TELLOMAK trial progresses as cohort 2 of KIR3DL2-expressing mycosis fungoides patients advances to Stage 2 earlier than anticipated
Company to initiate two new clinical trials to investigate lacutamab in peripheral T-cell lymphoma, including Phase 2 combination study with leading global lymphoma research network, LYSA
Webcast featuring key opinion leaders today at 2:00 p.m. CET / 8:00 a.m. ET
Innate Pharma SA (Euronext Paris: IPH – ISIN: FR0010331421; Nasdaq: IPHA) (“Innate” or the “Company”) today announced new clinical developments for its first-in-class, proprietary investigational asset, lacutamab, an anti-KIR3DL2 cytotoxicity-inducing antibody in development for T-cell lymphomas. This includes advancement of the KIR3DL2-expressing mycosis fungoides (MF) cohort (cohort 2) to Stage 2 in the TELLOMAK study, as well as the initiation of the peripheral T-cell lymphoma (PTCL) clinical program.
Mycosis Fungoides: Advancing TELLOMAK Cohort 2 to Stage 2
In TELLOMAK, an open-label, multi-cohort, Phase 2 trial, lacutamab demonstrated a positive early signal in cohort 2. This cohort reached the pre-determined number of responses needed to advance to stage 2, allowing the Company to recruit additional patients. The Company plans to present this preliminary data at a scientific meeting in 2021.
Recruitment is ongoing in cohort 3, evaluating lacutamab as a monotherapy in KIR3DL2 non-expressing MF patients.
Peripheral T-Cell Lymphoma: Introducing a Data-Driven Clinical Strategy
The Company today announced plans to initiate two parallel clinical trials to study lacutamab in KIR3DL2-expressing patients with relapsed/refractory PTCL. Together these trials offer a data-driven strategy to identify potential opportunities for lacutamab in the relapsed setting, and potential expansion into earlier lines of therapy for PTCL in the future.
- Phase 1b trial: a Company-sponsored Phase 1b clinical trial to evaluate lacutamab as a monotherapy in KIR3DL2-expressing patients with relapsed PTCL.
- Phase 2 KILT (anti-KIR in T Cell Lymphoma) trial: The Lymphoma Study Association (LYSA) will launch an investigator-sponsored, randomized trial to evaluate lacutamab in combination with chemotherapy GEMOX (gemcitabine in combination with oxaliplatin) versus GEMOX alone in KIR3DL2-expressing relapsed/refractory patients.
“Lacutamab is our priority clinical asset, and we are pleased to share important progress of this program. The early signal seen in the KIR3DL2-expressing mycosis fungoides patient population is encouraging and moves us past the pre-determined threshold for the cohort earlier than anticipated,” said Joyson Karakunnel, M.D., MSc, FACP, Chief Medical Officer of Innate Pharma. “In addition, our PTCL trials announced today demonstrate our strategy to first explore lacutamab’s potential in the relapsed/refractory setting, then potentially in earlier lines of treatment. Partnering with LYSA will provide invaluable expertise given their track record in advancing therapeutics for the lymphoma community.”
“Relapsed PTCL patients are in need of alternative, effective options and we are pleased to partner with Innate Pharma on this important study,” said Franck Morschhauser, Professor of Hematology in Lille (France) and President of LYSA. “KIR3DL2 represents a meaningful target, as it is expressed in up to 50% of PTCL across subtypes. Through our global network and deep expertise in lymphoma, we believe this study will help us better understand the potential for lacutamab to help these patients.”
To learn more about these updates, join Innate’s executive leadership team, as well as Pierluigi Porcu, M.D., Professor of Medical Oncology, Dermatology and Cutaneous Biology and Director, Division of Hematologic Malignancies and Hematopoietic Stem Cell Transplantation at Jefferson University Hospital and principal investigator of Innate’s Phase 2 TELLOMAK study, and Olivier Hermine, M.D., Professor of Hematology at the University of Paris Descartes, Director, Division of Adult Hematology at Hôpital Universitaire Necker Enfants Malades and principal investigator of the LYSA Phase 2 KILT study for a virtual presentation today.
Access to webcast replay: https://edge.media-server.com/mmc/p/yztsebvs
The replay of the webcast will be available on the Company website for 90 days following the event.