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IFx-Hu2.0 Expanded Access Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04853602
Expanded Access Status : Available
First Posted : April 21, 2021
Last Update Posted : July 13, 2021
Information provided by (Responsible Party):
Morphogenesis, Inc.

Tracking Information
First Submitted Date April 16, 2021
First Posted Date April 21, 2021
Last Update Posted Date July 13, 2021
Descriptive Information
Brief Title IFx-Hu2.0 Expanded Access Program
Official Title IFx-Hu2.0 Expanded Access Program
Brief Summary

Expanded access requests for IFx-Hu2.0 may be considered for the treatment of adult patients (greater than or equal to 18 years of age) with stage III through IV cutaneous melanoma, advanced Merkel cell carcinoma (MCC), or advanced cutaneous squamous cell carcinoma (cSCC) who have failed all available treatment options.

To request access, use Responsible Party contact information provided in this record.

Detailed Description Not Provided
Study Type Expanded Access
Expanded Access Type Individual Patients, Treatment IND/Protocol
  • Cutaneous Melanoma, Stage III
  • Cutaneous Melanoma, Stage IV
  • Merkel Cell Carcinoma
  • Cutaneous Squamous Cell Carcinoma
Intervention Biological: IFx-Hu2.0

The investigational drug product IFx-Hu2.0 is composed of the drug substance pAc/emm55 (pDNA) complexed with the two excipients in vivo-jetPEI® (linear polyethylenimine), a transfection reagent, and dextrose, a pDNA/polyethylenimine complex stabilizer.

Therapeutic Classification:

  • Immunomodulatory Agent

Route of Administration:

  • Intralesional (i.e. injection of cutaneous, subcutaneous or nodal lesions)

Mechanism of Action:

  • Injection of IFx-Hu2.0 into the lesion facilitates the expression of the immunogenic Emm55 protein by the tumor cells.

Physiological Effect:

  • Expression of the emm55 gene by the tumor cells triggers immune recognition of tumor-specific and -associated antigens which leads to innate and adaptive immune responses. In addition to priming anti-tumor immunity in immune checkpoint inhibitor (ICI)-naïve patients, this could re-sensitize patients with primary or secondary ICI clinical resistance.
Other Name: pAc/emm55
Publications * Bunch BL, Kodumudi KN, Scott E, Morse J, Weber AM, Berglund AE, Pilon-Thomas S, Markowitz J. Anti-tumor efficacy of plasmid encoding emm55 in a murine melanoma model. Cancer Immunol Immunother. 2020 Dec;69(12):2465-2476. doi: 10.1007/s00262-020-02634-4. Epub 2020 Jun 18.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Expanded Access Status Available
Eligibility Criteria

Inclusion Criteria:

  • To request more information use Responsible Party contact information provided in this record

Exclusion Criteria:

  • To request more information use Responsible Party contact information provided in this record
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Contact: James A Bianco, MD 813-875-6600 ext 104
Listed Location Countries Not Provided
Removed Location Countries  
Administrative Information
NCT Number NCT04853602
Other Study ID Numbers IFx-Hu2.0 Expanded Access
Responsible Party Morphogenesis, Inc.
Study Sponsor Morphogenesis, Inc.
Collaborators Not Provided
Investigators Not Provided
PRS Account Morphogenesis, Inc.
Verification Date July 2021