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16 hours ago
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KIF18A Inhibitor Clinical Trials FDA Approved KIF18A Targeting Therapies Market Report
KIF18A Therapy Commercial Launch Expected By 2030 Says Kuick Research in New Research Study Delhi, June 24, 2025 (GLOBE NEWSWIRE) -- Global KIF18A Targeting Therapies Market Trends, Clinical Trials, Technology Platforms & Future Outlook 2025 Report Highlights & Findings: First KIF18A Targeting Therapy Commercial Availability Expected By 2030 Highest Phase Of Development: Phase-I/II KIF18A Targeting Therapies In Clinical Trials: > 10 Therapies KIF18A Targeting Therapies Clinical Trials Insight By Company, Country, Indication & Phase KIF18A Targeting Therapies Market Development Trends Insight KIF18A Therapies Technology Platforms Insight Download Report: The global oncology landscape is witnessing rapid progress in precision medicine, and one of the most lead nominees in emerging targets is Kinesin Family Member 18A (KIF18A). It is a mitotic motor protein that is essential for chromosome alignment during mitosis, which facilitates proper segregation of chromosomes. Its perturbation leads to genomic instability, which is a distinguishing feature of cancer. Extrapolations of KIF18A have also been seen in various cancers such as ovarian and breast cancer, with an association with prognosis, drug resistance, and the potential to metastasize. As a crucial protein involved in mitosis and overexpression in cancer, KIF18A is now a promising therapeutic target. Targeting KIF18A interferes with mitotic mechanisms in chromosomally unstable (CIN-positive) cancer cells, causing selective death of cancer cells. In contrast to conventional chemotherapies, which indiscriminately impact all proliferating cells, KIF18A inhibitors provide a more selective and less toxic option by taking advantage of cancer cells' vulnerability to proper mitosis. The major approach is small molecule inhibitors that disrupt KIF18A's motor activity, hindering it from modulating microtubule dynamics at the kinetochore. It leads to mitotic arrest and failure of chromosome alignment, ultimately triggering apoptosis in cancer cells. Clinical development is progressing well. Volastra Therapeutics, a forerunner in this arena, is developing two KIF18A-targeting molecules: Sovilnesib (AMG650), acquired from Amgen and underway in Phase I trials for platinum-resistant high-grade serous ovarian cancer, and VLS-1488, an in-house oral inhibitor in Phase I/II. Both molecules displayed favorable safety profiles and early anti-tumor effects, with particular efficacy in high-chromosomal-instability tumors. Volastra's pipeline demonstrates the therapeutic potential of inhibiting KIF18A to treat difficult-to-treat cancers. Accent Therapeutics is also advancing with ATX-295, an oral KIF18A inhibitor in initial clinical testing for solid tumors such as triple-negative breast and high-grade serous ovarian cancers. Their biomarker strategy makes use of genomic instability markers such as whole-genome doubling to better optimize patient selection and optimize therapy outcomes. AI based drug discovery is providing additional impetus to this area. Insilico Medicine has utilized proprietary platforms such as Chemistry42 and PandaOmics to discover ISM9682, a new macrocyclic KIF18A inhibitor with high preclinical efficacy. The AI platforms facilitate rapid optimization of candidates with increased specificity and pharmacological profiles, highlighting the growing use of sophisticated computational approaches in drug discovery. Aside from clinical advancement, the market opportunity for KIF18A inhibitors is also robust. As precision oncology gains more attention, the therapies are well poised to capture the opportunity of targeted therapies, particularly in diseases that are refractory to current treatments. Various companies, including Nvidia-funded Iambic Therapeutics, Aurigene Oncology, Simcere Zaiming Pharmaceutical, and Amgen, are developing promising product candidates in preclinical phases. Overall, the KIF18A-targeted therapy market is changing very quickly, powered by strong scientific justification, initial clinical success, and novel development approaches. As additional preclinical and clinical information becomes available, the market has significant potential for strong growth, powered by partnerships, application of artificial intelligence and machine learning tactics, and the overall dedication to creating targeted and individualized cancer therapeutics. CONTACT: Neeraj Chawla Research Head Kuick Research neeraj@ in to access your portfolio
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05-06-2025
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FDA Approved Anticancer Peptide Drug Conjugate Market Clinical Trials Insight
Global Peptide Drug Conjugate Market USD 1400 Million Opportunity Says Kuick Research In New Study Delhi, June 05, 2025 (GLOBE NEWSWIRE) -- Global Peptide Drug Conjugate Market, Drug Sales, Price, Dosage and Clinical Trials Insight 2030 Report Highlights: Global Peptide Drug Conjugate Market Opportunity: > USD 1400 Million Global Peptide Drug Conjugate Market Trends By Region and Indications Global Peptide Drug Conjugate Market Growth 2018-2024: > 300% Absolute Growth and 27% CAGR Growth Approved Peptide Drug Conjugate Dosage, Sales and Price Insight Approved Peptide Drug Conjugate Sales Global and Regional Insight: 2 Drugs Approved Global Peptide Drug Conjugate Clinical Trials Insight: > 30 Drugs Global Peptide Drug Conjugates Clinical Trials Insight By Company, Country, Indication and Phase Peptide Drug Conjugate Proprietary Technologies and Methodologies Insight By Company Download Report: Peptide drug conjugates constitute a novel category of targeted therapies that make use of disease-targeting peptides to specifically deliver small molecule drugs to the target cells. This blended strategy enables drugs to be targeted more precisely to ailing tissues, minimizing systemic toxicity and maximizing therapeutic benefit. With more than 30 peptide drug conjugates candidates now in different stages of clinical trials, the domain is accelerating at breakneck speed. Most of these candidates are being developed and evaluated for oncology, where the demand for highly targeted therapies is still paramount. Nonetheless, investigations have also been pushed into neurodegenerative disease and inflammatory disorders, which suggests a wider therapeutic scope for this modality. As of May 2025, 2 peptide drug conjugates have been approved by the regulators. Novartis's Lutathera, a radiolabeled peptide for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs), exemplifies the potential of targeted delivery in cancer. The second agent that has been approved, Pepaxti (melflufen), by Oncopeptides, is employed to treat multiple myeloma and demonstrates the utility of peptide to enhance the therapeutic index of known cytotoxic agents. All these achievements underscore the potential for peptide drug conjugates and have opened up doors for more firms to enter the pipeline for developing new candidates. Platform technologies are leading the way in driving peptide drug conjugate innovation. For example, PeptiDream's PDPS (Peptide Discovery Platform System) leverages massive libraries of macrocyclic peptides to quickly find high-affinity binders. They are optimized as targeting agents in peptide drug conjugates, enabling more targeted drug delivery. By targeting cytotoxic payloads directly to disease-associated receptors, these technologies reduce off-target effects, improving efficacy and safety for patients. The growing use of such platforms by biotech companies and pharmaceutical companies highlights their significance in the present drug development scenario. Regulatory assistance is also supporting the development of peptide drug conjugates. Sudocetaxel zendusortide (TH1902), a peptide drug conjugate from Theratechnologies, was granted the Fast Track Designation by the FDA. This candidate has been designed against sortilin-expressing solid tumors and is undergoing Phase 1 clinical trials. As the first compound from Theratechnologies' SORT1+ Technology™, it is an example of innovation in peptide targeting and an accelerated regulatory pathway that allows for accelerated development. Designations such as these not only support the therapeutic potential of these compounds but also foster investment and accelerate clinical advancement. The peptide drug conjugate field involves a diverse range of stakeholders, including major pharmaceutical companies like Novartis and Oncopeptides, as well as specialized biotechnology firms such as Bicycle Therapeutics and Theratechnologies. Additionally, contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs) are increasingly becoming integral to the development process, providing essential services from early-stage discovery through to clinical and commercial manufacturing. In spite of this momentum, market hurdles exist. One major hindrance is the complexity of peptide drug conjugate manufacturing, which sometimes necessitates specialized facilities and intense quality control, potentially pushing up development expense. To overcome it, strategic alliances with seasoned CDMOs can streamline manufacturing and lower operational costs. Regulatory complexity regarding newer payloads or novel peptide-linker chemistries is another hurdle. Anticipation of the regulatory agencies through proactive interaction and utilization of existing designations can smooth over the complexity. Looking to the future, the prospects for peptide-drug conjugates are encouraging. As ever improving technology platforms advance and additional clinical information becomes available, peptide drug conjugates are destined to become a staple of targeted therapy, not just oncology, but perhaps a wide variety of chronic and orphan diseases. CONTACT: Neeraj Chawla Research Head Kuick Research neeraj@ +91-470679900Error 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
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29-05-2025
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Bispecific Antibody Drug Conjugates Clinical Trials Bispecific ADC Market Size Insight
Chinese Pharmaceutical Companies Dominating Global Research & Development Landscape Of Bispecific ADC Market Says Kuick Research In New Report Delhi, May 29, 2025 (GLOBE NEWSWIRE) -- Global Bispecific Antibody Drug Conjugates Clinical Trials, Regulatory Approvals and Future Market Opportunity Outlook 2029 Report: Report Answers Question On Why There Exist Need For Bispecific Antibody Drug Conjugates First Bispecific Antibody Drug Conjugates Commercial Approval Expected By 2029 Insight On Bispecific Antibody Drug Conjugates In Clinical Trials : > 60 Drug Conjugates China Dominating Bispecific Antibody Drug Conjugates Clinical Trials: > 35 Drug Conjugates Majority Of Bispecific Antibody Drug Conjugates For Breast Cancer Bispecific Antibody Drug Conjugates Clinical Trials Insight By Company, Country, Indication and Phase Bispecific Antibody Drug Conjugates In Combination Therapy By Indication and Clinical Phase Key Companies Involved In Development Of Bispecific Antibody Drug Conjugates Download Report: Bispecific antibody drug conjugates (BsADCs) are an innovative class of therapeutics that combine the dual-targeting capabilities of bispecific antibodies with the cytotoxic payloads characteristic of traditional antibody drug conjugates (ADCs). Unlike conventional ADCs, which typically target a single antigen, BsADCs engage two different antigens simultaneously, enhancing specificity and efficacy against cancer cells. This unique mechanism enables BsADCs to not only deliver cytotoxic agents directly to the tumor site but also improve selectivity for cancer cells, potentially reducing off-target effects. The development of BsADCs is supported by various advanced technology platforms. For instance, Alphamab Oncology has developed a proprietary ADC platform that allows for the precise construction of bispecific constructs. Similarly, Bi-Cygni Therapeutics employs its BiVictriX platform to enhance the efficacy and safety profiles of its bispecific antibodies. Debiopharm's Multilink™ platform is another example that enables the creation of multifunctional biotherapeutics. These technology platforms play a crucial role in optimizing the design and development of BsADCs, streamlining the path from research to clinical application. One of the most advanced bispecific antibody drug conjugates currently in development is BL B01D1, created by Sichuan Baili Pharmaceutical and its subsidiary, SystImmune. This candidate is undergoing clinical trials in China, showcasing the country's rapid advancements in this therapeutic area. With a focus on addressing unmet medical needs, BL B01D1 exemplifies the potential of BsADCs to provide effective treatment options for patients facing challenging cancers. The ongoing trials will provide valuable data on its safety and efficacy, contributing to the broader understanding of bispecific therapies. China has emerged as a dominant force in the development of BsADCs, with a significant number of clinical trials underway. This landscape is marked by intense competition, as various companies strive to launch their candidates and establish themselves as leaders in this burgeoning field. Notable players include ABL Bio, Bristol Myers Squibb, Amgen, Debiopharm, Doma Bio, ProEn Therapeutics, AstraZeneca, and Innovent Biologics. Each of these companies is racing to bring their innovative therapies to market, aiming to be the first in their class. As the market for bispecific antibody drug conjugates becomes increasingly competitive, the ongoing research and development will likely yield numerous advancements that could redefine cancer treatment paradigms. The potential of BsADCs to deliver targeted therapy more effectively than conventional ADCs makes them an exciting prospect in oncology. With continued investment and innovation, these therapeutics could significantly improve patient outcomes, offering new hope in the fight against cancer. The landscape is rapidly evolving, and as clinical data emerges, the true impact of bispecific antibody drug conjugates will begin to take shape, highlighting their role in the future of cancer treatment. CONTACT: Neeraj Chawla Research Head Kuick Research neeraj@ 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
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15-05-2025
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US Rare Cancer Market FDA Approved Rare Cancer Drug Clinical Trials Insight
Kuick Research Report Gives Detailed Insight On Ongoing Rare Disease Drug Market And Highlights Ongoing Clinical Trials Delhi, May 15, 2025 (GLOBE NEWSWIRE) -- US Orphan Designated Drugs Market Opportunity, Drugs Sales, Price, Dosage and Clinical Trials Insight 2030 Report Offering and Highlights: US Orphan Designated Drugs Market Opportunity: > US$ 190 Billion By 2030 Insight On FDA Designated Orphan Drugs In Clinical Trials: > 850 Orphan Drugs Clinical Trials Insight By Company, Indication, Phase and Priority Status Insight On FDA Designated Marketed Orphan Drugs: > 500 Orphan Drugs Pricing and Dosage Insight: > 400 Marketed Orphan Drugs US, Global, Regional, Annual Sales Insight (2019 – Q1'2025): >150 Orphan Drugs Sales, Price and Dosage Data Represented In More Than 1000 Charts and Tables Orphan Designation Insight By Indication, Company, Trial Phase, Marketed Drugs Represented In 1000 Tables Download US Orphan Designated Drugs Market Opportunity, Drugs Sales, Price, Dosage and Clinical Trials Insight 2030 Report: The US orphan market for rare cancers is a specialized oncology frontier that has seen tremendous development over the last decade. Each of these rare cancers, which individually affect fewer than 200,000 Americans, collectively affect millions of patients and their families and pose unique therapeutic challenges. Traditionally underserved with scant commercial interest, rare cancer therapies are now a center of innovation, with around 50% of all orphan drug designations aimed at oncology conditions. This niche market has expanded to a very lucrative segment, with scientific progress fueling clinical progress and commercial opportunity alike. Rare cancer therapies illustrate the potential for focused strategies to transform patient care. Bristol Myers Squibb's Opdivo (nivolumab), originally approved for rare types of Hodgkin lymphoma, is the successful development track many orphan oncology drugs take. Initially approved for restricted indications in small patient populations, Opdivo eventually gained approval for more extensive uses, revolutionizing treatment paradigms in several types of cancer. This strategy for development, targeted at defined patient populations, has become increasingly common, enabling firms to validate clinical proof-of-concept before expanding use. Precision medicine revolutionized the rare cancer space by making it possible to segment ordinary cancers into rare subtypes through molecular segmentation. Bayer's Vitrakvi (larotrectinib) is a prime example of this strategy, treating rare TRK fusion-positive cancers in several types of tumors instead of targeting common anatomical classes. This tissue-agnostic approval process has reframed the way that rare cancers are imagined, opening up possibilities for therapies focused on particular genetic mutations that occur in small groups of patients across many types of cancer. So, too, does Roche's Rozlytrek (entrectinib) target ROS1-positive non-small cell lung cancer, a rare molecular subgroup that occurs in about 2% of lung cancer patients. Outside of conventional pharma, the rare cancer segment has welcomed next-generation therapeutic modalities. Kymriah (tisagenlecleucel), Novartis's CAR-T cell therapy for rare B-cell cancers, illustrates how cellular therapies have gained early use in rare cancer indications where unmet need warrants novel approaches. This pattern carries over to antibody-drug conjugates such as Pfizer's Adcetris (brentuximab vedotin) for Hodgkin lymphoma and systemic anaplastic large cell lymphoma, marrying targeted delivery mechanisms with highly active cytotoxic agents to achieve maximum efficacy while limiting systemic toxicity. The orphan cancer drug environment for rare malignancies has enabled specialist development firms dedicated entirely to underrepresented cancers. Epizyme (acquired by Ipsen) developed its clinical pipeline from rare epigenetic cancer targets and gained approval for Tazverik (tazemetostat) in epithelioid sarcoma and follicular lymphoma. In the same vein, Y-mAbs Therapeutics has also focused on rare pediatric malignancies, with the development of Danyelza (naxitamab) for neuroblastoma, which occurs in about 700 children per year in the US. Collaborative models have gained prominence in rare cancer drug development. The Rare Cancer Research Foundation has organized tissue donation programs and research networks that link patients with scientists who are working on developing targeted therapies. Likewise, the TARGET pediatric cancer program has expedited molecular characterization of rare childhood cancers, generating publicly available datasets that guide drug development across the industry. These collaborative strategies overcome the inherent difficulties of creating treatments for diseases where patient populations are geographically remote and clinical trial recruitment is challenging. In the future, the rare cancer orphan drug market in the US is expected to evolve to develop with new technologies, such as artificial intelligence driving drug discovery and development. Machine learning computations are assisting the identification of new targets in uncommon cancers by studying intricate molecular datasets, and electronic platforms bring highly scattered patients in touch with the right clinical trials. These technological advances, together with growing biological insights into the drivers of rare cancers, predict the orphan oncology space as a vibrant domain for scientific breakthrough and therapeutic progress, bringing patients new hope that has long eluded them. CONTACT: Neeraj Chawla Research Head Kuick Research neeraj@
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04-04-2025
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Bispecific Trispecific Antibodies Market Size FDA Approval Clinical Trials Drug Sales Insight 2030
Global Bispecific Trispecific Antibodies Market Size Will Surpass US$ 50 Billion By 2030 Says Kuick Research Delhi, April 04, 2025 (GLOBE NEWSWIRE) -- Over the last two decades, immunotherapy has transformed treatment strategies across various medical fields. The effectiveness of monoclonal antibodies in specifically targeting certain antigens has led to the development of more advanced multi-targeted therapies. These antibodies have not only enhanced cancer treatment outcomes but have also demonstrated that leveraging the immune system can provide substantial therapeutic advantages. Building on this foundation, bispecific and trispecific antibodies have emerged as innovative biologics aimed at simultaneously engaging multiple targets, promising improved efficacy and safety profiles. While monoclonal antibodies remain fundamental to immunotherapy, the shift towards bispecific and trispecific formats signifies a strategic initiative to overcome challenges related to specificity and resistance that can affect traditional therapies. Global Bispecific Antibody Market Opportunity, Drug Dosage, Patent, Price, Sales and Clinical Trials Insight 2030 Report Findings and Highlights: Global and Regional Market Size, Clinical Trends Insight Global Bispecific Antibodies Sales Opportunity US$ 50 Billion By 2030 Approved Antibodies Dosage, Patent, Pricing and Sales Insight Comprehensive Insight On More than 600 Bispecific Antibodies In Clinical Trials Download Bispecific Antibodies Report: Global Trispecific Antibodies Clinical Trials, Fast Track Status, Technology Platforms and Market Opportunity Outlook 2025 Report Findings and Highlights: First Trispecific Antibody Commercial Approval Expected By 2028 Currently More Than 50 Trispecific Antibodies Are Under Clinical Trials Report Includes Clinical Trials Insight On More Than 50 Trispecific Antibodies By Company, Country, Indication and Phase China and USA Dominating Trispecific Antibody Research Highest Phase Of Development: Phase II/III Insight On Platforms Used For Pioneering Trispecific Antibody By Companies Download Trispecific Antibodies Report: Bispecific antibodies are designed to bind to two different antigens concurrently, often connecting immune effector cells directly to tumor cells or affected tissues to trigger a strong immune response. This dual-targeting ability has already resulted in clinical achievements, with 17 bispecific antibodies receiving approval for use. The success of these agents is evident in market valuations, with the bispecific antibody market estimated at around US$ 12 billion in 2024. Projections from KuicK Research indicate that this figure could rise to US$ 50 billion by 2030, fueled by a growing pipeline and wider therapeutic applications. Although many of these agents were initially developed for cancer treatment, the adaptable mechanisms of bispecific antibodies have generated interest in their potential applications for autoimmune and inflammatory diseases, as well as in combating viral infections. In contrast, trispecific antibodies take this concept a step further by targeting three distinct antigens. Although none have received regulatory approval to date, initial clinical results are encouraging. For example, ISB2001, created by Ichnos Glenmark Innovation, an alliance between Ichnos Sciences and Glenmark Pharmaceuticals, has demonstrated significant preclinical efficacy. In studies involving animal models, ISB2001 successfully reduced multiple myeloma tumors in mice, and when tested on human tissue, it exhibited a superior capacity to eliminate cancer cells compared to Tecvayli, a bispecific antibody. This indicates that trispecific antibodies may provide a more thorough approach to combating disease by activating additional pathways or immune responses. The capability to target three antigens could enable these advanced biologics to address challenges such as tumor heterogeneity and immune evasion, which have occasionally hindered the effectiveness of bispecific therapies. While the primary application of both bispecific and trispecific antibodies is in oncology, their potential uses are broadening into other medical areas. Current research is investigating their effectiveness in autoimmune disorders, where the simultaneous targeting of multiple immune factors could lead to improved immune balance. Likewise, inflammatory diseases may benefit from the targeted action of these agents, potentially minimizing side effects in comparison to more generalized immunosuppressive treatments. Furthermore, new studies are examining the application of multi-specific antibodies in neurodegenerative diseases and viral infections, where intricate disease mechanisms necessitate innovative therapeutic approaches. As research progresses, the development of bispecific and trispecific antibodies holds the promise of enriching our treatment options, offering hope for more effective and tailored therapies across a diverse range of conditions. CONTACT: Neeraj Chawla Research Head Kuick Research neeraj@ +911147067990Sign in to access your portfolio
