Metastatic Colorectal Cancer
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Accelerating Metastatic Colorectal Cancer Drug Development

Cancer, particularly colorectal and metastatic forms, presents significant therapeutic challenges due to its complexity, heterogeneity, and resistance to conventional treatments. Alfa Cytology stands as a specialized partner in the preclinical development of novel therapeutics targeting cancer, with a focus on colorectal and metastatic indications. Alfa Cytology delivers a comprehensive suite of preclinical services spanning target validation, lead optimization, pharmacology, safety assessment, and IND-enabling studies. Our scientific team brings deep expertise in oncology biology, advanced in vitro and in vivo modeling, and translational research, supported by state-of-the-art platforms and robust analytical technologies. Stringent adherence to global regulatory standards ensures the generation of reliable, decision-enabling data for every program. By integrating scientific rigor with innovative methodologies, Alfa Cytology empowers biopharmaceutical partners to de-risk and accelerate their oncology pipelines. Our unwavering commitment is to advance therapeutic breakthroughs that address the unmet needs of patients with cancer, colorectal, and metastatic disease.

What is Metastatic Colorectal CancerTargets for Metastatic Colorectal CancerDrug Discovery and Development ServicesWhy Choose Us

What is Metastatic Colorectal Cancer

Metastatic colorectal cancer (mCRC) is a form of colorectal carcinoma in which malignant cells have spread from the primary tumor in the colon or rectum to distant organs, most commonly the liver, lungs, and peritoneum. The disease arises through a series of genetic and epigenetic alterations, including mutations in tumor suppressor genes (such as APC and TP53) and activation of oncogenes like KRAS and BRAF, leading to uncontrolled cell growth and metastatic potential. The metastatic process involves local invasion, entry into the bloodstream, survival during circulation, and colonization of distant tissues. Risk factors include age over 50, family history, certain hereditary syndromes, inflammatory bowel disease, obesity, smoking, and high consumption of red or processed meats. Clinically, mCRC presents with symptoms such as abdominal pain, altered bowel habits, weight loss, fatigue, and, in advanced cases, organ dysfunction. Diagnosis relies on clinical assessment, laboratory tests, and imaging studies such as CT and MRI to determine the extent of disease, with colonoscopy and biopsy confirming the diagnosis. Molecular profiling, including testing for KRAS, NRAS, BRAF mutations, and microsatellite instability, guides targeted therapy. Treatment typically involves systemic chemotherapy, targeted agents like bevacizumab, encorafenib, and fruquintinib, and immunotherapy (e.g., nivolumab) for select patients. Surgical resection or local therapies may be considered in cases with limited metastatic spread.

Launched Drugs

Structure Generic Name CAS Registry Number Molecular Formula Molecular Weight
bevacizumab
bevacizumab; bevacizumab-bvzr
bevacizumab; bevacizumab-awwb
encorafenib (Rec INN; USAN) 1269440-17-6 C22 H27 Cl F N7 O4 S 540.011
fruquintinib (Rec INN; USAN) 1194506-26-7 C21 H19 N3 O5 393.393
binimetinib (Rec INN; USAN) 606143-89-9 C17 H15 Br F2 N4 O3 441.227
bevacizumab; bevacizumab-nwgd
nivolumab (Rec INN; USAN) 946414-94-4
ramucirumab (Prop INN; USAN) 947687-13-0
trifluridine/tipiracil; trifluridine/TPI

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Targets for Metastatic Colorectal Cancer

Targets in Clinical or Later Phases of Development

Target Name Gene Symbol
ATP binding cassette subfamily B member 1 ABCB1
B-Raf proto-oncogene, serine/threonine kinase BRAF
cytotoxic T-lymphocyte associated protein 4 CTLA4
dihydropyrimidine dehydrogenase DPYD
fms related receptor tyrosine kinase 4 FLT4
Fibroblast Growth Factor Receptor (FGFR) (nonspecified subtype)
epidermal growth factor receptor EGFR
DNA topoisomerase I TOP1
fms related receptor tyrosine kinase 1 FLT1
Folate Receptor (nonspecified subtype)

Metastatic colorectal cancer (mCRC) is driven by a diverse array of molecular targets that play crucial roles in tumor progression, metastasis, and resistance to therapy. Key oncogenic signaling proteins such as EGFR and BRAF orchestrate cell proliferation and survival through the MAPK/ERK pathway, with downstream effectors MAP2K1 and MAP2K2 further amplifying these signals. Drug resistance and altered metabolism are mediated by ABCB1, a transporter that effluxes chemotherapeutics, and DPYD, which metabolizes 5-fluorouracil, directly impacting treatment efficacy and safety. DNA replication and repair are influenced by TOP1, the target of irinotecan, while angiogenesis and tumor microenvironment remodeling are driven by VEGF receptors (FLT1, FLT4, KDR), facilitating tumor vascularization and metastatic spread. Immune evasion is enabled by checkpoint proteins PDCD1 (PD-1) and CTLA4, which suppress anti-tumor immune responses and allow cancer cells to escape immune surveillance. Therapeutically, these targets have shaped the landscape of mCRC treatment. Anti-EGFR antibodies and BRAF/MEK inhibitors have improved outcomes in molecularly selected patients, while anti-angiogenic agents targeting VEGF pathways (e.g., bevacizumab, ramucirumab) are standard in advanced disease. Immunotherapies blocking PD-1 and CTLA4 have demonstrated durable responses in mismatch repair-deficient or microsatellite instability-high mCRC subsets, leading to regulatory approvals. Biomarker-driven approaches, such as RAS/BRAF genotyping and DPYD screening, enable personalized therapy and toxicity mitigation. Ongoing research continues to explore novel combinations and resistance mechanisms, supporting the evolution of precision medicine strategies in mCRC.

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Drug Discovery and Development Services

In Vitro Efficacy Testing ServicesIn Vivo Model DevelopmentPK/PD Study ServicesIn Vivo Toxicity Assessment ServicesBiomarker Analysis Services
In Vitro Efficacy Testing Services

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Our In Vitro Efficacy Testing Service accelerates metastatic colorectal cancer drug discovery by providing robust, sensitive screening and mechanistic profiling of candidate therapies. Utilizing advanced methodologies such as ATP, chemiluminescent, flow cytometry, ELISA, FACS, HTRF, and surface plasmon resonance assays, we assess drug potency, efficacy, and selectivity across key cancer targets including EGFR, VEGF, RAS, BRAF, PD-1/PD-L1, and Wnt/β-catenin pathways. Comprehensive parameter measurement (IC-50, EC-50, Kd, MIC, MEC) enables informed candidate prioritization and dosing optimization, delivering actionable insights that drive the development of targeted and immunotherapeutic strategies for metastatic colorectal cancer.

B-Raf Proto-Oncogene, Serine/Threonine Kinase Cytotoxic T-Lymphocyte Associated Protein 4
Dna Topoisomerase I Epidermal Growth Factor Receptor
Fms Related Receptor Tyrosine Kinase 1 Fms Related Receptor Tyrosine Kinase 4
Kinase Insert Domain Receptor Kit Proto-Oncogene, Receptor Tyrosine Kinase
Programmed Cell Death 1

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Why Choose Us

Choosing Alfa Cytology means partnering with a team that is deeply committed to advancing the field of cancer therapeutics, with a particular focus on colorectal, metastatic cancers. At Alfa Cytology, our specialized expertise in cancer, colorectal, metastatic research and drug development sets us apart. Our professional teams are composed of experienced scientists and clinicians who utilize advanced technology platforms to deliver robust and reliable preclinical drug development services. Alfa Cytology has built a strong track record for reliability, consistently providing clients with high-quality data and insightful analysis that accelerate the path from discovery to clinical development. We adhere to the highest quality standards and maintain strict regulatory compliance at every stage of our processes, ensuring that all studies meet global requirements. Alfa Cytology is dedicated to supporting our clients’ missions to bring innovative and effective therapies to patients in need. By choosing Alfa Cytology, you are selecting a partner who values professionalism, scientific rigor, and a genuine commitment to advancing cancer, colorectal, metastatic therapeutics.

FAQs for Our Services

Q: What are the main preclinical research challenges specific to developing drugs for metastatic colorectal cancer?

A: Metastatic colorectal cancer presents unique preclinical challenges, including the need for robust in vitro and in vivo models that accurately recapitulate the metastatic process, tumor microenvironment, and genetic heterogeneity seen in patients. Developing models that reflect organ-specific metastasis, such as liver or lung, is critical for evaluating therapeutic efficacy and pharmacodynamics. Additionally, resistance mechanisms and tumor plasticity require comprehensive characterization to inform lead optimization.

Q: What are the key regulatory considerations in preclinical development for metastatic colorectal cancer therapeutics?

A: Regulatory agencies such as the FDA and EMA require rigorous preclinical data that demonstrate safety, proof-of-concept efficacy, and a clear rationale for clinical translation. For metastatic colorectal cancer, this includes validated animal models, robust pharmacokinetic and toxicology studies, and adherence to GLP standards. Early engagement with regulators is recommended to align on requirements for Investigational New Drug (IND) submissions, especially for novel modalities or first-in-class agents.

Q: What technical aspects should be considered when designing preclinical studies for metastatic colorectal cancer drugs?

A: Technical considerations include the selection of relevant cell lines and patient-derived xenograft (PDX) models, incorporation of biomarker analysis to track drug response, and the use of imaging modalities to monitor metastatic burden. It is also important to design studies that assess both primary tumor and metastatic site responses, evaluate combination therapies, and employ advanced molecular techniques such as single-cell sequencing to understand drug mechanisms and resistance.

Q: What are the typical timeline and cost considerations for preclinical development of metastatic colorectal cancer drugs?

A: Preclinical development timelines for metastatic colorectal cancer therapeutics typically range from 12 to 24 months, depending on the complexity of the program and regulatory requirements. Costs can vary significantly, with comprehensive programs—including efficacy, safety, PK/PD, and toxicology studies—ranging from $2 million to $6 million. Early planning and efficient study design are essential to optimize both timeline and budget.

Q: What are the critical success factors in preclinical development of drugs for metastatic colorectal cancer?

A: Success in preclinical development hinges on selecting predictive models, generating robust and reproducible data, and establishing clear translational endpoints. Close collaboration with clinical experts, early identification of biomarkers, and a strong understanding of the disease biology all contribute to de-risking the program. Regulatory compliance, transparent communication, and flexibility to adapt to new findings are also key to progressing candidates efficiently toward clinical trials.

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