oncoprime - patient derived platform for biologics research

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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... Onco Prime TM OncoPrimeplatform 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 OncoPrimecan 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: [email protected] | 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. OncoPrimeplatform 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 OncoPrimeplatform Product or product class Table 1. Some examples of the OncoPrimeplatform that cater to bio-better characterization TNBC – Triple negative breast cancer; CRC- colorectal cancer, NSCLC – Non small cell lung carcinoma

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Page 1: OncoPrime - Patient derived platform for Biologics research

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

SAARUMSCIENCES

Phenotypic Platforms for Drug & Biomarker Discovery

Di�erentiate your bio-similars to bio-bettersusing patient-derived primary cells ! A case study to showcase the bene�ts of our phenotypic drug discovery platform

Use to profile your bio-similar / bio-better on any type of primary cells...OncoPrimeTM“

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: [email protected] | 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

Page 2: OncoPrime - Patient derived platform for Biologics research

SAARUMSCIENCES

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: [email protected] | Website: http://www.saarum.com

OncoPrimeTM

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

DrugRepurposing

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