• PREDIX and PYTHIA studies have started and are including patients. First payment for inclusion in the PYTHIA study made to IBCSG/BIG.
• Communication/PR of our collaboration with IBCSG/BIG have been issued.
• Produced an initial investigative Health Economic report as foundation for future reimbursement arguments, strategy and marketing plan.
• Published a White Paper with the scientific rationale for using Biovicas technology in cell cycle regulating drugs like CDK 4/6 inhibitors.
• First results from a study including CDK 4/6 inhibitors with a US university have been accepted for presentation at scientific congress before the end of 2016.
• Biovica have produced all kits needed for full analysis of all samples from the PYTHIA and PREDIX studies.
• Presence at the SABCS 2015 and AACR & ASCO 2016 cancer congresses.
The PREDIX and PYTHIA studies, evaluating the addition of palbociclib (trade name Ibrance; Pfizer) to standard endocrine therapy have started and inclusion of patients is ongoing. The fact that these studies are ongoing and the first DiviTum results from a US study of palbociclib that soon will be presented, have resulted in increased interest and inclusion in new projects & trials with US cancer institutes. In total DiviTum have been able to initiate interest and be included in 5 US studies addressing CDK 4/6 inhibitors. The first of these collaborations is a clinical study that will report before the end of the year at a major US cancer congress, supporting the use of DiviTum as an efficacy biomarker for CDK 4/6 inhibitors. With the potential in the US and the imminent study results that will be presented, Biovica have chosen to expand in the US and contract a full time consultant responsible for US Business Development (from 1 January 2016).
The value and interest in the studies in BIOVALID was boosted by the approval of palbociclib in EU in November 2016. With that comes the need for authorities to negotiate price and reimbursement of the drug, making the fundamental questions asked in BIOVALID highly actual. The price for palbociclib in the US is approx. USD 120,000 per patient and year making the drug highly expensive. We assume that all EU member states will have a significant interest in the pricing of palbociclib in EU. The addition of an efficacy biomarker for the drug would be a significant contribution and aid in administration guidance for the drug to those who actually respond. The results from PYTHIA & PREDIX studies and the other ongoing CDK 4/6 trials where DiviTum is included will provide evidence and reimbursement information on how to best use DiviTum as a tool for evaluating efficacy in this class of new drugs. At the recent ESMO meeting (www.esmo.org) biomarker data from the PALOMA-2 study (palbociclib in addition to standard endocrine therapy) was presented (Finn R et al). In summary, none of the markers looked at in the study revealed any correlation to the efficacy of palbociclib, yet again underlining the need to find a biomarker for early identification of patients responding to palbociclib.
A collaboration has been initiated with a high profile European Cancer Research Institute to look at another drug in the class of CDK 4/6 compounds, demonstrating the interest for DiviTum as a biomarker for this class of drugs. Biovica have also built on the collaboration with the PYTHIA Principal Investigator to provide data for DiviTum as a tool in early development and preclinical model rationale for endocrine therapy and cell cycle regulating drugs.
