Following through on its strategy of showing CV301 could work in multiple tumor types, Bavarian Nordic has agreed to test the cancer vaccine in combination with AstraZeneca’s Imfinzi plus chemo in patients with metastatic colorectal or pancreatic cancers.
The two companies will contribute the respective meds and provide financial support for a Georgetown University-sponsored phase 1/2 study.
Researchers will first determine the safety of the combo and the primary phase 2 dose in a lead-in study. The phase 2 portion will enroll up to 26 patients for each indication, with progression-free survival set as the primary endpoint.
The Imfinzi trial marks the third checkpoint inhibitor combo under evaluation that includes CV301. BN first lined up the cancer vaccine with Bristol-Myers Squibb’s Opdivo in non-small cell lung cancer in late 2016. But for a phase 2 proof-of-concept study, Opdivo was replaced by Merck’s Keytruda in that setting. The second collaboration, a phase 2 with Roche’s Tecentriq in bladder cancer, is now expected to start in the second quarter of 2018.
All these collaborations allow BN to retain rights to CV301 and not enter into any agreement with first right of refusal or negotiation.
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BN didn’t just randomly pick the cancer type and the PD-1/L1 drug it wants to explore with. CV301 works by generating tumor T-cell response against CEA and MUC-1. Therefore, one of the most important factors from a selection perspective was that all of these tumors have high expression of the two tumor antigens, the company told FierceVaccines in an emailed statement.
“Colorectal and pancreatic cancers represent a slightly different opportunity as single agent activity for checkpoint inhibitors has been more difficult, therefore we hope to show not only the ability to benefit more patients, but to show that CV301 could possess the ability to show activity where others have yet to do so,” said the company.
For Keytruda in NSCLC and Tecentriq in bladder cancer, BN picked them because they are already market leaders in their respective fields. After winning a coveted first-line lung cancer monotherapy nod in 2016, Merck has been continuously building on that lead. The FDA granted accelerated approval to Tecentriq for bladder cancer in 2016 and later decided to keep that nod despite a phase 3 flop.
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The Danish company is a known advocate of cancer vaccine combo therapies. “[W]e remain steadfast believers in the power of combination treatments, including immunotherapies, to transform the future of cancer therapies,” CEO Paul Chaplin said last September as its lead cancer vaccine Prostvac failed as a monotherapy in prostate cancer. Tests combining Prostvac with BMS’ Opdivo or Yervoy are still actively recruiting patients.
Elsewhere in its pipeline, the company recently successfully completed phase 3 trials of its liquid-frozen smallpox vaccine Imvamune, and plans to file for FDA consideration later this year. Its MVA-BN RSV vaccine will also have readouts from a phase 2 extension study available soon.