XH001 / NeoCura - LARVOL DELTA

Clinical Trial on the Safety, Tolerance and Preliminary Efficacy of XH001 Injection Combined With Neoantigen Vaccine-induced Tumor-specific T-cell Injection in Advanced Gastric Cancer (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Jia Wei | Not yet recruiting ➔ Recruiting | Trial primary completion date: Nov 2027 ➔ Jun 2028

Enrollment open • Trial primary completion date • Gastric Cancer • Oncology • Solid Tumor

Safety, Tolerance and Preliminary Efficacy of XH001 Injection Combined With Neoantigen Vaccine-induced Tumor-specific T-cell Injection in Advanced Gastrointestinal Cancer (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Beijing GoBroad Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Gastrointestinal Cancer • Oncology • Solid Tumor

Safety, Tolerance and Preliminary Efficacy of XH001 Injection Combined With Neoantigen Vaccine-induced Tumor-specific T-cell Injection in Advanced Gastrointestinal Cancer (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Beijing GoBroad Hospital

New P1 trial • Gastrointestinal Cancer • Oncology • Solid Tumor

Ultrasmall episymbiont Nanosynbacter lyticus employs multiple ATP-generating metabolic pathways during horizontal transmission. (PubMed, ISME J) - "It displays an obligate episymbiotic lifestyle where TM7x lives on the surface of its bacterial host Schaalia odontolytica strain XH001...Glycolysis is particularly important for episymbiont ATP production under anoxic conditions during horizontal transmission between hosts. Our study demonstrates that TM7x employs two ATP-generating metabolic pathways, ADS and glycolysis, to ensure its viability and infectivity under different microenvironments when disassociated from its hosts during horizontal transmission, a critical phase of its life cycle."

Journal

Clinical Trial on the Safety, Tolerance and Preliminary Efficacy of XH001 Injection Combined With Neoantigen Vaccine-induced Tumor-specific T-cell Injection in Advanced Gastric Cancer (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Jia Wei

New P1 trial • Gastric Cancer • Oncology • Solid Tumor

To evaluate the safety, tolerability, and preliminary efficacy of XH001 injection as adjuvant therapy in patients with high-risk recurrent solid tumors (ChiCTR) - P1 | N=48 | Not yet recruiting | Sponsor: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences; Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

New P1 trial • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Gastric Adenocarcinoma • Gastric Cancer • Hepatocellular Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

XH001 (New Antigen Tumor Vaccine) Combined With Chemotherapy as Adjuvant Therapy in Pancreatic Cancer (clinicaltrials.gov) - P=N/A | N=12 | Not yet recruiting | Sponsor: Peking Union Medical College Hospital

New trial • Oncology • Pancreatic Cancer • Solid Tumor

Identifying essential genes in Schaalia odontolytica using a saturated transposon library. (PubMed, J Bacteriol) - "The constructed Tn-seq library enabled the identification of putatively essential genes in XH001, revealing growth requirements under laboratory conditions. This library can be leveraged in future studies to elucidate TM7x's dependence on XH001 at the molecular level."

Journal • Dental Disorders • Infectious Disease • Periodontitis

Study of XH001(Neoantigen cancer vaccine) in combination with chemtherapy for Adjuvant therapy of pancreatic cancer. (ChiCTR) - P=N/A | N=12 | Not yet recruiting | Sponsor: Peking Union Medical College Hospital; Peking Union Medical College Hospital

New trial • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CA 19-9

XH001 Combination With Immunocheckpoint Inhibitor and Chemotherapy for Patients With Resected Pancreatic Cancer (clinicaltrials.gov) - P=N/A | N=24 | Recruiting | Sponsor: Wu Wenming | Not yet recruiting ➔ Recruiting | N=12 ➔ 24

Checkpoint inhibition • Enrollment change • Enrollment open • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • CA 19-9

Identifying essential genes in Schaalia odontolytica using a highly-saturated transposon library. (PubMed, bioRxiv) - "A highly saturated Tn-seq library was generated with nearly 660,000 unique insertion mutations, averaging one insertion every 2-3 nucleotides. 203 genes, 10.5% of the XH001 genome, were identified as putatively essential."

Journal • Infectious Disease

Episymbiotic Saccharibacteria TM7x modulates the susceptibility of its host bacteria to phage infection and promotes their coexistence. (PubMed, Proc Natl Acad Sci U S A) - "Here, we showed that during surface-associated growth, a human oral Saccharibacteria isolate (named TM7x) protects its host bacterium, a Schaalia odontolytica strain (named XH001) against lytic phage LC001 predation...Our study highlights the tripartite interaction between the bacterium, episymbiont, and phage. More importantly, we present a mechanism, i.e., episymbiont-mediated modulation of gene expression in host bacteria, which impacts their susceptibility to phage predation and contributes to the formation of "source-sink" dynamics between phage and bacteria in biofilm, promoting their long-term coexistence within the human microbiome."

Journal • Infectious Disease

XH001 Combination With Ipilimumab and Chemotherapy for Patients With Resected Pancreatic Cancer (clinicaltrials.gov) - P=N/A | N=12 | Not yet recruiting | Sponsor: Wu Wenming

New trial • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

Episymbiotic Saccharibacteria induce intracellular lipid droplet production in their host bacteria. (PubMed, ISME J) - "A survival assay demonstrated that the presence of LDs plays a protective role in XH001, enhancing its survival under adverse conditions. In conclusion, our study sheds new light on the intricate interaction between Saccharibacteria and their host bacterium, highlighting the potential benefit conferred by TM7x to its host, and further emphasizing the context-dependent nature of symbiotic relationships."

Journal

Complete genome sequence of Schaalia odontolytica isolated from subgingival biofilm. (PubMed, BMC Genom Data) - "Additionally, we performed a comparative genome analysis using previously sequenced genomes of strain XH001 and strain FDAARGOS_732, both derived from the human oral cavity...The genome is 2,389,595 bp with a GC content of 66.37%, and contains 2,002 protein-coding genes, 9 rRNAs, and 48 tRNA. Comparative analysis with two previously sequenced strains revealed many strain-specific genes in KHUD_008, primarily related to envelope biogenesis and replication/recombination/repair processes."

Journal • Dental Disorders • Periodontitis

Ultrasmall epibiont Nanosynbacter lyticus strain TM7x and host bacteria transcriptional activity after initial host parasitism. (PubMed, J Oral Microbiol) - "Oral Saccharibacteria Nanosynbacter lyticus strain TM7× lives as an ultrasmall epibiont on the surface of its host, Schaalia odontolytica strain XH001...TM7× displayed higher expression of type IV pili, consistent with increased attachment to new hosts. As TM7× is a member of the broadly distributed Candidate Phyla Radiation with small genomes lacking numerous biosynthetic pathways, this study provides further insights into how these epibionts interact and modulate their host bacteria."

Journal

A Safety and Efficacy Study of XH001 Combined With Sintilimab Injection in Advanced Solid Tumors (clinicaltrials.gov) - P=N/A | N=9 | Recruiting | Sponsor: jianming xu

Metastases • New trial • Oncology • Solid Tumor