The challenges of finding a cure for lupus and related autoimmune conditions

In the current era of relatively high interest rates, a strained public and private funding environment, higher costs to fuel scientific breakthroughs and a recognition that a single funding source or stakeholder cannot independently progress products from bench to bedside, this method of advancing science and bridging connections between academia and industry is increasingly catching on.

Venture philanthropy is an asset class that deploys capital in the same way as venture capital or private equity (eg, preferred equity, debt, SAFEs, syndicated financings, etc), but success is measured by the mission of the philanthropic donors and investors. For disease advocacy organisations, the measure of success is advancing science to improve human health.

This differs from traditional non-profit research funding, which is donated or awarded with no return potential and focuses on hypothesis-driven work in academic settings, and from traditional private equity, where the sole measure of success is return on investment. When venture philanthropy is successful, investment returns can be recycled into more research and additional investments, expanding impact over time.
Why have autoimmune diseases, especially lupus, historically received less investment and drug development focus than areas like cancer or rare diseases?

NR: Investment has been lower mainly due to the complexity of the disease. The heterogeneity of autoimmune conditions – especially lupus – means that symptoms can vary and change over time, which makes it difficult to study, diagnose and treat. Lupus specifically affects nearly every organ system in the body. Variability is high among patients, with different underlying causes, triggers and responses to treatment. This makes drug development challenging and, therefore, historically, it is an area that has been underinvested.

The more progress we make in understanding the disease, identifying specific patient segments within lupus, removing barriers to clinical development and achieving new product approvals, the more investment will follow.

To what extent have disparities, such as higher prevalence in women and people of colour, played a role in underinvestment?

NR: This is a great question. 90% of people with lupus are women, most often diagnosed between the ages of 15 to 45. Black, Latinx, Indigenous, Asian and Pacific Islander people are disproportionately affected. Those demographics intersect with structural barriers from access to care, trial participation and more – often delaying diagnosis and slowing progress.

Those disparities have played a major role in underinvestment. For example, only 5% of global R&D funding was allocated to women’s health research in 2020.

We need to build, find and fund solutions that can help bridge this gap. Encouragingly, the tide is starting to shift as greater awareness of women’s health and the social determinants of health are leading to increased investment and new approaches to development, with an eye towards health equity.

Part of what we want Lupus Ventures, the venture investment fund of the Lupus Research Alliance, to do is help shift that dynamic by catalysing innovation and supporting approaches that can improve outcomes for the communities most impacted.

What recent scientific advances are changing expectations for lupus research and how could these new funding models help get promising ideas to patients faster?

NR: This is an exciting time in lupus research as the treatment landscape is at a turning point. Recent US Food & Drug Administration (FDA) approvals have renewed industry interest in lupus. Immunology & inflammation (I&I) is now one of pharma’s fastest-growing areas. We’re seeing a shift away from the legacy approach of broad immune suppression towards an emphasis on ‘immune tolerance’ or ‘immune reset’. There are advances in cell therapy to avoid lymphodepletion and burdensome pre-conditioning chemotherapy, advances in multi-specific biologics designed to enhance selectivity by targeting multiple receptors simultaneously and many other encouraging developments. Today, there are over 140 lupus therapies in clinical trials from 120+ companies and we have a long list of mechanisms and pathways that the Fund is exploring as targets for further investment and investigation.

This is the perfect storm of progress. A funding model like Lupus Ventures can help de-risk promising science and ensure we do all we can to bring new treatments and diagnostics to patients in need.

Why does advocacy-led venture philanthropy matter for the future of lupus and autoimmune disease innovation and how can biopharma leaders, investors and clinicians engage to help move promising science into the clinic faster?

NR: This work is critical to advance progress in lupus. We see our role as:

1. Advancing high-potential science that otherwise would go unfunded, using this model to make higher-risk investments and supporting innovation that does not typically attract for-profit investors.
2. Convening an unmatched bench of leading scientific, clinical, biotech and industry experts in lupus to inform investment decisions and support companies post-investment.
3. Catalysing additional investment into lupus by working closely with and co-investing with institutional VC funds interested in lupus and collectively helping biotech companies to improve the feasibility of successfully developing in this indication. We can do this by advising on trial design, leveraging our expertise in clinical operations, building connections with relevant industry partners and service providers, and other activities that will help us achieve our goal of getting new products to patients.

Of course, we cannot do this alone. We require collaboration with biopharma, investors, clinicians and other experts to advance programmes. Each part of the ecosystem plays an important role and as knowledgeable investors, part of our job is to make the right connections at the right time.

We absolutely hope others will join us on this journey.

Lupus Ventures, the venture investment fund of the Lupus Research Alliance, is an innovative model that blends philanthropy with venture capital to transform how autoimmune R&D is financed, invests in biotech, pharma, medtech and digital health companies developing solutions.

Find out more about lupus at lupusresearch.org/