Ludwig’s integrated technology development programs are built to seamlessly move the most promising breakthroughs from the laboratory to clinical testing. We don’t wait and hope for others to act on our work, we have dedicated teams to manage every step, from drug discovery to the clinic and beyond. At Ludwig, we test our work against the one measure that matters—human benefit.
Targeted small molecule therapies are critically important in the battle against cancer. Drugs of this type can be used to block the growth and spread of cancer by selectively interfering with proteins and cellular pathways involved in tumor progression, potentially minimizing their toxicity to healthy tissues. Ludwig formed its Small Molecule Discovery Program to use key fundamental research findings from its labs around the world to generate novel small molecule therapeutic candidates for testing in the clinic.
Based at the San Diego Branch of the Ludwig Institute, Andy Shiau (Director, Small Molecule Discovery Program) has recruited a veteran drug-hunting team with extensive experience in all aspects of drug discovery research. In their previous industrial positions, members of his team have contributed to the advancement of multiple compounds into clinical trials, including the marketed cancer drug apalutamide (Erleada).
Along with sensitive protein-based assays, the group uses sophisticated high-resolution cellular microscopy to rapidly test many compounds. These approaches help determine which of the small molecules control the activity of a protein or pathway that tells cancer cells to grow and multiply out of control. These compounds are then refined through cycles of computational design and medicinal chemistry. In this way, the team generates drug candidates that specifically block cellular processes related to disease development and progression, and cause cancer cells, but not normal ones, to die.
For more information about Ludwig Small Molecule Discovery Program projects, please click here.
Our in-house team has scientific expertise in all aspects of clinical trials management, from study design to managing international networks of sites, from analysis of data and evaluation of results to the design of potential next phases. Our internationally recognized clinical team has wide-ranging partnerships with universities, institutes, not-for-profit research foundations, and pharmaceutical and biotechnology companies.
Regulatory study sponsorship
We handle regulatory submissions for the United States and Europe, as well as annual and expedited safety reporting to health agencies using state-of-the-art electronic transmissions. We maintain study master files, both electronic and on paper, and provide clinical trial insurance and other liability coverage as needed through the Ludwig Institute.
Protocol development and study setup
Our highly experienced team develops study protocols from concept to full approval by site research committees, ethics boards and health authorities. We also initiate the study and the study sites, including managing drug chemistry, manufacturing and control; study site validations; shipping drug supply logistics and clinical specimens. We collaborate with a great number of highly experienced clinical investigators and study sites nationally and globally.
Data capture and study monitoring
The data generated in clinical studies is collected in a central online database using remote internet-based entry. Data is validated in real time using extensive edit checks and online coding tools. In addition, clinical study monitors verify the accuracy of the data against source data, e.g., the patient charts. The medical monitor reviews the data to screen for any safety issues, including any serious adverse events. All study monitoring is done according to Good Clinical Practice and in compliance with the all applicable laws and regulations. When a study closes, we ensure proper disposition of any remaining study drug and the secure archiving of all study-related documents.
Data management and analysis
Our experts create a data-management plan with validation guidelines for the captured data, program the validation routines, process the resulting queries and execute a database lock on the fully validated data. We manage the statistical analysis, presentation and storage of the data.
Clinical study report
Our medical writers draft an appropriate clinical study report based on the analyzed data, in compliance with applicable guidelines and regulations. Ludwig Institute experts and the involved clinical investigators review and approve the report before submission to health authorities, study sites and collaborators.
The first step in Ludwig’s drive to realize the life-changing possibilities of our science is careful management of intellectual property. The Ludwig Institute’s in-house technology development team works closely with our scientists, spotting patent opportunities, building partnerships and maximizing the potential uses of our breakthroughs. Our expertise in patents, licensing, contracts, portfolio development, clinical trials and start-up biotech ensures that our discoveries will be pursued along multiple avenues both within the Ludwig community and with partners anywhere in the world.
Monoclonal antibodies and hybridoma cell lines originated by Ludwig Institute scientists are available for licensing. Click here for a searchable PDF.
Several biological models also are available:
PI3K Transgenic models
Another way Ludwig accelerates discoveries to improve human health is by starting private companies that focus on a promising breakthrough with commercial potential. The Ludwig Institute typically holds a stake in the venture, providing scientific assistance and potentially generating financial returns to fund additional research.
Several Ludwig-born companies have been acquired by pharmaceutical and biotech companies, increasing the potential patient benefits of our discoveries.
Base Genomics is an epigenetics company applying technology developed at Ludwig Oxford to devise minimally invasive tests, or liquid biopsies, for cancer. The startup, launched in June 2020, has licensed its core technology—TET-assisted pyridine borane sequencing (TAPS)— from the Ludwig Institute for Cancer Research. TAPS is a vastly improved and cost-effective method for sequencing a modification made to DNA known as methylation that regulates gene expression and is widely disordered in cancer. Visit Website.
VACCITECH ONCOLOGY LIMITED
Vaccitech Oncology Limited (VOLT) is an oncology focused strategic collaboration between Ludwig Cancer Research and Vaccitech, a clinical stage T cell immunotherapy company. VOLT has licensed Vaccitech’s proprietary CD8+ T cell induction platform and research from the Ludwig Oxford Branch, validating this platform with MAGE and NY-ESO-1 cancer antigens. VOLT has entered into a clinical partnership with Cancer Research UK to develop VOLT’s VTP-600 immunotherapy as a treatment option for patients with non-small cell lung cancer.
iOx Therapeutics was established in 2015 to develop a novel cancer immunotherapy discovered through a collaboration between Ludwig Cancer Research and the University of Oxford’s Weatherall Institute of Molecular Medicine.
iTeos Therapeutics SA launched in 2012 to develop new methods to stimulate the immune system’s ability to attack cancer. Founded by the Ludwig Institute with the de Duve Institute at the Université catholique de Louvain in Belgium, iTeos is led by a team experienced in tumor immunology, immunotherapy, drug discovery, business development and entrepreneurship. Visit website.
Serametrix began operations in 2009 to develop and commercialize products based on the Ludwig Institute’s pioneering research into immunological biomarkers for predicting drug response. The tests determine immune reaction to tumor antigens and are of value to clinicians and drug developers alike. Visit website.
Recepta, Brazil’s first oncology start-up company, is pursuing clinical development of targeted antibodies generated by Ludwig investigators, and of second-generation antibodies generated by their scientific staff. In 2007, Recepta initiated the first FDA-registered phase II clinical trial fully conceived and conducted in Brazil. Visit website.
LIFE SCIENCE PHARMACEUTICALS
Life Sciences, established in 2006, is developing three targeted antibodies generated and assessed in clinical trials by the Ludwig Institute. These antibodies are potentially beneficial in treating or diagnosing a variety of cancers. Visit website.
Vegenics began in 2006 in collaboration with Licentia Ltd, the technology transfer arm of the University of Helsinki, to develop and commercialize products based on discoveries from the Ludwig Institute’s global angiogenesis program. In 2008, Vegenics was acquired by Circadian Technologies Ltd.
Lymphatix was created in 2004 with Licentia Ltd to develop and commercialize products based on discoveries from the Ludwig Institute’s global angiogenesis program. The company was acquired by Ark Therapeutics Group in 2008.
LICR started its first company, Piramed Ltd, to develop new cancer therapies based on selective small-molecule inhibitors of phosphatidyl-inositol 3-kinase (PI3K) signal transduction. These inhibitors resulted from research conducted at the former Ludwig Institute Branch in London, with collaborators at Cancer Research UK and the Institute of Cancer Research. In 2008, Piramed was acquired for by the pharmaceutical company Roche.