iLoF - Intelligent Lab on Fiber

iLoF is working to enable a new era of personalized medicine, by using AI and photonics to build a cloud-based library of diseases biomarkers and biological profiles.

During our seed round (2019), we conducted a thorough feasibility study involving over 100 stakeholders from over 15 countries to determine what the drug discovery industry’s largest pain points were, and how iLoF could generate optimal added value.

Following this, we were able to establish partnership/commercial relationships with more than 15 stakeholders from 4 continents (hospitals, biotechs and pharmas), with the goals of both:

- Have commercial validating projects
- Generate early renevue
- Accelerate the growth of our data-set (increase and populate our cloud-base library with fingerprints of a growing number of disease biomarkers and biological profiles)

We are also piqued the interest of several large pharmaceutical players.

Beachhead market Drastically reduce the cost and time of drug discovery / development
1) Pre-screening tool
E.g. With global Pharmas and biotechs to choose the right people for clinical trial according to their biological profiles and phenotypes, help assure homogeneous cohorts
2) New-drug tracking tool
Understand if a specific clinical trial is having the desired effect in patients, by tracking the changes over time in their blood optical fingerprints. Assess treatment efficacy easily, providing a tool to help decided when to kill a dead-end trial
3) Drug discovery platform:
Unlock the power of data from current and previous cohorts, and discover new biomarkers, and new targets, based on the biological profile of the super-respondents on the trials

Future vision:
3) Companion diagnostic:
Once a treatment reaches the market, we will be in a unique position to supply consumers with a companion diagnostics tool - that is able to provide the right treatment to the right patient.

4) Screening / Risk score:
iLoF will gradually be a substitute for the invasive and expensive techniques (e.g. PET-CT scan and CSF), providing screening, clinical prognosis tools in an affordable, non-invasive, label-free way
E.g. With leading Hospitals to pre-screen people for rare or heterogeneous diseases, in a fast, comfortable way, based on certain biological profiles

PROBLEM:
Many of the diseases for which there is no treatment are heterogeneous, complex diseases, in which the same treatment does not work homogeneously for the entire population. Tools are needed to stratify the population based on their different biological profiles, and thus allow the development of appropriate treatments for each profile.
However, personalized drug development is still a challenge. In recent years, many large-scale clinical studies have been suspended or even canceled, due to lack of promising results or budget/risk issues. This has happening for many neuro-degenerative diseases, and especially in Alzheimer's.
On Alzheimer's disease alone, for the past 14 years, more than 400 clinical studies have failed with no approved disease modifying treatment, much due to:
- Poor biological knowledge
- The heterogeneous nature of the disease,
- Severe challenges of running clinical trials

PROBLEM (Alzheimer's):
Per year, just the top 4 pharmaceutical companies spend over €400M in screening for Alzheimer's clinical trials.
90% of initially enrolled patients leave the clinical trials due to issues with invasive, expensive, inconvenient testing (PET Scan, CSF biomarker analysis). And worse, from the remaining 10%, 80% are discarded after expensive screening.
This screening phase has a cost of over €2k/patient, so the majority of money is spent on people that are later eliminated from the trial due to a lack of fit with the trial criteria.
This makes drug discovery for Alzheimer’s disease twice more expensive than the average ($5.5B vs the average of $2.7B). Due to these problems, many potential effective drugs are abandoned.
Thus, there is a need for tools that make the drug development experience more humane and convenient for the patients, while drastically making the whole process more efficient and flexible for the industry.

BOILERPLATE:

iLoF is using a patented platform technology, based on AI and photonics, to build a digital library of nano-scale diseases biomarkers and biological profiles.
We collect "fingerprints" from nano-scale structures in blood and provide personalized, screening and stratification tools in an affordable, fast, portable way.
This transforms drug discovery for heterogeneous diseases like Alzheimer's,making it comfortable for the patient/efficient for the industry.

HOW IT WORKS:
We use bodily fluids (e.g serum, plasma) to collect and store both biomarkers of different diseases, as well as personalized biological profiles of different types of patients.
With this cloud-based database (which can be compared to a fingerprint file), it is possible to offer inexpensive, portable, non-invasive screening and stratification tools that can be used to recruit patients for clinical studies in a inexpensive and efficiently way for the industry, while conveniently for the patient.

VALUE PROPOSITION:
We save up to 40% of the total costs for screening and 70% of the time spent screening for clinical trials.
By providing a blood-based tool, we transform the patient experience and make trials convenient and patient-centric. This also enables to check from the initial moment of recruiting if patients that enroll the clinical trial do have the right biological profile for the study.

iLoF is an unique platform, with an innovative approach capable of tackling various use cases.

On our beachhead market (severely cutting the cost and time spent recruiting patients for clinical trials), the techniques used to screen patients for trials can mainly be divided into imaging techniques (PET and MRI) and laboratory techniques (analysing blood or CSF using assays like ELISA).

Tacking our Alzheimer's vertical as an example:

While PET can detect Aβ plaques, their amount isn’t well-correlated with the cognitive function of the patient.
MRI doesn’t use a tracer, and hence cannot identify the composition of plaques (protein aggregation is a feature of several NDDs).
Antibody-based assays can only identify and quantify a given target and the sample is consumed during analysis. Fully automated immunoassays have been developed by several vendors with improved reliability and precision for CSF Aβ and tau species.

Using our label-free and agnostic technique, information is generated on a blood-derived samples as a whole, but without consuming it. Analysis can be continued using other laboratory techniques, or frozen
and reused.

Other relevant approaches for detecting amyloid (only one possible AD biomarker) are:

• MS (Mass Spectroscopy): Can perform absolute quantification of biomarkers. Shimadzu Amyloid MS™ Service offers to make AD predictions for drug discovery using blood samples.
• Fluorescence: Cognoptix Inc have patented a method in which a fluorescent signal is detected in the eye from an amyloid-binding compound (Aβ peptides and aggregates thereof can be found in the supranucleus of the lens of the eyes of people with AD).
• Flow cytometry and fluorescence resonance energy transfer (FRET): detection of Aβ in CSF has been shown to be possible using this multiparametric approach and shown to be highly sensitive.
• Calorimetry: A nanoparticle-based colorimetric sensor array has been developed by researchers to monitoring the ratio of β40 Aβ42 peptides. The sensor array had the capability to identify structurally similar Aβ peptides in human plasma samples.
• Thin gold film biosensor: researchers have developed a thin gold film biosensor for quantified determination of Aβ42 in human serum. The sensor is disposable, cost-effective, and time-efficient. Estimated production cost (including antibody) is under €3. Test time only requires 30 s.
• Field Effect Transistor (FET) biosensor: Another group have developed a biosensor for detection of amyloid-β fibrils in biological environments using a azo-dye immobilized FET biosensor.
• Surface-enhanced Raman spectroscopy: researchers have developed a technique to detect the conformational transition of Aβ from a predominantly α-helical structure to β-sheet using a nanofluidic biosensor using controlled, reproducible surface enhanced Raman spectroscopy.

The key selling point of our services focus on solving the largest pain point of our immediate targeted users: the bottleneck created in the patient recruitment process, where invasive procedures, and time delays caused by cumbersome tests and high cost are strongly prohibitive clinical development programs.
Taking Alzheimer as an example: it is a very heterogeneous disease. It is estimated that less than half of AD patients have pure AD – the majority suffer from mixed dementias.
The complexity of the disease leads to the exclusion of about 80% of all screened patients to stratify a desired patient cohort for a novel, tailored therapy.

We will generate cost saving in the millions per trial by avoiding expensive procedures like PET scans and lumbar punctures on patients that will be excluded from trials.

Our key selling points are:
• Cost-saving (pricing model guarantees cost savings for clients) and rapid (<10 seconds per scan)
• Reproducible and accurate (specificity and sensitivity both over 90%)
• Minimally invasive and simple (work on fluid biosamples such as plasma or serum)
• Agnostic and label-free (works both on current gold standard biomarkers, as in future targets)
• Non-destructive (samples can be reused, and analysis can be done on thawed samples)
• Rapid, portable test (< 30 seconds, can be done centralized or locally)

PRE-SCREENING MODEL:

We have a service based approach, with an industry validated dynamic pricing model that is essentially a win-win for both iLoF and our partners.

We only use photonics/light and AI in our test, so our operating costs are quite low.
For this reason, our pricing is directly related to the money we save the healthcare companies.

It is a Fixed Fee + Variable fee (per “positive”), where most of the revenue is created when value for the client exists (If no money is saved, the test is mostly free).

The pricing is adaptable to each trial and situation, calculated based on a formula developed with the inputs of:
- Base cost per extensive screening (PET, etc)
- Current usual inclusion rate (% of people discarded after screening - e.g. 80% on Alzheimer's disease)

As an example, when we successfully stratify 1500 patients to a clinical trial using our system, we save 6M € to a clinical trial, we keep 2M € for ourselves.

Drug Discovery Model:

- Biomarker validation, trial tracking: Platform fee (per month, per user)
- New targets discovery: Platform fee (per month, per user) + Royalty/Shared IP on new targets discovered (milestone based, according to the R&D evolution)

We have a healthy runway, which was the result of raising 3.1M USD in the last 12/15 months.

However, we are aiming to a pre-series A raise, mostly focused at:

A) Push for a larger production contract with one of the Pharmas we are currently engaged, and respond to the current traction we are experiencing

B) Get strategic investors onboard, that can accelerate our activities

Former:

Google for Startups UK Program

Currently:

Oxford Foundry (University of Oxford accelerator)
Microsoft for Startups

iLoF has received incredible traction over the past year, and has been the recipient of multiple awards, including:

• Selected by Forbes as 30 under 30, for Science and Healthcare, class of 2020
• Selected by CB Insights as one of the Top 150 Digital Health companies in the world
• 1st place, Melinda Gates' Deeptech Female Founder’s (Best Deep Tech Company)
• 1st place, Mckinsey & Google Digital Top 50 (Best technology)
• 1st place, European Institute of Technology Jumpstarter
• 1st place, Altice International Innovation awards
• 1st place, Startup World Cup UK
• 1st place, Infoshare Tech
• 1st place, Rockstart Digital Freedom Fest Awards (Future Unicorn)
• 2nd place, Roche's Neuro-science Building Tomorrow Together
• Top 7, Financial Times & IFC Transformational Business Awards (Health, Wellness and disease prevention)