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Zai Lab : Crescendo Biologics Announces That Zai Lab Has Achieved Proof-of-Concept for ZL-1102 (Humabody«, CB001) in a Phase 1b Clinical Trial in Psoriasis Patients

10/21/2021 | 03:01am EST

  • ZL-1102 (formerly CB001) is a fully human VH fragment antibody (Humabody®) targeting IL-17A that was discovered by Crescendo and licensed worldwide to Zai Lab
  • This is the first study to demonstrate penetration of a protein biological therapeutic through psoriatic skin resulting in a clinical response
  • The achievement of clinical proof-of-concept triggers a milestone payment from Zai Lab to Crescendo
  • Zai Lab plans to advance ZL-1102 into full development, including registrational studies

Crescendo Biologics Ltd (Crescendo), a clinical stage immuno-oncology company developing novel, targeted T cell enhancing therapeutics, today announces that Zai Lab (NASDAQ: ZLAB; HKEX: 9688) has reported positive topline results from a randomized, double-blind, placebo-controlled Phase 1b proof-of-concept study of ZL-1102, an anti-IL-17A targeting Humabody®.

The Phase 1b trial was a first-in-human study to evaluate the safety, pharmacokinetics and efficacy of a topical formulation of ZL-1102 in adults with mild-to-moderate chronic plaque psoriasis (CPP). The study recruited 53 patients with CPP, and it is reported that topical therapy with ZL-1102 resulted in clinical improvement in local PASI score, erythema and scaling, target lesion size and responder rates, and that a consistent improvement in patients was seen over time. The safety profile of ZL-1102 was comparable to placebo.

Further information can be found in the press release issued by Zai Lab on 20 October 2021.

Theodora Harold, Chief Executive Officer at Crescendo, said: “This is a very exciting day for Crescendo. These are the first clinical data from the first patients to be treated with a Humabody, and we are very pleased with the topline results reported by our partners at Zai Lab. This is also the first study to demonstrate penetration of a protein biological therapeutic through psoriatic skin resulting in clinical response, illustrating an important point of differentiation of our Humabody platform. We look forward to Zai Lab’s continued progress of ZL1102 into full development, including registrational studies.”

The declaration of clinical proof-of-concept for ZL-1102 by Zai Lab triggers a milestone payment from Zai Lab to Crescendo under the terms of the exclusive worldwide license agreement for ZL-1102 (formerly CB001) announced in May 2018. Under the terms of that agreement, Crescendo granted to Zai Lab a worldwide exclusive license to develop and commercialize ZL-1102 for all indications. Zai Lab is responsible for conducting all regulatory filings, clinical studies and commercialization activities, with Crescendo being eligible for certain development, regulatory, and commercial milestones as well as tiered royalties on global sales.

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 anti-cancer 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 for ZL-1102 (formerly CB001), an anti-IL-17A targeting Humabody®, which has recently successfully completed 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.

ę Business Wire 2021
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