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Aptevo Therapeutics and Alligator Bioscience to Present Additional Positive Interim Phase 1 Data Evaluating ALG.APV-527 Monotherapy in Multiple Solid Tumor Types, at SITC 2024

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Aptevo Therapeutics (NASDAQ:APVO) and Alligator Bioscience (ATORX) announced they will present new positive interim data from their Phase 1 trial of ALG.APV-527 at the SITC 2024 conference. The presentation will showcase results from the dose escalation phase evaluating ALG.APV-527 monotherapy in multiple solid tumor types. The poster presentation, titled 'Preliminary results from a phase I dose escalation study of ALG.APV-527, a 5T4 × 4-1BB bispecific antibody,' will demonstrate favorable safety and biological activity in patients with advanced solid tumors. The presentation is scheduled for November 8, 2024, at SITC 2024 in Houston, Texas.

Aptevo Therapeutics (NASDAQ:APVO) e Alligator Bioscience (ATORX) hanno annunciato che presenteranno nuovi dati intermedi positivi del loro trial di Fase 1 su ALG.APV-527 durante la conferenza SITC 2024. La presentazione mostrerà i risultati della fase di escalazione del dosaggio che valuta la monoterapia con ALG.APV-527 in diversi tipi di tumori solidi. La presentazione del poster, intitolata 'Risultati preliminari di uno studio di escalazione del dosaggio di fase I di ALG.APV-527, un anticorpo bispecifico 5T4 × 4-1BB,' dimostrerà un'attività biologica e di sicurezza favorevole nei pazienti con tumori solidi avanzati. La presentazione è programmata per l'8 novembre 2024, presso il SITC 2024 a Houston, Texas.

Aptevo Therapeutics (NASDAQ:APVO) y Alligator Bioscience (ATORX) anunciaron que presentarán nuevos datos interinos positivos de su ensayo de Fase 1 sobre ALG.APV-527 en la conferencia SITC 2024. La presentación contará con resultados de la fase de escalada de dosis que evalúa la monoterapia de ALG.APV-527 en múltiples tipos de tumores sólidos. La presentación en poster, titulada 'Resultados preliminares de un estudio de escalada de dosis de fase I de ALG.APV-527, un anticuerpo bispecífico 5T4 × 4-1BB,' demostrará una actividad biológica y seguridad favorables en pacientes con tumores sólidos avanzados. La presentación está programada para el 8 de noviembre de 2024, en SITC 2024 en Houston, Texas.

Aptevo Therapeutics (NASDAQ:APVO)와 Alligator Bioscience (ATORX)는 SITC 2024 회의에서 ALG.APV-527의 1상 시험에 대한 새로운 긍정적인 중간 데이터를 발표한다고 발표했습니다. 이 발표는 여러 고형 종양 유형에서 ALG.APV-527 단독요법을 평가하는 용량 증가 단계의 결과를 보여줄 것입니다. 'ALG.APV-527의 1상 용량 증가 연구의 예비 결과, 5T4 × 4-1BB 이중특이성 항체'라는 제목의 포스터 발표는 진행성 고형 종양 환자에서 안전성과 생물학적 활성이 유리하다는 것을 보여줄 것입니다. 발표는 2024년 11월 8일 텍사스주 휴스턴에서 열리는 SITC 2024에서 예정되어 있습니다.

Aptevo Therapeutics (NASDAQ:APVO) et Alligator Bioscience (ATORX) ont annoncé qu'ils présenteront de nouvelles données intermédiaires positives de leur essai de Phase 1 sur l'ALG.APV-527 lors de la conférence SITC 2024. La présentation mettra en avant les résultats de la phase d'escalade des doses évaluant la monothérapie avec l'ALG.APV-527 dans plusieurs types de tumeurs solides. La présentation du poster, intitulée 'Résultats préliminaires d'une étude d'escalade de dose de Phase I sur l'ALG.APV-527, un anticorps bispécifique 5T4 × 4-1BB,' montrera une sécurité et une activité biologique favorables chez les patients présentant des tumeurs solides avancées. La présentation est prévue pour le 8 novembre 2024 lors de la SITC 2024 à Houston, Texas.

Aptevo Therapeutics (NASDAQ:APVO) und Alligator Bioscience (ATORX) haben angekündigt, dass sie auf der SITC 2024 Konferenz neue positive Zwischenresultate aus ihrer Phase-1-Studie zu ALG.APV-527 präsentieren werden. Die Präsentation wird Ergebnisse aus der Dosissteigerungsphase zeigen, in der die Monotherapie mit ALG.APV-527 bei verschiedenen soliden Tumorarten bewertet wird. Die Posterpräsentation mit dem Titel 'Vorläufige Ergebnisse einer Phase-I-Dosissteigerungsstudie zu ALG.APV-527, einem 5T4 × 4-1BB bispezifischen Antikörper' wird eine günstige Sicherheit und biologische Aktivität bei Patienten mit fortgeschrittenen soliden Tumoren demonstrieren. Die Präsentation ist für den 8. November 2024 auf der SITC 2024 in Houston, Texas, angesetzt.

Positive
  • Positive interim Phase 1 data showing favorable safety profile
  • Demonstrated biological activity in advanced solid tumors
  • Successfully progressing through dose escalation phase
Negative
  • None.

SEATTLE WA AND LUND, SWEDEN / ACCESSWIRE / October 29, 2024 / Aptevo Therapeutics ("Aptevo") (NASDAQ:APVO) and Alligator Bioscience AB ("Alligator") (ATORX) today announced that new, 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 Friday, November 8, 2024, at the Society for Immunotherapy of Cancer 2024 (SITC), taking place November 6th - 10th, 2024 in Houston, Texas.

Presentation Details

Poster number: #673

Title: Preliminary results from a phase I dose escalation study of ALG.APV-527, a 5T4 × 4-1BB bispecific antibody, in patients with advanced solid tumors demonstrate favorable safety and biological activity

Presenter: Thomas Marron, MD, PhD

Date/Time: Friday, November 8 th from 12:15-1:45 and 5:30-7:00 PM US Central time.

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 six escalating dose levels in a 3+3 design*. The trial is enrolling 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.

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
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 war between Israel and Hamas, 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 interim Phase 1 results for Aptevo's ALG.APV-527 (APVO) in solid tumors?

The interim Phase 1 results for ALG.APV-527 showed favorable safety and biological activity in patients with advanced solid tumors, as reported in the dose escalation phase of the trial.

When will Aptevo (APVO) present the ALG.APV-527 trial data at SITC 2024?

Aptevo will present the ALG.APV-527 trial data on Friday, November 8, 2024, during two sessions at 12:15-1:45 PM and 5:30-7:00 PM US Central time at SITC 2024 in Houston.

What type of drug is Aptevo's (APVO) ALG.APV-527?

ALG.APV-527 is a 5T4 × 4-1BB bispecific antibody being evaluated as a monotherapy for multiple solid tumor types.

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