Xia JIN, co-founder & CEO of Hong Kong-based immunology biotech Immuno Cure, outlines the progress of its DNA vaccine platform, highlighting strong Phase I results for an HIV therapeutic vaccine and upcoming Phase II trials. He discusses regulatory and operational challenges in China, growing institutional support, partnership efforts, and expansion into oncology, while positioning the company for a Hong Kong IPO.
When we last spoke two years ago, the HIV vaccine programme was your lead asset and the platform was also being explored for cancer vaccines. There was no clinical readout at that point. Can you bring us up to date?
A great deal has happened. Our core technology is a DNA vaccine platform, from which we developed an HIV therapeutic vaccine aiming for a functional cure for HIV infection and, as a proof-of-concept exercise, a COVID-19 booster vaccine using the same underlying technology. Since we last spoke, we have completed two clinical trials. The first was a Phase II study of the COVID-19 booster vaccine, the results of which were published in 2025 in eBioMedicine, a Lancet subsidiary journal. That publication was significant because it demonstrated that the platform is functional in humans – a critical validation for everything that follows.
The more commercially important milestone, however, was completing the Phase I clinical trial of our HIV therapeutic vaccine by the end of 2024. When we last met, that trial had not yet begun. The results were outstanding: safety data was clean throughout, with no single severe adverse event recorded, and immunogenicity was highly robust across all three dose groups. In the low and middle dose cohorts, 75 percent of individuals mounted a positive immune response, compared with 33 percent in the placebo group. Enrolment and follow-up were 100 percent – not a single participant was lost. The full results have been submitted to a peer-reviewed international journal and are currently under review. On the back of that data, we filed two Phase II clinical trial plans with the NMPA, China’s regulator, and both were approved. Phase II enrolment is imminent.
Can you describe the Phase I trial design and the patient population in more detail?
The trial enrolled 45 subjects across three dose groups – low, medium, and high – with placebo and vaccine controls. The enrolled individuals were HIV-positive patients who had been on antiretroviral cocktail therapy for several years, with well-controlled viral loads, good T-cell recovery, and strong baseline immune function. These were the primary enrolment criteria. The vaccine is not a preventive intervention – it is a therapeutic one, aimed at what we call functional cure: enabling the immune system to control the virus without ongoing medication. Participants received a full vaccination course of five doses – four doses over the first four months and a fifth at nine months – with follow-up continuing for a further six months, under the cover of their existing antiretroviral therapy throughout.
It is worth clarifying that our vaccine is not in competition with lenacapavir or similar agents. Lenacapavir is a small molecule used for prevention; our vaccine is a large molecule aimed at stimulating an immune response in already-infected, already-treated individuals. The mechanisms and target populations are entirely different.
How does the Phase II design differ from Phase I, and when do you expect to enrol the first patient?
The Phase II design retains the same two-arm structure – placebo and vaccine groups – but introduces one important addition: a therapy interruption period. After completing the vaccination course, we will stop antiretroviral therapy for six months to assess whether the vaccine can sustain viral control in the absence of medication. That is the core efficacy experiment.
On dosing, we have simplified the regimen from five doses to four, eliminating the ninth-month booster. The rationale is straightforward: in Phase I, we observed no meaningful difference in safety or immunogenicity between the fourth and fifth doses across any of our measurement parameters. Given that finding, there is no scientific justification for retaining the fifth dose – so we proceed directly to four doses and then into the therapy interruption, effectively extending the overall trial window by approximately three months rather than six.
The trial will run across five centres: one in Hong Kong, two in Guangzhou and Shenzhen within the Greater Bay Area, and two in Beijing – with ten patients per centre, giving a total of 50 patients for this Phase II cohort. We are aiming to enrol the first patient by the end of June or the beginning of July.
In terms of operational readiness, all protocols are finalised. What remains is the contract review process – which typically takes several weeks as multiple parties are involved – followed by Institutional Review Board approval at each clinical site, which usually requires approximately one month. For a Hong Kong company conducting trials in mainland China, there is an additional requirement: a human genetic material export permit, which adds a further month to the timeline. This regulatory step is a persistent source of friction for cross-border trials, and we have been actively lobbying the relevant authorities in Guangzhou to streamline it. We made that case directly to ministerial level last week. Whether it moves or not, we keep making the argument – particularly now that the National Innovation Centre is involved and has every incentive to see the clinical trial system accelerate.
The trial has also attracted significant institutional recognition. Can you tell us about that?
The project has risen to a level we did not necessarily anticipate. Our Phase II trial is being conducted as a cross-border, multi-centre study spanning Hong Kong, Shenzhen, Guangzhou, and Beijing. Over the past two years, both the Hong Kong government and the Guangdong government established dedicated clinical trial research infrastructure – the Greater Bay Area International Clinical Trial Institute in Hong Kong and a mirror organisation, the Greater Bay Area Clinical Trial Centre, in Shenzhen – designed to operate collaboratively. Our HIV vaccine programme was selected as the first project to run through that joint system, which meant that what began as a local company initiative became a two-government project, elevated to the level of the Hong Kong and Guangdong administrations.
From that platform came further recognition. In an innovation competition organised by China’s Ministry of Human Resources and Social Welfare, jointly with the Guangzhou municipal government and the Hong Kong government, more than 7,000 teams competed across multiple rounds. Of 150 teams ultimately recognised with awards, we were awarded the grand prize – first place overall, and the highest-ranked Hong Kong team by a considerable margin.
We were subsequently invited to join the National Innovation Centre under the Ministry of Science and Technology, which operates three centres nationally – in the Greater Bay Area, the Yangtze River Delta around Shanghai, and Beijing. These centres are designed to address scientific and technological bottlenecks at the highest level. Our inclusion reflects both the significance of HIV as a public health challenge and the quality of our technology platform. Membership has tangible benefits: The Centre constructed a 300 square metre laboratory for us and provided RMB 10 million to support its operation for two years. Additionally, our HIV vaccine has been included as one of three lead products within a national mega-project on HIV functional cure, each of which carries government funding of RMB 50 million alongside RMB 200 million from industry partners.
On the commercial and fundraising side, you were actively seeking pharma partnerships two years ago. Where does that stand?
Progress has been real. We signed a collaboration agreement with a US-based medical device company specialising in drug delivery, and we are initiating a clinical study comparing their delivery system with ours – a partnership formalised in Boston last year. More significantly, at the BIO 2025 Congress in Boston we held substantive discussions with a major global player in the HIV space, presenting our Phase I data and our development roadmap. They expressed clear interest in continuing the dialogue.
Their position, as is typical for large pharmaceutical companies at this stage, is to see some early efficacy signals before moving towards a formal partnership discussion. We are currently conducting a bridging study between Phase I and Phase II, and the preliminary results are as strong as anything in the published literature on this topic. We are not yet ready to disclose those data publicly, but we are hoping to present within closed partnering circles at BIO in San Diego, and we are planning to secure inside access this year rather than remaining in the general conference circuit.
HIV is not an easy fundraising story for all investors – some will not engage with the therapeutic area regardless of the science. For those who are willing to listen, the commercial case is substantial. The addressable market in China alone is approximately RMB 2 billion, with a comparable opportunity in the US and Europe. Our target patient population – HIV-positive individuals with well-controlled viral loads on long-term antiretroviral therapy who cannot achieve viral clearance – represents approximately ten percent of the total treated population: a defined, premium segment willing to pay for a functional cure. Our anticipated pricing would be approximately RMB 40,000 per year for the initial regimen, with booster doses at around RMB 10,000 per administration – significantly more accessible than lenacapavir while targeting a complementary population.
For investors concerned about single-asset risk, we have also developed a second lead product, which brings me to the cancer vaccine programme.
Could you elaborate on your cancer vaccine pipeline and how your platform is being leveraged to advance oncology?
The DNA vaccine platform is scientifically applicable to oncology, and that is increasingly where investor and industry interest converges. We have identified several targets and have candidate vaccines in development. Without disclosing specific antigens at this stage, I can tell you we are working on hepatitis C-related targets, hepatitis B – using both traditional methods and AI-assisted design – and human papillomavirus. All of these are currently at pre-clinical stage, and a thorough competitive analysis will be required before we commit to a development pathway. The platform’s versatility is the point: once the HIV programme establishes proof of concept in humans at scale, the cancer applications become significantly more fundable.
Beyond the vaccine platform, we are also progressing two antibody assets that represent near-term commercial opportunities. The first is a therapeutic cancer antibody, for which we are in co-development discussions with an industry partner – we own the licence on the antibody and are not ready to out-license it outright, but a co-development arrangement is being actively negotiated. The second is a diagnostic antibody that we believe has strong potential as a companion screening tool – the logic being that any patient using a matched therapeutic drug would benefit from pre-screening with our diagnostic, creating a natural pairing. We own both antibodies, and discussions around a co-development agreement for the diagnostic are ongoing. Neither deal is concluded, but both represent the kind of incremental, tangible progress that strengthens the overall fundraising and IPO narrative.
We have also secured separate funding for a second company established by our founding professor through Hong Kong’s Innovation and Technology Commission initiative, which has committed 100 million Hong Kong dollars to support academic spin-outs that identify an industry partner. We are serving as that industry partner, contributing an additional 120 million Hong Kong dollars, giving us a well-capitalised second vehicle to advance new product development.
You are targeting a Hong Kong Stock Exchange listing this year. What is the timeline, and what will the proceeds fund?
We are aiming to submit our 18A listing application by the end of September 2026 and to complete the IPO before the end of the Hong Kong financial year – so the full cycle, from submission to issuance, within a single financial year. The IPO proceeds will fund the larger Phase II study of 300 patients, complete the full vaccine development cycle, advance the Phase I programme for our cancer antibody candidates into Phase II, cover ongoing operations, and support the launch of new product development. We will enter the listing process without a major pharma deal in place, but with several smaller agreements progressing – including discussions around a diagnostic antibody that would serve as a companion screening tool to our therapeutic vaccine. Owning both the diagnostic and the therapeutic antibody positions us well for a co-development arrangement, and those conversations are active.
The path ahead is demanding, but the clinical data is strong, the institutional recognition is real, and the regulatory pathway in China is open. We are moving forward.
