Positive Results in Cancer Vaccine Trial for Merkel Cell Carcinoma and Cutaneous Squamous Cell Carcinoma

 A recent article published in GlobeNewswire captured the results of the trial that was presented at the 2023 Annual ASCO Meeting from June 2nd to June 6th, 2023 in Chicago.

IFx-HU2.0 is a cancer vaccine that was studied in advanced Merkel cell carcinoma and squamous cell carcinoma. Five out of seven patients (71%) managed durable responses after IFx0HU2.0 (IFx) therapy. The patients were dosed at 3 different levels and were successfully rechallenged where they had previously shown resistance. Yet they exhibited a promising safety profile at all three dosing schedules.

Morphogenesis, Inc. is a biotechnology company focused on developing cancer vaccines. Morphogenesis, in partnership with CohBar, believes they have met their milestone with IFx-HU2.0. The intent is to overcome resistance to current immunotherapies. The poster presentation was given by Dr. Andrew Brohl of the Moffit Center. Although patients diagnosed with advanced MCC and also cSCC patients have been highly responsive to ICI therapy, there are very few treatment options for those who do not respond.

Dr. James Bianco, Morphogenesis CEO, commented that four out of five (80%) of patients received long-lasting responses.

He further stated that using pembrolizumab to treat MCC could resolve the primary tumor response issue.

IFx is the company’s lead cancer vaccine against checkpoint inhibitors. It has been developed to prevail over checkpoint inhibitor resistance. Results of an ongoing study of advanced melanoma were presented at the ASCO 2023 annual meeting.

To be eligible for the study, patients should have progressed in spite of standard therapies or alternatively are not able to tolerate or have refused standard therapies.

71% of the patients had anti-tumor responses to ICI’s rechallenge. One of the patients with cSCC had anti-tumor responses lasting from seven months to 23 months. It is noteworthy that all four MCC patients had experienced progression to this same class of drugs prior to receiving therapy on the protocol.

Preliminary test results justified plans for 11 patients to apply for enrollment in the expansion stage of Phase 1b study. Additional information is available by referencing NCT04160065.

About Immune Fx (IFx) Personalized Cancer Vaccines

Administration of IFx involves a simple injection into the patient’s tumor of a gene that encodes for an immunogenic bacterial protein which is 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 and educating the immune system about all of the patient’s tumor’s neoantigens. This results in the production of tumor-specific antibodies and cytotoxic T cells.

The activated T cells overpower checkpoint inhibitors, thus allowing the T cells to destroy the tumor.


Rose Duesterwald

Rose Duesterwald

Rose became acquainted with Patient Worthy after her husband was diagnosed with Acute Myeloid Leukemia (AML) six years ago. During this period of partial remission, Rose researched investigational drugs to be prepared in the event of a relapse. Her husband died February 12, 2021 with a rare and unexplained occurrence of liver cancer possibly unrelated to AML.

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