Innate Pharma(US:IPHA)2022-11-14 19:40Financial Data and Key Metrics Changes - The company reported a strong cash position with $151 million as of September 30, 2022, providing a runway into the second half of 2024 [37][86] - The financial outlook includes ongoing discussions with regulators regarding accelerated approval pathways, particularly for lacutamab [55] Business Line Data and Key Metrics Changes - The lead proprietary product candidate, lacutamab, is in development for T-cell lymphoma, with readouts expected in the second half of the year [8] - Encouraging preliminary data from the TELLOMAK trial for lacutamab showed a 28.6% overall response rate (ORR) in mycosis fungoides [15] - The company is advancing its multi-specific NK cell engager platform, ANKET, with the most advanced candidate, IPH6501, expected to file an IND next year [28][36] Market Data and Key Metrics Changes - The company is focusing on leveraging partnerships across industry and academia, including collaborations with AstraZeneca and Sanofi [10][36] - The competitive landscape for CD20 targeting bi-specifics is acknowledged, with plans to differentiate IPH6501 based on safety and efficacy [73] Company Strategy and Development Direction - The strategy centers around three key priorities: creating near-term value from lacutamab, developing innovative molecules through the ANKET platform, and building sustainable partnerships [8][10] - The company aims to validate its science and reinvest capital to advance its early portfolio [10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of lacutamab in heavily pretreated populations, with ongoing discussions with regulators about accelerated approval [55][80] - The company is encouraged by preliminary data and expects to achieve several milestones over the next two years, including updates on clinical trials [34][36] Other Important Information - The company plans to present data at upcoming conferences, including the ASH Annual Congress and ESMO IO [30][36] - The ANKET platform is designed to create a new class of tri- and tetra-specific engagers to induce synthetic immunity against cancer [25] Q&A Session Summary Question: What are the expectations for the TELLOMAK trial and the tetra-specific ANKET? - Management confirmed that the selection of CD20 as a target for the tetra-specific ANKET was to limit variables and leverage a well-validated target [41][46] - Responses in Cohort 3 of the TELLOMAK trial were attributed to tumor heterogeneity and assay conditions [48] Question: What are the regulatory expectations for accelerated approval? - Management indicated that discussions with regulators are ongoing, and the benchmark for accelerated approval has become tougher recently [55] Question: What is the future of lacutamab if PTCL does not deliver? - Management stated that while PTCL data is crucial, the company has multiple avenues to explore the potential of lacutamab, including monotherapy and combination trials [80] Question: How will the patient population change as moga is used earlier? - Management noted that the trial will likely continue to recruit heavily pretreated patients, as access to moga has not significantly changed [82] Question: How does the company plan to file for approval in Sézary syndrome and mycosis fungoides? - The decision will depend on data strength, regulatory landscape, and potential partnerships [77]