Immatics Announces Positive Clinical Data and Financial Update for Q3 2024
核心洞察
Immatics reported encouraging initial clinical data for TCER® IMA402 (搜索) in melanoma (搜索), demonstrating favorable tolerability and early signs of dose-dependent anti-tumor activity.
The company is set to initiate the SUPRAME Phase 3 trial for ACTengine® IMA203 (搜索) in melanoma (搜索) patients in December 2024, aiming for BLA submission in early 2027.
Immatics' financial position remains strong with $549.2 million in cash and equivalents as of September 30, 2024, extending the cash runway into the second half of 2027.
Immatics N.V. (NASDAQ: IMTX) has announced its third-quarter 2024 financial results and provided a clinical update on its cancer immunotherapy pipeline. The company highlighted promising initial clinical data from its TCER® IMA402 (搜索) program, targeting PRAME (搜索), and the upcoming Phase 3 trial for ACTengine® IMA203 (搜索) in melanoma (搜索). These advancements, coupled with a strong financial position, signal significant progress in Immatics' mission to develop T cell-redirecting cancer immunotherapies.
TCER® IMA402: Early Clinical Data
Immatics presented the first clinical data from its next-generation TCR Bispecific molecule, TCER® IMA402 (搜索), which targets PRAME (搜索) (Preferentially Expressed Antigen in Melanoma (搜索)). As of the data cut-off on November 6, 2024, the Phase 1 dose escalation trial included 33 heavily pretreated patients with recurrent and/or refractory solid tumors (搜索). Patients had received a median of three prior systemic treatments.
IMA402 demonstrated a favorable tolerability profile, with the most common treatment-related adverse events being mild to moderate cytokine release syndrome (CRS) and transient lymphopenia. Early pharmacokinetic data suggest a median half-life of approximately seven days, potentially enabling bi-weekly dosing.
Initial anti-tumor activity was observed, particularly in patients with PRAME (搜索)-positive tumors. In patients treated with relevant doses (3 mg and 4 mg), 78% (7/9) experienced shrinkage of their target lesions. One cutaneous melanoma (搜索) patient showed a confirmed partial response with -40.2% tumor shrinkage at 3 months post-treatment. These early results indicate a dose-dependent and PRAME expression-dependent clinical activity.
ACTengine® IMA203: Phase 3 Trial Planned
Based on Phase 1b data and discussions with the FDA, Immatics is on track to commence SUPRAME, a registration-enabling Phase 3 randomized-controlled clinical trial in melanoma (搜索) for IMA203, in December 2024. The trial will evaluate IMA203 targeting PRAME (搜索) in 360 HLA-A*02:01-positive patients with second-line or later (2L+) unresectable or metastatic melanoma who have received prior treatment with a checkpoint inhibitor.
Patients will be randomized 1:1 to receive IMA203 or investigator's choice of selected approved treatments. The primary endpoint for full approval will be median PFS, with secondary endpoints including objective response rate, safety, duration of response, no overall survival detriment, and patient-reported outcomes. Patient enrollment is expected to be completed in 2026, with a pre-specified interim analysis planned for early 2026. Immatics aims to submit a Biologics License Application (BLA) in early 2027 for full approval.
Financial Position
As of September 30, 2024, Immatics reported cash and cash equivalents of $549.2 million. Following a $150 million public offering in October 2024, the company projects a cash runway into the second half of 2027.
Total revenue for the three months ended September 30, 2024, was $56.7 million, compared to $6.6 million for the same period in 2023. This increase is primarily due to a one-time revenue associated with the termination of the IMA401 collaboration by Bristol Myers Squibb (搜索). Research and development expenses were $43.6 million, compared to $34.1 million for the three months ended September 30, 2023, reflecting increased investment in advancing clinical pipeline candidates. The net loss for the quarter was $9.6 million, compared to a net loss of $29.7 million for the three months ended September 30, 2023.
Strategic Focus
"This year, Immatics has demonstrated the strength of its pipeline by announcing data on clinical activity for its four clinical-stage assets across two therapeutic modalities," said Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics. "With our enhanced cash runway into the second half of 2027, Immatics is well positioned to advance all four candidates to highly relevant value inflection points with a specific focus on delivering meaningful clinical signals in multiple solid cancers in the coming year."