ST-001 IND Application Receives FDA Approval
The US Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application for a phase Ia/b trial evaluating the safety profile, maximum tolerated dose, and pharmacology of ST-001 for the treatment of relapsed or refractory small-cell lung cancer (SCLC).
This clearance follows the completion of a comprehensive safety review conducted by the FDA and allows researchers to begin recruiting participants.1
ST-001 is a fenretinide phospholipid suspension for intravenous infusion. It is engineered to deliver high doses of fenretinide to cancer cells intravenously with lower toxicity.1 The drug has already demonstrated early signs of efficacy and encouraging pharmacokinetics in a previous phase Ia trial for T-cell non-Hodgkin lymphoma.1
Researchers are optimistic that this trial will also yield promising results and demonstrate the wide-ranging therapeutic potential of the drug.
Given the limited treatment options available for patients whose SCLC has relapsed or not responded to initial therapy, researchers believe that this trial may help address a currently unmet need in oncology. At the time of publishing, the trial is expected to begin in Q2 or Q3 of 2025.1
FDA Gives Green Light to an IND Application for CVHNLC
The FDA has also approved an IND application for a phase I clinical trial evaluating CVHNLC in patients with squamous NSCLC (sqNSCLC). CVHNLC, an investigational mRNA-based precision immunotherapy, is made up of two mRNA constructs that encode eight tumor-associated antigens that are commonly found in sqNSCLC.2
These include a novel class of tumor-associated antigens, which haven’t been tested in prior cancer immunotherapy trials.2 The upcoming open-label trial will assess the safety and tolerability of CVHNLC in combination with pembrolizumab in patients with advanced sqNSCLC.2
The first part of the study, known as Part A, will evaluate CVHNLC as first-line maintenance treatment following either pembrolizumab monotherapy or chemotherapy with pembrolizumab.2 Eligible participants must have stage IV metastatic sqNSCLC and must have already received at least three cycles of pembrolizumab, either alone or in combination with chemotherapy.2
CVHNLC will be administered in doses ranging from 100 µg to 400 µg, in combination with pembrolizumab, for up to 12 months or until disease progression or intolerable toxicity occurs.2 In Part B, the optional dose-expansion phase, researchers will explore CVHNLC in combination with first-line chemotherapy and pembrolizumab.2
The primary endpoints of the trial include treatment-related and emergent adverse events, as well as the incidence of dose-limiting toxicities.2 Overall response rate (ORR), progression-free survival (PFS), duration of response (DOR), and disease control rate (DCR) are among the secondary endpoints.2
FDA Approves Bevacizumab-nwgd for non-sqNSCLC
The FDA has recently approved bevacizumab-nwgd for intravenous use. Bevacizumab-nwgd, a biosimilar bevacizumab, is a recombinant humanized monoclonal antibody.3
It has been used to treat various types of cancer, including unresectable, locally advanced, recurrent, or metastatic non-squamous non-small cell lung cancer (non-sqNSCLC) in combination with carboplatin and paclitaxel for first-line treatment.3
Bevacizumab-nwgd is a VEGF inhibitor that essentially cuts tumors off from the blood supply needed to grow and spread.3
This approval is based on analytical and functional data confirming that bevacizumab-nwgd is highly similar to bevacizumab, with no clinically significant differences between the biosimilars regarding safety, efficacy, immunogenicity, and pharmacokinetics.3
References
- 1. https://www.prnewswire.com/news-releases/scitech-development-announces-2nd-fda-approval-of-a-phase-1-ab-ind-for-st-001-new-ind-targets-the-treatment-of-relapsedrefractory-small-cell-lung-cancer-following-its-previous-approval-in-the-treatment-of-t-cell-nhl-302421487.html
- 2. https://www.curevac.com/en/curevac-receives-u-s-fda-ind-clearance-to-initiate-phase-1-clinical-trial-for-novel-mrna-based-precision-immunotherapy-in-squamous-non-small-cell-lung-cancer/
- 3. https://www.bioconbiologics.com/biocon-biologics-announces-u-s-fda-approval-for-jobevne-biosimilar-bevacizumab-expanding-its-oncology-portfolio/
