Korean pharmas ramp up development of shingles vaccines

GlaxoSmithKline’s shingles vaccines Shingrix

South Korean pharmaceutical and biotech companies are accelerating efforts to develop shingles vaccines, aiming to challenge the dominance of GlaxoSmithKline’s (GSK) Shingrix, which currently controls 90 percent of the global market.

According to industry sources on Tuesday, companies such as GC Pharma, CHA Vaccine Institute, and EuBiologics are conducting clinical trials to develop their own shingles vaccines using the same recombinant technology as Shingrix.

GC Pharma is leading the race with the fastest clinical trial progress. Its candidate, CRV-101, developed through its U.S. affiliate Curevo, is set to enter Phase 3 clinical trials in the United States by the end of the year.

Early this year, Phase 2 trial results demonstrated that CRV-101 is non-inferior to Shingrix in terms of efficacy and tolerability. CRV-101 showed a 100 percent vaccine response rate (VRR) compared to Shingrix’s 97.9 percent and exhibited lower rates of systemic and local adverse effects.

This marks GC Pharma’s first foray into developing a premium vaccine, traditionally focusing on basic vaccines. Alongside pneumococcal and cervical cancer vaccines, Shingles vaccines are categorized as premium vaccines.

According to BrandEssence Market Research, the global shingles vaccine market, valued at $3.58 billion in 2021, is expected to grow to $6.71 billion by 2027, driven by an aging population.

Successful clinical trials of CRV-101 could enable GC Pharma to expand its footprint in the premium vaccine sector, particularly in the U.S. and Europe.

CHA Vaccine Institute is also developing a shingles vaccine candidate, CVI-VZV-001. The company began its Phase 1 clinical trials in Korea in May 2023, completing patient dosing by February this year.

The company plans to conduct a one-year follow-up study until February next year. After completing Phase 1, CHA Vaccine Institute aims to pursue joint clinical trials or a licensing deal with global pharmaceutical companies.

CHA Vaccine Institute intends to overcome the limitations of Shingrix with CVI-VZV-001, which incorporates its proprietary adjuvant, Lipo-pam. Lipo-pam activates T-cells to induce a cellular immune response that directly attacks the virus, potentially preventing both shingles and postherpetic neuralgia (PHN) while also treating existing shingles cases.

EuBiologics has recently begun Phase 1 clinical trials for its shingles vaccine candidate, EuHZV, which utilizes its proprietary immunity enhancement technology (EuIMT) and antigen display technology (SNAP).

Approved by the Korean Ministry of Food and Drug Safety in April, EuHZV will be tested on healthy adults aged 50 to 69 to evaluate the safety and tolerability of low-dose (HZV-1) and high-dose (HZV-2) vaccines. Preclinical studies indicated that EuHZV demonstrated efficacy equal to or greater than the control group.

The domestic shingles vaccine market is poised for significant changes. With Zostavax withdrawing from the market in Korea, the competition will likely be between Shingrix and SK Bioscience’s Sky Zoster vaccine, according to an industry insider.

“The discontinuation of Zostavax, along with potential variables like the inclusion of shingles vaccines in the National Immunization Program (NIP), presents a dynamic landscape,” said the insider said.

In other notable biotech news, Orum Therapeutics has signed a licensing and option agreement with Vertex Pharmaceuticals, potentially worth over 1 trillion won ($723 million). This big deal follows Orum’s licensing agreement with Bristol-Myers Squibb just seven months prior.

Under the latest agreement, Vertex will use Orum’s dual-precision Targeted Protein Degradation (TPD) technology, TPD Square, to develop a pre-treatment agent for gene editing therapies. Orum will receive an upfront payment of $15 million.