Our drug, TRE-515, has a mechanism of action that impacts a wide range of bad-acting cells, reducing their ability to rapidly reproduce. This has the potential to diminish autoimmune flares and slow, or even stop, cancer growth. Our early-stage development pipeline priorities are data-driven, guided by preclinical and clinical progress as well as FDA insights and NIH funding.
Programs in detail
The lead focus is advanced solid tumors, with two featured combination programs. Autoimmune and neurodegeneration programs advance in parallel on the same mechanism.
Clinical: Phase 1A
Advanced Solid Tumors
The ongoing lead program, a US-based, multi-site, Phase 1a, dose escalation trial, successfully reached the maximum tested dose, evaluating TRE-515 as a monotherapy in patients with advanced solid tumors.
Trial Identifier: NCT05055609
Safety
Well tolerated, with no dose-limiting toxicities in any cohort (40 mg to 1440 mg) during dose escalation.
Dose
Rapid oral absorption, over a > 6 hour plasma half-life supporting a once-daily capsule.
Benefit
Multiple patients showed disease control over 200 days, despite aggressive late-stage cancers.
47%
disease control
* 14/30 evaluable patients; RECIST v1.1
$2.0M
NCI grant funded
>35
patients dosed, dose escalation portion complete
Dose exploration and expansion currently underway
Patient One
Stephanie was the first person ever to receive TRE-515. She joined the Phase 1 trial when there was no patient experience with the drug to go on, and she openly shared her experience after months of treatment.
“There are even days that I forget I have cancer.”
“I am able to live more normally. I’m thankful this is an oral medication instead of an infusion. On a daily basis, I’m not as sick feeling, and there are even days that I forget I have cancer. I’m able to travel and drive. I don’t have to have caregivers waiting on me after chemo. With this drug, I feel good the majority of the time.”
Stephanie, first patient to receive TRE-515
* Individual experiences do not establish safety or efficacy
Preclinical: Proof of Concept
Multiple Sclerosis, Optic Neuritis, Crohn’s Disease, and ADEM
TRE-515 modulates the immune-cell activation that drives disease, with significant improvement demonstrated in mouse models.
FDA Expanded Access Clinical Trial
ALS
Amyotrophic lateral sclerosis, aka Lou Gehrig’s disease
TRE-515 has been made available to ALS patients through the FDA Expanded Access pathway.
* Individual experiences do not establish safety or efficacy