Aum Bets On Asia-To-Global Oncology Model
Executive Summary
Emerging Company Profile: Singapore-based Aum Biosciences hopes to disrupt early stage oncology drug development with an Asia-pivoted model, and the fledgling firm has struck interesting alliances to progress its plans.
A young Singapore-based start-up, Aum Biosciences, is hoping to alter the general business approach for oncology R&D, which is traditionally largely US and EU-centric both in terms of development and market priorities.
Aum’s ambitious plans come against the backdrop of some startling numbers – 60% of all cancer cases in the world are likely to come from Asia and cancer patient numbers in the region are expected to rocket by 70% by 2030. Besides, less than a quarter of oncology drugs approved in 2017 are available in most "pharmerging" markets. And those that are, are likely unaffordable to many.
Aum’s founders, CEO Vishal Doshi and Chief Medical Officer Harish Dave, former colleagues at Quintiles (now IQVIA), are keen to change the cancer treatment narrative both from the drug development perspective and for patients. What began as initial conversations over dinner around “how Asian research wasn’t going global” at an event several years ago culminated with the duo eventually getting together to set up Aum.
“We are very excited about the fact that it can be Asian originator research or research that has originated globally but is developed in Asia and then taken global, so that the cost of drug development is nominal and at the same time patients don’t have to pay huge costs,” Doshi told Scrip in an interview.
Aum’s overall mission is clearly relevant from the standpoint of the West too. A recent report by the IQVIA Institute for Human Data Science noted that only patients in the US, Germany and the UK primarily have access to more than 40 of the 55 oncology medicines initially launched between 2012 and 2016, due to “manufacturers not filing for regulatory approval, delays or denials of approval, or manufacturers awaiting the results of reimbursement negotiations prior to launching the drug in the country.”
Primarily, though, Aum is driven by the fact there is still significant unmet need in oncology in Asia, with affordability and availability being the major concerns that it hopes to deal with. Aum expects to address these key challenges in the Asian pharmaceutical environment by targeting diseases that are prevalent in Asia with potential development for Western markets. “This Asia-to-global approach is a central thrust of Aum’s innovation strategy,” CEO Doshi said.
Biomarker-Driven Clinical Development
Doshi and Dave come with extensive domain expertise – cumulatively they have over 50 years of oncology drug development experience, while Dave has conducted over 100 oncology studies – and expect to disrupt the initial stages of clinical development, i.e., Phase I and II.
Aum’s strategy essentially entails in-licensing from various partners pre-IND or late preclinical small molecule assets and then using Asian regulatory and clinical infrastructures to accelerate early stage drug development. The start-up will develop the asset through Phase I to proof of concept using biomarker-driven strategies and incorporating a digital medicine approach, and then seek global partners for late-stage clinical development and commercialization.
A clear biomarker-driven clinical development strategy, the Aum team underscored, will accelerate trial timelines. “What it allows us to do is shorten the timelines for drug development and potentially require smaller studies, which, in turn, also saves time and money. As a consequence, we are able to deliver Phase III-ready drugs at a cost that are lower than in Western countries,” Doshi explained.
Crunching timelines, even if to a relatively limited extent, is something that industry could certainly embrace. IQVIA's oncology report noted that while many efforts have been in place to accelerate the time taken to bring a new cancer medicine to patients, the 2017 new drug approvals had a median time since patent filing of 14 years, just a tad faster than in 2013.
Aum believes that biomarker strategies need to be embedded in the early development plan for each compound, and clinical trials need to be designed to enable biomarker discovery and validation. Waiting to discover predictive biomarkers in Phase II or validate them in Phase III could be “very late.”
“Data suggests that a biomarker-driven strategy can improve a drug’s probability of success by up to three times. Aum will acquire targets with predefined biomarker strategies to improve the probability of success and to increase its overall portfolio value,” Doshi explained.
Aum Biosciences
Location: Singapore
R&D Focus: Small molecules backed by biomarker-driven clinical development
Disease Area: Oncology
Founding Date: June 2018
Founders: Vishal Doshi and Harish Dave
Employees: Core team of four employees; expects to expand the team with key focus on India, China, and Singapore
Financing To Date: SGD2.04m ($1.5m)
Investors: Founders/high and ultra-high net worth investors
Data-Centered Innovation
Aum expects to use digitalization to enable access to “smart data” and improve the patient management journey overall.
Digitalization and the use of artificial intelligence at a preclinical stage would allow Aum to identify drug-drug interactions, various toxicity signals and potential combinations early on. The start-up expects to partner with and invest in a variety of emerging technologies that could help make the drug development process “smarter, faster and cheaper.”
Doshi explained that in the early stages, data-centered innovation holds “great promise” to help the firm produce better treatments more efficiently.
“Biomedical sensors used by patients and physicians can provide valuable insights into treatment effectiveness and disease progression. Natural language processing, or computer understanding of human language, can help automate the management of millions of regulatory and safety documents each year,” Doshi said.
Aum believes advancements in AI will steer it toward more optimal personalized treatments for cancers, neurological and immunological disorders, as well as other challenging diseases.“Oncology drug development is at the cusp of disruption and Aum’s approach puts us at the forefront of the evolution in Asia,” Doshi declared.
Partnering With Research Institutions
Partnering with research institutions focused on Asian oncology innovation, global pharmaceuticals and large biotech companies is at the fulcrum of Aum’s business approach. The fledgling firm has already established a partnership with the National Cancer Centre Singapore (NCCS) and Centre for Cellular and Molecular Platforms in India (C-CAMP).
The collaboration with NCCS expects to employ precision and digital medicine techniques that can develop cancer drugs in a shorter time frame. It will combine NCCS’ PDX (Patient Derived Xenograft) laboratory model capabilities and knowledge on drug discovery with Aum Biosciences’ expertise in clinical drug development. PDX entails grafting of patients’ tumors onto mice, thereby creating valuable human cancer or PDX models. Different drugs can then be tested in these PDX models to evaluate their ability to inhibit tumor growth.
“By sharing our expertise and resources, our combined efforts will shorten the time it would normally take to test and develop new drugs, as well as to introduce safe and effective drug combinations,” Doshi maintained.
Aum is also keeping a close watch on ongoing developments in China. The start-up says it is keen to work with partners in Asia in the field of “genomically- defined cancers” and technology.
“China’s recent upward push on the innovation curve puts it in a unique position of becoming the Asian hub for globalizing high-quality oncology research. We believe that the recent regulatory reforms are all the indications towards making innovation affordable and expediting the process,” Doshi said.
Focus On Small Molecules
Importantly, however, Aum expects to stay focused on small molecules development, notwithstanding all the excitement around hot areas such as immuno-oncology research.
The current trend in immuno-oncology/large molecules and cell/gene therapy indicates that there is still a “significant component” of affordability that needs to be addressed, Doshi explained. The median annual cost of a new cancer drug launched in 2017 exceeded $150,000, compared with $79,000 for the new cancer drugs launched in 2013, as per data in the IQVIA report.
Aum’s strategy around having a small molecules focus “where the cost of goods are not very high," allows it to keep a control on the "actual cost of goods” while it conducts clinical trials and puts it in a position to achieve its mission of improving the affordability and accessibility to cancer drugs in Asia, he said.
The other business rationale , he added, is that the immuno-oncology trend could create a “great opportunity “for Aum to engage with pharma partners that have de-prioritized their small molecules assets from their pipeline.
In-Licensing Deal
For now, things seem to be working as per plan and at a fast clip. Late in 2018 Aum licensed its first novel highly selective anti-cancer drug, ETC-206, from A*STAR’s Experimental Therapeutics Centre (ETC). The Agency for Science, Technology and Research (A*STAR) is Singapore's lead public sector agency that spearheads economic-oriented research to advance scientific discovery and develop innovative technology.
Discovered and developed via a collaboration between ETC and the Duke-NUS Medical School (a partnership between Duke University School of Medicine and the National University of Singapore), ETC-206 moved into first-in-man trials in December 2016.
Initial studies have indicated that ETC-206 is “very well tolerated” and could be used as a therapy across a range of liquid and solid tumor types. A statement from the partners said that the drug promises a more targeted approach by inhibiting the MNK enzyme in cancer cells, which is a key player in promoting cancer growth when activated.
Aum said that it was speaking with investors to accelerate the development of ETC-206, and its broader molecule acquisition road map. “Aum will fund further clinical development and will be responsible for regulatory filings, and for clinical studies for this and future drugs,” Doshi said.
Focus On Creating Enterprise Value
Aum was officially launched in June 2018, with seed funding of SGD$2.04m ($1.5m) from its founders and a select group of high net worth and ultra-high net worth investors. The funds will be used to identify and acquire a specific number of oncology molecules by Q1 2019.
On whether Aum hopes to go public someday, Doshi said that it was a bit premature to comment on this aspect, but added that the firm was “observing the various trends in the public and private markets,” which will drive its commercial decisions in the future.
For now, though, Aum would like to “put its head down” and focus on creating and delivering "long-term enterprise value" by building a strong pipeline.