Cullinan Oncology is back in the business development saddle some nine months after returning rights for its lead asset to Taiho Pharmaceutical in a nine-figure licensing deal.
Now, the company is plucking U.S. rights to a phase 1 bispecific that Harbour BioMed developed. It is paying $25 million upfront, with more than $550 million in biobucks waiting in the wings. The new deal, announced late Monday, tacks on a fourth clinical-stage asset to Cullinan’s pipeline, three of which—including the bispecific—are in phase 1 trials.
The new med, CLN-418, is touted as the only bispecific under development targeting antigens B7H4 and 4-1BB, which is hypothesized to better stimulate T cells and limit tumor growth all while improving toxicity. Harbour BioMed believes the candidate is a “promising” option for patients who are PD-L1-negative and/or those resistant to PD-L1-targeting treatments.
In March 2022, Harbour BioMed launched a phase 1 solid tumor trial with the aim of enrolling 108 patients. The study is recruiting out of two sites in Australia and the Carolina BioOncology Institute in North Carolina.
Referring to the company's deal with Harbour BioMed, Cullinan CEO Nadim Ahmed said in a release, “Importantly, this transaction adds another clinical-stage asset to our portfolio, and with it, we are on track to have potentially six clinical-stage assets in our pipeline by the end of 2023.” And it shouldn’t be long before Cullinan’s two existing preclinical assets are joining the rest of the pipeline in clinical trials. Cullinan maintains that it plans to submit phase 1 trial applications to the FDA for both CLN-617 and CLN-978 in the first half of the year.
The agreement with Harbour BioMed follows Cullinan's agreement in May 2022 to return some of the commercial rights for its lead asset, zipalertinib, to Taiho for $275 million upfront. Taiho had originally given away ex-Japan rights to Cullinan but evidently elected to claw back rights to more markets. The two will co-develop the drug in the U.S., and Taiho will take the baton in all other ex-China markets.
Cullinan announced in its third-quarter earnings report in 2022 that the two companies had initiated a pivotal trial of zipalertinib in non-small cell lung cancer with EGFR exon 20 mutations. At the time, the company said it had just more than $600 million in cash and investments on hand.