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HER2-low Cancers Market Set to Register Immense Growth at a CAGR of 9.4% During the Study Period (2020-2034)
The future of the HER2-low cancer treatment market is poised for significant transformation, driven by the approval of ENHERTU and the advancement of other innovative antibody-drug conjugates (ADCs) like DATROWAY, TRODELVY, ifinatamab deruxtecan, BB-1701, and Disitamab vedotin. These ADCs are designed to target HER2-low-expressing cancer cells, with major development ongoing in Breast Cancer. LAS VEGAS, June 19, 2025 /PRNewswire/ -- DelveInsight's HER2-low Cancers Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, emerging HER2-low cancer therapies, market share of individual therapies, and current and forecasted HER2-low cancers market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Key Takeaways from the HER2-low Cancers Market Report HER2-low cancer refers to tumors with low HER2 protein expression that do not meet the criteria for HER2-positive classification. The prevalence of HER2-low expression varies across cancers, occurring in approximately 63% of breast cancers, 42% of biliary tract cancers, 38% of urothelial carcinomas, and 35% of gastric cancers. As per DelveInsight's analysis, the total market size of HER2-low cancers in the 7MM was USD 3.2 billion in 2024 and is projected to grow during the forecast period (2025-2034), driven by ENHERTU's usage and strong uptake in this cancer type. Of the target indications, breast cancer and gastric cancer are anticipated to generate the most revenue by 2034 due to the highest level of clinical development and authorization of HER2-low cancer therapies. Among all therapies, ENHERTU is expected to capture the highest market share, due to its proven clinical efficacy, strong safety, and first-mover advantage in treating HER2-low cancers. Based on Delveinsight's assessment in 2024, the 7MM had approximately 360,000 target pool cases of HER2-low cancers. These cases are projected to increase during the forecast period (2025–2034) due to recent clinical advances recognizing HER2-low as a distinct category, thereby expanding the treatable patient population There are no HER2-targeting therapies currently in the pipeline for first-line treatment; all available options are focused on the relapsed or refractory setting. The HER2-low breast cancer pipeline is becoming increasingly competitive, as ENHERTU has dramatically shifted market dynamics. Its approval for HER2-low breast cancer has significantly transformed the market trajectory, leading to a doubling of overall sales in 2023. Leading HER2-low cancer companies, such as AstraZeneca, Daiichi Sankyo, RemeGen, Pfizer (Seagen), Gilead Sciences, Merck, Bliss Biopharmaceutical (Hangzhou), Zymeworks, Jazz Pharmaceuticals, ALX Oncology, Dragonfly Therapeutics, Mersana Therapeutics, and others, are developing novel HER2-low cancer therapies that can be available in the HER2-low cancer market in the coming years. Some of the key HER2-low cancer therapies in the pipeline include DATROWAY (datopotamab deruxtecan/Dato-DXd), AIDIXI (disitamab vedotin), TRODELVY (sacituzumab govitecan), Ifinatamab deruxtecan (I-DXd)/MK-2400, BB-1701, ZIIHERA (zanidatamab), DF1001, Emiltatug ledadotin (XMT-1660), and others. Discover which therapies are expected to grab the HER2-low cancers market share @ HER2-low Cancers Market Report HER2-low Cancers Market Dynamics The HER2-low cancer market has recently garnered significant attention, primarily due to the advancements in targeted therapies for cancers with low expression of the HER2 protein. While HER2-positive cancers, such as breast and gastric cancers, have long been the focus of targeted treatments like trastuzumab (HERCEPTIN), HER2-low cancers represent a distinct subset that requires different therapeutic strategies. These cancers exhibit a lower level of HER2 expression, making them more challenging to treat with traditional HER2-targeted therapies. However, recent breakthroughs in ADCs and novel monoclonal antibodies are starting to offer new avenues for patients with this subgroup. As researchers continue to explore HER2-low cancers, one of the key dynamics driving the market is the recognition that these tumors can benefit from a broader range of treatments. In particular, ADCs are showing promise as they allow for more precise delivery of chemotherapy agents directly to tumor cells. This approach offers hope for patients whose cancers were previously thought to be less amenable to targeted therapies. The approval of drugs like ENHERTU for HER2-low breast cancer has created a significant shift in the oncology treatment landscape, leading to a surge of interest from pharmaceutical companies developing similar therapies. The growing understanding of HER2-low cancers has also influenced diagnostic practices, with an emphasis on accurate biomarker testing. Companies are now focusing on developing more sensitive and specific assays to detect low levels of HER2 expression, ensuring that patients are correctly identified for targeted treatment options. This has led to the rise of precision medicine in oncology, where treatments are tailored not only to the type of cancer but also to the molecular characteristics of the tumor. The better the diagnostics, the more likely it is that patients will receive appropriate therapies, boosting market potential. Additionally, market dynamics are shaped by the competitive landscape, with several big pharmaceutical companies investing heavily in the development of new agents for HER2-low cancers. The approval of HER2-targeted treatments for low-expressing cancers is expected to trigger a surge in demand, especially in indications such as breast and gastric cancers. However, challenges remain, including the cost of these novel therapies, their accessibility in different healthcare settings, and the need for continued clinical validation. As these therapies advance through the pipeline, the future market for HER2-low cancer treatments looks promising, but it will require a combination of scientific innovation, regulatory support, and healthcare infrastructure to realize its full potential. HER2-low Cancers Treatment Market HER2-low cancers, which are marked by low levels of the HER2 protein, pose distinct treatment challenges. Recent research has focused on targeted therapies for such cancers, especially breast cancers. Treatment options for HER2-low cancers, including gastric, endometrial, and other cancers, are evolving as research continues to explore the role of HER2 in these diseases. Traditional therapies, such as monoclonal antibodies and small molecular Tyrosine Kinase Inhibitors (TKIs), have shown limited effectiveness in breast cancers with HER2-low expression. For years, HER2-low breast cancer has been treated similarly to HER2-negative breast cancer, including HR+/HER2− and TNBC cases. For gastric cancer, particularly adenocarcinoma of the stomach and gastroesophageal junction, recent research has highlighted the potential of ENHERTU, an antibody-drug conjugate. ENHERTU has shown promising results in patients with HER2-low expression (IHC 1+ or 2+/ISH−). In January 2025, ENHERTU was approved by the US FDA for treating adult patients with unresectable or metastatic HR-positive, HER2-low, or HER2-ultralow (IHC 0 with membrane staining) breast cancer, who have progressed on one or more endocrine therapies in the metastatic setting, based on an FDA-approved test. For HR-negative/HER2-low breast cancer, treatment usually begins with first-line chemotherapy, potentially combined with immunotherapy for PD-L1-positive patients, followed by sequential chemotherapy treatments. For HR-positive breast cancer, due to its progression-free survival advantage over chemotherapy, PARP inhibitors (PARPi) are considered for patients with a germline BRCA mutation. Learn more about the FDA-approved HER2-low cancer therapies @ HER2-low Cancer Treatment Drugs HER2-low Cancers Pipeline Therapies and Key Companies Currently, the clinical development landscape includes late and mid-stage assets. Consequently, our forecast considers the potential impact of Pfizer's Disitamab vedotin, Immutep's Eftilagimod alpha (IMP321), AstraZeneca and Daiichi Sankyo's DATROWAY, Gilead Sciences' TRODELVY, Duality Biologics and BioNTech's DB-1303/BNT323, Daiichi Sankyo and Merck's Ifinatamab deruxtecan, Bliss Biopharmaceutical's BB-1701, and Dragonfly Therapeutics' DF1001. Dato-DXd is an experimental TROP2-targeted ADC, developed using Daiichi Sankyo's proprietary DXd ADC Technology. It is one of six DXd ADCs in their oncology pipeline and a key program in AstraZeneca's ADC scientific platform. In collaboration with Sapporo Medical University, Dato-DXd is designed with topoisomerase I inhibitor payloads linked via tetrapeptide-based cleavable linkers. The drug is currently in Phase III trials for inoperable or metastatic HR-positive, HER2-low or negative breast cancer (IHC 0, IHC 1+, or IHC 2+/ISH-) that has previously been treated with endocrine therapy and at least one systemic therapy. AstraZeneca expects Phase I results from the TROPION-PanTumor01 trial (NCT03401385) to be available in the latter half of 2025, as reported in their 2024 clinical trial appendix. In February 2025, Daiichi Sankyo presented data from the Phase III TROPION-Breast01 DATROWAY trial for HR+/HER2-low breast cancer at the ESMO Virtual Meeting. While overall survival did not reach statistical significance, Dato-DXd showed a manageable safety profile and continued to favor the investigator's choice of chemotherapy on secondary efficacy endpoints. TRODELVY is a first-in-class TROP-2-targeting ADC designed with a proprietary hydrolyzable linker and SN-38, a topoisomerase I inhibitor payload. This combination delivers potent activity to TROP-2-expressing cells and the surrounding microenvironment. It is currently undergoing Phase III trials for HR-positive/HER-negative (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH–]) inoperable, locally advanced, or metastatic breast cancer after endocrine therapy. Its patent is set to expire in the US by 2028 and in Europe by 2029. BNT323/DB-1303 is a third-generation ADC targeting HER2, built on DualityBio's proprietary Duality Immune Toxin Antibody Conjugates (DITAC) platform. This candidate has shown antitumor activity in HER2-positive and HER2-low tumor models, as well as in multiple solid tumors, including breast, gastric, endometrial, biliary tract cancers, and other advanced solid tumors. BNT323/DB-1303 is currently being evaluated in a Phase I/II study (NCT05150691) for advanced/metastatic solid tumors and in a pivotal Phase III study (NCT06018337) for HR-positive and HER2-low, metastatic breast cancer that has progressed on hormone and/or CDK4/6 therapy. The anticipated launch of these emerging therapies are poised to transform the HER2-low cancers market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the HER2-low cancers market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about HER2-low cancer drug clinical trials, visit @ HER2-low Cancer Drugs Recent Developments in the HER2-low Cancer Market In January 2025, the US FDA approved ENHERTU for adults with unresectable or metastatic HR+, HER2-low or HER2-ultralow breast cancer, based on DESTINY-Breast06 Phase III results following progression on one or more endocrine therapies. In January 2025, the US FDA granted FTD to emiltatug ledadotin, B7-H4 ADC, for advanced or metastatic HER2-low or HER2-negative breast cancer, including triple-negative cases previously treated with a topoisomerase-1 inhibitor ADC, based on promising results from a Phase I trial. As per BioNTech's Q4 2024 annual presentation, published in March 2025, the company plans to prioritize the advancement of DB-1303 for BLA submission in 2025 as a second-line or subsequent therapy in HER2-expressing advanced endometrial cancer. According to Pfizer's presentation, the launch of disitamab vedotin for second-line HER2+/low metastatic urothelial carcinoma is expected in 2026. HER2-low Cancers Overview HER2 is a transmembrane tyrosine kinase receptor encoded by the ERBB2 gene, playing a crucial role in cell growth, differentiation, and survival. It is part of the epidermal growth factor receptor family and is typically analyzed using molecular techniques. HER2 protein overexpression is assessed through immunohistochemistry (IHC), while gene amplification is determined using fluorescence in situ hybridization (FISH). A HER2-low status is defined as an IHC score of 1+ or 2+, with no gene amplification detected by FISH. HER2/neu primarily activates the MAPK and PI3K pathways, contributing to malignant transformation when overexpressed or amplified. This receptor is found in several cancers, including breast, colorectal, ovarian, endometrial, bladder, gastric, and biliary tract cancers, with breast cancer being the most prevalent. HER2-low Cancers Epidemiology Segmentation In the 7MM, in 2024, among all the HER2-low cancer indications, breast cancer accounted for the highest number of incident cases, while ovarian cancer occupied the bottom of the ladder. The HER2-low cancers market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Targeted Patient Pool of Selected Indications for HER2-low Cancers Treatment Eligible Pool of Selected Indications for HER2-low Cancers Total Incident Cases of HER2-low Breast Cancers Age-specific Cases of HER2-low Breast Cancers Stage-specific Cases of HER2-low Breast Cancers HER2-low Cancers Report Metrics Details Study Period 2020–2034 HER2-low Cancers Report Coverage 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] HER2-low Cancer Market CAGR 9.4 % HER2-low Cancer Market Size in 2024 USD 3.2 billion Key HER2-low Cancer Companies AstraZeneca, Daiichi Sankyo, RemeGen, Pfizer (Seagen), Gilead Sciences, Merck, Bliss Biopharmaceutical (Hangzhou), Zymeworks, Jazz Pharmaceuticals, ALX Oncology, Dragonfly Therapeutics, Mersana Therapeutics, and others Key HER2-low Cancer Therapies ENHERTU, DATROWAY (datopotamab deruxtecan/Dato-DXd), AIDIXI (disitamab vedotin), TRODELVY (sacituzumab govitecan), Ifinatamab deruxtecan (I-DXd)/MK-2400, BB-1701, ZIIHERA (zanidatamab), DF1001, Emiltatug ledadotin (XMT-1660), and others Scope of the HER2-low Cancers Market Report HER2-low Cancers Therapeutic Assessment: HER2-low Cancers current marketed and emerging therapies HER2-low Cancers Market Dynamics: Conjoint analysis of approved and emerging HER2-low Cancers Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Cost assumptions, HER2-low Cancers Market Access and Reimbursement Discover more about HER2-low cancer drugs in development @ HER2-low Cancers Clinical Trials Table of Contents 1 KEY INSIGHTS 2 REPORT INTRODUCTION 3 EXECUTIVE SUMMARY 4 KEY EVENTS 5 EPIDEMIOLOGY AND MARKET FORECAST METHODOLOGY 6 HER2-LOW CANCERS MARKET OVERVIEW AT A GLANCE 6.1 MARKET SHARE (%) DISTRIBUTION BY THERAPIES OF HER2-LOW CANCERS IN 2024 IN THE 7MM 6.2 MARKET SHARE (%) DISTRIBUTION BY THERAPIES OF HER2-LOW CANCERS IN 2034 IN THE 7MM 6.3 MARKET SHARE (%) DISTRIBUTION BY INDICATIONS IN 2024 IN THE 7MM 6.4 MARKET SHARE (%) DISTRIBUTION BY INDICATIONS IN 2034 IN THE 7MM 7 DISEASE BACKGROUND AND OVERVIEW 7.1 INTRODUCTION 7.2 SYMPTOMS 7.3 RISK FACTORS 7.4 PATHOPHYSIOLOGY OF HER2-LOW CANCERS 7.5 PROGNOSIS 7.6 DIAGNOSIS 7.7 TREATMENT 7.8 GUIDELINES 7.8.1 Diagnostic Guidelines and Recommendations for HER2-low Cancers 7.8.1.1 ASCO Diagnostic Recommendations for HER2 Testing 7.8.1.2 The ASCO-College of American Pathologists (CAP) Recommendations for HER2 Testing 7.8.1.3 ESCO Guidelines for HER2-low Cancers 7.8.1.4 Interpretation by the ASCO/CAP 2018 Guidelines and by the 2023 ESMO Consensus on HER2-low Breast Cancer Regarding Each Pattern of HER2 Staining 7.8.1.5 Pan-Asian Adapted ESMO Guidelines for HER2-low Cancers 7.8.1.6 Japanese Breast Cancer Society Clinical Practice Guidelines for Pathological Diagnosis of Breast Cancer, 2022 Edition 7.8.2 Treatment Guidelines and Recommendations for HER2-low Cancers 7.8.2.1 ESMO Guidelines for HER2-low Cancers 7.8.2.2 Pan-Asian Adapted ESMO Guidelines for HER2-low Cancers 8 EPIDEMIOLOGY AND PATIENT POPULATION 8.1 KEY FINDINGS 8.2 ASSUMPTION AND RATIONALE OF HER2-LOW CANCERS: THE 7MM 8.3 TOTAL TARGETED PATIENT POOL OF SELECTED INDICATIONS FOR HER2-LOW CANCERS IN THE 7MM 8.4 TREATMENT ELIGIBLE POOL OF SELECTED INDICATIONS FOR HER2-LOW CANCERS IN THE 7MM 8.5 THE UNITED STATES 8.5.1 Total Incident Cases of HER2-low Breast Cancers in the United States 8.5.2 Age-specific Cases of HER2-low Breast Cancers in the United States 8.5.3 Stage-specific Cases of HER2-low Breast Cancers in the United States 8.6 EU4 AND THE UK 8.6.1 Total Incident Cases of HER2-low Breast Cancers in EU4 and the UK 8.6.2 Age-specific Cases of HER2-low Breast Cancers in EU4 and the UK 8.6.3 Stage-specific Cases of HER2-low Breast Cancers in EU4 and the UK 8.7 JAPAN 8.7.1 Total Incident Cases of HER2-low Breast Cancers in Japan (2020-2034) 8.7.2 Age specific Cases of HER2-low Breast Cancers in Japan 8.7.3 Stage-specific Cases of HER2-low Breast Cancers in Japan 9 PATIENT JOURNEY 10 MARKETED DRUG 10.1 KEY COMPETITOR 10.2 ENHERTU (TRASTUZUMAB DERUXTECAN): DAIICHI SANKYO AND ASTRAZENECA 10.2.1 Product Description 10.2.2 Regulatory Milestones 10.2.3 Other Developmental Activities 10.2.4 Clinical Development 10.2.4.1 Clinical Trial Information 10.2.5 Safety and Efficacy 11 EMERGING THERAPIES 11.1 KEY CROSS COMPETITION 11.2 DATROWAY (DATOPOTAMAB DERUXTECAN/DATO-DXD): ASTRAZENECA AND DAIICHI SANKYO 11.2.1 Product Description 11.2.2 Other Developmental Activities 11.2.3 Clinical Development 11.2.3.1 Clinical Trials Information 11.2.4 Safety and Efficacy 11.2.5 Analyst Views 11.3 TRODELVY (SACITUZUMAB GOVITECAN): GILEAD SCIENCES 11.3.1 Product Description 11.3.2 Other Developmental Activities 11.3.3 Clinical Development 11.3.3.1 Clinical Trials Information 11.3.4 Safety and Efficacy 11.3.5 Analyst Views 11.4 DB-1303/BNT323 (TRASTUZUMAB PAMIRTECAN): DUALITY BIOLOGICS AND BIONTECH 11.4.1 Product Description 11.4.2 Other Developmental Activities 11.4.3 Clinical Development 11.4.3.1 Clinical Trials Information 11.4.4 Safety and Efficacy 11.4.5 Analyst Views 11.5 AIDIXI (DISITAMAB VEDOTIN): REMEGEN AND PFIZER (SEAGEN) 11.5.1 Product Description 11.5.2 Other Developmental Activities 11.5.3 Clinical Development 11.5.4 Safety and Efficacy 11.5.5 Analyst Views 11.6 EFTILAGIMOD ALPHA (IMP321): IMMUTEP 11.6.1 Product Description 11.6.2 Other Developmental Activities 11.6.3 Clinical Development 11.6.3.1 Clinical Trials Information 11.6.4 Safety and Efficacy 11.6.5 Analyst Views 11.7 IFINATAMAB DERUXTECAN (I-DXD)/MK-2400: DAIICHI SANKYO AND MERCK 11.7.1 Product Description 11.7.2 Other Developmental Activities 11.7.3 Clinical Development 11.7.3.1 Clinical Trials Information 11.7.4 Analyst Views 11.8 BB-1701: BLISS BIOPHARMACEUTICAL (HANGZHOU) 11.8.1 Product Description 11.8.2 Other Developmental Activities 11.8.3 Clinical Development 11.8.3.1 Clinical Trials Information 11.8.4 Safety and Efficacy 11.8.5 Analyst Views 11.9 DF1001: DRAGONFLY THERAPEUTICS 11.9.1 Product Description 11.9.2 Other Developmental Activities 11.9.3 Clinical Development 11.9.3.1 Clinical Trials Information 11.9.4 Safety and Efficacy 11.9.5 Analyst Views 11.1 ZIIHERA (ZANIDATAMAB): ZYMEWORKS/JAZZ PHARMACEUTICALS/ALX ONCOLOGY 11.10.1 Product Description 11.10.2 Other Developmental Activities 11.10.3 Clinical Development 11.10.4 Safety and Efficacy 11.10.5 Analyst Views 11.11 HF158K1/HF-K1: HIGHFIELD BIOPHARMACEUTICALS 11.11.1 Product Description 11.11.2 Other Developmental Activities 11.11.3 Clinical Development 11.11.3.1 Clinical Trials Information 11.11.4 Safety and Efficacy 11.11.5 Analyst Views 11.12 EMILTATUG LEDADOTIN (XMT-1660): MERSANA THERAPEUTICS 11.12.1 Product Description 11.12.2 Other Developmental Activities 11.12.3 Clinical Development 11.12.3.1 Clinical Trials Information 11.12.4 Safety and Efficacy 11.12.5 Analyst Views 12 HER2-LOW CANCERS: SEVEN MAJOR MARKET ANALYSIS 12.1 KEY FINDINGS 12.2 MARKET OUTLOOK 12.3 CONJOINT ANALYSIS 12.4 KEY MARKET FORECAST ASSUMPTIONS 12.4.1 Cost Assumptions 12.4.2 Pricing Trends 12.4.3 Analogue Assessment 12.4.4 Launch Year and Therapy Uptakes 12.5 TOTAL MARKET SIZE OF HER2-LOW CANCERS BY COUNTRY IN THE 7MM 12.6 TOTAL MARKET SIZE OF HER2-LOW CANCERS BY INDICATIONS IN THE 7MM 12.7 MARKET SIZE OF HER2-LOW CANCERS BY THERAPIES IN 7MM 12.8 UNITED STATES MARKET SIZE 12.8.1 Total Market Size of HER2-low Cancers in the United States 12.8.2 Market Size of HER2-low Cancers by Therapies in the United States 12.9 EU4 AND THE UK MARKET SIZE 12.9.1 Total Market Size of HER2-low Cancers in EU4 and the UK 12.9.2 Market Size of HER2-low Cancers by Therapies in EU4 and the UK 12.1 JAPAN 12.10.1 Total Market Size of HER2-low Cancers in Japan 12.10.2 Market Size of HER2-low Cancers by Therapies in Japan 13 UNMET NEEDS 14 SWOT ANALYSIS 15 KOL VIEWS 16 MARKET ACCESS AND REIMBURSEMENT 16.1 UNITED STATES 16.1.1 Centre for Medicare and Medicaid Services (CMS) 16.2 EU4 AND THE UK 16.2.1 Germany 16.2.2 France 16.2.3 Italy 16.2.4 Spain 16.2.5 United Kingdom 16.3 JAPAN 16.3.1 MHLW 16.4 MARKET ACCESS AND REIMBURSEMENT OF HER2-LOW CANCERS 17 APPENDIX 17.1 BIBLIOGRAPHY 17.2 REPORT METHODOLOGY 18 DELVEINSIGHT CAPABILITIES 19 DISCLAIMER 20 ABOUT DELVEINSIGHT Related Reports HER2+ Market HER2+ Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report deliver an in-depth understanding of HER2+, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key HER2+ companies, including Zymeworks, Jazz Pharmaceuticals, Ambrx, AnBogen Therapeutics, Enliven Therapeutics, Roche, among others. Metastatic HER2-Positive Breast Cancer Market Metastatic HER2-Positive Breast Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key metastatic HER2-positive breast cancer companies, including Byondis, Roche, Ambrx, Zymeworks, Jazz Pharmaceuticals, Pfizer, among others. Metastatic HR+/HER2-negativeBreast Cancer Market Metastatic HR+/HER2− Breast Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key metastatic HR+/HER2-negative breast cancer companies including Merck, Arvinas, Olema Pharmaceuticals, Celcuity, Roche, AstraZeneca, Daiichi Sankyo, Eli Lilly, Sermonix Pharmaceuticals, Genentech, Veru Pharma, DualityBio, BioNtech, Evgen Pharma, Carrick Therapeutics, EQRx, G1 Therapeutics, Immutep, among others. Triple Negative Breast Cancer Market Triple Negative Breast Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key TNBC companies including AstraZeneca, Daiichi Sankyo, OBI Pharma, Astellas Pharma, Pfizer, Galera Therapeutics, BioNTech, 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 Us Shruti Thakur info@ +14699457679 Logo: View original content: SOURCE DelveInsight Business Research, LLP Error 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
Business Upturn
5 days ago
- Business
- Business Upturn
UPDATED: Serina Therapeutics Congratulates Juvenescence Ltd. on $76M First Tranche Close of Series B Funding and Strategic Partnership with M42
HUNTSVILLE, June 17, 2025 (GLOBE NEWSWIRE) — This press release has been updated to reflect the correct timing of the funding round. Serina Therapeutics, Inc. ('Serina') (NYSE American: SER), a clinical-stage biotechnology company developing its proprietary POZ Platform™ drug optimization technology, today congratulates its strategic partner and largest shareholder, Juvenescence Ltd., on the $76 million first tranche close of its targeted $150 million Series B financing, as well as its new strategic partnership with M42, a global tech-enables health company headquartered in Abu Dhabi. 'Juvenescence has been a critical partner to Serina, providing strategic guidance and capital that have helped us advance our POZ Platform™ into the clinic,' said Steve Ledger, Chief Executive Officer of Serina Therapeutics. 'We congratulate Richard and the entire Juvenescence team on this next phase of growth and look forward to working together to deliver breakthrough treatments to patients around the world.' This significant investment and accompanying strategic alliance mark a major milestone in accelerating Juvenescence's mission to develop innovative therapies targeting age-related diseases and extending healthspan. As part of this partnership, Juvenescence and M42 will launch a drug development hub in Abu Dhabi, combining AI-enabled drug discovery with cutting-edge data and clinical infrastructure to speed the development of novel therapeutics. 'We are grateful for the continued support of our investors, including new investor and strategic partner M42, who have joined us on this remarkable journey. Our partnership with M42 signifies a shared commitment to developing sustainable, long-term collaborations,' said Dr. Richard Marshall CBE, CEO of Juvenescence. 'Together, we are excited about the opportunity to help build a leading life-sciences hub in Abu Dhabi and establish a pipeline of innovative therapeutics that will improve the lives of millions of patients.' As a core portfolio company of Juvenescence, Serina is proud to be part of a growing network of science-driven enterprises working to transform the future of medicine. About Serina Therapeutics Serina is a clinical-stage biotechnology company developing a pipeline of wholly owned drug product candidates to treat neurological diseases and other indications. Serina's POZ Platform™provides the potential to improve the integrated efficacy and safety profile of multiple modalities including small molecules, RNA-based therapeutics, and antibody-based drug conjugates (ADCs). Serina is headquartered in Huntsville, Alabama on the campus of the HudsonAlpha Institute of Biotechnology. For more information, please visit About Juvenescence Juvenescence is a clinical-stage AI-enabled biotech company developing novel medicines to extend healthy lifespan. Our approach centers around developing medicines that target core aging mechanisms to treat and prevent age-related diseases. It was founded by Jim Mellon, Dr Greg Bailey, and Dr Declan Doogan – with a track record of leading 2 of the 10 largest biopharma deals in the last decade, including the sale of Biohaven to Pfizer for $11.6bn. The Juvenescence team, led by Dr Richard Marshall CBE, consists of world-class R&D leadership that have previously been instrumental in the approval of medicines totaling $30bn in peak annual sales. Powered by an unrivaled drug development team, Juvenescence leverages innovative AI tools to unlock successful therapeutics. The company's diverse, AI-enabled medicines pipeline of clinical and near-clinical stage candidates targeting core ageing mechanisms are in development for cognition, cardio-metabolism, immunity, and cellular repair. In addition, Juvenescence has investments in a number of innovative companies and platform technologies focused on AI and regenerative medicine. For more information, visit: About M42 M42 is a global health champion powered by artificial intelligence (AI), technology and genomics to advance innovation in health for people and the planet. Headquartered in Abu Dhabi, M42 combines its specialized, state-of-the-art facilities with integrated health solutions like genomics and biobanks, and harnesses advanced technologies to deliver precise, preventive, and predictive care, impactfully disrupt traditional healthcare models and positively impact lives globally. Established in 2022, following the coming together of G42 Healthcare and Mubadala Health, M42 has more than 480 facilities in 26 countries and over 20,000 employees. M42 includes renowned healthcare providers including Cleveland Clinic Abu Dhabi, Danat Al Emarat, Diaverum, Imperial College London Diabetes Centre, Sheikh Sultan bin Zayed Hospital, and Moorfields Eye Hospital Abu Dhabi. As well as operating the Emirati Genome Program, M42 runs Abu Dhabi BioBank and ADHDS, a global tech-enabled healthcare company operating Malaffi. For inquiries, please contact:Stefan Riley [email protected] (256) 327-9630
Yahoo
5 days ago
- Business
- Yahoo
UPDATED: Serina Therapeutics Congratulates Juvenescence Ltd. on $76M First Tranche Close of Series B Funding and Strategic Partnership with M42
HUNTSVILLE, June 17, 2025 (GLOBE NEWSWIRE) -- This press release has been updated to reflect the correct timing of the funding round. Serina Therapeutics, Inc. ('Serina') (NYSE American: SER), a clinical-stage biotechnology company developing its proprietary POZ Platform™ drug optimization technology, today congratulates its strategic partner and largest shareholder, Juvenescence Ltd., on the $76 million first tranche close of its targeted $150 million Series B financing, as well as its new strategic partnership with M42, a global tech-enables health company headquartered in Abu Dhabi. 'Juvenescence has been a critical partner to Serina, providing strategic guidance and capital that have helped us advance our POZ Platform™ into the clinic,' said Steve Ledger, Chief Executive Officer of Serina Therapeutics. 'We congratulate Richard and the entire Juvenescence team on this next phase of growth and look forward to working together to deliver breakthrough treatments to patients around the world.' This significant investment and accompanying strategic alliance mark a major milestone in accelerating Juvenescence's mission to develop innovative therapies targeting age-related diseases and extending healthspan. As part of this partnership, Juvenescence and M42 will launch a drug development hub in Abu Dhabi, combining AI-enabled drug discovery with cutting-edge data and clinical infrastructure to speed the development of novel therapeutics. 'We are grateful for the continued support of our investors, including new investor and strategic partner M42, who have joined us on this remarkable journey. Our partnership with M42 signifies a shared commitment to developing sustainable, long-term collaborations,' said Dr. Richard Marshall CBE, CEO of Juvenescence. 'Together, we are excited about the opportunity to help build a leading life-sciences hub in Abu Dhabi and establish a pipeline of innovative therapeutics that will improve the lives of millions of patients.' As a core portfolio company of Juvenescence, Serina is proud to be part of a growing network of science-driven enterprises working to transform the future of medicine. About Serina Therapeutics Serina is a clinical-stage biotechnology company developing a pipeline of wholly owned drug product candidates to treat neurological diseases and other indications. Serina's POZ Platform™provides the potential to improve the integrated efficacy and safety profile of multiple modalities including small molecules, RNA-based therapeutics, and antibody-based drug conjugates (ADCs). Serina is headquartered in Huntsville, Alabama on the campus of the HudsonAlpha Institute of Biotechnology. For more information, please visit About Juvenescence Juvenescence is a clinical-stage AI-enabled biotech company developing novel medicines to extend healthy lifespan. Our approach centers around developing medicines that target core aging mechanisms to treat and prevent age-related diseases. It was founded by Jim Mellon, Dr Greg Bailey, and Dr Declan Doogan – with a track record of leading 2 of the 10 largest biopharma deals in the last decade, including the sale of Biohaven to Pfizer for $11.6bn. The Juvenescence team, led by Dr Richard Marshall CBE, consists of world-class R&D leadership that have previously been instrumental in the approval of medicines totaling $30bn in peak annual sales. Powered by an unrivaled drug development team, Juvenescence leverages innovative AI tools to unlock successful therapeutics. The company's diverse, AI-enabled medicines pipeline of clinical and near-clinical stage candidates targeting core ageing mechanisms are in development for cognition, cardio-metabolism, immunity, and cellular repair. In addition, Juvenescence has investments in a number of innovative companies and platform technologies focused on AI and regenerative medicine. For more information, visit: About M42 M42 is a global health champion powered by artificial intelligence (AI), technology and genomics to advance innovation in health for people and the planet. Headquartered in Abu Dhabi, M42 combines its specialized, state-of-the-art facilities with integrated health solutions like genomics and biobanks, and harnesses advanced technologies to deliver precise, preventive, and predictive care, impactfully disrupt traditional healthcare models and positively impact lives globally. Established in 2022, following the coming together of G42 Healthcare and Mubadala Health, M42 has more than 480 facilities in 26 countries and over 20,000 employees. M42 includes renowned healthcare providers including Cleveland Clinic Abu Dhabi, Danat Al Emarat, Diaverum, Imperial College London Diabetes Centre, Sheikh Sultan bin Zayed Hospital, and Moorfields Eye Hospital Abu Dhabi. As well as operating the Emirati Genome Program, M42 runs Abu Dhabi BioBank and ADHDS, a global tech-enabled healthcare company operating Malaffi. For inquiries, please contact:Stefan Rileysriley@ 327-9630Error 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
Yahoo
5 days ago
- Business
- Yahoo
UPDATED: Serina Therapeutics Congratulates Juvenescence Ltd. on $76M First Tranche Close of Series B Funding and Strategic Partnership with M42
HUNTSVILLE, June 17, 2025 (GLOBE NEWSWIRE) -- This press release has been updated to reflect the correct timing of the funding round. Serina Therapeutics, Inc. ('Serina') (NYSE American: SER), a clinical-stage biotechnology company developing its proprietary POZ Platform™ drug optimization technology, today congratulates its strategic partner and largest shareholder, Juvenescence Ltd., on the $76 million first tranche close of its targeted $150 million Series B financing, as well as its new strategic partnership with M42, a global tech-enables health company headquartered in Abu Dhabi. 'Juvenescence has been a critical partner to Serina, providing strategic guidance and capital that have helped us advance our POZ Platform™ into the clinic,' said Steve Ledger, Chief Executive Officer of Serina Therapeutics. 'We congratulate Richard and the entire Juvenescence team on this next phase of growth and look forward to working together to deliver breakthrough treatments to patients around the world.' This significant investment and accompanying strategic alliance mark a major milestone in accelerating Juvenescence's mission to develop innovative therapies targeting age-related diseases and extending healthspan. As part of this partnership, Juvenescence and M42 will launch a drug development hub in Abu Dhabi, combining AI-enabled drug discovery with cutting-edge data and clinical infrastructure to speed the development of novel therapeutics. 'We are grateful for the continued support of our investors, including new investor and strategic partner M42, who have joined us on this remarkable journey. Our partnership with M42 signifies a shared commitment to developing sustainable, long-term collaborations,' said Dr. Richard Marshall CBE, CEO of Juvenescence. 'Together, we are excited about the opportunity to help build a leading life-sciences hub in Abu Dhabi and establish a pipeline of innovative therapeutics that will improve the lives of millions of patients.' As a core portfolio company of Juvenescence, Serina is proud to be part of a growing network of science-driven enterprises working to transform the future of medicine. About Serina Therapeutics Serina is a clinical-stage biotechnology company developing a pipeline of wholly owned drug product candidates to treat neurological diseases and other indications. Serina's POZ Platform™provides the potential to improve the integrated efficacy and safety profile of multiple modalities including small molecules, RNA-based therapeutics, and antibody-based drug conjugates (ADCs). Serina is headquartered in Huntsville, Alabama on the campus of the HudsonAlpha Institute of Biotechnology. For more information, please visit About Juvenescence Juvenescence is a clinical-stage AI-enabled biotech company developing novel medicines to extend healthy lifespan. Our approach centers around developing medicines that target core aging mechanisms to treat and prevent age-related diseases. It was founded by Jim Mellon, Dr Greg Bailey, and Dr Declan Doogan – with a track record of leading 2 of the 10 largest biopharma deals in the last decade, including the sale of Biohaven to Pfizer for $11.6bn. The Juvenescence team, led by Dr Richard Marshall CBE, consists of world-class R&D leadership that have previously been instrumental in the approval of medicines totaling $30bn in peak annual sales. Powered by an unrivaled drug development team, Juvenescence leverages innovative AI tools to unlock successful therapeutics. The company's diverse, AI-enabled medicines pipeline of clinical and near-clinical stage candidates targeting core ageing mechanisms are in development for cognition, cardio-metabolism, immunity, and cellular repair. In addition, Juvenescence has investments in a number of innovative companies and platform technologies focused on AI and regenerative medicine. For more information, visit: About M42 M42 is a global health champion powered by artificial intelligence (AI), technology and genomics to advance innovation in health for people and the planet. Headquartered in Abu Dhabi, M42 combines its specialized, state-of-the-art facilities with integrated health solutions like genomics and biobanks, and harnesses advanced technologies to deliver precise, preventive, and predictive care, impactfully disrupt traditional healthcare models and positively impact lives globally. Established in 2022, following the coming together of G42 Healthcare and Mubadala Health, M42 has more than 480 facilities in 26 countries and over 20,000 employees. M42 includes renowned healthcare providers including Cleveland Clinic Abu Dhabi, Danat Al Emarat, Diaverum, Imperial College London Diabetes Centre, Sheikh Sultan bin Zayed Hospital, and Moorfields Eye Hospital Abu Dhabi. As well as operating the Emirati Genome Program, M42 runs Abu Dhabi BioBank and ADHDS, a global tech-enabled healthcare company operating Malaffi. For inquiries, please contact:Stefan Rileysriley@ 327-9630Error 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
CNBC
6 days ago
- Business
- CNBC
Targeted cancer drugs may replace chemo for some patients — and drugmakers say they're getting closer
Chemotherapy has long been a cornerstone of cancer treatment, saving millions of lives. But the pharmaceutical industry says a popular class of targeted cancer therapies could one day replace chemotherapy and its potential for harsh side effects. Antibody-drug conjugates (ADCs) have taken major strides in recent years, as companies including AstraZeneca, Daiichi Sankyo, Pfizer and Merck are developing drugs in the space that could ease the trials of cancer treatment and make them big money in the process. Drugmakers have poured billions of dollars into developing ADCs. The medicines are designed to deliver potent chemotherapy directly to cancer cells while sparing surrounding healthy cells. That's unlike traditional chemotherapy, which can affect both types of cells. But it will likely take years before ADCs can replace chemo, and some outside cancer experts say the pharmaceutical industry still has more work to do to refine the treatments. "I think we've had some successes in the space, but I think the early hopes that they would sweep away the need for chemotherapy have mostly been unfulfilled so far," Dr. John Heymach, chair of thoracic/head and neck medical oncology at MD Anderson Cancer Center, told CNBC. "There's clearly room for improvement." Still, some companies say ADCs have shown the ability to replace chemotherapy in certain settings. Other drugmakers say they are inching closer to developing ADCs that can be used before chemo — or at the very least, learning from previous missteps. "We are leading the way towards establishing ADCs as a precision-based approach to replace classic chemotherapy," David Fredrickson, executive vice president of AstraZeneca's oncology business, told CNBC. He was in part referring to AstraZeneca's promising data shared at the 2025 American Society of Clinical Oncology annual meeting in Chicago, where several other companies also delivered positive results on existing and experimental ADCs – or even data that could lead to new standards in cancer care. Since the first ADC hit the market in 2000, the field has made major progress. More than a dozen ADCs are now approved in the U.S., and some have become a preferred or commonly used treatment option for specific tumors. Hundreds more ADCs are in development. Large pharmaceutical companies have scooped up many of the approved and experimental ADCs in massive deals, such as Pfizer's $43 billion acquisition of Seagen in 2023. A range of drugmakers want in on the hype, and for good reason. ADCs could account for $31 billion of the $375 billion worldwide cancer market in 2028, according to estimates from the drug market research firm Evaluate. ADCs still pose major challenges. Among them, some treatments can release the toxic chemotherapy "payload" into the bloodstream too soon, affecting healthy cells and causing a range of side effects. Some health experts say drugmakers also need to identify the right cancer-causing proteins to target and new payloads for these drugs. The pharmaceutical industry is working to overcome these issues by developing next-generation ADCs and combination regimens. Some ADCs, such as a newly approved therapy from AbbVie, target new proteins, while others use new so-called linker platforms that better control when and where the toxic payload is released. "It's been hard. We haven't optimized everything perfectly yet. But I think that the field is still growing fast, and it's making improvements every year," said Dr. Jeffrey Infante, global head of early clinical development, translational research and oncology at Johnson & Johnson, which has several experimental ADCs. Most ADCs consist of three components: an antibody that targets a protein found in high amounts on the surface of cancer cells, a chemotherapy payload and a linker that connects them. The antibody guides the ADC to the cancer cell, and once inside, the linker releases the chemotherapy to kill the cancer from within. Newer ADCs leading the space, such as Enhertu from AstraZeneca and Daiichi Sankyo, improve on that design and are moving closer to becoming standard treatments for certain cancers. Enhertu delivers more chemotherapy per dose than older ADCs and uses a smart linker designed to release the drug only inside tumors. It can also kill nearby cancer cells with lower levels of HER-2, the protein it targets – a major milestone in oncology. Enhertu is approved in the U.S. to treat certain breast, lung and gastric cancers, with 2024 sales from both companies topping $3.7 billion. New data presented at ASCO could expand Enhertu's use and shift how breast cancer is treated for the first time in a decade. Enhertu stalled the growth of a common type of breast cancer by over a year in a late-stage trial when used as an initial treatment, and compared to a standard regimen containing chemotherapy. The study combined Enhertu with a medicine called pertuzumab as a first option for patients with HER-2-positive metastatic breast cancer. AstraZeneca and Daiichi Sankyo are seeking approval for that use. "We're moving this drug earlier and earlier, and the magnitude of benefit gets bigger and bigger," said Ken Keller, Daiichi Sankyo's CEO and head of oncology business. "The hope is that we can move it into earlier-stage settings where curing is the goal." Keller said the results and previous Enhertu data show "you can replace and knock the chemotherapy out." The companies also plan to release data on a subset of patients in the study who took Enhertu alone. MD Anderson's Heymach said the data "is the type of clear, major advance that we'd like to see more often, where this ADC could become the first option for patients." Other ADCs are advancing, too. Pfizer's Adcetris, which it acquired from Seagen, is approved as an initial treatment with chemotherapy for certain lymphomas. It raked in almost $1.1 billion in sales in 2024. Padcev from Pfizer and Astellas Pharma is approved with Merck's Keytruda as a first-line bladder cancer therapy, and booked $1.69 billion in sales last year. Keytruda is a blockbuster immune checkpoint inhibitor that blocks a protein called PD-1, helping immune cells more effectively recognize and kill cancer cells. Gilead's Trodelvy, an ADC that took in $1.3 billion in revenue in 2024, also turned heads at ASCO. As a first-line treatment, Trodelvy combined with Keytruda lowered the risk of disease progression by 35% in patients with an aggressive type of breast cancer in a late-stage trial. The study examined patients with advanced triple-negative breast cancer whose tumors express PD-L1. "What these studies demonstrate is that if you replace the chemotherapy with the antibody drug conjugate, then you do get improved efficacy and improved safety," said Dr. Dietmar Berger, Gilead's chief medical officer. Berger said there are early signs that the combination may also help patients live longer, but the data is still new. Gilead is also studying Trodelvy as a first-line treatment in another type of breast cancer and non-small cell lung cancer. The ASCO data was a win for Gilead after recent setbacks for Trodelvy. In October, Gilead pulled Trodelvy from the bladder cancer market in the U.S. after disappointing results in a trial meant to confirm its benefit. In January 2024, Trodelvy failed a phase three trial in non-small cell lung cancer. Berger said that's one challenge of developing ADCs: effectiveness can vary by cancer type, so some patients may benefit from a drug more than others. "You need to learn from the different studies and see the exact populations that might benefit," Berger said, adding that developing across cancers isn't "linear." British drugmaker GSK is learning from its missteps, too. The company pulled its blood cancer ADC, Blenrep, from markets worldwide in 2022 after it failed a study meant to verify its benefit. But Blenrep is now reapproved in the U.K., with a U.S. decision due on July 23. GSK's Chief Commercial Officer Luke Miels said the company had to "go back to the drawing board" to revive Blenrep, which involved building a team with deeper ADC expertise and reevaluating dosing. Blenrep, when combined with other therapies, has since succeeded in two key studies in previously treated blood cancer patients. Under its original approval, it was used on its own. GSK also presented data at ASCO showing Blenrep's main side effect – blurred vision in about 1 in 3 patients – is reversible and manageable with lower or spaced-out dosing. The company expects up to £3 billion ($3.97 billion) in peak annual Blenrep sales. It is also studying the drug as a first-line treatment, which could add to that revenue forecast, Miels said. Meanwhile, Merck and Daiichi Sankyo face a new hurdle for a drug they are developing. In May, they withdrew their U.S. application for an ADC targeting HER-3 after it failed to extend overall survival in a late-stage lung cancer trial. They scrapped the application even though the ADC met the study's main goal last year: delaying tumor progression compared to chemotherapy in patients previously treated for a certain non-small cell lung cancer. The drug is one of three ADCs that Merck is co-developing with Daiichi Sankyo as it prepares for Keytruda's upcoming patent expiration. Marjorie Green, Merck's head of oncology global clinical development, said the companies are learning from "what worked and what didn't" and still fully investing in refining the drug, with plans to test it in late-stage breast cancer trials. Other companies are trying to make waves in the ADC space with new approaches to the drugs. AbbVie, for example, is successfully developing ADCs with new cancer-causing protein targets. The company in May scored U.S. approval for the first-ever ADC targeting a protein called c-Met, which can be found in high levels in non-small cell lung cancer and is associated with a low likelihood of recovery or improvement. But the company also released several trial results on a next-generation product that could become a best-in-class c-Met ADC, said Pedro Valencia, the company's vice president of solid tumor pipeline strategy and execution. He called it the result of years of fine-tuning the company's ADC platform to "get to that sweet spot." AbbVie also released data on its ADC targeting SEZ6, a unique protein that is overexpressed in neuroendocrine tumors such as small-cell lung cancer but not in normal tissue, Valencia said. That ADC has demonstrated response rates that are two to three times more than chemotherapy in those tumors, he said. Meanwhile, Bristol Myers Squibb is developing a bispecific ADC, said the company's Chief Medical Officer Samit Hirawat. Those are designed to target two different proteins, or parts of a protein, on cancer cells to make the drug more precise and effective. Through a partnership with Chinese company SystImmune, Bristol Myers Squibb is developing a drug that hits EGFR and HER-3, both common in multiple cancers. Hirawat said the drug carries more chemotherapy per dose than older ADCs and uses a linker that appears to help avoid a common side effect of rival treatments called interstitial lung disease, a group of conditions that cause lung scarring. A phase three trial is underway in triple-negative breast cancer, with more late-stage studies planned. Hirawat said the company is also exploring non-chemotherapy payloads to improve efficacy and safety. That includes protein degraders, which eliminate cancer-causing proteins instead of blocking them. Eli Lilly is also developing ADCs with non-chemotherapy payloads, said Jake Van Naarden, president of Lilly Oncology. He said new types of payloads could help patients who relapse on existing ADCs, shrinking their "newly growing cancers" again in "a durable way." Dr. Jennifer Suga, co-chair of Kaiser Permanente's National Lung Cancer Program, said developing alternative payloads will be crucial, as cancer cells may become "resistant" to those used in current ADCs. Eli Lilly is also using linker technology from Mablink, acquired in 2023, to help its ADCs stay in the body longer and reach tumors more effectively. At ASCO, Eli Lilly released the first human data on an ADC that uses that linker and targets folate receptor alpha, a protein commonly found in ovarian cancer. AbbVie's approved ADC, Elahere, already targets that protein. But Eli Lilly hopes its drug can have fewer side effects, Van Naarden said. In the early trial, the company did not observe any eye-related effects linked to other ADCs. J&J hopes to stand out by focusing on prostate cancer, where it has deep expertise. The lead ADC J&J acquired from the Ambrx targets PSMA, a protein common in prostate tumors. There are currently no approved ADCs with that target. Infante said that ADC has a "very stable" linker platform and can be paired with an existing diagnostic test, allowing the company to easily identify eligible patients for the drug. Chemotherapy likely won't disappear entirely and could still offer "major benefits" as a later treatment option in some cases, according to MD Anderson's Heymach. But he and drugmakers expect more ADCs will be used to treat solid tumors – cancers that form as masses in organs like the lungs, breasts or ovaries – before chemotherapy over the next decade. Heymach said "more effective combinations" of ADCs and other drugs could help establish more ADCs as go-to treatment options across a wider range of cancers. Pfizer believes immune checkpoint inhibitors such as Keytruda are a particularly promising match for its ADCs, said the company's Chief Scientific Officer Chris Boshoff. Pfizer's ADCs, built on its vedotin platform, do more than just kill tumor cells. Boshoff said they also trigger immunogenic cell death – a process that sends distress signals to alert the immune system and train it to recognize and attack similar cancer cells. That sets the stage for checkpoint inhibitors to do their job even more effectively, which is to release the "brakes" on the body's immune system and help it mount a stronger attack on cancer. Together, they create a one-two punch: ADCs kill the cancer and sound the alarm, while checkpoint inhibitors enable the immune system to fully attack. "When we combine them, we see increased response rates, increased progression-free survival, and in the cases where we have tested, an increase in overall survival," Boshoff said, referring to measures of cancer treatment effectiveness. At ASCO, Pfizer shared early but encouraging data on two vedotin-based ADCs in combination with Keytruda. That includes one targeting a protein commonly found in lung cancers called integrin B6, and another targeting PD-L1. Boshoff said the results support starting late-stage trials this year on those combinations in certain cancers. Pfizer is also betting on a combination ADC approach with a drug it gained the rights for through a licensing agreement with Chinese company 3SBio: a bispecific antibody drug targeting PD-L1 and VEGF. BioNTech is banking on a similar combination approach with its bispecific antibody drug that targets those same two proteins. Bristol Myers Squibb in June said it will pay $1.5 billion in upfront fees to co-develop that product. BioNTech in April released the first early data to back that combination approach, but will also have to prove each of its four ADCs as solo treatments in trials, said Chief Commercial Officer Annemarie Hanekamp. She said BioNTech believes ADCs could take the place of traditional chemotherapy. But the company also hopes its bispecific antibody drug could serve as an improved version of immunotherapies that only target PD-1, such as Keytruda and Bristol Myers Squibb's Opdivo. "We can then combine these two powers together and that's truly exciting," Hanekamp said, noting that BioNTech has multiple trials on the combination approach ongoing. At J&J, Infante said the company plans to be the first to test an ADC in combination with one of its T-cell engagers – a type of immunotherapy that directs immune cells to recognize and kill cancer cells. The company is preparing to start enrolling patients in trials on that combination regimen, he said.
