78P - Novel allogeneic cell immunotherapy for advanced cancers

Background

Immune checkpoint inhibitor (ICI) and CAR-T cell immunotherapies have provided new treatment options for many patients with metastatic disease and hematological malignancy, respectively, inducing durable responses in some cases. CAR-T is not indicated for solid tumors and ICI responsiveness requires high tumor mutational load, CD8⁺ T cell infiltration and positive IFN-γ status, defining an inflamed phenotype (“hot tumors”). However, the majority of metastatic tumors present as non-inflamed (“cold tumors”), thus limiting the applicability of ICI to a minority subset of patients with highly immunogenic tumors. Immunological treatment of cold tumors is a great challenge as no pre-existing adaptive immune response has been established or maintained.

Methods

AlloStim®, was used on compassionate grounds AlloStim® is currently being evaluated in a phase IIB clinical trial in USA in MSI-S, chemotherapy-refractory, metastatic colorectal cancer patients, an indication known to present with “cold” lesions and to be non-responsive to ICI. AlloStim® is a living, non-genetically manipulated, allogeneic Th1-like cell therapy derived from precursor cells purified, expanded and differentiated from blood of normal donors. The AlloStim® mechanism of action is purported to convert “cold” tumors to “hot” tumors and naturally down-regulate checkpoint molecules in the tumor microenvironment. Single dose vials of formulated AlloStim® cells were delivered to our center in liquid nitrogen dry shippers. Administered either intradermally (ID) or intravenously (IV). The protocol included 3 weekly intradermal (ID) injections followed a week later by an intravenous (IV) infusion. This 4-week cycle was repeated 3 times. Upon approval of our institutional review board and obtaining informed consent.

Results

7 patients were acured 3 advanced/metastatic hepatocellular carcinoma, 2 breast cancer, 1 gall bladder and 1 Nasopharyngeal cancer. Due to the advanced status and poor ECOG status, only 3 completed the treatment schedule. 2 were still stable and alive at 1-year follow-up without receiving any other systemic therapy.

Conclusions

Simple to administer, minimal side-effects and appears to have activity in refractory metastatic disease. Further controlled clinical trials is warranted.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Kananathan.

Funding

Has not received any funding.

Disclosure

M. Har Noy: Leadership role, Shareholder/Stockholder/Stock options, Officer/Board of Directors: Mirror Biologics Inc. All other authors have declared no conflicts of interest.