Morphogenesis, Inc. and CohBar, Inc. Enter into Definitive Merger Agreement to Advance an Innovative Late-stage Clinical Immuno-oncology Pipeline of Therapies to Overcome Resistance to Cancer Immunotherapy
The companies hosted a joint webcast on May 23, 2023, to discuss the transaction.
Our IFx Personalized Cancer Vaccine technology is designed to overcome primary resistance to CPIs by making cancer cells look like bacteria, triggering an innate immune response.
Some personalized cancer vaccines being developed by others require tumor tissue from each individual patient, followed by extensive molecular processing and computational modeling in an attempt to predict which foreign or neoantigens are important to activate an immune response. Typically, only 30 or 40 neoantigens, among the tens of thousands in each patient’s tumor, are targeted using an mRNA construct that is specific to an individual patient. This complex process is expensive, time consuming and does not take full advantage of all of the neoantigens in a patient’s tumor.
In contrast, our IFx technology involves a simple injection into the patient’s tumor of a proprietary gene that encodes for emm55, an immunogenic bacterial protein that is then expressed on the surface of the tumor cell. Recognizing the bacterial protein as being foreign, the patient’s immune system is activated, “ingesting” the tumor cell. This process educates the immune system to all the patient’s tumor’s neoantigens, not just a few dozen predicted to be important.
Directly injecting IFx-Hu2.0 into the tumor ensures that emm55 is expressed by tumor cells, initiating an immune response directed against the tumor antigens contained within the patient’s tumor cells.
Our approach provides a potent, multivalent, and systemic response against all of the patient’s tumor sites, not just the ones that were injected, through a process called primary epitope spreading.
Our IFx personalized cancer vaccine can be used across a number of cancer indications and is initially being developed as a first line treatment for metastatic Merkel Cell Carcinoma.
Program Highlights:
In our Phase 1 trial among patients with treatment refractory advanced malignant Melanoma, after intralesional delivery of IFx-Hu2.0, correlative transcriptomic studies confirm the systemic nature of the ensuing innate and adaptive immune responses. Gene signatures consistent with an innate immune response are demonstrated in the injected tumor, while gene signatures consistent with an adaptive immune response are seen in the un-injected tumors. Both injected and un-injected tumors demonstrated substantial reduction in tumor size and a marked downregulation of genes encoding multiple melanoma antigens. Production of tumor-specific antibodies recognizing hundreds of previously unrecognized melanoma tumor epitopes similarly confirmed activation of a systemic immune response.
In our Phase 1/1b dose and schedule finding study, IFx-Hu2.0 demonstrated an ability to overcome checkpoint inhibitor resistance across multiple tumor types including metastatic Merkel Cell Carcinoma and other advanced malignant skin cancers.
In the Phase 1b portion of the study, the five patients with advanced metastatic Merkel Cell Carcinoma exhibited primary resistance to first line treatment with a checkpoint inhibitor (all having disease progression within three months of initiating checkpoint inhibitor therapy). These patients were then treated with IFx-Hu2.0, followed by re-administration of a checkpoint inhibitor. Four patients achieved a major objective systemic anti-tumor response, including one complete response, one near complete response, and two partial responses documented on restaging CT or MRI evaluation.