BMS, Ono expand cancer immunotherapy pact
This article was originally published in Scrip
Bristol-Myers Squibb and Ono Pharmaceuticals are joining up under a collaborative deal to develop a number of immunotherapies for various cancer indications in Japan, South Korea and Taiwan.
Financial details of the strategic collaboration were not disclosed by either firm, but the deal includes development plans for Opdivo (nivolumab) and Yervoy (ipilimumab) across a broad range of tumor types.
Opdivo, a PD-1 immune checkpoint inhibitor, was recently approved in Japan for the treatment of patients with unresectable melanoma, making it the world's first PD-1 checkpoint inhibitor. Ono and BMS already had a development and commercialization deal in place for Opdivo, signed in 2011. This deal gave BMS worldwide rights to the drug, excluding the three territories (Japan, South Korea and Taiwan), for which it has now struck an agreement.
"This collaboration strengthens our long-standing relationship with Ono," said Lamberto Andreotti, CEO, Bristol-Myers Squibb.
Meanwhile, Yervoy, a CTLA-4 immune checkpoint inhibitor, is approved in Taiwan for the treatment of patients with advanced melanoma who have received prior therapy, and is in late-stage development as a potential treatment option for melanoma, small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) in Japan.
In addition to these two licensed products, the agreement also includes three early stage clinical immuno-oncology assets from BMS: lirilumab, an antibody that blocks the KIR receptor on natural killer cells; urelumab, an agonist of the CD137 co-stimulatory receptor; and BMS-986016, a LAG3 immune checkpoint inhibitor.
Ono and BMS will jointly test the compounds as monotherapies and combination treatments with Opdivo as the foundational therapy, they said in a statement.
Development costs and commercial profits will be shared equally when Opdivo is used in combination with any BMS compound, the companies confirmed. However, for a BMS compound used as monotherapy, or two BMS compounds used in a combination regimen, the originator company will fund the substantial majority of development costs and receive the bulk of commercial profits. Similarly with development of Opdivo as a single agent, Ono will financing the majority of development costs and retaining a large chuck of the returns.
Other recent BMS immuno-oncology combination deals:
- BMS teamed up with Celldex Theraputics in May this year to carry out a Phase I/II trial of Opdivo with Celldex's CD27 antagonist varlilumab against multiple tumors, including non-small cell lung cancer, metastatic melanoma, ovarian, colorectal, and squamous cell head and neck. The trial is slated to begin in 4Q14. BMS paid $5m upfront and under the terms of the deal has a time-limited right of first negotiation to varlilumab if Celldex out-licenses the antibody.
- In March, BMS struck an alliance with Five Prime Therapeutics to use its platform of human extracellular protein targets to select immune checkpoints. BMS said at the time it was planning to pursue single drugs or potential combinations with candidates in its own immunotherapy pipeline. Five Prime received $41m upfront, including $20m in cash and a $21m equity investment (approximately 1.3m shares at $16.14, representing a 4.9% stake). And is eligible for $9.5m in R&D funding; $300m in development, regulatory, and sales milestones per target; and a tiered mid-single-digit to low-double-digit royalty.