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Eniluracil/5-FU/leucovorin has promise to produce therapeutic advantages over iv 5 FU and capecitabine

Eniluracil inactivates dihydropyrimidine dehydrogenase (DPD), thereby preventing the formation of α fluoro-β-alanine (F-BAL), and conferring 100% oral bioavailability and a 5 hr half life on 5 fluorouracil (5 FU).  An open-label Eniluracil, 5-FU and leucovorin vs. capecitabine (4:3 randomization) Phase II trial for metastatic breast cancer is in progress. Study drugs are administered orally for 1st- or 2nd-line treatment for metastatic disease in patients previously treated with an anthracycline and a taxane. Arm 1: eniluracil/5-FU/leucovorin administered once/week for 3 weeks/4 weeks. Arm 2: capecitabine (1000 mg/m2) taken bid for 14 days/21days.  Arm 2 patients with disease progression could crossover to take eniluracil/5-FU/leucovorin in Arm X.  Eniluracil/5-FU/leucovorin has been active and well tolerated in both Arm 1 and Arm X.  The primary endpoint, progression-free survival, will be determined approximately 7.5 months after the trial is enrolled with 140 evaluable patients, expected in 2Q 2013.    

• APEIRON Biologics AG, based in Vienna, Austria, is a biotech company with a focus on biological and immunological approaches to treat cancer and related conditions. The company was founded by Professor Josef Penninger and became operational in 2006. Apeiron currently employs around 25 people and is led by a management team with strong background in drug development, especially in cancer immune therapy.
• Apeiron has a portfolio of innovative projects, five of which are in clinical development. Its lead project APN311 is in an ongoing phase III trial in neuroblastoma, with more than half of the patients already recruited.

Astex Pharmaceuticals is dedicated to the discovery and development of novel small molecule therapeutics with a focus on oncology.  The Company is developing a proprietary pipeline of novel therapies and is creating de-risked products for partnership with leading pharmaceutical companies.  Astex Pharmaceuticals developed Dacogen® (decitabine) for Injection and receives significant royalties on global sales.

For more information about Astex Pharmaceuticals, Inc., please visit http://www.astx.com.

DIGNA Biotech is a private biotechnology company headquartered in Pamplona (Spain), with offices in Madrid and Pennsylvania (USA). It was founded in 2004 as a spin-off of the University of Navarra. The firm currently has a pipeline of 9 products at different stages of development in 3 therapeutic areas: Inflammatory/Autoimmune, Cardiovascular and Liver diseases.

 Digna Biotech is seeking private funding to spin out a new biotech company to conduct Phase IIb and Phase III trials of its more advanced candidate, a cytokine inhibitor for the treatment of patients with Systemic Sclerosis and Localized Scleroderma. The product (Disitertide) has already completed Phase I, Phase IIa and open-label extension (OLE) clinical trials under a topical formulation in patients with systemic sclerosis. Orphan drug designation by both FDA and EMA has been granted in the two indications.

Ennar Pharma was founded in July 2010 to develop a better and safer topical treatment for mild-to-moderate psoriasis. Patents, protecting the technology, have been granted in Europe and the USA. The company is financially supported by an investment by EVA- a Basel based venture capital company- and uses a network of strategic partners to develop the production of EGF and develop a suitable cream-based pharmaceutical product. Producers for the cGMP production of high-quality EGF(epidermal growth factor) and for a stable cream formulation of the active ingredient have been contracted and a Proof-of-Concept trial is running at the Dermatology Clinic of the University of Zurich. The trial, which is carried out with mild-to-moderate psoriasis patients, aims to establish the validity of the mode-of-action proposed for the EGF-based topical formulation and test an optimised formulation for clinical efficacy and safety. Results of the trial are expected in Q1 2013.

Genticel is a clinical stage biopharmaceutical company that develops multivalent vaccines for patients infected with Human Papillomavirus (HPV). Till date, the company has raised EUR 27 Mio in funding.

Current investors include Edmond de Rothschild Venture Partners, Innobio Fund, IDInvest (Allianz) and Amundi. 

Our lead investigational vaccine, ProCervix, has successfully finished a very positive data-rich Phase Ib trial on 47 HPV16 and/or 18 infected women. ProCervix is the first therapeutic vaccine offering a solution to the more than 93 million women worldwide already infected with HPV 16 and/or 18 before the appearance of high grade neoplasia. This very large population, exposed at high risk to develop cervical cancer, is only now becoming accessible thanks to new screening guidelines prescribing first line HPV-based testing.

A large survey of prescribers and a Market Access Study predict overwhelming acceptability and a very large market potential.

Genticel wants to take ProCervix into Clinical Phase II and further develop our second product, a heptavalent therapeutic HPV vaccine, up to clinical stage.

To do this, we intend to raise additional capital from our current and selected international investors. 

Helsinn is a privately owned pharmaceutical group with headquarters in Lugano, Switzerland, and operating subsidiaries in Ireland and the United States. Helsinn’s business model is focused on the licensing of pharmaceuticals, medical devices and nutritional supplement products in therapeutic niche areas. Helsinn Group in-licenses early-to-late stage new chemical entities, completes their development through the performance of pre-clinical /clinical studies and Chemistry, Manufacturing, and Control (CMC) development, and files and attains their market approvals worldwide. Helsinn’s products are out-licensed to its network of local marketing and commercial partners, selected for their deep in-market knowledge and know-how whom Helsinn assists and supports by providing a full range of product and scientific management services, including commercial, regulatory financial, legal, and medical marketing advice. The active pharmaceutical ingredients and the finished products are manufactured according to the highest quality, safety, and environmental standards at Helsinn’s GMP facilities in Switzerland and Ireland and supplied worldwide to its customers. Further information on Helsinn Group is available at www.helsinn.com.

Immunovaccine is a biotechnology company focused on the application of its novel vaccine delivery platform to the development of vaccines for cancer therapy and infectious diseases. The Company’s DepoVax™ platform is a patented lipid delivery system that presents antigens plus adjuvant to the immune system for a prolonged period and has the potential to enhance immune responses. Immunovaccine has advanced its platform technology and proprietary cancer vaccine into Phase I clinical trials and has demonstrated both safety and immunogenicity potential. Immunovaccine is also capitalizing on the broad potential of its delivery platform by creating new DepoVax-based vaccines through multiple development collaborations. In addition to the Company’s human health vaccine strategy, it continues to capture value from animal health vaccine applications. Immunovaccine has several key partnerships in the animal health sector including an agreement with Pfizer Animal Health, which has licensed the Company’s delivery technology platform to develop vaccines for livestock.

Headquartered in Geneva, Switzerland, NovImmune is a life science enterprise with a proprietary next-generation antibody drug discovery platform and expertise in advancing drug candidates from bench to bedside. The Company is applying its capabilities to realize a vision of generating drugs that provide more robust benefit to patients by attacking the cause rather than symptoms of disease. NovImmune has established a balanced pipeline of first- and best-in-class pre-clinical and clinical drug candidates with a mix of both clinically validated and novel targets.

§  CHF 182M raised from high net worth individuals, private and corporate venture funds

§  In 2009, received the European Biotechnica Award

§  In 2010, established Genentech/Roche partnership for NI-1401, anti-IL-17 drug candidate

§  In 2011, received Orphan Drug designation in Europe and the USA for, and EUR 6 million FP7 grant from the European Commission for development of NI-0501 for HLH

§  In 2012, filing to initiate important clinical studies including the first Phase II study for NI-0501 in HLH, and first-in-man study for leading anti-TLR4 drug candidate, NI-0101

§  Pursuing additional partnerships for its next-generation antibody platform as well as development and commercialization of selected drug candidates

§  Potential to independently bring selected drugs to the market for focused applications

Opsona is a leading immunology drug development company, focused on novel therapeutic approaches to key targets of the innate immune system associated with a wide range of major human diseases, including autoimmune and inflammatory diseases, transplant rejection, cancer, diabetes, Alzheimer's disease and atherosclerosis.

The company was founded in 2004 by three world-renowned immunologists at Trinity College in Dublin one of Ireland’s leading academic institution with a core focus on immunology research. Opsona's lead product, a fully human monoclonal IgG4 antibody (OPN-305) targeting Toll-like-receptor-2 (TLR2) has demonstrated activity in a number of animal models & recently was tested successfully in a phase 1 clinical trial in healthy volunteers. The Company plans to conduct a two-part multi-centered, double blinded and placebo controlled clinical study to evaluate the safety, tolerability and efficacy of OPN 305 in renal transplant patients at high risk of Delayed Graft Function(DGF) as the first clinical target indication for the development of OPN-305 to be initiated in 2012.

The Company is supported by an international venture consortium including Novartis Venture Fund, Roche Venture Fund, Seroba-Kernel Life Sciences, Fountain Healthcare Partners, Inventages Venture Capital and Enterprise Ireland. Further information is available at http://www.opsona.com/.