Coherent Biopharma inks potential $2B+ deal with MultiValent for prostate cancer drug CBP-1018

On December 23, Coherent Biopharma ("CBP") announced that it has entered into an exclusive licensing agreement with MultiValent Biotherapies, Inc. ("MultiValent") for CBP-1018, a peptide-drug conjugate (PDC) for the treatment of prostate cancer.

Under the terms of the agreement, MultiValent has been granted the exclusive rights to develop and commercialize CBP-1018 in all markets outside of Greater China. In return, CBP will receive an upfront payment of USD 20 million and a 20% equity stake in MultiValent. Additionally, CBP is eligible to receive future milestone payments potentially totaling up to approximately USD 2 billion, tied to development, regulatory, and commercial achievements, as well as tiered royalties on net sales.

CBP-1018 is a novel, next-generation bi-specific ligand conjugated molecule targeting both FRα and PSMA receptors, developed by CBP utilizing its proprietary Bi-XDC platform technology. The molecule incorporates an optimized bi-ligand system, an enzyme-cleavable linker, and the cytotoxin MMAE as its payload.

PSMA is highly and specifically expressed on the surface of prostate cancer cells, making it a target of exceptional value for molecular imaging and targeted therapies. FRα, a glycoprotein mediating folate uptake, is also highly expressed on various malignant cells. Through this dual-targeting mechanism, CBP-1018 is designed to achieve more precise tumor recognition and action.

According to public information, CBP-1018 represents the world's first out-licensed Bi-XDC drug and is the second innovative candidate from this platform. In a Phase I/II clinical trial involving over 110 patients with metastatic castration-resistant prostate cancer (mCRPC), CBP-1018 demonstrated a promising preliminary safety and efficacy profile. Across all dose cohorts, the treatment achieved a median Progression-Free Survival (mPFS) of 8.5 months, a result comparable to the reported mPFS data of the currently approved PSMA-targeted radioligand therapy.

MultiValent plans to develop CBP-1018 as a local treatment for prostate cancer. Preclinical studies have shown that localized administration of CBP-1018 can significantly increase drug exposure in prostate tissue while reducing systemic drug exposure and associated toxicity. MultiValent has expressed confidence in the development of CBP-1018 as a localized therapy and stated they are optimistic that, when administered locally, CBP-1018 will demonstrate superior efficacy and an improved safety profile. If successful, they believe the candidate has the potential to transform the clinical management for the majority of prostate cancer patients in the United States and other licensed territories.

Furthermore, a Phase I/II clinical trial evaluating the combination of CBP-1018 with the novel endocrine therapy enzalutamide is also underway. Enzalutamide, an androgen receptor inhibitor, is widely used in the clinic for the treatment of metastatic castration-resistant prostate cancer. The combination of CBP-1018, as a Bi-XDC drug, with enzalutamide is expected to enhance the synergistic effect of both agents, potentially offering superior therapeutic outcomes.

Founded in 2016, Coherent Biopharma (CBP) is an innovative biopharmaceutical company focused on the research and development of Bi-XDC (Bi-specific, Bi-ligand Drug Conjugate) therapeutics.

Since its inception, CBP has announced the completion of its Series B and B+ financing rounds, raising nearly USD 100 million in total. Notably, the lead investor in the B+ round was Shengdi Investment, the corporate venture capital arm of Hengrui Pharmaceuticals—one of China's largest pharmaceutical companies. Shengdi Investment stated that it would leverage its industrial resources to support CBP in expanding the applications of its Bi-XDC technology platform into new therapeutic directions.

What are the advantages of this Bi-XDC technology platform that attracted the investment from the market leader's fund? Public information highlights that localized administration is a key differentiator of the Bi-XDC platform. Unlike traditional antibody-drug conjugates (ADCs), Bi-XDC drugs offer core advantages including rapid tissue penetration, low immunogenicity, and dual targeting. The Bi-XDC platform technology enables the direct delivery of high-dose anticancer agents to tumor sites, enhancing therapeutic efficacy while reducing systemic toxicity. Furthermore, the synergistic action of its dual ligands reduces reliance on any single target, thereby broadening the spectrum of targetable pathways.

Currently, CBP has initiated multiple studies on localized administration strategies for its Bi-XDC pipeline candidates and plans to expand into other oncology areas, including ovarian, endometrial, breast, and pancreatic cancers. For instance, the company's first publicly disclosed pipeline candidate based on this platform, CBP-1008—also the world's first Bi-XDC drug to enter clinical trials—targets both folate receptor alpha (FRα) and transient receptor potential cation channel subfamily V member 6 (TRPV6). It is being developed for the treatment of platinum-resistant ovarian cancer, breast cancer, and other malignancies. To date, CBP-1008 has completed several clinical trials demonstrating favorable safety and anti-tumor activity, and has now advanced to Phase III clinical development.

CBP's technology platform has garnered recognition not only from investors but also from multiple industry partners. Beyond the recent agreement with MultiValent, the company established a strategic collaboration with Roche Diagnostics in March 2021 in the field of precision oncology diagnostics, covering technology R&D, product development, and integrated solution development. Furthermore, in June 2023, it entered into a comprehensive strategic partnership with C-Ray Therapeutics, focused on the development of peptide-radionuclide conjugates. This collaboration aims to jointly explore and apply the Bi-XDC technology platform in the field of radiopharmaceuticals, building novel technology platforms and development strategies for nuclear medicine.

Leveraging its core technology platform, CBP is not only focused on treating globally prevalent cancers but is also actively expanding into drug delivery for other organs and the treatment of chronic diseases. Currently, the company's R&D pipeline includes three oncology assets, with seven clinical trials underway concurrently in both China and the United States. With the support of strategic industry partners and leading investment funds, it is anticipated that CBP will accelerate the advancement of its product pipeline as well as its progress toward an initial public offering (IPO).