Cytune Pharma, an emerging leader in innovative immunomodulatory agents against cancer and infectious diseases, has received the European Patent and Trademark Office approval for patent EP06842352 on May 10 and for its recombinant Interleukin-15-based fusion protein CYP0150. The patent covers CYP0150 and all its related clinical applications.

The company also received two notices of allowance from Mexico and Russia indicating that a patent will be issued. The company will attend the BIO2012 to present its major achievements over the last 12 months and to foster partnering discussions.

“These patents, together with our current efforts with other patent offices, including the USPTO, and our will to expand and consolidate our patent positions, will provide a broad and long-term protection for Cytune Pharma's CYP0150,” said David Bechard, president and COO of Cytune Pharma.

In addition, the company raised 3 million euros to consolidate its financial position to boost CYP0150's and of its immunocytokines' developments. These funds were obtained from existing shareholders and new entrants together with a grant (2012-2013) from the French National Research Agency dedicated to the translational development of CYP0150.

“This financing enables Cytune to boost the development of CYP0150. In preclinical models, CYP0150 was shown to be more potent and safer than interleukin-2 and interleukin-15 and may, therefore, markedly expand the immunotherapy market that is extremely attractive as proven by the recent success of Yervoy,” added Dr Bechard.

“Furthermore, it allows us to further generate and develop our immunocytokines. Our 3 current immunocytokines (based on known and new antibodies) are very promising in terms of efficacy, the potencies of the parent antibodies being markedly increased. Cytune established a strong and focused pipeline of well-validated preclinical drug candidates and a robust technology platform. This novel proprietary Immunocytokines platform revisits the concept of coupling an antibody with a cytokine and is open to partnering,” he added.

Dr. Bechard informed that a wealth of major results on CYP0150 was accumulated over the last 12 months confirming its superior efficacy/safety profile relative to IL-2 and IL-15. With the successful transition to an industrial-scale biomanufacturing process, CYP0150, mimicking the transpresentation of interleukin-15 (down-regulated by immunosuppressive mechanisms), has a strong potential as an immunomodulatory agent. It is now time to offer CYP0150 to a larger set of prospects in addition to our current discussions with potential partners. We maximally de-risk the development of powerful immunomodulatory agents before handing them over to potential partners for their further commercial development.

Key data confirmed the superiority of CYP0150 relative to other cytokines like interleukin-2 (approved for treating metastatic melanoma and renal cell carcinoma) and interleukin-15 (ranked first among 124 other immunomodulatory agents in 2007 by a NCI-based consortium and currently investigated in several phase 1/2a clinical trials by the US NCI).

“Interleukin-2 was a major advance in cancer therapy 20 years ago but has major limitations: a poor safety profile and a non-optimal pharmacological profile leading to restricted but long-term clinical responses in patients. Because of its specific pharmacological and pharmacodynamic features on the immune system, CYP0150 is a major improvement over IL-2 and could bring major benefits to patients. In addition, promising combination approaches with CYP0150 pave the way for its development in multiple cancer indications,” said Didier Coquoz, CDO of Cytune.

"To have successfully transitioned our manufacturing process to those used widely in industry allows to push CYP0150 faster into the clinic,” added Guy de Martynoff, CTO of Cytune. “Demonstrating that classical USP and DSP can be applied to the manufacture CYP0150 has been a critical step and impacts positively on the features of the final product.”

CYP0150 is an optimized fusion protein based on huIL-15 mimicking IL-15 transpresentation even in pathologic conditions (cancer, infection) to bypass immunosuppression.

CYP0150 was shown to be markedly superior to IL-2 and IL-15. Given its specific pharmacological and pharmacodynamic features on the immune system, CYP0150 is a major improvement over ILâ€'2 and could bring major benefits to patients.

CYP0150 induces the expansion and activation of NK and CD8 T cells and increases the pool of NK cells in various primary and secondary lymphoid organs in mice. In Human Immune System mouse models, CYP0150 improves human innate and adaptive immunity.

In cancer models (metastatic melanoma, RCC, colon, lymphoma and other cancers), CPY0150 alone is more effective than IL-2 and IL-15. CYP0150 presents a promising and competitive efficacy/safety profile in different tumors models as well as in Non-Human Primates. Numerous therapeutic combinations with CYP0150 were shown to be promising.

Cytune develops a large portfolio of potent immunocytokines, i.e. monoclonal antibodies fused to CYP0150 allowing to manage the product Life Cycle Management for existing blockbusters (generating new IP to face coming patent expirations), to increase the efficacy of existing or future antibodies while reducing their toxicity profile.