Financing to boost late-stage development of novel therapy to treat life-threatening, virus-induced cancers
Loan supported by the “InnovFin – EU-finance for innovators” programme
The European Investment Bank and ISA Pharmaceuticals have signed a EUR 20 million loan agreement to support the development of ISA´s therapy for cancers caused by the Human Papillomavirus type 16 (HPV16). The EIB’s financing is supported under the “Infectious Diseases Finance Facility” (IDFF) of the InnovFin – EU-finance for innovators programme, which is financed from the EU’s research and innovation programme Horizon 2020.
Persistent HPV16 infection can cause cervical, head & neck and anogenital cancers. These cancers can be severe and life-threatening, with low overall survival rates of advanced stages. Cervical cancer is the 2nd most common cancer in women aged 15 to 44 years in Europe, with HPV16 causing over 35.000 new cases and 15.000 deaths each year. The virus is also a major cause of oropharyngeal cancer with over 25.000 new cases and 12.000 deaths each year in Europe alone1.
ISA Pharmaceuticals has developed a novel therapy, ISA101b, which targets HPV16-positive cancers through the specific activation of the patient’s own immune system. The treatment has proven to be safe with no serious side effects, and has demonstrated substantial benefit for patients, when used in addition to current treatment in advanced stages of the head & neck cancer and cervical cancer. ISA101b represents a unique and innovative treatment modality. It is designed to fight HPV16 driven premalignant conditions and early stage cancers as monotherapy, and metastatic malignancies when given together with standard of care.
“ISA's lead product is at a very exciting final stage of development. This loan from the EIB will help accelerate the programme all the way to our ultimate goal of making ISA101b available to all patients suffering from HPV16-induced cancers,”said Gerben Moolhuizen, CEO of ISA Pharmaceuticals.
“I am very pleased that we can actively contribute to combating cancer and its causes as a financial institution, thanks to the support of the European Commission’s Innovfin programme. After financing projects for research into the Zika virus and Ebola vaccines, this human papillomavirus project is one that we gladly participate in. The EIB has significantly increased its support for projects related to innovation in the health sector recently, and we see the ISA project as a very promising one with significant potential benefits for many patients.” said EIB Vice-President Ambroise Fayolle.
Through the support of IDFF, the EIB can provide stable long-term funding with a flexible repayment and interest structure, limiting the cash outflow from the company and thereby enabling it to focus on investing in innovation and growth.
Carlos Moedas, European Commissioner forResearch, Science and Innovation, said: “With more people living longer, cancer rates are increasing everywhere. Europe has 9% of the world’s population but a 23% share of the global cancer burden. This is why we support the development of new drugs to treat life-threatening diseases such as cancer through the EU research and innovation programme, Horizon 2020.”
The European Investment Bank (EIB) is the long-term lending institution of the European Union, owned by its Member States. It makes long-term finance available for sound investment in order to contribute towards EU policy goals. In 2018 alone, the Bank made available around EUR 2 Bln in loans for Dutch projects in various sectors, including research & development, transport, healthcare and SMEs.
Under Horizon 2020, the EU research and innovation framework programme for 2014-20, the ‘Infectious Diseases Finance Facility (IDFF)’ provides financial products ranging from standard debt to equity-type financing for amounts typically between EUR 7.5 million and EUR 75 million, to innovative players active in developing innovative vaccines, drugs, medical and diagnostic devices or novel research infrastructures for combatting infectious diseases. Project costs may include clinical trial costs, set-up of commercialization such as market access, development of prototypes or industrial roll out of novel equipment, pre-clinical R&D costs and working capital requirement. This facility is delivered directly by the EIB.
ISA Pharmaceuticals B.V. is an immunotherapy company developing rationally designed, fully synthetic immunotherapeutics against cancer and persistent viral infections. The Company has built a proprietary immunotherapy platform based on the Synthetic Long Peptide (SLP®) concept and AMPLIVANT® technology. SLP® immunotherapies are designed to fully harness and direct the body’s own defense mechanisms towards fighting the disease.
In December 2017, ISA Pharmaceuticals closed a clinical immuno-oncology collaboration with Regeneron to advance its SLP® lead compound ISA101, an immunotherapy targeting human papillomavirus type 16 (HPV16)-induced cancer, in combination with cemiplimab-rwlc (Libtayo®). Cemiplimab-rwlc is a PD-1 (programmed cell death protein 1) antibody developed by Regeneron and Sanofi. ISA develops a diverse SLP® immunotherapy portfolio targeting unmet medical needs in cancer and chronic infections, including tailored therapy for rare diseases.
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The EIB and Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, today announced the signing of a €24.5 million financing agreement. The venture loan is intended to support Immunic’s ongoing phase 2 CALVID-1 trial of its lead asset, IMU-838, in patients with moderate coronavirus disease 2019 (COVID-19). In addition, it is also intended to support the potential expansion of the CALVID-1 trial into a confirmatory phase 3 trial and the commercial-scale manufacturing for IMU-838. Immunic AG, the German subsidiary of Immunic, Inc., will receive the EIB loan in three tranches upon the completion of pre-defined milestones.