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FAP Inhibitors Market Analysis Across the 7MM: Key Insights and Outlook Through 2040
FAP Inhibitors Market Analysis Across the 7MM: Key Insights and Outlook Through 2040

Malaysian Reserve

time6 days ago

  • Business
  • Malaysian Reserve

FAP Inhibitors Market Analysis Across the 7MM: Key Insights and Outlook Through 2040

According to DelveInsight's analysis, the growth of the FAP inhibitor market is expected to be primarily driven by the anticipated launch of several emerging therapies such as [18F] FAPI-74, [68Ga] FAPI-46, AZD2389, BXCL701, AVA6000, and others targeting a range of indications. LAS VEGAS, Aug 7, 2025 /PRNewswire/ — DelveInsight's FAP Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, addressable patient population, which includes top indications such as NSCLC, Ovarian cancer, Pancreatic cancer, Metastatic colorectal cancer, Prostate cancer, Triple-negative breast cancer, Soft tissue sarcoma, and others. The selected indications are based on approved therapies and ongoing pipeline activity. The report also provides insights into the emerging FAP inhibitors, market share of individual therapies, and current and forecasted market size from 2020 to 2040, segmented into 7MM. Key Takeaways from the FAP Inhibitors Market Report As per DelveInsight's analysis, the total market size of FAP inhibitors in the 7MM is expected to surge significantly by 2040. The report provides the total potential number of patients in the indications, such as NSCLC, Ovarian cancer, Pancreatic cancer, Metastatic colorectal cancer, Prostate cancer, Triple-negative breast cancer, Soft tissue sarcoma, and others. Leading FAP inhibitor companies, such as SOFIE, BioXcel, OnkosXcel, AstraZeneca, Avacta, and others, are developing novel FAP inhibitors that can be available in the FAP inhibitors market in the coming years. Some of the key FAP inhibitors in the pipeline include [18F]FAPI-74, [68Ga]FAPI-46, BXCL701, AZD 2389, AVA6000, and others. In March 2025, Avacta announced promising early efficacy and safety data for AVA6000 in the Phase Ia Dose Escalation and ongoing enrollment in the Phase Ib Expansion Cohorts. In February 2024, BioXcel Therapeutics received US FDA Fast Track Designation for BXCL701 in combination with a checkpoint inhibitor (CPI) for the treatment of patients with metastatic small cell neuroendocrine prostate cancer (SCNC) with progression on chemotherapy and no evidence of microsatellite instability. Discover which indication is expected to grab the major FAP inhibitors market share @ FAP Inhibitors Market Report FAP Inhibitors Market Dynamics The FAP inhibitors market is gaining momentum as the understanding of FAP's role in various pathological conditions, particularly cancer and fibrosis, continues to evolve. FAP is highly expressed in cancer-associated fibroblasts (CAFs) within the tumor microenvironment and in fibrotic tissues, but is largely absent in normal adult tissues. This selective expression profile has made FAP an attractive target for therapeutic intervention, as it allows for more precise targeting of tumor stroma or fibrotic lesions with reduced off-target effects. As a result, the FAP inhibitor landscape is witnessing increased research and development activities from both pharmaceutical companies and academic institutions. Market growth is being fueled by multiple clinical programs evaluating FAP inhibitors in oncology, particularly in solid tumors such as pancreatic, breast, lung, and colorectal cancers. These inhibitors are being studied both as monotherapies and in combination with other agents like immune checkpoint inhibitors and chemotherapeutics. Several radiolabeled FAP inhibitors are also advancing in the diagnostics space, especially in PET imaging, offering real-time assessment of tumor burden and stromal activity. The dual diagnostic and therapeutic potential (theranostics) of FAP-targeting agents enhances their market appeal, with companies seeking to develop companion diagnostics and targeted radioligand therapies. Despite the promising potential, challenges persist in optimizing the pharmacokinetics, safety profiles, and therapeutic windows of FAP inhibitors. Many compounds in development are still in early- to mid-stage clinical trials, and efficacy data remain limited. Additionally, while FAP overexpression is common across various tumors, patient stratification and biomarker-driven approaches will be critical for successful commercialization. Addressing these challenges through improved drug design and clinical validation will be key to unlocking the full potential of this drug class. From a competitive standpoint, the market is moderately fragmented, with a mix of biotech startups and large pharmaceutical companies pursuing differentiated approaches. Some developers are focusing on small molecules, while others are leveraging antibody-drug conjugates (ADCs), bispecific antibodies, or FAP-targeted radiopharmaceuticals. Strategic collaborations, licensing deals, and academic partnerships are becoming common, as companies seek to access novel platforms and reduce development risk. This dynamic landscape suggests significant potential for innovation, particularly in niche indications where conventional therapies have limited efficacy. In the coming years, the FAP inhibitors market is expected to benefit from growing interest in tumor microenvironment modulation, expanding applications in fibrotic diseases, and increased investment in precision medicine. Regulatory pathways for novel cancer and fibrosis therapeutics continue to evolve, potentially accelerating time-to-market for promising FAP-targeted agents. With no approved therapies currently available, the first entrants into the market stand to capture substantial value, especially if they demonstrate meaningful clinical benefit in underserved patient populations. FAP Inhibitors Treatment Market FAPI belongs to a novel class of tracers with emerging roles in cancer diagnosis and therapy. Clinical trials are actively investigating the safety and efficacy of FAP inhibitors for both oncologic and fibrotic conditions, with several candidates advancing into mid-stage trials. Currently, no FAP inhibitors have received regulatory approval. While challenges remain, such as enhancing drug delivery and reducing toxicity, FAP-targeted therapies represent a promising step forward in precision treatment for cancer and fibrotic diseases. Continued research and clinical validation could position FAP inhibitors as an innovative option for patients with these complex conditions. FAP has gained recognition as a specific biomarker for carcinoma-associated fibroblasts (CAFs) and activated fibroblasts found in tissues undergoing extracellular matrix (ECM) remodeling due to persistent inflammation, fibrosis, or tissue repair. FAPI agents have been studied extensively across multiple tumor types, in both diagnostic imaging and therapeutic applications. The tumor microenvironment (TME), predominantly consisting of ECM components like blood vessels, cytokines, growth factors, and fibroblasts, plays a central role in cancer development. Fibroblasts contribute to collagen synthesis and modulate local inflammatory and homeostatic processes. A specialized subgroup, myofibroblasts, exhibits contractile features similar to smooth muscle cells. In colorectal cancer, FAP overexpression in fibroblasts has been associated with poor prognosis, including increased lymph node involvement, tumor recurrence, angiogenesis, and decreased overall survival. Learn more about the FAP inhibitors @ FAP Inhibitors Analysis Key Emerging FAP Inhibitors and Companies Key players in the FAP inhibitor market include AstraZeneca (AZD 2389), Sofie ([18F]FAPI-74; [68Ga]FAPI-46), BioXcel/OnkosXcel (BXCL701), Avacta Life Science (AVA6000), and several other companies. A radiopharmaceutical known as [18F] FAPI-74 combines FAPI-74, a quinoline-based compound that targets fibroblast activation protein (FAP), with the chelating agent NOTA (1,4,7-triazacyclononane-N,N',N'-triacetic acid), and is labeled with the positron-emitting isotope fluorine-18. It is designed for PET imaging of tumors and cancer-associated fibroblasts (CAFs) that express FAP. After administration, FAPI-74 binds to FAP-expressing tumor cells and CAFs. These bound cells can then be visualized via PET scans. FAP is a surface protein highly expressed in many cancers and in CAFs within the tumor microenvironment (TME). A Phase II clinical trial (NCT05641896) is underway to evaluate [18F] FAPI-74 PET imaging in patients with gastrointestinal cancers. This study is multicenter, single-arm, open-label, and non-randomized. In October 2023, SOFIE and GE HealthCare entered into a licensing agreement for the development and commercialization of [68Ga] FAPI-46 and [18F] FAPI-74. Under this deal, GE HealthCare acquired global rights to [68Ga] FAPI-46 and ex-U.S. rights to [18F] FAPI-74, while SOFIE retained U.S. rights for [18F] FAPI-74's clinical development and commercialization. AVA6000, a prodrug of the chemotherapy agent doxorubicin, functions by inhibiting an enzyme that promotes cancer cell growth. Unlike standard doxorubicin, AVA6000 remains inactive until it reaches tumor tissue, potentially reducing side effects. It is administered intravenously. On January 16, 2025, Avacta reported encouraging results from its Phase I trial of AVA6000. In patients with salivary gland cancer, five out of ten showed tumor shrinkage—ranging from partial to minor responses—with a disease control rate of 90%. The anticipated launch of these emerging therapies are poised to transform the FAP inhibitors market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the FAP inhibitors market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about FAP inhibitors clinical trials, visit @ FAP Inhibitors Treatment FAP Inhibitors Overview Fibroblast activation protein (FAP) is a type II transmembrane serine protease predominantly found on activated fibroblasts, especially within the tumor microenvironment and areas of tissue remodeling. It is largely absent in healthy adult tissues but becomes markedly upregulated in more than 90% of epithelial cancers, where it plays a key role in promoting tumor progression by remodeling the extracellular matrix, supporting angiogenesis, suppressing immune responses, and aiding tumor cell invasion. Elevated levels of FAP are also observed in various fibrotic and inflammatory conditions, including liver cirrhosis, pulmonary fibrosis, rheumatoid arthritis, and during wound healing, emphasizing its broader involvement in pathological tissue remodeling. Because of its disease-restricted expression and functional significance, FAP has gained traction as a target for diagnostic and therapeutic applications. Radiolabeled FAP inhibitors (FAPIs) have delivered strong results in PET imaging by offering high-contrast visualization of tumors and fibrotic tissues with minimal background interference. These promising outcomes have led to the development of FAP-targeted treatments such as radioligand therapies, antibody-drug conjugates, and CAR T-cell approaches designed to modulate the tumor stroma and boost anti-cancer activity. Nevertheless, challenges remain, particularly in achieving specificity over related proteases and managing potential side effects in fibrotic conditions. Current research efforts are focused on optimizing FAPI pharmacokinetics, enhancing therapeutic effectiveness, and evaluating synergistic strategies with immunotherapies. Notably, FAP-targeted imaging and treatment approaches are expanding beyond oncology into fields like cardiology, pulmonology, and autoimmune disease, underscoring its growing importance as a biomarker and therapeutic target with the potential to transform precision medicine for both cancer and fibrotic disorders. FAP Inhibitors Epidemiology Segmentation The FAP inhibitors market report proffers epidemiological analysis for the study period 2020–2040 in the 7MM, segmented into: Total Cases in Selected Indications for FAP Inhibitor Total Eligible Patient Pool in Selected Indications for FAP Inhibitor Total Treated Cases in Selected Indications for FAP Inhibitor FAP Inhibitors Report Metrics Details Study Period 2020–2040 FAP Inhibitors Report Coverage 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] Key Indications Covered in the Report NSCLC, Ovarian cancer, Pancreatic cancer, Metastatic colorectal cancer, Prostate cancer, Triple-negative breast cancer, Soft tissue sarcoma, and others Key FAP Inhibitors Companies SOFIE, BioXcel, OnkosXcel, AstraZeneca, Avacta, and others Key FAP Inhibitors [18F]FAPI-74, [68Ga]FAPI-46, BXCL701, AZD 2389, AVA6000, and others Scope of the FAP Inhibitors Market Report FAP Inhibitors Therapeutic Assessment: FAP Inhibitors' current marketed and emerging therapies FAP Inhibitors Market Dynamics: Conjoint Analysis of Emerging FAP Inhibitor Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, FAP Inhibitors Market Access and Reimbursement Discover more about FAP inhibitors in development @ FAP Inhibitors Clinical Trials Table of Contents 1. Key Insights 2. Report Introduction 3. Executive Summary of FAP Inhibitor 4. Key Events 5. Epidemiology and Market Forecast Methodology 6. FAP Inhibitor Market Overview at a Glance in the 7MM 6.1. Market Share (%) Distribution by Therapies in 2024 6.2. Market Share (%) Distribution by Therapies in 2040 6.3. Market Share (%) Distribution by Indications in 2024 6.4. Market Share (%) Distribution by Indications in 2040 7. FAP Inhibitor: Background and Overview 7.1. Introduction 7.2. Potential of FAP Inhibitor in Different Indications 7.3. Clinical Applications of FAP Inhibitor 8. FAP Target Patient Pool 8.1. Key Findings 8.2. Assumptions and Rationale: 7MM 8.3. Epidemiology Scenario in the 7MM 8.4. Total Cases in Selected Indications for FAP Inhibitor in the 7MM 8.5. Total Eligible Patient Pool for FAP Inhibitor in Selected Indications in the 7MM 8.6. Total Treated Cases in Selected Indications for FAP Inhibitor in the 7MM 9. Emerging Therapies 9.1. Key Competitors 9.2. [ F]FAPI-74: SOFIE 9.2.1. Product Description 9.2.2. Other developmental activities 9.2.3. Clinical development 9.2.4. Safety and efficacy 9.2.5. Analyst Views 9.3. AVA6000: Avacta List to be continued in the report 10. FAP Inhibitor: Seven Major Market Analysis 10.1. Key Findings 10.2. Market Outlook 10.3. Conjoint Analysis 10.4. Key Market Forecast Assumptions 10.4.1. Cost Assumptions and Rebates 10.4.2. Pricing Trends 10.4.3. Analogue Assessment 10.4.4. Launch Year and Therapy Uptakes 10.5. Total Market Size of FAP Inhibitor in the 7MM 10.6. Market Size of FAP Inhibitor by Indication in the 7MM 10.7. The United States 10.8. EU4 and the UK 10.9. Japan 11. Market Access and Reimbursement 12. SWOT Analysis 13. KOL Views 14. Unmet Needs 15. Bibliography 16. Report Methodology Related Reports Prostate Cancer Market Prostate Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key prostate cancer companies, including Janssen Research and Development, Sanofi, Astellas Pharma, Bayer, Novartis, Curium, Merck, Orion, Pfizer, Exelixis, Ipsen Pharma, Takeda, AB Science, Lantheus, Eli Lilly, POINT Biopharma, Telix Pharmaceuticals, Tavanta Therapeutics, Jiangsu Hengrui Pharmaceuticals, Kangpu Biopharmaceuticals, Fusion Pharma, Merus, Bristol-Myers Squibb, Syntrix Pharmaceuticals, Promontory Therapeutics, Xencor, Taiho Pharmaceutical, Madison Vaccines, MacroGenics, Zenith Epigenetics, Modra Pharmaceuticals, Arvinas, Laekna Therapeutics, Blue Earth Therapeutics, Oncternal Therapeutics, Essa Pharma, Clarity Pharmaceuticals, BioNTech and DualityBio, Daiichi Sankyo, Fortis Therapeutics, ORIC Pharmaceuticals, Amgen, among others. Non-Small Cell Lung Cancer Market Non-Small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key NSCLC companies, including AstraZeneca, Boehringer Ingelheim, Takeda, Johnson & Johnson Innovative Medicine, Eli Lilly and Company, Merck, Bristol-Myers Squibb, Roche, Shanghai Henlius Biotech, AbbVie, Daiichi Sankyo, Nuvation Bio, PDC*line Pharma, Moderna Therapeutics, Pfizer, GSK, Gilead Sciences, BieGene, Nuvalent, among others. Metastatic Colorectal Cancer Market Metastatic Colorectal Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key metastatic colorectal cancer companies, including Johnson & Johnson Innovative Medicine, Shanghai Henlius Biotech, Inspirna, Treos Bio, Cardiff Oncology, Agenus, Leap Therapeutics, Arcus Biosciences, Enterome, Tizona Therapeutics, Innovative Cellular Therapeutics, among others. Pancreatic Cancer Market Pancreatic Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key pancreatic cancer companies, including AstraZeneca, Merck Sharp & Dohme LLC, Bayer, Roche, Celgene, BioLineRx, Alligator Bioscience, Bellicum Pharmaceuticals, OSE Immunotherapeutics, Actuate Therapeutics, FibroGen, NeoImmuneTech, NOXXON Pharma, Silenseed Ltd., Amgen, NGM Biopharmaceuticals, Merus, Mirati Therapeutics, Rexahn Pharmaceuticals, Ocuphire Pharma, Processa Pharmaceuticals, ImmunityBio, Berg, Panbela Therapeutics, GlaxoSmithKline, Eleison Pharmaceuticals, Molecular Templates, Lokon Pharma AB, Cantargia AB, Bristol-Myers Squibb, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact UsShruti Thakur info@ +14699457679 Logo: View original content:

CISION® Candidate FAP-Dox (AVA6000) at the 2025 AACR Annual Meeting
CISION® Candidate FAP-Dox (AVA6000) at the 2025 AACR Annual Meeting

Yahoo

time28-04-2025

  • Business
  • Yahoo

CISION® Candidate FAP-Dox (AVA6000) at the 2025 AACR Annual Meeting

Compelling Phase 1 safety and efficacy data for FAP-Dox (AVA6000) with preliminary evidence of efficacy in salivary gland cancers and no severe cardiac toxicity Progression free survival (PFS) data to date represents a near doubling of the benchmarking data in this patient population without reaching median PFS LONDON and PHILADELPHIA, April 28, 2025 (GLOBE NEWSWIRE) -- Avacta Therapeutics (AIM: AVCT), a life sciences company developing next generation peptide drug conjugates (PDC) targeting powerful anti-tumor payloads directly to the tumor, today announced Phase 1 data from its lead program FAP-Dox (AVA6000), that were presented alongside preclinical pharmacokinetic results from its second pre|CISION® candidate AVA6103 (FAP-EXd) at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, IL. Both programs are designed to target fibroblast activation protein-alpha (FAPα), the protease that forms the basis of the pre|CISION® platform. FAP is consistently overexpressed across a broad range of solid tumors and enriched at the tumor-stroma interface, making it an ideal target for tumor-localized drug activation. Avacta's proprietary pre|CISION® chemistry leverages this tumor-specific biology to activate potent drugs selectively at the tumor site, enhancing efficacy while minimizing systemic toxicity. "Today's clinical results mark the achievement of a proof-of-concept milestone with our proprietary pre|CISION® platform demonstrating meaningful activity,' said Christina Coughlin, CEO of Avacta Therapeutics. 'With AVA6000 demonstrating strong early signs of efficacy in a specific patient population of salivary gland cancers and a differentiated safety profile, we are not only validating a tumor-targeted approach to cytotoxics delivery – we are establishing a foundation for this new class of precision oncology therapeutics. These data underscore the tremendous potential of our pipeline to deliver meaningful benefits for patients and drive sustained value creation for our key stakeholders.' AVA6000 (FAP-Dox) Clinical Highlights (Abstract #CT15, Apil 29, 2025) AVA6000 is a FAP-activated form of doxorubicin designed to reduce the systemic side effects of conventional chemotherapy. In the Phase 1a dose-escalation study, AVA6000 was well-tolerated across both every-three-week (Q3W) and every-two-week (Q2W) dosing regimens. No maximum tolerated dose (MTD) was reached despite dosing up to 385 mg/m² every three weeks. In patients with salivary gland cancers (SGC, n=11) treated at or above the dose level of 250 mg/m2, AVA6000 demonstrated multiple confirmed responses and a disease control rate of 91%. Median progression-free survival (PFS) has not yet been reached, with median follow-up exceeding 25 weeks (25.3 weeks, 5.9 months). These FAP-Dox PFS results compare favorably to recent benchmarking data in this patient population presented at ESMO 2024, with a reported PFS of 3.5 months (15 weeks) in a large cohort (n=54) in a similar setting of pretreated patients with SGC (Licitra et al. ESMO 2024). Despite dosing up to 4x the dose of conventional doxorubicin, the exposure of released doxorubicin in plasma and normal tissues is lower than that observed with conventional dose doxorubicin (75 mg/m2 Q3W) and the median tumor to plasma ratio is 100:1. In addition, no severe cardiac toxicity was observed, further supporting a markedly improved safety profile over conventional doxorubicin. The lack of toxicity is explained by the limited tissue distribution as well as limited first pass effect exposure of released doxorubicin. The full Phase 1a data across all patients (n=63), including a full assessment of the cardiac safety data with long-term follow-up are expected in the second half of 2025. Avacta continues to enroll patients in three Phase 1b expansion cohorts in salivary gland cancer, triple negative breast cancer and high-grade soft tissue sarcoma with data anticipated by the end of 2025. Abstract Number and Title: #CT15: Comparative pharmacokinetics and tumor activation of fibroblast activation protein (FAP)-enabled pre|CISION® peptide drug conjugates· Session Title: First-in-Human Phase I Clinical Trials 2· Session Date and Time: Tuesday, April 29, 2025, 9:00 a.m. - 12:00 p.m. CT For further information from Avacta, please contact: Avacta Group plcMichael Vinegrad, Group CommunicationsDirector Peel Hunt (Nomad and Broker)James Steel / Chris Golden Panmure Liberum (Joint Broker)Emma Earl / Will Goode / Mark Rogers ICR HealthcareMary-Jane Elliott / Jessica Hodgson / Stephanie Cuthbert avacta@ Investor ContactRenee Leck THRUST Strategic Communications renee@ Media ContactCarly ScadutoCarly Scaduto Consulting Carly@ About Avacta - Avacta Therapeutics is a clinical-stage life sciences company expanding the reach of highly potent cancer therapies with the pre|CISION® platform. pre|CISION® is a proprietary warhead delivery system based on a tumor-specific protease (fibroblast activation protein or FAP) that is designed to concentrate highly potent warheads in the tumor microenvironment while sparing normal tissues. Our innovative pipeline consists of pre|CISION® peptide drug conjugates (PDC) or Affimer® drug conjugates (AffDC) that leverage the tumor-specific release mechanism, providing unique benefits over traditional antibody drug conjugates. About the pre|CISION® PlatformThe pre|CISION® platform comprises an anticancer payload conjugated to a proprietary peptide that is a highly specific substrate for fibroblast activation protein (FAP) which is upregulated in most solid tumors compared with healthy tissues. The pre|CISION® platform harnesses this tumor specific protease to cleave pre|CISION® peptide drug conjugates and pre|CISION® antibody/Affimer® drug conjugates in the tumor microenvironment, thus releasing active payload in the tumor and reducing systemic exposure and toxicity, allowing dosing to be optimized to deliver the best outcomes for in to access your portfolio

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