Hamburg, Germany – Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) announced today that the Company has entered into both a licensing and master service agreement with Kazia Therapeutics Limited (“Kazia”, ASX: KZA; NASDAQ: KZIA), an Australian oncology-focused biotechnology company. Under the contract, Evotec will grant Kazia an exclusive worldwide license for research, development and commercialisation of Evotec’s oncology project EVT801.
- Evotec has granted Kazia an exclusive global worldwide license to develop, manufacture, and commercialise EVT801 in all territories and indications.
- Under the terms of the agreement, Kazia will pay an immediate upfront of €1 million (AU$ 1.6 million), contingent milestones of up to €308 million (AU$ 480 million) related to achievement of clinical, regulatory, and commercial outcomes over the lifetime of the drug, and a tiered single-digit royalty on net sales.
- Evotec is a leading drug discovery and development company, headquartered in Hamburg, Germany, and listed on the Frankfurt Stock Exchange.
- EVT801 is a small-molecule inhibitor of VEGFR3. Its primary activity is to inhibit lymphangiogenesis, the formation of new lymphatic vessels around a growing tumour. By doing so, EVT801 is expected to starve the tumour of vital nutrients and to reduce metastasis. EVT801 also has marked activity on the immune system within the tumour and may therefore enhance the activity of immuno-oncology therapies.
- Kazia and Evotec have also entered into a master services agreement, under which the two companies will collaborate closely on the further development of EVT801.
- EVT801 was originally discovered by Sanofi (NASDAQ: SNY), the largest pharmaceutical company in France and among the five largest in the world and was developed through a partnership between Sanofi and Evotec.
- Kazia expects to launch a phase I clinical trial in CY2021. The initial exploratory indications for EVT801 include renal cell carcinoma (kidney cancer), hepatocellular carcinoma (liver cancer), and soft tissue sarcoma.
EVT801 is a pre-clinical-stage, orally available, small molecule inhibitor of the lymphatic growth factor receptor VEGFR3, originally developed within Evotec’s partnership with Sanofi. The high selectivity of EVT801 for VEGFR3 over other VEGF receptors differentiates the compound from other small-molecule multi-kinase inhibitors that target multiple VEGF receptors, which are associated with significant toxicity. EVT801 provides the potential to specifically antagonise VEGFR3 to combine high efficacy both against the primary tumour and lymphatic-borne metastases with a highly favourable toxicology profile.
Kazia seeks to clinically evaluate EVT801 both as a single agent and in combination with immunotherapy in a set of specific oncology indications. Evotec will manage the Phase I trial under the full sponsorship of Kazia. Kazia will be responsible for any subsequent clinical evaluation and commercialisation of EVT801.
Evotec receives a small upfront payment as well as further payments for continued support progressing EVT801 into the clinic and beyond, e.g. for biomarker development and CMC. Additionally, Evotec is eligible to receive clinical and commercial milestones of more than € 300 m as well as tiered high single-digit royalties on the net sales of EVT801, which will be shared with Sanofi, Evotec’s partner for the discovery and early development of EVT801.
Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: “We are excited to enter this licensing agreement with Kazia, who have a strong track record of clinical expertise in oncology. EVT801 comes with a comprehensive pre-clinical data package, very well-characterised pharmacology, and a clear mechanistic understanding that can inform rational selection of target populations and therapeutic combinations. In addition to a great asset, Evotec provides Kazia with a world-class team to continue progression into the clinic. We look forward to working with Kazia, to make EVT801 available to patients globally, thus providing a new treatment option for their severe unmet medical needs.”
Dr James Garner, Chief Executive Office of Kazia, said: “We are delighted to add this tremendously exciting new compound to the Kazia pipeline. Evotec have done first-class work in the early development of EVT801, and the preclinical data package is exceptionally strong. Our intention is to fast track a phase I clinical trial of the drug, which we expect to commence in CY2021.”
ABOUT KAZIA THERAPEUTICS LIMITED
Kazia Therapeutics Limited (ASX: KZA, NASDAQ: KZIA) is an oncology-focused drug development company, based in Sydney, Australia. Our lead program is paxalisib, a brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, which is being developed to treat glioblastoma, the most common and most aggressive form of primary brain cancer in adults. Licensed from Genentech in late 2016, paxalisib commenced recruitment to GBM AGILE, a pivotal study in glioblastoma, in January 2021. Seven additional studies are active in other forms of brain cancer. Paxalisib was granted Orphan Drug Designation for glioblastoma by the US FDA in February 2018, and Fast Track Designation for glioblastoma by the US FDA in August 2020. In addition, paxalisib was granted Rare Pediatric Disease Designation and Orphan Designation by the US FDA for DIPG in August 2020. In March 2021, Kazia licensed Greater China rights for paxalisib to Simcere Pharmaceutical Company. For more information, please visit www.kaziatherapeutics.com.
ABOUT EVOTEC SE
Evotec is a drug discovery alliance and development partnership company focused on rapidly progressing innovative product approaches with leading pharmaceutical and biotechnology companies, academics, patient advocacy groups and venture capitalists. We operate worldwide and our more than 3,500 employees provide the highest quality stand-alone and integrated drug discovery and development solutions. We cover all activities from target-to-clinic to meet the industry’s need for innovation and efficiency in drug discovery and development (EVT Execute). The Company has established a unique position by assembling top-class scientific experts and integrating state-of-the-art technologies as well as substantial experience and expertise in key therapeutic areas including neuronal diseases, diabetes and complications of diabetes, pain and inflammation, oncology, infectious diseases, respiratory diseases, fibrosis, rare diseases and women’s health. On this basis, Evotec has built a broad and deep pipeline of more than 100 co-owned product opportunities at clinical, pre-clinical and discovery stages (EVT Innovate). Evotec has established multiple long-term alliances with partners including Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CHDI, Novartis, Novo Nordisk, Pfizer, Sanofi, Takeda, UCB and others. For additional information please go to www.evotec.com and follow us on Twitter @Evotec.