was observed in patients with both kidney failure and respiratory failure, which mirrors the intended patient population for our ongoing Phase 2 KOURAGE study." The presentation is now available on the Medical Events & Presentations section of CalciMedica's IR website at . About CalciMedica CalciMedica is a clinical-stage biopharmaceutical company focused on developing novel CRAC channel inhibition therapies for inflammatory and immunologic diseases. CalciMedica's proprietary technology targets the inhibition of CRAC channels to modulate the immune response and protect against tissue cell injury, with the potential to provide therapeutic benefits in life-threatening inflammatory and immunologic diseases for which there are currently no approved therapies. CalciMedica's lead product candidate Auxora™ has demonstrated positive and consistent clinical results in multiple completed efficacy clinical trials. CalciMedica has announced data for a Phase 2b trial (called CARPO – NCT04681066) in patients with acute pancreatitis (AP) and accompanying systemic inflammatory response syndrome (SIRS). The Company has also completed a Phase 2 trial (called CARDEA – NCT04345614) in patients with COVID pneumonia. The Company is currently conducting a Phase 2 trial (called KOURAGE – NCT06374797) in patients with acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF) with data expected in 2025 and continuing to support the ongoing Phase 1/2 trial (called CRSPA – NCT04195347) in pediatric patients with asparaginase-induced pancreatic toxicity (AIPT) with data expected in 2025. CalciMedica was founded by scientists from Torrey Pines Therapeutics and the Harvard CBR Institute for Biomedical Research, and is headquartered in La Jolla, CA. For more information, please visit . Forward-Looking Statements This communication contains forward-looking statements which include, but are not limited to, results of post-hoc analyses from the previously completed Phase 2 CARDEA trial of Auxora and CalciMedica's ongoing and planned clinical trials and the timing and design thereof, and the expected timing for the release of data from those trials, including its ongoing Phase 1/2 CRSPA trial of Auxora in pediatric patients with AIPT and its ongoing Phase 2 KOURAGE trial of Auxora in AKI with associated AHRF; the potential benefits of Auxora for the treatment of AP, AKI and AIPT; and the potential of CalciMedica's proprietary technology to provide therapeutic benefits in life-threatening inflammatory and immunologic diseases. These forward-looking statements are subject to the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. CalciMedica's expectations and beliefs regarding these matters may not materialize. Actual outcomes and results may differ materially from those contemplated by these forward-looking statements as a result of uncertainties, risks, and changes in circumstances. Risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption "Risk Factors" in CalciMedica's Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the U.S. Securities and Exchange Commission (SEC) on November 13, 2024, and elsewhere in CalciMedica's subsequent reports on Form 10-K, Form 10-Q or Form 8-K filed with the SEC from time to time and available at . These documents can be accessed on CalciMedica's web page at ir.calcimedica.com/financials-filings/sec-filings. The forward-looking statements contained herein are made as of the date hereof, and CalciMedica undertakes no obligation to update them after this date, except as required by law. Contact Information Argot Partners Sarah Sutton/Kevin Murphy [email protected] (212) 600-1902 SOURCE CalciMedica, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Vabysmo PFS is the first and only prefilled syringe containing a bispecific antibody, offering a convenient alternative to currently available Vabysmo vials Vabysmo has demonstrated rapid and robust vision and anatomical improvements in neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME) and retinal vein occlusion (RVO) The ready-to-use Vabysmo PFS is co-packaged with the only CE-marked needle specifically designed for intravitreal injection 13 December 2024– Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency has approved Vabysmo® (faricimab) 6.0 mg single-dose prefilled syringe (PFS) for use in the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO). Together, these three conditions affect more than nine million people in the European Union (EU) and can have a devastating impact – physically, emotionally, and economically – on those affected, their families and caregivers.1-5 “Approval of the Vabysmo prefilled syringe in the EU offers a convenient way for ophthalmologists to administer this treatment for people with three of the most common causes of vision loss,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “This simplified administration may thereby help reduce the treatment burden for patients and retina specialists.” The Vabysmo PFS provides ophthalmologists with the first and only CE-labelled needle for intravitreal injection. Vabysmo PFS delivers the same medicine as the currently available 6.0 mg Vabysmo vials in an alternative, ready-to-use format.6 More than five million doses of Vabysmo have been distributed globally since its initial US approval in 2022.6-11 Vabysmo PFS was first approved for nAMD, DME and RVO by the United States Food and Drug Administration in July 2024.7 Vabysmo PFS will be the European Union’s first and only prefilled syringe containing a bispecific antibody to treat retinal conditions that can cause blindness. Vabysmo is the first bispecific antibody approved for the eye.7,8,12 It targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Ang-2 and VEGF-A contribute to vision loss by destabilising blood vessels, causing new leaky blood vessels to form and increasing inflammation. By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilise blood vessels.12,13 Vabysmo is approved in more than 100 countries around the world, including the United States (US), Japan, the United Kingdom and the European Union (EU) for people with neovascular or ‘wet’ age-related macular degeneration and diabetic macular edema, and in more than 30 countries, including the US, EU and Japan, for people with macular edema following retinal vein occlusion. Review by other health authorities is ongoing.6-11 Roche is focused on saving people’s eyesight from the leading causes of vision loss through pioneering therapies. Through our innovation in the scientific discovery of new potential drug targets, personalised healthcare, molecular engineering, biomarkers and continuous drug delivery, we strive to design the right therapies for the right patients. We have the broadest retina pipeline in ophthalmology, which is led by science and informed by insights from people with eye diseases. Our pipeline includes innovative treatments across different modalities, such as antibodies, and gene and cell therapies targeting multiple vision-threatening conditions, including retinal vascular and diabetic eye diseases, geographic atrophy, and autoimmune conditions, such as thyroid eye disease and uveitic macular edema. Applying our extensive experience, we have already brought breakthrough ophthalmic treatments to people living with vision loss. Susvimo® (previously called Port Delivery System with ranibizumab) 100 mg/mL for intravitreal use via ocular implant is the first United States Food and Drug Administration-approved refillable eye implant for neovascular or ‘wet’ age-related macular degeneration that continuously delivers a customised formulation of ranibizumab over a period of months.14,15 Vabysmo® (faricimab) is the first bispecific antibody approved for the eye, which targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 and vascular endothelial growth factor-A.7,8,12,13 Vabysmo is approved around the world for people living with nAMD, diabetic macular edema and macular edema following retinal vein occlusion.6-11 Lucentis® (ranibizumab injection)* was the first treatment approved to improve vision in people with certain retinal conditions.16 Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. References [1] National Institute for Health and Care Excellence. Macular degeneration – age-related: how common is it? [Internet; cited December 2024]. Available from: https://cks.nice.org.uk/topics/macular-degeneration-age-related/background-information/prevalence. [2] Bright Focus Foundation. Age-related macular degeneration: facts & figures. [Internet; cited December 2024]. Available from: https://www.brightfocus.org/macular/article/age-related-macular-facts-figures. [3] European Commission. Diabetes prevention. [Internet; cited December 2024]. Available from: https://knowledge4policy.ec.europa.eu/health-promotion-knowledge-gateway/diabetes-prevention. [4] Im JHB, et al. Prevalence of diabetic macular edema (DME) based on optical coherence tomography in people with diabetes: A systematic review and meta-analysis. Survey of Ophthalmology. 2022 Jul-Aug;67(4):1244-1251. [5] Li JQ, et al. Prevalence of retinal vein occlusion (RVO) in Europe: a systematic review and meta-analysis. Ophthalmologica. 2019;241(4):183-189. [6] European Medicines Agency. Summary of product characteristics, Vabysmo. 2024. [Internet; cited December 2024]. Available from: https://www.ema.europa.eu/en/documents/product-information/vabysmo-epar-product-information_en.pdf. [7] United States (US) Food and Drug Administration (FDA). Highlights of prescribing information, Vabysmo. 2024 [Internet; cited December 2024]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761235s005lbl.pdf. [8] Medicines and Healthcare products Regulatory Agency approves faricimab through international work-sharing initiative. [Internet; cited December 2024]. Available from: https://www.gov.uk/government/news/mhra-approves-faricimab-through-international-work-sharing-initiative. [9] Chugai obtains regulatory approval for Vabysmo, the only bispecific antibody in the ophthalmology field, for additional indication of macular edema associated with RVO. [Internet; cited December 2024]. Available from: https://www.chugai-pharm.co.jp/english/news/detail/20240326160000_1054.html. [10] Chugai obtains regulatory approval for Vabysmo, the first bispecific antibody in ophthalmology, neovascular age-related macular degeneration (nAMD) and DME. [Internet; cited December 2024]. Available from: https://www.chugai-pharm.co.jp/english/news/detail/20220328160002_909.html. [11] Roche data on file. [12] Heier JS, et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for nAMD (TENAYA and LUCERNE): two randomised, double-masked, phase III, non-inferiority trials. The Lancet. 2022; 399:729-40. [13] Wykoff C, et al. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with DME (YOSEMITE and RHINE): Two randomised, double-masked, phase III trials. The Lancet. 2022; 399:741-755. [14] US FDA. Highlights of prescribing information, Susvimo. 2021. [Internet; cited December 2024]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761197s000lbl.pdf. [15] Holekamp N, et al. Archway randomised phase III trial of the Port Delivery System with ranibizumab for nAMD. Ophthalmology. 2021. [16] US FDA. Highlights of prescribing information, Lucentis. 2014. [Internet; cited December 2024]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125156s0069s0076lbl.pdf. The content above comes from the network. if any infringement, please contact us to modify.