Moleculin Biotech Amends Clinical Trial Protocol for Phase 3 Trial

On November 14, 2024, Moleculin Biotech, Inc. filed an 8-K report with the Securities and Exchange Commission (SEC) announcing the amendment of its clinical trial protocol with the U.S. Food and Drug Administration (FDA) for its Phase 3 pivotal trial protocol evaluating Annamycin in combination with Cytarabine (referred to as “AnnAraC”) for the treatment of Acute Myeloid Leukemia (AML) patients who are refractory to or have relapsed after induction therapy (R/R AML).

The company disclosed that a press release was issued on the same day detailing the amendment to the clinical trial protocol. The trial protocol aims to evaluate the efficacy of the combination therapy for AML patients in the MB-108 study.

The information shared in the 8-K report and associated press release has been furnished and is not intended to be filed as per the requirements of the Securities Exchange Act of 1934, nor will it be incorporated by reference in any filings unless specifically identified for such purposes.

The document also includes details of the financial statements and exhibits that were part of the filing. Exhibit 99.1 attached to the report contains the press release issued on the same day, which outlined the updates regarding recent corporate highlights for Candel Therapeutics, Inc., a clinical-stage biopharmaceutical company. The said press release included information about the company’s financial results for the third quarter of 2024, ongoing clinical trials, and future milestones.

In the attached exhibit, Candel Therapeutics provided updates on its phase 3 randomized controlled clinical trial for CAN-2409 in localized intermediate/high risk prostate cancer, the phase 2b clinical trial for CAN-2409 in the active surveillance population with localized low/intermediate risk prostate cancer, as well as data on therapeutic potential for CAN-3110 in melanoma.

Moleculin Biotech’s recent amendment to its clinical trial protocol signifies a significant step in advancing its treatment options for patients with AML. The company’s move aligns with its commitment to developing innovative therapies and addressing unmet medical needs in the field of oncology. Investors and stakeholders will be keen to track the progress of the company’s clinical trials and the potential impact of the amended protocol on the AML patient population.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Moleculin Biotech’s 8K filing here.

Moleculin Biotech Company Profile

Moleculin Biotech, Inc, a clinical stage pharmaceutical company, focuses on the development of drug candidates for the treatment of cancers and viruses. Its lead drug candidate is Annamycin, which is in Phase 1B/2 clinical trials for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma metastasized to the lungs.