IFx-Hu2.0 Expanded Access Program

IFx-Hu2.0 Expanded Access Program

Sponsors

Lead Sponsor: Morphogenesis, Inc.

Source Morphogenesis, Inc.
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.

Overall Status Available
Study Type Expanded Access
Condition
Intervention

Intervention Type: Biological

Intervention Name: IFx-Hu2.0

Description: 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

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Overall Contact

Last Name: Michael JP Lawman, PhD

Phone: 813-875-6600

Phone Ext.: 101

Email: [email protected]

Verification Date

2021-05-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse

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