Today, Tongyi Pharmaceuticals announced that it has entered into an exclusive licensing agreement with MultiValent for CBP-1018, a peptide-drug conjugate for the treatment of prostate cancer .

Under the terms of the agreement, MultiValent will obtain exclusive rights to develop and commercialize CBP-1018 in markets outside of Greater China. Tongyi Pharmaceuticals will receive an upfront payment of US$20 million, a 20% equity stake in MultiValent, and up to approximately US$2 billion in future payments for development, regulatory, and commercial milestones, as well as tiered sales royalties.

CBP-1018 is a bispecific peptide drug developed by Yimei Pharmaceuticals based on its proprietary Bi-XDC (bispecific dual-ligand conjugate) platform. It is conjugated with Auristatin-E and targets two proteins highly expressed in prostate cancer cells: PSMA and FRα .

In a phase I/II clinical trial involving more than 110 patients with metastatic castration-resistant prostate cancer, intravenous CBP-1018 demonstrated encouraging preliminary safety and efficacy. A median progression-free survival (mPFS) of 8.5 months was achieved across all dose groups , a figure comparable to the published mPFS data for the only currently approved PSMA-targeted radioligand therapy.

The drug's greater potential lies in combination therapies and local administration strategies .

According to Tongyi Pharmaceuticals' press release, its Bi-XDC technology platform aims to overcome many limitations of traditional antibody-drug conjugates (ADCs). Among these, local drug delivery is a unique advantage of the Bi-XDC platform. Unlike traditional ADCs, Bi-XDC drugs offer core advantages such as rapid tissue penetration, low immunogenicity, and dual targeting. The Bi-XDC platform technology enables the direct delivery of high-dose anticancer drugs to cancerous lesions, thereby enhancing efficacy while reducing toxicity.

MultiValent plans to develop CBP-1018 as a focal therapy for prostate cancer . If successful in clinical trials and approved by regulatory agencies, CBP-1018 could become a highly attractive alternative to radiation therapy, prostate ablation, prostatectomy, and androgen deprivation therapy, all of which have been shown to cause significant adverse urinary and sexual side effects in many patients. Preclinical studies have shown that topical administration of CBP-1018 significantly increases drug exposure in prostate tissue while reducing systemic drug exposure and toxicity.

In addition to CBP-1018, Tongyi Pharmaceuticals has two other Bi-XDC pipelines that have entered the clinical stage: CBP-1008 and CBP-1019, which are in Phase 3 and Phase 1 clinical trials, respectively.
CBP-1008 is Tongyi Pharmaceutical's first Bi-XDC technology product, targeting folate receptor α (FRα) and transient receptor potential channel vanillic acid receptor 6 (TRPV6). Currently, the drug has received NMPA approval to conduct a Phase 3 clinical trial (PROC registration) in platinum-resistant ovarian cancer.

CBP-1019 is a next-generation FRα and TRPV6 dual-ligand conjugate drug loaded with DX-8951, a camptothecin derivative of the topozyme I inhibitor (TOPOIi). This drug has received Orphan Drug Designation from the US FDA for three indications: pancreatic cancer, esophageal cancer, and small cell lung cancer, as well as Fast Track Designation for the treatment of recurrent endometrial cancer (EC) in patients who have received at least one first-line systemic platinum-based chemotherapy.

The fact that Tongyi Pharmaceuticals' CBP-1018 has gone global through the NewCo model once again demonstrates China's strength in innovative drug development.

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