CleveXel and Dynamix to develop a dual mechanism SYK/JAK small molecule inhibitor to clinical proof-of-concept

Clevexel Pharma, a pharmaceutical company specialized in investing in the development of new molecules between proof-of-concept in animal and proof-of-concept in humans announces today they have entered into a partnering agreement with Dynamix Pharmaceuticals, a venture-backed Israeli biopharmaceutical company focused on the discovery and development of novel, targeted, small-molecule drugs for cancer and autoimmune disorders.
 
The partnership will cover the development of a dual mechanism SYK/JAK molecule in rheumatoid arthritis. The orally active SYK/JAK product has a new action and is Dynamix’ lead development program. Over the past decade, efforts have been made to provide an oral treatment for rheumatoid arthritis (RA) with the desired efficacy and safety profile. Oral administration is of great interest as current treatments are mainly only injectable.
 
The joint aim of the collaboration between CleveXel and Dynamix is to bring the rheumatoid arthritis project to a clinical proof of concept stage. Preclinical development is planned for early 2014. The first in human clinical trial is expected to start in 2015.
 
Rheumatoid arthritis is a chronic and debilitating autoimmune disease of unknown etiology. It is linked to significant morbidity. The associated inflammatory processes cause the destruction of cartilage and bone, leading to joint swelling, pain and, ultimately, joint destruction.
 
Over the next few years, the global rheumatoid arthritis market is expected to grow from USD 18.6 billion in 2012 to USD 26.0 billion in 2017 (FirstWord, June 2013). Rheumatoid arthritis affects 1.3 million Americans and 2.9 million Europeans (Arthritis Foundation) (Abbott). Patients are currently mainly treated with anti-TNF monoclonal antibodies therapies.
 
“We are happy to collaborate with CleveXel and to gain access to their development expertise”, said Batsheva Elran, managing partner at Opal Ventures and chairman of Dynamix. “This collaboration is an excellent opportunity to share the risks in developing an innovative project in inflammatory diseases and to address unmet needs,” said Dr Itzchak Angel, CEO of Angel Pharmaceutical Consulting and Technologies, who represent Dynamix Pharmaceuticals in this partnership.
 
“For CleveXel, the partnership will innovate in inflammatory disease, potentially also in oncology,” said Christian Bloy, CEO of CleveXel. “JAK3 and SYK represent new targets that are extremely interesting in order to develop an orally administered product. CleveXel Pharma is very happy to be part of this leading project with Dynamix.”
 
This new agreement will strengthen CleveXel’s product portfolio both in financial and non-monetary asset investments. This is the fourth molecule in CleveXel’s portfolio since the beginning of 2013.

About CleveXel Pharma
With over 20 years of experience in pharmaceutical development, CleveXel Pharma is a strong new player in France. By operating as an investor, CleveXel Pharma is introducing a new business model to the industry. With its own incubator, CleveXel Pharma invests in the development of new molecules between proof-of-concept in animal and proof-of-concept in humans. With an expert team in the whole chain of development activities, CleveXel Pharma significantly reduces early capital needs by securing and consolidating the major milestones of the project. CleveXel Pharma can enhance the attractiveness of projects for other partners and, if necessary, facilitate fundraising. CleveXel Pharma is already engaged in four projects and continues to actively expand its portfolio in the areas of Oncology, CNS and Immuno-Inflammation.

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About Dynamix Pharmaceuticals
Dynamix was created in 2009 by Dr Oren Becker, founder and former CEO. It is a venture-backed biopharmaceutical company focused on the discovery and development of novel, targeted, small-molecule drugs for cancer and autoimmune disorders. Dynamix focuses on two drug classes – cancer metabolism modulators and type II selective kinase Inhibitors. Both drug classes explore some of the newest and most promising therapeutic routes to treat urgent, unmet medical needs in cancer and autoimmune disorders. This pipeline was created with the company’s innovative proprietary DynamixFit(TM) technology, which Dr Becker invented, applied and developed himself. It is uniquely suitable for discovering novel kinase inhibitors. DynamixFit technology significantly shortens drug development times and lowers R&D costs.

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About the SYK/JAK product (DNX-04042).
Both SYK and JAK3 are intracellular tyrosine kinases involved in cytokine and antibody receptor signaling. JAK3, which is a member of the JAK family, is frequently activated during the course of inflammatory autoimmune diseases. However, unlike JAK1 which is ubiquitously expressed and JAK2 which is prominent in erythrocytes, JAK3 is predominantly expressed in immune cells (B- and T-cells) making it a promising target for treating autoimmune diseases and hematological malignancies. SYK is a key kinase in B-cell signaling. DNX-04042 is a potent, oral, small-molecule inhibitor of both SYK and JAK3 with significant selectivity within the JAK-family and across the kinome. Specifically, DNX-04042 exhibits more than 1,500 fold selectivity in cells for JAK3 over JAK2 inhibition. DNX-04042 has a promising pharmacological profile and has demonstrated excellent safety in a preclinical MTD study. DNX-04042 has also demonstrated a very strong anti-cancer effect in a mouse xenograft study of B-cell lymphoma.

more about SKY/JAK3