BEIJING – Yantai, China-based biologics maker Remegen Ltd. has raised about $100 million in a private round led by Lilly Asia Ventures and Lake Bleu Capital to advance its autoimmune, oncology and ophthalmology drug candidates, especially its NDA-stage RC-18 (telitacicept) for system lupus erythematosus (SLE).

The biotech said the funding will support its early stage drug discovery platform, the development of its R&D pipeline and the expansion of its manufacturing facilities.

"Reaching this funding milestone will allow us to further pursue our vision of developing biologics of the future,” said Remegen CEO Jianmin Fang, noting that the company aims to advance monoclonal antibodies and antibody-drug conjugates (ADCs) to tackle autoimmune diseases and cancer.

Remegen declined to tell BioWorld more about the funding round but said a significant portion of the funding will go to drug development.

Much of the focus is expected to be on RC-18, a TACI-Fc fusion protein currently undergoing phase II and phase III trials for seven autoimmune disease indications. The trials that are progressing fastest investigate the drug candidate’s efficacy in rheumatoid arthritis, neuromyelitis optica spectrum disorder and SLE. The company has filed an NDA for SLE in China.

RC-18 has a dual-targeting mechanism that is designed to inhibit the development and survival of plasma cells and mature B cells, which are implicated in several autoimmune diseases. The drug candidate binds to two cell-signaling molecules: B lymphocyte stimulator and a proliferation-inducing ligand. It only affects mature B cells to minimize impacts on early and memory B cells, which are important in body immune functions.

In November 2019, Remegen reported promising phase II data for RC-18 in patients with SLE, with a phase IIb trial meeting the primary endpoint of a greater than four-point reduction in the SLE responder Index (SRI4), and 75.8% of patients achieving clinically meaningful disease activity improvement (p<0.001), as compared to placebo (33.9%). Clinically meaningful disease activity improvement is achieved if a greater than four-point reduction in SRI4 occurred.

"These data show the promise of RC-18 to precisely target lupus with its novel dual-target mechanism and become a first-in-class and best-in-class treatment,” said Fang.

For now, RC-18 is in a phase III trial in China, in 318 patients with mild and critical SLE. The study is investigating its efficacy and safety vs. placebo in combination with standard therapy.

Xian Janssen Pharmaceutical Ltd.’s ustekinumab is also in a phase III multicenter trial with a Chinese site for SLE. It has completed enrolling 25 patients in China. The drug has already been marketed as Stelara in China for plaque psoriasis.

Remegen declined to comment on when it is expected to obtain NDA approval, its strategy and operations officer Yu Meihua told BioWorld.

But institutional investors moved quickly to bet on the clinical-stage biotech with confidence in RC-18 and its pipeline. Global investors such as Vivo Capital, Janchor Partners, Orbimed and Hudson Bay Capital contributed to the $100 million private funding, which was co-led by Lilly Asia Ventures, a long-term investor. Loyal Valley Capital and China Reform Conson Soochow Overseas Fund also invested through the purchase from existing shareholders.

Funds also are expected to go toward commercialization of RC-18, assuming approval, as well as for commercialization of RC-48, a HER2-targeted ADC that is also making strides in Remegen’s pipeline. It has completed phase II trials in gastric, urothelial and breast cancers, and is in phase I studies in lung and bile duct cancers.

Meanwhile, the biotech has three more drug candidates in the early clinical stages.

In ophthalmology, Remegen is developing RC-28, a recombinant dual decoy receptor IgG1 Fc-fusion protein that blocks both VEGF and FGF2. In early diabetic rat retina models, it has shown anti-apoptosis, antigliosis and anti-leakage effects, and improvement in ultrastructures and proinflammatory microenvironment. It is now undergoing a phase I trial for diabetic macular edema and has completed phase I studies in wet age-related macular degeneration.

The other two drug candidates, RC-88 and RC-98, are being developed for multiple solid cancer. RC-88 is an ADC targeting mesothelin protein in phase I trials, while RC-98 is a PD-L1 antibody in the IND-stage.

Remegen was founded in 2008 and has now built a pipeline of more than 10 molecules. It is headquartered in Yantai while it also has laboratories and offices in Beijing and California. Its founder, Fang, is a Harvard Medical School-trained scientist.

No Comments