Latest news with #AACRAnnualMeeting
Yahoo
07-05-2025
- Business
- Yahoo
Merck (NYSE:MRK) Presents Promising KEYTRUDA Trial Data at AACR 2025 Meeting
Merck recently announced promising results from its Phase 3 KEYNOTE-689 trial of KEYTRUDA, presented at the AACR Annual Meeting, which seems likely to have bolstered investor confidence, contributing to a 6% price increase over the past week. The supplemental Biologics License Application under FDA review further highlights KEYTRUDA's significance in Merck's portfolio. This comes amid a broader market upswing, as the S&P 500 and Nasdaq climbed overall. While Merck's earnings were steady, the lawsuit from Halozyme presents a potential challenge ahead. Overall, Merck seems to align positively with broader market trends. We've identified 1 possible red flag with Merck and understanding the impact should be part of your investment process. NYSE:MRK Earnings Per Share Growth as at Apr 2025 These 13 companies survived and thrived after COVID and have the right ingredients to survive Trump's tariffs. Discover why before your portfolio feels the trade war pinch. The recent success of Merck's KEYNOTE-689 trial and its potential to enhance investor confidence could further strengthen the company's narrative around robust pipeline growth. This aligns well with Merck's strategy of driving future success in its oncology and cardiometabolic sectors through innovative launches like WINREVAIR. Despite short-term setbacks, such as the paused shipments of GARDASIL in China, Merck's long-term growth outlook remains positive, as these developments may bolster revenue and earnings forecasts significantly. Over the past five years, Merck's total shareholder return, inclusive of share price appreciation and dividends, was 31.62%. In the recent year, however, Merck underperformed, with the US Pharmaceuticals industry seeing a 1.3% increase in returns, while Merck struggled to keep pace amidst market challenges. Despite these near-term hurdles, the market response to the positive trial results has been promising, pushing Merck's current share price toward the consensus analyst price target of US$108.98, suggesting potential upside. Insights from our recent valuation report point to the potential undervaluation of Merck shares in the market. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Yahoo
06-05-2025
- Business
- Yahoo
Standard BioTools Reports First Quarter 2025 Financial Results
Services revenue, which includes both Lab Services and Field Services, was $17.6 million in the first quarter of 2025, down 16% year-over-year. Lab Services revenue was down 19% due to a tough comparable to prior-year levels that benefited from elevated backlog as well as project timing. Instruments revenue was $7.8 million in the first quarter of 2025, up 24% year-over-year. Instrument revenue was driven by strong growth in our Hyperion XTi spatial proteomics platform. Consumables revenue was $14.5 million in the first quarter of 2025, down 16% year-over-year. Consumables revenue declined due to lower volume. Revenue was $40.8 million in the first quarter of 2025, down 10% year-over-year: Dr. Egholm added, "On a product level, I am particularly excited by our strategic foothold in proteomics and the momentum building for SomaScan and SOMAmers. The advantages and performance over legacy antibody-based approaches is now well-documented, most recently at the AACR Annual Meeting and through a growing list of publications. As population-based proteomics studies continue to favor our technology, the upcoming launch of our Illumina partnered NGS-based product will only further expand access. Together we expect this momentum to accelerate as we help usher in an exciting new era of proteomic discovery. 'Standard BioTools delivered a solid first quarter in line with our expectations, reflecting focused execution in a challenging Life Sciences macro backdrop,' said Michael Egholm, PhD, President and Chief Executive Officer of Standard BioTools. "We remain grounded and disciplined, driving a 29% year-over-year improvement in adjusted EBITDA through Standard BioTools Business System (SBS). We believe our unique model, world class operational platform and healthy capital position will allow us to continue to take advantage of the current environment and deliver shareholder value over time.' Strong balance sheet with $261 million in cash & cash equivalents and no material debt as of March 31, 2025 SOUTH SAN FRANCISCO, Calif., May 06, 2025 (GLOBE NEWSWIRE) -- Standard BioTools Inc. (NASDAQ: LAB) (the 'Company' or 'Standard BioTools') today announced financial results for the first quarter ended March 31, 2025. Story Continues Gross margins in the first quarter of 2025 were 48.4%, versus 53.1% in the first quarter of 2024; and non-GAAP gross margins, which exclude depreciation, amortization, and stock-based compensation, were 53.2% in the first quarter of 2025 versus 56.2% in the first quarter of 2024. Gross margins were impacted by lower volume, price realization and product mix, partially offset by incremental improvements from SBS. Operating expenses in the first quarter of 2025 were $52.7 million, a decrease of $31.7 million, or down 38%, compared to the first quarter of 2024; and non-GAAP operating expenses, which exclude merger-related costs, stock-based compensation, and restructuring charges, were $38.6 million in the first quarter of 2025, a decrease of $10.7 million, or down 22%, compared to the first quarter of 2024. The decrease in operating expenses is a result of the realization of merger cost synergies and continued productivity gains from SBS. Net loss for the first quarter of 2025 was $26.0 million, compared to a net loss of $32.2 million in the first quarter of 2024, representing an improvement of $6.2 million or 19%, while adjusted EBITDA for the first quarter of 2025 was a loss of $16.9 million, versus an adjusted EBITDA loss of $23.7 million in the first quarter of 2024, an improvement of $6.8 million, or 29%. Full Year 2025 Revenue Outlook For fiscal year 2025, the Company continues to expect revenue in the range of $165 million to $175 million. This outlook assumes a high single-digit millions decline in our Americas academic revenue due to anticipated NIH funding pressures, no expected effect from U.S. export controls and limited impact from tariffs. Conference Call Information Standard BioTools will host a conference call and webcast on May 6th, 2025, at 4:30 p.m. ET to discuss the first quarter 2025 financial results. Live audio of the webcast will be available online along with an archived version of the webcast under the Events & Presentations page of the Company's website. Individuals interested in listening to the conference call may do so by dialing: US domestic callers: (888) 346-3970 Outside US callers: (412) 902-4297 Use of Non-GAAP Financial Information Standard BioTools has presented certain financial information in accordance with U.S. GAAP and on a non-GAAP basis. The non-GAAP financial measures included in this press release are non-GAAP gross margin, non-GAAP gross profit, non-GAAP operating expenses, and adjusted EBITDA. Management uses these non-GAAP financial measures, in addition to GAAP financial measures, as a measure of operating performance because the non-GAAP financial measures do not include the impact of items that management does not consider indicative of the Company's core operating performance. Management believes that non-GAAP financial measures, taken in conjunction with GAAP financial measures, provide useful information for both management and investors by excluding certain non-cash and other expenses that are not indicative of the Company's core operating results. Management uses non-GAAP measures to compare the Company's performance relative to forecasts and strategic plans and to benchmark the Company's performance externally against competitors. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of the Company's operating results as reported under U.S. GAAP. Standard BioTools encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP information and the reconciliations between these presentations, to more fully understand its business. Reconciliations between GAAP and non-GAAP operating results are presented in the accompanying tables of this release. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, among others, statements regarding future financial and business performance, including with respect to future revenue; operational and strategic plans; deployment of capital; market and growth opportunity and potential; and the potential to realize the expected benefits and synergies of prior and potential future acquisitions, including the potential for such transactions to drive long-term profitable growth. Forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from currently anticipated results, including, but not limited to, risks that the anticipated benefits and synergies of prior and potential future acquisitions and the integration of any such businesses, including the potential for such transactions to drive long-term profitable growth, may not be fully realized or may take longer to realize than expected; risks that the Company may not realize expected cost savings from such transactions; possible integration, restructuring and transition-related disruption resulting from such transactions, including through the loss of customers, suppliers, and employees and adverse impacts on the Company's development activities and results of operation; integration and restructuring activities, including customer and employee relations, management distraction, and reduced operating performance; risks that internal and external costs required for ongoing and planned activities may be higher than expected, which may cause the Company to use cash more quickly than it expects or change or curtail some of the Company's plans, or both; risks that the Company's expectations as to expenses, cash usage, and cash needs may prove not to be correct for other reasons such as changes in plans or actual events being different than our assumptions; changes in the Company's business or external market conditions; anticipated NIH funding pressures; the expected effect from U.S. export controls and the expected impact from tariffs; challenges inherent in developing, manufacturing, launching, marketing, and selling new products; interruptions or delays in the supply of components or materials for, or manufacturing of, the Company's products; reliance on sales of capital equipment for a significant proportion of revenues in each quarter; seasonal variations in customer operations; unanticipated increases in costs or expenses; continued or sustained budgetary, inflationary, or recessionary pressures; uncertainties in contractual relationships; reductions in research and development spending or changes in budget priorities by customers; uncertainties relating to the Company's research and development activities, and distribution plans and capabilities; potential product performance and quality issues; risks associated with international operations; intellectual property risks; and competition. For information regarding other related risks, see the 'Risk Factors' section of the Company's annual report on Form 10-K filed with the SEC on March 11, 2025, and in the Company's other filings with the SEC. These forward-looking statements speak only as of the date hereof. The Company disclaims any obligation to update these forward-looking statements except as may be required by law. About Standard BioTools Inc. Standard BioTools Inc. (Nasdaq: LAB), has an established portfolio of essential, standardized next-generation technologies that help biomedical researchers develop medicines faster and better. As a leading solutions provider, the company provides reliable and repeatable insights in health and disease using its proprietary SomaScan, mass cytometry and microfluidics technologies, which help transform scientific discoveries into better patient outcomes. Standard BioTools works with leading academic, government, pharmaceutical, biotechnology, plant and animal research and clinical laboratories worldwide, focusing on the most pressing needs in translational and clinical research, including oncology, immunology and immunotherapy. Learn more at or connect with us on X, Facebook®, LinkedIn, and YouTube™. For Research Use Only. Not for use in diagnostic procedures. Limited Use Label License and other terms may apply: Patent and License Information: Trademarks: Any other trademarks are the sole property of their respective owners. ©2025 Standard BioTools Inc. (f.k.a. Fluidigm Corporation). All rights reserved. Investor Contact: ir@ STANDARD BIOTOOLS INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except per share amounts) (Unaudited) Three Months Ended March 31, 2025 2024 Revenue: Product revenue $ 22,232 $ 23,592 Services revenue 17,607 21,027 Collaboration and other revenue 956 921 Total revenue 40,795 45,540 Cost of revenue: Cost of product revenue 10,730 12,781 Cost of services revenue 10,302 8,509 Cost of collaboration and other revenue 22 62 Total cost of revenue 21,054 21,352 Gross profit 19,741 24,188 Operating expenses: Research and development 11,328 15,980 Selling, general and administrative 38,707 46,943 Restructuring and related charges 1,552 4,284 Transaction and integration expenses 1,124 17,163 Total operating expenses 52,711 84,370 Loss from operations (32,970 ) (60,182 ) Bargain purchase gain — 25,213 Interest income 2,916 6,207 Interest expense (2 ) (1,033 ) Other income (expense), net 3,872 (2,234 ) Loss before income taxes (26,184 ) (32,029 ) Income tax benefit (expense) 151 (128 ) Net loss $ (26,033 ) $ (32,157 ) Induced conversion of redeemable preferred stock — (46,014 ) Net loss attributable to common stockholders $ (26,033 ) $ (78,171 ) Net loss per share attributable to common stockholders, basic and diluted $ (0.07 ) $ (0.27 ) Shares used in computing net loss per share attributable to common stockholders, basic and diluted 378,228 294,125 STANDARD BIOTOOLS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands) (Unaudited) March 31, December 31, 2025 2024 ASSETS Current assets: Cash and cash equivalents $ 150,880 $ 166,728 Short-term investments 107,182 126,146 Accounts receivable, net 35,480 33,608 Inventory 42,125 40,737 Prepaid expenses and other current assets 8,352 8,661 Total current assets 344,019 375,880 Inventory, non-current 18,281 18,528 Property and equipment, net 43,593 42,556 Operating lease right-of-use asset, net 27,422 28,828 Other non-current assets 6,506 6,301 Acquired intangible assets, net 28,057 28,954 Goodwill 111,719 111,297 Total assets $ 579,597 $ 612,344 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 11,778 $ 12,282 Accrued liabilities 21,972 30,739 Operating lease liabilities, current 6,334 6,228 Deferred revenue, current 12,763 13,118 Deferred grant income, current 3,389 3,527 Total current liabilities 56,236 65,894 Convertible notes, non-current 299 299 Deferred tax liability 1,031 1,081 Operating lease liabilities, non-current 24,897 26,469 Deferred revenue, non-current 32,548 32,674 Deferred grant income, non-current 6,501 7,243 Other non-current liabilities 3,490 6,962 Total liabilities 125,002 140,622 Total stockholders' equity 454,595 471,722 Total liabilities and stockholders' equity $ 579,597 $ 612,344 STANDARD BIOTOOLS INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (In thousands) (Unaudited) Three Months Ended March 31, 2025 2024 Operating activities Net loss $ (26,033 ) $ (32,157 ) Bargain purchase gain — (25,213 ) Stock-based compensation expense 9,009 11,611 Amortization of acquired intangible assets 898 2,106 Depreciation and amortization 3,273 3,088 Accretion of discount on short-term investments, net (841 ) (2,660 ) Non-cash lease expense 1,438 1,446 Provision for excess and obsolete inventory 815 655 Change in fair value of warrants (232 ) 853 Change in fair value of contingent consideration (3,400 ) — Other non-cash items 385 293 Changes in assets and liabilities, net (15,595 ) (22,498 ) Net cash used in operating activities (30,283 ) (62,476 ) Investing activities Cash and restricted cash acquired in merger — 280,033 Purchases of short-term investments (32,321 ) (73,177 ) Proceeds from sales and maturities of investments 52,000 112,000 Purchases of property and equipment (5,054 ) (781 ) Net cash provided by investing activities 14,625 318,075 Financing activities Repayment of term loan and convertible notes — (8,192 ) Payment of term loan fee — (545 ) Repurchase of common stock — (11,051 ) Payments for taxes related to net share settlement of equity awards and other (46 ) (17 ) Proceeds from exercise of stock options — 72 Net cash used in financing activities (46 ) (19,733 ) Effect of foreign exchange rate fluctuations on cash and cash equivalents 357 (21 ) Net increase in cash, cash equivalents and restricted cash (15,347 ) 235,845 Cash, cash equivalents and restricted cash at beginning of period 168,818 52,499 Cash, cash equivalents and restricted cash at end of period $ 153,471 $ 288,344 Cash, cash equivalents, and restricted cash consists of: Cash and cash equivalents $ 150,880 $ 287,057 Restricted cash 2,591 1,287 Total cash, cash equivalents and restricted cash $ 153,471 $ 288,344 STANDARD BIOTOOLS INC. REVENUE (In thousands) (Unaudited) Three Months Ended March 31, 2025 2024 Product revenue: Instruments $ 7,778 $ 6,285 Consumables 14,454 17,307 Total product revenue 22,232 23,592 Service revenue: Lab services 12,106 14,862 Field services 5,501 6,165 Total service revenue 17,607 21,027 Product and service revenue 39,839 44,619 Collaboration and other revenue 956 921 Total revenue $ 40,795 $ 45,540 STANDARD BIOTOOLS INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (In thousands) (Unaudited) ITEMIZED RECONCILIATION OF GROSS PROFIT TO NON-GAAP GROSS PROFIT AND MARGIN PERCENTAGE Three Months Ended March 31, 2025 2024 Gross profit $ 19,741 $ 24,188 Amortization of acquired intangible assets 717 1,956 Depreciation and amortization 736 1,024 Stock-based compensation expense 495 239 Loss on disposal of property and equipment 32 — Cost of sales adjustment — (1,812 ) Non-GAAP gross profit $ 21,721 $ 25,595 Gross margin percentage 48.4% 53.1% Amortization of acquired intangible assets 1.8% 4.3% Depreciation and amortization 1.7% 2.3% Stock-based compensation expense 1.2% 0.5% Loss on disposal of property and equipment 0.1% 0.0% Cost of sales adjustment 0.0% (4.0)% Non-GAAP gross margin percentage 53.2% 56.2% STANDARD BIOTOOLS INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (In thousands) (Unaudited) ITEMIZED RECONCILIATION OF GAAP TO NON-GAAP OPERATING EXPENSES Three Months Ended March 31, 2025 2024 Operating expenses $ 52,711 $ 84,370 Restructuring and related charges (1,552 ) (4,284 ) Transaction and integration expenses (1,124 ) (17,163 ) Stock-based compensation expense (8,514 ) (11,372 ) Amortization of acquired intangible assets (181 ) (150 ) Depreciation and amortization (2,537 ) (2,064 ) Loss on disposal of property and equipment (154 ) (14 ) Non-GAAP operating expenses $ 38,649 $ 49,323 R&D operating expenses $ 11,328 $ 15,980 Stock-based compensation expense (740 ) (1,328 ) Depreciation and amortization (590 ) (871 ) Loss on disposal of property and equipment (112 ) — Non-GAAP R&D operating expenses $ 9,886 $ 13,781 SG&A operating expenses $ 38,707 $ 46,943 Stock-based compensation expense (7,774 ) (10,044 ) Amortization of acquired intangible assets (181 ) (150 ) Depreciation and amortization (1,947 ) (1,193 ) Loss on disposal of property and equipment (42 ) (14 ) Non-GAAP SG&A operating expenses $ 28,763 $ 35,542 STANDARD BIOTOOLS INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (In thousands) (Unaudited) ITEMIZED RECONCILIATION OF GAAP NET LOSS TO ADJUSTED EBITDA Three Months Ended March 31, 2025 2024 Net loss $ (26,033 ) $ (32,157 ) Income tax (benefit) expense (151 ) 128 Interest income (2,916 ) (6,207 ) Interest expense 2 1,033 Amortization of acquired intangible assets 898 2,106 Depreciation and amortization 3,273 3,088 Bargain purchase gain — (25,213 ) Restructuring and related charges 1,552 4,284 Transaction and integration expenses 1,124 17,163 Stock-based compensation expense 9,009 11,611 Cost of sales adjustment — (1,812 ) Loss on disposal of property and equipment 185 14 Other non-operating (income) expense (3,871 ) 2,234 Adjusted EBITDA $ (16,928 ) $ (23,728 )
Yahoo
28-04-2025
- Business
- Yahoo
Avacta Therapeutics Presents Preclinical and Translational Data from pre
FAP-EXd (AVA6103) demonstrates tumor growth inhibition and durable complete responses in multiple therapy-resistant preclinical models LONDON and PHILADELPHIA, April 28, 2025 (GLOBE NEWSWIRE) -- Avacta Therapeutics (AIM: AVCT), a life sciences company developing next generation peptide drug conjugates (PDC) targeting powerful anti-tumor payloads directly to the tumor, today announced preclinical results from its second pre|CISION® candidate FAP-EXd (AVA6103) and new analyses around the potential of the pre|CISION® platform at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, IL. The pre|CISION® programs are designed to target fibroblast activation protein-alpha (FAPα), the protease that forms the basis of the platform. FAP is consistently overexpressed across a broad range of solid tumors and enriched at the tumor-stroma interface, making it an ideal target for tumor-localized drug activation. Avacta's proprietary pre|CISION® chemistry leverages this tumor-specific biology to activate potent drugs selectively at the tumor site, enhancing efficacy while minimizing systemic toxicity. "The encouraging results we are showcasing at this year's AACR Annual Meeting highlight the versatility of our pre|CISION® platform,' said Michelle Morrow, CSO of Avacta Therapeutics. 'Our data presented today demonstrate that the platform can deliver potent payloads like exatecan with remarkable tumor selectivity and our novel sustained release mechanism. Together, these programs reinforce the broad potential of our pipeline to transform outcomes for patients and generate long-term value for shareholders.' AVA6103 (FAP-EXd) Preclinical Candidate Highlights (Abstract 3139, 28 April 2025) Avacta presented preclinical data from its second clinical candidate, AVA6103, a novel FAP-activated pre|CISION® PDC delivering the topoisomerase I inhibitor exatecan directly to the tumor-stroma interface. This mechanism minimizes systemic toxicity while ensuring precise delivery of the cytotoxic agent directly to the tumor with a sustained release mechanism that optimizes the pharmacokinetics of the released payload. Importantly, despite a very short half-life of 9 hours with conventional exatecan, FAP-EXd (AVA6103) is capable of delivering high tumor concentration vs. plasma with exposures of more than 60 hours projected with a single dose. Additionally, FAP-EXd's bystander effect enables exatecan to induce cytotoxicity in surrounding FAP-negative cancer cells, enhancing its therapeutic impact. The compound has demonstrated significant tumor growth inhibition and durable complete responses in multiple patient-derived xenograft models, including those that are resistant to topoisomerase I inhibition. These results reinforce the potential of FAP-EXd to deliver effective, targeted treatment with minimal off-target effects. The investigational new drug (IND) submission is anticipated in December 2025 and initiation of the first-in-human study in the first quarter of 2026. Abstract Number and Title: #3139: The novel PDC AVA6103 is a FAP-enabled pre|CISION® medicine which targets exatecan, a topoisomerase I inhibitor, to the tumor microenvironment following FAP cleavage· Session Category: Experimental and Molecular Therapeutics· Session Title: Therapeutic Approach to Attack the Tumor Microenvironment· Session Date and Time: Monday, April 28, 2025, 2:00 - 5:00 p.m. CT FAP Targeting Approach with pre|CISION® medicines (Abstract 2699, 28 April 2025) FAP is overexpressed across a wide range of solid tumors, with estimated frequency of over 90% of patients with evidence of FAP expression. This expression is spatially enriched at the tumor-stroma interface, demonstrating the effective nature of the pre|CISION® mechanism to deliver highly potent payloads directly to the tumor. Given the broad expression of FAP in human solid tumors and correlation of the protein and RNA levels of FAP, an AI-based approach to this target was employed with the Avacta strategic collaboration with Tempus. Avacta's work with Tempus has demonstrated several key aspects of the pre|CISION® platform, namely (1) FAP expression remains consistent across lines of therapy and in pre- and post-tumor samples, and (2) co-expression of genes associated with sensitivity to the payload and FAP identify the optimal patient populations for pre|CISION® medicines including FAP-EXd. These data reinforce the potential of Avacta's pre|CISION® platform to deliver potent therapies across multiple solid tumor indications with broad clinical utility. Abstract Number and Title: #2699: Investigating fibroblast activation protein alpha (FAPα) as a therapeutic target for delivery of pre|CISION® cancer medicines: Expression, spatial localization and functional insights· Session Category: Tumor Biology· Session Title: Targeting the Tumor Microenvironment: A Brave New World· Session Date and Time: Monday, April 28, 2025, 2:00 - 5:00 p.m. CT For further information from Avacta, please contact: Avacta Group plcMichael Vinegrad, Group CommunicationsDirector Peel Hunt (Nomad and Broker)James Steel / Chris Golden Panmure Liberum (Joint Broker)Emma Earl / Will Goode / Mark Rogers ICR HealthcareMary-Jane Elliott / Jessica Hodgson / Stephanie Cuthbert avacta@ Investor ContactRenee Leck THRUST Strategic Communications renee@ Media ContactCarly ScadutoCarly Scaduto Consulting Carly@ About Avacta - Avacta Therapeutics is a clinical-stage life sciences company expanding the reach of highly potent cancer therapies with the pre|CISION® platform. pre|CISION® is a proprietary warhead delivery system based on a tumor-specific protease (fibroblast activation protein or FAP) that is designed to concentrate highly potent warheads in the tumor microenvironment while sparing normal tissues. Our innovative pipeline consists of pre|CISION® peptide drug conjugates (PDC) or Affimer® drug conjugates (AffDC) that leverage the tumor-specific release mechanism, providing unique benefits over traditional antibody drug conjugates. About the pre|CISION® PlatformThe pre|CISION® platform comprises an anticancer payload conjugated to a proprietary peptide that is a highly specific substrate for fibroblast activation protein (FAP) which is upregulated in most solid tumors compared with healthy tissues. The pre|CISION® platform harnesses this tumor specific protease to cleave pre|CISION® peptide drug conjugates and pre|CISION® antibody/Affimer® drug conjugates in the tumor microenvironment, thus releasing active payload in the tumor and reducing systemic exposure and toxicity, allowing dosing to be optimized to deliver the best outcomes for patients.
Yahoo
26-04-2025
- Business
- Yahoo
City of Hope Scientists Present Leading-Edge Research at American Association for Cancer Research (AACR) Annual Meeting
Highlights include work focused on AI, precision medicine, immunotherapies and more LOS ANGELES, April 25, 2025--(BUSINESS WIRE)--Researchers with City of Hope®, one of the largest and most advanced cancer research and treatment organizations in the U.S. with its National Medical Center named top 5 in the nation for cancer by U.S. News & World Report, will present more than 74 chaired, plenary, educational, minisymposium, poster and other sessions on innovative clinical trial results, breakthrough diagnostic techniques and advances in treatment options at the AACR Annual Meeting, which started April 25 and ends April 30 in Chicago. In addition to City of Hope's innovative research being presented throughout the meeting, David W. Craig, Ph.D., professor and founding chair of the Department of Integrative Translational Sciences within Beckman Research Institute of City of Hope, is chairing the final plenary session of the conference, "Opportunities in Predictive Oncology," on Wednesday from 8 to 10 a.m. CT. He will also present an educational session on using a biological analysis approach called multiomics to investigate the unique genetic makeup of different cell populations in solid tumors on Friday from 4:46 to 5:06 p.m. CT. On Saturday from 10:00 to 11:30 a.m. CT, Michael A. Caligiuri, M.D., former president of City of Hope National Medical Center and professor in the Department of Hematology & Hematopoietic Cell Transplantation, will chair a session on advances in the application of natural killer (NK) cells and present on "Innate immune lymphocytes, including NK cells." He will also chair "Academic Entrepreneurship: Getting Your Discovery to Patients, Part 1—Liftoff" on Saturday from 8:00 to 9:30 a.m. CT, which will help define the steps required for translating research from the bench to the bedside. As part of a session on advances in diagnostics and therapeutics, Hope Rugo, M.D., who recently joined City of Hope as director of its Women's Cancers Program, will talk about new findings in managing toxicities from antibody-drug conjugates on Monday from 1:25 to 1:45 p.m. CT. Dr. Rugo will also serve as a discussant at the Clinical Trials Plenary Session on Biologics and T-cell Engagers on Tuesday from 10:15 a.m. to 12:15 p.m. CT. Highlights of City of Hope research presented at the AACR conference include: Phase 3 clinical trial shows promising results for novel immunotherapy Cancer of the nasopharynx, or the upper part of the throat that plays a crucial role in breathing and swallowing, is relatively rare. However, in certain regions like China and North Africa, the disease is much more common. To combat recurrent or metastatic nasopharyngeal carcinoma, a new immunotherapy drug has been tested in combination with standard chemotherapy. Data from a phase 3 clinical trial of the medication called penpulimab resulted in the Food and Drug Administration (FDA) approving its use this past week in combination with cisplatin or carboplatin and gemcitabine for the first-line treatment of adult patients with recurrent or metastatic nasopharyngeal carcinoma. The FDA also approved penpulimab as a single agent for similar patients with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. Medical oncologist Aditya Shreenivas, M.D., M.S. will present the supporting data from "Penpulimab versus placebo in combination with chemotherapy as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma: A global, multicenter, randomized, double-blind, phase 3 trial (AK105-304)" during a clinical trials minisymposium session on Sunday from 3:50 to 4:00 p.m. CT. Penpulimab is an anti-PD-1 inhibitor, a type of treatment that helps the immune system recognize and attack cancer. Building on previous studies that have shown that the combination of PD-1 inhibitors with chemotherapy exhibits promising efficacy as a first-line treatment for Asian patients, phase 3 of the trial included 291 patients from both Asian and non-Asian countries. Patients received either a combination of penpulimab and standard chemotherapy or a placebo plus chemotherapy. The study's findings showed that patients who had penpulimab added to their treatment plan had their cancer controlled for 9.63 months on average, compared to just 7.00 months for those who did not. This represents a 55% reduction in the risk of disease progression. The researchers also found that the combination of penpulimab with chemotherapy had a manageable safety profile with tolerable side effects. "What makes penpulimab unique is that it is an anti-PD-1 antibody with a modified structure designed to potentially improve efficacy while reducing immune-related side effects," said Dr. Shreenivas, who led at the study at City of Hope, one of 46 trial sites worldwide. "This research supports use of penpulimab plus chemotherapy as a new first-line treatment option for patients with recurrent or metastatic nasopharyngeal carcinoma." He also says that since penpulimab has already been approved in China for some other cancers, like relapsed or refractory classic Hodgkin's lymphoma and metastatic squamous non-small-cell lung cancer, this study might lead to expanded approvals for penpulimab in additional countries. According to Dr. Shreenivas, future findings from the clinical trial could include explorations of how to identify which patients benefit most from this treatment, as the researchers analyzed various subgroups including those with liver metastases, different protein expression levels, and different DNA levels of Epstein-Barr virus, which is considered a strong risk factor for nasopharyngeal carcinoma. The clinical trial was sponsored by Akeso, a Chinese biopharmaceutical company that developed penpulimab. Researchers use innovative technologies to learn more about treatment responses on ovarian, prostate and breast cancer patients Ovarian cancer Not all patients with aggressive, high-grade serous ovarian cancer — the most common type of the disease — respond the same way to immunotherapy. To elucidate differences that might help tailor immunotherapy strategies for individual patients, a group of researchers from City of Hope and USC led by Jing Qian, a doctoral student in the lab of John D. Carpten, Ph.D., City of Hope's chief scientific officer, Irell & Manella Cancer Center Director's Distinguished Chair and Morgan & Helen Chu Director's Chair of the Beckman Research Institute, sought to characterize the cancer and immune cells within the tumor environments of patients with different responses to treatment. By using spatial transcriptomic technologies to map interactions between cancer and immune cells, the team was able to reveal differing immune cell behavior and composition in tumors with varied responses to immunotherapy. Spatial transcriptomic methods can provide valuable insights into gene expression within tissue and the technology is an area of rapid development in medical research. "In the future, this approach could help identify patients who are more likely to benefit from immunotherapy and uncover new targets to improve treatment for those who don't respond," said Qian. "Ultimately, it pushes the field closer to precision immuno-oncology in high-grade serous ovarian cancer." Next, the team plans to use cell models and additional patient cohorts to explore whether targeting specific immune cell types can improve responses to immunotherapy in ovarian cancer. Qian will present "Spatial transcriptomics reveals differences in the tumor and immune microenvironment of high-grade serous ovarian cancers with differing responses to immune checkpoint inhibitors" as a late breaking poster session on Sunday from 2:00 to 5:00 p.m. CT. Prostate cancer Recent studies suggest that a complex interplay between ethnicity and disease biology could influence how metastatic hormone sensitive prostate cancer (mHSPC) behaves in different patients. To investigate differences in tumor tissue from patients of Hispanic background compared to those not of Hispanic background, a team of City of Hope researchers led by Tanya Barauskas Dorff, M.D., professor in the Department of Medical Oncology & Therapeutics Research, borrowed pre-treatment prostate biopsy specimens from an existing clinical trial. Using digital spatial profiling, a technology used to study gene and protein expression in tissues, the researchers were able to interrogate the tumor microenvironment from different patients with mHSPC with greater granularity and depth. They found a difference in expression of certain proteins like Foxp3, PARP and STING, all of which are targets of certain cancer medications, between Hispanic and non-Hispanic patients. "This type of exploration in tissue samples from patients of diverse backgrounds may help uncover factors that could account for differences in treatment response," said Dr. Dorff. "As we complete the testing on additional tissue samples, we hope to compare results against treatment outcomes, to see a clearer signal emerge identifying candidate proteins for future validation." She said the team hopes to increase the variety of samples being tested and compare their findings to clinical outcomes from the trial, which should become available early 2026. Peter Zang, M.D., a hematology & oncology fellow and first author on "Digital spatial profiling with GeoMx to identify differential protein expression in Non-Hispanic/Latino and Hispanic/Latino Patients with metastatic hormone sensitive prostate cancer," will present the team's poster abstract on Tuesday from 2:00 to 5:00 p.m. CT. Breast cancer A poster presentation by Sydney Grant, a postdoctoral fellow, and Aritro Nath, Ph.D., assistant professor in the Department of Medical Oncology & Therapeutics Research, on Tuesday from 9:00 a.m. to 12:00 p.m. CT, "Integrating multimodal data with survival-based variational autoencoders to predict recurrence-free survival in breast cancer," will highlight a powerful new AI-based approach the team developed to predict recurrence-free survival in breast cancer patients. By enhancing existing generative AI models to process a broader range of real-world patient data, which extend far beyond traditional biomarkers currently used in the clinic, Grant and Nath established an approach that enables more accurate and personalized predictions about cancer patient outcomes. "This work could lead to new clinical tests used at the time of diagnosis to guide treatment decisions and bring us closer to truly personalized care," said Dr. Nath. "For example, these tools would help doctors identify which patients need more aggressive therapy and which patients could avoid overtreatment and unnecessary side effects." The team is now working to extend their models to predict which types of treatment or drug classes will work best for individual patients, with the goal of guiding therapy selection in the clinic using AI. New technology identifies unique genetic changes in early-onset colorectal cancer among Hispanic and Latino patients Colorectal cancer is the second leading cause of cancer-related deaths and cases among younger patients are rising, particularly among Hispanic and Latino populations. A new study from the lab of Enrique Velazquez Villarreal, M.D., Ph.D., M.P.H., M.S., assistant professor in the Department of Integrative Translational Sciences, has found that early-onset colorectal cancer in Hispanic and Latino patients has unique genetic changes that help explain how the cancer grows and spreads. "This is the first study to look closely at the genetics of colorectal cancer in Hispanic and Latino patients from the Los Angeles area, a group that's often left out of cancer research," said postdoctoral fellow Francisco (Paco) Carranza, who is first author on the study. "By understanding how colorectal cancer affects different populations, especially those who are often overlooked, we can help create better and more targeted treatments." To find genetic changes, the research team used DNA and RNA sequencing plus a powerful new technology called 10x Genomics Visium that let them see which genes are turned on or off in specific parts of a tumor. This helped them better understand how cancer cells interact with the immune system and how the disease behaves in this patient population. "This kind of research brings us closer to making sure all patients—no matter their background—have access to the best possible care and the same chance at successful outcomes," said Dr. Velazquez Villarreal, whose research is focused on addressing colorectal cancer health disparities in Hispanic and Latino communities. Next, Carranza and his collaborators plan to move this research even closer to patient care by using an advanced version of the 10x Genomics Visium platform that allows researchers to look at tumors one cell at a time to give even more detailed information that could lead to better tailored therapies and help design new clinical trials. Carranza will discuss the team's work during a minisymposium session called "Multi-omics analysis of MYC gene and WNT signaling pathway alterations in early-onset colorectal cancer in Hispanic/Latino patients, enhanced with spatial transcriptomics approaches" on Monday from 2:35 to 2:50 p.m. CT. AI tool developed at City of Hope makes precision medicine more accessible and inclusive Dr. Velazquez Villarreal will also present a poster on his lab's development of a new precision medicine AI tool that addresses key challenges in the integration of different data sets to promote better equity in cancer research. The new tool, called the Precision Medicine Artificial Intelligence Agent (PM-AI), is a conversational AI system that can understand plain-language questions and automatically run complex data analyses. It combines clinical information, genetic data, and social factors like income or access to care to make it easier for scientists to study cancer in a more complete and inclusive way. "By making it easier to analyze large and complex datasets, PM-AI can help researchers and doctors discover which treatments work best for different groups of people," said Dr. Velazquez Villarreal. This means patients could one day receive more personalized care based on their genetics, health history, and social conditions—leading to better outcomes for everyone, especially underserved communities." He said the research team plans to keep expanding PM-AI's capabilities by applying it to more types of cancer and integrating even more kinds of data. The goal is to support clinical decisions, help design new studies and ultimately make precision medicine more accessible for all patients. The study, "PM-AI agent: A conversational artificial intelligence system for precision medicine and advancing health equity through integrative clinical, genomic and social determinants of health data analysis," is the first accepted by AACR to use a cutting-edge technology known as an AI-driven conversational agent and will be presented during a poster session on Sunday from 2:00 to 5:00 p.m. CT. Combination treatment found to overcome therapy resistance in ER+ breast cancer In patients with estrogen receptor-positive (ER+) breast cancer — the most common type of the disease — 30-50% eventually develop resistance to primary endocrine therapy and progress to advance disease. While cell cycle inhibitor therapies help slow down metastatic ER+ breast cancer, patients often become resistant to these treatments, too. Now, a new study by City of Hope researchers has revealed that ER+ breast cancers resistant to cell cycle inhibitors undergo dynamical rewiring of both apoptosis (or cell death) pathways and proliferative pathways, which regulate cell division and growth, to survive. To overcome this resistance, the team looked for add-on therapies that target growth factor receptors. Their goal was to find a combination that provides a blockade of proliferative pathways with sustained upregulation of apoptosis pathways to maintain treatment effectiveness. Using leading-edge integration of short- and long-term biological experimentation cell models with mathematical and computational analysis, they discover a new proposed combination therapy of ribociclib (a cell cycle inhibitor) plus afatinib (a growth factor inhibitor) that can durably control breast cancer cell growth over time. "Although cell growth-targeted drugs have improved outcomes for hormone-dependent breast cancer patients, resistance remains a major clinical challenge limiting their long-term benefit," said Andrea Bild, Ph.D., professor in the Department of Medical Oncology & Therapeutics Research and senior author of the study. "Our research presents a novel strategy to enhance the durability and effectiveness of current treatments." Next, the research team aims to translate their findings for patient benefit in the clinic. To do so, Dr. Bild said they will expand their use of temporal computational and mathematical modeling to monitor molecular changes over time and identify dynamic biomarkers that can guide future treatment strategies. Kimya Karimi, a doctoral student in Dr. Bild's lab, will present the team's study "Overcoming intrinsic mechanisms of cell cycle inhibitor resistance in estrogen receptor-positive (ER+) breast cancer" during a minisymposium on Tuesday from 3:05 to 3:20 p.m. CT. About City of Hope City of Hope's mission is to make hope a reality for all touched by cancer and diabetes. Founded in 1913, City of Hope has grown into one of the largest and most advanced cancer research and treatment organizations in the United States, and one of the leading research centers for diabetes and other life-threatening illnesses. City of Hope research has been the basis for numerous breakthrough cancer medicines, as well as human synthetic insulin and monoclonal antibodies. With an independent, National Cancer Institute-designated comprehensive cancer center that is ranked Top 5 in the nation for cancer care by U.S. News & World Report at its core, City of Hope brings a uniquely integrated model that spans cancer care, research and development, academics and training, and a broad philanthropy program that powers its work. City of Hope's growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and cancer treatment centers and outpatient facilities in the Atlanta, Chicago and Phoenix areas. City of Hope's affiliated group of organizations includes Translational Genomics Research Institute and AccessHope™. For more information about City of Hope, follow us on Facebook, X, YouTube, Instagram and LinkedIn. View source version on Contacts Letisia Marquezlemarquez@ 626-476-7593 Sign in to access your portfolio
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23-04-2025
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Iovance Biotherapeutics Announces Participation in Upcoming Scientific Congresses
SAN CARLOS, Calif., April 23, 2025 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, announced that pre-clinical data for IOV-5001, a genetically engineered, inducible, and tethered interleukin-12 (IL-12) TIL cell therapy, will be presented at the 2025 AACR Annual Meeting. In addition, five-year outcomes data from the C-144-01 study of lifileucel monotherapy in patients with advanced melanoma, and a poster on study design for lifileucel in frontline advanced non-small cell lung cancer, will be presented at the 2025 ASCO Annual Meeting. 2025 AACR Annual Meeting, April 25-30, 2025, Chicago, IL Poster: IOV-5001, autologous tumor-infiltrating lymphocytes armored with inducible membrane-tethered interleukin-12, shows enhanced antitumor efficacy with an improved cellular state (Abstract 4863) Session: Immune Fitness and Metabolic Regulation of Cancer Immunity, Tuesday, April 29, 2025, 9:00 am – 12:00 pm CDT 2025 ASCO Annual Meeting, May 30-June 3, 2025, Chicago, IL Rapid Oral Presentation: Lifileucel in patients with advanced melanoma: 5-year outcomes of the C-144-01 study (Abstract 9515) Session: Melanoma/Skin Cancers, Monday, June 2, 2025, 9:45 am – 11:15 am CDT Trial-in-Progress Poster: Phase 2, multicenter study of the lifileucel regimen and pembrolizumab after frontline platinum-doublet chemotherapy and pembrolizumab in advanced non-small cell lung cancer (Abstract 133A) Session: Lung Cancer—Non-Small Cell Metastatic, Saturday, May 31, 2025, 1:30 pm – 4:30 pm CDT Iovance will host a panel discussion on the evening of Saturday, May 31, 2025 at 6 pm CDT (7 pm EDT) featuring key opinion leaders in melanoma. The live and archived webcast will be available in the Investors section of the company's website at About Iovance Biotherapeutics, Inc. Iovance Biotherapeutics, Inc. aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system's ability to recognize and destroy diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. Iovance's Amtagvi® is the first FDA-approved T cell therapy for a solid tumor indication. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. For more information, please visit Amtagvi® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners. Forward-Looking StatementsCertain matters discussed in this press release are 'forward-looking statements' of Iovance Biotherapeutics, Inc. (hereinafter referred to as the 'Company,' 'we,' 'us,' or 'our') within the meaning of the Private Securities Litigation Reform Act of 1995 (the 'PSLRA'). Without limiting the foregoing, we may, in some cases, use terms such as 'predicts,' 'believes,' 'potential,' 'continue,' 'estimates,' 'anticipates,' 'expects,' 'plans,' 'intends,' 'forecast,' 'guidance,' 'outlook,' 'may,' 'can,' 'could,' 'might,' 'will,' 'should,' or other words that convey uncertainty of future events or outcomes and are intended to identify forward-looking statements. Forward-looking statements are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments, and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, many of which are outside of our control, that may cause actual results, levels of activity, performance, achievements, and developments to be materially different from those expressed in or implied by these forward-looking statements. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in our filings with the U.S. Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and include, but are not limited to, the following substantial known and unknown risks and uncertainties inherent in our business: the risks related to our ability to successfully commercialize our products, including Amtagvi, for which we have obtained U.S. Food and Drug Administration ('FDA') approval, and Proleukin, for which we have obtained FDA and European Medicines Agency ('EMA') approval; the risk that the EMA or other ex-U.S. regulatory authorities may not approve or may delay approval for our marketing authorization application submission for lifileucel in metastatic melanoma; the acceptance by the market of our products, including Amtagvi and Proleukin, and their potential pricing and/or reimbursement by payors, if approved (in the case of our product candidates), in the U.S. and other international markets and whether such acceptance is sufficient to support continued commercialization or development of our products, including Amtagvi and Proleukin, or product candidates, respectively; future competitive or other market factors may adversely affect the commercial potential for Amtagvi or Proleukin; the risk regarding our ability or inability to manufacture our therapies using third party manufacturers or at our own facility, including our ability to increase manufacturing capacity at such third party manufacturers and our own facility, may adversely affect our commercial launch; the results of clinical trials with collaborators using different manufacturing processes may not be reflected in our sponsored trials; the risk regarding the successful integration of the recent Proleukin acquisition; the risk that the successful development or commercialization of our products, including Amtagvi and Proleukin, may not generate sufficient revenue from product sales, and we may not become profitable in the near term, or at all; the risks related to the timing of and our ability to successfully develop, submit, obtain, or maintain FDA, EMA, or other regulatory authority approval of, or other action with respect to, our product candidates; whether clinical trial results from our pivotal studies and cohorts, and meetings with the FDA, EMA, or other regulatory authorities may support registrational studies and subsequent approvals by the FDA, EMA, or other regulatory authorities, including the risk that the planned single arm Phase 2 IOV-LUN-202 trial may not support registration; preliminary and interim clinical results, which may include efficacy and safety results, from ongoing clinical trials or cohorts may not be reflected in the final analyses of our ongoing clinical trials or subgroups within these trials or in other prior trials or cohorts; the risk that enrollment may need to be adjusted for our trials and cohorts within those trials based on FDA and other regulatory agency input; the risk that the changing landscape of care for cervical cancer patients may impact our clinical trials in this indication; the risk that we may be required to conduct additional clinical trials or modify ongoing or future clinical trials based on feedback from the FDA, EMA, or other regulatory authorities; the risk that our interpretation of the results of our clinical trials or communications with the FDA, EMA, or other regulatory authorities may differ from the interpretation of such results or communications by such regulatory authorities (including from our prior meetings with the FDA regarding our non-small cell lung cancer clinical trials); the risk that clinical data from ongoing clinical trials of Amtagvi will not continue or be repeated in ongoing or planned clinical trials or may not support regulatory approval or renewal of authorization; the risk that unanticipated expenses may decrease our estimated cash balances and forecasts and increase our estimated capital requirements; the risk that we may not be able to recognize revenue for our products; the risk that Proleukin revenues may not continue to serve as a leading indicator for Amtagvi revenues; the risks regarding our anticipated operating and financial performance, including our financial guidance and projections; the effects of global pandemic; the effects of global and domestic geopolitical factors; and other factors, including general economic conditions and regulatory developments, not within our control. Any financial guidance provided in this press release assumes the following: no material change in our ability to manufacture our products; no material change in payor coverage; no material change in revenue recognition policies; no new business development transactions not completed as of the period covered by this press release; and no material fluctuation in exchange rates. CONTACTS InvestorsIR@ ext. 150 MediaPR@ 650-260-7120 ext. 150Sign in to access your portfolio
