Medicus Pharma Ltd. (NASDAQ: MDCX) and Boston-based Helix Nanotechnologies Inc. have entered into a non-binding memorandum of understanding to develop a new generation of thermostable mRNA vaccines that can be delivered without needles and stored at room temperature. The partnership aims to combine HelixNano's proprietary mRNA vaccine platform with Medicus's microneedle array (MNA) delivery technology to address key challenges in vaccine distribution and administration.
Technology Integration and Clinical Development
The collaboration seeks to merge two innovative platforms: HelixNano's messenger ribonucleic acid (mRNA) technology that instructs the immune system to fight infectious diseases, and Medicus's dissolvable microneedle patches that can deliver vaccines through the skin without traditional injection methods. This combination is designed to eliminate the need for cold-chain storage, a significant logistical challenge for mRNA-based vaccines.
"The potential of combining HelixNano's potent mRNA vaccine platform with our uniquely formulated dissolvable microneedle array (MNA) technology, is designed to unlock next generation vaccination paradigm," stated Dr. Raza Bokhari, Executive Chairman & CEO of Medicus. The approach aims to "develop needle-free, thermostable vaccines that could eliminate cold-chain logistics, reduce distribution costs, improve patient access and offer global scale."
Preliminary Research Framework
Before establishing a formal joint venture, the companies have outlined specific preliminary development activities. They will enter into a Sponsored Research Agreement with the University of Pittsburgh, where research will be conducted under the direction of Dr. Lou Falo, Professor and Chair of the Department of Dermatology at the University of Pittsburgh School of Medicine.
The initial research phase involves several key components: HelixNano will supply clinical drug product HN-0001, consisting of mRNA-LNP formulated vaccine material, in quantities suitable for the project. The University of Pittsburgh will then test and optimize the incorporation of the HN-0001 mRNA-LNP drug product into microneedle arrays. Once sufficient loading conditions are achieved, clinical-grade MNAs will be loaded with the HN-0001 drug product at an agreed dosage and concentration.
Clinical Study Plans
The collaboration's immediate goal is to produce a batch of clinical-grade mRNA vaccine-loaded microneedle arrays for use in a Phase 1 clinical bridging study. This study is designed to compare the safety and preliminary efficacy of intramuscular injection versus intradermal MNA delivery of HelixNano's vaccine candidate HN-0001. The HN-0001-loaded clinical MNAs are intended for future use in human clinical studies following the creation of the joint venture.
Company Backgrounds and Strategic Context
Medicus Pharma operates through its subsidiary SkinJect and has previously conducted trials using microneedle patches for treating skin cancer. The company completed a Phase 1 safety and tolerability study in March 2021, which met its primary objective and demonstrated efficacy with six participants experiencing complete response on histological examination. Medicus is currently conducting randomized, controlled, double-blind, multicenter clinical studies in the United States, Europe, and the UAE.
HelixNano, headquartered in Boston, focuses on building a universal interface to the immune system and is developing mRNA-based drug products across multiple therapeutic areas including infectious disease, solid organ transplant, and oncology.
Regulatory and Commercial Considerations
The memorandum of understanding is non-binding and does not obligate either party to proceed with the joint venture unless definitive agreements are executed. The companies acknowledge that preliminary activities do not constitute a binding commitment to pursue the proposed joint venture, which remains subject to negotiation and execution of definitive agreements.
Both companies have issued cautionary statements regarding forward-looking information, noting that actual results may differ materially from expectations due to known and unknown risks and uncertainties. The partnership represents an exploration of combining complementary technologies to address significant challenges in vaccine delivery and storage, particularly for mRNA-based vaccines that typically require cold-chain logistics.
