Obsidian Therapeutics
  • About Us
    • Overview
    • Our Vision
    • Management Team
    • Board of Directors
    • Scientific Advisory Board
    • Investors
  • Our Science
    • Overview
    • Our Pipeline
    • cytoDRiVE® PLATFORM
    • Publications
    • Partners
  • Our Lead Clinical Program
    • Overview
    • For Patients
    • Expanded Access Policy
    • OBX-115
  • News
  • Join Our Team
    • Overview
    • Our Culture
    • Testimonials
    • Benefits
    • Job Postings
  • Contact

News

Back to News
Previous
Next
July 21, 2022

MD Anderson and Obsidian Therapeutics announce FDA Clearance of IND application for novel TIL therapy OBX-115

FDA granted IND clearance for OBX-115, Obsidian’s lead engineered TIL therapy, for the treatment of patients with solid tumors

HOUSTON and CAMBRIDGE, Mass., July 21, 2022 – The University of Texas MD Anderson Cancer Center and Obsidian Therapeutics, Inc. today announced Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for an MD Anderson-sponsored Phase I clinical study of OBX-115, Obsidian’s lead engineered tumor infiltrating lymphocyte (TIL) therapy candidate.

OBX-115 has been developed in collaboration with MD Anderson as part of an agreement announced in 2020. The planned first-in-human single-arm, open-label, Phase I study will evaluate the safety and preliminary efficacy of OBX-115 as monotherapy in adult patients with metastatic melanoma who are relapsed or refractory to prior therapeutic regimens containing anti-PD-1 antibodies.

“There is a significant opportunity to improve the standard of care in melanoma, especially in later line patients and those who have not responded well to immune checkpoint therapies,” said Rodabe Amaria, M.D., associate professor of Melanoma Medical Oncology at MD Anderson and principal investigator of the OBX-115 study. “Preclinical studies suggest OBX-115 has the potential to show efficacy in these patients, and OBX-115 does not require patients to receive concomitant IL2 therapy. We look forward to continuing our collaboration with Obsidian to advance this novel therapy for our patients in need of new treatment options.”

The OBX-115 therapy for the Phase I trial is planned to be manufactured by CTMC, a joint venture between MD Anderson and National Resilience, Inc. CTMC was launched to speed the development and manufacturing of innovative cell therapies for patients with cancer. CTMC researchers, formerly part of MD Anderson’s Therapeutics Discovery division, contributed to the early development of OBX-115.

“The FDA clearance of the IND application for OBX-115 represents an important milestone for Obsidian and our colleagues at MD Anderson, and it is the result of years of commitment to developing a novel class of engineered TILs,” said Paul Wotton, Ph.D., CEO of Obsidian Therapeutics. “We believe OBX-115 therapy has the potential to significantly transform the treatment landscape for patients, bringing broader access to TILs with the elimination of concomitant IL2 therapy, and the potential to achieve improved clinical outcomes.”

Disclosure

MD Anderson is implementing an Institutional Conflict of Interest Management and Monitoring Plan for any research related to this relationship.

About MD Anderson

The University of Texas MD Anderson Cancer Center in Houston ranks as one of the world’s most respected centers focused on cancer patient care, research, education and prevention. The institution’s sole mission is to end cancer for patients and their families around the world. MD Anderson is one of only 53 comprehensive cancer centers designated by the National Cancer Institute (NCI). MD Anderson is No. 1 for cancer in U.S. News & World Report’s “Best Hospitals” rankings. It has been named one of the nation’s top two hospitals for cancer since the rankings began in 1990. MD Anderson receives a cancer center support grant from the NCI of the National Institutes of Health (P30 CA016672).

About OBX-115

OBX-115 is a novel engineered tumor-infiltrating lymphocyte (TIL) therapy armed with regulated membrane-bound IL15 that is designed to remove the need for concomitant IL2 therapy, a toxic and costly requirement for conventional TILs. OBX-115 preclinical data have demonstrated enhanced TIL persistence, potency and improved tumor control compared to unengineered TILs, which is anticipated to improve clinical outcomes in patients suffering from different types of solid tumors.

About Obsidian Therapeutics

Obsidian Therapeutics, Inc. is a clinical biotechnology company pioneering engineered cell and gene therapies to deliver transformative outcomes for patients with intractable diseases. Obsidian’s proprietary cytoDRiVE® technology provides a way to precisely control the timing and level of protein function by using FDA-approved small molecules. Obsidian is headquartered in Cambridge, Mass. The Company has collaborations with Bristol Myers Squibb and Vertex Pharmaceuticals. For more information, please visit www.obsidiantx.com and follow us on LinkedIn and Twitter.

 

Obsidian Therapeutics Media Contact:

Erica Fiorini, Ph.D., or Liz Philips

Russo Partners, LLC

Erica.Fiorini@RussoPartnersLLC.com

Elizabeth.Phillips@russopartnersllc.com

+1 (914) 310-8172

 

MD Anderson Media Contact:

Clayton Boldt, Ph.D.

MD Anderson Public Relations

CRBoldt@MDAnderson.org

713-792-9518

Back to News
Obsidian Therapeutics
  • About Us
  • Our Science
  • Our Lead Clinical Program
  • News
  • Join Our Team
  • Contact

Privacy // Terms of Use
© 2025 Obsidian Therapeutics, Inc. All Rights Reserved.

Our programs, including OBX-115, and cytoDRIVE® Platform are investigational and have not been approved by the FDA or any other regulatory agency.

Our Pipeline Job Postings
We use cookies on our website to optimize your experience, analyze site usage, and to assist with our marketing activities. By continuing to navigate our website, you consent to the use of cookies, our privacy policy and terms of use.
Accept
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