Bicycle Therapeutics (BCYC) announced positive BT8009 Phase I data today in heavily pre-treated cancer patients at ASCO GI. In our view, the strong data point out the potential for BT8009 to become a best-in-class drug and a significant differentiated treatment option for cancer patients, writes analyst John McCamant, biotech expert and editor of The Medical Technology Stock Letter.
We are also impressed by the duration of tumor response as patients are able to stay on BT8009 therapy longer than the more toxic Padcev.
By way of background, BT8009, a BTC targeting Nectin-4, has demonstrated anti-tumor activity in heavily pre-treated urothelial, lung and breast cancer patients with signs of differentiation compared to antibody-based approaches (Padcev). BCYC has established two recommended Phase II doses (RP2Ds) at 5 mg/m2 weekly and 7.5 mg/m2 2 weeks on, 1-week off (over a 21-day cycle).
The company is currently focusing its efforts on the 5 mg/m2 weekly dose and enrollment in the expansion cohorts remains ongoing. A Phase II combo trial of BT8009 with a PD-L1 (pembrolizumab) remains on track to commence this year. Positive data is likely here as Padscev has shown that a Nectin-4 can work in combo with a PD-L1.
Safety Looks Good: BT8009 was well tolerated at or below the two RP2Ds. At or below the RP2Ds of 5 mg/m2 weekly and 7.5 mg/m2 2 weeks on, 1-week off (over a 21-day cycle), treatment-related dose modifications were rare. There were no treatment-related discontinuations. The incidence of Grade 3 or higher related adverse events at or below the two RP2Ds was low. At the 5 mg/m2 weekly dose, there were no cases of Grade 3 or higher skin rash, eye disorders, neuropathy or pneumonitis.
Safety is huge for BT8009 as an approved drug, SGEN’s Padcev which is an ADC, also targets Nectin-4 but has safety issues with Grade 3 or higher severe skin rash and neuropathy. ADCs have historically been tricky to develop as the killing agent attached to the antibody can cause excessive toxicity. Despite the toxicity, Padcev is a $500 million a year drug.
In our view, the strong data point out the potential for BT8009 to become a best-in class-drug and a significant differentiated treatment option for cancer patients. We are also impressed by the duration of tumor response as patients are able to stay on BT8009 therapy longer than the more toxic Padcev.
BT8009 received orphan drug status for the FDA in January for late stage UC patients. In our view, this is the fastest path to market and the company has already begun discussions with the agency about what an accelerated path may look like.
Recommended Action: Buy BCYC under $50.