RemeGen has received $100 million in private financing to continue advancing RC18 (telitacicept), its lead treatment candidate for autoimmune diseases like systemic lupus erythematosus (SLE) now in a pivotal clinical trial.
The funding will also support the China-based company’s early stage treatment discovery platform, help expand its manufacturing facilities, and support the ongoing development of other products in the pipeline. Commercialization efforts for RC48, being developed for HER2-positive solid cancers, will also benefit from the proceeds.
“It is a great honor to receive the recognition and support from the top investment institutions in the biomedical space,” Jianmin Fang, PhD, founder and CEO of RemeGen, said in a press release.
“Through research, development, manufacturing and commercialization of novel biologics — most notably monoclonal antibodies (mAb) and antibody-drug conjugates (ADCs) — RemeGen aims to fulfill the unmet medical needs of patients everywhere facing conditions such as autoimmune diseases and cancer,” Fang added.
In the field of autoimmune diseases, RemeGen is developing fusion molecules that block the activity of two disease-causing proteins at the same time. This is the case of RC18, which blocks the lymphocyte stimulator (BLyS) and the A proliferation-inducing ligand (APRIL) proteins.
Both molecules are involved in the development and survival of mature B-cells and in the production of autoantibodies — those that wrongly attack the body’s own cells and tissues — linked with autoimmune conditions.
By blocking these two proteins, RC18 is intended to lower disease activity, while leaving early and memory B-cells — which are important for immune defense — unharmed.
RC18 has been investigated as an add-on SLE treatment. A prior pivotal Phase 2b clinical trial (NCT02885610), which included 249 adults with moderate-to-severe disease, aimed to determine if RC18 plus standard treatment was better than standard therapy alone at reducing disease activity — defined as a four or more point drop in SLE Responder Index 4 (SRI4) scores from the study’s start (baseline measure) to week 48.
While continuing to receive standard SLE treatments, participants were randomly assigned to one of three RC18 weekly doses — 80 mg, 160 mg, 240 mg — or to a placebo for 48 weeks.
Results showed that more patients on RC18 achieved such meaningful reductions in disease activity — 68.3% to 75.8% in the three groups — compared to those on placebo (33.9%).
Other measures of disease activity confirmed the findings, and safety assessments showed a good tolerability profile for RC18 in this population.
The pivotal nature of the Phase 2 trial means its results can be used to support a request for approval by regulatory authorities. RemeGen has already filed a new drug application in China based on the findings.
An ongoing Phase 3 trial (NCT04082416) is assessing RC18’s safety and efficacy in a larger population of SLE patients. It will include 318 adults in China who, like those in the Phase 2 study, will continue with their stable SLE treatment for moderate-to-severe disease.
Enrolled patients will be randomly assigned to RC18 at a 160 mg dose or a placebo, given weekly for 52 weeks (one year).
This trial’s main goal is to assess changes in disease activity, also defined as a drop in SRI4 scores by four or more points from baseline to week 52. Changes in other measures of disease activity will also be examined, as well as the proportion of patients whose prednisone dose has been meaningfully reduced. Top-line data is expected by late 2021.
The investment round was co-led Lilly Asia Ventures and Lake Bleu Capital, which were joined by Vivo Capital, Janchor Partners, OrbiMed, Hudson Bay Capital, and RemeGen’s existing investors. By purchasing from existing shareholders, Loyal Valley Capital and China Reform Conson Soochow Overseas Fund also participated in the financing round.
“We are honored to lead this round of funding,” said Fei Chen, managing partner of Lilly Asia Ventures. “As a long-term investor, we look forward to partnering with RemeGen to become a leading global biopharmaceutical. We believe that the biologic drugs innovated by RemeGen will continue to benefit patients at home and abroad.”
RC18 is also being investigated in a series of ongoing clinical trials across multiple autoimmune disease indications, including in two pivotal Phase 3 trials for rheumatoid arthritis (NCT03016013) and neuromyelitis optica spectrum disorder (NCT03330418), and in Phase 2 trials for multiple sclerosis, myasthenia gravis (NCT04302103), Sjögren’s syndrome (NCT04078386), and IgA nephritis (NCT04291781).
Most of these studies are currently enrolling participants. For more information, please click on their identifying numbers.
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