On September 28, 2020 CureVac reported that Its focus is squarely on getting an mRNA vaccine against COVID-19 onto the market, but has bigger ambitions from its deep pipeline (Press release, CureVac, SEP 28, 2020, View Source [SID1234567807])
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CEO: Franz-Werner Haas
Based: Tübingen, Germany
Founded: 2000
Clinical focus: Prophylactic vaccines, cancer immunotherapies and protein therapies
The scoop: CureVac, alongside BioNTech and Moderna, is one of the biotechs that put mRNA on the map. It suffered the field’s first big clinical setback when prostate cancer vaccine CV9104 flunked a phase 2b in 2017, only to bounce back through the progression of other programs and a significant infectious disease pact with Eli Lilly.
Then COVID-19 happened. As the coronavirus spread, CureVac received €300 million ($356 million) from the German government, struck a broad, big-ticket deal with GlaxoSmithKline, completed a Nasdaq IPO and briefly became a mainstream news story when President Donald Trump reportedly tried to buy it.
What makes CureVac Fierce: The biotech that emerged from the early months of the pandemic has a new CEO, Franz-Werner Haas, a new near-term focus, COVID-19, and, by extension, a radically revised outlook and strategy for the next year or two.
"[COVID-19] is really transforming the company," Haas said.
CureVac went into 2020 thinking it was still years away from bringing a product to market, meaning its focus was on running clinical trials and manufacturing materials for use in them. Now, CureVac is planning to bring a COVID-19 vaccine to market next year and lining up a contract to sell up to 405 million doses to the European Union.
The rapid acceleration of CureVac’s time to market has changed the focus of the leadership team. Today, Haas is occupied with questions about how to establish the expertise and scale CureVac will need to succeed as a commercial company. In January, those questions were distant concerns.
CureVac has a little more time to address the questions than some other developers of COVID-19 vaccine. While its peers were racing into the clinic, CureVac spent more time in preclinical doing the optimization work that it thinks will enable its vaccine to trigger balanced immune responses and be readily manufactured at scale. CureVac took a different approach to other mRNA vaccine developers.
"These other candidates, they’re building upon chemical modification of the RNA, which we don’t do. We are optimizing the RNA on the RNA level, so using the potency of the untranslated regions. That’s a differentiating factor," Haas said. One consequence of CureVac’s approach is the maximum dose in its first clinical trial is 8 µg. Moderna is testing a 100-µg dose in its phase 3.
The relatively small amount of mRNA used in its vaccine should enable CureVac to get more doses out of the manufacturing capacity it is adding. Infrastructure set up to support the COVID-19 vaccine could prove valuable as other assets get to market. CureVac’s rabies vaccine could come to market within the next five years. Perhaps more significantly, CureVac is retaining the commercialization rights in three European countries to the five candidates covered by its deal with GSK.
"These are big products, which need huge capacity in terms of manufacturing. And so there will be a kind of decision point: Where are these five projects? How can we bring these into the market? This is a transforming platform deal for us," Haas said.
Haas sees vaccines as the "sweet spot" for CureVac’s technology today as they are given at low doses in two-shot prime-boost regimens, rather than the repeated administration needed to treat disease. That is reflected in CureVac’s pipeline, which is led by vaccines against COVID-19 and rabies, but the biotech’s ambitions, like those of its mRNA rivals, extend well beyond prophylactics.
CureVac is testing its tumor microenvironment modulator CV8102 in cancer patients in combination with anti-PD-1 antibodies, and the Boehringer Ingelheim-partnered self-adjuvanting mRNA vaccine CV9202 is in early-phase development in non-small cell lung cancer. A third wing of the biotech is working on protein-based therapies, including in programs that pair its technology with the potentially complementary capabilities of CRISPR Therapeutics and Genmab.
Investors: Dievini Hopp BioTech holding, Kreditanstalt für Wiederaufbau and GlaxoSmithKline