ImmVirX and Innovent Enter into Clinical Trial Collaboration to Investigate the Combination of IVX037 and Sintilimab in Difficult-to-treat Cancers

ImmVirX’s Oncolytic Virus IVX037 to be assessed in combination with Innovent’s checkpoint inhibitor TYVYT® in Colorectal, Ovarian and Gastric Cancer to Investigate the Combination of IVX037 and Sintilimab in Difficult-to-treat Cancers

  • Investigating combination therapy of ImmVirX oncolytic virus, IVX037, with Innovent’s checkpoint inhibitor, TYVYT® (sintilimab injection), in difficult-to-treat cancers.
  • A Phase 1b clinical trial to commence in mid-2024 in Australia.

ImmVirX is conducting a first-in-human Phase 1 clinical trial (NCT05427487) in Australia of intratumoral IVX037. Initial results from Part 1a of IVX037 as a monotherapy indicate that multiple injections of IVX037 have been well tolerated with early signs of induction of potentially beneficial inflammatory cytokines/chemokines such as CXCL10 and with anti-tumour activity observed in some individual injected lesions. 

Part 1b is planned to begin in mid-2024, to assess the anti-cancer activity and tolerability of intra-tumoural administration of IVX037 in combination with intravenous sintilimab injection in patients with advanced colorectal, ovarian and gastric cancer. Approximately 45 patients will be enrolled. Under the collaboration agreement, Innovent will provide clinical drug supplies of TYVYT® (sintilimab injection) in this multi-center trial in Australia.

“We are excited to collaborate with Innovent on this clinical trial to explore the combination of IVX037, our receptor targeted oncolytic virotherapy, with the checkpoint inhibitor TYVYT® (sintilimab injection) in difficult to treat cancers.” said Dr Malcolm McColl, CEO and Co-Founder of ImmVirX.  “We are pleased to have this opportunity to work with a leader in the global oncology field to evaluate the potential synergy of these two immunotherapies in very common cancer types. We believe the cancer killing and immune stimulating activity of IVX037 when used in combination with checkpoint inhibitors has the potential to drive meaningful responses in these cancer types which are generally refractory to checkpoint inhibitor monotherapy.” 

“We believe that there may be potential benefit in combining IVX037 with our anti-PD-1 therapy, TYVYT® (sintilimab injection) because they play complementary roles in engaging the immune system to fight cancer. We are pleased to be collaborating with ImmVirX and look forward to seeing encouraging results from this study.” said Dr. Hui Zhou, Senior Vice President of Innovent.

About IVX037

IVX037 is a proprietary oncolytic RNA virus which has been bio-selected to target receptors overexpressed on cancer cells.  It is able to target, infect, replicate in, and subsequently kill tumour cells, leading to the potential generation of both innate and adaptive immune responses against cancer. The clinical goal is to use IVX037 to enhance the rate, depth, and durability of response to immune checkpoints as a therapy which has the following characteristics:

  • Highly inflames “cold” tumor types with current low responsiveness to immune checkpoint therapy;
  • Triggers both innate and adaptive immune responses;
  • Infiltrates tumors with immune cells at a high rate;
  • Activates immune stimulating genes to create synergy with immune checkpoint and CAR-T therapies;
  • Favourable safety profile for patients;
  • Off the shelf therapy / no need for personalisation.

About Sintilimab

Sintilimab, marketed as TYVYT® (sintilimab injection) in China, is a PD-1 immunoglobulin G4 monoclonal antibody co-developed by Innovent and Eli Lilly and Company. Sintilimab is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells.

In China, sintilimab has been approved and included in the National Reimbursement Drug List (NRDL) for seven indications. The updated NRDL reimbursement scope for TYVYT® (sintilimab injection) includes:

  • For the treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy;
  • For the first-line treatment of unresectable locally advanced or metastatic non-squamous non-small cell lung cancer lacking EGFR or ALK driver gene mutations;
  • For the treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous non-small cell lung cancer who progressed after EGFR-TKI therapy;
  • For the first-line treatment of unresectable locally advanced or metastatic squamous non-small cell lung cancer;
  • For the first-line treatment of unresectable or metastatic hepatocellular carcinoma with no prior systematic treatment;
  • For the first-line treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma;
  • For the first-line treatment of unresectable locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma.

In addition, two clinical studies of sintilimab have met their primary endpoints:

  • Phase 2 study of sintilimab monotherapy as second-line treatment of esophageal squamous cell carcinoma;
  • Phase 3 study of sintilimab monotherapy as second-line treatment for squamous NSCLC with disease progression following platinum-based chemotherapy.

About ImmVirX 

ImmVirX is developing novel oncolytic viruses to create powerful new cancer immunotherapy combinations. The first virus is in clinical studies with further agents in pre-clinical development. Its novel oncolytic immunotherapy harnesses the power of viruses to preferentially infect and kill cancer cells and induce local and systemic anti-tumour immune responses. 

The proprietary bio-selection platform enables the development of RNA viruses targeting specific receptor proteins highly expressed on a range of cancer cell types, allowing them to selectively enter, replicate in, and destroy tumour cells while creating beneficial changes in the tumour micro-environment, potentially leading to the generation of specific innate and adaptive immune responses against cancer cells.  In this way, the viral candidates are intended to increase the effectiveness of current immunotherapies, primarily immune checkpoint inhibitors and CAR-T cell therapies, in fighting cancers of high unmet need including colorectal, gastric, ovarian and liver cancer.

About Innovent Biologics

Innovent is a leading biopharmaceutical company founded in 2011 with the mission to provide high-quality biologics that are affordable to all. The company discovers, develops, manufactures and commercializes innovative medicines that treat some of the most intractable illnesses. Its pioneering therapies to treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has 10 products in the market, 3 new drug applications under the NMPA review, 4 assets in Phase III or pivotal clinical trials and 20 more molecules in early clinical stage. Innovent partners with over 30 global healthcare leaders, including Eli Lilly, Roche, Sanofi, Adimab, Incyte and MD Anderson Cancer Center.

Guided by the motto, “Start with Integrity, Succeed through Action,” Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit, or follow Innovent on Facebook and LinkedIn.

Media Contact 

Dr Malcolm McColl 
Chief Executive Officer, Acting Chairman and Co-Founder  
E: [email protected]  

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