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BiolineRx (BLRX) is slated to report on complete data at the European Society for Medical Oncology (ESMO) from the KEYNOTE-202 study. This study evaluates the company’s peptide CXCR4 antagonist (BL-8040) in combination with Merck’s (MRK) Pembrolizumab (Keytruda). The study is targeted to enroll 30 patients with metastatic pancreatic cancer who have taken at least one prior therapy, but naive to PD-1. Patients are given a loading dose of BL-8040 daily for five days, followed by three week cycles of weekly Keytruda and three times weekly Bl-8040 until discontinuation. So far, the company has presented data at ASCO-GI in January of this year in seven patients willing to provide biopsies following the initial loading dose. Three of these individuals showed an increase in immune infiltrate into the tumor of CD3+ T-cells. Later the company has reported that T-cell infiltration has increased in 75% of patients in the mono-therapy lead-in
The company’s hypothesis behind the combination is to turn an immunologically cold tumor such as pancreatic warmer through this means and hopefully elicit responses. Further it is hypothesized that CXCR4 blockade reduces the migration of myeloid derived suppressor cells (MDSCs) into the tumour. The bar here is set pretty low for an immuno-oncology (IO) combination, given that outside of cancers with mismatch repair deficiency, overall response rates (ORR) are next to nil. A rate above 15% would be of significant interest, given that Five Prime (FPRX) showed a 13% response rate in this setting, but had significant doubts about its safety profile. The safety on BL-8040 has been mostly clean by comparison in the setting of transplantation where the company is running a registration trial.
This tolerability advantage allows Bioline to explore a triplet combination with an immunologically stimulating agent. Along these lines, the company has expanded its collaboration with Merck to include a triple combination with chemotherapy. The biomarkers that can be drawn from the doublet will help inform the design of future studies including a broader basket trial being run in collaboration with Roche. The study isn’t without some due skepticism, however. Bristol-Myers Squibb (BMY) abandoned a CXCR4 antibody in combination with Nivolumab due to lack of efficacy. Bioline is hoping for better fortunes with its smaller, high affinity peptide antagonist which should get improved bio-distribution. This peptide occupies the CXCR4 domain for over two days, which can potentially improve outcomes over the BMY study. If Bioline presents a respectable ORR for this setting, we could see shares trade in the 2s, potentially higher if data is seen a stellar, whereas downside is limited given that there is still many other shots on goal over the next 2 years with the company’s pipeline profile. Over the mid-term shares could continue to appreciate into the triplet study data due at the second half of next year.
