Eli Lilly will partner to develop and commercialize up to five cancer vaccines based on CureVac's RNActive® technology, the companies said today, through a collaboration that could generate up to $1.795 billion-plus for CureVac.

The companies plan to use RNActive to deliver mRNA that directs the human immune system to target neoantigens across multiple tumor types. These neoantigens, which are tumor-specific, in turn direct the patient's existing immune system to mount a selective and potent response to eradicate the cancer.

By modifying the sequence of mRNA, CureVac says, the stability of the molecule is improved while translational levels are enhanced without changing the amino acid sequence of the corresponding protein. The immunogenicity of the molecule is increased by complexation with protamine.

Lilly agreed to pay CureVac $50 million upfront, as well as an equity investment of €45 million (about $53 million). Lilly also agreed to pay CureVac more than $1.7 billion in payments tied to achieving development and commercialization milestones if all five vaccines are successfully developed, as well as tiered royalties on product sales.

Lilly agreed to oversee target identification, clinical development, and commercialization, while CureVac agreed to take responsibility for mRNA design, formulation, and manufacturing of clinical supply and retains the option to co-promote the vaccine products in Germany.

The deal is subject to clearance under the Hart–Scott–Rodino Antitrust Improvements Act and other customary closing conditions. Lilly has projected it will incur an acquired in-process research and development charge against earnings of approximately $0.03 per share.

“This new collaboration with Lilly is a testimony to the progress and sophistication of CureVac's RNActive technology and the potential of mRNA-based therapeutics,” CureVac co-founder and CEO Ingmar Hoerr, Ph.D., said in a statement. “We now have the opportunity to combine forces to further expand the exciting space of immuno-oncology with the next generation of cancer therapies.”

Added Greg Plowman, M.D., Ph.D., VP of oncology research at Lilly: “This collaboration reinforces Lilly's commitment to delivering life-changing medicines to treat and cure people living with cancer around the world.”

Bolstering Oncology Pipeline

The collaboration with CureVac is Lilly’s latest effort to strengthen its oncology pipeline, which the pharma giant committed to overhauling in July, and bolstered in August by partnering with Cancer Research UK on a Phase I trial for the cell division cycle 7 kinase (Cdc7) inhibitor LY3143921 hydrate.

Lilly’s cancer effort scored an FDA approval on September 28 for Verzenio™ (abemaciclib) in a pair of advanced or metastatic breast cancer indications. But the newly authorized cyclin-dependent kinase (CDK)4 and CDK6 inhibitor missed its primary endpoint of overall survival (OS) in the Phase III JUNIPER trial, Lilly acknowledged on October 10.  

JUNIPER assessed the efficacy and safety of abemaciclib versus the Genentech/Astellas-marketed Tarceva® (erlotinib) in patients with stage IV non-small cell lung cancer with a detectable KRAS mutation, who have progressed after platinum-based chemotherapy and who may have received one additional systemic therapy.

Verzenio is indicated for women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2) advanced or metastatic breast cancer with disease progression following endocrine therapy, and as monotherapy for the treatment of adult patients with HR+, HER2 advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.

CureVac also had a clinical setback of its own this year, acknowledging in January that its prostate cancer immunotherapy vaccine candidate CV9104 failed a Phase IIb clinical trial in patients with asymptomatic or minimally symptomatic metastatic castrate-resistant forms of the disease.

Topline results showed that CV9104 failed to meet the trial’s primary endpoint of improving overall survival. At the time, Dr. Hoerr said that despite the failure, CureVac saw a path forward for its RNActive cancer immunotherapies through development in combination with checkpoint inhibitors.

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