Highlight Therapeutics Reported Positive Cancer Trial Results
The Phase 2b study of BO-112 demonstrated significant response rates in patients with basal cell carcinoma.
Updated on Sept. 30, 2026 in Cancer
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Highlight Therapeutics has reported positive phase 2b trial results for its drug BO-112, which aims to treat resectable primary basal cell carcinoma. The study met its primary endpoint of visual and pathological response at week 24, with no serious adverse events reported.
Why it matters
These results provide clinical validation for BO-112 as a therapeutic option by leveraging RNA nanoparticles to transform immunologically cold tumors into hot ones. The company has announced plans to advance the drug to late-stage development following the trial's success.
A total of 61% of 46 study participants achieved visual and pathological response at week 24. While 91% of patients experienced grade 1 adverse events, 88% of those cases resolved within three days.
The players
Highlight Therapeutics
This biotechnology company focuses on developing RNA-based cancer therapies.
MSD
Known as Merck in the United States and Canada, this global biopharmaceutical company collaborates on research and development.
The details
BO-112 functions as a double-stranded RNA nanoparticle that activates innate antiviral sensing pathways to induce tumor cell death and adaptive immunity. The study results showed 58% of high-risk patients and 70% of low-risk patients achieved the target response.
Timeline
Highlight Therapeutics was founded in 2010.
The company collaborated with MSD on a BO-112 trial in 2019.
The FDA approved Libtayo for advanced basal cell carcinoma in 2021.
The primary endpoint was evaluated at week 24.
Trial results were presented at the EADV congress on September 30, 2026.
The Big Picture
This development follows the 2021 FDA approval of Libtayo for advanced basal cell carcinoma, marking a shift in available treatment protocols. The results suggest a new therapeutic pathway for patients previously limited by standard intervention options.
The study suggests that BO-112 may offer a targeted treatment option for patients with facial lesions or high-risk head and neck cancer. Future late-stage trials will further clarify how this therapy integrates into standard dermatological care routines.
The takeaway
This study highlights the growing potential of RNA nanoparticle technology to improve outcomes in skin cancer treatment. Patients should discuss evolving clinical options with their healthcare providers as late-stage research progresses.
Further reading
Learn more about the latest research and breakthroughs in the Cancer section.
Source note: This article includes information reported by FierceBiotech - free daily biotech briefing.
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