Periodic Reporting for period 1 - PDClungSME1 (A therapeutic vaccine candidate for lung cancer based on an exclusive cell line of Plasmacytoid Dendritic Cells (PDC*line))
Reporting period: 2016-08-01 to 2017-02-28
Since 2014, the revolution of immuno-oncology gives unprecedented hope for cure to cancer patients thanks to immunotherapies such as anti-PD(L)-1. However around 80% patients still don’t respond to anti-PD(L)-1. Several barriers are still to be overcome to sustain the path of a novel paradigm responding both unmet therapeutic needs and health economy sustainability; cancer being estimated as a leading cause of deaths in Europe (350’000 deaths in 2012– Globocan) corresponding to an economical burden of €126BN in total costs
PDC*line Pharma develops a ground-breaking therapeutic vaccine platform using an exclusive cell line of Plasmacytoid Dendritic Cells (PDC*line); potentially doubling the response rate to anti-PD(L)-1 without additional toxicity, eliminating complex and costly process usually required by cell therapies.
Our innovation project is aiming to establish the clinical proof of concept that PDC*lung, our leading candidate for lung cancer can induce strong anti-tumour immunity in patients. Lung cancer is of high priority for Europe since 1.9 million people are affected worldwide of which 340 000 in Europe (Globocan, 2012). It also represents an attractive market segment opportunity for PDC*line Pharma with an expected market growth of 4% per year: $6.1BN in 2013 to $8.6BN in 2023 worldwide (IMS, 2015).
PDC*line Pharma develops a ground-breaking therapeutic vaccine platform using an exclusive cell line of Plasmacytoid Dendritic Cells (PDC*line); potentially doubling the response rate to anti-PD(L)-1 without additional toxicity, eliminating complex and costly process usually required by cell therapies.
Our innovation project is aiming to establish the clinical proof of concept that PDC*lung, our leading candidate for lung cancer can induce strong anti-tumour immunity in patients. Lung cancer is of high priority for Europe since 1.9 million people are affected worldwide of which 340 000 in Europe (Globocan, 2012). It also represents an attractive market segment opportunity for PDC*line Pharma with an expected market growth of 4% per year: $6.1BN in 2013 to $8.6BN in 2023 worldwide (IMS, 2015).
The main goal was to study the clinical and business feasibility and design the development strategy of PDC*line Pharma’s leading candidate for lung cancer, PDC*lung.
A global clinical development path scenario of PDC*lung has been determined. The first indication for the clinical proof-of-concept is focused on patients with advanced stage non-small cell lung cancer (NSCLC), non-eligible to targeted therapies, in combination with an anti-PD-1 antibody. The antigen mix composition of PDC*lung has been fine-tuned in order to match the target patient population. A clinical synopsis have been designed and discussed with clinical and industrial experts and specialized CRO. Discussion are ongoing with potential clinical centres and investigators.
On the business side, PDC*line Pharma met over 20 potential industrial partners in order test their interest and specify the key drivers for future industrial deal. Estimations have been done regarding the market potential of PDC*lung in NSCLC, the risk adjusted net present value of the project, the structure and the value of a potential future out-licensing deal, the company’s funding need and the return of investment for investors.
Since mid-2016, PDC*line Pharma have raised 4 M€ in a seed round and recruited 12 people. We are now preparing a new large round of funding in 2017 in order reach the clinical proof-of-concept by 2022.
A global clinical development path scenario of PDC*lung has been determined. The first indication for the clinical proof-of-concept is focused on patients with advanced stage non-small cell lung cancer (NSCLC), non-eligible to targeted therapies, in combination with an anti-PD-1 antibody. The antigen mix composition of PDC*lung has been fine-tuned in order to match the target patient population. A clinical synopsis have been designed and discussed with clinical and industrial experts and specialized CRO. Discussion are ongoing with potential clinical centres and investigators.
On the business side, PDC*line Pharma met over 20 potential industrial partners in order test their interest and specify the key drivers for future industrial deal. Estimations have been done regarding the market potential of PDC*lung in NSCLC, the risk adjusted net present value of the project, the structure and the value of a potential future out-licensing deal, the company’s funding need and the return of investment for investors.
Since mid-2016, PDC*line Pharma have raised 4 M€ in a seed round and recruited 12 people. We are now preparing a new large round of funding in 2017 in order reach the clinical proof-of-concept by 2022.