oncoprime - differentiate your biosimilars using patient derived assay platform
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A bio-better, with substantive benefits to patients in the form of faster action, lower dosing, different
form of delivery or a better side effect profile offers a very valuable commercial opportunity. Development
of bio-betters is less risky vis-à-vis novel biologics because they build on already-validated targets while
still offering the advantage of patentability and increased profitability vis-a-vis bio-similars. Hence many
bio-similar players are also evaluating their molecules for bio-better potential.
Some strategies currently in use for bio-better development include chemical modifications, PEGylation,
glycosylation, altered formulation, controlled release to claim benefits as mentioned above. E.g. Altered
glycosylation pattern has been demonstrated to affect half-life (PK) and immunogenicity in the patient, as
well as binding affinity, activity and stability in the case of TrastuzuMab (TrasGex).
Use OncoPrime™: Profile your bio-similar/bio-better on the primary cells that
you intend to treat!
Characterization of bio-similars/bio-betters with cytotoxicity/proliferation assays, receptor binding/target
displacement assays and mechanism of action assays are routinely performed using cell lines that may
have been misidentified and/or have aberrant pathways that are not representative of the clinical setting.
OncoPrime™ platform uses patient-derived primary samples that offer clinically-relevant genotypic and
phenotypic diversity that translates better to the clinic vis-à-vis cell lines. Functional assays, when
adapted to OncoPrime™ can not only help in claiming physiological relevance but also add additional
layers of information for more informed clinical trials.
Some examples of the OncoPrime™ platform that cater to bio-better characterization
Product or product class Examples leveraging the OncoPrime™ platform
Herceptin (Trastuzumab)
Breast cancer patient samples with various genotypes (including several TNBCs) are available as optimized cultures in 2D & mammosphere formats Can also be tested on NSCLS patient samples to expand indication.
Avastin (Bevacizumab)
Patient samples with different grades of glioma available as optimized cultures in 2D & Neurosphere formats. Can also be tested on CRC/NSCLS patient samples to expand indication
Humira (Adalimumab) Remicade (Infliximab)
Can be tested on relevant patient samples from rheumatoid arthritis, psoriatic arthritis, psoriasis and other immune-inflammation pathologies.
Cancer Targeted Mabs and Non-Mabs
OncoPrime™ platform encompasses several cancer types with varied genotypes and phenotypes that can be offered for testing various cancer therapies
TNBC – Triple negative breast cancer; CRC- colorectal cancer, NSCLC – Non small cell lung carcinoma
Differentiate your bio-similars to bio-betters using
patient-derived primary cells!
Using assays with diseased cells will provide relevant information on binding, immune cell recruitment, ADCC/CDC and other mechanism of actions vis-à-vis comparator but in a clinically relevant context !
Get more from your pre-clinical characterization!
Move to the clinic more informed …
Saarum Sciences Pvt. Ltd., Indian Institute for Chemical Technologies Tarnaka, Hyderabad 500007, India. Tel: +91-40- 27160035 Email: [email protected] Website: http://www.saarum.com
Test your molecules on the diverse primary cancer samples as would be seen in the clinic! Use this data to better predict clinical PK behavior of your molecule vis-a-vis comparator even before you move into the clinic.
Assess if your drug candidate offers a differential activity advantage. Test your molecule for radiation sensitivity/ sensitization, activity against cancer stem cells, chemo-resistance, synergy with other SOC drugs, anti-metastatic activity etc.
Determine your molecules’ cytotoxicity on
patient-derived primary vs normal samples
for more accurate & clinically meaningful
selectivity, safety and therapeutic window
assessments.
Alternative pathways that inhibit or substantiate effectiveness can be investigated more effectively prior to entering the clinic, e.g., Assessment of reduced Trastuzumab activity against patient samples harboring a PTEN mutation (loss of function).