TSXV:MDCX
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Zacks initiates coverage of Medicus Pharma Ltd.
➢ Medicus Pharma Ltd. (TSXV:MDCX) is a holding company specializing in the acquisition life-science / biotechnology companies that are advancing novel therapies through clinical trials toward commercialization.
➢ Medicus Pharma completed its first acquisition, SkinJect, Inc., in September 2023. The SkinJect Dissolvable Microneedle Array drug delivery system for basal cell carcinoma (BCC) is in the process of finalizing the protocol, which has been recently been submitted to the FDA for review prior to enrolling patients for a Phase II clinical study.
▪ Management amending the Phase II protocol with expectations that a request to waive a Phase 3 study will be granted.
➢ The company was listed on the TSX Venture Exchange, and began trading on October 11, 2023.
➢ Medicus Pharma presents the opportunity to participate in the development of relatively advanced novel therapies that already have completed a clinical trial.
Medicus Pharma Ltd. (TSXV:MDCX) is a holding company in the healthcare sector focused on acquiring or partnering with life-science / biotechnology companies, and then advancing specific therapies through FDA-approved clinical trials toward commercialization. Prospective target companies are being identified by the Directors and management through a collaborative process that seeks out novel pharmaceutical compounds, treatments and/or delivery systems that already have progressed to the clinical stage.
Management is agnostic to the particular healthcare field that the therapeutic medical treatment addresses, but rather concentrates on the level of innovation and the degree to which the therapy has been de-risked through the clinical study process. The company accelerates the advancement of these prospective therapies through higher level clinical trials. On an ongoing basis, the Directors and management actively explore for additional candidates in order to expand the company’s therapy development pipeline.
SkinJect
The first company under the Medicus Pharma holding company umbrella is SkinJect, which holds an exclusive license to a patented drug delivery system (a patch with dissolvable microneedle arrays capable of delivering chemotherapeutic agents) that is being advanced for the treatment of cancers. Currently, the microneedle arrays (MNAs) are infused with doxorubicin, and these arrays will noninvasively deliver the agent in the vicinity of the basal cell layer. The initial target of the clinical studies is the most common form of skin cancer, basal cell carcinoma.
SkinJect, now a wholly-owned subsidiary of Medicus Pharma, was acquired through a Business Combination (via a reverse takeover transaction) that closed on September 29, 2023. A concurrent private placement of subscription receipts provided Medicus Pharma with approximately US$5.1 million in gross proceeds, which is principally earmarked for R&D, professional fees and corporate expenses.
In October 2018, Investigational New Drug (IND) application 122448 was submitted to the FDA, which approved a Phase I study of the SkinJect patch for the treatment of basal cell carcinoma through a Study May Proceed letter issued in November 2018. A 13-patient Phase I safety and tolerability study was completed in May 2021, which demonstrated that the SkinJect patch is safe and well-tolerated.
The company received an initial FDA approval to perform a Phase II clinical trial for basal cell carcinoma (BCC) in September 2021. This upcoming clinical study is structured as a randomized, controlled, double blind, multi-center study, of which the purpose is to further test the safety and assess the efficacy the SkinJect microneedle array patch on basal cell carcinoma patients. The recent submission of the protocol (SKNJCT-003) proposes a sample size of up to 60 patients, which is subject to further alignment after receipt of any comments from the FDA. As with most submissions, the company and the FDA have had discussions on the planned study, and management is receptive to adopting any suggestions that might facilitate an accelerated approval process. After the FDA approves a protocol for the Phase II trial, management anticipates recruiting the initial patient, probably during the first quarter of 2024.
Medicus Pharma Listed on the TSX Venture Exchange
Medicus Pharma Ltd. was listed on the TSX Venture Exchange, and began trading on October 11, 2023. The final non-offering prospectus was filed on SEDAR on October 11, 2023.
The listing on the TSX-V represents a significant milestone for the company by adding liquidity, financing opportunities and investor awareness of management’s mission to advance innovative medical therapies through the FDA approval process.
The SkinJect Microneedle Patch
The SkinJect microneedle patch is a promising novel approach for treating non-melanoma skin cancers. The initial treatment target of the SkinJect drug delivery system is basal cell carcinoma (BCC) with squamous cell carcinoma (SCC) anticipated to be the subsequent target.
The SkinJect patch is approximately 15mm x 15mm in size and consists of 13mm x 13 mm array of 400 dissolvable microneedles, each of which is approximately 750 microns (aka 0.75mm) in length. The microneedles are composed of buffered carboxymethyl cellulose, in which is deposited a cargo load of a chemotherapeutic agent, doxorubicin hydrochloride.
When applied to the skin, the microneedles are designed to penetrate the skin down to the interstitial fluid lying between the basal cell layer & the dermis and thereafter, to dissolve within 30 minutes, transdermally delivering a defined quantity of doxorubicin to the BCC lesion. The doxorubicin induces apoptosis (a programmed cell death) by causing an immune system reaction.
SkinJect – Method of Action
Doxorubicin (the cancer chemotherapeutic agent used to destroy cancerous basal cells) has a very potent cytotoxic effect on cells since it induces local cell apoptosis. Though doxorubicin is FDA-approved for human use, systematic exposure when administered by injection (intramuscularly or subcutaneously) entails risks due to the life-threatening toxic side effects of cell necrosis, particularly as related to cardiotoxicity, thrombocytopenia, myelosuppression and nephrotoxicity.
However, when delivered by dissolvable microneedle arrays in small amounts transdermally, the result is a release of doxorubicin into a specific targeted area (the lower part of epidermis and upper area of the dermis). Consequently, a higher local concentration is delivered within a micro-environment in the vicinity of the basal cell layer affected by BCC. This delivery process improves both the effectiveness of the chemotherapeutic agent and the safety profile (by minimizing and/or avoiding systemic exposure to the cytotoxic agent).
A variety of designs of microneedle arrays have been developed in order to provide a method of delivering therapeutic compounds transdermally; the categories include solid, hollow, coated, hydrogel-forming and dissolving microneedles. Transdermal drug delivery with microneedle arrays can evade some issues related to topical, oral and systemic delivery methods, such as topical creams, pills/tablets/capsules and hypodermic needles, respectively.
Dissolving microneedles appear to provide higher therapeutic agent loading than other methods by delivering higher local concentrations of the required drugs for treatment to the target area within the skin layers, thereby enhancing the level of absorption in the target area and reducing systemic side effects, including potential drug interactions.
The Upcoming Phase II Clinical Trial of SkinJect Patch
In its effort to fast track the clinical development program for the SkinJect D-MNA patch, Medicus Pharma submitted a clinical protocol (SKNJCT-003) to the FDA for a Phase II clinical trial on its non-invasive treatment of nodular BCC of the skin. The proposed protocol is a randomized, double-blinded, placebo-controlled clinical study. Up to 60 patients with nodular BCC of the skin will be enrolled, and the efficacy of two dose levels (100μg and 200μg of doxorubicin hydrochloride) will be evaluated compared to the placebo control group. The participants will be randomly and equally placed in one of three groups: the placebo-controlled group, a low-dose group (100μg) and a high-dose group (200μg). The SKNJCT-003 protocol follows the FDA guidelines for fast-tracking the approval process. The FDA is expected to comment on protocol, potentially revising and/or amending the proposed protocol and/or IND. This Phase II study was initially approved by the FDA in September 2021 and was originally entitled Proof of Concept Testing of Efficacy and Safety of Doxorubicin Microneedle Arrays in Subjects with Basal Cell Cancer.
Utilizing a financial model based on DCF methodology, which forecasts out to 2031 and uses a 10% discount rate (based on CAPM), and a terminal P/S multiple of 2.76 (based on Specialty Drug Manufacturers that focus on developing and commercializing novel therapeutics for unmet healthcare needs), the indicated value of MDCX is CDN$6.04 per share.
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