Teon Therapeutics Announces FDA Acceptance of IND Application for Novel, Oral Immune Checkpoint Inhibitor, TT-816

First-in-class, oral cannabinoid CB2 antagonist acting as an immune checkpoint inhibitor has potential to enhance immune response to treat solid tumors Company on track to initiate Phase 1/2 clinical trial in third quarter 2022 SAN FRANCISCO, June 1, 2022 – Teon Therapeutics (Teon), a clinical-stage biopharmaceutical company targeting metabolic signaling pathways and pioneering the development of G-Protein Coupled Receptor (GPCR) immuno-oncology therapies in difficult-to-treat cancers, today announced the acceptance by the U.S. Food and Drug Administration (FDA) of Teon’s Investigational New Drug (IND) application for the study of TT-816. TT-816 is a novel, oral cannabinoid CB2 receptor antagonist acting as an immune checkpoint inhibitor for the treatment of a broad range of solid tumors. The IND enables Teon to initiate its planned Phase 1/2 clinical trial designed to assess the dosing, tolerability and safety of TT-816 in patients with advanced cancers as a monotherapy and in combination with existing standard of care anti-PD-1 checkpoint inhibitors. “The FDA’s acceptance of the IND for TT-816 is an important validation of our approach to targeting a novel immune checkpoint pathway and marks a significant milestone for Teon,” said Serge Messerlian, Chief Executive Officer of Teon. “As a highly-selective orally-administered checkpoint inhibitor, we believe that TT-816 has the promise to change the treatment landscape in many difficult-to-treat cancers, including lung, renal, and ovarian, and we are very pleased to begin evaluating its potential in the clinic.” The cannabinoid CB2 receptor belongs to the G protein-coupled receptor family. The cannabinoid CB 2 receptor, selectively targeted by TT-816, is a peripheral receptor found predominantly in the immune system and regulates inflammation and the immune response. Elevated CB 2 receptor expression is associated with worse overall survival [1-5] and aggressiveness of cancer. [6,7] Research has shown that CB 2 receptor activation does not have any psychoactive properties unlike CB 1 receptors which are located primarily in the brain. 8 Preclinical results indicate that TT-816 enhances both the effect of NK cell tumor killing and T cell activation in vitro and increases both tumor infiltrating T cells and NK cells in vivo. TT-816 dose-dependently inhibits tumor growth in animal models, has an additive effect with anti-PD-1 in the ‘hot’ tumor model and acts synergistically with anti-PD-1 in the ‘cold’ tumor model where the anti-PD-1 alone had no effect. “TT-816 is a novel immune checkpoint inhibitor that has demonstrated that it may have the potential to enhance both innate and adaptive immunity, synergize antitumor effects with current immune checkpoint inhibitor therapies and directly promote immune cell penetration into solid tumors,” said Lina Yao, MD, PhD, Chief Scientific Officer of Teon. “TT-816 adds to Teon’s strong portfolio of highly-selective small molecules furthering the Company’s aim to advance first- or best-in-class cancer immunotherapies to patients.” Initiation of the Phase 1/2 TT-816 clinical trial is on track for third quarter 2022. About TT-816 TT-816 is a first-in-class, oral cannabinoid CB 2 receptor antagonist acting as an immune checkpoint inhibitor and is highly selective for the CB 2 receptor versus the CB 1 receptor. By inhibiting the actions of the CB 2 receptors found in many difficult-to-treat cancers, including lung, renal, and ovarian, TT-816 has the potential to enhance immune response to treat solid tumors. Targeting GPCR for Oncology – Tomorrow’s Treatments With more than 700 approved drugs currently directed at them, GPCRs are the most commonly utilized target in today’s treatment paradigm, however, their potential in oncology and moreover, immuno-oncology, has yet to be leveraged. GPCRs control a broad range of cellular processes vital to the formation and progression of tumors. Small molecules are the most prevalent modulators of GPCR-targeted therapies. Insights into the roles of GPCRs in the tumor microenvironment and how they modulate both tumorgenerating signal transduction pathways as well as interactions with immune system defense mechanisms may allow the pursuit of more novel GPCR-directed therapies. About Teon Therapeutics Teon Therapeutics is a clinical-stage biopharmaceutical company dedicated to improving the lives of cancer patients by developing a focused portfolio of oral, GPCR-targeted small molecules that inhibit immunosuppressive and cancer-promoting signaling pathways in difficult-to-treat cancers. Teon’s rich pipeline includes adenosine pathway inhibitors as well as a small molecule, cannabinoid CB 2 receptor antagonist acting as an immune checkpoint inhibitor. Teon initiated a Phase1/2 trial with its lead program, TT-702, an A 2B receptor-specific antagonist, in 2021 and expects to initiate a Phase 1/2 trial for TT-816, a cannabinoid CB 2 antagonist in the third quarter 2022. The highly accomplished scientific leadership team are experts in tumor metabolism, cell signaling and GPCR therapeutic design. Teon completed its $30M Series A financing round in February 2021. For more information about Teon Therapeutics, please visit: www.teontherapeutics.com. 1 Chen L., Chen H., Li Y., Li L., Qiu Y., Ren J. Endocannabinoid and ceramide levels are altered in patients with colorectal cancer. Oncol Rep. 2015;1:447–454. 2 Martinez-Martinez E., Gomez I., Martin P., Sánchez A., Román L., Tejerina E., Bonilla F., Merino A.G., de Herreros A.G., Provencio M., et al. Cannabinoids receptor type 2, CB2, expression correlates with human colon cancer progression and predicts patient survival. Oncoscience. 2015;2:131–141. 3 Pérez‐Gómez, E. , Andradas C., Blasco‐Benito S., Caffarel M. M., García‐Taboada E., Villa‐Morales M., et al. 2015. Role of cannabinoid receptor CB2 in HER2 pro‐oncogenic signaling in breast cancer. J Natl Cancer Inst. 2015 Apr 8;107(6):djv077. 4 Tsoukalas N, Giaginis C, Alexandrou P, Tolia M, Binas I, Baxevanos P, et al. 2018 Clinical Significance of Cannabinoid Receptor CB2 Expression in Non Small Cell Lung Cancer (NSCLC), Journal of Thoracic Oncology Vol. 13 No. 10S, S563-S564. 5 Xu S, Ma H, Bo Y, Shao M. The oncogenic role of CB2 in the progression of non-small-cell lung cancer. Biomed Pharmacother. 2019 Sep;117:109080. 6 Fraguas-Sánchez AI, Martín-Sabroso C, Torres-Suárez AI. Insights into the effects of the endocannabinoid system in cancer: A review. Br. J. Pharmacol. 2018, 175(13):2566-2580. 7 Śledziński P, Zeyland J, Słomski R, Nowak A. The current state and future perspectives of cannabinoids in cancer biology. Cancer Med. 2018 Mar;7(3):765-775. 8 Mackie K. Cannabinoid receptors: where they are and what they do. J Neuroendocrinol. 2008 May;20 Suppl 1:10-4. Media Contact: Shani Lewis LaVoieHealthScience Email: [email protected] Phone: 609-516-5761 Stay Connected Stay up to date with our latest news and updates. Success! Email Teon’s goal is working to restore anti-tumor immunity with once-daily, oral cancer medications allowing patients to spend time on what matters most. Follow Follow Quick Links Who We Are Patients Our Science Investors What’s New Careers Our Pipeline Overview TT-816 TT-702 Contact 555 Twin Dolphin Dr, Suite 120 Redwood City, CA 94065 [email protected] Email Us ©2025 – Teon Therapeutics. All Rights Reserved. Privacy Policy | Terms of Use We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept”, you consent to the use of ALL the cookies. We will never sell your personal information. Cookie settings ACCEPT Manage Consent Close Privacy Overview This website uses cookies to improve your experience while you navigate through the website. Out of these cookies, 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 have an effect on your browsing experience. View our full cookie policy: HERE Necessary 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. Cookie Duration Description cookielawinfo-checkbox-advertisement 1 year Set by the GDPR Cookie Consent plugin, this cookie is used to record the user consent for the cookies in the "Advertisement" category . cookielawinfo-checkbox-analytics 11 months This 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-functional 11 months The cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional". cookielawinfo-checkbox-necessary 11 months This 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-others 11 months This 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-performance 11 months This cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance". CookieLawInfoConsent 1 year Records the default button state of the corresponding category & the status of CCPA. It works only in coordination with the primary cookie. laravel_session 30 minutes laravel uses laravel_session to identify a session instance for a user, this can be changed viewed_cookie_policy 11 months The 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 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 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 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. Cookie Duration Description _ga 2 years The _ga cookie, installed by Google Analytics, calculates visitor, session and campaign data and also keeps track of site usage for the site's analytics report. The cookie stores information anonymously and assigns a randomly generated number to recognize unique visitors. _ga_EH5MV2MF7P 2 years This cookie is installed by Google Analytics. _gat_gtag_UA_238867775_1 1 minute Set by Google to distinguish users. _gid 1 day Installed by Google Analytics, _gid cookie stores information on how visitors use a website, while also creating an analytics report of the website's performance. Some of the data that are collected include the number of visitors, their source, and the pages they visit anonymously. Save & Accept

The release as fetched from its publisher. teontherapeutics.com ↗