Colorectal Cancer : Update Bulletin # 2 [March 2019]

This edition presents key opinion leader (KOL) views on recent developments in the colorectal cancer (CRC) market. Topics covered include: Gritstone Oncology announcing that the FDA had granted Fast Track designation to GRANITE-001, its personalised immunotherapy containing tumour-specific neoantigens (TSNA), for the treatment of CRC; Isofol Medical reporting that the first patient had been enrolled in the pivotal Phase III AGENT study evaluating its intravenously administered folate-based compound arfolitixorin as a first-line treatment for metastatic CRC (mCRC); Noxxon Pharma announcing that it would present updated safety and survival data for its CXCL12 chemokine inhibitor olaptesed pegol (NOX-A12), from the Phase I KEYNOTE-559 trial, at the American Association for Cancer Research (AACR) Annual Meeting in April 2019 (AACR19).

Business Questions:

• Is combining the tumour-specific neoantigen-based immunotherapy GRANITE-001 with the immune checkpoint inhibitors Opdivo and Yervoy regarded as a logical approach for treating CRC?
• Do KOLs foresee any safety issues arising from the use of GRANITE-001 in combination with Opdivo/Yervoy?
• How do KOLs rate the chances of GRANITE-001 plus Opdivo/Yervoy combination reaching the oncology market?
• Will the shift in practice towards administering 5-fluorouracil by infusion, rather than by a bolus dose, impact the need for folate-based drugs such as arfolitixorin and leucovorin for mCRC treatment?
• Do KOLs expect arfolitixorin to demonstrate superiority over leucovorin in the Phase III AGENT trial?
• Can arfolitixorin successfully reach the market for mCRC? What do KOLs say?
• Is the combination of the CXCL12 chemokine inhibitor olaptesed pegol with the immune checkpoint inhibitor Keytruda viewed as a rational design for tumour treatment in patients with cancer?
• How do KOLs view the early data for olaptesed pegol/Keytruda? Is it possible to predict whether the combination will reach the market as an anti-tumour therapy on the basis of these data?