Moleculin Biotech

WHO Approves "Naxtarubicin" as International Generic Name for Moleculin's Cancer Drug Annamycin

19 days ago

• Moleculin Biotech's next-generation anthracycline Annamycin receives WHO approval for the international non-proprietary name "naxtarubicin," marking a significant milestone in its development and potential commercialization. • The drug, designed to avoid multidrug resistance and eliminate cardiotoxicity common with current anthracyclines, is currently in a pivotal Phase 3 MIRACLE trial for relapsed or refractory acute myeloid leukemia with data expected in H2 2025. • Moleculin has strengthened Annamycin's intellectual property portfolio with two new U.S. patents extending protection until June 2040, bolstering the company's position as it advances this potential treatment for hard-to-treat cancers.

Newron Pharmaceuticals Advances Pivotal Phase III Program for Treatment-Resistant Schizophrenia

2 months ago

• Newron Pharmaceuticals has received regulatory approval for its ENIGMA-TRS Phase III program evaluating Evenamide as an add-on therapy for treatment-resistant schizophrenia, with patient recruitment beginning immediately. • The pivotal program consists of two studies designed to meet requirements for marketing authorization in major markets including the USA and Europe, with results expected by late 2026. • Evenamide, a first-in-class glutamate modulator, has shown promising results in earlier trials with 70% of TRS patients experiencing clinically significant benefits and 25% achieving remission during one-year treatment.

Promising Pipeline for Soft Tissue Sarcoma Treatment Expands with 130+ Therapies in Development

2 months ago

• Global soft tissue sarcoma pipeline constitutes 125+ companies developing 130+ treatment therapies, with significant progress in clinical trials across various stages of development. • FDA grants Orphan Drug Designation to Actuate Therapeutics' elraglusib for soft tissue sarcoma treatment, highlighting its potential to address unmet needs in this rare cancer. • Novel approaches include tumor-targeting antibody-cytokine fusion proteins, intratumoral administration techniques, and GSK-3β inhibition, offering hope for improved outcomes in this challenging disease.

Over 120 Pipeline Therapies Target Acute Myeloid Leukemia as Research Intensifies

3 months ago

• DelveInsight's latest report reveals a robust pipeline with 110+ companies developing 120+ therapies for acute myeloid leukemia (AML), showing significant investment in this aggressive blood cancer. • Several promising candidates are advancing through clinical trials, including GlycoMimetics' uproleselan in Phase III, BioSight's aspacytarabine (BST-236) in Phase II, and novel approaches like Senti Biosciences' logic-gated CAR-NK cell therapy. • Recent developments include Moleculin Biotech's Phase III MIRACLE trial for annamycin, Qurient's adrixetinib IND approval, and Rigel Pharmaceuticals' trial of REZLIDHIA in combination therapy for IDH1-mutated AML.

FDA Guidance Enables Moleculin to Streamline Phase 3 Trial for Novel AML Treatment AnnAraC

3 months ago

• Moleculin Biotech receives FDA feedback allowing a 10% reduction in Phase 3 trial size for AnnAraC, their combination therapy targeting refractory/relapsed Acute Myeloid Leukemia. • The MIRACLE Phase 3 study will evaluate high-dose cytarabine combined with two different doses of Annamycin (190 mg/m2 and 230 mg/m2) against placebo in 75-90 initial subjects. • Annamycin holds Fast Track Status and Orphan Drug Designations from both FDA and EMA, with preliminary efficacy data expected in second half of 2025.

PDS Biotech's VERSATILE-003 Phase 3 Trial for HPV16-Positive Head and Neck Cancer to Start Q1 2025

4 months ago

• PDS Biotech reaffirms the initiation of the VERSATILE-003 Phase 3 clinical trial in Q1 2025 for HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma. • The VERSATILE-003 trial will evaluate Versamune® HPV in combination with pembrolizumab as a first-line treatment option. • The FDA has cleared the amended trial design, paving the way for the trial's commencement at the beginning of 2025. • PDS Biotech presented rationale for combining PDS01ADC + Xtandi® (Enzalutamide) versus Xtandi® alone for recurrent prostate cancer.

Moleculin Biotech's Annamycin Shows Promise in Overcoming Treatment Resistance in AML

5 months ago

• Moleculin Biotech's Annamycin demonstrates the ability to overcome resistance to Venetoclax in acute myeloid leukemia (AML) based on preclinical and clinical data. • Preliminary clinical data from the MB-106 trial indicates a 60% complete remission rate in relapsed or refractory AML patients treated with Annamycin plus Ara-C. • Moleculin has received regulatory approval in Europe to begin recruiting for its Phase 3 MIRACLE trial, evaluating Annamycin in combination with Cytarabine for R/R AML. • The FDA has provided positive guidance on Moleculin's IND amendment, potentially accelerating the approval timeline for Annamycin in AML treatment.