New Phase 1 data showed strong response rates and a favorable safety profile for its experimental leukemia drug TERN-701.
- Terns shares jumped after new Phase 1 data showed strong response rates and a continued favorable safety profile for TERN-701.
- Updated results showed high 24-week molecular responses across doses with no loss of response and no dose-limiting toxicities.
- The company said the findings support Phase 2 advancement, with deep responses seen even in patients previously failing multiple therapies.
Terns Pharmaceuticals (TERN) shares jumped over 40% on Monday after the company reported additional positive Phase 1 results for its investigational chronic myeloid leukemia (CML) therapy TERN-701 at the 67th American Society of Hematology Annual Meeting.
The biotech company said updated data from the ongoing CARDINAL trial showed a 64% major molecular response (MMR) rate by 24 weeks across all efficacy-evaluable patients, with a 75% MMR rate among those receiving doses above 320 mg once daily.
The company said the treatment continued to show an encouraging safety and tolerability profile with longer exposure.
Terns Sets Phase 2 Doses
CEO Amy Burroughs said the higher MMR rate at doses of 320 mg and 500 mg supports selection of those levels as recommended Phase 2 doses. She said study enrollment has surpassed 85 patients, enabling further progression into dose-expansion and pivotal studies.
Chief Medical Officer Emil Kuriakose said the data include response achievements in patients who had previously experienced lack of efficacy on drugs such as Asciminib, Ponatinib and other tyrosine kinase inhibitors. He said the updated findings show deep molecular responses (DMR) at 24 weeks and a continued favorable safety profile across doses.
Strong 24-Week Response Rates
As of the Sept. 13 cutoff, 63 patients had been enrolled across doses ranging from 160 mg to 500 mg. Among 38 efficacy-evaluable patients, the overall MMR rate by 24 weeks was 74%. No patients had lost MMR at the time of analysis.
The company said the study population reflected heavily pretreated, refractory disease, including a median of three prior tyrosine kinase inhibitors (TKIs) and high rates of lack of efficacy to previous therapy.
Safety data showed that 87% of patients remained on treatment, with no dose-limiting toxicities observed and no maximum tolerated dose reached. Most treatment-emergent adverse events were low grade, and rates of cytopenias were generally under 10%.
Responses At Higher Doses
Among patients treated at doses of 320 mg or higher, the company reported an 80% overall MMR rate by 24 weeks in the efficacy-evaluable population. Deep molecular responses were observed across a wide range of baseline transcript levels.
Stocktwits Traders Cheer Momentum
On Stocktwits, retail sentiment for Terns was ‘bullish’ amid ‘low’ message volume.
One user said, “congrats! Bio market is starting to have some movers. Good to see!”
Another user urged investors to “buy it up.”
Tern’s stock has surged 620% so far this year.
For updates and corrections, email newsroom[at]stocktwits[dot]com.<