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Corporation
HEALTHCARE | Medical Devices & Equipment / Imaging & Diagnostic Equipment
sofie.com

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Founded Year

2008

Stage

Loan | Alive

Total Raised

$16.65M

Last Raised

$3.5M | 2 yrs ago

About Sofie Biosciences

Sofie Biosciences develops and manufactures molecular imaging systems for oncology and immunology research. The company produces imaging systems, probes, and radiochemistry platforms for research laboratories.

Sofie Biosciences Headquarter Location

6162 Bristol Parkway

Culver City, California, 90230,

United States

310-242-6794

Latest Sofie Biosciences News

08:00 ET SOFIE gets greenlight from U.S. FDA to proceed to Phase II Pancreatic Cancer Study

Nov 10, 2021

News provided by Share this article Share this article DULLES, Va., Nov. 10, 2021 /PRNewswire/ -- SOFIE Biosciences (SOFIE), an established US manufacturer and developer of radiopharmaceuticals, has received clearance to proceed with its Fibroblast Activation Protein Inhibitor (FAPI) clinical trial after completing a 30-day IND review with the FDA. The IND is for a Phase 2, Multicenter, Single Blind, Non-randomized Study of [68Ga]FAPI-46 PET for imaging patients with Pancreatic Ductal Adenocarcinoma (PDAC)1. The filing for the IND took place on October 8th and following the 30-day review by the FDA, it was deemed safe for SOFIE to proceed into Phase 2 trial implementation. This paves the way for SOFIE to pursue PDAC as an initial step for [68Ga]FAPI-46 clinical development in oncologic and non-oncologic indications. SOFIE's President & CEO,  Patrick Phelps  stated, "This approval concludes a series of productive meetings with the Agency. We greatly appreciate their guidance and feedback throughout this process. Every month new publications come out from academia showing the excitement around FAP targeted radiopharmaceuticals, so this IND approval is timely." Sherly Mosessian Ph.D, SOFIE's Vice President of Clinical and Regulatory Affairs added, "An active IND is a major milestone for SOFIE and the FAPI program. This IND and the Phase 2 trial will be the first key step in clinical development of [68Ga]FAPI-46 in the United States, and we are excited to partner with our collaborators to expand the utilization of this IND in pursuing other trials and indications." About SOFIE SOFIE's vision is to improve patient outcomes by developing and delivering molecular diagnostics and therapeutics (theranostics). With its robust radiopharmaceutical production and distribution network, mature contract manufacturing services, and now, high value theranostic intellectual property, SOFIE is poised to deliver on the promise of radiopharmaceuticals. For more information, contact  [email protected] . About Pancreatic Cancer Pancreatic cancer is an aggressive disease with a high mortality rate and challenging patient management due to conventional diagnostic options that may miss established or developing metastatic disease. Pancreatic cancer's aggressive nature is highlighted by 2021 estimates where 60,430 new cases are expected to be diagnosed in the US with an estimated 48,220 deaths from the disease2. In 2020 worldwide statistics revealed 495,773 new cases with 466,003 deaths3. At present, there is no screening or early detection test for pancreatic cancer that has been shown to reduce mortality from the disease. About FAPI Fibroblast Activation Protein (FAP)  is highly expressed in cancer associated fibroblasts (CAF) across several tumor entities. Quinoline-based PET tracers that act as FAP inhibitors (FAPI), developed by the team at the Heidelberg University Hospital (UKHD) and licensed exclusively by SOFIE, have shown encouraging results in pre-clinical and clinical studies. FAPI is an important diagnostic or therapeutic (theranostic) entity that can be deployed alone or in combination with other tumor-targeting therapies such as chemo, immunologic, radiation or cell-based therapies whose function may be otherwise blunted by the tumor stroma. About [68Ga]FAPI-46 [68Ga]FAPI-46 is the Gallium-68 radiolabeled PET tracer consisting of FAPI - 46 precursor small molecule critical drug intermediate consisting of a FAPI moiety conjugated with a DOTA chelator. This agent is currently optimized for production within SOFIE and its clinical trial partners and will be manufactured at its facilities as supply needs dictate. 1 [68Ga]-FAPI-46 is not currently approved in any jurisdiction including the United States and European Union. Contact:

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Expert Collections containing Sofie Biosciences

Expert Collections are analyst-curated lists that highlight the companies you need to know in the most important technology spaces.

Sofie Biosciences is included in 2 Expert Collections, including Medical Devices.

M

Medical Devices

7,884 items

Companies developing medical devices (per the IMDRF's definition of "medical device"). Includes software, lab-developed tests (LDTs), and combination products. *Columns updated as regularly as possible.

C

Cancer

3,605 items

Companies researching, developing, or offering products & services that aid in the screening, prevention, diagnosis, management, and treatment of cancer.

Sofie Biosciences Patents

Sofie Biosciences has filed 2 patents.

The 3 most popular patent topics include:

  • Chemical processes
  • Chemical reactions
  • Chemical synthesis
patents chart

Application Date

Grant Date

Title

Related Topics

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9/7/2017

3/17/2020

Chromatography, Fluid dynamics, Chemical synthesis, Chemical processes, Chemical reactions

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Application Date

9/7/2017

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Grant Date

3/17/2020

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