On May 15, 2023 Ikena Oncology, Inc. (Nasdaq: IKNA, "Ikena", "Company"), a targeted oncology company forging new territory in patient-directed cancer treatment, reported financial results for the first quarter ended March 31, 2023 (Press release, Ikena Oncology, MAY 15, 2023, View Source [SID1234631721]). The Company also provided an update across the organization and pipeline.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"The start to 2023 has been full of exciting developments, including external clinical validation of the Hippo pathway and targeting TEAD. In addition to this de-risking event, we have been able to highlight our own differentiation in the space with IK-930’s unique selectivity profile, optimized therapeutic index, and broad applicability as both a monotherapy and in combination across several patient populations. As we continue to advance in the clinic, our ability to continuously dose patients will allow us to fully explore IK-930’s therapeutic potential," commented Mark Manfredi, Ph.D., Chief Executive Officer of Ikena. "The first quarter also was the first time we shared the novel profile of IK-595, our MEK-RAF complex inhibitor. We designed IK-595 to optimize the potential therapeutic window and durably bind the RAFs, focusing on preventing multiple CRAF mechanisms that can cause tumorigenesis. Both of these programs are aiming to serve patient populations in which current approved and experimental therapies are insufficient or failing. That need is driving our entire team to continue delivering on development in the clinic, including the IK-595 IND filing and the initial IK-930 clinical data expected later this year."
Summary of Recent Pipeline Progress and Corporate Update
IK-930: TEAD1-Selective Hippo Pathway Inhibitor
•
IK-930 revealed as a TEAD1 selective inhibitor with significant advantages in therapeutic index at American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2023
•
Multiple preclinical datasets comparing IK-930 to panTEAD inhibition presented, including nonhuman primate tolerability and comparable efficacy in multiple models
•
Data presented demonstrated that the combination of IK-930 and several targeted agents, including EGFR, KRAS G12C, and MEK inhibitors, showed a decrease in the development of drug-resistant persister cells, suggesting the potential of IK-930 to expand the number of patients who could benefit from these targeted therapies
LOGO
•
Initial clinical data from the monotherapy portion of the ongoing Phase 1 clinical trial of IK-930, including patients from the dose escalation cohorts and backfilling, is planned for the fourth quarter of 2023
•
The study continues to progress as planned through dose escalation with no reported dose-limiting toxicities to date
•
The protocol includes backfilling of cohorts at efficacious exposures in patients with NF2-deficient mesothelioma and epithelioid hemangioendothelioma (EHE)
•
The expansion cohorts of the trial will evaluate IK-930 as a monotherapy in these indications, as well as in other patients with solid tumors with detectable alterations in the Hippo pathway, including NF2 deficiency and YAP/TAZ alterations
•
Combination cohorts in the IK-930 clinical program are planned based on emerging pharmacokinetic and pharmacodynamic data from monotherapy dose escalation; osimertinib is the first combination partner through a clinical collaboration with AstraZeneca
•
Preclinical data exemplified the potential of IK-930 in combination with osimertinib in EGFR mutant cancers, both in first line as a resistance-preventative combination and in later lines, post-resistance emergence
•
Additional combinations of IK-930 with MEK inhibitors and KRAS inhibitors have the potential to address resistance to and durability of targeted treatments in RAS mutant cancers
IK-595: MEK-RAF Complex Inhibitor
•
Data presented at the AACR (Free AACR Whitepaper) Special Conference on Targeting RAS demonstrated key differentiation characteristics of IK-595 from first and second generation MEK inhibitors including:
•
IK-595 traps MEK and RAF in an inactive complex to overcome CRAF bypass mechanism and block its kinase-independent activity, more durably and completely inhibiting RAS-MAPK signaling than existing inhibitors
•
The optimization of the half-life of IK-595 can enable dosing schedules to achieve plasma exposure above IC90 to drive tumor cell killing, while allowing a break from target engagement for normal tissues to recover
•
Investigational new drug (IND) application submission for IK-595 planned for the second half of 2023
•
Potential indications for the clinical program are being explored based on IK-595 sensitivity and unmet clinical need; indication models that have shown high sensitivity for IK-595 to date include:
•
NRAS mutant cancers, including melanoma, colorectal cancer, and acute myeloid leukemia
•
KRAS mutant cancers, including non-small cell lung, colorectal and pancreatic cancers, and
LOGO
•
CRAF altered cancers, which represent an orphan population with a high unmet need and a unique potential to benefit from IK-595’s mechanism
•
Additionally, IK-595 has been shown to be active as a monotherapy in many RAF models, including BRAF mutant cancers, and synergistic in combination with other targeted agents, including KRAS G12C, SHP2, SOS1, TEAD, EGFR, PI3K and mTOR inhibitors in various RAS mutant cancer cell lines
IK-175: AHR Inhibitor in Collaboration with Bristol Myers Squibb
•
In March 2023, the FDA granted Fast Track designation for IK-175, the Company’s novel aryl hydrocarbon receptor (AHR) antagonist, in combination with immune checkpoint inhibitors, in patients with advanced urothelial carcinoma who have progressed on or within three months of receiving the last dose of checkpoint inhibitors
•
The Phase 1 clinical trial in urothelial carcinoma has completed enrollment; treatment is ongoing and the program is eligible for opt-in from Bristol Myers Squibb through early 2024
Corporate Update
•
Today the Company announced the pricing of an underwritten offering for estimated gross proceeds of approximately $40 million
•
Together with its existing cash, cash equivalents, and investments, the Company believes that cash at hand will be sufficient to meet its operating requirements into 2026 and will fund additional data events for both IK-930 and IK-595 beyond the initial read outs
Financial Results for the Quarter Ended March 31, 2023
As of March 31, 2023, Ikena had $137.8 million in cash, cash equivalents and marketable securities, which does not include proceeds from the recent underwritten offering that priced today.
Collaboration revenue was $5.3 million and $3.4 million for the three months ended March 31, 2023 and 2022, respectively. The increase in collaboration revenue was primarily due to the Company’s decision to stop the IK-175 head and neck study.
Research and development expenses were $15.6 million and $14.3 million for the three months ended March 31, 2023 and 2022, respectively. The increase in research and development expenses of $1.2 million was primarily related to personnel and overhead costs due to an increase in headcount, partially offset by a decrease in other discovery stage programs, as a result of the Company prioritizing its focus on advancing its clinical stage programs.
General and administrative expenses were $5.3 million and $6.0 million for the three months ended March 31, 2023 and 2022, respectively. The decrease in general and administrative expenses of $0.7 million was primarily attributable to a decrease in legal, consulting, and insurance expenses.