TH103 / Kalaris Therapeutics - LARVOL DELTA

Kalaris Therapeutics Reports Positive TH103 Phase 1a SAD Results from Expanded Neovascular AMD Cohorts (GlobeNewswire) - "Enrollment in the Phase 1b/2 multiple-ascending dose trial of TH103 continues, with preliminary data on track for 1H 2027...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-naïve patients (N=17) 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 (N=3) was extended by an average of 2 months compared with prior anti-VEGF treatment intervals."

Enrollment status • P1 data • P1/2 data • Age-related Macular Degeneration

Kalaris Announces Upcoming Presentation of TH103 Phase 1a Clinical Data at American Society of Retina Specialists; Ph 1b/2 Clinical Trial Actively Enrolling (GlobeNewswire) - "Kalaris also confirms that its Phase 1b/2 multiple ascending dose study of TH103 for neovascular Age-related Macular Degeneration is actively enrolling and dosing patients. The company remains on-track to share initial data from the study in 1H 2027 which is designed to accelerate TH103’s clinical development and inform dose selection for potential future Phase 3 development."

Enrollment status • P1 data • P1/2 data • Wet Age-related Macular Degeneration

A Novel Long-Acting VEGF Inhibitor Demonstrates Suppression of VEGF-Induced Retinal Leakage (ARVO 2026) - "These early findings indicate that V23 could offer patients more durable protection against retinal swelling and may decrease the number of injections required to maintain vision. This new therapy, known as TH103, is now being evaluated in a clinical trial for patients with neovascular AMD."

Age-related Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Kalaris pauses dosing in eye drug trial to stamp out cases of ocular inflammation (FierceBiotech) - "The company reassured investors it had since tweaked the manufacturing process for TH103 to 'significantly reducing host cell protein (HCP) levels.'...Despite these changes, Kalaris revealed in a corporate presentation March 9 that the first patient who received a 5-mg dose of the updated version of TH103 as part of a phase 1b/2 multiple ascending dose extension had also experienced moderate IOI....Kalaris has paused dosing patients until it receives these new batches of the drug, which the company told Fierce Biotech it is expecting in the second quarter. Once those batches have arrived, dosing on the trial will restart....As a result, Kalaris has pushed back the expected readout of the phase 1b/2 study from the second half of 2026 until the first half of 2027. If those data hit the mark, the aim is to launch a phase 3 trial by the end of next year."

New P3 trial • P1/2 data • Trial status • Age-related Macular Degeneration

Kalaris Announces Closing of Merger with AlloVir (GlobeNewswire) - "Kalaris Therapeutics... announced the completion of its previously announced merger with AlloVir....The combined company will operate under the name Kalaris Therapeutics, Inc. and its shares are expected to begin trading on The Nasdaq Global Market on March 19, 2025 under the ticker symbol 'KLRS'. Kalaris is currently developing TH103, a novel, differentiated anti-vascular endothelial growth factor ('VEGF') agent engineered to potentially provide longer-lasting and increased anti-VEGF activity to treat neovascular and exudative diseases of the retina. TH103 was specifically engineered to address the limitations of current neovascular Age-related Macular Degeneration ('nAMD') therapies and has demonstrated both potent anti-VEGF activity and sustained ocular residence time in preclinical studies. Kalaris expects to report initial data from Part 1 of its ongoing Phase 1 clinical trial of TH103 in the second half of 2025."

M&A • P1 data • Wet Age-related Macular Degeneration