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Pasithea Therapeutics Corp. (NASDAQ: KTTA) recently presented encouraging interim results from its Phase 1 study evaluating PAS-004, a next-generation macrocyclic MEK inhibitor, at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting. The study, a multi-center, open-label, dose escalation, modified 3+3 design, aims to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of PAS-004 in advanced cancer patients with documented RAS, NF1, or RAF mutations, or those who have failed BRAF/MEK inhibition [1].

As of April 2, 2025, 21 patients had been enrolled and received at least one dose of PAS-004 across six cohorts. The most common cancer diagnoses were pancreatic cancer (28.6%), colorectal cancer (28.6%), and melanoma (23.8%). Preliminary data suggest that PAS-004 demonstrates a dose-dependent PK profile and preliminary clinical activity as a monotherapy in heavily pre-treated, refractory solid tumors. In the efficacy evaluable population (n=16), 10 patients achieved stable disease (SD) by RECIST 1.1 at some point during the trial, with progression-free survival (PFS) of up to 159 days and overall survival (OS) of up to 253 days [1].

One patient in cohort 4A (15mg capsule) with stage 4 BRAF-mutated melanoma achieved over 5 months of stable disease with a tumor volume reduction of 14.9% and remains on treatment. The pharmacokinetics profile of PAS-004 suggests linear PK with an estimated half-life in excess of 60 hours. All treatment-related adverse events (AEs) were grade 1 or 2, and no dose-limiting toxicities (DLTs) were reported [1].

Pasithea's Chief Executive Officer, Dr. Tiago Reis Marques, commented, "The interim results from our ongoing Phase 1 study are encouraging and underscore the potential of PAS-004 as a best-in-class MEK inhibitor to serve patients with a broad range of MAPK pathway-driven tumors." The poster presentation will be available on the Pasithea website following the ASCO 2025 session [1].

References:
[1] https://www.nasdaq.com/articles/pasithea-therapeutics-reports-promising-interim-results-pas-004-phase-1-trial-refractory