Latest news with #ADC
The Hindu
9 hours ago
- General
- The Hindu
Amaravati translocates over 4,000 trees
In a major green initiative, Amaravati Development Corporation Limited (ADCL) has translocated over 4,000 trees from different parts of the Amaravati Capital Region, saving them from infrastructure development works. The project, being implemented along with an instant tree nursery at Ananthavaram village, aims to preserve decades-old trees and replant them in the buffer zone. According to ADCL data, the highest number of trees moved are from the Ficus species (2,200), followed by Amla (472), Bahunia (315), Legestromia (350), Maredu (250), Bignonia (296) and Millingtonia (117). ADC chairperson and MD Devarakonda Lakshmi Parthasarathy said the translocation involves pruning tree branches to reduce weight, applying chemical treatment to the cut surfaces, and digging trenches around the root systems. Following this, the tap roots are cut, and the entire root ball is protected with cloth or sheets before being shifted to the nursery. There, the trees are placed in large bags filled with potting mixtures for protection. The survival rate of translocated trees has been recorded at 85–90%. Officials highlight that the preserved trees are all over 12 years old, each of which would otherwise cost nearly ₹2–3 lakh if procured commercially. Encouraged by the success of the first phase, ADCL has now identified another 4,000 trees for translocation under phase II, which is expected to be completed by December 2025.
Yahoo
a day ago
- Business
- Yahoo
Pfizer Oncology Drugs Drive Sales in Q2: Will the Trend Continue?
Pfizer PFE is one of the largest and most successful drugmakers in oncology. It boasts a strong portfolio of approved cancer medicines as well as a robust pipeline of cancer candidates with a focus on multiple modalities, including small molecules, antibody-drug conjugates (ADCs) and immuno-oncology biologics. The addition of Seagen in 2023 also strengthened its position in oncology by adding four ADCs — Adcetris, Padcev, Tukysa and Tivdak. The acquired Seagen products contributed meaningfully to Pfizer's revenues in 2024 and in the first half of 2025. Seagen also has some next-generation ADC candidates in its pipeline. Oncology sales comprise more than 25% of Pfizer's total revenues. Its oncology revenues grew 9% in the first half of 2025, driven by drugs like Xtandi, Lorbrena, the Braftovi-Mektovi combination and Padcev, which made up for declining sales of drugs like Ibrance. Xtandi recorded alliance revenues of $566 million in the quarter, up 14% year over year. Lorbrena sales rose 48% to $251 million. Braftovi/Mektovi revenues were $182 million, up 23% year over year. New drug, Elrexfio, generated sales of $85 million in the second quarter. Ibrance revenues declined 8% year over year to $1.05 billion due to continued competitive pressure across markets. Among the ADCs added from the acquisition of Seagen, Adcetris sales were $255 million in the second quarter, which declined 9% year over year due to competitive pressure in the United States. Padcev rose 38% to $542 million, driven by strong demand trends. Pfizer has ventured into the oncology biosimilars space and markets six biosimilars for cancer. Revenues from oncology biosimilars were $353 million in the second quarter, up 27% year over year. Pfizer also advanced its oncology clinical pipeline with several candidates entering late-stage development, like sasanlimab, vepdegestrant and sigvotatug vedotin. By 2030, it expects to have eight or more blockbuster oncology medicines in its portfolio. In July, it closed a global ex-China in-licensing agreement with China's 3SBio for exclusive rights to the latter's dual PD-1 and VEGF inhibitor, which will strengthen its oncology pipeline. Pfizer is also working on expanding the labels of approved oncology drugs like Padcev, Adcetris and Elrexfio, among others. With all the above developments, Pfizer's future in cancer treatment looks promising. Continued growth of Pfizer's diversified portfolio of oncology drugs should support top-line growth in the second half of 2025. Competition in the Oncology Space Other large players in the oncology space are AstraZeneca AZN, Merck MRK and Bristol-Myers BMY. For AstraZeneca, oncology sales now comprise around 43% of total revenues. Sales in its oncology segment rose 16% in the first half of 2025. AstraZeneca's strong oncology performance was driven by medicines such as Tagrisso, Lynparza, Imfinzi, Calquence and Enhertu (in partnership with Daiichi Sankyo). Merck's key oncology medicines are PD-L1 inhibitor, Keytruda and PARP inhibitor, Lynparza, which it markets in partnership with AstraZeneca. Keytruda, approved for several types of cancer, alone accounts for around 50% of Merck's pharmaceutical sales. Keytruda's sales rose 6.6% to $15.1 billion in the first half of 2025. Bristol-Myers' key cancer drug is PD-L1 inhibitor, Opdivo, which accounts for around 20% of its total revenues. Opdivo's sales rose 9% to $4.82 billion in the first half of 2025. PFE's Price Performance, Valuation and Estimates Pfizer's stock has declined 0.4% so far this year compared with a decrease of 1.2% for the industry. Image Source: Zacks Investment Research From a valuation standpoint, Pfizer appears attractive relative to the industry and is trading below its 5-year mean. Going by the price/earnings ratio, the company's shares currently trade at 8.08 forward earnings, lower than 14.45 for the industry and the stock's 5-year mean of 10.78. Image Source: Zacks Investment Research The Zacks Consensus Estimate for 2025 earnings has risen from $3.05 per share to $3.12 per share, while that for 2026 has gone up from $3.08 to $3.09 per share over the past 30 days. Image Source: Zacks Investment Research Pfizer has a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report AstraZeneca PLC (AZN) : Free Stock Analysis Report Bristol Myers Squibb Company (BMY) : Free Stock Analysis Report Pfizer Inc. (PFE) : Free Stock Analysis Report Merck & Co., Inc. (MRK) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research 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 Wire
a day ago
- Business
- Business Wire
InnoCare Releases 2025 Interim Results and Business Highlights
BEIJING--(BUSINESS WIRE)--InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, today announced the 2025 interim results as of 30 June 2025. Over the next three to five years, InnoCare will launch multiple drugs into the market, bring three to four products to the global market, and continue to deepen its innovation efforts and develop five to ten differentiated molecules. Significant Revenue Growth from Orelabrutinib Total Revenue of InnoCare increased by 74.3% year-on-year (YoY) to RMB731.4 million 1 for the six months ended 30 June 2025, primarily attributable to the robust sales growth of orelabrutinib and license-out revenue from Prolium. Drug sales increased by 53.5% YoY to RMB641.2 million in the first half of 2025, driven by coverage expansion, an increase in the number of patients treated by orelabrutinib, especially in marginal zone lymphoma, as well as strong commercial execution. Loss for the period decreased by 86.7% to RMB35.6 million for the six months ended 30 June 2025, attributed to revenue growth and improved cost efficiency. Research and development expenses increased by 6.9% YoY to RMB449.7 million for the six months ended 30 June 2025 primarily due to increased investment in advanced technology platforms and a greater number of Phase III clinical trials. Cash and related accounts balances 2 stood at approximately RMB7.7 billion as of 30 June 2025. This robust cash position provides flexibility for the Company to expedite clinical development and invest in a competitive pipeline, including ADC programs. Accelerating Innovation, Commercialization and Globalization In the first half of 2025, InnoCare made substantial progress in advancing its pipeline with multiple key milestones achieved: Orelabrutinib received approval for first-line chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), tafasitamab in combination with lenalidomide was approved for adult patients with relapsed or refractory DLBCL (R/R DLBCL), BCL-2 inhibitor Mesutoclax (ICP-248) entered two registrational clinical studies, the NDA for TRK inhibitor Zurletrectinib (ICP-723) was accepted and granted priority review, and the Company's proprietary antibody-drug conjugate (ADC) platform reached a major milestone with IND approval. Building on this R&D momentum, InnoCare further expanded its global footprint through strategic collaborations. In January, InnoCare partnered with Prolium to explore global potential for a CD3×CD20 bispecific antibody. InnoCare remains committed to advancing global partnerships that will enhance innovation, maximize the value of its pipeline, and support long-term growth. Orelabrutinib drove significant revenue growth through strong commercial execution and broader market penetration. This momentum demonstrates the Company's key abilities to translate scientific innovations into sustained business performance. Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, 'Over the past decade, we have built a fully-integrated platform encompassing original innovation, clinical development, commercialization, manufacturing, and BD, achieving a series of great milestones. As we embark on the next decade, we will accelerate our company's rapid development of Stage 2.0, driving innovation, commercialization, and globalization. Over the next three to five years, we will launch multiple drugs into the market, significantly increasing commercial revenue. We will bring three to four products to the global market. We will also continue to deepen our innovation efforts and develop five to ten differentiated molecules. With our innovative and entrepreneurial spirit, the company is set to reach new heights.' Building A Leading Franchise in Hemato-Oncology In the first half of 2025, InnoCare took major steps toward establishing a leadership position in hematology-oncology, driven by three cornerstone therapies - orelabrutinib, tafasitamab, and mesutoclax. With orelabrutinib's approval in first-line CLL/SLL and tafasitamab's approval in combination with lenalidomide for adult patients with R/R DLBCL, InnoCare's commercial hematology portfolio has significantly expanded. InnoCare's novel BCL2 inhibitor, mesutoclax, further strengthens this franchise with two registrational trials now underway: a fixed-duration combination regimen with orelabrutinib in 1L CLL/SLL and a study for BTKi-treated mantle cell lymphoma (MCL). Additionally, InnoCare completed dose exploration in the first line acute myeloid leukemia (AML), with data to be presented at ASH 2025, and received clearance to initiate a myelodysplastic syndromes (MDS) trials in both U.S. and China. Tafasitamab Tafasitamab (trade name: Minjuvi ®) is a potential best profile therapy for R/R DLBCL. In a pivotal Phase II study, it demonstrated a high overall response rate (ORR) with durable responses, achieving an ORR of 57.5%, a median duration of response of 43.9 months, and a median overall survival (OS) of 33.5 months. With a large patient base and significant unmet medical need, approximately 40-55% of DLBCL patients relapse or become refractory after standard treatment. Mesutoclax (ICP-248) The registrational Phase III trial of mesutoclax in combination with orelabrutinib as first-line treatment for CLL/SLL is advancing rapidly. This fixed-duration therapy is expected to provide deeper remissions for treatment-naïve CLL/SLL patients, while avoiding resistance mutations and offering the hope for clinical cure. Together, these benefits position the regimen as a highly promising therapeutic approach. In a Phase II study of mesutoclax in combination with orelabrutinib, no tumor lysis syndrome (TLS) was observed. At week 36, data showed an ORR of 100%, target lesion complete response rate (CRR) of 57%, and undetectable minimal residual disease (uMRD) rate of 65%. In R/R MCL patients who were refractory to prior BTKi treatment, ORR reached 84% with a 36% CRR. In the dose-expansion study of mesutoclax in combination with azacytidine as first-line treatment for AML, the regimen demonstrated strong efficacy with a favorable safety profile, with a CRR of 70%, a uMRD rate of 57%, and a 60-day mortality rate of 0%. Accelerating Multiple Phase III Clinical Trials in Autoimmune Diseases Autoimmune diseases can affect almost every organ in the body and may arise at any stage of life. The global market for autoimmune disease therapeutics anticipated to reach $185 billion by 2029 3. The Company has fortified its powerful discovery engine to focus on cutting-edge targets for the development of autoimmune therapeutics through B-cell and T-cell pathways, with the aim of delivering first-in-class and/or best-in-class treatments to address the massive unmet medical needs and strong market potential in China and worldwide. Orelabrutinib to Provide Novel Treatment for ITP Patients The Company has completed patient enrollment of the Phase III registrational trail of orelabrutinib for the treatment of Immune Thrombocytopenia (ITP) and expects to submit the NDA application in the first half of 2026. ITP represents hundreds of thousands of patients globally with a prevalence of 23.6 cases out of 100,000 in U.S. and a prevalence of 9.5 cases out of 100,000 in China. Current therapies, including corticosteroids and thrombopoietin receptor agonists, lack long-term tolerability or durable sustained responses. New safe and effective treatment options are needed for patients who have inadequate responses to previous lines of therapy. BTK is a key kinase in the B cell receptor signaling pathway, which is essential for the activation of B lymphocytes, macrophages, and other immune cells as well as the production of antibodies in the pathological process of ITP. No BTK inhibitor has yet been approved for the treatment of patients with ITP. Orelabrutinib, with its high target selectivity and good safety profile, has the potential to become a novel treatment option for ITP patients. InnoCare is accelerating the global Phase III studies for Primary Progressive Multiple Sclerosis (PPMS) and Secondary Progressive Multiple Sclerosis (SPMS). The Phase IIb clinical trial for orelabrutinib in SLE completed patient enrollment in 2024, with data readout expected Q4 2025. InnoCare's two in-house developed TYK2 inhibitors have demonstrated good efficacy with excellent safety profiles in Phase II studies. Soficitinib (ICP-332) is being developed for multiple autoimmune indications. Its Phase III trial for AD is expected to complete patient enrollment this year, while the phase II/III of clinical trial in vitiligo is advancing rapidly, and a global Phase II study in prurigo nodularis (PN) is about to be initiated. The registrational Phase III trial of ICP-488 in psoriasis is also expected to complete patient enrollment this year, and its Phase II clinical data were presented as a high-impact oral report at the 2025 American Academy of Dermatology (AAD) Annual Meeting. As oral small-molecule therapies for autoimmune indications, these drugs are expected to leverage convenient administration to better benefit patients. Building Innovative Solid Tumor Assets As part of InnoCare's strategic focus on solid tumor therapeutics, the Company is building a competitive and diversified drug portfolio to address significant unmet medical needs across multiple tumor types. Precision Medicine: Zurletrectinib In March 2025, the new drug application of zurletrectinib for the treatment of adult and adolescent patients (12 to 18 years) with NTRK gene fusion-positive tumors was accepted by the CDE and granted priority review. The registrational trial for pediatric patients (2 to 12 years) is ongoing, with NDA submission later 2025. Zurletrectinib was shown to overcome acquired resistance to the first generation TRK inhibitors, bringing hope for patients who failed prior TRKi therapy. Zurletrectinib demonstrated outstanding efficacy with a good safety profile, achieving an ORR of 85.5%. Zurletrectinib has also shown a long duration of response, with longest beyond 36 months. Proprietary ADC Platform with First ADC Drug Entering the Clinic The Company has developed a cutting-edge ADC platform with proprietary linker-payload (LP) technologies, aimed at the delivery of potent and targeted therapies for cancer treatment. This platform allows for the creation of highly differentiated ADCs with improved efficacy and safety profiles. Key features of the platform include: Novel connector: Irreversible connector to avoid linker detachment caused by instability. Hydrophilic linker: Enhancing ADC stability and achieving high drug-to-antibody ratio (DAR). Novel payload: Incorporating highly potent cytotoxic payloads with strong bystander killing effect. The first in-house ADC candidate, ICP-B794, a B7-H3–targeting ADC, received IND approval in July 2025, and the Company expects first patient-in and clinical proof-of-concept later this year. ICP-B794 is a novel ADC comprising a humanized anti-B7-H3 monoclonal antibody conjugated to potent in-house developed payload via a protease-cleavable linker. This combination ensures precise targeting of tumor cells while minimizing off-target effects, offering a promising treatment for solid tumors such as lung cancer, esophageal cancer, nasopharyngeal cancer, head and neck squamous cell carcinomas, prostate cancer, and others. Currently, there are no B7-H3 targeted therapies approved for marketing globally. B7-H3 is a type I transmembrane protein that is highly expressed in a variety of solid tumors. Due to its specific expression in tumor cells, it is considered a highly promising anti-tumor target. ICP-B794 has demonstrated superior anti-tumor activity in animal models compared to other ADCs, and exhibited significant tumor-killing effects even in large tumors. Upon achieving proof-of-concept, it is anticipated that multiple ADC-based molecules from this platform will have IND submissions next year, which will significantly expand the solid tumor pipeline. Through these efforts, InnoCare aims to establish a robust and innovative oncology portfolio, positioning the Company as a future leader in innovative therapies for solid tumors. To know more about the detailed financial data and business updates of InnoCare 2025 interim results, please log in to Conference Call Information InnoCare will host a conference call at 8:30 p.m. Beijing time on August 19 in English and at 9:00 a.m. Beijing time in Chinese on August 20, 2025. Participants must register in advance of the conference call. Details are as follows: For English conference call, please register through the below link: For Chinese conference call, please register through the below link: Forward-looking Statement This report contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management's intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance. About InnoCare InnoCare (HKEX: 09969; SSE: 688428) is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and United States. ____________________ Expand 1 The financial figures in this article are based on Hong Kong Financial Reporting Standards 2 Include cash and bank balances, other financial assets balance and interest receivables balance. 3
Yahoo
2 days ago
- Business
- Yahoo
Daiichi Sankyo Presents New Data in Small Cell Lung Cancer and Updates Across ADC Portfolio Highlighting Progress in Creating New Standards of Care for Patients with Lung Cancer at WCLC
Late-breaking data from IDeate-Lung01 phase 2 trial demonstrate potential of ifinatamab deruxtecan to become first-in-class B7-H3 directed ADC for pretreated extensive-stage small cell lung cancer Investor briefing to discuss WCLC data and ifinatamab deruxtecan clinical development program TOKYO & BASKING RIDGE, N.J., August 14, 2025--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) will present new clinical research across its DXd antibody drug conjugate (ADC) portfolio in lung cancer at the IASLC 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC25). Data at WCLC will showcase the company's progress towards creating new standards of care for patients with lung cancer, including a late-breaking oral presentation featuring the primary analysis from the dose optimization and dose expansion parts of the IDeate-Lung01 phase 2 trial (OA06.03) of ifinatamab deruxtecan (I-DXd) in patients with pretreated extensive-stage small cell lung cancer (ES-SCLC). Interim data from the dose optimization part of the trial was previously presented at 2024 WCLC. "The late-breaking data at WCLC continues to demonstrate the potential of ifinatamab deruxtecan to become a first-in-class B7-H3 directed antibody drug conjugate for patients with pretreated extensive-stage small cell lung cancer, where treatment options following platinum-based chemotherapies are limited," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "These data along with other important updates across our portfolio continue to demonstrate how our DXd antibody drug conjugate technology is being leveraged to create new medicines for patients with cancer." Additional data updates at WCLC include an oral presentation featuring a retrospective analysis of the intracranial efficacy of DATROWAY® (datopotamab deruxtecan) or docetaxel in patients with non-small cell lung cancer (NSCLC) and baseline brain metastases in the TROPION-Lung01 phase 3 trial (0A10.01), and a poster presentation of the final results of the DESTINY-Lung05 phase 2 trial (P2.10.12) of ENHERTU® (trastuzumab deruxtecan) in patients from China with previously treated HER2 mutant NSCLC. Trials-in-Progress Across DXd ADC Portfolio Several trials-in-progress poster presentations at WCLC further highlight the Daiichi Sankyo R&D strategy of continuing to expand the DXd ADC portfolio to address a broad spectrum of unmet needs for patients with lung cancer, including the DESTINY-Lung06 phase 3 trial evaluating the efficacy and safety of ENHERTU plus pembrolizumab versus platinum-based chemotherapy plus pembrolizumab as a first-line treatment strategy for patients with HER2 overexpressing, PD-L1 TPS <50% metastatic NSCLC. Other early phase trials evaluating additional treatment strategies in lung cancer include the KEYMAKER-U01 substudy 01G phase 2 trial evaluating patritumab deruxtecan (HER3-DXd) in combination with pembrolizumab with or without platinum chemotherapy in patients with previously untreated stage 4 NSCLC, and a phase 1b/2 trial evaluating ifinatamab deruxtecan and gocatamig, a DLL3 targeted T-cell engager, in patients with relapsed or refractory ES-SCLC will be highlighted. Investor Briefing Following WCLC Daiichi Sankyo will hold a virtual conference call for investors on Wednesday, September 17, 2025 from 7:00 to 8:15 pm EDT / Thursday, September 18 from 8:00 to 9:15 am JST. Executives from Daiichi Sankyo will provide an overview of the late-breaking WCLC data and clinical development plan for ifinatamab deruxtecan. WCLC Presentation Overview Presentation Title Presenter Abstract Presentation (CEST) Ifinatamab Deruxtecan (I-DXd) Ifinatamab deruxtecan (I-DXd) in extensive-stage small cell lung cancer: primary analysis of the phase 2 IDeate-Lung01 study M. Ahn OA06.03 Oral Presentation Sunday, September 7 4:45– 6:00 pm A phase 1b/2 study of gocatamig and ifinatamab deruxtecan for relapsed or refractory extensive-stage small cell lung cancer P. Rocha P3.18.73 Poster Presentation Tuesday, September 9 10:00 – 11:30 am ENHERTU (trastuzumab deruxtecan; T-DXd) Trastuzumab deruxtecan in patients from China with pretreated HER2 mutant NSCLC: final results from the DESTINY-Lung05 study B. Wang P2.10.12 Poster Session Monday, September 8 10:30 am – 12:00 pm Trastuzumab deruxtecan + pembrolizumab as first-line treatment in HER2 overexpressing, PD-L1 TPS <50% NSCLC (DESTINY-Lung06) W.N. William P3.18.58 Poster Session Tuesday, September 9 10:00 – 11:30 am Concordance of HER2 protein overexpression by IHC and ERBB2 gene amplification by NGS in lung cancer S. Yeramaneni P1.17.22 Poster Session Sunday, September 7 10:30 am – 12:00 pm DATROWAY (datopotamab deruxtecan; Dato-DXd) Intracranial efficacy of datopotamab deruxtecan (Dato- DXd) in patients with advanced/metastatic NSCLC in TROPION-Lung01 E. Pons-Tostivint OA10.01 Oral Presentation Monday, September 8 3:30 – 4:45 pm Real world assessment of TROP2-NMR by quantitative continuous scoring (QCS) in non-small cell lung carcinoma (NSCLC) F. Lopez-Rios OA09.03 Oral Presentation Monday, September 8 3:30 – 4:45 pm Patritumab Deruxtecan (HER3-DXd) KEYMAKER-U01 substudy 01G: pembrolizumab + patritumab deruxtecan ± chemotherapy in previously untreated stage IV NSCLC V. Velcheti P3.18.28 Poster Presentation Tuesday, September 9 10:00 – 11:30 am About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo. The ADC platform furthest in clinical development is Daiichi Sankyo's DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU, a HER2 directed ADC, and DATROWAY, a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo. The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform. Ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical needs. For more information, please visit View source version on Contacts Media Contacts: Global/US Media: Jennifer BrennanDaiichi + 1 908 900 3183 (mobile) Japan: Daiichi Sankyo Co., Investor Relations Contact: DaiichiSankyoIR_jp@ 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 Wire
2 days ago
- Business
- Business Wire
Ifinatamab Deruxtecan Granted Breakthrough Therapy Designation by U.S. FDA for Patients with Pretreated Extensive-Stage Small Cell Lung Cancer
BASKING RIDGE, N.J. & RAHWAY, N.J.--(BUSINESS WIRE)--Ifinatamab deruxtecan (I-DXd) has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy. Ifinatamab deruxtecan is a specifically engineered, potential first-in-class B7-H3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed by Daiichi Sankyo and Merck (NYSE: MRK), known as MSD outside of the United States and Canada. The FDA BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. The medicine is required to have shown encouraging preliminary clinical results that demonstrate substantial improvement on a clinically significant endpoint over currently available medicines. The FDA granted the BTD based on data from the IDeate-Lung01 phase 2 trial, with support from the IDeate-PanTumor01 phase 1/2 trial. Results from the primary analysis of IDeate-Lung01 will be presented in a late-breaking oral presentation at the IASLC 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC25). This is the first BTD for ifinatamab deruxtecan and represents the first BTD since the start of the Daiichi Sankyo and Merck collaboration. 'This Breakthrough Therapy Designation granted by the FDA to ifinatamab deruxtecan highlights the urgent need for new treatment options for patients with pretreated extensive-stage small cell lung cancer,' said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. 'We are committed to advancing this medicine with the goal of bringing the first B7-H3 directed antibody drug conjugate to patients in order to transform the outcomes of those facing this aggressive disease.' 'Patients living with extensive-stage small cell lung cancer often have limited therapeutic options following disease progression after standard of care treatments,' said Eliav Barr, MD, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, Merck Research Laboratories. 'This Breakthrough Therapy Designation reinforces our confidence in the promise of ifinatamab deruxtecan to play an important role in the treatment of extensive-stage small cell lung cancer, and we are looking forward to sharing data at the upcoming IASLC 2025 World Conference on Lung Cancer that show the potential of this novel option.' About IDeate-Lung01 IDeate-Lung01 is a global, multicenter, randomized, open-label, two-part phase 2 trial evaluating the safety and efficacy of ifinatamab deruxtecan in patients with extensive-stage small cell lung cancer who were previously treated with at least one prior line of platinum-based chemotherapy and a maximum of three prior lines of therapy. Patients with asymptomatic brain metastases (untreated or previously treated) were eligible. In the first part of the trial (dose optimization), patients were randomized 1:1 to receive ifinatamab deruxtecan 8 or 12 mg/kg intravenously Q3W. In the second part of the trial (dose expansion), patients received ifinatamab deruxtecan 12 mg/kg intravenously Q3W. The primary endpoint is objective response rate (ORR) as assessed by blinded independent central review (BICR) per RECIST v1.1. Secondary endpoints included duration of response, progression-free survival, disease control rate, time to response, overall survival, pharmacokinetics and safety. Intracranial ORR was assessed by BICR as an exploratory analysis. IDeate-Lung01 enrolled 187 patients in Asia, Europe and North America. For more information about the trial, visit About IDeate-PanTumor01 IDeate-PanTumor01 is a global, multicenter, first-in-human, open-label phase 1/2 trial evaluating the safety and efficacy of ifinatamab deruxtecan in patients with advanced/unresectable or metastatic solid tumors that are refractory or intolerable to standard treatment or for whom no standard treatment exists. The phase 1 part of the trial (dose escalation) is assessing the safety and tolerability of increasing doses of ifinatamab deruxtecan to determine the maximum tolerated dose and recommended dose for expansion (RDE). The phase 2 part of the trial (dose expansion) is evaluating the safety and efficacy of ifinatamab deruxtecan at the RDE of 12 mg/kg in patients with squamous non-small cell lung cancer, metastatic castration-resistance prostate cancer or esophageal squamous cell carcinoma. The dose escalation part of the trial is evaluating dose-limiting toxicity and safety. The dose expansion part of the trial is evaluating overall response rate, duration of response, disease control rate, progression-free survival, overall survival and safety. Pharmacokinetic endpoints, exploratory biomarker and immunogenicity endpoints will also be assessed. IDeate-PanTumor01 enrolled approximately 250 patients in Asia and North America. For more information about the trial, visit About Small Cell Lung Cancer More than 2.48 million lung cancer cases were diagnosed globally in 2022. 1 Small cell lung cancer (SCLC) is the second most common type of lung cancer, accounting for approximately 15% of cases. 2 SCLC is aggressive and progresses rapidly to the distant metastatic stage, which has a low five-year survival rate 3,4 While conventional standard of care treatments for patients with advanced SCLC may help improve outcomes, there is a need for additional subsequent treatment approaches. 5,6,7,8 About B7-H3 B7-H3 is a transmembrane protein that belongs to the B7 family of proteins, which bind to the CD28 family of receptors that includes PD-1. 9,10 B7-H3 is overexpressed in a wide range of cancer types, including SCLC, and its overexpression has been shown to correlate with poor prognosis, making B7-H3 a promising therapeutic target. 11,12,13,14 There are currently no B7-H3 directed medicines approved for the treatment of any cancer. About Ifinatamab Deruxtecan Ifinatamab deruxtecan (I-DXd) is an investigational potential first-in-class B7-H3 directed ADC. Designed using Daiichi Sankyo's proprietary DXd ADC Technology, ifinatamab deruxtecan is comprised of a humanized anti-B7-H3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. Ifinatamab deruxtecan has been granted orphan drug designation by the U.S. FDA, European Commission, Japan Ministry of Health, Labour and Welfare and Taiwan Food and Drug Administration for the treatment of SCLC. About the Ifinatamab Deruxtecan Clinical Development Program A comprehensive global clinical development program is underway evaluating the efficacy and safety of ifinatamab deruxtecan monotherapy and in combination with other anticancer medicines across multiple cancers. About the Daiichi Sankyo and Merck Collaboration Daiichi Sankyo and Merck (known as MSD outside of the United States and Canada) entered into a global collaboration in October 2023 to jointly develop and commercialize patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd) and raludotatug deruxtecan (R-DXd), except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and supply. In August 2024, the global co-development and co-commercialization agreement was expanded to include gocatamig (MK-6070/DS3280), which the companies will jointly develop and commercialize worldwide, except in Japan where Merck & Co., Inc., Rahway, N.J., USA will maintain exclusive rights. Merck & Co., Inc., Rahway, N.J., USA will be solely responsible for manufacturing and supply for gocatamig. About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo. The ADC platform furthest in clinical development is Daiichi Sankyo's DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU ®, a HER2 directed ADC, and DATROWAY ®, a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, N.J., USA. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo. The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform. Ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical needs. For more information, please visit Merck's Focus on Cancer Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 25 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the 'company') includes 'forward-looking statements' within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2024, and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( ____________________________ World Health Organization. International Agency for Research on Cancer. U.S. Cancer Fact Sheet. Accessed June 2025. Schabath MB, et al. Cancer Epidemiol Biomarkers Prev. 2019 Oct;28(10):1563-1579. Rudin CM, et al. Nat Rev Dis Primers. 2021;7(1):3. National Cancer Institute. SEER Explorer. Small cell carcinoma of the Lung and Bronchus: 5-year Relative Survival. Accessed June 2025. American Cancer Society. Treatment Choices for Small Cell Lung Cancer, by Stage. Accessed June 2025. Liu SV, et al. J Clin Oncol. 2021;39(6):619-30. Paz-Ares L, et al. ESMO Open. 2022;7(2):100408. von Pawel J, et al. J Clin Oncol. 2014; 32:4012-4019. Zhao B, et al. J Hematol Oncol. 2022;15(1):153. Janakiram M, et al. Immunol Rev. 2017;276(1):26-39. Qiu M-j, et al. Front. Oncol. 2021;11:600238. Picarda E, et al. Clin Cancer Res. 2016;22(14):3425-3431. Bendell JC, et al. J Clin Oncol. 2020;39(15 suppl 1). Abstract TPS3646. Kontos F, et al. Clin Cancer Res. 2021;27(5):1227-1235.
