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Nurix Therapeutics Reports Second Quarter 2025 Financial Results and Provides a Corporate Update
Nurix Therapeutics Reports Second Quarter 2025 Financial Results and Provides a Corporate Update

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time10-07-2025

  • Business
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Nurix Therapeutics Reports Second Quarter 2025 Financial Results and Provides a Corporate Update

Presented updated data for bexobrutideg (NX-5948) at EHA2025 and ICML-18, demonstrating a favorable safety profile and deepening responses in patients with r/r chronic lymphocytic leukemia (CLL) and Waldenström macroglobulinemia (WM) Secured $15M license fee as Sanofi extends STAT6 collaboration to target type 2 inflammatory diseases Announced FDA clearance of IND application for novel IRAK4 degrader GS-6791/NX-0479, enabling collaboration partner Gilead to initiate Phase 1 trial Well capitalized with cash and marketable securities of $485.8 million SAN FRANCISCO, July 09, 2025 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, today reported financial results for the fiscal quarter ended May 31, 2025, and highlighted significant progress across its clinical programs and strategic collaborations. "During our second quarter, Nurix delivered important collaboration milestones, resulting in Sanofi's extension of its license for our STAT6 program and FDA clearance of the IND for IRAK4 degrader GS-6791/NX-0479 in collaboration with Gilead," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "We are now entering a transformative period as we advance bexobrutideg into pivotal studies in CLL and progress our efforts to bring degrader-based therapies to patients with autoimmune diseases and inflammation." Recent Business Highlights Data presented at the 30th European Hematology Association Congress (EHA2025) and the 18th International Conference on Malignant Lymphoma (ICML-18):At EHA2025 and ICML-18 in June 2025, Nurix presented updated Phase 1 clinical data for bexobrutideg (NX-5948), its investigational oral, brain-penetrant degrader of Bruton's tyrosine kinase (BTK). The data demonstrated a robust objective response rate (ORR) of 80.9% across all doses in patients with relapsed or refractory CLL, including a complete response (CR) in a high-risk patient. The responses were durable, deepened over time, and were accompanied by a favorable safety profile, with no atrial fibrillation, systemic fungal infections, or dose-limiting toxicities observed. These results support the advancement of bexobrutideg to pivotal studies in CLL and underscore its potential to address significant unmet needs in B-cell malignancies. Sanofi extended its license for Nurix's STAT6 program, including STAT6 development candidate NX-3911: In June 2025, Nurix announced that Sanofi exercised its option to extend its license for Nurix's STAT6 program, including the STAT6 degrader development candidate NX-3911, triggering a $15 million payment and bringing the total received by Nurix under this collaboration to $127 million. Nurix remains eligible for an additional $465 million in development, regulatory, and commercial milestones, plus future royalties and retains the option to co-develop and co-promote the program in the United States. NX-3911 is an oral, highly selective STAT6 degrader. STAT6 is a key transcription factor within the IL-4/IL-13 signaling pathways that drive inflammation in allergic and type 2 inflammatory conditions. Targeting STAT6 for degradation represents a promising therapeutic approach, supported by extensive insights from genetic studies and clinical validation of upstream biologics (IL-4/IL-13 inhibitors) and Janus kinase (JAK) inhibitors. Unlike JAK inhibition, which can impact multiple cytokine pathways and is associated with safety concerns, STAT6 degradation offers a more precise mechanism to modulate inflammation. FDA clearance of IND application for GS-6791/NX-0479: In April 2025, Nurix announced that the U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug (IND) application for GS-6791 (previously NX-0479), a novel, first-in-class oral degrader of IRAK4 being developed in collaboration with Gilead Sciences. GS-6791 is designed to selectively degrade IRAK4, a key signaling protein that drives inflammation in autoimmune and inflammatory diseases. The clearance of this IND represents an important milestone in Nurix's partnership with Gilead and paved the way for the initiation of first-in-human clinical trials. Data presented at the American Academy of Cancer Research (AACR) Annual Meeting: In April 2025, Nurix presented positive preclinical data at the AACR Annual Meeting highlighting its portfolio of orally available, brain-penetrant degraders targeting BTK, pan-mutant BRAF, and Aurora A kinase, key drivers of oncogenic signaling and tumor growth in cancers with central nervous system (CNS) involvement. Bexobrutideg, Nurix's lead BTK degrader, demonstrated exceptional catalytic efficiency, with a single molecule degrading approximately 10,000 BTK copies per hour, supporting its potential to deliver deep, durable responses at low doses. Nurix's BRAF degrader showed broad preclinical activity across all three classes of BRAF mutations, including those resistant to approved therapies, while Nurix's Aurora A degrader demonstrated significant anti-tumor activity in models of pediatric and adult the AACR Annual Meeting, Nurix also presented data highlighting the transformative potential of its DEL-AI platform, which leverages a first-in-class DEL Foundation Model trained on proprietary DNA-encoded library (DEL) data to enable rapid in silico identification of novel binders for a broad range of therapeutically relevant proteins, including targets previously considered undruggable. This innovative machine learning platform has the potential to significantly accelerate the discovery of degrader-based medicines and other small molecule therapeutics for Nurix's internal pipeline and discovery collaborations. European Medicines Agency (EMA) granted Orphan Drug Designation (ODD) to bexobrutideg for the treatment of lymphoplasmacytic lymphoma: In July 2025, Nurix announced that the EMA granted ODD to bexobrutideg for the treatment of lymphoplasmacytic lymphoma, of which Waldenström macroglobulinemia is the most common subtype. The EMA's Orphan Drug Designation program grants orphan status to therapies intended for the treatment, diagnosis, or prevention of rare diseases that affect fewer than 5 in 10,000 people in the European Union. This designation provides several incentives to encourage the development of treatments for rare conditions, including 10 years of market exclusivity in the EU upon approval, access to protocol assistance, eligibility for centralized marketing authorization, and significant reductions in regulatory fees. Upcoming Program Highlights* Bexobrutideg (NX-5948): Building on the recent positive data in CLL and WM, Nurix anticipates providing additional clinical updates for bexobrutideg and remains on track to initiate pivotal trials for bexobrutideg in CLL in the second half of 2025. To support future development of bexobrutideg in autoimmune and inflammatory diseases, Nurix has expanded a new Phase 1b cohort for patients with CLL and autoimmune hemolytic anemia and is exploring the filing of a non-malignant hematology IND for autoimmune cytopenias in 2025. More information on the ongoing Phase 1a/1b trial of bexobrutideg is available at (NCT05131022). Zelebrudomide (NX-2127): Zelebrudomide is an orally bioavailable degrader of BTK and the cereblon neosubstrates IKZF1 (Ikaros) and IKZF3 (Aiolos) designed for the treatment of relapsed or refractory B-cell malignancies. Nurix is conducting a Phase 1a/1b clinical trial, including a Phase 1b expansion cohort focused on patients with diffuse large B-cell lymphoma and mantle cell lymphoma. Nurix is enrolling a dose escalation study within the current Phase 1a/1b trial using its new chirally controlled drug product. Future clinical updates are anticipated in the second half of 2025. Additional information on the zelebrudomide clinical trial can be accessed at (NCT04830137). NX-1607: NX-1607 is an investigational oral inhibitor of the E3 ligase Casitas B-lineage lymphoma proto-oncogene B (CBL-B) being developed for immuno-oncology indications, including a range of solid tumor types and lymphomas. Nurix is evaluating NX-1607 in an ongoing Phase 1 trial in adults in a range of oncology indications. This study includes a thorough investigation of both dose and schedule in the Phase 1a portion. Future clinical updates are anticipated in the second half of 2025. Additional information on the NX-1607 clinical trial can be accessed at (NCT05107674). Continued pipeline advancement of strategic collaborations with Gilead, Sanofi and Pfizer: Nurix expects to continue to achieve substantial research collaboration milestones throughout the terms of its collaborations with Gilead, Sanofi, and Pfizer. *Expected timing of events throughout this press release is based on calendar year quarters. Fiscal Second Quarter 2025 Financial Results for the three months ended May 31, 2025, was $44.1 million, compared with $12.1 million for the three months ended May 31, 2024. The increase was primarily due to $30 million of license revenue from the achievement of two Sanofi license extensions and a $5 million clinical milestone achieved under Nurix's collaboration with Gilead during the three months ended May 31, 2025. for the three months ended May 31, 2025, were $78.1 million compared with $48.9 million for the three months ended May 31, 2024. The increase was primarily related to clinical, contract manufacturing and consulting costs as Nurix continued to accelerate the enrollment of patients in the ongoing trial of bexobrutideg and prepare for the initiation of pivotal trials. for the three months ended May 31, 2025, were $14.3 million, compared with $11.7 million for the three months ended May 31, 2024. The increase was primarily due to an increase in compensation and related personnel costs and consulting costs. for the three months ended May 31, 2025, was $43.5 million, or ($0.52) per share, compared with $44.5 million, or ($0.71) per share, for the three months ended May 31, 2024. was $485.8 million as of May 31, 2025, compared to $609.6 million as of November 30, 2024. Cash, cash equivalents and marketable securities as of May 31, 2025, does not include a $4.0 million milestone earned in the first fiscal quarter of 2025 and received post fiscal quarter end, and a $15.0 million license extension payment received post fiscal quarter end. About Nurix Therapeutics, Inc. Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Nurix's wholly owned, clinical stage pipeline includes degraders of Bruton's tyrosine kinase (BTK), a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene B (CBL-B), an E3 ligase that regulates activation of multiple immune cell types including T cells and NK cells. Nurix also is advancing multiple potentially first-in-class or best-in-class degraders and degrader antibody conjugates (DACs) in its preclinical pipeline. Nurix's partnered drug discovery pipeline consists of preclinical stage degraders of IRAK4 and STAT6, as well as multiple additional programs under collaboration agreements with Gilead Sciences, Inc., Sanofi S.A. and Pfizer Inc., within which Nurix retains certain options for co-development, co-commercialization and profit sharing in the United States for multiple drug candidates. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix's dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine's next chapter with a new script to outmatch disease. Nurix is headquartered in San Francisco, California. For additional information visit Forward-Looking Statements This press release contains statements that relate to future events and expectations and as such constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. When or if used in this press release, the words 'anticipate,' 'believe,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'outlook,' 'plan,' 'predict,' 'should,' 'will,' and similar expressions and their variants, as they relate to Nurix, may identify forward-looking statements. All statements that reflect Nurix's expectations, assumptions or projections about the future, other than statements of historical fact, are forward-looking statements, including, without limitation, statements regarding: Nurix's future financial or business performance; Nurix's future plans, prospects and strategies; Nurix's plans and expectations with respect to its current and prospective drug candidates; the tolerability, safety profile, therapeutic potential and other advantages of Nurix's drug candidates; the planned timing and conduct of Nurix's clinical trials; the planned timing for the provision of updates and findings from Nurix's preclinical studies and clinical trials; the potential benefits of and Nurix's expectations with respect to its strategic collaborations, including the achievement of research milestones; and the potential benefits and advantages of Nurix's scientific approach, Nurix's DEL-AI platform, degrader antibody conjugates and Orphan Drug Designation. Forward-looking statements reflect Nurix's current beliefs, expectations, and assumptions regarding the future of Nurix's business, its future plans and strategies, its development plans, its preclinical and clinical results, future conditions and other factors Nurix believes are appropriate in the circumstances. Although Nurix believes the expectations and assumptions reflected in such forward-looking statements are reasonable, Nurix can give no assurance that they will prove to be correct. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and changes in circumstances that are difficult to predict, which could cause Nurix's actual activities and results to differ materially from those expressed in any forward-looking statement. Such risks and uncertainties include, but are not limited to: (i) whether Nurix will be able to advance its drug candidates, obtain regulatory approval of and ultimately commercialize its drug candidates; (ii) uncertainties related to the timing and results of preclinical studies and clinical trials; (iii) whether Nurix will be able to fund development activities and achieve development goals; (iv) uncertainties related to the timing and receipt of payments from Nurix's collaboration partners, including milestone payments and royalties on future product sales; (v) the impact of global business, political and macroeconomic conditions, cybersecurity events, instability in the banking system, and global events, including regional conflicts around the world, on Nurix's business, clinical trials, financial condition, liquidity and results of operations; (vi) whether Nurix will be able to protect intellectual property and (vii) other risks and uncertainties described under the heading 'Risk Factors' in Nurix's Quarterly Report on Form 10-Q for the fiscal quarter ended May 31, 2025, and other SEC filings. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. The statements in this press release speak only as of the date of this press release, even if subsequently made available by Nurix on its website or otherwise. Nurix disclaims any intention or obligation to update publicly any forward-looking statements, whether in response to new information, future events, or otherwise, except as required by applicable law. Contacts: InvestorsKris FortnerNurix Therapeutics, Elizabeth Wolffe, Life Science Advisorslwolffe@ MediaAljanae ReynoldsWheelhouse Life Science Advisorsareynolds@ Nurix Therapeutics, Statements of Operations(in thousands, except share and per share amounts)(unaudited) Three Months Ended Six Months Ended May 31, May 31, 2025 2024 2025 2024 Revenue: Collaboration revenue $ 14,056 $ 12,092 $ 32,509 $ 28,677 License revenue 30,000 - 30,000 - Total revenue 44,056 12,092 62,509 28,677 Operating expenses: Research and development 78,096 48,922 147,759 98,927 General and administrative 14,282 11,710 25,936 23,509 Total operating expenses 92,378 60,632 173,695 122,436 Loss from operations (48,322 ) (48,540 ) (111,186 ) (93,759 ) Interest and other income, net 5,618 4,084 12,131 7,875 Loss before income taxes (42,704 ) (44,456 ) (99,055 ) (85,884 ) Provision for income taxes 760 90 760 180 Net loss (43,464 ) (44,546 ) (99,815 ) (86,064 ) Net loss per share, basic and diluted $ (0.52 ) $ (0.71 ) $ (1.19 ) $ (1.47 ) Weighted-average number of shares outstanding, basic and diluted 83,882,477 62,377,551 83,723,403 58,660,900 Nurix Therapeutics, Balance Sheets(in thousands)(unaudited) May 31, November 30, 2025 2024 Assets Current assets: Cash and cash equivalents $ 84,260 $ 109,997 Marketable securities, current 401,521 499,586 Accounts receivable 19,000 - Prepaid expenses and other current assets 10,549 9,804 Total current assets 515,330 619,387 Operating lease right-of-use assets 50,214 28,139 Property and equipment, net 18,773 17,757 Restricted cash 901 901 Other assets 6,337 3,159 Total assets $ 591,555 $ 669,343 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 5,954 $ 11,482 Accrued expenses and other current liabilities 37,005 37,994 Operating lease liabilities, current 5,235 8,014 Deferred revenue, current 27,420 38,364 Total current liabilities 75,614 95,854 Operating lease liabilities, net of current portion 46,696 20,289 Deferred revenue, net of current portion 21,642 26,207 Total liabilities 143,952 142,350 Stockholders' equity: Common stock 76 76 Additional paid-in-capital 1,286,131 1,265,536 Accumulated other comprehensive income (loss) (20 ) 150 Accumulated deficit (838,584 ) (738,769 ) Total stockholders' equity 447,603 526,993 Total liabilities and stockholders' equity $ 591,555 $ 669,343 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

AstraZeneca Presents Positive Phase I/II Data for Surovatamig in B-cell ALL at EHA 2025
AstraZeneca Presents Positive Phase I/II Data for Surovatamig in B-cell ALL at EHA 2025

Yahoo

time25-06-2025

  • Business
  • Yahoo

AstraZeneca Presents Positive Phase I/II Data for Surovatamig in B-cell ALL at EHA 2025

AstraZeneca (NASDAQ:AZN) is one of the most active stocks to buy according to analysts. On June 16, the preliminary results for AstraZeneca's surovatamig, a next-gen CD19xCD3 bispecific T-cell engager (BiTE), were presented at the 2025 Congress of the European Hematology Association (EHA 2025). The event was held from June 12 to 15 in Milan, Italy. The findings come from the global, multicenter, open-label, and single-arm Phase I/II SYRUS clinical trial (NCT06137118), which is evaluating surovatamig as a monotherapy for patients aged 12 and over with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL). B-ALL is an aggressive hematologic malignancy that accounts for 7% to 85% of all acute lymphoblastic leukemia cases and is most commonly diagnosed in young children and adolescents, although its incidence also rises in older adults. A pharmacy worker distributing prescription medicines to patientsreceiving treatment for oncology, cardiovascular, renal, metabolism and respiratory diseases. Surovatamig is designed with Fc-engineering for an extended half-life and optimized CD3 binding, which allows for intermittent dosing and controlled T-cell activation. This could offer a convenient and safer alternative to continuous infusion therapies like Blincyto. Beyond R/R B-ALL, surovatamig is also in Phase III trials as a monotherapy for diffuse large B-cell lymphoma and in combination with Biogen's Rituxan (rituximab) for untreated follicular lymphoma. While surovatamig shows promise, it will need to demonstrate superior performance against established therapies such as Blincyto and Aucatzyl. AstraZeneca (NASDAQ:AZN) is a biopharmaceutical company that discovers, develops, manufactures, and commercializes prescription medicines. While we acknowledge the potential of AZN as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the . READ NEXT: and . Disclosure: None. This article is originally published at Insider Monkey. Sign in to access your portfolio

EDGE Recognised as ‘Best Company to Work For' at the Employee Happiness Awards 2025 - Middle East Business News and Information
EDGE Recognised as ‘Best Company to Work For' at the Employee Happiness Awards 2025 - Middle East Business News and Information

Mid East Info

time23-06-2025

  • Business
  • Mid East Info

EDGE Recognised as ‘Best Company to Work For' at the Employee Happiness Awards 2025 - Middle East Business News and Information

EDGE wins gold in 'Best Company to Work For' category, further elevating its reputation as an employer of choice for top talents to thrive. Abu Dhabi, UAE: June, 2025 – EDGE, one of the world's leading advanced technology and defence groups, has been awarded gold in the 'Best Company to Work For – Large' category at the Employee Happiness Awards 2025 (EHA 2025), a platform that recognises companies and human resources (HR) professionals who promote happiness and well-being in the workplace. The award reflects EDGE's unwavering dedication to HR best practices, employee satisfaction, and constant innovation. Sana Al Daoumi, Senior Vice President of Human Capital, EDGE, said: 'Our relentless pursuit of excellence in HR continues to drive our successes. This award belongs to every team member whose passion, dedication, and care make our culture exceptional. As a testament to our team's hard work and commitment to people-first practices, this award further elevates EDGE as an organisation that values its people and fosters a culture of continuous improvement in HR.' The latest HR award follows EDGE's certification as a Great Place to Work® in December 2024, reinforcing its reputation as an employer of choice and organisation where top talents thrive in a a dynamic, supportive, and innovative workplace. About EDGE: Launched in November 2019, the UAE's EDGE is one of the world's leading advanced technology groups, established to develop agile, bold and disruptive solutions for defence and beyond, and to be a catalyst for change and transformation. It is dedicated to bringing breakthrough innovations, products, and services to market with greater speed and efficiency, to position the UAE as a leading global hub for future industries, and to creating clear paths within the sector for the next generation of highly-skilled talent to thrive. With a focus on the adoption of 4IR technologies, EDGE is driving the development of sovereign capabilities for global export and for the preservation of national security, working with front-line operators, international partners, and adopting advanced technologies such as autonomous capabilities, cyber-physical systems, advanced propulsion systems, robotics and smart materials. EDGE converges R&D, emerging technologies, digital transformation, and commercial market innovations with military capabilities to develop disruptive solutions tailored to the specific requirements of its customers. Headquartered in Abu Dhabi, capital of the UAE, EDGE consolidates more than 35 entities into six core clusters: Platforms & Systems, Missiles & Weapons, Space & Cyber Technologies, Trading & Mission Support, Technology & Innovation, and Homeland Security.

AbelZeta Announces Promising Long-Term Outcomes for C-CAR039, a Novel CD19/CD20 Bi-Specific CAR-T Therapy, in Patients with R/R B NHL at EHA 2025
AbelZeta Announces Promising Long-Term Outcomes for C-CAR039, a Novel CD19/CD20 Bi-Specific CAR-T Therapy, in Patients with R/R B NHL at EHA 2025

Yahoo

time16-06-2025

  • Business
  • Yahoo

AbelZeta Announces Promising Long-Term Outcomes for C-CAR039, a Novel CD19/CD20 Bi-Specific CAR-T Therapy, in Patients with R/R B NHL at EHA 2025

MILAN, June 16, 2025 /PRNewswire/ -- AbelZeta Pharma, Inc. ("AbelZeta" or the "Company"), a global clinical-stage biopharmaceutical company focused on discovery and development of innovative and proprietary cell-based therapeutic products, presented promising four-year clinical outcomes from 48 relapsed or refractory B-cell non-Hodgkin lymphoma (R/R B-NHL) patients treated with C-CAR039 (also known as Prizloncabtagene Autoleucel) in greater China, at the European Hematology Association (EHA) 2025 Congress. The study evaluated the safety and efficacy of C-CAR039, a novel anti-CD19/CD20 bi-specific CAR-T therapy. The dual-targeting approach to both CD20 and CD19 antigens aims to enhance therapeutic efficacy and reduce the likelihood of antigen escape, a common mechanism of resistance in B-cell malignancies. Key Findings: The overall response rate (ORR) and complete response (CR) rate were 91.5% and 85.1%, respectively for all patients Among the 43 LBCL pts, ORR and CR were 90.7% and 86.0%, respectively With a median follow-up of 45.5 months (range, 3.1–62.8), the median duration of response (DOR), progression-free survival (PFS), and overall survival (OS) were not reached KM estimates of 48-m PFS rate are 52.5% for all patients and 53.4% for LBCL patients, respectively KM estimates of 48-m OS rate are 65.4% for all patients and 66.7% for LBCL patients, respectively Safety Highlights: CRS of any grade: 93.8% | Grade ≥3: 2.1% ICANS of any grade: 6.3% | No severe cases (Grade ≥3) reported No new safety signals were observed with longer follow-up C-CAR039 has continued to show an excellent safety profile and deep and durable responses in R/R B-NHL patients, especially in those with R/R LBCL. These results continue to provide strong support for the curative potential of C-CAR039 as a next-generation therapy for R/R B-NHL. Late-stage clinical development is ongoing. "The long-term clinical outcomes data for C-CAR039 are highly encouraging, demonstrating sustained responses in patients with relapsed or refractory B-cell non-Hodgkin lymphoma," said Tony (Bizuo) Liu, Chairman and Chief Executive Officer of AbelZeta. "These results underscore our commitment and corporate goal to develop transformative therapies that address significant unmet medical needs in cancer." Dr. Yihong Yao, Chief Scientific Officer of AbelZeta, commented, "The strong clinical results of C-CAR039 demonstrate the added value of targeting CD20 in addition to CD19 in aggressive B-NHL. By addressing the limitations of single-antigen therapies - such as CD19 antigen escape - C-CAR039 enables deeper tissue penetration and more complete B-cell depletion. The durable responses observed support the continued advancement of C-CAR039 as a promising new treatment for patients with aggressive B-cell malignancies." For more information on the study and access to the poster presentation, please visit the EHA Library poster here. AbelZeta previously presented 30-month Phase 1 clinical trial results at the 65th American Society of Hematology (ASH) Annual Meeting in December 2023, through oral presentation #1025, as well as at EHA 2024, through poster presentation #P1475. The data with 30 months follow up was published in Blood 2025 Apr 3;145(14):1526-1535. AbelZeta Inc. (formerly known as Cellular Biomedicine Group, Inc.), entered into a worldwide collaboration and licensing agreement with Johnson & Johnson* in 2023 to develop and commercialize next-generation CAR-T cell therapies (excluding Greater China). The Phase 1 study for C-CAR039 was conducted by AbelZeta in China for the treatment of patients with B-cell non-Hodgkin lymphoma. Johnson & Johnson is evaluating the safety and efficacy of this asset (known as JNJ-90014496 outside of Greater China) through a separate study involving a global patient population. Phase 1b data for JNJ-90014496 were presented at EHA 2025 on Friday, June 13, informing the recommended Phase 2 dose and an initial assessment of safety, efficacy and pharmacokinetics in R/R LBCL patients. For more information, please visit Johnson and Johnson website: *The legal entity to the worldwide collaboration and license agreement is Janssen Biotech, Inc., a Johnson & Johnson company. About AbelZeta Pharma, is a global clinical-stage biopharmaceutical company with centers of excellence in Rockville, Maryland and Shanghai, China. AbelZeta is focusing on developing innovative and proprietary cell-based therapeutic products and is committed to ushering in bespoke treatments that harness the body's own immune system to fight against hematological malignancies and solid tumors, as well as inflammatory and immunological diseases. AbelZeta advances research and development in its own GMP facilities at its centers of excellence for early-stage clinical studies, with a pipeline comprised of CAR-T therapies. Forward-Looking StatementsStatements in this communication relating to plans, strategies, specific activities, and other statements that are not descriptions of historical facts are forward-looking statements. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, which include any risks detailed from time to time in the Company's reports. Such statements are based on the management's current beliefs and expectations and are subject to significant risks and uncertainties outside of management and the Company's control. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as otherwise required by law, the Company does not undertake any obligation, and expressly disclaims any obligation, to update, alter or otherwise revise any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise. Company Contact:Sarah KellyDirector of CommunicationsAbelZeta Pharma, Inc.+1 (240) 552 View original content to download multimedia: SOURCE AbelZeta Pharma, Inc.

Incyte announces data from two studies evaluating INCA033989
Incyte announces data from two studies evaluating INCA033989

Business Insider

time16-06-2025

  • Health
  • Business Insider

Incyte announces data from two studies evaluating INCA033989

Incyte (INCY) announced the first clinical data from two studies evaluating the safety, tolerability and efficacy of INCA033989, a novel, first in class, Incyte-discovered, targeted monoclonal antibody in patients with mutant calreticulin-expressing myeloproliferative neoplasms, MPNs. These data – featured today in the Late-Breaking Oral Session at the European Hematology Association 2025, EHA 2025, Congress in Milan, Italy – focus on the dose escalation portion of the studies in patients with high risk essential thrombocythemia who are resistant/intolerant to prior cytoreductive therapy. The studies evaluated the safety and efficacy of INCA033989 in patients with ET as measured by hematologic response and reduction in mutCALR variant allele frequency. Results as of April 4, 2025, showed rapid and durable normalization of platelet counts across all dose levels, with a trend toward improved responses in higher doses, in patients with ET treated with INCA033989. Notably, 86% of patients at doses 400 mg and above achieved a complete or partial hematologic response, with the majority of patients achieving complete response. Eighty-nine percent of evaluable patients showed a reduction in mutCALR VAF from baseline. A partial molecular response was observed in 21% of evaluable patients after only 3 cycles of treatment.

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