Novaferon (recombinant anti-tumor and anti-virus protein) / Genova - LARVOL DELTA

Nivolumab, Fluorouracil, and Interferon Alpha 2B for the Treatment of Unresectable Fibrolamellar Cancer (clinicaltrials.gov) - P1/2 | N=15 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Suspended ➔ Recruiting | Trial completion date: Jul 2025 ➔ Feb 2026 | Trial primary completion date: Jul 2025 ➔ Feb 2026

Enrollment open • Trial completion date • Trial primary completion date • Hepatocellular Cancer • Oncology • Solid Tumor • CD4 • CD8

Drugs and natural products for the treatment of COVID-19 during 2020, the first year of the pandemic. (PubMed, Bol Med Hosp Infant Mex) - "These include some that are not considered anti-inflammatory, such as Aviptadil, pyridostigmine bromide, anakinra, imatinib, baricitinib, and bevacizumab, as well as the combination of ivermectin, aspirin, dexamethasone, and enoxaparin...On the other hand, tofacitinib, novaferon with ritonavir, and lopinavir were also effective, as well as in combination with antiviral therapies such as danoprevir with ritonavir. The natural products colchicine and Vitamin D3 were only effective in patients with mild-to-moderate COVID-19, as was hydroxychloroquine. Drug repositioning has been the main tool in the search for effective therapies by expanding the pharmacological options available to patients."

Journal • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases

Nivolumab, Fluorouracil, and Interferon Alpha 2B for the Treatment of Unresectable Fibrolamellar Cancer (clinicaltrials.gov) - P1/2 | N=15 | Suspended | Sponsor: M.D. Anderson Cancer Center | Active, not recruiting ➔ Suspended

Trial suspension • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • CD4 • CD8

Nivolumab, Fluorouracil, and Interferon Alpha 2B for the Treatment of Unresectable Fibrolamellar Cancer (clinicaltrials.gov) - P1/2 | N=15 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • CD4 • CD8

Novaferon gene modification promotes NK92 cell anti-tumor activity. (PubMed, Int Immunopharmacol) - "NK92-nova cells significantly inhibited HepG2 tumor growth in a xenograft model without systemic toxicity. Therefore, NK92-nova cells are a novel and safe strategy for cancer immunotherapy."

IO biomarker • Journal • Oncology • GZMB • IFNA1 • IFNG • NKG2D

Nivolumab, Fluorouracil, and Interferon Alpha 2B for the Treatment of Unresectable Fibrolamellar Cancer (clinicaltrials.gov) - P1/2 | N=15 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Jul 2023 ➔ Jul 2025 | Trial primary completion date: Jul 2023 ➔ Jul 2025

Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

"If we take in account, pegIFN-III together trials, activ-2, and the initial early hong kong trials IFN-b1, novaferon trials, IFNa retrospective use from wang et al. The story looks like mab." (@MARYau_MCU_PH)

Retrospective data

Novaferon Effectively Inhibits Ancestral SARS-CoV-2 and Omicron Variant in Vitro, 2022. (PubMed, China CDC Wkly) - "The in vivo effects of Nova need to be further tested in animal models. And large-scale randomized double-blind clinical trials are needed to reveal its potentially clinical application."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Efficacy and safety of lopinavir-ritonavir in COVID-19: A systematic review of randomized controlled trials. (PubMed, J Infect Public Health) - "There is no benefit of the addition of lopinavir-ritonavir to the standard care in COVID-19 patients."

Clinical • Journal • Review • Infectious Disease • Novel Coronavirus Disease • Oncology • Respiratory Diseases

Nivolumab, Fluorouracil, and Interferon Alpha 2B for the Treatment of Unresectable Fibrolamellar Cancer (clinicaltrials.gov) - P1/2; N=15; Recruiting; Sponsor: M.D. Anderson Cancer Center; Not yet recruiting ➔ Recruiting; Trial completion date: Jul 2021 ➔ Jul 2023; Initiation date: Sep 2020 ➔ Jan 2021; Trial primary completion date: Jul 2021 ➔ Jul 2023

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Oncology • Solid Tumor

Determination of Antioxidant 264 in the Butyl Rubber Stopper and the Compatibility with Recombinant Potent Antitumor and Antivirus Protein Injection. (PubMed, J Anal Methods Chem) - "The results indicated that antioxidant 264 was not detected in Novaferon after the accelerated test and three months of long-term test. The established validated method in this study can be used for the determination of antioxidant 264 in the rubber stopper, and the brominated butyl rubber stopper has good compatibility with Novaferon."

Journal • Oncology

Nivolumab, Fluorouracil, and Interferon Alpha 2B for the Treatment of Unresectable Fibrolamellar Cancer (clinicaltrials.gov) - P1/2; N=15; Not yet recruiting; Sponsor: M.D. Anderson Cancer Center

New P1/2 trial • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Phase II Study of Recombinant Antitumor and Antivirus Protein Injection Compared With Placebo in Metastatic Colorectal Cancer After Failure of Standard Treatment. (PubMed) - "Novaferon showed moderate efficacy and was well tolerated in patients with mCRC, especially with the 20-μg dose injected 3 times per week. Furthermore, Novaferon might improve immune function of these patients."

Journal • Biosimilar • Colorectal Cancer • Oncology

Recombinant Anti-tumor and Anti-virus Protein for Injection in Treatment of Metastatic Colorectal Cancer (clinicaltrials.gov) - P2/3; N=105; Recruiting; Sponsor: Beijing Genova Biotech Company, Ltd.

New P2/3 trial • Biosimilar • Colorectal Cancer • Oncology