"Overcoming immuno-oncology limits with Salmonella"...​CNCure

Recruiting immune cells to target "cold" tumors, aiming to achieve effective combination with immune checkpoint inhibitors

Has deleted 73 virulence genes·completed production of clinical agent…developing intravenous therapy

Has confirmed human safety data in a Phase 1 clinical trial in Australia…expanding into drug delivery·out-licensing

One factor in determining the efficacy of immuno-oncology therapeutics is the degree of immune cell infiltration into a tumor. In 'cold tumors,' which lack infiltrating immune cells, therapeutic response can remain limited even when immunosuppressive signaling pathways are blocked.

​CNCure is a biotechnology company aiming to overcome this limitation using Salmonella. The company's strategy is to infect tumors with attenuated Salmonella to activate immune cells and remodel the environment so conventional immune checkpoint inhibitors can function effectively.  

​DailyPharm met with Joong Gon Park (56), CEO of CNCure, to discuss the mechanism of action of its Salmonella-based anticancer therapeutics, strategies for ensuring clinical safety, and commercialization roadmaps after clinical trials.

​Recruiting immune cells into "cold" tumors…The role of Salmonella

CNCure CEO Joong Gon Park

Founded in 2019, CNCure is a novel anticancer drug development company. Co-CEO Jung-Joon Min, a professor of Nuclear Medicine at Chonnam National University Medical School, leads research and development. Co-CEO Joong Gon Park oversees executive management and business development (BD).  

The company established the Synthetic Anticancer Microbe (SAM) platform, based on more than two decades of bacterial oncology research led by Co-CEO Min. It is currently developing its lead pipeline asset, CNC-101, alongside a follow-on pipeline candidate, CNC-105.  

​Bacteria-based oncology therapeutics use the inherent properties of attenuated Salmonella to penetrate and colonize the hypoxic, immunosuppressive tumor microenvironment selectively. As host immune cells congregate to eliminate the bacteria, the therapeutics convert immunologically "cold tumors" into "hot tumors" that have an activated antitumor immune response.  

​CEO Park explained, "CNC-101 selectively penetrates tumors to activate both innate and adaptive immunity," and added, "The goal is to convert cold tumors, which lack infiltrating immune cells, into hot tumors, thereby enhancing response rates in combination therapies."  

​CNCure confirmed potential antitumor synergy when combining CNC-101 with an anti-PD-L1 antibody in colorectal cancer animal models. Because the program is currently in preclinical stages, clinical validation in patients will be required to confirm safety and combination effectiveness.  

​Deleting 73 virulence genes…Intravenous safety has been secured

Administering live bacteria intravenously requires preserving tumor-penetrating capabilities while minimizing infection risks in healthy non-target tissues.

​CNCure engineered CNC-101 by deleting 73 genes associated with Salmonella virulence. This includes knocking out gene clusters involved in the type III secretion system (T3SS), the mechanism by which bacteria deliver effector toxins into host cells, thereby structurally minimizing the potential for normal cell invasion.  

​CEO Park stated, "Safety is one of the key factors in the development of bacterial oncology therapeutics. CNC-101 significantly attenuates toxicity and pathogenicity by eliminating 73 genes related to Salmonella virulence."  

​Preclinical biodistribution studies also confirmed that CNC-101 selectively penetrated tumors over normal tissues. The company's strategy is to achieve both safety and immune activation through an engineered attenuated strain that selectively targets tumors and recruits immune effector cells.  

To transition the research strain into a clinical-grade investigational drug product, CNCure partnered with a US contract development and manufacturing organization (CDMO). After executing the contract in April 2022, the company completed culture scale-up, process optimization, and stability testing to manufacture a cGMP-compliant investigational drug product (DP).  

Initial safety validation via monotherapy…Expanding into checkpoint combinations

​CNCure plans to initiate the early-stage clinical development of CNC-101 as a monotherapy. After evaluating safety, tolerability, and the recommended dose in patients with advanced solid tumors, the development scope will broaden to evaluate combinations with immune checkpoint inhibitors.  

​Target indications include colorectal cancer, melanoma, and breast cancer. In particular, the trials will evaluate whether the therapeutic can successfully remodel the tumor microenvironment in patients who are refractory or have developed resistance to prior immuno-oncology therapies.

CNCure aims to enter a Phase 1 clinical trial in Australia in the second to third quarter of 2027, after completing additional preclinical safety evaluations and securing additional data packages.

​CEO Park considered first-in-human safety data as the key turning point for commercialization. Park noted that even with positive preclinical results, proving safe administration in human subjects is essential to initiating serious partnering discussions with global pharmaceutical companies.  

Park said, "Global pharmaceutical companies demand human safety data," and added, "They argue that regardless of how promising preclinical packages look, discussions can begin once safety is demonstrated in human administration."

​Once safety is established, the company plans to pursue co-development and out-licensing partnerships with multinational pharma holding immune checkpoint inhibitor pipelines. 

​Beyond combination therapy to drug delivery…Expanding follow-on pipelines

​The follow-on pipeline candidate CNC-105 is a drug delivery-oriented bacterial oncology platform engineered to express therapeutic payloads on top of CNC-101. It is designed to express cytotoxic and immunostimulatory proteins directly within the tumor, attacking cancer cells while inducing antitumor immune responses.  

​CEO Park explained, "While CNC-101 is being developed as a combination therapy to enhance the efficacy of existing immuno-oncology agents, CNC-105 is designed as a next-generation pipeline asset expanding into monotherapy therapeutic potential."

​The company is planning not only single-candidate out-licensing deals, but also indication-specific co-development of CNC-101 and novel pipeline development utilizing the SAM platform.  

​CNCure is pursuing a Series B funding round to support its global clinical programs. Of its KRW 7.0 billion goal, KRW 1.5 billion has been paid, and the secured funds will be prioritized for CNC-101's subsequent preclinical and clinical development.  

​Radiopharmaceuticals are another long-term expansion platform. By utilizing diagnostic tracer CNC-201 to delineate malignant melanoma lesions and target patient populations, the company envisions connecting to therapeutic radiopharmaceuticals to evolve into a theranostics company.

​CEO Park stated, "​CNCure plans to grow into a core player driving the global field of bacteria-based cancer therapeutics, beyond simply increasing corporate valuation.