Our Science

State-of-the-art science driving disruptive small molecule drug, biologic drug and drug delivery, and companion diagnostic programs.

CCM RAS Sciences CCM PROTAC Sciences CCM Immune Sciences CCM Protein Upregulation CCM Nanothera Sciences CCM 5Prime Sciences

CCM 5Prime Sciences



Oncology and Autoimmune Companion Diagnostic (CDx) Pipeline

TARGET MUTATION
COMPANION THERAPEUTICS
Cdx IP
HIT-TO-LEAD
LEAD OPTIMIZATION
IND ENABLING
CLINICAL
KRAS G12V
CCM-001
CCM-MRX
1. Bias-free NGS
2. FADS PCR
1. Bias-free NGS
2. FADS PCR
ROS1 / Trk Fusions
CCM-TRX
1. Bias-free NGS
2. FADS PCR
FLT3 Fusions
CCM-FLX
1. Bias-free NGS
2. FADS PCR
EGFR: 1. T790M/L858R 2. T790M/L858R/C797S 3. T790M/Exon 20 4. T790M/del19/C797S
CCM-EGX
1. Bias-free NGS
2. FADS PCR
EGFR: 1. EGFRvIII 2. EGFR overexpression
Fast, robust FADS PCR
Panel of 134 Fibrosis-associated Genes
CCM-7314, CCM-7560
Bias-free NGS


Prenatal IVD Pipeline

TARGET MUTATION
COMPANION THERAPEUTICS
Cdx IP
HIT-TO-LEAD
LEAD OPTIMIZATION
IND ENABLING
CLINICAL
Preimplantation embryo aneuploidy
CCM-SRX
Noninvasive pre-implantation genetic testing
Triplet Repeat Disease (Autism-Fragile X)
NA
Nonsense Mutation
CCM-848,914,930 (Codagen)
Highly processive polymerase + GC-rich PCR

  • Ultrahigh-throughput Enzyme Engineering Platform & New Platforms for ddPCR & NGS Based Diagnostic Tests

Products:

  • Novel polymerases for IVD tests, gene therapy manufacturing, and synthetic biology applications (enzymatic DNA synthesis).
  • Biomarker tests for selecting patient populations in clinical trials.

Enzyme Engineering & Biocatalysis Technology Capabilities:

  • Enzyme engineering using ultrahigh-throughput droplet microfluidics.
  • Upstream processing: Proteins/biologics production by fermentation; Nucleic acids production by biocatalysis.
  • Downstream processing : Purification, scale-up and characterization.
  • Antibodies, bioconjugates manufacturing.
  • A biologists team dedicated to produce, purify and characterize proteins.
  • A dedicated laboratory to perform molecular biology and enzyme engineering, production and characterization.
  • Integration with computational biophysics and machine learning methods to accelerate optimization of enzyme designs beyond directed evolution alone.

Application:

  • Production and characterization of proprietary polymerase enzymes, used in PCR technology, DNA sequencing and enzymatic DNA/RNA (gene therapy) manufacturing
protac

DNA Biotechnology Platform:

  • DNA Biotechnology is the basis for all forms of synthetic biology and genetic diagnostics. 5Prime’s genetic engineering platforms provide disruptive capabilities in both areas.
  • Target applications include detection of genetic mutations in blood, manufacturing of gene therapy APIs, and enzymatic DNA synthesis.
  • Commercialized patent portfolio in DNA Biotechnology has generated over $30 million annual revenue for licensees such as Celera, Quest Diagnostics, New England Biolabs.
  • 5Prime is the exclusive licensor of these patents, which enable the sequencing of otherwise intractable genes.

New Platforms for In-Vitro Diagnostic Tests:

NGS is the modern gold standard for simultaneously testing for mutations and associated copy numbers of multitudes of genes from blood, simultaneously ddPCR has many applications, such as

  • Rare allele detection
  • Copy number variation
  • Pathogen detection
  • Quantification of Next-Generation sequencing libraries
  • Gene expression heterogeneous samples
  • Multiplexing
  • Quantification of viral DNA
  • Non-invasive pre-natal diagnosis
  • Detection of mutants in free circulating DNA

Next Steps, Key Milestones & Funding Required:
Preclinical development of NGS and ddPCR liquid biopsy tests.