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Accelerating Kidney Drug Development

Cancer and kidney diseases present complex therapeutic challenges, demanding innovative solutions and rigorous scientific validation. Alfa Cytology is a specialized partner in preclinical drug development, dedicated to advancing novel therapies for oncology and kidney indications. Our integrated preclinical platform spans the entire drug discovery continuum—from target validation and mechanism-of-action studies to comprehensive IND-enabling toxicology and pharmacology. Alfa Cytology’s scientific team brings deep expertise in cancer biology and renal therapeutics, leveraging state-of-the-art in vitro and in vivo models, high-content screening, and advanced biomarker analysis to generate robust, translatable data. Our operations adhere to the highest standards of regulatory compliance, ensuring data integrity and alignment with global regulatory expectations. By combining scientific rigor with advanced technology and regulatory insight, Alfa Cytology accelerates the path from discovery to clinical development. We are committed to empowering our partners with actionable data and strategic guidance, driving forward the development of effective therapies for patients with cancer and kidney disease.

What is KidneyTargets for KidneyDrug Discovery and Development ServicesWhy Choose Us

What is Kidney

Kidney disease encompasses a range of disorders affecting the structure and function of the kidneys, including chronic kidney disease (CKD), acute kidney injury (AKI), glomerulonephritis, polycystic kidney disease, and renal cell carcinoma. Etiologies are multifactorial, involving genetic predisposition, metabolic disturbances (such as diabetes and hypertension), immune-mediated injury, environmental exposures, and vascular compromise. CKD is marked by gradual, irreversible nephron loss and impaired waste excretion, while AKI presents as a rapid, often reversible decline in renal function. Inherited conditions like polycystic kidney disease lead to cyst formation and progressive dysfunction, and malignancies such as renal cell carcinoma arise from the renal epithelium. Clinically, kidney disease may manifest as edema, hypertension, hematuria, proteinuria, and, in advanced cases, symptoms of uremia. Diagnosis relies on clinical evaluation, laboratory tests (including serum creatinine, eGFR, and urinalysis), and imaging studies to assess renal structure and function. Renal biopsy may be necessary for definitive diagnosis, especially in glomerular diseases. Treatment approaches depend on the underlying cause and disease type, ranging from supportive care and management of complications to immunosuppressive therapy for glomerulonephritis and targeted therapies for malignancies. Advanced CKD may require dialysis or kidney transplantation, while renal cancers are managed with agents such as bevacizumab, belzutifan, and immune checkpoint inhibitors.

Launched Drugs

Structure Generic Name CAS Registry Number Molecular Formula Molecular Weight
bevacizumab
belzutifan (Rec INN; USAN) 1672668-24-4 C17 H12 F3 N O4 S 383.342
toripalimab (Rec INN; USAN) 1924598-82-2
bevacizumab; bevacizumab-bvzr
bevacizumab; bevacizumab-awwb
bevacizumab; bevacizumab-nwgd
avelumab (Rec INN; USAN) 1537032-82-8
tivozanib (Prop INNM; USAN) 682745-41-1 C22 H19 Cl N4 O5 . Cl H . H2 O 509.339
lenvatinib mesylate (Rec INNM; USAN) 417716-92-8 (free base); 857890-39-2 C21 H19 Cl N4 O4 . C H4 O3 S 522.959
lambrolizumab; pembrolizumab (Rec INN; USAN) 1374853-91-4

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Targets for Kidney

Targets in Clinical or Later Phases of Development

Target Name Gene Symbol
Interferon-gamma Receptor
Vascular endothelial growth factors (VEGF) (nonspecified subtype)
epidermal growth factor receptor EGFR
erb-b2 receptor tyrosine kinase 2 ERBB2
BCL2 apoptosis regulator BCL2
ATP binding cassette subfamily A member 1 ABCA1
B-Raf proto-oncogene, serine/threonine kinase BRAF
ALK receptor tyrosine kinase ALK
checkpoint kinase 1 CHEK1
fms related receptor tyrosine kinase 3 FLT3

Kidney cancer, particularly renal cell carcinoma (RCC), is driven by a complex interplay of molecular targets that regulate oncogenic signaling, apoptosis, drug resistance, and epigenetic modification. Central to disease progression are receptor tyrosine kinases (RTKs) such as EGFR, ERBB2, FLT1, FLT3, FLT4, BRAF, and RAF1, which activate downstream MAPK/ERK and PI3K/AKT pathways, promoting proliferation, angiogenesis, and metastasis. Apoptosis regulators like BCL2 enable tumor cells to evade programmed cell death, while drug resistance proteins such as ABCB1 facilitate the efflux of chemotherapeutics, undermining treatment efficacy. Epigenetic modifiers, notably EZH2, further contribute by altering chromatin states, supporting aggressive tumor phenotypes and therapy resistance. Therapeutically, these targets offer multiple avenues for intervention. Tyrosine kinase inhibitors (e.g., sunitinib, sorafenib for VEGFRs; erlotinib for EGFR) are established in RCC management, while HER2-targeted agents and BRAF inhibitors are under clinical investigation for specific molecular subtypes. BCL2 inhibitors like venetoclax and ABCB1 modulators are being evaluated to overcome apoptosis resistance and multidrug resistance, respectively. EZH2 inhibitors represent a promising strategy to counteract epigenetic-driven tumor progression. Collectively, these targets form the foundation for precision medicine in kidney cancer, enabling tailored therapies that improve outcomes and address the challenges of resistance and heterogeneity.

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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

Our In Vitro Efficacy Testing Service accelerates cancer and kidney drug discovery with robust, sensitive platforms tailored for renal targets. We evaluate compound efficacy, cytotoxicity, and molecular interactions using advanced biochemical, cellular, and molecular assays. Key methodologies include ATP, chemiluminescent, FRET, ELISA, flow cytometry, and surface plasmon resonance assays. We assess targets such as ABCB1, EGFR, Bcl2, and kinases, measuring critical parameters like IC-50, MIC, EC-50, and Kd. Our comprehensive approach delivers precise pharmacological insights, supporting dose optimization, safety profiling, and candidate selection to streamline preclinical development of innovative kidney and cancer therapies.

Atp Binding Cassette Subfamily B Member 1 B-Raf Proto-Oncogene, Serine/Threonine Kinase
Bcl2 Apoptosis Regulator Dna Topoisomerase I
Enhancer Of Zeste 2 Polycomb Repressive Complex 2 Subunit Epidermal Growth Factor Receptor
Erb-B2 Receptor Tyrosine Kinase 2 Fms Related Receptor Tyrosine Kinase 1
Fms Related Receptor Tyrosine Kinase 3 Fms Related Receptor Tyrosine Kinase 4
Raf-1 Proto-Oncogene, Serine/Threonine Kinase

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Why Choose Us

Choosing Alfa Cytology as your partner in cancer and kidney drug development means working with a team that is deeply specialized in these therapeutic areas. At Alfa Cytology, our scientists and researchers possess extensive experience and a proven track record in advancing innovative solutions for cancer and kidney diseases. We are equipped with cutting-edge technology platforms that enable us to deliver comprehensive and reliable preclinical drug development services. Our commitment to professionalism is reflected in our adherence to the highest quality standards and strict regulatory compliance, ensuring that every project meets or exceeds industry expectations. Alfa Cytology’s reputation for reliability is built on years of successful collaborations and consistent delivery of high-quality results. We are dedicated to supporting our clients throughout every stage of the drug development process, with a clear focus on accelerating the discovery of effective cancer and kidney therapeutics. At Alfa Cytology, we are not just a service provider—we are your trusted partner in the pursuit of better treatments and improved patient outcomes.

FAQs for Our Services

Q: What are the main preclinical research challenges specific to developing new drugs for cancer and kidney diseases?

A: Preclinical research for cancer and kidney drugs faces unique challenges, including the complexity and heterogeneity of tumor and renal pathophysiology, limitations of current in vitro and in vivo models in accurately mimicking human disease, and the need to address drug toxicity and off-target effects in sensitive renal tissues. Our company addresses these challenges by utilizing advanced 3D cell cultures, patient-derived xenograft (PDX) models, and state-of-the-art imaging and biomarker technologies to enhance translational relevance and predict clinical outcomes.

Q: What are the key regulatory considerations in the preclinical development of cancer and kidney therapeutics?

A: Regulatory agencies such as the FDA and EMA require comprehensive safety pharmacology, toxicology, and pharmacokinetics data for oncology and nephrology drug candidates. For cancer drugs, additional guidance exists for combination therapies and immuno-oncology agents, while kidney drugs often require specific renal function and toxicity assessments. Our team ensures all studies adhere to GLP standards and regulatory guidelines, and we provide expert support in preparing IND-enabling data packages tailored to cancer and kidney indications.

Q: What technical aspects should be considered when designing preclinical studies for cancer and kidney drug candidates?

A: Technical considerations include the selection of relevant disease models (e.g., orthotopic tumor models, genetically engineered mouse models, or models of chronic kidney disease), the use of biomarkers for efficacy and toxicity, and the implementation of advanced imaging and molecular analysis techniques. We offer a comprehensive suite of validated models and analytical platforms, enabling robust assessment of pharmacodynamics, pharmacokinetics, and safety profiles in both oncology and nephrology contexts.

Q: How long does the preclinical development process typically take for cancer and kidney drugs, and what are the associated costs?

A: The preclinical development timeline for cancer and kidney drugs typically ranges from 12 to 24 months, depending on the complexity of the program and specific regulatory requirements. Costs can vary widely based on the number and type of studies required, but generally range from $2 million to $8 million for a full IND-enabling package. Our company offers flexible, milestone-driven project management and transparent budgeting to help clients optimize timelines and control costs.

Q: What are the key success factors for advancing cancer and kidney drug candidates through preclinical development?

A: Success in preclinical development hinges on selecting the most predictive models, generating high-quality and reproducible data, ensuring early identification of safety and efficacy signals, and maintaining strong regulatory compliance. Our integrated approach combines scientific expertise, cutting-edge technology, and regulatory acumen to de-risk drug development and maximize the likelihood of successful IND submission and clinical advancement.

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