Partners

Partnership Approach / Rationale

 

As we seek to develop innovative therapies for patients with cancer and non-cancerous proliferation disorders, collaboration is a core value and a key to our success.

Mayne Pharma

 

INHIBITOR is party to an exclusive Supply and License Agreement with Mayne Pharma Ventures (Mayne Pharma) under which INHIBITOR has the exclusive U.S. rights to pursue clinical development of Mayne Pharma’s patented formulation of SUBA-Itraconazole for treatment of certain cancers and non-cancerous proliferation disorders.  As a result of past funding provided by Mayne Pharma, an affiliate of Mayne Pharma is also INHIBITOR’s majority stockholder.

Mayne Pharma

The Supply and License Agreement provides for the supply of specially formulated capsules of SUBA-Itraconazole, manufactured by Mayne Pharma under cGMP (current good manufacturing practice) standards, for use by us in our planned clinical trials for late-stage prostate and lung cancers, and for the future exclusive commercial supply following FDA approvals, if obtained.

 

“SUBA” technology (which stands for “super bioavailability”) is designed to improve the bioavailability of orally administered drugs that are poorly soluble. SUBA-Itraconazole is a patented formulation developed by Mayne Pharma, which has improved absorption and significantly reduced variability compared to generic itraconazole. These benefits are intended to provide enhancements to patients and prescribers with reduced intra- and inter-patient variability, enabling a more predictable clinical dose response and a reduction in the amount of active drug required to deliver therapeutic blood levels.

 

INHIBITOR completed a Phase 2b trial testing SUBA-Itraconazole for the treatment of basal cell carcinoma in patients with Basal Cell Carcinoma Nevus Syndrome (BCCNS) and transferred the program to Mayne Pharma which is planning to begin a global Phase 3 trial during 2020.

PSI CRO

 

PSI CRO has significant experience in clinical trials designed to test new therapies for prostate cancer and has been chosen to spearhead the effort for INHIBITOR’S SUBA Prostate Program titled the “PREDICT” Study (Prostate Response Evaluating Docetaxel-Itraconazole Combination Therapy). This clinical program will be carried out across approximately 32 sites in five countries in North America, Western Europe and Eastern Europe.

Assuming IND clearance by FDA and adequate funding, PREDICT will be launched as a Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2b Clinical Study Evaluating the Efficacy and Safety of SUBA-Itraconazole Capsules in combination with Docetaxel and Prednisone in Patients with Metastatic Castrate-Resistant Prostate Cancer (mCRPC).

 

PSI CRO is a privately-owned, full-service clinical research organization (CRO) operating globally. PSI’s global reach supports clinical trials across multiple countries and continents and is known to be highly selective about the work that they pursue. With an exceptionally high repeat and referral business rate combined with minimal staff turnover, PSI is committed to being the best CRO in the world as measured by its customers and its employees. In both 2015 and 2017, PSI was ranked as a Top CRO by the CenterWatch Investigative Site Survey. In 2018 PSI received 4 CRO Leadership Awards and added a 5th award to its collection in 2019.

The Weinberg Group

 

Since 2017, The Weinberg Group, a ProPharma Group Company, has provided regulatory support for SUBA-Itraconazole, initially for the BCCNS indication and more recently, for the metastatic castration-resistant prostate cancer (mCRPC) indication with a pre-IND meeting at FDA in the second quarter of 2019 and an EOP2 (End of Phase 2) Meeting scheduled for the fourth quarter of 2019 followed by an IND filing thereafter.

For the past 36 years, The Weinberg Group has assisted its drug and device clients in achieving FDA approvals by combining decades of regulatory experience with deep and broad scientific knowledge. This combination enables The Weinberg Group to optimize the path to approval, diminishing cost, shortening timelines, and increasing the likelihood of success.

University of Connecticut (UConn)

 

In July 2018, INHIBITOR entered into a one-year world-wide option agreement concerning itraconazole analogues, which are being developed by Dr. M. Kyle Hadden, Associate Professor of Medicinal Chemistry, Department of Pharmaceutical Sciences at UConn. These analogues have modifications to particular regions of the itraconazole scaffold. There are patents and patent applications which include compositions of matter claims covering the itraconazole analogues and method claims covering their use for the treatment of cancer.

Data from Dr. Hadden’s laboratory suggest that certain of these analogues maintain potent Hedgehog pathway inhibition while exhibiting improved pharmacokinetic parameters and reduced off-target side effects sometimes associated with itraconazole. INHIBITOR and UConn signed a one-year extension of the original world-wide option agreement in July 2019, which now includes additional new analogues and patent applications. The partnership with UConn will focus on pre-clinical animal testing of key analogues for treatment of human BCC tumors.

 

The University of Connecticut is one of the top 25 public research universities in the nation and is a research leader in the fields of advanced materials, additive manufacturing, biomedical devices, cybersecurity, energy, life sciences, sensors, and nanotechnology. As Connecticut’s flagship institution of higher education, UConn serves as an important resource for Connecticut economic development and is dedicated to building collaborations with industry and entrepreneurs with more than $3.6B in investment from the state of Connecticut and industry partners.