Latest news with #AntibodyDrugConjugates
Medscape
a day ago
- Health
- Medscape
Rapid Review: Bladder Cancer
Bladder cancer remains one of the most frequently diagnosed cancers of the genitourinary system, and it presents a unique set of challenges. It is marked by high rates of recurrence, varied clinical presentations, and a need for ongoing surveillance long after initial treatment. Patients often face invasive diagnostic procedures and complex treatment pathways, particularly in the case of non-muscle-invasive vs muscle-invasive disease. Intravesical gene-based therapies represent a newly approved class of treatment for patients with high-risk non-muscle-invasive bladder cancer who are unresponsive to BCG. These therapies work by introducing genetic material directly into bladder cells to stimulate local immune responses or alter tumor biology. Administered via catheter into the bladder, they aim to generate therapeutic effects with minimal systemic exposure, offering an organ-sparing option for patients who might otherwise face radical cystectomy. Instead of delivering preformed proteins or cytotoxic agents, intravesical gene-based treatments enable the bladder to produce therapeutic proteins locally. Although the immune checkpoint inhibitor pembrolizumab can be used for BCG-unresponsive bladder cancer, tumor necrosis factors are not specifically recommended by the National Comprehensive Cancer Network (NCCN), nor are radiation-based immunotherapies. Antibody drug conjugates are recommended for other aspects of disease. Learn more about the treatment of non-muscle-invasive disease. Although combination PET/CT with fluorodeoxyglucose is used for primary staging of muscle-invasive bladder cancer, detecting recurrence after radical cystectomy, and detecting lymph node metastasis, it has 'no clinical role' in diagnosing upper-tract urothelial cancer. This is due to the physiologic uptake of FDG in the bladder, and NCCN guidelines specifically recommend against its use for visualizing the anatomy of the upper urinary tract. However, the NCCN does recommend FDG PET/CT for certain other circumstances, such as suggesting it for staging in patients with T2 and ≥ cT3 disease, and for those with suspected metastasis with or without cystectomy. Research is ongoing on using non-FDG agents for PET that have less urinary uptake. Learn more about imaging for bladder cancer. ctDNA assay is a novel noninvasive surveillance tool that has been shown to be able to predict recurrence before traditional radiologic monitoring. Specifically, studies consistently show that ctDNA can detect recurrence at least 2.7 months earlier than traditional clinical methods such as cystoscopy and cytology, and up to up to 6 months before radiologic progression. This gives clinicians a bigger window for offering neoadjuvant therapy, which could improve survival outcomes. Further, ctDNA is shown to be more sensitive than traditional methods and is less invasive than cystoscopy. Although the NCCN notes that ctDNA has demonstrated ultrasensitive capabilities for tracking treatment response and progression, it does not have sufficient data to recommend basing treatment practices on ctDNA assays. Learn more about monitoring for bladder cancer. The NCCN suggests TURBT alone as an option for patients with stage II disease who are ineligible for cystectomy. Even without adjuvant therapy, TURBT alone may be curative in cases with small solitary lesions and minimal muscle invasion. However, it should not be used in cases with an associated in situ component, palpable masses, or associated hydronephrosis. Furthermore, if TURBT alone is used as primary treatment, a second re-resection should be performed 4 weeks after the primary procedure, and then it can be managed conservatively if there is no evidence of residual tumor and the patient is not a candidate for definitive management or prefers bladder preservation. Learn more about TURBT for bladder cancer. FGFR-targeted kinase inhibitors are a precision therapy used in a subset of patients with advanced urothelial carcinoma whose tumors harbor FGFR genetic alterations. These drugs improve clinical outcomes by directly inhibiting the abnormal FGFR signaling pathways that drive tumor growth in these patients. In a phase 2 trial, erdafitinib showed a 40% objective response rate and extended progression-free and overall survival in this biomarker-defined subgroup. By selectively targeting this oncogenic driver, FGFR inhibitors can induce tumor regression and prolong progression-free survival. In regard to the other answer choices, FGFR inhibitors do not stimulate broad immune responses. Also, these therapies require molecular profiling to identify patients with FGFR alterations and act through selective, not cytotoxic or nonspecific, mechanisms. Learn more about medications for bladder cancer.
Yahoo
11-07-2025
- Business
- Yahoo
Cancer Antibody Drug Conjugates Treatment Market Size Clinical Trials FDA Approved Report
Cancer Antibody Drug Conjugates Treatment Market USD 50 Billion Opportunity Says Kuick Research Delhi, July 11, 2025 (GLOBE NEWSWIRE) -- Global Cancer Antibody Drug Conjugates Market Size, Drugs Approval, Price, Sales and Clinical Trials Insight 2030 Report Finding & Inclusions: Global Cancer Antibody Drug Conjugates Market: 2020 – 2030 Global Cancer Antibody Drug Conjugates Market Opportunity > US$ 50 Billion By 2030 Approved Cancer Antibody Drug Conjugates: 16 Drugs Approved Cancer Antibody Drug Conjugates Sales Insights, Patent, Dosage and Price Analysis Cancer Antibody Drug Conjugates In Clinical Trials: > 500 Drugs Cancer Antibody Drug Conjugates Clinical Trials Insight By Company, Country, Indication and Phase Insight On Commercially Approved Antibody Drug Conjugates By Brand Name, Company and Indication Download Report: The global cancer antibody-drug conjugate (ADC) market represents one of the most dynamic and rapidly advancing areas in oncologic therapy. ADCs combine the precision targeting of monoclonal antibodies with potent cytotoxic agents, delivering effective treatment directly to cancer cells while sparing healthy tissue. As of July 2025, nineteen ADCs have been approved worldwide, underscoring both clinical acceptance and regulatory momentum. Key approved ADCs include Enhertu (trastuzumab deruxtecan), which generated over US$ 3.75 billion in 2024 sales, led by its strong performance in HER2-positive cancers. Kadcyla (trastuzumab emtansine) also continues to deliver blockbuster revenue, with approximately US$ 2.3 billion in sales in 2024. Other top-performing ADCs include Adcetris (US$ 1.91 billion), Padcev (US$ 1.59 billion), Trodelvy (US$ 1.32 billion), and Polivy (US$ 1.30 billion). The commercial success of these therapies reflects their differentiated clinical value and growing adoption across multiple oncology indications. The market outlook remains strong, with forecasts projecting the ADC segment to surpass US$ 50 billion by 2030, driven by indication expansion, global market penetration, and sustained innovation. The clinical pipeline features over 500 ADC candidates utilizing diverse payloads, bispecific constructs, and next-generation linker technologies. Trials are being conducted globally, with leadership from US and European pharmaceutical companies and rising activity across the Asia-Pacific region—particularly in China, where domestic ADCs such as Aidixi (disitamab vedotin) have gained approval. Approved ADCs have demonstrated significant impact across different tumor targets. Enhertu and Kadcyla underscore the potential of HER2-directed therapy, while agents like Trodelvy (Trop-2), Polivy (CD79b), and Padcev (Nectin-4) exemplify ADC effectiveness in other solid and hematologic malignancies. Patent protection varies across the field, with many agents maintaining extended market exclusivity through novel payload-linker innovations and optimized delivery mechanisms. The ADC clinical pipeline reveals deep innovation. Over 500 molecules are in development, with trials mapped by company, geography, indication, and phase. This breadth enables stakeholders to track development trends across solid and hematologic cancers, with indications expanding into lung, urothelial, ovarian, and beyond. Company-level insights spotlight R&D activity, with several early-stage ADCs progressing into pivotal trials. Commercially approved ADC brands are profiled thoroughly in our report. Enhertu, Kadcyla, Adcetris, Padcev, Polivy, Trodelvy, and newer agents such as Datroway (datopotamab deruxtecan) and Zynlonta (loncastuximab tesirine) are explored in-depth, analyzing mechanisms, development history, regulatory milestones, and indication-specific adoption. This provides a tactical overview of competitive positioning and licensing trends—especially in Asia-Pacific, where local players are launching biosimilar or region-specific ADCs. Our Global Cancer ADC Market Report delivers a comprehensive, data-driven foundation for stakeholders. It includes sales performance and patent analysis for 19 approved ADCs, pricing strategy insights and dosage regimens, pipeline tracking of 500+ clinical ADCs by indication and trial phase, and brand-by-brand commercial intelligence. This resource empowers pharmaceutical executives, biotech investors, and clinical researchers with the insights needed to navigate a sector poised for exponential growth. As ADC therapy evolves, our report is the strategic compass for development prioritization, portfolio building, and market entry planning—at the frontline of oncology Neeraj Chawla Research Head Kuick Research neeraj@ +91-11-47067990 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
15-05-2025
- Business
- Yahoo
Akari Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Update
Advancing development of novel Antibody Drug Conjugates (ADCs) with immuno-oncology payloads to treat multiple cancer tumors Rounding out executive team with deep oncology experience by appointing new Head of Business Development - Oncology BOSTON and LONDON, May 15, 2025 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a biotechnology company developing novel Antibody Drug Conjugates (ADCs) with immuno-oncology payloads for the treatment of cancer, today reported its financial results for the first quarter ended March 31, 2025 and provided a corporate update. "We remain laser focused on becoming a key player in the ADC space and advancing our novel ADC platform built around immuno-oncology payloads and our lead asset AKTX-101, an ADC targeting Trop2 with our immuno-oncology payload, PH1. We continue to develop and execute a clear path forward for our ADC pipeline and support these efforts with ongoing activities and building the team that we believe positions us for success in the near and long term,' commented Abizer Gaslightwala, President and Chief Executive Officer of Akari. 'In particular, we were pleased to recently welcome Mark Kubik, a seasoned leader in the Antibody Drug Conjugate space, as Head of Business Development, Oncology and believe his expertise will be invaluable as we continue to advance our novel ADC platform technology.' Leveraging its innovative payload platform, the Company is advancing a pipeline of potentially first-in-class, best-in-class ADC candidates across a wide range of cancer tumor targets. These initial candidates have shown significant tumor-killing activity in preclinical models with the ability to robustly activate the immune system to drive durable, and sustained outcomes. Upcoming Expected Value-Driving Milestones Novel ADC's With Immuno-Oncology Payloads Anticipate presenting preclinical data showing that a proof-of-concept ADC with PH1 payload exhibits robust immuno-oncology activity, at a scientific conference in second half of 2025. Complete additional preclinical studies for novel PH1 payload exploring activity in prostate cancer cell lines. Explore preclinical activity for AKTX-101 in different solid tumor indications including lung, as single agent and in combination with other approved agents. Continue to focus on operational excellence and efficient capital allocation to advance novel payload ADC platform. Ongoing efforts to seek strategic partners for research collaborations on PH1 immuno-oncology payload across customized tumor targets. Continued discussions with partners on advancing AKTX-101 ADC (Trop2/PH1 payload) through additional IND-enabling activities. Non-Core Asset Out Licensing Continue efforts to out-license non-core assets across inflammation, ophthalmology, and rare diseases as a source of non-dilutive capital to invest into ADC platform. Summary of Financial Results for First Quarter 2025 The net loss from operations for the three months ended March 31, 2025 was approximately $3.7 million compared to $5.6 million for the same period in 2024. The Company reported research and development expenses of $0.8 million for the three months ended March 31, 2025 compared to approximately $2.3 million for the same period in 2024. The decrease was primarily due to our decision to suspend our HSCT-TMA clinical stage program with nomacopan in May 2024. General and administrative expenses were approximately $2.7 million for the three months ended March 31, 2025 compared to approximately $3.7 million for the same period in 2024. The decrease was primarily due to (i) decreases in legal and professional fees (primarily related to the Merger) and (ii) a decrease in directors' and officers' insurance. As of March 31, 2025, the Company had cash of approximately $2.6 million. The net proceeds from the Company's March 2025 offering, after deducting placement agent fees and other offering expenses, were approximately $6.0 million, of which $4.0 million was received in April 2025. About Akari Therapeutics Akari Therapeutics is an oncology biotechnology company developing novel Antibody Drug Conjugates (ADCs) with immuno-oncology payloads, the first being PH1. Utilizing its innovative ADC discovery platform, the Company has the ability to generate ADC candidates to any cancer tumor target of interest. Akari's lead candidate, AKTX-101, targets the Trop2 receptor on cancer cells to deliver its novel PH1 immuno-oncology payload directly into the tumor cells. Unlike current ADCs that use tubulin inhibitors and DNA damaging agents as their payloads, PH1 is a novel payload that is a spliceosome inhibitor designed to disrupt RNA splicing within cancer tumor cells. This splicing inhibition has been shown in preclinical animal models to induce cancer cell death while activating immune cells to drive robust and durable activity. In preclinical studies, AKTX-101 has shown to have significant activity and prolonged survival, relative to ADCs with traditional payloads. Additionally, AKTX-101 has the potential to be synergistic with checkpoint inhibitors and has demonstrated prolonged survival as both a single agent and in combination with checkpoint inhibitors, as compared to appropriate controls. The Company is generating validating data on its immuno-oncology payload PH1 to continue advancing its lead asset, AKTX-101, as well as developing ADCs against other undisclosed targets with its lead immuno-oncology payload, PH1. For more information about the Company, please visit and connect on X and LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release includes express or implied forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, about the Company that involve risks and uncertainties relating to future events and the future performance of the Company. Actual events or results may differ materially from these forward-looking statements. Words such as 'will,' 'could,' 'would,' 'should,' 'expect,' 'plan,' 'anticipate,' 'intend,' 'believe,' 'estimate,' 'predict,' 'project,' 'potential,' 'continue,' 'future,' 'opportunity' 'will likely result,' 'target,' variations of such words, and similar expressions or negatives of these words are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. Examples of such forward-looking statements include, but are not limited to, express or implied statements regarding the ability of the Company to advance its product candidates for the treatment of cancer and any other diseases, and ultimately bring therapies to patients; the Company's targets, plans, objectives or goals for future operations, including those related to its product candidates. These statements are based on the Company's current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. A number of important factors, including those described in this communication, could cause actual results to differ materially from those contemplated in any forward-looking statements. Factors that may affect future results and may cause these forward-looking statements to be inaccurate include, without limitation: the potential impact of unforeseen liabilities, future capital expenditures, revenues, costs, expenses, earnings, synergies, economic performance, indebtedness, financial condition and losses on the future prospects, business and management strategies for the management, expansion and growth of the business; risks related to global as well as local political and economic conditions, including interest rate and currency exchange rate fluctuations; potential delays or failures related to research and/or development of the Company's programs or product candidates; risks related to any loss of the Company's patents or other intellectual property rights; any interruptions of the supply chain for raw materials or manufacturing for the Company's product candidates, including as a result of potential tariffs; the nature, timing, cost and possible success and therapeutic applications of product candidates being developed by the Company and/or its collaborators or licensees; the extent to which the results from the research and development programs conducted by the Company, and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; uncertainty of the utilization, market acceptance, and commercial success of the Company's product candidates; risks related to competition for the Company's product candidates; and the Company's ability to successfully develop or commercialize its product candidates. While the foregoing list of factors presented here is considered representative, no list should be considered to be a complete statement of all potential risks and uncertainties. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the SEC, copies of which may be obtained from the SEC's website at The Company assumes no, and hereby disclaims any, obligation to update the forward-looking statements contained in this press release except as required by law. Investor Relations Contact JTC Team, LLC Jenene Thomas 908-824-0775 AKTX@ THERAPEUTICS, PLCCondensed Consolidated Balance Sheets(Amounts in thousands, except share and per share data)(unaudited) March 31, December 31, 2025 2024 ASSETS Current assets: Cash $ 2,582 $ 2,599 Restricted cash 60 60 Prepaid expenses 627 92 Other current assets 80 201 Total current assets 3,349 2,952 Goodwill 8,430 8,430 Other intangible assets 39,180 39,180 Total assets $ 50,959 $ 50,562 LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities: Accounts payable $ 13,067 $ 12,407 Accrued expenses 3,494 3,137 Convertible notes 700 700 Convertible notes, related party 250 250 Notes payable 228 659 Notes payable, related party 668 1,651 Warrant liabilities 1,066 1,012 Liability related to deposits received for share subscriptions 950 — Other current liabilities 484 94 Total current liabilities 20,907 19,910 Other non-current liabilities 266 383 Deferred tax liability 8,040 8,040 Total liabilities 29,213 28,333 Commitments and contingencies (Note 13) Shareholders' equity: Share capital of $0.0001 par value Authorized: 245,035,791,523 ordinary shares at March 31, 2025 and December 31, 2024, respectively; issued and outstanding: 57,752,981,523 and 53,186,919,523 ordinary shares at March 31, 2025 and December 31, 2024, respectively 5,776 5,319 Additional paid-in capital 215,506 212,706 Capital redemption reserve 52,194 52,194 Accumulated other comprehensive loss (773 ) (738 ) Accumulated deficit (250,957 ) (247,252 ) Total shareholders' equity 21,746 22,229 Total liabilities and shareholders' equity $ 50,959 $ 50,562 AKARI THERAPEUTICS, PLCCondensed Consolidated Statements of Operations and Comprehensive Loss(amounts in thousands, except share and per share data)(unaudited) Three Months Ended March 31, 2025 2024 Operating expenses: Research and development $ 813 $ 2,279 General and administrative 2,712 3,710 Total operating expenses 3,525 5,989 Loss from operations (3,525 ) (5,989 ) Other income (expense): Interest income — 2 Interest expense (55 ) — Gain on debt extinguishment 54 — Change in fair value of warrant liabilities (54 ) 649 Foreign currency exchange loss, net (125 ) (226 ) Other expense, net — (2 ) Total other (expense) income, net (180 ) 423 Net loss $ (3,705 ) $ (5,566 ) Net loss per share –– basic and diluted $ (0.00 ) $ (0.00 ) Weighted-average number of ordinary shares used in computing net loss per share –– basic and diluted 54,588,283,841 13,453,147,979 Comprehensive loss: Net loss $ (3,705 ) $ (5,566 ) Other comprehensive (loss) income, net of tax: Foreign currency translation adjustment (35 ) 279 Total other comprehensive (loss) income, net of tax (35 ) 279 Total comprehensive loss $ (3,740 ) $ (5,287 )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
Yahoo
03-04-2025
- Business
- Yahoo
Innate Pharma to Participate in the 2025 Stifel Virtual Targeted Oncology Forum
MARSEILLE, France, April 03, 2025--(BUSINESS WIRE)--Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") today announced that members of its executive team will present and host 1x1 meetings at the Stifel 2025 Virtual Targeted Oncology Forum being held on April 8 – 9, 2025. The executive team will participate in a fireside chat scheduled on Wednesday, April 9, 2025, from 12:30 - 12:55 p.m. ET. A live webcast and a replay of the presentation will be available on the Events page in the Investors section of Innate Pharma website. About Innate Pharma Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Its innovative approach aims to harness the innate immune system through three therapeutic approaches: multi-specific NK Cell Engagers via its ANKET® (Antibody-based NK cell Engager Therapeutics) proprietary platform and Antibody Drug Conjugates (ADC) and monoclonal antibodies (mAbs). Innate's portfolio includes several ANKET® drug candidates to address multiple tumor types as well as IPH4502, a differentiated ADC in development in solid tumors. In addition, anti-KIR3DL2 mAb lacutamab is developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, and anti-NKG2A mAb monalizumab is developed with AstraZeneca in non-small cell lung cancer. Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as leading research institutions, to accelerate innovation, research and development for the benefit of patients. Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US. Learn more about Innate Pharma at and follow us on LinkedIn and X. Information about Innate Pharma shares ISIN code Ticker code LEI FR0010331421 Euronext: IPH Nasdaq: IPHA 9695002Y8420ZB8HJE29 Disclaimer on forward-looking information and risk factors This press release contains certain forward-looking statements, including those within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. The use of certain words, including "anticipate," "believe," "can," "could," "estimate," "expect," "may," "might," "potential," "expect" "should," "will," or the negative of these and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company's reliance on third parties to manufacture its product candidates, the Company's commercialization efforts and the Company's continued ability to raise capital to fund its development. For an additional discussion of risks and uncertainties, which could cause the Company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors ("Facteurs de Risque") section of the Universal Registration Document filed with the French Financial Markets Authority ("AMF"), which is available on the AMF website or on Innate Pharma's website, and public filings and reports filed with the U.S. Securities and Exchange Commission ("SEC"), including the Company's Annual Report on Form 20-F for the year ended December 31, 2024, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public by the Company. References to the Company's website and the AMF website are included for information only and the content contained therein, or that can be accessed through them, are not incorporated by reference into, and do not constitute a part of, this press release. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by the Company or any other person that the Company will achieve its objectives and plans in any specified time frame or at all. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country. View source version on Contacts For additional information, please contact: Investors Innate Pharma Henry WheelerTel.: +33 (0)4 84 90 32 Media Relations NewCap Arthur RouilléTel.: +33 (0)1 44 71 00 15innate@ Sign in to access your portfolio
