Innate Pharma (NASDAQ:IPHA) said it has initiated a Phase 3 study of its lymphoma drug lacutamab and expects to present Phase 1 data for its experimental cancer treatment IPH4502 on Nov. 18, as the company outlined its third-quarter 2026 business update.
The company also said results from PACIFIC-9, a Phase 3 lung cancer study led by partner AstraZeneca, are now expected in the first half of 2027. Innate reported cash of €96.8 million as of Sept. 30 and expects its cash runway to extend through the end of the first quarter of 2028, CEO Jonathan Dickinson said.
Lacutamab trial and Sobi partnership
Innate has started TELLOMAK-3, a confirmatory Phase 3 study of lacutamab in cutaneous T-cell lymphoma, with the first patient expected to be dosed in the first quarter of 2027. The study includes a confirmatory cohort in Sézary syndrome and a registrational cohort in mycosis fungoides, Chief Medical Officer Markus Jensen said.
The company plans to file a biologics license application with the U.S. Food and Drug Administration in the second half of 2027, seeking accelerated approval for Sézary syndrome based on existing Phase 2 TELLOMAK data. Jensen said potential accelerated approval could come in the first half of 2028. Primary progression-free survival analyses for both Phase 3 cohorts are projected 12 months after enrollment is complete, with potential regular approval thereafter.
Dickinson said Innate’s partnership with Sobi is effective and that the company has received a $75 million upfront payment. Innate is eligible for up to $40 million in near-term milestones tied to Sézary syndrome and up to another $465 million related to Sobi’s option to obtain full development rights and future regulatory and commercial milestones. The agreement also includes tiered double-digit royalties on future net sales.
Sobi will receive global commercialization rights if lacutamab receives accelerated approval and will be eligible to obtain full global development rights following positive Phase 3 results, Dickinson said.
IPH4502 data and development plans
Innate plans to present Phase 1 data for IPH4502, a Nectin-4 antibody-drug conjugate being studied in advanced solid tumors, at the EORTC-NCI-AACR Symposium on Nov. 18. The company will also hold an event in London and a webcast that day.
Jensen said enrollment in the dose-escalation portion of the study is complete. Innate has previously reported preliminary antitumor activity, including objective responses in heavily pretreated patients, and a favorable safety profile observed to date.
During the question-and-answer session, Dickinson said the dose-finding study enrolled 76 patients across more than 10 tumor types. He said the presentation would include safety data and results across those tumor types. The company previously reported activity in urothelial cancer after Padcev treatment and responses in non-small cell lung cancer and head and neck cancer.
Dickinson cautioned that the dataset for each individual tumor type is limited and includes patients treated at different doses, making specific conclusions difficult. Jensen said more information about the program’s next steps will be released on the day of the presentation.
PACIFIC-9 timing and CFO departure
PACIFIC-9 enrolled 1,051 patients with unresectable stage III non-small cell lung cancer whose disease had not progressed after platinum-based concurrent chemoradiotherapy. The study compares durvalumab plus oleclumab, durvalumab plus monalizumab, and durvalumab plus placebo, with progression-free survival as its primary endpoint.
Asked about the later expected readout, Dickinson said events in the event-driven study were occurring more slowly, but that it was difficult to draw conclusions about the performance of either the experimental or control arms. Jensen noted that the AstraZeneca-led study remains blinded.
Chief Operating Officer Yannis Morel said Innate has received $450 million to date under its AstraZeneca partnership and is eligible for up to $825 million in additional potential milestones, along with double-digit royalties outside Europe and a 50% profit share in Europe.
Dickinson also said Chief Financial Officer Frédéric Lombard will leave Innate at the end of December to pursue a new career opportunity. The company has started a search for his successor.
About Innate Pharma (NASDAQ:IPHA)
Innate Pharma SA is a clinical-stage biotechnology company focused on developing immunotherapies for cancer. The company researches treatments designed to activate or enhance the immune system’s ability to recognize and eliminate tumor cells, with an emphasis on natural killer cells and other components of the innate immune system.
Its pipeline includes lacutamab, an antibody directed at KIR3DL2 that is being studied in certain forms of cutaneous T-cell lymphoma. Innate Pharma has also developed monalizumab, an antibody targeting the NKG2A immune checkpoint, through a collaboration with AstraZeneca.
