News & Events zu Kalaris Therapeutics Inc (KLRS)KLRSKalaris Therapeutics Inc

Kalaris Therapeutics CEO Reports Significant Advances in TH103 Study

"We made significant advances over the second quarter," said Andrew Oxtoby, Chief Executive Officer of Kalaris Therapeutics. "We successfully manufactured new batches of clinical material and are currently dosing patients in our Phase 1b/2 study of TH103 for neovascular Age-related Macular Degeneration. We recently released expanded Phase 1a data for TH103 which continues to strengthen our confidence in potential TH103 differentiation. The additional data is consistent with the initial structural, functional and pharmacokinetic findings and reinforces our belief that TH103 has the potential to offer a best-in-class treatment option for patients with neovascular AMD."

Kalaris Therapeutics Appoints Liisa Bayko as CFO

Kalaris Therapeutics announced the appointment of Liisa Bayko as CFO. She most recently served as managing director and senior biotechnology analyst at Evercore ISI.

Kalaris Therapeutics Releases New Data on TH103 Trial

Kalaris Therapeutics announced additional data from its Phase 1a single ascending dose trial of TH103 in neovascular age-related macular degeneration. Data from the expanded cohorts build on previously reported positive findings from the trial, with additional patients showing improvements in vision and retinal anatomy and further supporting the potential for extended treatment durability after a standard four-dose loading regimen. The expanded Phase 1a SAD dataset now includes a total of 17 treatment-naive patients, as well as an additional 3 treatment-experienced patients which were included in the safety cohort. All 20 patients completed six months of follow-up. Consistent with Kalaris' previously reported findings, the expanded efficacy analysis, which includes the 17 treatment-naive patients, continued to demonstrate robust structural and functional improvements. TH103 plasma pharmacokinetic findings continued to suggest greater intraocular retention, with 27- to 53-fold lower Cmax compared to current leading anti-VEGF agents on a molar equivalence basis. Additionally, the time to retreatment results further supported the hypothesis that increased intraocular retention may contribute to prolonged biological activity: following only a single TH103 injection, 41% of treatment-naive patients received a first retreatment at 4 months or later, 35% at 5 months or later, and 29% received no additional anti-VEGF treatment during the entire six-month follow-up period. Separately, after a single TH103 injection, time to retreatment in treatment-experienced patients was extended by an average of 2 months compared with prior anti-VEGF treatment intervals. No cases of intraocular inflammation were observed among the six patients treated at the 2.5 mg dose using product manufactured following process adjustments to reduce impurities. As previously reported, one patient treated at the 5 mg dose experienced transient IOI that resolved without sequelae. Building on these findings, Kalaris is actively enrolling and dosing patients in its ongoing Phase 1b/2 study aimed at evaluating a standard four-dose loading regimen of TH103 in treatment-naive patients using an ascending-dose design. The study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of repeated TH103 intravitreal injections as well as time to retreatment following a complete loading course. Study results will inform dose selection for potential future Phase 3 trials of TH103, and Kalaris remains on track to share initial data from the Phase 1b/2 study in the first half of 2027.