Aptevo Therapeutics and Alligator Bioscience to Present Positive Interim Phase 1 Data Evaluating ALG.APV-527 Monotherapy in Multiple Solid Tumor Types, at ESMO Congress 2024
Aptevo Therapeutics (NASDAQ:APVO) and Alligator Bioscience (ATORX) announced positive interim data from the Phase 1 dose escalation trial of ALG.APV-527 in multiple solid tumor types. The results will be presented at the ESMO Congress 2024 in Barcelona, Spain. The poster presentation, titled 'First-in-Human Phase I Dose Escalation Study of ALG.APV-527, a 5T4 Tumor Antigen-Conditional 4-1BB Bispecific Antibody, in Patients with Advanced Solid Tumors,' demonstrates positive safety profiles, signals of biological activity, and patients with lasting stable disease. This marks a significant milestone in the development of ALG.APV-527, a novel bispecific antibody targeting 5T4 tumor antigen and 4-1BB, potentially offering a new treatment option for advanced solid tumors.
Aptevo Therapeutics (NASDAQ:APVO) e Alligator Bioscience (ATORX) hanno annunciato dati provvisori positivi dal trial di dose escalation di Fase 1 di ALG.APV-527 in diversi tipi di tumori solidi. I risultati saranno presentati al Congresso ESMO 2024 a Barcellona, Spagna. La presentazione poster, intitolata 'Studio di Fase I di Dose Escalation First-in-Human di ALG.APV-527, un anticorpo bispecifico 5T4 Tumor Antigen-Conditional 4-1BB, in pazienti con tumori solidi avanzati,' dimostra profili di sicurezza positivi, segnali di attività biologica e pazienti con malattia stabile duratura. Questo segna un'importante pietra miliare nello sviluppo di ALG.APV-527, un nuovo anticorpo bispecifico che mira all'antigene tumorale 5T4 e 4-1BB, offrendo potenzialmente una nuova opzione di trattamento per tumori solidi avanzati.
Aptevo Therapeutics (NASDAQ:APVO) y Alligator Bioscience (ATORX) anunciaron datos interinos positivos del ensayo de escalada de dosis de Fase 1 de ALG.APV-527 en múltiples tipos de tumores sólidos. Los resultados se presentarán en el Congreso ESMO 2024 en Barcelona, España. La presentación en cartel, titulada 'Estudio de Escalado de Dosis de Fase I First-in-Human de ALG.APV-527, un anticuerpo bispecífico 5T4 Tumor Antigen-Conditional 4-1BB, en pacientes con tumores sólidos avanzados,' demuestra perfiles de seguridad positivos, señales de actividad biológica y pacientes con enfermedad estable duradera. Esto marca un hito significativo en el desarrollo de ALG.APV-527, un anticuerpo bispecífico nuevo que se dirige al antígeno tumoral 5T4 y 4-1BB, ofreciendo potencialmente una nueva opción de tratamiento para tumores sólidos avanzados.
Aptevo Therapeutics (NASDAQ:APVO)와 Alligator Bioscience (ATORX)는 긍정적인 중간 데이터를 발표했습니다. 이는 ALG.APV-527의 1상 용량 증량 시험에서 다양한 고형종양 유형에 대해 조사한 결과입니다. 이 결과는 스페인 바르셀로나에서 열리는 ESMO Congress 2024에서 발표될 예정입니다. 'ALG.APV-527의 제1상 용량 증량 연구: 고형종양 환자를 위한 5T4 종양 항원 조건부 4-1BB 이중 특이 항체'라는 제목의 포스터 발표는 긍정적인 안전성 프로파일, 생물학적 활성의 신호, 그리고 지속적인 안정병 환자를 보여줍니다. 이는 5T4 종양 항원과 4-1BB를 표적으로 하는 새로운 이중 특이 항체 ALG.APV-527 개발에 있어 중요한 이정표입니다. 이는 진행된 고형종양에 대한 새로운 치료 옵션을 제공할 수 있습니다.
Aptevo Therapeutics (NASDAQ:APVO) et Alligator Bioscience (ATORX) ont annoncé des données intermédiaires positives issues de l'essai de dose escaladée de Phase 1 de l'ALG.APV-527 concernant plusieurs types de tumeurs solides. Les résultats seront présentés lors du Congrès ESMO 2024 à Barcelone, en Espagne. La présentation poster, intitulée 'Étude de Dose Escaladée de Phase I First-in-Human de l'ALG.APV-527, un anticorps bispécifique conditionnel 4-1BB ciblant l'antigène tumoral 5T4, chez des patients atteints de tumeurs solides avancées,' démontre des profils de sécurité positifs, des signaux d'activité biologique et des patients avec une maladie stable durable. Cela représente une étape importante dans le développement de l'ALG.APV-527, un nouvel anticorps bispécifique ciblant l'antigène tumoral 5T4 et le 4-1BB, offrant potentiellement une nouvelle option de traitement pour les tumeurs solides avancées.
Aptevo Therapeutics (NASDAQ:APVO) und Alligator Bioscience (ATORX) haben positive Zwischenresultate aus der Phase-1-Dosiserhöhung-Studie zu ALG.APV-527 bei verschiedenen soliden Tumorarten bekannt gegeben. Die Ergebnisse werden auf dem ESMO Congress 2024 in Barcelona, Spanien, präsentiert. Die Posterpräsentation mit dem Titel 'First-in-Human Phase I Dosiserhöhungsstudie zu ALG.APV-527, einem 5T4 Tumorantigen-bedingen 4-1BB bispezifischen Antikörper, bei Patienten mit fortgeschrittenen soliden Tumoren' zeigt positive Sicherheitsprofile, Hinweise auf biologische Aktivität und Patienten mit langanhaltend stabiler Erkrankung. Dies stellt einen bedeutenden Meilenstein in der Entwicklung von ALG.APV-527 dar, einem neuartigen bispezifischen Antikörper, der auf das 5T4 Tumorantigen und 4-1BB abzielt und potenziell eine neue Behandlungsoption für fortgeschrittene solide Tumoren bietet.
- Positive interim data from Phase 1 dose escalation trial of ALG.APV-527
- Demonstration of positive safety profiles in patients with advanced solid tumors
- Signals of biological activity observed in the trial
- Patients showing lasting stable disease
- Presentation of results at a major oncology conference (ESMO Congress 2024)
- None.
SEATTLE WA and LUND, SWEDEN / ACCESSWIRE / September 13, 2024 / Aptevo Therapeutics ("Aptevo") (NASDAQ:APVO) and Alligator Bioscience AB ("Alligator") (ATORX) today announced that positive interim data from the dose escalation phase of their Phase 1 trial evaluating ALG.APV-527 will be presented in a poster session on Saturday, September 14, 2024, at the European Society for Medical Oncology (ESMO) Annual Congress 2024, taking place September 13 th - 17 th , 2024 in Barcelona, Spain.
Presentation Details
Poster number: #668P
Title: First-in-Human Phase I Dose Escalation Study of ALG.APV-527, a 5T4 Tumor Antigen-Conditional 4-1BB Bispecific Antibody, in Patients with Advanced Solid Tumors, Demonstrates Positive Safety, Signals of Biological Activity and Patients with Lasting Stable Disease
Presenter: Thomas Marron, MD, PhD
Date/Time: Saturday, September 14 th
About the Trial
The ALG.APV-527 Phase 1 trial is a multi-center, multi-cohort, open-label dose-escalation trial that will include administration of ALG.APV-527 up to sixescalating dose levels in a 3+3 design*. The trial will be conducted at up to 10 sites in the U.S. and will enroll adult patients with multiple solid tumor types/histologies likely to express the 5T4 antigen. ALG.APV-527 will be given intravenously once every two weeks. The trial will assess the safety and tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of ALG.APV-527.
*The 3+3 design proceeds in cohorts of three patients treated at increasing dose levels. Dose escalation stops when at least two out of three or six patients experience dose limiting toxicities (DLTs) at that dose level.
About ALG.APV-527
ALG.APV-527 is a bispecific conditional 4-1BB agonist, only active upon simultaneous binding to 4-1BB and 5T4. This has the potential to be clinically important because 4-1BB can stimulate the immune cells (antitumor-specific T cells and NK cells) involved in tumor control, making 4-1BB a particularly compelling target for cancer immunotherapy. 5T4 is an oncofetal tumor associated antigen overexpressed on numerous solid tumors including non-small-cell lung carcinoma (NSCLC), breast, head and neck, cervical, renal, gastric, and colorectal cancer.
Preclinical studies, highlighting the differentiated design of the molecule that minimizes systemic immune activation, allowing for highly efficacious tumor-specific responses as demonstrated by potent activity in preclinical models, has been published in the peer-reviewed publication, Molecular Cancer Therapeutics , a journal of the American Association for Cancer Research (AACR).
About Aptevo Therapeutics
Aptevo Therapeutics Inc. is a clinical-stage biotechnology company focused on developing novel bispecific immunotherapies for the treatment of cancer. Aptevo is seeking to improve treatment outcomes and transform the lives of cancer patients. For more information, please visit www.aptevotherapeutics.com.
About Alligator Bioscience
Alligator Bioscience AB is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs. Alligator's portfolio includes several promising drug candidates, with the CD40 agonist mitazalimab as its key asset. Furthermore, Alligator is co-developing ALG.APV-527 with Aptevo Therapeutics Inc., several undisclosed molecules based on its proprietary technology platform, Neo-X-Prime™, and novel drug candidates based on the RUBY™ bispecific platform with Orion Corporation. Out-licensed programs include AC101/HLX22, in Phase 2 development, by Shanghai Henlius Biotech Inc. and an undisclosed target to Biotheus Inc.
Alligator Bioscience's shares are listed on Nasdaq Stockholm (ATORX) and is headquartered in Lund, Sweden. For more information, please visit alligatorbioscience.com.
For additional information, please contact:
Aptevo Therapeutics
Miriam Weber Miller
Aptevo Therapeutics
IR@apvo.com or millerm@apvo.com
+1 (206) 859 6629
Alligator Bioscience
Corporate
Søren Bregenholt, CEO
soren.bregenholt@alligatorbioscience.com
+46 46-540 82 00
Media
Sam Cage
Cohesion Bureau
sam.cage@cohesionbureau.com
+45 24 37 63 42
Investors
Frank Hoerning Andersen
Cohesion Bureau
frank.hoerning@cohesionbureau.com
+45 25 66 86 02
Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, without limitation, Aptevo's expectations about the activity, efficacy, safety and tolerability of its therapeutic candidates and potential use of any such candidates as therapeutics for treatment of disease, whether preclinical studies will be indicative of later stage studies or clinical trials, whether biomarker analyses will continue to confirm biological activity of ALG.APV-527, whether higher dose ranges will result in increased signs of clinical activity, whether further study of ALG.APV-527 across a cross section of multiple tumor types will continue to show clinical benefit, whether Aptevo's final trial results will vary from its preliminary or interim assessments, the possibility and timing of preliminary or interim data readouts for ALG.APV-527, statements related to the progress of and enthusiasm for Aptevo's clinical programs, its expectations regarding the effectiveness of its ADAPTIR and ADAPTIR-FLEX platforms, and any other statements containing the words "may," "continue to," "believes," "expects," "optimism," "potential," "designed," "promising," "plans," "will" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Aptevo's current intentions, beliefs, and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo's expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement.
There are several important factors that could cause Aptevo's actual results to differ materially from those indicated by such forward-looking statements, including a deterioration in Aptevo's business or prospects; further assessment of preliminary data or different results from later clinical trials; adverse events and unanticipated problems, adverse developments in clinical development, including unexpected safety issues observed during a clinical trial; and changes in regulatory, social, macroeconomic and political conditions. For instance, actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the uncertainties inherent in the results of preliminary data and preclinical studies being predictive of the results of later-stage clinical trials, initiation, enrollment and maintenance of patients, and the completion of clinical trials, the availability and timing of data from ongoing clinical trials, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners or raise funds on acceptable terms or at all and other matters that could affect the availability or commercial potential of Aptevo's product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the coronavirus (referred to as COVID-19), geopolitical risks, including the current war between Russia and Ukraine and the rising conflict in the Middle East, and macroeconomic conditions such as economic uncertainty, rising inflation and interest rates, increased market volatility and decreased consumer confidence. These risks are not exhaustive, Aptevo faces known and unknown risks. Additional risks and factors that may affect results are set forth in Aptevo's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and its subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Aptevo's expectations in any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not assume any obligation to update any forward-looking statement to reflect new information, events, or circumstances.
SOURCE: Aptevo Therapeutics
View the original press release on accesswire.com
FAQ
What are the key findings of the ALG.APV-527 Phase 1 trial presented at ESMO 2024?
What is ALG.APV-527 and what does it target?
When and where will Aptevo Therapeutics (APVO) present the ALG.APV-527 trial results?
What is the significance of the ALG.APV-527 trial results for Aptevo Therapeutics (APVO)?
