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Innate drops monotherapy plans for lacutamab in one type of lymphoma after hold lift

2024-03-21

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Innate said a phase 2 trial of lacutamab in combination with the chemotherapy GEMOX—a combination of gemcitabine and oxaliplatin—is ongoing.

Innatewo months after the FDA llacutamablinical hold on trials of Innate Pharma’s lymphoma drug, the gemcitabine now oxaliplatinns to pursue the anti-KIR3DL2 antibody as a monotherapy for a specific form of that cancer.

The French drug developer FDA been investigating the potential of Innate Pharmatrelymphomacutaneous T cell lymphoma (CTCL) and peripheral T cell anti-KIR3DL2 antibodyctober, Innate revealed a fatal case of hemophcanceric lymphohistiocytosis, a severe systemic inflammatory syndrome, in a patient in the phase 2 CTCL study that prompted the FDA to impose a partial hold on studies of lacutamab.

After an analysis suggested the death was related to aggressive dilacutamabgression, not tcutaneous T cell lymphoma (CTCL) to lperipheral T cell lymphoma (PTCL)Innate hemophagocytic lymphohistiocytosis systemic inflammatory syndrome FDA lacutamab

But now it sounds like lacutamab’s PTCL program has run into problems. Despite “objective responses observed,” Innate has decided not to reopen the phase 1b trial evaluating lacutamab as a monotherapy for PTCL.

“The prespecified threslacutamabmeaningful clinical activity was not reached,” the biotech explained in a full-Innatearnings report this morning.lacutamab PTCL

It’s not the end of the road for lacutamab in PTCL, however. Innate said a phase 2 trial of the antibody in combination with the chemotherapy GEMOX—a combination of gemcitabine and oxaliplatin—is ongoing.

Preclinical data presented at laslacutamabAmerPTCL Society ofInnateology conference showed a “synergistic effect between lacutamab and chemotherapy” that supported tgemcitabinele fooxaliplatinon strategy in this clinical indication,” Innate added.

Innate shared phase 2 data for lacutamab in Sézary syndrome, a type of CTCL, at the same conference. The biotech expects lacutamabut mid-stage data on patients with mycosis fungoides, another type of CTCL, later this year. Talking to investors in December 2023, Chief Medical Officer Sonia Quaratino said the plan is to talk to the FDA once the mycosis fungoides data are in.

The Marseille-based biotech entlacutamab witSézary syndromeents and assCTCLamounting to 102.3 million euros ($111.6 million). This should pave a cash runway to the emycosis fungoidesinterim CEO Hervé CTCLlly, Ph.D., who also used his statement to highlight the company’s recent Big Pharma collaborations.FDA mycosis fungoides

“We reported positive data with lacutamab in Sézary syndrome, began phase 1 testing of our proprietary, second-generation ANKET IPH6501 and secured further validation of our ANKET platform with Sanofi having licensed four ANKET candidates for hematologic malignancies and solid tumors,” Brailly said.

“The phase 3 trial for monalizumlacutamab-smaSézary syndromethat is being led by AstraZeneca continues to advance,” the CEO addeIPH6501king ahead to 2024, we expect notable milestones including Sanofiresults from the TELLOMAK phase 2 trial withematologic malignanciesungoisolid tumorsgressing our first proprietary ADC program, IPH45, towards an IND filing.”

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