Epithelioid Hemangioendothelioma

Ikena is looking to find new homes for the assets dropped by BMS. Ikena Oncology is going all in on its two lead assets. After missing out on $90 million from Bristol Myers Squibb, the biotech has outlined plans to lay off 35% of its workforce and shift resources from drug discovery to clinical development of its two top cancer prospects. In 2019, Celgene handed Kyn Therapeutics $95 million in return for options on two drug candidates. The names of the players changed, with Kyn rebranding as Ikena and Celgene joining BMS, but the collaboration continued—until now. With its option expiring this month, BMS has walked away from the AHR antagonist IK-175 and kynureninase IK-412. The decision has deprived Ikena of a cash injection. BMS needed to pay $50 million to license IK-175 and $40 million to exercise its option on IK-412. Ikena disclosed details of BMS’ decision alongside news of a reduction in its headcount. Seeking to stretch its $175 million cash pile into the second half of 2026, the biotech is laying off around 20 people. The 35% reduction in headcount will mainly affect drug discovery positions, although “select employees working in development and general and administrative functions” also face the chop. The layoffs will leave Ikena with around 37 full-time employees.  The remaining staff will work to advance the TEAD1 inhibitor IK-930 and MEK/RAF molecular glue IK-595 to clinical milestones. Ikena is studying two formulations of IK-930—one of which is intended to improve on an original preparation that failed to hit efficacious exposure in eight of 15 patients last year—and has expanded recruitment in mesothelioma and epithelioid hemangioendothelioma (EHE).  “The enrollment of mesothelioma and EHE patients will provide the best look at IK-930’s efficacy given that TEAD activation is known to drive the majority of mesothelioma cases and Hippo mutations define 100% of EHE cases,” analysts at William Blair wrote in a note to investors this morning. A data update is due in the second half of the year. Ikena dosed an initial cohort with IK-595 last month. Enrollment of RAS and RAF mutant cancer patients in the dose-escalation study is ongoing. The biotech also plans to enroll “backfill and expansion cohorts ... in multiple indications where IK-595 may have differentiated advantages.” With Ikena prioritizing those candidates, it has opted against further investment in the assets dumped by BMS. IK-175 completed a phase 1b study in urothelial carcinoma last year, while IK-412 is IND ready. Ikena is looking to find new homes for the candidates, with the assets joining Ikena’s internal discovery-stage projects in Hippo-altered and RAS-mutated cancers on the cutting room floor.

Ikena Oncology plans to reduce its workforce by approximately 35% as it focuses efforts on its two clinical-stage cancer drugs. The company noted that the downsizing will see it reallocate resources from exploratory research and discovery towards advancing development of the lead assets IK-930 and IK-595. CEO Mark Manfredi said Ikena expects “interpretable and clear data reads” for the two candidates this year.In November, Ikena’s shares sunk 69% after initial data from the dose-escalation part of IK-930’s Phase I study in patients with mesothelioma and epithelioid hemangioendothelioma highlighted proteinuria as an adverse effect of special interest. The company said that an optimised formulation of the TEAD1-selective Hippo pathway inhibitor is now being investigated alongside the original formulation, with an update expected in the latter part of 2024.Meanwhile, dose escalation is ongoing in a study of IK-595, a MEK-RAF molecular glue, with the programme continuing to enrol patients with RAS and RAF mutations. Ikena had around $175 million in cash and equivalents as of December 31, which is now expected to fund operations into the first half of 2026.

Ikena’s two lead oncology assets, IK-930 and IK-595, are currently in Phase I clinical trial. Image Credit: Billion Photos / Shutterstock. Ikena Oncology has initiated cash reduction measures including layoffs to funnel its resources into advancing its lead oncology assets IK-930 and IK-595. The workforce reduction of approximately 35% of its staff will occur over Q1 this year. Furthermore, the US-based company has paused exploratory research and discovery to direct the funds towards clinical programmes, as per an 18 January press release. Ikena reported cash reserves of approximately $175m as of 31 December 2023. The company has a market cap of 79.14m. IK-930 is a selective Hippo pathway inhibitor that targets TEA domain transcription factor 1 (TEAD1). The drug is being investigated in a Phase I trial (NCT05228015) to evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity in patients with solid tumours. The initial data from the trial showed grade I-II treatment-related proteinuria in 3 out of 26 dose escalation patients. Other adverse events included low-grade nausea, fatigue, and diarrhoea. In light of the data, the company has focused on targeted monotherapy indications, such as epithelioid haemangioendothelioma (EHE) and mesothelioma, as per a 9 November 2023 press release. The clinical update for the Phase I trial is planned for H2 2024. Another Ikenea clinical asset includes IK-595, a MEK-RAF molecular glue that targets the RAS signalling pathway – responsible for cancer cell proliferation. The drug is currently in Phase I trial, with the initial cohort dosed in December 2023. The initial cohort has since cleared the safety evaluation window. The company is enrolling targeted RAS and RAF mutant cancer patients in the dose escalation cohort, where Ikena exploring multiple dosing schedules. The company is also planning backfill and expansion cohorts across multiple indications where IK-595 may have differentiated advantages, as per an 18 January press release. Several pharmaceutical companies have announced layoffs in recent months amidst a difficult economic environment . In September 2023, NexImmune fired 53% of its workforce and paused the development of its three adoptive T cell therapies. In the same month, Kinnate Biopharma laid off 70% of its staff and paused three of its clinical programmes.