February 15, 2008 (Vol. 28, No. 4)

“Genesis” Conference Served as a Platform for the City’s Companies to Meet Possible Partners

The London Biotechnology Network recently presented the seventh annual “Genesis” conference. The meeting  brought London’s biotech companies and research groups together with delegates from many locations around the world, including the U.S., India, Korea, and Norway.

Bioinformatics is a major strength in London’s academic community. Among the emerging companies showcasing their work at “Genesis” was Equinox Pharma, a spin-out from the structural bioinformatics labs at Imperial College, London. The company offers tools for protein-structure prediction based on fold recognition and de novo modeling. Its lead product, Phyre (protein homology/analogy recognition engine), scans a query protein sequence or multiple sequence alignment against a database of all known protein folds and superfamilies.

The instrument is popular because it is easy to use, automatically predicts domain boundaries, and always gives a confidence level prediction with each structure, according to Riccardo Bennett-Lovsey, Ph.D., business development manager. The academic version of Phyre at Imperial College London has been used to predict around 100,000 protein structures for the academic community since its launch and has given good results with many difficult proteins such as GPCRs.

Phyre is now available on a pay-as-you-go basis on www.equinoxppu.com, with a free academic version of the product. The new launch guarantees access to the most up-to-date software and latest database. The web portal offers commercial and academic clients advantages over conventional software licensing. For example, there is no need to install software locally. Also, it runs on the secure Equinox server, eliminating memory-capacity concerns. “This is the first time bioinformatics software has been delivered in this way,” David Gough, CEO, stated.

The website is expected to facilitate the distribution of other important structural biology tools. While Phyre is the first system to be offered on www.equinoxppu.com, more will be added, such as Phragment. This package will offer a fragment-based approach to de novo protein structure prediction. Also, tools from sources other than Equinox will also  be offered on the site. “There is a lot of bioinformatics software out there in academia that currently cannot be delivered to a third party,” Gough pointed out.

London is also strong in ophthalmology and is carrying out significant research into blindness. Francesca Cordiero, Ph.D., from the UCL Institute of Ophthalmology, described the DARC (detection of apoptosing retinal cells) project. It allows, for the first time, direct observation of the pathogenesis and progression of glaucoma through imaging. Currently, detection technologies can only establish glaucoma once a significant number of nerve cells have died and vision is already impacted.

Therapeutic Focus Areas

The DARC project is the main focus for Ophthaltec. The firm was established last year and is dedicated to the detection, diagnosis, and treatment of eye disease. The company has a strategic partnership with UCL Institute of Ophthalmology, Moorfields Eye Hospital, and Moorfields Pharmaceuticals. Funding from Ophthaltec will allow the DARC team to move the program into clinical trials probably in early 2009, according to Peter Adamson, Ph.D., CEO.

Ophthaltec is pursuing a threefold business model. Initially, it carries out ophthalmic development with regenerative medicine and ophthalmic imaging approaches. Then, it  reprofiles drugs that were terminated at a late stage of development. Finally, the company licenses out its expertise to organizations wishing to get involved in this area.
Meanwhile, Pete Coffey, Ph.D., professor of cellular therapy and visual sciences, Institute of Ophthalmology, University College, London, established the London Project to Cure Blindness (www.thelondonproject.org), to investigate a stem cell approach to age-related macular degeneration (AMD). The disease arises from degeneration of the retinal pigment epithelial cells (RPEs). Human embryonic stem cells can form RPE progenitor cells.

Currently, autologous transplantation of RPE cells from the peripheral regions of the retina into the AMD-affected area is feasible, but the procedure is lengthy. Lucentis and other mAbs have proven effective in the wet form of AMD, yet there is nothing for the dry form.

Dr. Coffey’s procedure will be similar yet faster than autologous transplantation. “This is a true cellular therapy,” Dr. Coffey commented. Currently, a number of trials of autologous RPE cell transplantation are under way to further establish the clinical feasibility of cellular replacement prior to proceeding with stem cells.

Plethora Solutions was created in 2003 to develop new treatments for urological disorders affecting men and women.

In the last four years, the company has built a product portfolio targeting male sexual health, urinary incontinence, and women’s health. ErecAid®, RigiScan®, and Acticuf®, the firm’s commercialized products, are distributed through its sales force in the U.S. Another two drugs currently in Phase III are expected to reach the market at the end of 2009. The company also has four candidates in late Phase II development.

Licensing Wish List

At “Genesis,” companies put forward their wants in terms of deal opportunities during the “All I want for Christmas” slot. Mega-mergers in big pharma lead to a loss of focus, commented Andrew Wood, M.D., executive director of global external R&D at Eli Lilly. He spoke of the company’s efforts to find novel structural models for partnering.

“I think the greatest long-term value comes from broader, more flexible structures, which play on the greatest strengths of each partner,” Dr. Wood explained. He noted that biotech has a funding gap, saying that, “It is especially difficult to find money for early drug development.”

Smaller companies need to balance risk against speed, and Lilly wants to share risk and costs at these early stages. The firm will refine its milestones, so that the most able partner runs key development tests. Lilly could then conduct proof-of-concept studies on the biotech company’s molecule. “Companies that are open to more realistic partnerships will have a competitive advantage,” Dr. Wood asserted.

Antisoma, on the other hand, is seeking to acquire early-stage compounds. “We are now looking for more preclinical products with excellent in vivo data and at least one product in late Phase I through an M&A deal,” said Nick Adams, director of business development.

Adams went on to update attendees on the firm’s pipeline. ASA404, a vascular-disrupting agent, is entering Phase III for non-small-cell lung cancer; AS1402 is a humanized mAb going into Phase II in breast cancer; and AS1409 is an antibody-cytokine fusion protein for targeted delivery of IL-12 about to begin Phase I for renal cancer and melanoma.

Neill MacKenzie, Ph.D., senior vp business development at Medigene, spoke about needing marketing partnerships for two products: Eligard®, an LH/RH agonist for prostate cancer, which is already on the market, and Polyphenon®, a cream for genital warts, awaiting approval. They are also looking for approval of Oracea®, an antimicrobial and anti-inflammatory for rosacea.

The company is also seeking pharma partners for EndoTAG™, its development candidate. It is a vascular-disrupting agent targeting proliferating endothelial cells and is intended for pancreatic and breast cancer. It would also like to partner Phase II RhuDex®, which prevents cytokine release and is intended for rheumatoid arthritis.

Finally, with London striving to become a global hub for biotech, there was much interest in the perspective of Kiran Mazumdar-Shaw, chairman and managing director of the Indian firm Biocon. She reminded delegates that the cost of drug development in India and China are only about 30% of that in the West.

There are other advantages to locating in these countries, she added. “It is not just about the costs of trials but the speed of enrolling patients. This factor allows commercialization in India to happen two years ahead of the U.S., while the country’s large population can help bring an element of personalized medicine into trials.

“India is now active in terms of new drug development,” Mazumdar-Shaw said. She pointed to Dr. Reddy’s recent licensing of three diabetes molecules to Novartis and Merck & Co.’s drug discovery collaboration with Advinus (www. advinus.com).

For its part, Biocon reportedly developed India’s first mAb, nimotuzumab. It targets EGFR and has undergone successful clinical trials in head and neck cancer. The company recently entered a partnership with IATRICa, a U.S.-based start-up, for immunoconjugates to treat cancer and infection.

Susan Aldridge, Ph.D., is a freelance science and medical writer specializing in biotechnology, pharmaceuticals, chemistry, medicine, and health. E-mail: [email protected].

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