US-based Loxo Oncology has entered a global collaboration with Bayer to develop and commercialise LOXO-101 (larotrectinib) and LOXO-195 for the treatment of patients with tropomyosin receptor kinases (TRK) fusion cancers.
Under the deal, the company is eligible to receive up to $1.55bn in upfront, regulatory, and commercial milestone payments.
Loxo Oncology is a biopharmaceutical company that focuses on the development of highly selective therapies for patients with genetically defined cancers.
TRK fusions are chromosomal abnormalities that occur when one of the neurotropic tropomyosin receptor kinase (NTRK) genes (NTRK1, NTRK2, NTRK3) becomes abnormally connected to another unrelated gene, such as ETV6, LMNA, TPM3.
This abnormality leads to uncontrolled TRK signalling that, in turn, can cause cancer.
Loxo Oncology’s larotrectinib is a potent, oral and selective investigational new drug currently in clinical development for the treatment of cancer patients with abnormalities involving the TRKs.
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LOXO-195 is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that have obtained resistance to initial TRK treatment such as larotrectinib.
Bayer Oncology Strategic Business Unit executive vice-president and head Robert LaCaze said: “We see great potential in larotrectinib and moreover the follow-on compound LOXO-195, which may provide additional benefit for patients who might progress on an initial TRK inhibition therapy.
“These agents have the potential to fulfil the promise of precision medicine, where tumour genetics rather than tumour site of origin define the treatment approach for patients.”
As part of the agreement, Loxo Oncology will be eligible to receive $400m upfront payment, $450m in milestone payments upon larotrectinib regulatory approvals and first commercial sale events in certain major markets. It will also receive another $200m in milestone payments upon LOXO-195 regulatory approvals and first commercial sale events in certain major markets.
The company will lead global development activities and US regulatory activities, while Bayer will lead ex-US regulatory activities and worldwide commercial activities.
Loxo Oncology and Bayer will also share development costs globally on a 50 / 50 basis.
In the US, where they will co-promote the products, the two companies will share commercial costs and profits on a 50 / 50 basis.
Bayer will pay $25m to Loxo Oncology as a milestone payment upon attaining a certain US net sales threshold.
Outside of the country, where Bayer will commercialise the products, the company will pay Loxo Oncology tiered, double-digit royalties on net sales, and sales milestones totalling $475m.