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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).
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.
Page 1
SAARUM
SCIENCES
Phenotypic Platforms for Drug & Biomarker Discovery
Differentiate your bio-similars to bio-betters
using patient-derived primary cells !
A case study to showcase the benefits of our phenotypic drug discovery platform
Use to profile your bio-similar / bio-better on any type of primary cells...OncoPrime
TM
“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.
Correspondence:
Sreevatsa Natarajan, Co-Founder & CEO
Saarum Sciences Pvt. Ltd.,
1st Floor, AIMSR Building, Apollo Health City,
Jubilee Hills, Hyderabad 500096, India.
All Rights Reserved | Saarum Sciences | Phone: +91-9704600283, +91-40-20084362 | Email: info@saarum.com | Website: http://www.saarum.com
Breast cancer patient samples with various genotypes (including several TNBCs) are available as optimized cultures in 2D & mammosphere formats
Can also be tested on NSCLC patient samples to expand indication.
Patient samples with different grades of glioma available as optimized cultures in 2D & Neurosphere formats.
Can also be tested on CRC / NSCLC patient samples to expand indication
Can be tested on relevant patient samples from rheumatoid arthritis, psoriatic arthritis, psoriasis and other immune-inflammation pathologies.
OncoPrime™ platform encompasses several cancer types with varied genotypes and phenotypes that can be offered for testing various cancer therapies
Herceptin (Trastuzumab)
Avastin (Bevacizumab)
Humira (Adalimumab)
Remicade (Infliximab)
Cancer Targeted Mabs and Non-Mabs
Examples of leveraging the OncoPrime™ platformProduct or product class
Table 1. Some examples of the OncoPrime™ platform that cater to bio-better characterization
TNBC – Triple negative breast cancer; CRC- colorectal cancer, NSCLC – Non small cell lung carcinoma
SAARUM
SCIENCES
Phenotypic Platforms for Drug & Biomarker Discovery
Get more from your pre-clinical characterization!
Move to the clinic more informed …
An infographic to highlight the utility & features of our phenotypic drug discovery platform
Page 2All Rights Reserved | Saarum Sciences | Phone: +91-9704600283, +91-40-20084362 | Email: info@saarum.com | Website: http://www.saarum.com
OncoPrime
TM
Develop scientific rationale for alternativeindications
using patient derived cancer cells of different origins.
Develop MOA assays to be able to EXTRAPOLATE
the use of your molecule for various
indications e.g. Trastuzumab for
Breast cancer & Lung cancer
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.
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 !
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).
Accurate efficacy /
Half Life Assessment
Use the platform
to repurpose your
exsiting pipeline
Accelerate your
preclinical
development
Drug
Repurposing
Better
Clinical Positioning
Better Selectivity
against Clinically
Relevant Mutations
Accurate
Therapeutic Window
Assessment
Use our platform to ID novel targets
& accelerate the discovery phase
Use our platform for validating
your novel targeted therapies
Target Identification
& Validation
Accurate
Pharmacokinetic
Predictions
Assays for
Alternative Indications

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OncoPrime - Patient derived platform for Biologics research

  • 1. 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). 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. Page 1 SAARUM SCIENCES Phenotypic Platforms for Drug & Biomarker Discovery Differentiate your bio-similars to bio-betters using patient-derived primary cells ! A case study to showcase the benefits of our phenotypic drug discovery platform Use to profile your bio-similar / bio-better on any type of primary cells...OncoPrime TM “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. Correspondence: Sreevatsa Natarajan, Co-Founder & CEO Saarum Sciences Pvt. Ltd., 1st Floor, AIMSR Building, Apollo Health City, Jubilee Hills, Hyderabad 500096, India. All Rights Reserved | Saarum Sciences | Phone: +91-9704600283, +91-40-20084362 | Email: info@saarum.com | Website: http://www.saarum.com Breast cancer patient samples with various genotypes (including several TNBCs) are available as optimized cultures in 2D & mammosphere formats Can also be tested on NSCLC patient samples to expand indication. Patient samples with different grades of glioma available as optimized cultures in 2D & Neurosphere formats. Can also be tested on CRC / NSCLC patient samples to expand indication Can be tested on relevant patient samples from rheumatoid arthritis, psoriatic arthritis, psoriasis and other immune-inflammation pathologies. OncoPrime™ platform encompasses several cancer types with varied genotypes and phenotypes that can be offered for testing various cancer therapies Herceptin (Trastuzumab) Avastin (Bevacizumab) Humira (Adalimumab) Remicade (Infliximab) Cancer Targeted Mabs and Non-Mabs Examples of leveraging the OncoPrime™ platformProduct or product class Table 1. Some examples of the OncoPrime™ platform that cater to bio-better characterization TNBC – Triple negative breast cancer; CRC- colorectal cancer, NSCLC – Non small cell lung carcinoma
  • 2. SAARUM SCIENCES Phenotypic Platforms for Drug & Biomarker Discovery Get more from your pre-clinical characterization! Move to the clinic more informed … An infographic to highlight the utility & features of our phenotypic drug discovery platform Page 2All Rights Reserved | Saarum Sciences | Phone: +91-9704600283, +91-40-20084362 | Email: info@saarum.com | Website: http://www.saarum.com OncoPrime TM Develop scientific rationale for alternativeindications using patient derived cancer cells of different origins. Develop MOA assays to be able to EXTRAPOLATE the use of your molecule for various indications e.g. Trastuzumab for Breast cancer & Lung cancer 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. 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 ! 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). Accurate efficacy / Half Life Assessment Use the platform to repurpose your exsiting pipeline Accelerate your preclinical development Drug Repurposing Better Clinical Positioning Better Selectivity against Clinically Relevant Mutations Accurate Therapeutic Window Assessment Use our platform to ID novel targets & accelerate the discovery phase Use our platform for validating your novel targeted therapies Target Identification & Validation Accurate Pharmacokinetic Predictions Assays for Alternative Indications