ALX Oncology Highlights Focused Evorpacept Development Plan, Clinical Progress and Corporate Updates at R&D Day Webcast Event
ALX Oncology (ALXO) announced key updates during its R&D Day webcast event, highlighting the advancement of its clinical pipeline. The company is focusing on the development of evorpacept, a CD47-blocker, and introducing new clinical trials in breast and colorectal cancers expected to start in H1 2025.
The company revealed plans to submit an IND application for ALX2004, their novel EGFR-targeted antibody-drug conjugate (ADC) candidate, in Q1 2025. ALX2004 has shown potent anti-tumor activity in multiple xenograft models.
In a strategic move, ALX Oncology announced a 30% workforce reduction, primarily affecting preclinical research functions, as part of resource optimization efforts. This restructuring, along with decreased preclinical research investments, is expected to extend the company's cash runway into Q4 2026.
ALX Oncology (ALXO) ha annunciato importanti aggiornamenti durante il suo evento webcast R&D Day, evidenziando i progressi del suo pipeline clinico. L'azienda si sta concentrando sullo sviluppo di evorpacept, un bloccante CD47, e sta introducendo nuovi studi clinici per i tumori della mammella e del colon-retto, previsti per iniziare nel primo semestre del 2025.
L'azienda ha rivelato piani per presentare una domanda IND per ALX2004, il loro nuovo candidato di coniugato anticorpo-farmaco (ADC) mirato all'EGFR, nel primo trimestre del 2025. ALX2004 ha mostrato una potente attività anti-tumorale in diversi modelli di xenotrapianto.
In una mossa strategica, ALX Oncology ha annunciato una riduzione del 30% della forza lavoro, che colpirà principalmente le funzioni di ricerca preclinica, come parte degli sforzi di ottimizzazione delle risorse. Questa ristrutturazione, insieme alla diminuzione degli investimenti nella ricerca preclinica, dovrebbe estendere il periodo di liquidità dell'azienda fino al quarto trimestre del 2026.
ALX Oncology (ALXO) anunció actualizaciones clave durante su evento webcast del Día de I+D, destacando el avance de su pipeline clínico. La empresa se está enfocando en el desarrollo de evorpacept, un bloqueador de CD47, e introduciendo nuevos ensayos clínicos en cáncer de mama y colorrectal que se espera comiencen en el primer semestre de 2025.
La compañía reveló planes para presentar una solicitud IND para ALX2004, su nuevo candidato de conjugado anticuerpo-fármaco (ADC) dirigido a EGFR, en el primer trimestre de 2025. ALX2004 ha mostrado una potente actividad antitumoral en múltiples modelos de xenoinjerto.
En un movimiento estratégico, ALX Oncology anunció una reducción del 30% en la fuerza laboral, que afecta principalmente a las funciones de investigación preclínica, como parte de los esfuerzos de optimización de recursos. Esta reestructuración, junto con la disminución de las inversiones en investigación preclínica, se espera que extienda el periodo de liquidez de la empresa hasta el cuarto trimestre de 2026.
ALX Oncology (ALXO)는 R&D Day 웹캐스트 이벤트 중 주요 업데이트를 발표하며 임상 파이프라인의 발전을 강조했습니다. 이 회사는 CD47 차단제인 evorpacept의 개발에 집중하고 있으며, 2025년 상반기에 시작될 예정인 유방암 및 대장암에 대한 새로운 임상 시험을 도입하고 있습니다.
회사는 2025년 1분기에 EGFR을 표적하는 새로운 항체-약물 접합체(ADC) 후보인 ALX2004에 대한 IND 신청서를 제출할 계획을 밝혔습니다. ALX2004는 여러 이종 이식 모델에서 강력한 항종양 활성을 보여주었습니다.
전략적 조치로, ALX Oncology는 자원 최적화 노력의 일환으로 주로 전임상 연구 기능에 영향을 미치는 30% 인력 감축을 발표했습니다. 이 구조조정은 전임상 연구 투자 감소와 함께 회사의 현금 소진 기간을 2026년 4분기까지 연장할 것으로 예상됩니다.
ALX Oncology (ALXO) a annoncé des mises à jour clés lors de son événement webcast R&D Day, mettant en évidence l'avancement de son pipeline clinique. L'entreprise se concentre sur le développement de evorpacept, un bloqueur de CD47, et introduit de nouveaux essais cliniques dans les cancers du sein et colorectal, qui devraient commencer au premier semestre 2025.
L'entreprise a révélé des plans pour soumettre une demande IND pour ALX2004, leur nouveau candidat de conjugué anticorps-médicament (ADC) ciblant l'EGFR, au premier trimestre 2025. ALX2004 a montré une puissante activité antitumorale dans plusieurs modèles de xénogreffes.
Dans un mouvement stratégique, ALX Oncology a annoncé une réduction de 30 % de ses effectifs, touchant principalement les fonctions de recherche préclinique, dans le cadre des efforts d'optimisation des ressources. Cette restructuration, ainsi que la diminution des investissements dans la recherche préclinique, devrait prolonger la durée de liquidités de l'entreprise jusqu'au quatrième trimestre 2026.
ALX Oncology (ALXO) hat während seines R&D Day-Webcast-Events wichtige Updates bekanntgegeben und die Fortschritte in seiner klinischen Pipeline hervorgehoben. Das Unternehmen konzentriert sich auf die Entwicklung von evorpacept, einem CD47-Blocker, und führt neue klinische Studien zu Brust- und Dickdarmkrebs ein, die voraussichtlich im ersten Halbjahr 2025 beginnen werden.
Das Unternehmen gab Pläne bekannt, im ersten Quartal 2025 einen IND-Antrag für ALX2004, ihren neuartigen EGFR-zielgerichteten Antikörper-Wirkstoff-Konjugat (ADC)-Kandidaten, einzureichen. ALX2004 hat in mehreren Xenotransplantationsmodellen eine starke antitumorale Aktivität gezeigt.
In einem strategischen Schritt kündigte ALX Oncology eine 30%ige Reduzierung der Belegschaft an, die hauptsächlich die präklinische Forschungsfunktion betrifft, als Teil der Bemühungen zur Optimierung von Ressourcen. Diese Umstrukturierung, zusammen mit einem Rückgang der Investitionen in die präklinische Forschung, wird voraussichtlich die finanzielle Laufzeit des Unternehmens bis zum vierten Quartal 2026 verlängern.
- Extended cash runway into Q4 2026
- New clinical trials expansion into breast and colorectal cancers
- IND submission for new ADC candidate ALX2004 in Q1 2025
- 30% workforce reduction
- Substantial decrease in preclinical research investments
Insights
ALX Oncology's announcement represents a significant strategic realignment with both positive and challenging elements. The company is extending cash runway into Q4 2026 through workforce reductions (approximately 30%) and resource optimizations, primarily affecting preclinical research. This financial decision, while difficult, demonstrates prudent capital management for a small-cap biotech (
The pipeline prioritization strategy focuses resources on advancing evorpacept into additional clinical trials for breast and colorectal cancers in H1 2025, while maintaining momentum on existing trials. This targeted approach allows ALX to pursue multiple potential regulatory paths simultaneously, including their ASPEN-03/04 studies in head and neck cancer and ASPEN-06 in gastric cancer.
The planned IND submission for ALX2004 (EGFR-targeted ADC) in Q1 2025 represents potential pipeline diversification beyond evorpacept. The company appears to be making calculated trade-offs - sacrificing preclinical research capacity to fund clinical advancement of their most promising assets, effectively transitioning from discovery to development-stage focus.
From a financial perspective, this restructuring reflects the challenging funding environment for early-stage biotechs, but demonstrates management's willingness to make difficult decisions to preserve capital while still advancing key value-driving programs.
ALX's clinical development strategy demonstrates strategic positioning within promising therapeutic areas. The company is leveraging evorpacept's CD47-blocking mechanism to potentially enhance antibody therapies against established cancer targets - specifically trastuzumab in HER2+ breast cancer and cetuximab in colorectal cancer. This approach has scientific merit as CD47 blockade can reduce the "don't eat me" signal that protects cancer cells from immune clearance, potentially amplifying the efficacy of these standard therapies.
The company's decision to pursue HER2+ breast cancer is particularly noteworthy given the competitive landscape dominated by established ADCs like trastuzumab deruxtecan (Enhertu). Unlike those direct-killing approaches, evorpacept's immune-enhancing mechanism could theoretically work synergistically with existing therapies.
The ALX2004 program represents entry into the highly competitive ADC space. While described as potentially "best- and first-in-class," specific differentiating details about the EGFR-targeting approach aren't provided. EGFR remains a clinically validated target with significant unmet need despite existing therapies.
The company's resource reallocation reflects a necessary evolution from research to clinical development, though the
- 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
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. ET
Webcast Access: https://edge.media-server.com/mmc/p/yfucf8t5
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 www.alxoncology.com 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 Consultant
ewebb@alxoncology.com
Media Contact:
Audra Friis, Sam Brown, Inc.
audrafriis@sambrown.com
(917) 519-9577
FAQ
When will ALX Oncology (ALXO) initiate new clinical trials for evorpacept in breast and colorectal cancer?
What is the expected cash runway for ALX Oncology (ALXO) following the workforce reduction?
How many employees will be affected by ALXO's workforce reduction?
When does ALX Oncology (ALXO) plan to submit the IND application for ALX2004?
