First patient dosed in monalizumab Phase 3 lung cancer trial, PACIFIC-9 sponsored by AstraZeneca, which triggered a $50 million milestone payment extending Company cash runway into 2024
Monalizumab data presented by AstraZeneca at AACR and in Journal of Clinical of Oncology
Cash position to €131.7 million1 as of March 31, 2022 (not including the $50 million payment from AstraZeneca)
Conference call to be held today at 2:00 p.m. CEST / 8:00 a.m. EDT
Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today reported its consolidated financial results for the quarter ending March 31, 2022.
“Again this quarter we made significant progress in our pipeline in particular with the presentation of positive data and clinical progress with our anti-NKG2A, monalizumab. We also saw a $50 million milestone from AstraZeneca triggered due to the first patient dosed in April in the Phase 3 lung cancer trial. This means our cash position is considerably strengthened to fund our pipeline ambitions into 2024,” said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. “We look forward to additional clinical milestones this year from our broad antibody pipeline, specifically readouts for lacutamab in the second half and further progress on ANKETTM, as we leverage scientific expertise and strong partnerships to deliver innovative treatments for people with cancer.”
Webcast and conference call will be held today at 2:00pm CEST (8:00am EDT)
The replay of the webcast will be available at the following link:
This information can also be found on the Investors section of the Innate Pharma website, www.innate-pharma.com.
A replay of the webcast will be available on the Company website for 90 days following the event.
Lacutamab (IPH4102, anti-KIR3DL2 antibody):
- The Phase 2 TELLOMAK study in Sézary syndrome and mycosis fungoides (MF) continues to progress and the Company expects to report preliminary data from both cohorts in the second half of 2022. In March 2022, Innate announced the opening of a new MF all-comers cohort in the TELLOMAK study. The all-comers cohort will be recruiting both KIR3DL2 expressors and non-expressors to explore the correlation between the level of KIR3DL2 expression and treatment outcomes utilizing a formalin-fixed paraffin embedded (FFPE) assay as a potential companion diagnostic.
- Two clinical trials are underway evaluating lacutamab in patients with KIR3DL2-expressing, relapsed/refractory peripheral T-cell lymphoma (PTCL):
- Phase 1b trial: a Company-sponsored Phase 1b clinical trial to evaluate lacutamab as a monotherapy in patients with KIR3DL2-expressing relapsed PTCL.
- Phase 2 KILT (anti-KIR in T Cell Lymphoma) trial: The Lymphoma Study Association (LYSA) investigator-sponsored, randomized trial to evaluate lacutamab in combination with chemotherapy GEMOX (gemcitabine in combination with oxaliplatin) versus GEMOX alone in patients with KIR3DL2-expressing relapsed/refractory PTCL.
ANKETTM (Antibody-based NK cell Engager Therapeutics):
- Recruitment continues in the Phase 1/2 clinical trial by Sanofi evaluating IPH6101/SAR443579, the first NKp46/CD16-based NK cell engager, in patients with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL) or high risk- myelodysplastic syndrome (HR-MDS).
- IPH64, the second ANKETTM drug candidate of the research collaboration with Sanofi, is progressing and the Company looks forward to updates on this asset.
- Innate will provide updates on IPH65, the tetra-specific ANKETTM, throughout the year as progress is made toward an IND-enabling study in 2023.
Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:
- On April 29, 2022, Innate announced a $50 million milestone payment from AstraZeneca was triggered for dosing the first patient in the Phase 3 clinical trial, PACIFIC-9, evaluating durvalumab (anti-PD-L1) in combination with monalizumab or AstraZeneca’s oleclumab (anti-CD73) in patients with unresectable, Stage III non-small cell lung cancer (NSCLC) who have not progressed following definitive platinum-based concurrent chemoradiation therapy (CRT). This is a post-period event.
- Detailed results from the randomized AstraZeneca-sponsored Phase 2 COAST clinical trial, including monalizumab data in combination with durvalumab, were published in the Journal of Clinical Oncology on April 22, 2022. The results were initially presented during the European Society for Medical Oncology (ESMO) Congress 2021. The results of the interim analysis showed monalizumab in combination with durvalumab improved progression-free survival (PFS) and objective response rate (ORR) compared to durvalumab alone in patients with unresectable, Stage III non-small cell lung cancer (NSCLC) who had not progressed after concurrent chemoradiation therapy (CRT). The Journal of Clinical Oncology publication now includes exploratory subgroup analysis.
- An oral presentation on April 11, 2022 at the American Association for Cancer Research (AACR) Annual Meeting from the AstraZeneca-sponsored Phase 2 NeoCOAST randomized trial in resectable, early-stage NSCLC highlighted improved disease responses with durvalumab in combination with monalizumab, oleclumab or danvatirsen, when compared to durvalumab alone. The follow-up randomized clinical trial, NeoCOAST-2, is enrolling patients with resectable, stage IIA-IIIA NSCLC to receive neoadjuvant durvalumab combined with chemotherapy and either oleclumab or monalizumab, followed by surgery and adjuvant durvalumab plus oleclumab or monalizumab.
- The AstraZeneca-sponsored Phase 3 INTERLINK-1 trial of monalizumab plus cetuximab in immuno-oncology-pretreated head and neck cancer is ongoing with final data expected in 2024.
IPH5201 (anti-CD39), partnered with AstraZeneca:
- Data for the Phase 1 trial in solid tumors with IPH5201 alone or in combination with durvalumab (PD-L1) are expected to be presented in 2023.
- In March 2022, The Institut Paoli-Calmettes announced that the first patient had been dosed in the investigator-sponsored Phase 1 trial of IPH5301 (CHANCES). The trial will be conducted in two parts, Part 1, the dose escalation, followed by a Part 2 safety expansion study cohort. Part 2 will evaluate IPH5301 in combination with chemotherapy and trastuzumab in HER2+ cancer patients.
- On May 05, 2022, Innate announced the commencement of an At-The-Market (ATM) program, pursuant to which it may, from time to time, offer and sell to eligible investors a total gross amount of up to $75 million American Depositary Shares (“ADS”). Each ADS representing one ordinary share of Innate.
Cash, cash equivalents and financial assets of the Company amounted to €131.7 million as of March 31, 2022. At the same date, financial liabilities amounted to €43.8 million. Cash, cash equivalents and financial assets as of March 31, 2022 do not include the $50.0 million payment to be received from AstraZeneca.
Revenues for the first three months of 2022 amounted to €2.6 million (€4.5 million for the same period in 2021). For the three-month period, ended March 31, 2022, revenue from collaboration and licensing agreements mainly results from the spreading of the payments received under our agreements with AstraZeneca.
 Including short term investments (€16.3 million) and non-current financial instruments (€38.8 million). Not including PACIFIC-9 milestone payment to be received by the Company.