Breakthrough Clinical Trial: First Patient Receives Dose of Revolutionary Drug ALG.APV-527 from Alligator Bioscience and Aptevo Therapeutics

Alligator Bioscience AB and Aptevo Therapeutics are delighted to announce that the first patient has been dosed in the companies’ Phase 1 trial of ALG.APV-527, with the aim of treating solid tumors that express the tumor-associated antigen 5T4. This groundbreaking bispecific antibody combines a tumor-directed 4-1BB agonistic effect with the power to mobilize antitumor-specific T cells and NK cells involved in tumor control, opening up a new era of promise for cancer patients.

We are delighted to share news of the initiation of a clinical trial for ALG.APV-527 in patients with solid tumors that express the 5T4 antigen. This marks the beginning of Aptevo’s second clinical program, allowing us to develop effective treatments for both solid tumors and hematological malignancies. Preclinical studies have shown ALG.APV-527 to be a promising option in terms of safety and efficacy, with the potential to activate key immune cell populations in the tumor microenvironment. We anticipate the first results of the trial to be available in 2023, and are thrilled to be able to offer this new therapeutic candidate to patients in need.

Alligator Bioscience is thrilled to announce the launch of its Phase 1 first-in-human study for ALG.APV-527, a testament to the success of its partnership with Aptevo. This marks Alligator’s third asset in clinical development and is especially exciting as it has the potential to offer a broad therapeutic window and superior safety and efficacy profile compared to other 4-1BB agonists. We look forward to the results of this study and its promise for the future.

The ALG.APV-527 Phase 1 trial is an exciting, multi-center, open-label study that will be conducted in up to 10 sites across the United States. This 3+3 design trial will assess the safety, tolerability, pharmacokinetic, pharmacodynamic and preliminary anti-tumor activity of intravenously administered ALG.APV-527 in adult patients with multiple solid tumor types, including non-small cell lung cancer, gastric/gastro-esophageal cancer, and head and neck cancer. Join us in this revolutionary study as we explore new possibilities in cancer treatment.

About ALG.APV-527

ALG.APV-527 is a game-changing bispecific conditional 4-1BB agonist, designed to be activated only upon simultaneous binding to 4-1BB and 5T4. This breakthrough in cancer immunotherapy has the potential to treat a wide range of solid tumors, such as NSCLC, breast, head and neck, cervical, renal, gastric, and colorectal cancer, by stimulating the antitumor-specific T cells and NK cells involved in tumor control. This remarkable combination of 4-1BB and 5T4 offers unprecedented hope to those suffering from these types of cancers.

Recent preclinical studies, published in the prestigious Molecular Cancer Therapeutics journal of the American Association for Cancer Research (AACR), have highlighted the unique and differentiated design of ALG.APV-527 molecule. This design has enabled minimal systemic immune activation, whilst demonstrating potent tumor-specific responses in preclinical models.

About Alligator Bioscience

Alligator Bioscience AB is a pioneering biotechnology company that is leading the charge in developing life-saving tumor-directed immuno-oncology therapies. With its flagship CD40 agonist mitazalimab, Alligator’s drug portfolio also includes co-developed ALG.APV-527 with Aptevo Therapeutics Inc., new molecules based on its proprietary Neo-X-Prime™ platform, and drugs powered by the RUBY™ bispecific platform with Orion Corporation. Alligator’s out-licensed programs include the Phase 2 AC101/HLX22 developed by Shanghai Henlius Biotech Inc. and an undisclosed target by Biotheus Inc., which promise to revolutionize the way cancer is treated.

About Aptevo Therapeutics

Aptevo Therapeutics Inc. is revolutionizing cancer care and transforming the lives of patients with its innovative bispecific immunotherapies. This clinical-stage biotechnology company is dedicated to developing groundbreaking treatments and improving outcomes for those afflicted with cancer. Aptevo is leading the way in creating a brighter future for cancer patients everywhere.

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