Bicycle Therapeutics reports promising BT8009 study results, shares tank 30%

Bicycle Therapeutics plc (NASDAQ: BCYC) is down 30% after the biotech firm pioneering novel and differentiated therapeutics class based on its bicyclin peptide tech announced preliminary first phase results from the Phase 1/2 study of BT8009. BT8009 is a second-generation BTC targeting Nectin-4 that the company is developing.

Interim anti-tumor results confirmed in BT8009 study

Chief Medical Officer Dominic Smethurst said:

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Since our initial BT8009 Phase I/II trial interim results last year, we are encouraged to see BT8009’s promising profile endure over time. Over the last six months, the preliminary anti-tumor findings have been confirmed, the initial responses have deepened and remained durable, and the tolerability profile remains unchanged.

BT8009 has the potential of offering clinically significant differentiation relative to existing therapies. The company presented the results in an oral presentation on April 10, 2022, during this year’s American Association for Cancer Research Annual Meeting in New Orleans. Bicycle Therapeutics plans to continue advancing the program after finalizing the escalation phase.

CEO Kevin Lee stated:

As previously hypothesized, we believe that the differentiated pharmacokinetic profile of BTCs can deliver improved outcomes for patients. It is pleasing to see these clinical data mature and with it, the promise for a potentially industry-leading product profile. We look forward to providing additional updates on BT8009 as well as updates from our broad Bicycle oncology pipeline this year.

As of the cut-off date of March 7, 2022, the company had dosed 37 patients in the Phase 1/II BT8009 study. The company doses 12 response evaluable urothelial cancer patients in monotherapy groups of 5.0mg/m² and 2.5mg/m² weekly.  

75% disease control rate observed in the 2.5mg/m² cohort

Of the four patients that received 2.5mg/m² weekly, one had tumor reduction confirming partial response, and two had a stable disease which reflects 25% ORR and 75% diseases control rate. For those that received 5mg/m², four showed complete or partial response, including one with a complete response, three with partial response, and two showed stable disease.

Tolerability in the study is consistent with previous results without any dose-limiting toxicities observed in both cohorts. The first phase of dose escalation is currently in progress, and the company will offer additional updates later this year.