Periodic Reporting for period 1 - THUNDER (Development of the Cyclin-Dependent Kinase Inhibitor VS2-370 to Target HIV-associated Malignancies and to Purge Viral Reservoir)
Reporting period: 2017-03-01 to 2017-07-31
Having reached an advanced stage of preclinical development with VS2-370 we have been able to complete a due diligence package suitable for inspection from the potential Pharma Customer. Two sets of presentations have been prepared: a non-confidential and a confidential one illustrating the results achieved so far and elaborating on future plans for first-in-man study (FIM).
The confidential deck can not be disclosed here, here we have only reported the non-confidential set of slides (see technical report for complete slide deck) which has been used for initial contacts with pharmaceutical industries during several international meetings. Aim of ViroStatics is to conclude an out-licensing or M&A event. The outline of the message delivered to the audience was as follows:
ViroStatics is developing novel CDK4/6/9 inhibitors for aggressive cancers and viral diseases, this robust pipeline of compounds distinguish themselves from the competition through their unique selectivity, efficacy and safety profiles. Our lead compound VS2-370:
• Has a distinct anti-CDK4/6/9 profile
• Is active in vitro and in vivo against aggressive cancers (i.e. primary effusion lymphoma, an HIV-related cancer with very poor survival rate)
• Has a good therapeutic window between activity and toxicity
• Is orally bioavailable, has promising ADME and CMC has been completed
Coaching support has been very important during the preparation of this presentation, providing us with very useful suggestions to review and complete the slide deck, as well as indications about value proposition, sales collateral development and investment planning.
Thanks to coaching support a series of interesting meetings for developing international partenerships and sustain corporate development have been set up.
Interaction with potential first customers was one of the main goals in this project. Pharma companies with franchise in HIV and/or oncology have been contacted and involved to identify the preferred initial indication(s) for VS2-370 in oncology. Three leading worldwide Pharmas with franchise both in HIV and Oncology had already expressed initial interest and promptly signed Confidentiality Agreements. During this project we have intensified the process of meeting pharmas and, also thanks to the Investment Bank Stifel’s network, we were able to contact several companies, the main contacts that were created during this project are listed in the final report attached.
Pharmas were met during the following international meetings:
ICTO, The International Congress on Clinical Trials, March 16-17, 2017
Bio-Europe Spring, March 20-22, 2017
AACR Annual Meeting, April 1-5, 2017
ASCO, American Society of Clinical Oncology Annual Meeting, June 2-6, 2017
ViroStatics and Stifel reached out to 34 likely potential future oncology-oriented partners for ViroStatics. Primary goal was to educate these potential partners ahead of a formal process in the Fall after further pre-clinical studies.
Durign this project ViroStatics intended also to improve the IP valorization plan. ViroStatics has developed a robust patent portfolio covering the composition of matter and use of the family of compounds designed to cure HIV infection, with a broad filing and patent protection beyond 2030. Part of the resources have been committed to maintain this broad coverage by paying due annual fees in the numerous countries where we have filed thereby making the project appealing for deal with a Pharma. Two independent analyses from specialized third parties have confirmed ViroStatics’ freedom to operate. A final IND enabling package has been elaborated based on the feedback from big Pharmas and meeting with EMA. According to timelines one year would be necessary to complete the IND-enabling studies, ViroStatics will try to get required funds through the application in SME Instrument Phase II. A FIM study design has also been put together and it is elucidated in the final report.
The advantages for the final users (HIV-infected individuals with associated malignancies) will be: tumor- and ART-free remissions, quality of life improvement, decreased side effects associated with ART, cost savings for the patients and the Health Systems. ViroStatics has demonstrated that the compound VS2-370 is active in primary effusion lymphoma, an HIV-associated tumor, and therefore has identified the indication for its lead compound. The goal of ViroStatics program would be to complete the Preclinical Phase of development for VS2-370, performing further in vitro and in vivo characterization of the compound to complete an Investigational New Drug (IND) application package, necessary to run a First-In-Man (FIM) study.