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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - FIBROHALT (Advancing a novel peptide-based therapeutic for pancreatic cancer)

Teaser

Summary

Pancreatic cancer is a devastating disease with a median 5-year survival rate of 3-5%. One explanation for the dismal prognosis is the failure of many chemotherapies. Pancreatic tumor cells stimulate neighbouring non-tumor cells (stromal cells) to join and grow around them. This stroma forms a fibrous matrix that promotes 1) aggressive tumor growth, 2) distant metastasis, and 3) form a barrier to chemotherapy and drug delivery. There is a high need to enhance the success of pancreatic cancer treatment by intensively pursuing strategies that target the tumor stroma. We are developing a novel peptide-based drug (AV3), that targets and reduces tumor stroma in pancreatic cancer, and potentially in other fibrosis associated cancers. We have demonstrated that AV3 reduces fibrosis (>50%) and enhanced the efficacy of chemotherapy in clinically relevant patient-derived xenograft models (achieving up to 80% tumor regression). Thus, our novel peptide has the potential to become a breakthrough add-on to chemotherapy in the treatment of pancreatic cancer. We are a biopharmaceutical company, spun-out in 2016 by the University of Twente. Our mission is to develop novel, targeted, peptide-based drugs to treat pancreatic cancer and other fibrosis-associated cancers and diseases with high unmet medical needs. The FIBROHALT project will (1) create a clear overview of the clinical opportunity for AV3 in pancreatic cancer, 2) develop a strategy to position the drug in the pancreatic cancer market, and (3) create an optimal development strategy, including a de-risk plan for future clinical studies. We will pursue a co-development or licensing deal for AV3 with a pharmaceutical company which will perform latestage clinical development, obtain EMA/FDA approvals, market and sell AV3.

Work performed

The SME Phase 1 grant enabled ScarTec to conduct a fruitful feasibility analysis into the pancreatic cancer market centered around three parts:

1. Complete a technical feasibility study involving radiolabelling of AV3.
2. Create a clear overview of the clinical opportunity for AV3 in pancreatic cancer.
3. Create an optimal development strategy, including a de-risking plan for future clinical studies.

The work performed included interviews with key opinion leader drug developers and oncologists, review of competitive intelligence reports to obtain valuable feedback on the pancreatic cancer field, the competition in the early-stage pipeline and the optimal route to market for AV3. The findings from this work has been incorporated into the company\'s business plan and a confidential technical report that will be uploaded.

Final results

Many new drugs for pancreatic cancer fail to succeed due to the high attrition rates in clinical development. Key opinion leaders have consistently pointed to the pivotal role of the stroma as an important reason, which significantly impairs the penetration of promising drugs. ScarTec is in an advantageous position as our agent directly targets this stroma. With the support from the H2020 SMEi Phase I grant, we were able to 1) gain a clear understanding of the clinical opportunity for our agent in pancreatic cancer, 2) develop a strategy to position our agent in the pancreatic cancer market, and (3) create an optimal development strategy, including a de-risking plan for future clinical studies. The potential impact of our agent is significant. Unlike other oncology indications, treatments for pancreatic cancer are scarce. There is an urgent need for new drugs to improve response rates in the adjuvant setting (combination use of chemotherapies) and novel treatments that can provide a major improvement in efficacy to extend survival well over a year in the metastatic stage. The impact of a drug that can enhance the efficacy of existing treatments will be substantial. Our agent has the potential to fulfil these needs as it is able to deplete the pancreatic tumor stroma and increase the efficacy of chemotherapy. To preselect patients most amenable to our agent, we will â€“ as a companion diagnostic â€“ develop a labelable variant of our agent that will reveal the extent of tumor uptake in patients by imaging.