New Publication in Molecular Cancer Therapeutics Highlights Data from Preclinical Development of exoIL-12™ for the Treatment of Cancer
– exoIL-12 has demonstrated tissue-retained pharmacology, enhanced anti-tumor activity, potent M1 myeloid recruitment, and superior T cell responses in vivo –
– Novel engineered exosome therapeutic candidate currently in Phase 1 clinical trial with data from healthy volunteers expected at year end –
CAMBRIDGE, Mass., Dec. 21, 2020 (GLOBE NEWSWIRE) -- Codiak BioSciences, Inc. (NASDAQ: CDAK), a clinical-stage company focused on pioneering the development of exosome-based therapeutics as a new class of medicines, today announced the online publication of a new manuscript, Exosome surface display of IL-12 results in tumor-retained pharmacology with superior potency and limited systemic exposure compared to recombinant IL-12, in Molecular Cancer Therapeutics, a journal of the American Association for Cancer Research. exoIL-12 is a novel engineered exosome therapeutic candidate currently being investigated in a Phase 1 clinical trial as a single agent for the treatment of early-stage cutaneous T cell lymphoma (CTCL) and potentially other cancers. This publication details the findings from the preclinical development program and highlights the potential of exoIL-12 to inhibit tumor growth by facilitating potent local pharmacology, precisely quantified doses, undetectable systemic exposure, and the robust generation of systemic anti-tumor immunity superior to recombinant IL-12 (rIL-12).
“We believe exoIL-12 represents a potentially first-in-class approach for a number of cancers that have previously shown clinical responses to IL-12, a potent anti-tumor cytokine for which prior development has been limited due to unwanted systemic exposure and related toxicity,” said Sriram Sathyanarayanan, PhD, Senior Vice President, Preclinical Research, Codiak. “This publication profiles the strength of the preclinical results that supported the advancement of exoIL-12 into the clinic and provides preclinical evidence that we can leverage the inherent biology of exosomes as delivery vehicles and potentially widen the therapeutic window of this potent cytokine.”
exoIL-12 is the first engineered exosome therapeutic candidate to be evaluated in humans and one of two Codiak programs currently in clinical development. exoIL-12 was engineered using the company’s proprietary engEx™ Platform and designed to display IL-12 on the exosome surface using the exosomal protein, PTGFRN, as a scaffold, the capability of which was identified by Codiak scientists.
Data from the Phase 1 single-ascending dose trial of exoIL-12 in healthy volunteers are expected by the end of 2020, including safety, toerability, and systemic IL-12 exposure. The trial, which consists of two parts, is designed to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of exoIL-12 first in healthy volunteers, followed by repeat dose exoIL-12 in patients with stage IA-IIB CTCL. Patients with CTCL will be monitored for safety, pharmacokinetics, pharmacodynamic effects in blood and tumor biopsies, and local and systemic anti-tumor efficacy using validated CTCL assessment criteria. Safety, biomarker and preliminary efficacy results from CTCL patients are anticipated in mid-2021.
Codiak intends to focus development of exoIL-12 on tumors that have, in previous clinical testing, shown clinical responses to IL-12 used as a monotherapy. This includes cutaneous T cell lymphoma (CTCL), melanoma, Merkel cell carcinoma, Kaposi sarcoma, glioblastoma multiforme and triple negative breast cancer.
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