Mycidac-C (mycobacterium indicus pranii heat-killed) / Cadila - LARVOL DELTA

Optimal drug regimens for squamous non-small cell lung cancer: a systematic review and a Bayesian network meta-analysis of randomized trials. (PubMed, J Thorac Dis) - "The network meta-analysis showed that for PFS, paclitaxel-based doublet chemotherapy combined with programmed cell death-1 and programmed death-ligand 1 [PD-(L)1] checkpoint inhibitors [surface under the cumulative ranking curve (SUCRA): 96.52%] and gemcitabine-based doublet chemotherapy combined with PD-(L)1 checkpoint inhibitors (SUCRA: 85.16%) were the most effective. For OS, paclitaxel-based doublet chemotherapy combined with a Toll-like receptor-2 agonist (CADI-05) (SUCRA: 92.11%), paclitaxel-based doublet chemotherapy combined with PD-(L)1 and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) checkpoint inhibitors (SUCRA: 89.65%), and paclitaxel-based doublet chemotherapy combined with PD-(L)1 checkpoint inhibitors (SUCRA: 83.58%) were the top three choices...For first-line treatment of sqNSCLC, the current evidence supports the use of paclitaxel-based doublet chemotherapy combined with PD-(L)1 checkpoint inhibitors as one of the preferred treatment options...."

Journal • Retrospective data • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • PD-1 • PD-L1 • TLR2

Desmocolin-3–directed immunotherapy in recurrent/metastatic head and neck squamous cell carcinoma. (ASCO 2026) - "In pre-treated R/M HNSCC observed response rates were 13.0% (nivolumab; CheckMate 141) and 14.6% (pembrolizumab; KEYNOTE- 040), with median PFS 2.0 months and 2.1 months, respectively...DSC3 directed immunotherapy (CADI-05) is useful in DSC3 expressing cancer like Squamous NSCLC, bladder cancer, and melanoma... DSC3 targeted immunotherapy was safe and improved outcomes in pre-treated R/M HNSCC expressing DSC3, with disease control rate 45%, response rate 35%. Median duration of response was 332 days with median PFS and OS of 115 and 155 days, respectively."

IO biomarker • Metastases • Bladder Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Neoadjuvant CADI-05 in Combination With Pembrolizumab for Surgically Resectable Locally Advanced Head and Neck Squamous Cell Carcinomas (clinicaltrials.gov) - P1 | N=22 | Recruiting | Sponsor: Fox Chase Cancer Center | Not yet recruiting ➔ Recruiting

Enrollment open • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Correlation between PD-L1, desmocollin 3, and stromal lymphocytes in recurrent head and neck squamous cell carcinomas (AACR 2026) - "DSC3 is a predictive biomarker for an investigational product CADI-05. Samples from patients with rmHNSCC were evaluated PD-L1 expression using standard protocol and expressed as combined proportion score (CPS) and tumor proportion score ( TPS)... DSC3 is expressed in 93% of rmHNSCC , irrespective of PD-L1 and TIL expression suggesting DSC3 specific therapy may be useful in management of patients with rmHNSCC with absent/low PD-L1 and or TIL ."

IO biomarker • Stroma • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Neoadjuvant CADI-05 in Combination With Pembrolizumab for Surgically Resectable Locally Advanced Head and Neck Squamous Cell Carcinomas (clinicaltrials.gov) - P1 | N=22 | Not yet recruiting | Sponsor: Fox Chase Cancer Center

New P1 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Impact of an Immune Modulator Mycobacterium-w on Adaptive Natural Killer Cells and Protection Against COVID-19. (PubMed, Front Immunol) - "RNA-seq analysis at 6 months showed an upregulation of the ANK pathway genes and an enhanced ANK-mediated antibody-dependent cellular cytotoxicity (ADCC) signature. Thus, Mw was observed to have a salutary impact on the ANK cell profile and a long-term upregulation of ANK-ADCC pathways, which could have provided protection against COVID-19 in a non-immune high-risk population."

Journal • Immune Modulation • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases • IFNG • KLRC1

TLR2 agonist as a novel therapeutic approach to treat pancreatic adenocarcinoma (AACR 2022) - "In presence of established tumor, TLR2 agonist Cadi-05 improves effector function, increases CD4+ and CD8+ expressing TIL, decreases immune suppressive TIL and retards tumor growth. Our study suggests that combination of gemcitabine and Cadi-05 inhibits the tumor growth irrespective of its size and it is coupled with increased anti-tumor response and decreased immunosuppressive function"

IO biomarker • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • CD4 • CD8 • FOXP3 • PD-1