Jumping the Couch

Feb 27, 2024

We met someone the other day who asked us to rate how enthusiastic we are about lead EpicentRx therapies, AdAPT-001 and RRx-001 (nibrozetone), on a scale of 1 to 10.

Had a couch been available at the time we would have jumped up and down on it, Tom Cruise-style, with unbridled enthusiasm and gratitude. LOL 😂

The first reason that AdAPT-001 and RRx-001 (nibrozetone) make us want to jump the couch is that both have demonstrated promising anti-disease activity in the absence of any dose limiting toxicities or related serious adverse events, which patients, and clinical investigators undoubtedly welcome.

Secondly, in a Phase 2 clinical trial, several durable complete and partial responses have been observed with AdAPT-001 plus a checkpoint inhibitor in hard-to-treat tumor types like soft tissue sarcoma and triple negative breast cancer that were previously resistant to all checkpoint inhibitors.

Thirdly, RRx-001 (nibrozetone) is part way through a Phase 3 clinical trial for the treatment of small cell lung cancer (SCLC) in combination with a previously tried – and failed – platinum doublet, which, if it is successful, could lead to marketing approval.

Fourthly, RRx-001 (nibrozetone) was awarded FDA Fast Track designation for its activity as an anti-mucositis agent during the treatment of head and neck cancer in a randomized Phase 2a clinical trial called PREVLAR.

Fifthly, both may protect normal tissues from the toxicities of standard therapies like immunotherapy in the case of AdAPT-001 and like chemotherapy, radiation therapy, targeted therapy, and immunotherapy in the case of RRx-001 (nibrozetone).

Sixthly, both wholly owned EpicentRx therapies are not only patent-protected but also first-in-class since RRx-001 (nibrozetone) comes from the aerospace and defense industry, where its closest relative is a component of rocket fuel, and the oncolytic adenovirus AdAPT-001 carries a never-before-used transforming growth factor beta (TGF-β) trap that binds to and neutralizes the jack-of-all-trades cytokine, TGF-β, which many tumors overexpress.

In the end, however indecorous it may seem for seasoned pharmaceutical professionals like us to jump the couch out of enthusiasm and gratitude, at least we didn’t jump the shark, which looks WAY harder and more dangerous, as shown below in this clip from the 1977 sitcom, Happy Days.