Bildnachweis: Anastasiia – stock.adobe.com.
To no one’s surprise, the oncology sector dominates the top deals in biopharma year by year. The industry simply ‘knows’ how to develop novel anti-tumour products, reimburse them, improve diagnostics and serve the patients better. The fight against cancer is by no means over, but to the patient’s benefit, the oncology sector reached a cycle of ‘sustained innovation’ and consequently goes after the long-standing unmet medical needs.
Other sectors, however, are just not there yet. One example are the cardiovascular diseases (CVDs), which in sharp contrast to oncology still await the ‘breakthrough innovation’ cycle first.
The rising tide of cardiovascular diseases
CVDs are the number one killer in Germany, Europe, as well as globally in developing and developed countries, taking about 20 million lives each year. A direct health-care cost of CVDs in the EU alone in 2021 was estimated to reach EUR 130 billion, excluding indirect costs associated with social, informal care and productivity losses (further EUR 150 billion). It is a tremendous socio-economic burden, with the number of deaths and healthcare costs undeniably surpassing the oncology sector.
Up to 80% of CVD deaths are a consequence of heart attack or stroke. The in-hospital mortality rate of the heart attack has immensely dropped since the mid-20th century, though it has not changed much in the last decade, remaining at around 3% to 5%. The same is true of stroke mortality, which also plateaued. The rates of heart attack and stroke in young adults (18 to 44 and 45 to 64 years old) in various countries are, however, on the rise. It goes hand in hand with ascending CVD-risk factors, such as obesity, incl. childhood obesity, diabetes, hypertension, or kidney failure, just to name a few comorbidities. It is also quite noteworthy that up to 40% of heart attacks can occur in patients with previously undiagnosed CVD.
Challenges facing the cardiovascular drug development
Between 2011 and 2023, the U.S. Food and Drug Administration (FDA) approved 28 new molecular entities for treatment of CVDs. It approves on average about 2.3 medicines per year, which is also the case for the European Medicines Agency (EMA). Within the same time span, the oncology sector approved at least seven times as many medicines each year. So far, the CVD drug approval output has been disappointing. Perhaps again to nobody’s surprise, if historically, for example, less than 50% of National Institutes of Health (NIH) funding (when compared to cancer funding) backed CVD research. The translation of preclinical discoveries is not any easier. The clinical development in the CVD sector can be three to six times more expensive than in other diseases, reflecting large heterogeneous patient populations enclosed in the study, longer study run periods to prove the intended effect or a demonstration of conclusive non-inferiority to the standard of care (SoC). The SoC can vary across countries.
It is enough to derail any good and promising R&D programme per se and to deflect venture capital investments. Nevertheless, every challenge is an opportunity.
Promising innovations: biotech companies leading the way in cardiovascular treatments
Such opportunities have already been grasped by some biotechs, potentially heralding new trends on the biopharma horizon. Cardior Pharmaceuticals, currently conducting a phase II study (acquired by Novo Nordisk for about EUR 1 billion), utilizes an oligonucleotide to block a non-coding RNA (miR-132) to reverse the cellular pathology and restore normal functions of cardiomyocytes in patients with heart failure. Argo Biopharma with its siRNA platform technology RADS (RNA molecules with superior activity, durability, and safety) is developing the best-in-class treatment in undisclosed cardiovascular and metabolic diseases, which were partially out-licensed to Novartis with a total value up to USD 4.1 billion. Some early-stage programmes are also eye-catching. 4TEEN4 Pharmaceuticals just entered the clinical development phase with its blood-based biomarker, key in selecting the cardiogenic shock patients, whose lives can be saved by an antibody-based therapy that the company co-develops as well. The mechanism of action still requires clinical validation, though the in-hospital or 30-day mortality rate for cardiogenic shock patients remains at 50% and has not changed for decades, clearly stressing the medical need.
A call for holistic innovation
Altogether, the CVDs require a holistic medical innovation, including pharmaceuticals, medical devices, precise diagnostics, and digital health solutions. Any breakthrough innovation cycle requires the pioneering and bold programmes pursuing new targets and novel mechanisms of action, deploying novel technologies as well as finally routinely deploying companion diagnostics. Once more, the oncology sector possesses over 90% of all companion diagnostics tests approved to date. CVDs require the precision medicine approaches as well. The oncology sector provides many lessons to take advantage of in other sectors. In our current distressed world, it is time for more heart-centred solutions.
Let’s keep innovating together.
NRW.Venture
NRW.Venture (EUR 400 million under management) is an earlystage venture capital investor in life sciences, cleantech and digital sectors. Since 2005, NRW.Venture has invested in over 30 companies across biotech, medtech, diagnostics, lab tools and digital health. NRW.Venture is currently investing from its fourth fund’s generation (EUR 150 million) focusing on seed to series B opportunities with novel technologies, secured IP and strong market demands across the life sciences and healthcare sectors.
Autor/Autorin
Marek Kozlowski
Marek Kozlowski, PhD MScEng, is a Senior Investment Director at NRW.Venture (NRW.BANK) combining 20 years of experience in research, industry and company building across life sciences and healthcare with a focus on therapeutics, diagnostics, and research tools. He is a trained biotechnologist and molecular biologist.
