evorpacept

Search documents
ALX Oncology to Present Updated Data from Phase 2 ASPEN-06 Trial, Highlighting CD47 Expression as a Predictive Biomarker in HER2+ Gastric Cancer, at 40th Society for Immunotherapy of Cancer (SITC) Annual Meeting
Globenewswire· 2025-10-03 13:05
Company will share data demonstrating CD47 overexpression as key predictive biomarker for response with the Company’s lead candidate, evorpacept, in HER2+ gastric cancer SOUTH SAN FRANCISCO, Calif., Oct. 03, 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 updated data from its Phase 2 ASPEN-06 (NCT05002127) ...
ALX Oncology Appoints Board Member Barbara Klencke, M.D., as Interim Chief Medical Officer
Globenewswire· 2025-09-12 12:30
Core Viewpoint - ALX Oncology has appointed Dr. Barbara Klencke as Interim Chief Medical Officer, succeeding Dr. Alan Sandler, who will return to the Board of Directors [1][2][5] Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing novel therapies for cancer treatment, with a pipeline that includes evorpacept and ALX2004 [3] - Evorpacept is positioned as a cornerstone therapy in immuno-oncology and is currently undergoing multiple clinical trials across various cancer indications [3] - ALX2004 is a novel EGFR-targeted antibody-drug conjugate that entered Phase 1 clinical trials in August 2025 [3] Leadership Changes - Dr. Klencke brings over 30 years of experience in oncology and has previously served as CMO at Sierra Oncology, contributing to its acquisition by GlaxoSmithKline [2][5] - The transition aims to enhance the execution of the company's development strategy for its clinical programs [2]
ALX Oncology to Participate in Upcoming Investor Conferences in September
Globenewswire· 2025-08-29 16:00
Core Insights - ALX Oncology is participating in two significant healthcare conferences in New York, showcasing its commitment to advancing cancer therapies [1][2]. Group 1: Conference Participation - ALX Oncology leadership will engage in the Cantor Global Healthcare Conference on September 3, 2025, featuring a fireside chat and one-on-one meetings [2]. - The H.C. Wainwright 27th Annual Global Investment Conference will take place on September 9, 2025, with a focus on one-on-one meetings [2]. - Webcasts for both conferences will be available on ALX Oncology's website, with replays archived for up to 90 days [2]. Group 2: Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing novel therapies aimed at treating cancer and improving patient survival [3]. - The lead therapeutic candidate, evorpacept, is being evaluated in multiple clinical trials across various cancer indications, indicating its potential as a cornerstone therapy in immuno-oncology [3]. - ALX2004, the second pipeline candidate, is an EGFR-targeted antibody-drug conjugate that entered Phase 1 trials in August 2025, highlighting the company's innovative approach to cancer treatment [3].
ALX Oncology Doses First Patient in Phase 1 Dose Escalation Trial Evaluating ADC ALX2004 for the Treatment of EGFR-Expressing Solid Tumors
Globenewswire· 2025-08-19 12:00
Core Insights - ALX2004 is a potential best- and first-in-class antibody-drug conjugate (ADC) designed for treating EGFR-expressing solid tumors, with components optimized to maximize the therapeutic window [1][4] - The first patient has been dosed in the Phase 1 clinical trial for ALX2004, marking a significant milestone for ALX Oncology [2][3] - Initial safety data from the trial is expected in the first half of 2026 [1][3] Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing novel therapies for cancer treatment [6] - The company’s lead candidate, evorpacept, is being evaluated in multiple clinical trials across various cancer indications [6] Clinical Trial Details - The Phase 1 clinical trial (NCT07085091) is an open-label multicenter study targeting advanced or metastatic EGFR-expressing solid tumors, including non-small cell lung cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, and colorectal cancer [3][5] - The trial consists of a Phase 1a dose escalation followed by a Phase 1b dose expansion [3] Preclinical Data - Preclinical studies indicate that ALX2004 has a differentiated linker-payload construct, demonstrating superior stability and dose-dependent anti-tumor activity [5] - The preclinical model findings suggest a favorable safety profile, with no EGFR-related skin toxicity or payload-related interstitial lung disease observed at clinically relevant doses [5]
ALX Oncology(ALXO) - 2025 Q2 - Earnings Call Presentation
2025-08-12 20:30
Clinical Trial Updates - Data from the ASPEN-06 trial highlights CD47 expression as a key predictive biomarker, demonstrating a compelling clinical response of evorpacept activity in HER2+ gastric cancer[12] - The Phase 2 ASPEN-Breast evorpacept trial design was updated to enable a CD47 and HER2 biomarker-driven strategy in a single-arm study[12] - Dose escalation was completed in the Sanofi-sponsored trial of evorpacept with SARCLISA® and dexamethasone in previously treated multiple myeloma, with Sanofi moving into dose optimization[12] - The first patient is anticipated to be enrolled in August in the phase 1 clinical trial of the novel EGFR-targeted antibody-drug conjugate (ADC), ALX2004[12] Financial Strategy - Focus on evorpacept in ASPEN-Breast and ALX2004, while pausing ASPEN-CRC, results in cash runway extended into Q1 2027[12] - The company had cash, cash equivalents, and investments of $84 million as of June 30, 2025[100] Upcoming Milestones - ASPEN-06 CD47 expression data update is expected in Q4 2025[12] - Initial safety data for ALX2004 is anticipated in 1H 2026[12] - ASPEN-breast interim data readout is expected in Q3 2026[12] ASPEN-06 Trial Results - In the ITT population, Evorpacept + TRP showed a 41% ORR compared to 27% in the TRP control arm[42] - In patients with HER2-positivity confirmed by fresh biopsy or ctDNA, evorpacept demonstrated a 49% ORR compared to 245% in control[45] - In patients with HER2+ and CD47-high gastric cancer (n=43), evorpacept + TRP had a 65% ORR versus 26% ORR for TRP[53] ASPEN-Breast Trial - In breast cancer patients with confirmed HER2-positivity, evorpacept + zanidatamab had a 56% confirmed ORR[63]
ALX Oncology Reports Second Quarter 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-08-12 20:05
Core Insights - ALX Oncology is advancing its clinical programs, particularly focusing on evorpacept and ALX2004, with significant data expected in the coming years [1][3][4] Clinical Developments - The ASPEN-06 trial indicates that CD47 expression is a predictive biomarker for response to evorpacept in HER2+ gastric cancer, with a 65% objective response rate (ORR) in CD47-high patients compared to 26% with standard treatment [4] - The ASPEN-Breast trial design has been updated to a single-arm study to evaluate CD47 and HER2 biomarker-driven strategies, with interim data expected in Q3 2026 [1][4] - The Phase 1 clinical trial for ALX2004 is on track to enroll its first patient in August 2025, targeting EGFR-expressing solid tumors [1][4][6] Financial Overview - As of June 30, 2025, ALX Oncology reported cash, cash equivalents, and investments totaling $83.5 million, sufficient to fund operations into Q1 2027 [11][16] - Research and Development (R&D) expenses for Q2 2025 were $18.0 million, a decrease from $34.7 million in the prior year, attributed to reduced clinical trial material manufacturing and other cost-saving measures [11][14] - The net loss for Q2 2025 was $25.9 million, down from $39.4 million in Q2 2024, reflecting lower R&D expenses [11][14] Corporate Updates - Daniel Curran, M.D., has been appointed to the Board of Directors, bringing extensive experience in drug discovery and corporate strategy [2][3][5] - The company has extended its cash runway into Q1 2027, allowing for the achievement of multiple data milestones across its pipeline [1][4][11]
ALX Oncology to Report Second Quarter 2025 Financial Results on August 12, 2025
Globenewswire· 2025-08-05 12:00
Core Viewpoint - ALX Oncology Holdings Inc. is set to report its second quarter 2025 financial results and provide a business update on August 12, 2025, after market close [1] Group 1: Financial Results Announcement - The company will host a teleconference in conjunction with its financial results press release [1] - The webcast for the financial results will take place on August 12, 2025, at 1:30 PM PT / 4:30 PM ET [2] - Access to the conference call can be made via phone or through a dedicated link for instant telephone access [3] Group 2: Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing novel therapies for cancer treatment [4] - The lead therapeutic candidate, evorpacept, is being evaluated in multiple ongoing clinical trials across various cancer indications [4] - The second pipeline candidate, ALX2004, is an EGFR-targeted antibody-drug conjugate expected to enter Phase 1 trials in mid-2025 [4]
ALX Oncology to Present at the Jefferies 2025 Global Healthcare Conference
Globenewswire· 2025-05-30 12:00
Core Insights - ALX Oncology Holdings Inc. is a clinical-stage biotechnology company focused on developing novel therapies for cancer treatment and improving patient survival [2] Group 1: Company Overview - ALX Oncology's lead therapeutic candidate, evorpacept, shows promise as a foundational therapy for future immuno-oncology treatments and is currently undergoing multiple clinical trials across various cancer indications [2] - The second pipeline candidate, ALX2004, is an innovative EGFR-targeted antibody-drug conjugate with a unique mechanism of action, expected to enter Phase 1 trials in mid-2025 [2] Group 2: Upcoming Events - Management will participate in the Jefferies 2025 Global Healthcare Conference, scheduled for June 5, 2025, at 1:25 PM ET in New York, NY [1] - A live webcast of the event will be available on ALX Oncology's website, with a replay accessible for up to 90 days post-event [1]
ALX Oncology Highlights Differentiated Design, Preclinical Data and Development Plans for EGFR-Targeted ADC, ALX2004, in R&D Webcast Event
Globenewswire· 2025-05-20 12:00
Core Insights - ALX Oncology is advancing ALX2004, a potential best- and first-in-class antibody-drug conjugate (ADC) targeting EGFR-expressing solid tumors, designed to maximize therapeutic efficacy while minimizing toxicity [1][2] - The U.S. FDA has cleared the IND application for ALX2004, with clinical studies set to begin in mid-2025 and initial safety data expected in the first half of 2026 [1][6] - The company plans to initiate trials for its lead therapy, evorpacept, in breast and colorectal cancers around the same time, with significant milestones anticipated in 2026 [1] ALX2004 Development Overview - ALX2004 is developed using a proprietary linker-payload platform, featuring an affinity-tuned EGFR antibody and a stable linker-Top1i payload, aimed at enhancing anti-tumor activity and reducing toxicity [3][4] - Preclinical data indicates that ALX2004 has superior stability and a favorable safety profile compared to other ADCs, showing dose-dependent activity across various tumors and EGFR expression levels [5] Clinical Trial Plans - The Phase 1 clinical trial for ALX2004 will target EGFR-expressing solid tumors, including non-small cell lung cancer and colorectal cancer, focusing on patients with relapsed or refractory cancers [6] - The trial is expected to begin in mid-2025, with initial safety data anticipated in the first half of 2026 [1][6]
ALX Oncology to Host R&D Webcast Event Highlighting its Novel EGFR Targeting Antibody-Drug Conjugate, ALX2004, on May 20, 2025
Globenewswire· 2025-05-13 12:00
Core Insights - ALX Oncology will host a webcast on May 20, 2025, to provide updates on ALX2004, a potentially first-in-class antibody-drug conjugate designed to treat cancer [1][3] - ALX2004 is developed in-house and utilizes a proprietary topoisomerase I inhibitor payload platform, targeting EGFR-expressing tumors to enhance anti-tumor activity [2] Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing novel therapies for cancer treatment, with its lead candidate evorpacept currently in multiple clinical trials [4] - ALX2004 is expected to enter Phase 1 trials in mid-2025, showcasing a differentiated mechanism of action [4]