As you may have noticed, EpicentRx is a company on the move.
From the award of FDA Fast Track status for RRx-001 as an anti-oral mucositis agent to invited talks at premier venues like the AD/PD conference in Gothenburg, Sweden and the World Parkinson Congress in Barcelona, Spain, EpicentRx continues to make a splash wherever it goes. Also, in June the company pilgrimaged to ASCO in Chicago, the mecca of all cancer conferences, where it presented on its lead candidates, RRx-001 and AdAPT-001. From ASCO, members of the company traveled directly to BIO in Boston for productive back-to-back partnering meetings with several large pharmaceutical companies.
In addition to the award of FDA Fast Track status, EpicentRx also announced the assignment of a new generic name for RRx-001, nibrozetone, to indicate that it is a first-in-class small molecule, which does not resemble any approved products or fit into any established categories. As an officially recognized first-in-class drug, nibrozetone (RRx-001) will command a price premium on approval. This announcement comes at an opportune time for EpicentRx as nibrozetone (RRx-001), hopefully, nears approval in either small cell lung cancer, and/or severe oral mucositis during the treatment of head and neck cancer.
Another huge milestone for the company was the completion of the Phase 1 first-in-man (FIM) clinical trial for AdAPT-001, the modified adenovirus that carries a TGF-β trap. This FIM trial established that AdAPT-001 was not only safe and well tolerated, but also active as a single agent in a range of hard-to-treat tumor types like sarcoma. Enrollment to a Phase 2 trial with AdAPT-001 +/- an immune checkpoint inhibitor is ongoing.
Read more about some recent clinical progress updates given around ASCO, our write up in Drug Discovery and Development, and watch CEO, Tony Reid, M.D. PhD, and CDO, Bryan Oronsky, M.D. PhD, in a video interview with Oncology Tube about RRx-001.
And as always, please continue to check out the always entertaining and timely EpicentRx blog, now entering its second year, with over 50 posts to date on a range of topics from midichlorians to the microbiome and to musicians like Taylor Swift that are (mostly) relevant to the company. The blog is supported by MCS, a healthcare-related PR firm, which repurposes the content for Twitter and LinkedIn to raise the company’s profile.
Finally, we’re excited to share our team has been published in four new peer-reviewed publications: learn more below! Stay tuned for more exciting updates in the next newsletter.
Thank you for taking the time catch up with us,
The EpicentRx Team
- AdAPT-001 oncolytic adenovirus shows promising phase 1 cancer treatment results. Drug Discovery and Development. June 8, 2023.
- Molecule RRx-001 Receives Fast Track Designation From the FDA – EpicentRx. Oncology Tube. May 22, 2023.
- United States Adopted Name (USAN) Council and International Nonproprietary Names (INN) Expert Committee Recognizes New Therapeutic Class by Granting “nibrozetone” as New Generic Name for EpicentRx’s Lead Small Molecule NLRP3 Inhibitor, RRx-001. EpicentRx press release. July 6, 2023.
- EpicentRx Presents Updates on its Oncology Clinical Development Programs at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. EpicentRx press release. June 7, 2023.
- EpicentRx Receives Fast Track Designation from the U.S. FDA for Lead Asset, RRx-001, to Prevent/Attenuate Chemotherapy and Radiation Treatment Induced Severe Oral Mucositis.. EpicentRx press release. March 29, 2023.
- A Local and Abscopal Effect Observed with Liposomal Encapsulation of Intratumorally Injected Oncolytic Adenoviral Therapy. Cancers. June 12, 2023. June 12, 2023.
- A multicenter, phase 1, dose escalation clinical trial (G-FORCE-1) of XRT, RRx-001 and temozolomide followed by temozolomide +/- RRx-001 in newly diagnosed glioblastoma. Frontiers in Oncology. June 5, 2023.
- RRx-001: a chimeric triple action NLRP3 inhibitor, Nrf2 inducer, and nitric oxide superagonist. Frontiers in Oncology. May 29, 2023.
- Data Management 101 for Drug Developers: A Peek Behind the Curtain. Clinical and Translational Science (CTS). June 29, 2023.