Aulos BioscienceAulos Bioscience
  • Our Approach
    • Overview
    • Platform
    • Abstracts and Publications
  • Our Pipeline
    • Overview
  • About Us
    • Overview
    • Leadership
    • Board of Directors
    • Investors
    • Corporate Presentation
  • Newsroom
    • Latest News
    • Media Inquiries
  • Careers
    • Join the team
  • Contact
    • General Inquiries
Search
  • Our Approach
    • Overview
    • Platform
    • Abstracts and Publications
  • Our Pipeline
    • Overview
  • About Us
    • Overview
    • Leadership
    • Board of Directors
    • Investors
    • Corporate Presentation
  • Newsroom
    • Latest News
    • Media Inquiries
  • Careers
    • Join the team
  • Contact
    • General Inquiries
Slide

Newsroom

  • Latest News
  • Media Inquiries

Aulos Bioscience Announces FDA Clearance of IND Application for AU-007, a Novel Immunotherapy for the Treatment of Solid Tumors

AU-007 represents the company’s first program to receive IND clearance

Expansion of Phase 1/2 clinical study into the U.S. marks major milestone for first-ever human trial of a computationally designed human monoclonal antibody for cancer treatment

LARKSPUR, Calif., October 31, 2022 – Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through the development of potentially best-in-class IL-2 therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for AU-007, a monoclonal antibody computationally designed by Biolojic Design. AU-007 leverages a unique approach to harnessing the power of interleukin-2 (IL-2) to eradicate solid tumors. This is the first time that a computationally designed human monoclonal antibody has been cleared for human trials in the United States.

“We are thrilled to have received IND clearance to advance our AU-007 program and expand our Phase 1/2 clinical trial into the United States,” said Aron Knickerbocker, Aulos Bioscience’s chief executive officer. “Receiving IND clearance is a testament to the strength of the preclinical data and initial clinical data from Australia. AU-007’s mechanism of action is unique among all other IL-2 therapeutics in development, and we are excited to pursue the promise of AU-007 in solid tumor cancer care.”

The company’s Phase 1/2 clinical trial (NCT05267626) is an open label, first-in-human study currently enrolling patients in Australia. The study is evaluating the safety, tolerability, immunogenicity and clinical activity of AU-007 in patients with unresectable locally advanced or metastatic cancer. Initial safety results from the ongoing clinical trial will be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting, being held November 8-12, 2022, in Boston, Massachusetts.

About AU-007
AU-007 is a computationally designed, human IgG1 monoclonal antibody that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 leverages IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by T effector cells, from binding to trimeric receptors on T regulatory cells while still allowing IL-2 to bind and expand T effector and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to trimeric receptors on vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

About Aulos
Aulos Bioscience is an immuno-oncology company working to revolutionize cancer patient care through best-in-class IL-2 therapeutics that direct patients’ immune systems toward killing tumor cells. Matching world-class machine learning from co-founder Biolojic Design with an in-depth understanding of the immune system, Aulos’ initial clinical candidate, AU-007, is a computationally designed human antibody that harnesses the power of IL-2 to induce tumor killing while limiting the immunosuppression and toxicities typically associated with this validated pathway. The company was founded by Biolojic Design and ATP with $40 million in Series A funding from ATP and is led by pioneers in the field of artificial intelligence, antibody development and cancer immunotherapies. For more information, visit www.aulosbio.com.

Contact: info@aulosbio.com
Media inquiries: Mike Beyer, Sam Brown Inc. / 312-961-2502 / mikebeyer@sambrown.com

Aulos Bio favicon-32x32

AULOS BIOSCIENCE
700 LARKSPUR LANDING CIRCLE
SUITE 108
LARKSPUR, CA 94939

LinkedIn
twitter
  • Our Approach
  • Overview
  • Platform
  • Abstracts and Publications
  • Our Pipeline
  • Overview
  • About Us
  • Overview
  • Leadership
  • Board of Directors
  • Investors
  • Corporate Presentation
  • Careers
  • Join the Team
  • Newsroom
  • Latest News
  • Media Inquiries
  • Contact
  • General Inquiries
  • Terms of Use
  • Privacy
  • Social Media
  • CA Compliance
© Copyright 2023. All Rights Reserved.
We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept All”, you consent to the use of ALL the cookies. However, you may visit "Cookie Settings" to provide a controlled consent.
Cookie SettingsAccept All
Manage consent

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
Necessary
Always Enabled
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
CookieDurationDescription
cookielawinfo-checkbox-analytics11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-functional11 monthsThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-necessary11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-others11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-performance11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
viewed_cookie_policy11 monthsThe cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Functional
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Performance
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytics
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
Advertisement
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
Others
Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet.
SAVE & ACCEPT