Latest news with #ALXOncology
Yahoo
30-05-2025
- Business
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ALX Oncology to Present at the Jefferies 2025 Global Healthcare Conference
SOUTH SAN FRANCISCO, Calif., May 30, 2025 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology" or the "Company") (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients' lives, today announced that management will participate in the Jefferies 2025 Global Healthcare Conference. Details are as follows: Format: Fireside Chat Date: Thursday, June 5, 2025Time: 1:25 PM ETLocation: New York, NYWebcast link: Available here The live webcast of the Jefferies fireside chat can be accessed by visiting the Investors section of ALX Oncology's website at under the Events section of the Events and Presentations tab. A replay of the webcast will be archived for up to 90 days following the fireside chat date. About ALX OncologyALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients' lives. ALX Oncology's lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. ALX Oncology's second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action and is anticipated to enter Phase 1 trials mid-2025. More information is available at and on LinkedIn @ALX Oncology. Investor Relations Contact:Elhan Webb, CFA, IR Consultantewebb@ Media Contact:Audra Friis, Sam Brown Healthcare Communicationsaudrafriis@ 519-9577Error 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
02-05-2025
- Business
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ALX Oncology to Report First Quarter 2025 Financial Results on May 8, 2025
SOUTH SAN FRANCISCO, Calif., May 02, 2025 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ('ALX Oncology' or the 'Company') (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients' lives, today announced plans to report its first quarter 2025 financial results on Thursday, May 8th, 2025, before market open. The company will not be hosting a teleconference in conjunction with its financial results press release. About ALX OncologyALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients' lives. ALX Oncology's lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. ALX Oncology's second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action and is anticipated to enter Phase 1 trials mid-2025. More information is available at and on LinkedIn @ALX Oncology. Investor Relations Contact:Elhan Webb, CFA, IR Consultantewebb@ Media Contact: Audra Friis, Sam Brown, (917) 519-9577Sign in to access your portfolio
Yahoo
28-04-2025
- Business
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ALX Oncology's CD47-blocker and Keytruda combo fails in two Phase II trials
ALX Oncology's CD47-blocker evorpacept, in combination with MSD's blockbuster Keytruda (pembrolizumab), has failed to show benefit in two Phase II trials. The combination was being investigated in the ASPEN-03 (NCT04675294) and ASPEN-04 (NCT04675333) clinical trials as a first-line treatment for patients with advanced head and neck squamous cell carcinoma (HNSCC). ALX said the combination did not improve objective response rates (ORR) compared to historical controls of Keytruda alone or Keytruda with chemotherapy. As a result, the company will no longer pursue evorpacept in combination with Keytruda in HNSCC, with ALX to now focus on trials investigating evorpacept with other anti-cancer antibodies, including Cyramza (ramucirumab), Herceptin (trastuzumab), Rituxan (rituximab) and Ziihera (zanidatamab). The company's Nasdaq-listed stock fell 9.8% on 25 April 2025, dropping from $0.601 at Thursday's close to $0.542. ALX Oncology CEO Jason Lettmann said: "Based on the positive data and strong mechanistic rationale, we maintain our confidence in the evorpacept clinical development programme and intend to deliver on that promise with additional clinical data in breast cancer and colorectal cancer in the near-term. "With evorpacept and ALX2004, our novel EGFR-targeted antibody-drug conjugate, we continue our commitment to bringing forth meaningful therapies for patients living with cancer." Despite the efficacy failure, the combination demonstrated a manageable safety profile consistent Keytruda and chemotherapy in the same patient population. ALX said more detailed data from the two studies will be submitted to a future medical meeting. Evorpacept acts by blocking CD47, a molecule commonly found on the surface of many cancers that acts as a 'don't eat me signal', allowing them to invade immune cells such as macrophages. By inhibiting CD47, evorpacept helps trigger anti-tumour activity. This marks another bump in the road for ALX after it downsized staffing by 30% and slashed preclinical research within the company in March 2025 to redirect funding to trials of evorpacept. Last year, the company's stock fell after full Phase II data from a Phase II study of the drug in gastric cancer data were not as strong as an interim analysis had suggested. CD47 inhibition has also struggled as a mechanism of action, with no CD47 drugs yet approved. Gilead has stopped the development of a CD47 inhibitor, magrolimab, which it obtained during a $4.9bn acquisition of Forty Seven in 2020 after a string of trial failures and clinical holds by the US Food and Drug Administration (FDA). AbbVie also tried to throw its hat in the CD47 ring, creating a deal with I-Mab, gaining ex-China rights to lemzoparlimab. However, the pharma giant has since cut ties after several failures with the drug. Despite AbbVie pulling out of the collaboration, I-Mab is still forging ahead with Phase III trials. "ALX Oncology's CD47-blocker and Keytruda combo fails in two Phase II trials" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
07-04-2025
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ALX Oncology Receives IND Clearance from U.S. FDA for ALX2004, a Novel EGFR-targeted Antibody-drug Conjugate
ALX2004 is a potential best- and first-in-class antibody-drug conjugate (ADC) for the treatment of EGFR-expressing solid tumors that was created from ALX Oncology's proprietary linker-payload platform ALX2004, the company's first ADC, was fully designed and developed in-house by ALX Oncology scientists Company expects to initiate Phase 1 clinical trials of ALX2004 in mid-2025, with initial safety data available in 1H 2026 SOUTH SAN FRANCISCO, Calif., April 07, 2025 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ('ALX Oncology' or the 'Company') (Nasdaq: ALXO), a clinical-stage biotechnology company advancing therapies that boost the immune system to treat cancer and extend patients' lives, today announced receipt of U.S. Food and Drug Administration (FDA) clearance for the Investigational New Drug (IND) application for ALX2004, the company's potential best- and first-in-class antibody-drug conjugate (ADC) for the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors. Based on this clearance, ALX Oncology will initiate a single-agent dose-escalation and expansion Phase 1 clinical trial for ALX2004 in mid-2025. 'Clinical advancement of our first ADC and the first drug candidate developed on our proprietary linker-payload platform is an important milestone in our mission to deliver breakthrough therapies that will help transform the future of cancer treatment,' said Jason Lettmann, Chief Executive Officer at ALX Oncology. 'We meticulously designed all aspects of ALX2004 – the antibody backbone, linker and payload – to optimize the targeted delivery of a powerful chemotherapy payload to tumor cells while minimizing systemic toxicity. The resulting, highly differentiated molecule has demonstrated potent anti-tumor activity in preclinical models and is a strategic addition to our clinical pipeline, which also includes multiple trials evaluating our lead therapeutic candidate, evorpacept.' EGFR is a transmembrane protein located on the surface of cells that regulates cell growth; overexpression occurs across various tumor types, including breast cancer, colorectal carcinoma, head and neck squamous cell carcinoma and non-small cell lung cancer. EGFR is clinically validated as a therapeutic target with several FDA-approved targeted antibodies and small molecules. However, there are currently no approved EGFR-targeted ADCs. Early-generation attempts to develop EGFR-targeted ADCs were limited by drug design, on-target off-tumor toxicities and toxicity of older generation payloads. Utilizing the company's proprietary, highly differentiated topoisomerase I inhibitor payload platform, ALX Oncology scientists designed ALX2004 to optimize ADC-based mechanisms of anti-tumor activity and improve outcomes in patients with EGFR-expressing tumors. The ALX2004 molecule, created entirely in ALX Oncology labs, comprises an antibody backbone engineered to optimize anti-EGFR activity, a linker with enhanced stability and a proprietary topoisomerase I payload that can generate an enhanced bystander effect. ALX Oncology plans to conduct an R&D call focused on ALX2004 in Q2 2025 and to initiate a Phase 1 clinical trial of the investigational therapy in mid-2025. About ALX OncologyALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing therapies that boost the immune system to treat cancer and extend patients' lives. ALX Oncology's lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. More information is available at and on LinkedIn @ALX Oncology. Cautionary note regarding forward-looking statementsThis press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objectives of management for future operations, as well as statements regarding industry trends. Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission (SEC), including ALX Oncology's Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investor Relations Contact: Elhan Webb, CFA, IR Consultantewebb@ Media Contact: Audra Friis, Sam Brown, 519-9577 Sign in to access your portfolio
Yahoo
05-03-2025
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ALX Oncology Highlights Focused Evorpacept Development Plan, Clinical Progress and Corporate Updates at R&D Day Webcast Event
Event to include updates on ongoing evorpacept clinical development program and introduction of clinical trials in breast and colorectal cancers Advancing novel EGFR-targeted antibody-drug conjugate (ADC) candidate, ALX2004, into clinical-stage development with IND submission planned for Q1 2025 Company implements strategic prioritization, resource optimizations and reductions to extend cash runway into Q4 2026 Webcast featuring company leadership and external key opinion leaders to take place today at 6:00 a.m. PT/9:00 a.m. ET SOUTH SAN FRANCISCO, Calif., March 05, 2025 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ('ALX Oncology' or the 'Company') (Nasdaq: ALXO), a clinical-stage biotechnology company advancing therapies that boost the immune system to treat cancer and extend patients' lives, will highlight progress across its clinical pipeline, including continued advancement of investigational CD47-blocker evorpacept and planned entry into the clinic of its novel EGFR-directed ADC clinical candidate ALX2004, and provide key business and financial updates in an R&D Day webcast event today. ALX Oncology leadership will be joined by external key opinion leaders in the oncology field, Paula R. Pohlmann, M.D., M.S., Ph.D., Chief, Clinical Research, Department of Breast Oncology, and Associate Professor, Department of Breast Medical Oncology and Department of Investigational Cancer Therapeutics, University of Texas MD Anderson Cancer Center, and Eric Van Cutsem, M.D., Ph.D., Professor of Gastroenterology and Digestive Oncology, University Hospitals Gasthuisberg and KU Leuven in Leuven, Belgium. 'Our conviction in evorpacept's potential to deepen responses to important available anti-cancer antibody therapies, particularly in patients with HER2-positive cancers, has been strengthened by recent data. These results support our confidence moving into further clinical trials evaluating evorpacept in breast and colorectal cancers and pave additional regulatory paths forward,' said Jason Lettmann, Chief Executive Officer at ALX Oncology. 'We look forward to our near-term milestones with ASPEN-03 and ASPEN-04 topline results in head and neck cancer and discussion with the FDA regarding the registrational path in gastric cancer based on the ASPEN-06 data. To ensure that the company is strongly positioned to focus on our highest priority programs, we are streamlining our organization and prioritizing resources to execute on our current studies, progress our de-risked anti-cancer antibody combinations for evorpacept, as well as advance our novel ADC into the clinic. In order to achieve these additional value generating milestones for breast cancer, colorectal cancer and ALX2004 with our existing cash, we are optimizing resources and making the difficult decision to reduce our workforce, primarily in preclinical research. We look forward to sharing more information at today's R&D Day event, which provides an opportunity for our leadership team and leading clinicians to detail our most recent data, scientific progress and corporate strategy.' Evorpacept Clinical Program Updates During the R&D Day event, ALX Oncology leadership will discuss the mechanistic rationale and clinical data that support further development of evorpacept with anti-cancer antibodies. In addition to updates on ongoing trials leveraging this combination approach, new plans will be introduced around the initiation of studies evaluating evorpacept in combination with trastuzumab in HER2-positive breast cancer and in combination with cetuximab in colorectal cancer (CRC). Both are anticipated to initiate in the first half of 2025. Drs. Pohlmann and Van Cutsem will also discuss current treatment paradigms and unmet needs within these cancers, and how evorpacept may provide a new treatment option for patients in the future. Introduction of New EGFR-Targeted ADC with IND Submission Planned for Q1 2025 During the R&D Day event, Jaume Pons, Ph.D., will introduce a new ALX Oncology ADC clinical candidate, ALX2004. This is a potential best- and first-in-class compound that is designed to optimize ADC-based mechanisms of anti-tumor activity and has demonstrated potent anti-tumor activity in multiple clinically relevant xenograft models. ALX Oncology intends to submit an Investigational New Drug (IND) application for ALX2004 to the U.S. Food & Drug Administration (FDA) in Q1 2025. Corporate and Financial Updates In order to support the newly planned clinical trial programs in breast cancer and CRC, ALX Oncology has conducted a strategic prioritization and resource optimization exercise resulting in substantial decreases in preclinical research investments, including an approximately 30% workforce reduction primarily in the preclinical research function. As a result, ALX Oncology now expects its cash runway to extend into Q4 of 2026. R&D Day Webcast Information The ALX Oncology virtual R&D Day will be webcast live and a replay will be available after the event by visiting the 'Investors' section of ALX Oncology's website and selecting 'Events and Presentations.' Date & Time: Wednesday, March 5, 2025, 6:00 a.m. PT/9:00 a.m. ETWebcast Access: About ALX Oncology ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing therapies that boost the immune system to treat cancer and extend patients' lives. ALX Oncology's lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. More information is available at and on LinkedIn @ALX Oncology. Cautionary note regarding forward-looking statements This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objectives of management for future operations, as well as statements regarding industry trends. Such forward-looking statements are based on ALX Oncology's beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology's actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology's filings with the Securities and Exchange Commission (SEC), including ALX Oncology's Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investor Relations Contact: Elhan Webb, CFA, IR Consultantewebb@ Media Contact: Audra Friis, Sam Brown, 519-9577Sign in to access your portfolio
