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AiViva Biopharma has been recognized by Life Sciences Review Magazine as the exclusive recipient of “Top 20 Clinical-Stage Biopharmaceutical Companies - 2022,” based on our proprietary methodology, reflecting its position in the industry. This profile has been developed by the Life Sciences Review research and editorial team based on insights from an interview with , .

AiViva Biopharma
Pioneering Transformational Treatments with Prolonged Therapeutic Effects

AiViva Biopharma

Diane Tang-Liu, CEO and President, AiViva BiopharmaDiane Tang-Liu, CEO and President
A group of seasoned pharmaceutical industry veterans laid the foundation of AiViva Biopharma in 2015. Their mission was to address select diseases that lacked safe, long-lasting, and effective treatments in eye, skin, and cancer. AiViva has been developing novel, innovative therapies that can be delivered at the site of the disease to improve the effectiveness and decrease the side effects commonly seen for drugs taken orally. The company is dedicated to developing drug products with prolonged therapeutic effects—whose time of drug administration varies between three to six months. This reduces the treatment burden for both patients and physicians and improves the treatments’ benefit-risk profile.

AiViva has identified multiple novel drug candidates to treat major diseases that are associated with overgrowth of blood vessels and cells and scarring. “We aim to provide a complete cure as opposed to most commonly seen partially satisfactory therapies that address only a portion/ symptom of the disease in question. In fact, the foundation of AiViva was laid after realizing that the existing products in the market and competitive products in development were partially addressing the disease, for example, blood vessel overgrowth, without taking into account all the factors that account for the disease.

AiViva has developed a proprietary JEL™ Technology that will allow placing the drug directly at the site of disease and forming a drug depot for prolonged drug release, thereby delivering an effective therapy. This JEL™ Technology is unique because it enables the delivery medium to be a liquid at room temperature, and upon injection into the diseased tissue, it transformed into a jello-like mass. This drug-containing “jello,” serves as a focal depot, immerses into the diseased tissue, and releases the drug over time. For example, if the drug is injected into the skin, the “jello” stays where it is placed and slowly dissolves over time.

Because of the “focal” placement, the drug will focus on treating the disease in the skin without affecting other body parts.

In a nutshell, the easy administration, drug depot, and no side effects in other body parts make Aiviva’s JEL™ technology novel and suitable for medical use.

It has been observed that AiViva’s drug delivered in the JEL™ can shrink human tumors in animal cancer models in contrast to a continuous, slow tumor growth when the same drug was administered orally.

AiViva employs a team with deep experience in developing drugs using animal models, manufacturing investigational products, conducting human trials, and working with the FDA for approval. These experts use their extensive expertise to develop their own intellectual property and protected/save their drugs for use in many major countries, including the US.

The company has developed two drugs—AIV007 that would be ideal for treating specific eye disorders and tumors, and AIV001 that can treat wound healing at a site of injury, skin cancer, and other skin diseases. AiViva has advanced these two compounds (AIV007 & AIV001) to human testing. The company has completed three human trials that give them information that their drugs have promise in treating disease and may be safe for human use. Their next steps will be to determine the best diseases to be studied for their drugs and how best to test them in bigger trials. Their plan is to generate enough data to file with the US regulatory agency (FDA) within the next five years.

AiViva has developed a proprietary JEL™ Technology that will allow placing the drug directly at the site of disease and forming a drug depot for prolonged drug release thereby delivering an effective therapy


Today, AiViva has a diverse pipeline of multiple drug products at various stages of investigation. Its strategy is to protect these drugs by ensuring global market exclusivity so the company owns the rights and continues to generate data that provides strong evidence that they will work in humans. The company continues to seek drugs that will benefit humans by improving how well they work, reducing side effects, and decreasing the overall treatment burden for patients and doctors that treat these patients.

AiViva Biopharma News

AiViva Biopharma Completes Enrollment in a Phase 1 Clinical Trial of AIV007 for Age-Related Macular Degeneration and Diabetic Macular Edema

Monday, September 16, 2024

Novel JEL™ Technology for Periocular Administration
COSTA MESA -
AiViva Biopharma Inc., announced that it has fully enrolled and completed dosing the last patient in a Phase 1 trial with wet age-related macular degeneration (wAMD), and/or diabetic macular edema (DME). “We have achieved a major milestone, full enrollment in our Phase 1, Safety Trial in the U.S.” said Diane Tang-Liu, PhD, CEO, President & Co-Founder of AiViva Biopharma. “AIV007 (lenvatinib) is a broad-spectrum tyrosine kinase inhibitor, targeting the convergence of fibrosis, angiogenesis, and inflammation. We believe AIV007, formulated with our proprietary JEL™ technology and administered periocularly, has the potential to address the root causes of wet AMD, DME and many other ocular diseases. We are on target to have the study completed, and full results Q1 2025.”
This Phase 1 trial is a multicenter, open-label, dose-escalation safety clinical trial, with 18 subjects, who have received a single periocular injection of AIV007 and will undergo monthly evaluation for up to 6 months to assess safety, tolerability, biological activity, and the reduction of treatment burden.

Top 20 Clinical-Stage Biopharmaceutical Companies - 2022
Current Issue

Company : AiViva Biopharma

Management
Diane Tang-Liu, CEO and President

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