Regulatory FDA Imposes Partial Clinical Hold on Innate Pharma's Lymphoma...

FDA Imposes Partial Clinical Hold on Innate Pharma’s Lymphoma Program Following Safety Concerns


Innate Pharma, a prominent player in the biotechnology sector, has encountered an unforeseen setback in its lymphoma program. Recent developments have seen the U.S. Food and Drug Administration (FDA) impose a partial clinical hold on trials involving lacutamab, a groundbreaking anti-KIR3DL2 antibody, following a tragic incident where a patient succumbed to a rare hematologic disorder. This unexpected safety issue has had a ripple effect, causing a decline in Innate Pharma’s stock value.

At the core of Innate Pharma’s lymphoma program lies lacutamab, also recognized as IPH4102. This innovative antibody represents a potential paradigm shift in the treatment of cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL). Lacutamab is designed to target KIR3DL2, a receptor that is prevalent in various blood cancer types, with the ultimate goal of enhancing lymphoma outcomes by depleting the cancerous cells expressing this receptor.

However, amidst the efforts to validate this approach, Innate Pharma faced a devastating event – the demise of a trial participant due to hemophagocytic lymphohistiocytosis (HLH). HLH is a rare and severe systemic inflammatory syndrome that can occur when the immune system becomes excessively activated, often in response to conditions such as cancer. In some cases, it can have a genetic basis.

In response to this distressing incident, the FDA imposed a partial clinical hold on lacutamab studies, prompting the agency to request Innate Pharma to promptly take measures to mitigate the risk of further occurrences of HLH. Innate Pharma has shared limited details about the incident, disclosing only that a patient experienced an unexpected and severe adverse reaction resulting in HLH.

Dr. Mondher Mahjoubi, CEO of Innate Pharma, has affirmed the company’s unwavering commitment to addressing the FDA’s concerns, stating, “We are currently undertaking efforts to address the FDA’s requests, which include the incorporation of strategies to mitigate and manage the risk of hemophagocytic lymphohistiocytosis in ongoing lacutamab studies.”

Despite the partial clinical hold, there is some positive news for Innate Pharma. The hold solely affects the enrollment of new patients in lacutamab trials, allowing the company to continue administering the treatment to participants who are already benefiting from it. Consequently, the phase 2 CTCL trial and the initial cohort of a phase 1 PTCL study, both of which are fully enrolled, should experience minimal disruption to their near-term timelines. Innate Pharma remains on track to release final phase 2 data and preliminary phase 1 results later this year.

Nevertheless, the journey leading up to this point has proven to be longer and more arduous than initially anticipated. The phase 1 clinical trial of lacutamab commenced back in 2015, with its original completion date set for 2018 but ultimately concluding in 2020. Similarly, the primary completion date for the phase 2 trial, which is poised to release final data shortly, encountered delays, shifting from March 2022 to October 2023.

In response to the FDA’s announcement, Innate Pharma’s stock price experienced a setback, falling by 8.5% to 2.30 euros during early trading on the Paris Stock Exchange.

While Innate Pharma’s lymphoma program has faced an unexpected safety hurdle with the FDA-imposed partial clinical hold, the company remains steadfast in its commitment to advancing this groundbreaking treatment.

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