TH103

Analysts said Kalaris Therapeutics\' \"swift response to identify the issue and implement … steps to resolve it is encouraging.\"\n Kalaris Therapeutics has paused dosing patients in a phase 1 study of its next-gen eye drug while it attempts to finally resolve cases of eye inflammation.The New Jersey-based biotech had initially tested its eye drug, dubbed TH103, in a phase 1a study of 13 patients with neovascular age-related macular degeneration (nAMD). TH103 is an anti-VEGF fusion protein Kalaris has designed to inhibit VEGF more effectively and for longer periods than existing options.Kalaris unveiled data from that study in December, which it said at the time suggested “potential for extended treatment durability” as well as clinically meaningful improvements in vision and retinal anatomy. However, the biotech also noted two cases of mild to moderate intraocular inflammation (IOI) had been observed at Day 4 among patients who had received the 2.5-mg dose.The company reassured investors it had since tweaked the manufacturing process for TH103 to “significantly reducing host cell protein (HCP) levels.” None of the further six patients who received a 2.5-mg dose of the new process material in the same trial experienced IOI, according to the biotech.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.It meant Kalaris is making further tweaks to the drug, specifically using “advanced analytical methods” to “provide a granular identification of the specific remaining constituent HCP sub-types,” according to the presentation.These additional refinements are designed to “eliminate all remaining sub-HCPs,” the company explained.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. “We continue to make significant progress on our understanding of what comprises the remaining specific HCP sub-types in the manufactured product of TH103, which is enabling us to implement tailored process modifications,” Kalaris CEO Andrew Oxtoby said in a statement sent to Fierce. “These approaches are aimed at the elimination of HCP to levels at which it can no longer be detected.”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. While eye disease patients are already well catered for with anti-VEGF drugs like Roche’s blockbuster Vabysmo and Regeneron and Bayer’s Eylea, Kalaris believes it can find a gap in the market by offering patients a reduced frequency of injections.William Blair analysts have bought into Kalaris’ vision, reaffirming in a March 10 note that they “believe TH103 has the potential to offer better outcomes and longer treatment intervals than current anti-VEGF therapies for the treatment of retinal vascular diseases, which represent a roughly $15 billion market globally.”While the pause in the phase 1b/2 study is “unfortunate,” the analysts said the company’s “swift response to identify the issue and implement additional purification steps to resolve it is encouraging, and positions TH103 well for future development.”TH103 was developed by Napoleone Ferrara, M.D., Ph.D.—whose team at Genentech in the 1980s was the first to isolate and clone vascular endothelial growth factor (VEGF). As well as taking TH103 forward, Kalaris absorbed immunotherapy biotech AlloVir in 2024.

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