SJP1604 / Samjin Pharma, AptaBio - LARVOL DELTA

A Phase I First in Human Study of Apta-16, an Anti-Nucleolin Aptamer Drug (Cytarabine) Conjugate, in Patients with Relapsed or Refractory Acute Myeloid Leukemia (ESMO 2026) - No abstract available

Clinical • First-in-human • P1 data • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • NCL

Targeting nucleolin overcomes MCL-1-mediated venetoclax resistance in acute myeloid leukemia (AACR 2026) - "Therefore, the results suggest that Apta-16 has strong potential as an effective therapy approach to overcome venetoclax resistance in in patients with relapsed or refractory AML. GLP safety/toxicity studies of APTA-16 have been completed, and orphan drug designation (ODD) was granted by FDA."

IO biomarker • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Mantle Cell Lymphoma • Oncology • CASP3 • NCL

A novel approach to treat relapsed/refractory acute myeloid leukemia by targeting nucleolin as an innovative and promising biomarker (AACR 2025) - "Cytarabine (Ara-C) and daunorubicin are treated as the standard first-line chemotherapy for AML but approximately 30% of the patients are refractory and more than 50% of them face a relapse because of resistance. Based on the excellent ex vivo results using patient-derived AML cells, successful clinical results are expected. GLP safety/toxicity studies of APTA-16 have been completed and orphan drug designation (ODD) was grantd by FDA in 2021."

Biomarker • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • DCK • DNMT1 • FLT3 • NCL

AptaBio Announces Results of Three Studies at AACR, Including CAF Targeting Therapy and Blood Cancer Treatment [Google translation] (BioTimes) - "At this AACR, AptaBio plans to present the research results of its anticancer drug ‘APX-343A’ with a CAF inhibition mechanism, as well as the first study to elucidate the mechanism of action of NOX2, which plays a critical role in regulating CAF and M2 macrophages in the tumor microenvironment (TME). In addition, it plans to disclose the scientific evidence supporting the claim that ‘Apta-16’, an innovative treatment applied with the Aptamer-drug conjugate (Apta-DC) platform technology, can provide a new treatment option for patients with relapsed and refractory acute myeloid leukemia."

Preclinical • Acute Myelogenous Leukemia

[VIRTUAL] In vivo PoC study and design for Phase I clinical study of SJP1604, a nucleolin-targeted therapeutic agent to treat entire population of relapsed/refractory acute myeloid leukemia patients (AACR 2021) - "Therefore, our results mentioned above are very noteworthy finding showing the high potential of SJP1604 to be further developed as the first innovative targeted therapy to treat entire population of R/R AML patients. Herein, we show a phase I clinical trial design of SJP1604 to perform an open-label, first-in-human, dose escalation study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity in patients with R/R AML."

P1 data • Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • FLT3 • NCL

Korean drugmakers aim to export technology during US cancer convention (Korea Biomedical Review) - "Despite the protracted Covid-19 pandemic, many Korean biopharmaceutical companies plan to participate in the 2021 American Association for Cancer Research (AACR)...Abclone will present the CAR-T cell therapy research results AT101 (blood cancer treatment) and AT501 (ovarian cancer treatment)...Aptabio will present the phase 1 clinical trial design for SJP1604 in treating patients with acute myeloid leukemia (AML), which is under joint research with Samjin Pharmaceutical...PharmAbcine plans to announce the preclinical results of PMC-309, an immune anticancer candidate."

P1 data • Preclinical • Acute Myelogenous Leukemia • Gynecologic Cancers • Hematological Malignancies • Leukemia • Oncology • Ovarian Cancer

Samjin Pharmaceutical, designated as an orphan drug by the US FDA for leukemia treatment [Google translation] (Rapportian) - "Samjin Pharmaceutical...announced on the 1st that 'SJP-1604', a relapsed and refractory acute myelogenous leukemia treatment, has been approved by the US FDA for the designation of an orphan drug."

Orphan drug • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology