NK012 / Nippon Kayaku - LARVOL DELTA

Generation of anti-SN38 antibody for loading efficacy and therapeutic monitoring of SN38-containing therapeutics. (PubMed, Heliyon) - "However, it has garnered significant scientific interest as a payload in conjugated nanomedicine platforms (e.g., SN-38lip, NK012, SNB-101, and ADCs) to enhance their effectiveness and safety...The immunization efficiency, reactivity, binding affinity, specificity, and cross-reactivity of purified pAb and mAb against Irinotecan, a model for the emergence of an SN38 derivative in clinical settings, were evaluated using ELISA and western blotting (WB) techniques...The affinity of both pAb and mAb also meets the acceptance criteria for quantifying SN38 in fluidic material, as well as in Therapeutic drug monitoring (TDM) studies, a crucial aspect of personalized medicine. The potential applications of the anti-SN38 antibodies extend to reducing SN38-induced systemic toxicity through an inverse targeting strategy, a novel approach that piques further interest in our findings."

Journal • Oncology

Polymeric micelles paving the Way: Recent breakthroughs in camptothecin delivery for enhanced chemotherapy. (PubMed, Int J Pharm) - "The shell portion of polymeric micelles is composed of hydrophilic polymers Furthermore, the hydrophilic segment of polymeric micelles plays an important role in protecting against the reticuloendothelial system (RES). This review provides a discussion on recent research and developments in the delivery of camptothecin using polymeric micelles for the treatment of cancers."

Journal • Review • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Ovarian Cancer • Solid Tumor

Phase 3 Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012) (clinicaltrials.gov) - P3; N=870; Not yet recruiting; Sponsor: Merck Sharp & Dohme Corp.

Combination therapy • New P3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

A Phase I/II Study for Dose-finding, and to Investigate the Safety, Pharmacokinetics and Preliminary Efficacy of NK012, an SN-38-Incorporating Macromolecular Polymeric Micelle, in Patients with Multiple Myeloma. (PubMed, Intern Med) - "However, this phase I/II study was terminated at the end of the phase I stage because no patients showed an objective response. Additional clinical studies of combination therapy with NK012 and other agents are warranted."

Journal • Biosimilar • Hematological Malignancies • Multiple Myeloma • Oncology

MLN0128 and MLN0128 + MLN1117 Compared With Everolimus in the Treatment of Adults With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma (clinicaltrials.gov) - P2; N=96; Active, not recruiting; Sponsor: Millennium Pharmaceuticals, Inc.; Trial completion date: Nov 2019 ➔ May 2020; Trial primary completion date: Nov 2019 ➔ May 2020

Clinical • Trial completion date • Trial primary completion date

A phase II study of NK012, a polymeric micelle formulation of SN-38, in unresectable, metastatic or recurrent colorectal cancer patients. (PubMed, Cancer Chemother Pharmacol) - "NK012 monotherapy yielded an RR similar to the RR of irinotecan monotherapy that was reported in the phase III EPIC trial (4.2%), and the incidence of grade ≥ 3 diarrhea was low. Based on the incidence and severity of febrile neutropenia and grade ≥ 3 neutropenia, the initial dose of NK012 28 mg/m may be too high for colorectal cancer patients who have previously been treated with an oxaliplatin-based chemotherapy regimen."

Clinical • Journal • P2 data

MLN0128 and MLN0128 + MLN1117 Compared With Everolimus in the Treatment of Adults With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma (clinicaltrials.gov) - P2; N=96; Active, not recruiting; Sponsor: Millennium Pharmaceuticals, Inc.; Trial completion date: May 2019 ➔ Nov 2019; Trial primary completion date: May 2019 ➔ Nov 2019

Trial completion date • Trial primary completion date