Industry News Update - Dec 11

VineHealth closed a $5.5 million seed round as it prepares to expand into the U.S.

• Headline: VineHealth combines behavioral health as well as AI to provide timely patient support and nudges. 
• Founders: The startup founded by 2 co-founders, Georgina Kirby has background in AI and the other Raynna Patel has behavioral science expertise.
• The science: Multiple studies show that systematic monitoring of patients using patient reported outcomes improves patient-clinician communication, clinician awareness of symptoms, symptom management, patient satisfaction, quality of life, and overall survival. Kirby (co-founder) points to evidence that when patients track their PRO data effectively, survival rates can increase by up to 20%. “Better self-management can have such a huge impact on survival,” she said. “We want to show not only improvements in survival but in quality of life. too.”
• The technology: 
• Vinehealth has built a content recommender system that is specialized in oncology and personalized to the patient: tuned to their diagnosis, adapting to their ongoing input, and factoring in content that other similar patients are reading and finding supportive.
• They use A/B testing and AI to configure personalized and timely recommendations to surface appropriate resources, as well as to determine how best to nudge and motivate patients to take medications and manage what can be complex medication regimes for cancer treatment.
• Notifications: There are a number of nudges in the app — some small ones, some bigger ones. We build medication nudges and reminders to be delivered in a certain way that is really effective and isn’t just dismissed by patients
• Vinehealth’s platform also acts as a channel through which patients can be remotely monitored by their clinicians as they provide feedback on symptoms and report any treatment side-effects.
• Future plans
• Use of more AI
• US expansion: Vinehealth is gearing up for growth via a U.S. launch — which it hopes will happen “early next year”
• Aggregated Insights: VineHealth can provide “properly anonymized” data sets based on purely aggregated insights provided by patients — so it might, for example, be able to highlight demographic groups that experience particular side effects of certain drugs.
• More funding: Plan for series A in next 12 to 18 months.
• Other notes:
• Patient-centric positioning: The user (patient) data is not shared with anybody unless they have given explicit consent to do that. By just signing up to the platform, they’re NOT consenting to sharing their data as part of a clinical trial. That is a completely separate piece of consent 
• Customer segment
• Oncology patients in UK and Ireland.
• Who pays?
• The patient-support app is offered free for cancer patients to download themselves currently available in the U.K. and Ireland.
• For pharma, Vinehealth provides its platform as a software as a service — supporting drug companies in recruiting patients for trials and gathering PRO to help with R&D and drug development.
• Analysis
• Starting a company backed by scientific evidence provides a good foundation. PROs certainly seems like a highly valuable method for conducting clinical research. However the particular research quoted here seem a little far fetched. If using digitized PROs efficiently can make up to 20% difference in survival outcome then it basically says all the trials conducted so far without proper PROs have noisy data, including some of the approved therapies as well as countless failed trials.
• Overall there is a good story. Each founder has their area of expertise which is crucial to solve the problem. They proved their tech on small scale and now wants to expand.
• Like social media business models, the users are not the payers here. By providing free access to useful personalized information the user acquisition become easier. Once there is significant user base there are multiple ways to commercialize it and VineHealth wisely chose the pharma companies to start with hoping it can help them with patient recruitment.
• The therapeutic area chosen by VineHealth makes sense since Oncology research is the most active therapeutic area, with more than 10,000 drug programs in process, accounting for 18% of all development programs, according to BioPharm Insight.

California-based biotech company Freenome raised a $300 million Series D

• Headline: The Freenome platform uses machine learning artificial intelligence to analyze multiomics (genomic, transcriptomic, methylomic and proteomic) data in a routine blood draw to spot the earliest signs of cancer, including biological signals derived from both tumors and non-tumor sources.
• Founders: The startup founded by a team of 4 
• Charles Roberts
• Gabriel Otte
• Michael Otte
• Riley Ennis
• The science (source):
• Current cancer screening methods are often invasive, inconvenient, expensive, and/or have suboptimal clinical performance (i.e., sensitivity or specificity), particularly for early-stage disease and precancerous lesions
• Recently, blood-based screening tests for cancer have been proposed in an effort to address some of the aforementioned challenges. One key area of both academic and commercial interest is circulating cell-free DNA (cfDNA), which includes both tumor-derived DNA (so-called “circulating tumor DNA”, or ctDNA) and DNA derived from non-tumor cells, such as hematopoietic and stromal cells.
• There are two different approaches to detect circulating tumor DNA (ctDNA) in liquid biopsies. Whole-genome methylation was recently approved by the FDA for early cancer detection based on the results of the Circulating Cell-free Genome Atlas study (CCGA; NCT02889978). In the validation study assessing this methylation-based multi-cancer early detection (MCED) test, specificity was shown to be 99.5% for both solid and hematological tumors. Sensitivity was shown to increase with stage, with a 16.8% sensitivity for stage I tumors. Fragmentomics is another approach used for early cancer detection based on the DELFI approach (DNA evaluation of fragments for early interception) which uses whole genome sequencing (WGS) to determine cell-free DNA (cfDNA) fragmentation profiles across the genome. The specificity of this approach is 80%. Importantly, this method has the potential to be used as a screening mechanism for high-risk populations. 
• Then there are other methods for early cancer detection including analysis of circulating tumor cells (CTCs), metabolomics and microRNAs (miRNAs). 
• In the future, it is likely that a multi-omics approach using several of these technologies simultaneously will be used to achieve a satisfactory specificity and sensitivity. As per an interview of Christian Rolfo, MD, PhD, Icahn School of Medicine at Mount Sinai at the World Conference on Lung Cancer (WCLC) 2021.
• Freeome's machine learning approach using cfDNA achieved high sensitivity and specificity in a large, predominantly early-stage, colorectal cancer cohort.
• The progress:
• A previous study, dubbed AI-Emerge, found that the test demonstrated 94% sensitivity and specificity in detecting stage 1 and 2 colorectal adenocarcinoma, and 91% sensitivity in spotting later-stage cancers.
• The company’s first test, for colorectal cancer, is now in the clinical testing stage. Enrollment is currently wrapping up for the Preempt CRC validation study, which aims to study the blood samples of 25,000 patients between the ages of 45 and 85 who are at average risk of contracting colorectal cancer and have no symptoms of the disease.
• Freenome is already beginning to develop other tests on the liquid biopsy platform. Results of a retrospective study presented in September showed that its blood test looking for signs of pancreatic cancer in both DNA methylation and the carbohydrate antigen 19-9 (CA19-9) was able to detect stage 2, 3 and 4 cancer with 93% sensitivity, outperforming the only currently FDA-cleared test for monitoring pancreatic cancer, which looks solely at CA19-9 signals.

• Future plans
• 
  
• Other notes:
• 
  
• Customer segment
• Colorectal cancer screening in high-risk patients (current)
• Pancreatic cancer (near future)
• Other tumors (future)
• Who pays?
• The financial reasoning here is, if the cancer is detected at early stage then it not only saves lives but lot of procedural ad financial overload down the line. Hence payers would be highly interested in this.
• That is likely why companies like Freenome are aiming to build these partnerships with payers.
• Competition
• The table below lists some of the companies working to create non-invasive liquid-biopsy based early cancer detection tests. The recent funding round certainly puts Freenome in the top-tier position to continue the development of this innovative approach.
• However that doesn't change the fact that some competitors have tests in market which are approved by regulators whereas Freenome doesn't as of now.
• Also, all top-tier companies are based in California creating stiff competition for local partnerships, finding talent and additional funding.

Company	Founded in	Location	Funding	Comments
Grail	2016	San Frasisco, CA	$2B	- acquired by Illumina - develops a pan-cancer screening test designed to detect cancers at an early stage.  - Its pan-cancer screening test measures circulating nucleic acids in blood using high-intensity sequencing, population-scale clinical trials
Freenome	2014	San Frasisco, CA	$807M	- developing a simple blood test to detect early-stage cancer and make treatments more effective  - provides a platform that helps designhealthy conditions for an individual based on his/her cell-free genome
Guardat health	2014	Redwood City, CA	$550M	- although Guardant Health positions itself as a platform more than early cancer detection services, the diagnostic tests are core part of it's business. - the tests are based on blood drop (liquid biopsy)
Thrive Detect	2019	Cambridge, Massachusetts	$367M	- It develops CancerSEEK, a liquid biopsy test that is designed to detect many cancers at earlier stages of the disease.  - CancerSEEK will serve as the core of Thrive’s integrated cancer information offering.
RainDance Technologies	2004	Greater Boston Area	$164	- acquired by BioRad - The company’s ultra-sensitive genomic tools enable better research of novel non-invasive Fluid Biopsy™ applications that should result in more accurate, reliable, cost-effective and early detection of cancer
IMB Dx	2018	Seoul, South Korea	$28	- liquid biopsy platform AlphaLiquid® is designed for early & advanced cancer patients for the purpose of accurate tumor profiling, therapy selection, recurrence monitoring, and early cancerdetection. - proprietary technology detects and analyzes trace amount of circulating tumor DNA (ctDNA) from a single draw of blood.
SAGA	2016	Lund, Sweden	$18	- SAGA Diagnostics AB is a personalized cancer diagnostics and disease monitoring company focused on molecular genetic analyses of a powerful cancer biomarker: circulating tumor DNA (ctDNA).  - mission to improve precision cancer medicine,provide more accurate treatment monitoring, and improve patient survival using minimally-invasive liquid biopsy cancer testing services and kits.
OncoCyte	2009	Irvine, CA	$8.30	- a biotechnology company that focuses on the discovery, development, and commercialization of novel, non-invasive, liquid biopsy diagnostics for the early detection of cancer. The company's mission is to provide actionable answers to physicians and patients at critical decision points along the lung cancer care continuum, tooptimize diagnosis and treatment, improve patient outcomes, and reduce the overall cost of care.
OxCan	2018	Oxford, UK	$1.50	- OxCan is a startup that uses machine learning and liquid biopsy for early lung cancer detection.

• Analysis
• In last decade there have been a lot of startups focusing on the early cancer detection using liquid biopsy and now it has became a crowded space with some well funded companies focusing on solving the problem. So it is very likely the success might boil down to scientific advancement, robust validation and strategic partnerships with payers. 
• With Immuonnotherapies a heavy focus have been on getting better treatments. More recent advancements like CAR-T also give some additional edge. But it is time to make this flight against cancer multi-pronged. It might look like earlier detection + better therapies + precise monitoring. With earlier detection some of the existing treatments might provide a better survival rate.
• Liquid biopsies have several technical challenges still to overcome, but could unlock a $150 billion market for preventative cancer screening as per the research of Motley Fool's lead adviser Simon Erickson.