Innate Pharma has encountered a safety issue in its lymphoma program, resulting in the FDA imposing a partial clinical hold on its studies following the death of a patient due to a rare hematologic disorder. The biotech is still planning to release data from its two fully enrolled trials, but the safety signal caused a drop in its stock price.
The partial clinical hold specifically pertains to lacutamab, an anti-KIR3DL2 antibody being investigated by Innate in patients with cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL). The biotech views lacutamab, also known as IPH4102, as a pioneering candidate that could enhance lymphoma outcomes by depleting cells expressing KIR3DL2, a receptor commonly found in various forms of blood cancer.
During the validation of this concept, Innate encountered a fatal case of hemophagocytic lymphohistiocytosis (HLH), a severe systemic inflammatory syndrome that can occur when the immune system is strongly activated, such as during cancer treatment. In some patients, HLH has a genetic origin.
Also Read: Innate Pharma Showcases Breakthrough Tetra-Specific ANKET NK Cell Engager IPH6501 At The EHA 2023 Congress
Innate has disclosed limited details about the incident, stating only that a patient died as a result of an unexpected severe adverse reaction, specifically HLH. In response, the FDA imposed a partial hold on lacutamab trials and requested that Innate take measures to mitigate the risk.
The partial hold prohibits the enrollment of new patients in lacutamab trials but allows for the continued dosing of existing participants who are experiencing clinical benefits. Since the phase 2 CTCL trial and the initial cohort of a phase 1 PTCL study are already fully enrolled, the partial hold is not expected to significantly impact near-term timelines. Innate still intends to release final phase 2 and preliminary phase 1 data later this year.
“Patient safety is of paramount importance to us, and we are currently undertaking efforts to address the FDA requests, which include incorporation of risk mitigation and management strategies for hemophagocytic lymphohistiocytosis in ongoing lacutamab studies. Additionally, with all patients recruited into the Phase 2 TELLOMAK study, we do not currently anticipate any delay for the TELLOMAK Phase 2 final data due shortly.”
– Mondher Mahjoubi, Chief Executive Officer of Innate Pharma
Also Read: FDA Rejects Citius’ Resurrected IL-2 Lymphoma Treatment
Although no delay is anticipated for the phase 2 data release, Innate has taken longer than expected to reach this stage. The phase 1 clinical trial of lacutamab commenced in 2015, originally scheduled for primary completion in 2018 but ultimately concluding in 2020. The primary completion date for the phase 2 trial, set to report final data soon, was also pushed back from March 2022 to October 2023.
Following the safety issue, Innate Pharma’s shares declined by 8.5% to 2.30 euros in early trading in Paris.
