A Phase Ib Investigation of Pembrolizumab in Combination with Intratumoral Injection of Clostridium Novyi-NT in Patients with Treatment-Refractory Solid Tumors

Some tumors are difficult to treat with chemotherapy or radiation. One of the reasons is that areas of the tumor do not have many blood vessels, which makes it difficult for drugs to reach those areas. One way that researchers have recently tried to overcome this problem is by injecting special kinds of bacteria into the tumors. These bacteria have been genetically changed to remove the chemicals that are poisonous to humans, but are still able to cause tumor cells to break down and die. The idea is that these bacteria may be able to assist chemotherapy drugs in fighting cancer.
The goal of this clinical research study is to find the highest tolerable dose of one of these bacterial therapies (Clostridium novyi-NT spores) that can be given in combination with pembrolizumab to patients with advanced solid tumors. The safety of this drug will also be studied, as well as whether it can help to control the disease.
This is an investigational study. Clostridium novyi-NT is not FDA approved or commercially available. It is currently being used for research purposes only. Pembrolizumab is FDA approved for the treatment of melanoma and different types of head and neck and non-small cell lung cancers. It is investigational to use these drugs in combination with each other in various types of advanced cancers.
The study doctor can describe how the study drugs are designed to work.
Up to 18 participants will be enrolled in this study. All will take part at MD Anderson.

Start Date10 Jul 2018

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

[+2]

NCT01924689 / CompletedPhase 1

Phase I Safety Study of Intratumoral Injection of Clostridium Novyi-NT Spores in Patients With Treatment-refractory Solid Tumor Malignancies

This protocol will examine the safety of intratumoral administration of Clostridium Novyi-NT spores in patients with treatment-refractory solid tumor malignancies. This investigational study will measure anti-tumor activity of C. novyi-NT administered intratumoral in patients with treatment-refractory solid tumor malignancies.

Start Date01 Oct 2013

Sponsor / Collaborator

BioMed Valley Discoveries, Inc.

NCT01118819 / TerminatedPhase 1

Phase I Safety Study of Clostridium Novyi-NT Spores in Patients With Treatment-refractory Solid Tumor Malignancies

This protocol will examine the safety of intravenous administration of Clostridium novyi-NT spores in patients with treatment-refractory solid tumor malignancies. This investigational study will measure anti-tumor activity of C. novyi-NT administered intravenously in patients with treatment-refractory solid tumor malignancies.

Start Date01 Apr 2011

Sponsor / Collaborator

BioMed Valley Discoveries, Inc.

100 Clinical Results associated with Clostridium novyi-NT

100 Translational Medicine associated with Clostridium novyi-NT

100 Patents (Medical) associated with Clostridium novyi-NT

129

Literatures (Medical) associated with Clostridium novyi-NT

01 Aug 2024·BMJ Case Reports

Posterior reversible encephalopathy syndrome (PRES) in classic Hodgkin’s lymphoma, complicated by anthracycline-induced cardiomyopathy

Article

Author: Cunningham, David ; Atmaja, Bambang ; Sharma, Bhupinder ; Hall, Rose

A woman in her 20s with no medical history was diagnosed with bulky stage II classic Hodgkin’s lymphoma after an 8-week history of shortness of breath, cough and lethargy. A regimen of doxorubicin (Adriamycin), bleomycin, vinblastine and dacarbazine (ABVD) was commenced with six cycles planned. During the first cycle, the patient was profoundly hypertensive. She then suffered two self-terminating tonic-clonic seizures.Examination and investigations diagnosed posterior reversible encephalopathy syndrome (PRES), which resolved completely in 11 days with strict blood pressure control and withholding chemotherapy. Treatment was further complicated by anthracycline-induced cardiomyopathy, requiring a switch in regimen to gemcitabine BVD.The patient made a full recovery from neurology and cardiology perspectives and completed six cycles of chemotherapy, achieving a complete metabolic response by the tumour. We illustrate the case, describe differential diagnoses and management of PRES, its association with chemotherapy and the successful chemotherapy rechallenge.

01 Aug 2024·New England Journal of Medicine

Belantamab Mafodotin, Bortezomib, and Dexamethasone for Multiple Myeloma

Article

Author: Oriol, Albert ; Sandhu, Irwindeep ; Baig, Hena ; Rogers, Rachel ; Zherebtsova, Vera ; Dimopoulos, Meletios ; Opalinska, Joanna ; Fu, Chengcheng ; McNamara, Simon ; Eccersley, Lydia ; Gatt, Moshe E ; Kim, Kihyun ; Nichols, Maureen ; Bryant, Adam ; Sureda Balarí, Anna Maria ; Ganly, Peter ; Ward, Christopher ; Sia, Hanlon ; Ribas de Almeida, Ana Carolina ; Pitombeira de Lacerda, Marcelo ; Ho, P Joy ; Cerchione, Claudio ; Roy-Ghanta, Sumita ; Robak, Pawel ; Pirooz, Nick ; Lewis, Eric ; Garg, Mamta ; Fujisaki, Tomoaki ; Abdallah, Al-Ola ; Aparecida Martinez, Gracia ; Zhou, Xiangdong ; McKeown, Astrid ; Mielnik, Michał ; Mateos, María-Victoria ; Cavo, Michele ; Rifkin, Robert ; Grosicki, Sebastian ; Hus, Marek ; Hajek, Roman ; Hungria, Vania

BACKGROUNDBelantamab mafodotin had single-agent activity in patients with relapsed or refractory multiple myeloma, a finding that supports further evaluation of the agent in combination with standard-care therapies.METHODSIn this phase 3, open-label, randomized trial, we evaluated belantamab mafodotin, bortezomib, and dexamethasone (BVd), as compared with daratumumab, bortezomib, and dexamethasone (DVd), in patients who had progression of multiple myeloma after at least one line of therapy. The primary end point was progression-free survival. Key secondary end points were overall survival, response duration, and minimal residual disease (MRD)-negative status.RESULTSIn total, 494 patients were randomly assigned to receive BVd (243 patients) or DVd (251 patients). At a median follow-up of 28.2 months (range, 0.1 to 40.0), median progression-free survival was 36.6 months (95% confidence interval [CI], 28.4 to not reached) in the BVd group and 13.4 months (95% CI, 11.1 to 17.5) in the DVd group (hazard ratio for disease progression or death, 0.41; 95% CI, 0.31 to 0.53; P<0.001). Overall survival at 18 months was 84% in the BVd group and 73% in the DVd group. An analysis of the restricted mean response duration favored BVd over DVd (P<0.001). A complete response or better plus MRD-negative status occurred in 25% of the patients in the BVd group and 10% of those in the DVd group. Grade 3 or higher adverse events occurred in 95% of the patients in the BVd group and 78% of those in the DVd group. Ocular events were more common in the BVd group than in the DVd group (79% vs. 29%); such events were managed with dose modifications, and events of worsening visual acuity mostly resolved.CONCLUSIONSAs compared with DVd therapy, BVd therapy conferred a significant benefit with respect to progression-free survival among patients who had relapsed or refractory multiple myeloma after at least one line of therapy. Most patients had grade 3 or higher adverse events. (Funded by GSK; DREAMM-7 ClinicalTrials.gov number, NCT04246047; EudraCT number, 2018-003993-29.).

01 Jun 2024·Journal of Molecular Graphics and Modelling

Structural and functional analysis of Cyanovirin-N homologs: Carbohydrate binding affinities and antiviral potential of cyanobacterial peptides

Article

Author: Gonçalves, Evonnildo ; Queiroz Dos Santos, Larissa ; Santos Siqueira, Andrei ; Xavier, Gabriel ; Aguiar, Délia ; Lima Farias de Sousa, Alenna Crystiene

Cyanobacteria, a group of photosynthetic prokaryotes, can sinthesize several substances due to their secondary metabolism, with notable properties, such as Cyanovirin-N(CVN), a carbohydrate-binding lectin, that exhibits antiviral activity against several pathogens, due to its ability to bind viral surface carbohydrates such as mannose, thus interfering with the viral entry on the cell. CVN has been described in several cyanobacterial strains and shows biotechnological potential for the development of drugs of pharmaceutical interest. This study focuses on the genomic exploration and characterization of Cyanovirin-N homologs to assess the conservation of carbohydrate-binding affinity within the group. The analysis of their antiviral properties was carried out using bioinformatics tools to study protein models through an in silico pipeline, following the steps of genomic prospection on public databases, homology modeling, docking, molecular dynamics and energetic analysis. Mannose served as the reference ligand, and the lectins' binding affinity with mannose was assessed across Cyanovirin-N homologs. Genomic mining identified 33 cyanobacterial lectin sequences, which underwent structural and functional characterization. The results obtained from this work indicate strong carbohydrate affinity on several homologs, pointing to the conservation of antiviral properties alongside the group. However, this affinity was not uniformly distributed among sequences, exhibiting significant heterogeneity in binding site residues, suggesting potential multi-ligand binding capabilities on the Cyanovirin-N homologs group. Studies focused on the properties involved in these molecules and the investigation of the genetic diversity of Cyanovirin-N homologs could provide valuable insights into the discovery of new drug candidates, harvesting the potential of bioinformatics for large-scale functional and structural analysis.

100 Deals associated with Clostridium novyi-NT

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Neoplasms	Phase 1	-	The Johns Hopkins University	-
Refractory Malignant Solid Neoplasm	Preclinical	US	BioMed Valley Discoveries, Inc.	01 Apr 2011

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03435952 (AACR2023) Manual	Phase 1	HR-positive/HER2-low Solid Tumors Second line	16	Pembrolizumab + Clostridium Novyi-NT	(xudpzpczei) = Most prevalent grade 1 and 2 adverse events were injection site reaction (25%), pyrexia (19%), pruritus (13%), leukopenia (13%) and anemia (13%). No grade 3 or 4 treatment related adverse events noted dyapshfcej (mebncsqjza )	Positive	14 Apr 2023

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