PMV Pharmaceuticals Q2 2024 Financial Results and PYNNACLE Trial Update

PMV Pharmaceuticals, Inc., a company focusing on precision oncology, has shared its financial results for the second quarter ending June 30, 2024, along with updates on its PYNNACLE clinical trial involving the drug rezatapopt. The company is currently advancing its Phase 2 monotherapy and Phase 1b combination trials.

PYNNACLE Phase 2 Monotherapy Progress

The Phase 2 monotherapy segment of the PYNNACLE trial is actively enrolling patients and is proceeding on schedule. This segment is a multicenter, single-arm, and registrational trial that aims to evaluate the efficacy of rezatapopt as a monotherapy at a daily dose of 2000 mg. The trial focuses on patients with advanced solid tumors carrying the TP53 Y220C mutation and KRAS wild-type. The primary endpoint is overall response rate assessed by a blinded independent central review. The trial plans to enroll 114 patients across five cohorts and is being conducted at about 60 sites in the U.S., Europe, and the Asia-Pacific region. Over 60% of these sites have already been activated. Data from an interim analysis is expected by mid-2025, with a potential New Drug Application (NDA) anticipated by late 2026.

PYNNACLE Phase 1b Combination Arm

The Phase 1b combination arm of the PYNNACLE trial is also making progress. This segment evaluates the combination of rezatapopt with pembrolizumab in patients with advanced solid tumors harboring the TP53 Y220C mutation. Initially, eight patients were given 1000 mg of rezatapopt daily along with pembrolizumab. However, three patients experienced dose-limiting toxicities (DLTs). Subsequently, the dose of rezatapopt was adjusted to 500 mg daily, and since no DLTs were observed at this level, the dose was again increased to 1000 mg daily. Enrollment at this dose level is ongoing, and the pembrolizumab dose remains steady at 200 mg every three weeks. The combination has shown a consistent safety profile. Preliminary data suggests that KRAS wild-type patients exhibit more clinical benefit than those with a KRAS single-nucleotide variant (SNV). Consequently, patients with a KRAS SNV will be excluded from this trial arm, aligning it with the Phase 2 monotherapy portion of the PYNNACLE trial.

Financial Overview

As of June 30, 2024, PMV Pharmaceuticals reported having $212.9 million in cash, cash equivalents, and marketable securities, which is expected to sustain operations until the end of 2026. The company used $17.8 million in operations during the first half of 2024, compared to $27.9 million during the same period in 2023. The net loss for the second quarter of 2024 was $1.2 million, a significant reduction from the $17.4 million loss in the same quarter the previous year. This decrease was primarily due to a $16.2 million income tax benefit from selling its New Jersey accumulated net operating losses. Research and development expenses increased slightly to $14.6 million, while general and administrative expenses decreased to $5.5 million for the quarter.

About Rezatapopt and the PYNNACLE Clinical Trial

Rezatapopt is a pioneering small molecule p53 reactivator designed to bind selectively to the p53 Y220C mutant protein, restoring its tumor-suppressor function. The FDA has granted it Fast Track designation for treating locally advanced or metastatic solid tumors with this mutation.

The PYNNACLE clinical trial is structured to evaluate rezatapopt in patients with advanced solid tumors carrying the TP53 Y220C mutation. The Phase 1 segment aimed to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D), achieving a 38% overall response rate at the RP2D. The Phase 2 monotherapy portion includes five cohorts (ovarian, lung, breast, endometrial cancers, and other solid tumors) focusing on evaluating the drug's efficacy.

In summary, PMV Pharmaceuticals continues to make notable progress in its clinical trials and maintains a strong financial position to support its ongoing research and development activities.

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