Only a few months after CEO Nadim Ahmed came over from Bristol Myers Squibb and joined as the top brass at the cancer-focused biotech Cullinan Oncology, the second half of a major deal has finally clicked into place — giving Cullinan a well-timed $275 million.
The Massachusetts biotech announced early Thursday morning that it has completed Part II of a deal with Japanese biotech Taiho that originally started back in 2019 — culminating in a co-commercialization and co-development partnership for CLN-081, a tyrosine kinase inhibitor candidate being investigated for NSCLC with a specific type of mutation already pursued by at least two pharma giants: EGFR exon 20.
The CEO said that while not a high percentage of NSCLC patients have that exact mutation — somewhere between 1 and 4, maybe 5% overall — they tend to have a poor diagnosis. From his view, there’s an unmet need.
Ahmed told Endpoints News that before he came on board with Cullinan, the biotech had actually licensed the drug in question from Taiho back in February 2019. The first patient was dosed that December, Cullinan presented proof-of-concept data at ASCO in 2021, and then the FDA granted the drug breakthrough therapy designation back in January.
At the time of the original deal, Taiho’s candidate was put in a Cullinan subsidiary called Cullinan Pearl, which Taiho will acquire as part of the deal announced this week. At the time the 2019 deal was announced, the candidate then called TAS6417 was described as sparing wild type EGFR, which was thought to possibly distinguish it from other drugs in the space.
The new pact is also relatively front-loaded, with only $130 million in regulatory milestone payments. And so far, Ahmed said Cullinan is pretty pleased with the direction that it is now going.
As to more of the specific details: Taiho gets rights to the drug outside the US and certain Asian markets, including already-established rights in Japan. Rights to the drug in China, Taiwan, Macau and Hong Kong were already given to Zai Lab back in 2020, the biotech said in a statement. When it comes to the US, however, Taiho’s US subsidiary and Cullinan are co-commercializing it and will be splitting profits from US sales 50/50.
On the co-development side, Ahmed said that Cullinan and Taiho are looking at starting a pivotal trial in the second half of 2022. Unless things change, it will be similar to other trials that have been used by other companies with now-approved drugs for niche EFGR mutations: a single-arm study that will enroll somewhere around 100 patients. So far, at least two pharmas have drugs targeting EGFR exon 20: Takeda’s Exkivity approved last September and J&J’s Rybrevant back in May 2021.
And while Cullinan and Taiho will see the indication for NSCLC all the way to the finish line (as long as the FDA gives it the regulatory green lights), the biotechs are keeping room open to potentially pursue other indications for CLN-081, including as a potential candidate for a combination therapy approach.
The $275 million cash that Taiho is giving Cullinan boosts the biotech’s bank balance to just around $600 million, after raising $249 million via IPO last year and $131 million in 2020 via a VC-backed Series C. For right now, that should give the 40-strong biotech enough runway to continue its operations until 2026 — and allow for expansion. Currently, Cullinan has eight programs in hematology and solid tumor indications, and clinical progress has been rapid, from Ahmed’s perspective.
“When I joined the company in October, we had one program in the clinic, which is CLN-081, that we’re talking about today. By December, we had another two programs in the clinic,” Ahmed said — referring to two antibodies in development, one for AML and one targeting MICA/B.
“By this time next year, we’ll have another two programs in the clinic,” the CEO added, which brings the company to five drugs in clinicals in the span of 19 months.
That said, the company will be adding another 40 employees by the end of the year — and with the deal, Ahmed said it’s the next step in the company shifting into a late-stage oncology biotech.
