Melanoma Study Gives Boost to Sona Nanotech as Shares Surge 19%

Sona Nanotech reported promising results from its first-in-human trial of Targeted Hyperthermia Therapy (THT) for advanced melanoma, with 8 out of 10 patients showing a strong clinical response. THT uses biocompatible gold nanorods inserted into tumors, which are then activated with near-infrared light, selectively killing cancer cells and stimulating the immune system. The company is preparing a Canadian clinical trial to explore THT in a broader range of solid tumors. Shares surged 19% to close at C$0.75, just shy of a 52-week high.

CERO Therapeutics (Nasdaq: CERO) reported significant progress in its Phase 1 clinical trial for CER-1236, an innovative T cell therapy. Investigators have administered a third infusion of CER-1236 to a patient in Cohort One, following the completion of the first two doses. This infusion is part of the ongoing study aimed at evaluating the safety and preliminary efficacy of CER-1236 in patients with acute myeloid leukemia (AML) CERo Therapeutics Announces Third Dose for Patient in Phase 1 Clinical Trial of CER-1236 in AML^[1].

The third infusion precedes the first dosing in Cohort Two, which is anticipated in the coming weeks, pending regulatory notifications. CERO has completed the first tranche of a planned $7 million financing, amounting to approximately $2.3 million, to extend its cash runway and support Nasdaq compliance. The company's Chief Financial Officer, Al Kucharchuk, highlighted the company's ability to execute and advance CER-1236 despite challenging financial conditions. He expressed gratitude for the continued support of shareholders, which is crucial for moving the promising program forward CERo Therapeutics Announces Third Dose for Patient in Phase 1 Clinical Trial of CER-1236 in AML^[1].

CER-1236 is designed to redirect patient-derived T cells toward tumor cells through both adaptive and innate mechanisms. This unique approach, referred to as Chimeric Engulfment Receptor T cells (CER-T), aims to offer advantages over currently approved CAR-T therapies and potentially extend the reach of cellular immunotherapy to both hematologic malignancies and solid tumors CERo Therapeutics Announces Third Dose for Patient in Phase 1 Clinical Trial of CER-1236 in AML^[1].

The Phase 1/1b study is designed to evaluate the safety and preliminary efficacy of CER-1236. Primary outcome measures include the incidence of adverse events (AEs) and serious adverse events (SAEs), incidence of dose-limited toxicities, and estimation of overall response rate (ORR), complete response (CR), composite complete response (cCR), and measurable residual disease (MRD). While no toxicities attributable to CER-1236 have been observed in the first three patients to date, the trial is ongoing, and no safety or efficacy conclusions should be made at this stage CERo Therapeutics Announces Third Dose for Patient in Phase 1 Clinical Trial of CER-1236 in AML^[1].

Meanwhile, Replimune, the developer of RP1, announced that the FDA has accepted the resubmission of a biologics license application (BLA) for RP1 plus nivolumab in advanced melanoma. The FDA has assigned a target action date of April 10, 2026, for a class II resubmission timeline. The resubmission follows a July 2025 complete response letter (CRL) issued by the FDA, which cited concerns about the adequacy of the phase 1/2 IGNYTE trial. Replimune has addressed the feedback from the CRL and is working closely with the FDA to expedite the review process FDA Accepts BLA Resubmission for RP1 Plus Nivolumab in Advanced Melanoma^[2].