Crescendo Biologics announces initiation of Phase 1 study of CB307 in patients with advanced, PSMA-positive solid tumours

• POTENTIA: a Phase I, open-label, dose escalation and cohort expansion study
• CB307: a novel half-life extended CD137 x PSMA Humabody® designed to enable potent T cell activation while avoiding systemic toxicity
• First clinical trial from Crescendo’s proprietary pipeline of novel, targeted T cell enhancing Humabody® therapeutics; initial clinical data expected in 2022

CAMBRIDGE, England--(BUSINESS WIRE)-- Crescendo Biologics Ltd (Crescendo), a clinical stage immuno-oncology company developing novel, targeted T cell enhancing therapeutics, today announces that the first patient has entered the POTENTIA trial, a Phase 1, open-label, monotherapy study of CB307, the most advanced Humabody® in Crescendo’s portfolio of T cell enhancers.

CB307 is a unique, half-life extended Humabody® targeting prostate-specific membrane antigen (PSMA) and the potent co-stimulatory molecule CD137 (4-1BB). Monospecific monoclonal antibodies against CD137 have been shown to enhance T cell activity in clinical studies as a cancer therapy, and CB307 is designed to enable potent, conditional and tumour-specific T cell activation whilst avoiding systemic toxicity.

The POTENTIA trial is a Phase 1, multi-centre, non-randomised study of CB307 in patients with advanced and/or metastatic PSMA-positive solid tumours. The study is designed to recruit up to 50 patients across dose escalation and expansion cohorts. The primary endpoint of the trial is to assess the safety and tolerability of CB307 and to determine the maximum tolerated dose.

Additional endpoints include initial evaluation of clinical efficacy, and the trial also includes a comprehensive panel of pharmacokinetic and other translational endpoints. Initial data from the dose escalation part of the trial are expected to be presented at a medical conference in 2022.

More information about the POTENTIA trial can be found on clinicaltrials.gov via NCT04839991 and in the poster recently presented at the American Association for Cancer Research (AACR) annual meeting in April 2021.

Dr Kenji Hashimoto, Chief Medical Officer of Crescendo Biologics, said: “Recent clinical data have provided important validation for both PSMA and CD137 as therapeutic targets. We are therefore delighted to have initiated the CB307 clinical programme with our investigators. CB307 is a unique immuno-oncology therapy which we believe has potential to bring significant benefit to people suffering from hard-to-treat cancers.”

Theodora Harold, Chief Executive Officer of Crescendo Biologics, added: "The initiation of the POTENTIA trial is an important milestone for Crescendo as it marks the beginning of clinical development of the first product candidate in our proprietary pipeline of T cell enhancing Humabody® therapeutics. We have reached this point thanks to the dedication and focus of the Crescendo team, and we look forward to applying the data emerging from this trial to guide future clinical programmes.”

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About Crescendo Biologics

Crescendo Biologics is a private, clinical stage immuno-oncology company developing novel, targeted T cell enhancing Humabody® therapeutics.

Leading its proprietary pipeline, Crescendo Biologics has developed CB307, a novel half-life extended CD137 x PSMA Humabody® for the selective activation of tumour-specific T cells exclusively within the tumour microenvironment. CB307 is designed to achieve a longer lasting anticancer effect whilst avoiding systemic toxicity, and the clinical programme for CB307 is underway in patients with PSMA positive solid tumours.

The Company’s ability to develop multi-functional Humabody® therapeutics is based on its unique, patent protected, transgenic mouse platform generating 100% human VH domain building blocks (Humabody® VH). These robust molecules can be configured to engage therapeutic targets in such a way that they deliver novel biology and superior bio-distribution. This results in larger therapeutic windows compared to conventional IgG approaches. Humabody®-based formats can also be applied across a range of non-cancer indications.

Beyond Crescendo’s proprietary pipeline, the Company has a global, multi-target discovery and development collaboration with Takeda; a clinical development partnership with Cancer Research UK; and an exclusive, worldwide licensing agreement with Zai Lab, the product candidate of which is in a Phase 1 clinical trial.

Crescendo Biologics is located in Cambridge, UK, and is backed by blue-chip investors including Sofinnova Partners, Andera Partners, IP Group, Takeda Ventures, Quan Capital and Astellas.

For more information, please visit www.crescendobiologics.com and follow @HUMABODY.

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