fenretinide nanoparticle (ST-001 nanoFenretinide) / SciTech Development - LARVOL DELTA

Subtype-Specific Mechanisms of Treatment Resistance and Relapse in Diffuse Large B Cell Lymphoma (DLBCL) (ASH 2024) - "Methods : Tumor biopsies (N=228) collected at the time of relapse were obtained from n=85 participants in the Mayo Clinic/University of Iowa Lymphoma Molecular Epidemiology Resource (MER), n=73 in the Mayo Clinic Biobank, and n=38 from CC-122-DLBCL-001 or n=32 CC-122-ST-001 trials...For example, rrDLBCL patients may be strong candidates for MYC pathway targeting agents (BETi), or a Lenalidomide-based regimen (R2 or Tafa-Len), as Lenalidomide has been shown to reprogram the LME via PD-L1 expression in addition to downregulation of MYC and MYC target genes. Or, due to enrichment of variants affecting anti-apoptotic proteins including BCL6 or BCL2 in DZsig and GCB rrDLBCL, a venetoclax-based therapeutic may be considered. Further targeted strategies should be considered as development of a more personalized approach remains an unmet need."

IO biomarker • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • B2M • BCL2 • BCL6 • CD79B • CD8 • CD83 • EP300 • LRP1B • MYBPC2 • MYC • PD-L1 • PRKCB • TCF4 • TP53

Molecular Classification of Relapsed DLBCL Reveals Novel Biologic Subgroups (ASH 2023) - P1 | "Methods Data used in this study included RNA (n=143) and whole exome (n=126) sequencing data from available FFPE tumor samples at the time of a relapse (any line of treatment, r1-r10 relapse timepoints included in analysis, one per patient), consented to the Molecular Epidemiology Resource (n=61), banked in the Mayo Lymphoma Biobank (n=50), or consented to the CC-122-ST-001 clinical trial (n=32, NCT01421524). In summary, we show for the first time that rrDLBCL patients can be classified into four gene expression clusters that are associated with distinct pathway, TME, and genetic programs. These clusters should now be tested to learn if they can help select patients for newer therapies for rrDLBCL such as CAR-T and bispecific antibodies."

IO biomarker • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Metabolic Disorders • Non-Hodgkin’s Lymphoma • Oncology • BCL7A • CD4 • CD8

ST-001 nanoFenretinide in Relapsed/ Refractory Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=44 | Recruiting | Sponsor: SciTech Development, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Paclitaxel and rose bengal loaded microbubbles for the ultrasound targeted chemo-sonodynamic therapy of pancreatic cancer. (PubMed, Eur J Pharm Biopharm) - "Preclinical efficacy studies demonstrated a significant survival advantage in ST-001 treated mice, which survived more than twice as long as those treated with standard Taxol, despite receiving only 14% of the paclitaxel dose. Additionally, a preclinical toxicology study in healthy mice demonstrated an excellent safety profile for ST-001, with no adverse effects observed in key hematological and blood biochemical markers, or in the histology of the spleen, liver, and kidneys."

Journal • Hematological Disorders • Oncology • Pancreatic Cancer • Solid Tumor

First-in-Human Phase 1a Clinical Trial of the Investigational New Drug ST-001, a Novel Nano-Phospholipid Dispersion Formulation of Fenretinide, in Relapsed/Refractory T-Cell Non-Hodgkin Lymphoma (ASH 2024) - P1 | "In a recently reported trial of intravenous fenretinide in hematologic malignancies, responses were reported in cutaneous T-cell lymphoma (CTCL) and angioimmunoblastic T-cell lymphoma (AITL) (Mohrbacher et al, PMID 28420721), including a sustained complete response in a Sézary Syndrome (SS) patient who did not benefit from bexarotene (Crandon and Yancey, PMID 19349262), thereby confirming lack of retinoid cross-resistance. The clinical development objectives of this first-in-human Trial in Progress are (i) confirm that ST-001 achieves previously reported clinically active blood levels of fenretinide without any formulation liabilities, (ii) determine the pharmacological behavior of intravenous fenretinide delivered by this novel approach for delivery of poorly soluble drugs, (iii) and determine the safety profile, toxicity, DLT, and recommended treatment dose to evaluate disease activity and response rates in the follow-on Phase 1b trial in CTCL, AITL, and any..."

Clinical • First-in-human • P1 data • Cutaneous T-cell Lymphoma • Dyslipidemia • Hematological Malignancies • Hypertriglyceridemia • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Ophthalmology • Peripheral T-cell Lymphoma • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma

Biodegradation of polyhydroxyalkanoate film in soil: a sustainable approach for bioplastic management. (PubMed, Prep Biochem Biotechnol) - "These findings highlight the potential of B. cereus ST001 as a dual-purpose strain for PHB biosynthesis and degradation, shedding light on the future of bioplastics and sustainable waste management techniques. This aligns with the concept of a circular economy and sustainable production and consumption patterns."

Journal

Novel FOXM1 degrader STL001 sensitizes diverse group of human cancers to a broad-spectrum of cancer therapies (AACR-NCI-EORTC 2025) - "Inhibition of FOXM1 in AML sensitizes AML cells to the BCL2 inhibitor, venetoclax. Also, gene regulation by STL001 showed extensive overlap with FOXM1-KD, suggesting a high selectivity of STL001 toward the FOXM1 regulatory network. Collectively, STL001 offers intriguing translational opportunities as combination therapies targeting FOXM1 activity in a variety of human cancers."

IO biomarker • Oncology • Solid Tumor • BCL2A1 • FOXM1 • NPM1

Phase I/II study of claudin 18.2 ADC ATG-022 in patients with advanced gastric/gastroesophageal junction cancer (CLINCH) (ESMO 2025) - P1 | "Clinical trial identification ATG-022-ST-001, 18 Nov 2022. Conclusions ATG-022 demonstrated a manageable safety profile and encouraging preliminary antitumor effects in GC/GEJC pts in current dosing levels, suggesting further clinical investigation in pts with variable CLDN 18.2 expression. The enrollment of GC and other solid tumors is ongoing."

Clinical • Metastases • P1/2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18

Likelihood of polyhydroxyalkanoates production using canola oil cake and specific bacterial isolates for eco-friendly bioplastics. (PubMed, Biomater Sci) - "Chemical fingerprinting of the PHA film using Fourier transform infrared spectroscopy (FTIR) displayed unique functional groups - carbonyl (-CO-) and ester (-COO-) - at an explicit peak of 1718 cm-1, demonstrating that the polymer was polyhydroxybutyrate (PHB), for Bacillus cereus strain ST001 and Enterobacter cloacae strain AP001; however Rhodococcus ruber strain TESIII revealed a peak at 1653 cm-1 implying the existence of methylene (-CH-). It was further recorded that there was an increase in the intensity of 76.92% of tensile strength in PHA samples when bacteria were cultured in GRPD supplemented with the renewable carbon source. These findings explain the potential of canola oil cake as a cost-effective, renewable feedstock additive for enhancing PHA production and material quality, thus paving the way for future advancements in sustainable bioplastic development."

Journal

A Phase 1a/1b Trial in Relapsed/Refractory T-cell Non-Hodgkin Lymphoma to Determine the Safety Profile, Pharmacology, and Maximum Tolerated Dose of ST-001, an Intravenous Fenretinide Phospholipid Suspension (12.5 mg/mL) (EORTC-CLTG 2025) - No abstract available

Clinical • P1 data • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

SciTech Development Announces the Closing of Oversubscribed $5.5 Million Funding Round to Continue Cancer Clinical Trials (Newswise) - "The strong investor response is driven by extraordinary interim results from SciTech's lead drug candidate, ST-001 nanoFenretinide (ST-001), which is currently being evaluated in clinical trials for T-cell Non-Hodgkin Lymphoma (T-cell NHL) across nine prestigious cancer centers."

Financing • T Cell Non-Hodgkin Lymphoma

ST-001-010: Phase 1 Trial of ST-001 nanoFenretinide in Relapsed/Refractory T-cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=46 | Recruiting | Sponsor: SciTech Development, Inc. | Trial completion date: Nov 2025 ➔ May 2027 | Trial primary completion date: May 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Cutaneous T-cell Lymphoma • Dermatology • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma • TNFRSF8

Genome-wide association study and genomic prediction of leaf spot (Stemphylium vesicarium) resistance in spinach diversity panel. (PubMed, Front Plant Sci) - "A total of 311 diverse spinach genotypes, including USDA germplasm accessions and commercial cultivars, were evaluated under greenhouse conditions at the University of Arkansas using the S. vesicarium isolate Sb-1-St001 from 2019 to 2021...The GWAS-derived marker sets produced higher prediction accuracies in cross-population prediction, with r-values of 0.45 and 0.51 for the 4- and 18-SNP sets, respectively. These results underscore the potential of marker-assisted selection (MAS) and genomic selection (GS) to accelerate the development of spinach cultivars resistant to Stemphylium leaf spot."

Journal

ST-001 nanoFenretinide in Relapsed/ Refractory Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=44 | Not yet recruiting | Sponsor: SciTech Development, Inc. | Trial completion date: Jun 2028 ➔ Oct 2028 | Initiation date: Jun 2025 ➔ Oct 2025 | Trial primary completion date: Jan 2027 ➔ May 2027

Trial completion date • Trial initiation date • Trial primary completion date • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Resistance development and transcriptional responses of Salmonella enterica strains to bacteriophage SF1 treatment on Arabidopsis thaliana. (PubMed, Food Microbiol) - "We examined three Salmonella Typhimurium strains, ST001, ST536, and ST580, that developed phage resistance on Arabidopsis plants...This research underscores the complexity of phage-host interactions and reveals potential trade-offs, such as increased sensitivity to oxidative and acidic stresses. It offers insights into the dynamics of phage resistance, which could improve phage applications against foodborne pathogens, enhancing the efficacy and sustainability of phage-based safety interventions."

Journal

A phase 1a/1b trial in relapsed/refractory T-cell non-Hodgkin lymphoma to determine the safety profile, pharmacology, and maximum tolerated dose of ST-001, an intravenous fenretinide phospholipid suspension (12.5 mg/mL). (ASCO 2025) - P1 | "The accelerated stage has completed enrollment, and the standard stage is open for enrollment as of January 2025. This study investigates a novel fenretinide formulation aiming to address treatment challenges in T-cell NHL, with a focus on safety, tolerability, clinical activity, and pharmacology."

Clinical • P1 data • Cutaneous T-cell Lymphoma • Dyslipidemia • Follicular Lymphoma • Hematological Malignancies • Hypertriglyceridemia • Immunology • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Peripheral T-cell Lymphoma • T Cell Non-Hodgkin Lymphoma

Characterization of targeted ADC and small molecule therapy efficacy toward HER2-mutated XPDX models (AACR 2025) - "Models harboring an R678Q mutation in the juxtamembrane domain included ST022 (ovary), ST026 (colorectal) and STF001 (pancreas)...For in vivo studies, T-DXd, T-DM1, neratinib, tucatinib, and afatinib were evaluated at standard treatment regimens... We have established and characterized a panel of XPDX models harboring various HER2 mutations and benchmarked in vivo sensitivity toward targeting ADCs and small molecule therapies. This data and model panel can be utilized as a valuable tool in better understanding the utility of HER2-targeting therapies in HER2-mutated cancers."

Clinical • Bladder Cancer • Oncology • Solid Tumor • HER-2

ST-001 nanoFenretinide in Relapsed/ Refractory Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=44 | Not yet recruiting | Sponsor: SciTech Development, Inc.

New P1 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

SciTech Development Announces 2nd FDA Approval of a Phase 1 a/b IND For ST-001. New IND Targets the Treatment of Relapsed/Refractory Small Cell Lung Cancer Following Its Previous Approval in the Treatment of T-Cell NHL (PRNewswire) - "SciTech Development, Inc...has approved its Investigational New Drug (IND) application for 'A Phase 1a/b Trial in Relapsed/Refractory Small Cell Lung Cancer (SCLC) to Determine the Safety Profile, Pharmacology, and Maximum Tolerated Dose of ST-001, a Fenretinide Phospholipid Suspension for Intravenous Infusion.' This milestone greenlights SciTech to begin recruiting patients and initiates another Phase 1a/b clinical trial of ST-001, a novel nanoparticle drug designed to deliver fenretinide effectively to cancer cells....SciTech is preparing to launch the SCLC trial in Q2/3 2025."

IND • New P1 trial • Small Cell Lung Cancer

A novel FOXM1-BCL2A1 axis determines unfavourable response to venetoclax in AML. (PubMed, J Biol Chem) - "Venetoclax in combination with FOXM1 inhibitor STL001 inhibited BCL2A1 and circumvented venetoclax resistance. Pharmacological inhibition of FOXM1/BCL2A1 axis represents a therapeutic strategy to sensitize AML cells to venetoclax-induced apoptosis."

IO biomarker • Journal • Acute Myelogenous Leukemia • Oncology • BCL2A1 • FOXM1 • NPM1

Research note: Prevalence and genetic characteristics of pathogenic E. coli isolates from domestic pigeons in central China. (PubMed, Poult Sci) - "Eleven sequence types (ST) were identified, and ST646, ST38 and ST2001 were the dominant genotypes. Among these 60 pathogenic E. coli strains, high resistance rates to florfenicol (96.7 %), tetracycline (96.7 %), ampicillin (98.3 %) and trimethoprim (96.7 %) were observed...In addition, diarrhoeagenic E. coli-associated gene eaeH was detected in 96.67 % of the pathogenic isolates, highlighting their foodborne threat. Overall, this study extends our knowledge of the epidemiology of pathogenic E. coli in domestic pigeons."

Journal • Infectious Disease

SCITECH DEVELOPMENT ANNOUNCES PROMISING PRELIMINARY RESULTS IN PHASE 1A TRIAL FOR T-CELL NON-HODGKIN LYMPHOMA (PRNewswire) - P1 | N=46 | NCT04234048 | Sponsor: SciTech Development, LLC | "Preliminary data from the accelerated Phase 1a trial in patients with Cutaneous T-cell Lymphoma indicates favorable clinical improvements to ST-001 treatment, including earlier-than-anticipated stable disease and partial responses - one initial and one confirmed....In addition, results from patients treated with ST-001 demonstrate that the advanced nanoparticle delivery system successfully achieves the desired pharmacokinetic profile. It enables rapid and targeted delivery of fenretinide directly to tissues while minimizing side effects and toxicity. These findings exceed expectations and mark a significant milestone in the continued development of ST-001."

P1 data • Cutaneous T-cell Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • Sezary Syndrome

SciTech Development Raises Additional $3.2M to Expand Clinical Trials for Cancer (PRNewswire) - "This new funding brings SciTech's total raised to over $12 million. SciTech's financing was led by Storm Lake Capital and Pointe Angels, alongside new and existing accredited investors. Proceeds from the financing will be used to advance the company's Phase 1b clinical trials of ST-001 for T-NHL and subsequent clinical trials for small cell lung cancer."

Financing • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

Oxidative Stress and Chronic Myeloid Leukemia: A Balance between ROS-Mediated Pro- and Anti-Apoptotic Effects of Tyrosine Kinase Inhibitors. (PubMed, Antioxidants (Basel)) - "The ideal environment for tyrosine kinase inhibitor therapy is produced by a favorable oxidative status. We discuss the latest studies that aim to manipulate the redox system to alter the apoptosis of cancerous cells."

Journal • Review • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Myeloproliferative Neoplasm • Oncology • ABL1 • BCR

Novel FOXM1 inhibitor STL001 sensitizes human cancers to a broad-spectrum of cancer therapies. (PubMed, Cell Death Discov) - "A completely new activity of FOXM1, mediated through steroid/cholesterol biosynthetic process and protein secretion in cancer cells was also detected. Collectively, STL001 offers intriguing translational opportunities as combination therapies targeting FOXM1 activity in a variety of human cancers driven by FOXM1."

Journal • Acute Myelogenous Leukemia • Oncology • Solid Tumor • FOXM1 • NPM1