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

Lund, Sweden and Seattle, Washington, September 13, 2024 – Alligator Bioscience AB (“Alligator”) (Nasdaq Stockholm: ATORX) and Aptevo Therapeutics (“Aptevo”) (Nasdaq: APVO) 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 13th – 17th, 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: Saturday, September 14th, 2024

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 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 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.

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