Merck Gains Late-Stage Eye Disease Drug Candidate with EyeBio Acquisition

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Editor's note: this story was originally published on BioPharmInternational.com.

Eyebiotech Limited (EyeBio) has become a wholly owned subsidiary of Merck, known as MSD outside of the United States and Canada, following the completion of Merck's acquisition of the company, according to a July 12, 2024 press release.

Under the agreement, Merck acquired all outstanding shares of EyeBio through a Merck subsidiary for approximately $0.50 per share, or $1.3 billion, which Merck will record as a charge in the third quarter of 2024 (to be included in non-generally accepted accounting principles results). The acquisition adds EyeBio’s lead candidate, Restoret (EYE103), an investigational, potentially first-in-class tetravalent, tri-specific antibody, to Merck’s eye disease therapy pipeline.

“The EyeBio acquisition further diversifies our late-stage pipeline with the addition of a promising candidate based on novel biology and genetics for the treatment of certain retinal diseases,” said Dean Y. Li, PhD, president, Merck Research Laboratories, in the press release. “We are excited to welcome the EyeBio team and look forward to working together to advance Restoret for the patients that need it.”

Restoret acts as an agonist of the Wingless-related integration site (Wnt) signaling pathway, which is part of innate immunity. The Wnt signaling pathway is believed to have a major role in the regulation of inflammation (1). Following positive results from a Phase Ib/IIa study (AMARONE) in patients with diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD), Restoret will enter a pivotal Phase IIb/III trial in the second half of 2024 to evaluate its potential in treating patients with DME.

In addition to Restoret, Merck gains other pipeline candidates through the acquisition, including clinical and preclinical assets in development for preventing and treating vision loss associated with retinal vascular leakage, which is a known risk factor for retinal diseases, according to the press release.

Restoret is administered as an intravitreal injection. Its aim is to eliminate vascular leakage in retinal diseases by agonizing the Wnt pathway, and in so doing, restore and maintain the blood-retinal barrier. “Preclinical evidence indicates that agonizing the Wnt pathway in the retina may reduce vascular leakage,” Merck stated in the press release.

The completion of the EyeBio acquisition follows Merck’s other planned acquisition for Harpoon Therapeutics, a US-based clinical-stage immuno-oncology company, which Merck announced in January 2024 (2) and completed in March 2024 (3). This approximately $680 million transaction adds Harpoon’s lead candidate, HPN328 (now designated as MK-6070), a T-cell engager targeting delta-like ligand 3 (DLL3) to Merck’s pipeline. DLL3 is an inhibitory canonical Notch ligand expressed at high levels in small cell lung cancer (SCLC) and neuroendocrine tumors. HPN328 is in clinical study as a monotherapy for advanced cancers associated with the expression of DLL3 and is being studied in combination with atezolizumab for treating SCLC. FDA granted the drug candidate orphan drug designation in March 2022 for the treatment of SCLC.

The Harpoon acquisition also gives Merck additional pipeline candidates, including HPN217, a T-cell engager targeting B-cell maturation antigen currently in Phase I clinical development for relapsed/refractory multiple myeloma treatment and several preclinical stage candidates, including HPN601, a conditionally activated targeting epithelial cell adhesion molecule (EpCAM) in development for treating certain patients with EpCAM-expressing tumors (3).

References

1. Krüger, B. D.; Hofer, G.E.; Rudiger, A.; et al. Wingless-Related Integration Site (WNT) Signaling is Activated During the Inflammatory Response Upon Cardiac Surgery: A Translational Study. Front. Cardiovasc. Med. 2022, 9, 997350. DOI: 10.3389/fcvm.2022.997350
2. Merck. Merck to Acquire Harpoon Therapeutics, Further Diversifying Oncology Pipeline. Press Release, Jan. 8, 2024.
3. Merck. Merck Completes Acquisition of Harpoon Therapeutics, Inc. Press Release, March 11, 2024.

Source: Merck