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August 15, 2017

Translating Innovation into Therapies

Antimicrobial Resistance and Drug Commercialization Were Key Topics at the Recent ON Helix Conference in Cambridge, U.K.

Translating Innovation into Therapies

F-star's scientists develop the next generation of immuno-oncology therapies directed at improving the treatment of cancer. The biotech harnesses its proprietary technology for the generation of bispecifics by introducing an antigen binding site into the constant region of a full-length antibody.

  • At the recent ON Helix conference in Cambridge, U.K., a senior representative of the Wellcome Trust, a major contributor of funding to U.K. science stated: “The Wellcome Trust has £23 billion [about $30 billion] in funds and will continue to invest in neuroscience, antimicrobials, mental health, and neglected tropic diseases.” According to this representative, the U.K. is full of scientists with ideas ripe for development. To address this opportunity, in 2012 the Wellcome Trust created Syncona to help commercialize these ideas and concepts. To date, Syncona investments have helped create seven successful U.K.-based life science businesses. Wellcome has since sold Syncona in 2016 to a hedge fund in which it is also a significant shareholder. As a result, Wellcome participates in the market both as a for-profit and nonprofit entity. This unique position allows it to take a longer-term view and take more risks in where it invests.

  • Accessing Capital

    Sharon Vosmek, CEO at Astia and member of Astia Angels, a nonprofit organization that identifies and invests in women entrepreneurs with high growth potential, believes in patient capital when investing in biotech and Medtech companies. Vosmek stated: “VCs having a seven- to ten-year investment cycle is ridiculous, and this needs to change. I am a heretic, I like to find under-invested areas and entrepreneurs to invest in, and my early-stage investments are always personal. I’m someone who likes to bet early and champion a project all the way through. [I] am often the first one in before fools, family, and friends and often the last one out, because getting from the lab to the patient takes time.” 

    Vosmek invests in companies that have a woman as a founder or on the executive team. Today, less than 3% of venture capital is invested in companies with women on the founding team. “If you have a woman on your C-suite, I expect your company to win,” she said, citing 2012 research by Dow Jones showing that 64% of successful VC-backed exits had at least one female executive.

    Other speakers ranging from Medicxi Ventures and the The Milner Institute to MedImmune and F-star discussed ways to access capital in the U.K. and also detailed a variety of successful business models. Single-asset versus platform and/or pipeline were debated. Jane Dancer, Ph.D., chief business officer at F-star, a company developing bispecific antibodies, commented on the benefits of a model her firm employs that allows it to keep its platform technology, while also maintaining rights over its molecules. “As a biotech, you often get to a point where your pipeline is not mature enough for an IPO so you have to do a mergers and acquisitions deal with a big pharma,” Dr. Dancer noted. “However, often your pharma partner will want the asset but not your platform and vice versa. What we are doing is a partial exit with a pharma when they want a specific type of molecule or set of molecules in a disease area. That way we get to keep our platform so can continue to develop new antibodies. For example, our most recent deal with Merck is F-star’s fourth asset centric vehicle, F-star Delta. It will provide us with €115 million [$149 million] in up-front revenue over two years, and allows Merck the option to develop and commercialize five bispecific immuno-oncology antibodies.”

  • Accessing and Building Communities

    Click Image To Enlarge +
    LifeArc industrial placement student in the biotherapeutics team.

    Another important driver was highlighted at ON Helix for finding innovations that can be commercialized—accessing and building communities. “At Astia, we started investing in 2013 when we launched Astia Angels. We rely on the wisdom of the crowd using a model known as Astia’s Expert Sift™ to find those high-growth companies because if you ask a diverse group of industry experts, entrepreneurs, and investors, you’ll often get a great result,” said Vostek.

    David Pardoe, Ph.D., associate director and head of innovation and initiatives at LifeArc (previously MRC Technology) echoed the importance of community noting; “With big disease areas like dementia, we need to create a community for impact in which we share a collaboration, complementary skills, and a common purpose.” The Dementia Consortium, which includes AbbVie, Alzheimer’s Research UK, Astex, Eisai, Lilly, LifeArc, and MSD, successfully employs this model by working together to develop new drugs for dementia via support for research into novel targets for neurodegeneration.

    “At LifeArc our role in the Dementia Consortium is to progress academic work to the point that it can be commercialized. We have laboratories in Stevenage where around 80 scientists work on antibody and small-molecule projects, while our Edinburgh lab progresses diagnostics development,” Dr. Pardoe noted. “At Stevenage we perform validation experiments, because around 70% of results from studies in academic labs are not reproducible. We take projects in house and do the crucial experiment if academics don’t have the funding to validate the work. This validated data package then gives pharma companies the confidence to take forward the most promising projects.”

    According to Dr. Pardoe, LifeArc’s new vision for funding these communities for impact includes investing up to £500 million [$648 million] over the next five years on innovations in antimicrobials, neuroscience, personalized oncology, and respiratory medicine.

    Another area that benefits from community collaboration is antimicrobial development. According to Peter Jackson, Ph.D., executive chairman of the Antimicrobial Resistance (AMR) Centre, economist, Jim O’Neill’s 2016 "Review on Antimicrobial Resistance" sets out a pretty grim future. Jackson said: “By 2050, there will be 10 million deaths per year globally related to AMR, which will cost the global economy $100 trillion. In the future, everybody will be affected by AMR and the death rate will be higher than that caused by cancer.”

    Unfortunately, AMR receives a very low level of investment. “Between 1983 and 1987, the FDA approved 16 new antimicrobials but from 2006 to 2012 only two new ones have been approved. We also have fewer than 150 researchers in industry in the U.K. working on AMR. When you consider that there are over 4000 researchers funded by Cancer Research UK working in research and clinical trials to tackle cancer you can see the scale of the problem,” Dr. Jackson said.

    According to Dr. Jackson, one reason for this may be the high level of investment required to get new antimicrobials to market. “Due to high attrition rates in drug development, to get one new product to market, we need to work for 14 years and have 64 programs in early-stage preclinical research,” he said. “When you build in the cost of failures in clinical trials, the investment required is estimated at $600 million just to get one antimicrobial to market. Since we need more than one product in the pipeline, the realistic cost of developing enough effective antimicrobials is $2 billion.”

    The U.K.’s response to the AMR threat was to establish the AMR Centre at Alderley Park in the north of England. This joint private–public initiative supports the development of new antibiotics and diagnostics from preclinical research through to the clinical proof-of-concept stage. However, this center alone cannot tackle the problem. Jackson stated: “There are so few researchers working on AMR in the U.K. that it would be insane not to collaborate.” He further explained that the AMR Centre is part of an international collaboration, the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, or CARB-X. This collaboration, which includes funding from the Wellcome Trust, BARDA, and the NIH, will invest $250 million over five years to help biotech companies and research teams in the U.S. and U.K. develop new antimicrobials and diagnostics.

    “We need to understand the scale of funding needed to make an impact in developing new antimicrobials, and it was great to see the G20 ministers recognize this at their meeting in July and at international policy level. There’s a clear call for countries, philanthropic organizations, academics, and the private sector to get involved in supporting this initiative and to try and do something about this emerging threat or everyone is going to be personally affected by AMR in the next 10 years,” Dr. Jackson warned.

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