ALX2004

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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 Holdings (ALXO) Earnings Call Presentation
2025-05-23 07:41
ALX2004 Program Overview - ALX2004 is an EGFR-targeted ADC with a DAR of 8, utilizing a topoisomerase I inhibitor (Top1i) payload, with IND cleared in April 2025[13, 98] - ALX2004 is designed to maximize the therapeutic window and overcome toxicity challenges, with a focus on EGFR-expressing solid tumors[14, 99] - ALX2004's Phase 1a dose escalation trial is planned to start in mid-2025, targeting NSCLC, CRC, HNSCC, and ESCC[14, 99] ALX2004 Design and Preclinical Data - ALX2004's EGFR antibody binding epitope is selected to minimize off-tumor skin toxicities, and its affinity is tuned to maximize the therapeutic window[20] - The linker-payload is designed for lysosomal cleavage, similar to deruxtecan ADCs, with improved linker-antibody stability to minimize off-tumor payload release[20] - Preclinical data demonstrates dose-dependent activity across a range of tumors and EGFR expression levels, with a differentiated safety profile in NHP toxicity studies, showing no EGFR-related skin toxicity at clinically relevant doses[24] - In preclinical studies, ALX2004 demonstrated superior anti-tumor activity compared to DXd ADCs in CDX mouse models, showing improved bystander effect[47, 49] Clinical Development Plan - The Phase 1 trial is rationally designed around tumor types with established sensitivity to EGFR-directed therapies, including HNSCC, CRC, NSCLC, and ESCC, representing over 250,000 patient prevalence in the US[87] - The Phase 1 clinical development plan includes dose escalation (Phase 1a, up to 40 patients), dose exploration (up to 50 patients), and dose expansion (Phase 1b, up to 80 patients)[89, 90, 91] - ALX Oncology anticipates initial safety data for ALX2004 in EGFR-expressing solid tumors in the first half of 2026[101]
ALX Oncology Holdings (ALXO) Update / Briefing Transcript
2025-05-20 16:00
Summary of ALX Oncology Holdings (ALXO) Conference Call Company Overview - **Company**: ALX Oncology Holdings (ALXO) - **Focus**: Development of ALX2004, a differentiated antibody-drug conjugate (ADC) targeting EGFR Key Points and Arguments Industry and Product Development - **ADC Focus**: ALX2004 is designed to maximize therapeutic window and overcome historical toxicity challenges associated with EGFR-targeted ADCs [5][6][10] - **Clinical Pipeline**: The company is advancing its ADC in combination with anti-cancer antibodies, specifically targeting breast and colorectal cancers [4][5] - **IND Clearance**: ALX2004 has received Investigational New Drug (IND) clearance, with plans to launch a Phase I trial in mid-2025 [5][7] Scientific Rationale - **Payload and Linker Design**: ALX2004 utilizes a proprietary topoisomerase one inhibitor payload, designed to minimize off-target toxicity while maximizing tumor cell killing [17][20] - **Immunogenic Cell Death**: The payload triggers immunogenic cell death, potentially enhancing long-term tumor control through adaptive immune response [18][28] - **Optimized Antibody**: The antibody component is designed to block EGFR signaling and bind to a unique epitope, potentially overcoming resistance to existing therapies [30][32] Clinical Development Plans - **Phase I Study**: The study will focus on four tumor types: head and neck squamous cell carcinoma, colorectal cancer, non-small cell lung cancer, and esophageal squamous cell carcinoma, targeting patients with relapsed or refractory disease [40][41] - **Safety and Efficacy Goals**: Initial safety data is expected in the first half of 2026, with an emphasis on establishing a recommended dosing schema [42][43] Competitive Landscape - **Market Positioning**: ALX Oncology aims to be a leader in the ADC space targeting EGFR, which currently lacks an approved drug [43][85] - **Comparison with Competitors**: The company is aware of other ADCs in development, such as MRG003, but believes its optimized design gives it a competitive edge [85] Additional Important Insights - **Preclinical Data**: Robust preclinical data supports the efficacy and safety profile of ALX2004, with encouraging results in various tumor models [14][34] - **Toxicity Management**: The design aims to avoid common toxicities seen in previous EGFR-targeted ADCs, such as skin toxicity and interstitial lung disease [14][72] - **Funding and Capital Allocation**: The company has sufficient cash to fund its ongoing studies into 2024, with plans to explore additional capital options as needed [51][52] This summary encapsulates the critical aspects of ALX Oncology's conference call, highlighting the company's strategic focus on developing ALX2004 and its potential impact on the oncology market.
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]