The Freenome Vallania Experience by Jessica Jones Croley, MD

The Freenome Vallania Experience

February 23, 2023

Jessica Jones Croley, MD

The Vallania Study

A Case Control Study for the Development of Multiomics Blood Tests for Cancer Screening

Study Background

Study Sponsor: Freenome

Study Name: The Vallania Study

Who is Freenome?

● A biotech company dedicated to developing next-generation blood tests to detect cancer in its earliest, most treatable stages

● First application is early detection of CRC with a routine blood test

● Conducted PREEMPT CRC, a 30,000+ participant registrational clinical study

● Part of a multi-cancer research program (built upon Project Danube feasibility study)

● Looks beyond tumor signals to detect the body’s early warning signs of cancer in blood.

Study Background

Study analyzes newly diagnosed cancer patients along with age and sex matched healthy controls.

Study Details

Intended use population: Age 30+ ~5400 treatment-naive participants

● ~2200 cancer participants (100-400 per cancer)

● ~2200 non-cancer participants

● ~1000 comorbidity participants (specific non-cancer chronic conditions or diseases)

Freenome Vallania Study Core Inclusion & Exclusion Criteria

Core Exclusion Criteria

Core Inclusion Criteria

(cancer & control cohorts)

Age ≥ 30 years of age within 30 days of enrollment

1. Solid organ or bone marrow transplantation

2. Any physical trauma or surgery requiring inpatient hospitalization in the 30 days preceding enrollment

3. Received a blood transfusion in the 30 days preceding enrollment

Able and willing to provide a blood sample per protocol

4. A medical condition which, in the opinion of the Investigator, should preclude enrollment in the study

5. Known to be pregnant

Able to comprehend and willing to sign and date the informed consent document(s)

6. Any therapy for cancer, including but not limited to surgery, chemotherapy, immunotherapy, and/or radiation therapy or any therapy that impacts the constituency of the blood sample, in the 5 years preceding enrollment

7. Participated or currently (up to collection of blood sample for this study) participating in a clinical research study in which an experimental medication has been administered during the 30 days preceding enrollment

8. Participated or currently participating in another Freenome-sponsored clinical study

9. Having Prospectively scheduled for dialysis or had a dialysis session in the 30 days preceding enrollment

Freenome Vallania Study Additional Inclusion & Exclusion Criteria

Control

Cohort

No additional criteria

Liver Cancer Subject must be diagnosed with HCC or have a presumptive diagnosis of or high clinical suspicion for HCC by imaging (e.g., CT, MRI) and have not yet received any cancer treatment (including but not limited to surgery, chemotherapy, and/or radiation)

Lung Cancer Subject must be diagnosed with pathologically-confirmed lung cancer (i.e., adenocarcinoma, squamous cell carcinoma, large cell carcinoma, small cell carcinoma) or have a presumptive diagnosis of or high clinical suspicion for the same by imaging (e.g., CT, MRI, PET) and have not yet received any cancer treatment (including but not limited to surgery, chemotherapy, and/or radiation)

Ovarian Cancer Subject must be diagnosed with histologically-confirmed serous or endometrioid ovarian cancer, fallopian tube cancer or primary peritoneal cancer, or have a presumptive diagnosis of or high clinical suspicion for the same by imaging (e.g., CT, MRI, PET or ultrasound) and have not yet received any cancer treatment (including but not limited to surgery, chemotherapy, and/or radiation)

Pancreatic Cancer Subject must be diagnosed with pathologically-confirmed pancreatic cancer (i.e., adenocarcinoma, acinar cell carcinoma, cystadenocarcinomas, and mucinous cystic neoplasms) or have a presumptive diagnosis of or high clinical suspicion for the same by imaging (e.g., CT, MRI, PET or ultrasound) and have not yet received any cancer treatment (including but not limited to surgery, chemotherapy, and/or radiation)

Freenome Vallania Study Additional Inclusion & Exclusion Criteria

Ovarian Cancer

Subject must be diagnosed with histologically-confirmed serous or endometrioid ovarian cancer, fallopian tube cancer or primary peritoneal cancer, or have a presumptive diagnosis of or high clinical suspicion for the same by imaging (e.g., CT, MRI, PET or ultrasound) and have not yet received any cancer treatment (including but not limited to surgery, chemotherapy, and/or radiation)

Pancreatic Cancer Subject must be diagnosed with pathologically-confirmed pancreatic cancer (i.e., adenocarcinoma, acinar cell carcinoma, cystadenocarcinomas, and mucinous cystic neoplasms) or have a presumptive diagnosis of or high clinical suspicion for the same by imaging (e.g., CT, MRI, PET or ultrasound) and have not yet received any cancer treatment (including but not limited to surgery, chemotherapy, and/or radiation)

Prostate Subjects must be diagnosed with prostate cancer, and have not yet received any cancer treatment (including but not limited to surgery, chemotherapy, biologic therapy, immunotherapy, and/or radiation therapy)

Thyroid Received Subjects must be diagnosed with cytologically-confirmed primary thyroid carcinoma and have not yet received any cancer treatment (including but not limited to surgery, chemotherapy, and/or radiation therapy)

Uterine Subjects must be diagnosed with histologically-confirmed uterine endometrioid carcinoma, uterine carcinosarcoma, or high grade serous carcinoma, or have a presumptive diagnosis of or high clinical suspicion of the above by imaging (e.g., CT or MRI) which will then be confirmed, and have not yet received any cancer treatment (including but not limited to surgery, chemotherapy, and/or radiation therapy)

Financial Budget Sample:

$1,500 per patient

$300 per Investigator

$1,200 site fees*

*Pre CSHRI fee

Study Strengths

Single visit

-Ease of consent and treatment completion (single visit) across Kentucky market of 6 cancer centers

Multiple tumor types

Both suspected and confirmed cases can be used

Challenges

Requires PRE-TREATMENT specimen

-Research team has forged new connections to pulmonologists, thoracic surgeons, colorectal surgeons for patient identification

-Sometimes awkward to discuss paid research opportunity at initial visit

Innovation of care delivery

-Time sensitive so as not to delay treatment start

-Consents and blood specimens have occurred in pre-operative area, various clinics outside the cancer center, infusion center

Need for healthy controls

-Research staff worked alongside our cancer center screening and prevention events to raise awareness for the study

-Developed a database of willing volunteers to “activate” after each cancer patient is enrolled.

Partnership Takeaways

-Connects industry with much needed patient samples at the source

-Has funded 2 FTE positions to be complement staffing provided by CSHIRI for cooperative group studies

-Incentivizes providers to participate in clinical research

Sincerest Thanks

CHI Saint Joseph Cancer Centers

Blazer

Bob O Link

Corbin

Flaget

London

Mount Sterling

CSHIRI Staff

Jane Green, PhD

Jennifer Kohlman - RN, BSN, CCRP

Dalton Lyons - CRA

Rachel Kiebler - RN, BSN, CRA

Tracie Carl-Nagel - RN, BSN, CCRC

Leila Scandrani - RN, BSN, CRA

Syed Zain Shah - CRA

Patients and Families