ChemDiv – Nerviano Partnership
ChemDiv – Nerviano MS successful collaboration was a hit-to-lead optimization campaign of previously discovered through HTS active molecules. The goal of the program was development of Lead compounds with confirmed efficacy in animal models (POC). The collaboration plan included chemistry optimization, in vitro biology, in vitro and in vivo DMPK, efficacy models in animals and comprehensive IP strategy all of which were successfully executed at ChemDiv facilities. Initially, Nerviano discovered several confirmed hits by screening ChemDiv off-the-shelf collection of small molecules. To move ahead with discovered molecules, Nerviano was looking for a reliable partner who could provide resources to complete the program efficiently and by meeting aggressive deadlines.
Within extremely short period of time (9 months) and through close interactions with Nerviano’s scientists, ChemDiv team managed to rapidly move the compound from Hit level to fully patentable Lead molecules with confirmed efficacy in animals and managed to exceed customers’ expectations in achieving milestones.
This project represents a comprehensible example of harmonious collaboration between partners where ChemDiv demonstrated versatility of research approaches to outstanding challenges and delivered ultimate value to the customer.
About Nerviano MS
Nerviano Medical Sciences is the largest pharmaceutical R&D facility in Italy and one of the largest oncology-focused, integrated discovery and development companies in Europe.
ChemDiv – Dendreon Partnership
Dendreon Corporation is a Seattle based company dedicated to discovery, development and commercialization of novel therapeutics to fight cancer. Dendreon was looking for a partner to support its TRPM8 (also known as TRPP8) inhibitor discovery program, which was identified through in-house efforts. Having lots of in-house expertise in and knowledge of immunotherapeutics, the company lacked sufficient internal resources in small-molecule drug discovery to rapidly and efficiently move the program towards a series of critical milestones put in place by Dendreon. This triggered Denderon’s quest to find a reliable and experienced partner in small-molecule drug discovery, specifically with an excellent track record in medicinal chemistry. Dendreon had already worked with ChemDiv before on a number of smaller-scale chemistry projects and its decision to approach ChemDiv with a larger and therefore more challenging program was a logical step in building up relationships between two organizations. ChemDiv’s expertise in custom chemistry and lead optimization solutions as well as stellar reputation in the industry has sealed the deal.
In the course of a few years, a group of dedicated ChemDiv scientists (chemists and biologists) worked hand-in-hand with Dendreon’s team to advance the program to the clinical candidate stage. Looking back at major stepping stones of this collaboration’s success, one would recognize the highest level of commitment of both teams to thrive through trust, resourcefulness, dedication, communication and highest level of professionalism. Currently, the lead molecule, D3263, is in a Phase 1 clinical trial for clinical evaluation in cancer patients.
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics. Dendreon applies its expertise in antigen identification, engineering and cell processing to produce ACI product candidates designed to stimulate an immune response. Dendreon is also developing an orally-available small molecule that targets TRPM8 that could be applicable to multiple types of cancer as well as benign prostatic hyperplasia. Dendreon has its headquarters in Seattle, Washington.
ChemDiv – Avineuro Partnership
ChemDiv Inc. and Avineuro Pharmaceuticals Inc. move ahead a productive relationship in the area of neurological and psychiatric disorders. With a number of compounds in early development, Avineuro was seeking to move them through pre-clinical and early clinical development in order to generate maximally informative data package for further development and potential pharma partnering in the shortest amount of time. Full package of pre-clinical work required for 4 regulatory submissions for development candidates in Alzheimer’s Disease, Anxiety and Scizophrenia were completed and approved at an optimal cost point within 1 to 1,5 years from initiation to dosing in first volunteers. Next phase of safety studies included certain patient population in agreement with recommendations of Ethical Committee. Safety studies were accomplished within 2 to 4 months for all drug candidates. Proof of Concept studies were executed for 2 out of 4 molecules within 2 years from initiation of the service research programs. All clinical and pre-clinical data generated by ChemDiv in its Research Institute in Russia were used for an IND package.
By contracting with ChemDiv, Avineuro worked with an expert scientific and project management group overseeing all aspects of pre-clinical and early clinical development. Normally, a company will contract out to multiple vendors for chemistry formulation; scale up of investigational product, pre-clinical studies and clinical studies. ChemDiv has completed fully integrated drug development programs from target to Proof of Concept. ChemDiv’s consistency in project management and data quality along the development of a compound has been very helpful in further Avineuro’s partnering effort.
About Avineuro Pharmaceuticals, Inc.
Avineuro Pharmaceuticals, Inc. discovers and develops novel small molecules for unmet medical needs in neurology and psychiatry. Founded in August 2008 and headquartered in San Diego, California, Avineuro is managed by seasoned professionals experienced in drug discovery and development. By acquiring lead compounds through collaborations and partnerships, Avineuro plans to develop novel products and extend the reach of marketed compounds for indications with a significant commercial potential. Avineuro emphasizes a rational approach that combines modern medicinal chemistry with streamlined pre-clinical and clinical development studies, thus allowing a fast transition to proof-of-concept product candidates.
In October 2007 iDialog had a series of proprietary compounds that were showing anti-viral activity. This is when iDialog made a decision to enter into collaboration with ChemDiv to move compounds though drug discovery process and into pre-clinical and clinical stages. ChemDiv successfully maintains the integrated R&D program for iDialog having moved it from early discovery to clinic in 26 months.
As a result, the novel small molecule is currently in a clinical stage of development. It is an orally-bioavailable inhibitor of hepatitis C virus (HCV) that blocks early stage of viral infection. Vadim Bichko, Ph.D, ChemDiv’s Vice President of Virology, stated: “We are very encouraged by the safety, potency, PK profile, and novel molecular mechanism of action, exhibited by iDialog’s HCV inhibitor in the preclinical studies. We are quite excited by the ability of ID-12 to prevent spread of viral infection through cell-cell contact, which makes it superior to the neutralizing antibodies and other viral entry inhibitors. This mechanism of action is complimentary to that of other classes of HCV inhibitors currently on the market, or in late stage clinical development. Thus, ID-12 is a potentially important component of therapeutic cocktails for chronic hepatitis C.”
In September 2009 pre-clinical stage was completed and the drug candidate received regulatory approval shortly after that. Phase 1A was initiated in January 2010 and is expected to be completed in the second quarter of 2010. By conducting these clinical studies in Russia, the program takes advantage of a notably large pool of recently diagnosed patients potentially eligible for enrollment (due to regular screening for viral diseases in Russia). Moreover, the fraction of naïve treatment patients is higher than in Western European countries or the United States. ChemDiv’s approach resulted in rapid and cost-effective advance of iDialog’s clinical HCV candidates.
iDialog was established in 2006 as an innovative biopharma start up. It received over USD$3M of seed investment from Torrey Pines Investment in 2007 and subsequently won the research partnership award of over USD$3 from the Russian Federal Agency of Science and Innovation for development of novel anti-infective agents to match unmet needs in Russia. iDialog conducted and continues the broad program to discover novel therapies for Tuberculosis, hepatitis C and Influenza, in partnership with Moscow State University and other academic organizations. In 2008 iDialog established the R&D collaboration with ChemDiv’s Chemical Diversity Research Institute for discovery and development of novel small molecule anti-infective agents, which is extended to 2011.
Viriom, Russia and Hoffman La Roche Ltd., Switzerland, signed a collaboration agreement for research and development of innovative medicines for HIV, and ChemDiv was chosen by Viriom as a strategic partner to carry out pre-clinical and clinical development of this program.
Due to changes in corporate strategy, Roche was looking for a partner to take over its internal HIV program and had a couple of very promising compounds in the pipeline that showed good potential to become best-in-class drugs. ChemDiv stepped forward with an innovative solution for Roche and proposed to form a partnership and consolidate Roche’s HIV assets in a start up biotech company Viriom to be able to move forward the compounds. ChemDiv offered its services and expertise in preclinical research and clinical development to help advance the program in the most time- and cost-efficient way.
In a press statement, Vadim Bichko, ChemDiv’s VP of Virology, noted: “These HIV inhibitors have shown excellent antiviral properties in vitro, good bioavailability, PK and safety profiles, as well as a high genetic barrier to resistance.”
In this one-of-a- kind deal, Roche made a bold decision, which helped the company advance the innovative HIV program with an experienced and reliable partner and at a fraction of the costs typically associated with such development. For Roche, it also opened new opportunities as well as strategic access to the emerging Russian pharmaceutical market.
Roche’s promising HIV program was not abandoned and ChemDiv had successfully completed all pre-clinical studies and had submitted the preclinical data package with the Russian regulatory agencies. Viriom is planning to initiate clinical studies in the middle of second quarter of 2010.
Viriom is an innovative company, established in 2009 at the ChemRar High Tech Center for development of targeted drugs to treat HIV / AIDS. Viriom plans to conduct scientific research in Russia using the experience and knowledge of the Russian scientists. The company is partnering – among others – with Chemical Diversity Research Institute on preclinical studies of molecules, “Drug Technologies” on development of complete dosage forms, and the Moscow Center for HIV/AIDS Prevention.