ALX Oncology Receives IND Clearance from U.S. FDA for ALX2004, a Novel EGFR-targeted Antibody-drug Conjugate
ALX Oncology (ALXO) has received FDA clearance for its Investigational New Drug (IND) application for ALX2004, a potential first-in-class antibody-drug conjugate (ADC) for treating EGFR-expressing solid tumors. The company plans to initiate Phase 1 clinical trials in mid-2025, with initial safety data expected in 1H 2026.
ALX2004, developed entirely in-house using the company's proprietary linker-payload platform, targets EGFR - a transmembrane protein overexpressed in various cancers including breast, colorectal, head and neck, and non-small cell lung cancer. The drug is designed to optimize targeted delivery of chemotherapy to tumor cells while minimizing systemic toxicity.
The molecule features an engineered antibody backbone for optimized anti-EGFR activity, enhanced stability linker, and a proprietary topoisomerase I payload capable of generating an enhanced bystander effect. An R&D call focused on ALX2004 is planned for Q2 2025.
ALX Oncology (ALXO) ha ricevuto l'approvazione della FDA per la sua domanda di Nuovo Farmaco Investigativo (IND) per ALX2004, un potenziale anticorpo-coniugato farmaco (ADC) di prima classe per il trattamento dei tumori solidi che esprimono EGFR. L'azienda prevede di avviare gli studi clinici di Fase 1 a metà del 2025, con i primi dati di sicurezza attesi nella prima metà del 2026.
ALX2004, sviluppato interamente internamente utilizzando la piattaforma proprietaria di linker-payload dell'azienda, mira a colpire l'EGFR - una proteina di membrana trasversale sovraespressa in vari tumori, tra cui il cancro al seno, il cancro colorettale, i tumori della testa e del collo e il cancro polmonare non a piccole cellule. Il farmaco è progettato per ottimizzare la somministrazione mirata di chemioterapia alle cellule tumorali, riducendo al contempo la tossicità sistemica.
La molecola presenta una struttura di anticorpo ingegnerizzata per un'attività anti-EGFR ottimizzata, un linker di stabilità migliorata e un payload proprietario di topoisomerasi I in grado di generare un effetto di bystander potenziato. È prevista una chiamata di R&S incentrata su ALX2004 per il secondo trimestre del 2025.
ALX Oncology (ALXO) ha recibido la aprobación de la FDA para su solicitud de Nuevo Medicamento en Investigación (IND) para ALX2004, un potencial anticuerpo-conjugado de fármacos (ADC) de primera clase para el tratamiento de tumores sólidos que expresan EGFR. La compañía planea iniciar ensayos clínicos de Fase 1 a mediados de 2025, con los primeros datos de seguridad esperados en la primera mitad de 2026.
ALX2004, desarrollado completamente internamente utilizando la plataforma propietaria de linker-payload de la empresa, tiene como objetivo el EGFR, una proteína transmembrana sobreexpresada en varios cánceres, incluidos el cáncer de mama, colorrectal, de cabeza y cuello, y el cáncer de pulmón no microcítico. El fármaco está diseñado para optimizar la entrega dirigida de quimioterapia a las células tumorales, minimizando la toxicidad sistémica.
La molécula presenta un esqueleto de anticuerpo diseñado para una actividad anti-EGFR optimizada, un linker de estabilidad mejorada y un payload propietario de topoisomerasa I capaz de generar un efecto de bystander mejorado. Se planea una llamada de I+D centrada en ALX2004 para el segundo trimestre de 2025.
ALX Oncology (ALXO)는 ALX2004에 대한 임상 시험 신약 신청(IND)이 FDA의 승인을 받았습니다. ALX2004는 EGFR을 발현하는 고형 종양을 치료하기 위한 잠재적인 최초의 항체-약물 접합체(ADC)입니다. 이 회사는 2025년 중반에 1상 임상 시험을 시작할 계획이며, 초기 안전성 데이터는 2026년 상반기에 예상됩니다.
ALX2004는 회사의 독점적인 링커-페이로드 플랫폼을 사용하여 내부에서 완전히 개발되었으며, EGFR을 표적으로 합니다. EGFR은 유방암, 대장암, 두경부암 및 비소세포 폐암을 포함한 여러 암에서 과발현되는 세포막 단백질입니다. 이 약물은 종양 세포에 대한 화학요법의 표적 전달을 최적화하면서 전신 독성을 최소화하도록 설계되었습니다.
이 분자는 최적화된 항-EGFR 활성을 위한 엔지니어링된 항체 백본, 향상된 안정성 링커 및 향상된 바이스탠더 효과를 생성할 수 있는 독점적인 톱이소머라제 I 페이로드를 특징으로 합니다. ALX2004에 초점을 맞춘 연구 개발 전화가 2025년 2분기에 계획되어 있습니다.
ALX Oncology (ALXO) a reçu l'autorisation de la FDA pour sa demande de Nouveau Médicament Expérimental (IND) pour ALX2004, un potentiel anticorps-conjugué médicamenteux (ADC) de première classe pour le traitement des tumeurs solides exprimant l'EGFR. La société prévoit de commencer des essais cliniques de Phase 1 à la mi-2025, avec des données de sécurité initiales attendues au premier semestre 2026.
ALX2004, entièrement développé en interne à l'aide de la plateforme propriétaire de linker-payload de l'entreprise, cible l'EGFR - une protéine transmembranaire surexprimée dans divers cancers, y compris le cancer du sein, le cancer colorectal, les cancers de la tête et du cou, et le cancer du poumon non à petites cellules. Le médicament est conçu pour optimiser la délivrance ciblée de chimiothérapie aux cellules tumorales tout en minimisant la toxicité systémique.
La molécule présente un squelette d'anticorps conçu pour une activité anti-EGFR optimisée, un linker de stabilité améliorée, et un payload de topoisomérase I propriétaire capable de générer un effet de voisinage amélioré. Un appel de R&D axé sur ALX2004 est prévu pour le deuxième trimestre 2025.
ALX Oncology (ALXO) hat die Genehmigung der FDA für seinen Antrag auf ein Investigational New Drug (IND) für ALX2004 erhalten, ein potenzieller Antikörper-Wirkstoff-Konjugat (ADC) der ersten Klasse zur Behandlung von EGFR-exprimierenden soliden Tumoren. Das Unternehmen plant, Mitte 2025 mit klinischen Phase-1-Studien zu beginnen, wobei erste Sicherheitsdaten in der ersten Hälfte von 2026 erwartet werden.
ALX2004, das vollständig intern mit der firmeneigenen Linker-Payload-Plattform entwickelt wurde, zielt auf EGFR ab – ein transmembranäres Protein, das in verschiedenen Krebsarten, einschließlich Brust-, Kolorektal-, Kopf-Hals- und nicht-kleinzelligem Lungenkrebs, überexprimiert wird. Das Medikament ist darauf ausgelegt, eine gezielte Abgabe von Chemotherapie an Tumorzellen zu optimieren und gleichzeitig die systemische Toxizität zu minimieren.
Das Molekül verfügt über ein optimiertes Antikörpergerüst für eine verbesserte anti-EGFR-Aktivität, einen stabileren Linker und eine proprietäre Topoisomerase-I-Payload, die in der Lage ist, einen verstärkten Bystander-Effekt zu erzeugen. Ein F&E-Call, der sich auf ALX2004 konzentriert, ist für das zweite Quartal 2025 geplant.
- FDA clearance received for IND application, enabling clinical trials to proceed
- First-in-class potential for EGFR-expressing solid tumors treatment
- Fully in-house developed drug using proprietary technology
- Clear development timeline with Phase 1 trials starting mid-2025
- Long wait for initial safety data (1H 2026)
- No proven clinical efficacy yet - only preclinical data available
- Entering a competitive space with existing FDA-approved EGFR treatments
Insights
The FDA's IND clearance for ALX2004 represents a significant regulatory milestone for ALX Oncology, validating their proprietary ADC platform technology and enabling clinical development. This achievement is particularly noteworthy as ALX2004 targets a novel therapeutic opportunity - while EGFR is a well-validated oncology target with multiple approved therapies, there are currently no approved EGFR-targeted ADCs on the market.
ALX has designed this molecule to overcome historical limitations with EGFR-targeted ADCs, specifically addressing the on-target off-tumor toxicities and payload issues that derailed earlier development attempts. The company's approach includes three critical engineering elements: an optimized anti-EGFR antibody backbone, an enhanced stability linker, and their proprietary topoisomerase I inhibitor payload with improved bystander effect capabilities.
The potential therapeutic applications span multiple high-value cancer indications including breast cancer, colorectal carcinoma, head and neck squamous cell carcinoma, and non-small cell lung cancer - all representing significant market opportunities with substantial unmet needs. While the candidate has demonstrated "potent anti-tumor activity" in preclinical models, investors should note that first human data remains approximately a year away, with initial safety results not expected until first half of 2026.
This program complements their lead candidate evorpacept, diversifying ALX's clinical portfolio and potentially creating multiple value-driving catalysts over the coming years. The ability to internally develop a complex modality like an ADC also validates the company's R&D capabilities and suggests platform potential beyond their current disclosed pipeline.
This IND clearance fundamentally strengthens ALX Oncology's competitive position within the highly sought-after ADC space. With a minuscule
The ADC market has witnessed remarkable momentum recently with multiple blockbuster approvals and high-value acquisitions. ALX's potential "first-in-class" positioning for an EGFR-targeted ADC creates a compelling strategic opportunity, especially considering EGFR's established validation as an oncology target.
Internal development capabilities are particularly valuable in the current biotech landscape, and ALX has demonstrated technical proficiency by designing all aspects of ALX2004 in-house - from antibody backbone to linker-payload system. This suggests the company possesses a versatile platform with potential applications beyond their current pipeline.
The company has outlined a clear development timeline with trial initiation in mid-2025 and initial data in 1H 2026. While this represents a relatively long catalyst pathway, the IND clearance itself serves as validation of their scientific approach and should enhance their strategic optionality.
For a micro-cap oncology company, pipeline diversification beyond a single lead asset significantly mitigates clinical development risk. With evorpacept advancing in multiple trials and now ALX2004 entering the clinic, the company has established multiple potential value-creating pathways. This FDA clearance confirms regulatory acceptance of their preclinical package and enables progression to human studies - a critical value inflection point in biotech development.
- 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 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
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