Since spinning out of the University of Liverpool, ReNewVax has started to build its scientific team and progressed its vaccine programme RVX-001 towards regulatory studies that will allow clinical trials to begin. CSO Dr. Marie O’Brien and CEO Dr. Neil Murray reflect on what the company has achieved to date and what the future has in store.

What do you think is ReNewVax’s biggest achievement so far?

NM: Surviving our first year! We have achieved a lot over the 12 months as we progress RVX-001 towards clinic. We’ve established a strong team of employees and collaborators to give us the best chance of success moving forwards.

MOB: I would echo Neil’s point about aligning the right team to support the launch and growth of ReNewVax towards a sustainable business. This includes the recruitment of a seasoned CEO, hiring our first employees, the meticulous selection of consultants, and the formation of a strategic advisory board with wide-ranging and complementary expertise. It is no easy task to find a group of people that will get along and work in synergy, and it is still early days for ReNewVax, but so far we seem to have achieved that.

What has been your biggest challenge?

MOB: I believe the human factors, – understanding and managing the capabilities, individual characteristics, and expectations of all staff and stakeholders – will always be the big challenges for any organisation, should they be micro, small, medium or large in size.

NM: On top of these, fundraising is invariably the biggest challenge for early-stage biotechs, and we are no exception.  The current fundraising climate for biotech in the UK is very tough although this is showing signs of easing.

What has the past year taught you about how to successfully navigate the early stages of commercialising academic research?

MOB: It’s hard work! Launching a vaccine programme such as RVX-001, or similar biotech assets, demands a profound understanding of the customers and target market – barriers vs. enablers, clinical vs. commercial need, a detailed understanding of the competitive landscape and of the potential regulatory hurdles.

One needs a holistic approach towards developing a solid commercialisation plan to turn a spin-out company into an investment-ready organisation.

On a more personal note, in many ways, I have had to “learn on the job” and was very fortunate to have been supported and coached by very patient and talented mentors and advisors.

Communication, preparation, and planning/risk management are key. Once you have done all this well, raising investment should be a piece of cake!

What has the industry reaction been to what you are trying to do?

MOB: The feedback has been very positive overall. The rational approach that we have developed towards vaccine discovery has been widely recognised as a novel approach.

NM: ReNewVax’s platform, and especially our lead program, RVX-001, the first universal vaccine for pneumococcal disease, has been particularly well received, both technically and commercially. Feedback on the quality of our science has been very positive, which is testament to the work of Marie and the team.

What do the next 12 months hold for the company?

NM: The next phase for the company is about delivering on the promise of our first 12 months. We look forward to closing our Series A round and progressing RVX-001 into regulatory studies that will enable us to begin clinical trials in 2025.

MOB: Should our fundraising go according to plan, the objectives we will be pursuing over the next 12 months are three-fold.

First, we plan to complete the CTA-enabling studies for RVX-001 and prepare for the filing of our clinical trial authorisation.

As RVX-001 progresses, we anticipate that another two scientists will join ReNewVax over the next 12 months, to support the development of RVX-002 and -003, our Group B and Group A streptococcal vaccines. We also plan to recruit a clinical manager to support the initiation and conduct of our phase I clinical trial for RVX-001.

We will also begin the relocation of our lab and offices off campus to a biotech hub – whether it be a large incubator or a science campus – to maximise our interactions with like-minded organisations and create opportunities to build robust partnerships. The University of Liverpool has been very supportive of the company but it is time to spread our wings!

Any further comments on current external factors, e.g. delay in UK rejoining Horizon Europe/danger of London measles outbreak?

MOB: There has never been a better time for the introduction of new vaccine technologies against antimicrobial resistant infections.  Both the Department of Health and Social Care’s AMR action plan 2024-2029 and the reintroduction of the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act in the US can only bolster ReNewVax’s vaccine development effort.

NM: The UK Government’s Industrial Strategy calls for the country to become a science superpower. Recent healthcare events globally, and the UK’s role in addressing health security, only serve to highlight the importance of this ambition. It is critical, whichever party is in power, that the UK Government delivers policies that support and enable the growth of the country’s science base – both in academia and industry.