Research and Development

We are currently involved in new approaches to providing affordable, safe, and effective CAR T cells, CAR Dentritic cells, CAR NK cells, CAR Alpha & Beta T cells, CAR Delta & Gamma T cells and gene Therapy, biosimilar and Vaccine are a copy of a biological medical drug that is similar, but not identical, to the original biologic medical drug, The path to their approval is shorter as clinical trials and spend on research & development is much less than on the original biologic medical drug, thus fostering cheaper cost.

1.LYSINE BIOTECH development of 2nd, 3rd, 4th & 5th generation of CAR T cells, CAR Dentritic cells, CAR NK cells Expressing Cell & Lenti Virus Vector

To make a new approach to custom design provide affordable, safe, and effective Autologous & Allogeneic anti human scFv and Alpha & Beta T cells, and Delta & Gamma T cells, CAR T cells, NK cells and Neoantigen p53 Dentritic cells targeting to treat the specific antigens, solid tumors and Cardiac fibrosis Autologous (Human anti-CD19CART, anti-CD20CART, anti-GD2CART, anti-BCMACART, anti-FAPCART, (bi-cistronic anti-GPRC5D-hCD3CART, bi- cistronic hMSCs-anti-hGD2hCART, bi-cistronic anti-CD19-20CART and tri-cistronic anti-CD19-20-22CART by using Ribosomal skipping or skipping exon) and Allogenic CD5CART, CD34CART, Neoantigen p53CART, Neoantigen p53CAR Dentritic cells etc.,

1.1 LYSINE BIOTECH Example design for a bi-cistronic & tri-cistronic CAR T cell therapy with separate signal peptides, separate co-stimulators, and CD3ζ:

- Signal peptide 1: CD19-targeting signal peptide

- Signal peptide 2: CD20-targeting signal peptide

- Signal peptide 3: CD22-targeting signal peptide

- Linker: Gly-Ser linker

- Co-stimulator 1: CD27

- Co-stimulator 2: CD28

- Co-stimulator 3: 4-1BB

- Co-stimulator 4: NFAT

- CD3ζ: Optimized CD3ζ domain

- ScFv regions: CD19- CD20 and CD22-targeting ScFv regions

- Hinge and transmembrane regions: Optimized hinge and transmembrane regions

- CAR endodomain: Designed to incorporate separate co-stimulators and CD3ζ

1.2 LYSINE BIOTECH Novel binders construct huanti-CAR19 cation-pi interaction improved binding affinity, specificity, and therapeutic efficacy

The CAR ScFv heavy and light chain variable fragment region contains aromatic residues e.g., phenylalanine (Phe, F), tyrosine (Tyr, Y), or tryptophan (Trp, W). that participate in cation-pi interactions with positively charged residues e.g., lysine (Lys, K) or arginine (Arg, R) on the target of the antigen, Solid tumor, Cardiac fibrosis, etc.,

The cation-pi interaction helps stabilize the CAR ScFv region binding to the target antigen, Solid tumor, Cardiac fibrosis, etc., increasing the binding affinity, specificity, and therapeutic efficacy.

Strong capabilities in new future scientific platforms of bi-cistronic & Tri-cistronic CAR T cell therapy by using Ribosomal skipping or skipping exon.

1.3 LYSINE BIOTECH development of Lentiviral Envelope, 2nd Packaging Plasmids and 3rd generation transfer plasmids for CAR T Cell Therapy

To make a new approach to custom design Gag, Pol, Rev, VSV-G and Tat 2nd, 3rd generation transfer plasmids and Gag & Pol; can be used with 3rd generation transfer plasmids along with a plasmid encoding Rev.

1.4.Lysine Biotech Product: Development of Commercial Novel anti-huCAR19T-CD27/41-BB-CD3Z Cells Therapy: Towards Enhanced Efficacy and Safety

Phase 1: Establishing proof of concept (POC) for Lenti Virus Vector and CAR-T Cell

Phase 2: Adherent 293T cells to establish the Master Cell Bank (MCB)

Phase 3: Pre-Clinical Trial (PCT) Efficacy and Safety

Phase 4: Plasmid DNA GMP Production

Phase 5: Lentiviral GMP Production

Phase 6: CAR-T Cell GMP Manufacturing

Phase 7: Clinical Partnership

Phase 8: Clinical Trial (CT)

Phase 9: Business Strategy

Phase 10: Commercial Manufacturing Collaboration

2.LYSINE BIOTECH development of mRNA based Gene therapy

To make a new approach to custom design provide affordable, safe, and effective gene therapy designed to deliver a copy of the mRNA encoding the human FGFR2, FVIII, RPE65, BCL11A, BCL6A, COL7A1, FIX, HBB, DDC, TIMP2, TTN, POT1 and BAG3.

2.2 LYSINE BIOTECH Adeno-associated virus (AAV2-9) serotypes for mRNA based gene therapeutics

To make a new approach to custom design adeno-associated virus serotype (AAV2, AAV3, AAV4, AAV5, AAV6, AAV7, AAV8, and AAV9).

3.LYSINE BIOTECH development of Biosimilar

To make a new approach to Custom design provide affordable, safe, and effective Biosimilar Pembrolizumab, Crizanlizumab, Ranibizumab, Rituximab, Benralizumab, Caplacizumab, Durvalumab, Cemiplimab, Ibalizumab, Moxetumomab pasudodox, Romosozumab, Risankizumab and Brolucizumab.

4.LYSINE BIOTECH development of LNP based mRNA delivery for Vaccine

To make a new approach to Custom design provide affordable, safe, and effective mRNA vaccine four in one Dengue 1-4, Chikungunya, Circumsporozoite (malaria), monkeypox , Horsepox, Buffalopox, Vaccinia, African swine fever virus and FMD vaccine (unique India).

Read More About Products R&D Pipline

3.Publications

I).Mayakrishnan Vijayakumar, BalakarthikeyanJanani, PriyaKannappan, Senthil Renganathan*, SameerAl-Ghamdi, Mohammed Alsaidan, Mohamed AAbdelaziz, Abubucker Peer Mohideen, Mohammad Shahid, Thiyagarajan Ramesh, 2021.In silico identification of potential inhibitors against main protease of SARS-CoV-2 6LU7 from Andrographis panniculata via molecular docking, binding energy calculations and molecular dynamics simulation studies Saudi Journal of Biological Sciences. Oct.29-2021. doi: 10.1016/j.sjbs.2021.10.060.

II).Renganathan Senthil*, Manokaran Sakthivel, Singaravelu Usha, 2021. Structure-based drug design of peroxisome proliferator-activated receptor gamma inhibitors: ferulic acid and derivatives. J Biomol Struct Dyn. 39(4):1295-1311.doi: 10.1080/07391102.2020.1740790.

III).Konda Mani Saravanan, Haiping Zhang, Renganathan Senthil*, Kevin Kumar Vijayakumar, Vignesh Sounderrajan, Yanjie Wei, Harshavardhan Shakila, 2020. Structural basis for the inhibition of SARS-CoV2 main protease by Indian medicinal plant-derived antiviral compounds. J Biomol Struct Dyn. 1-9.doi: 10.1080/07391102.2020.1834457.

IV).Mahendrarajan Venkatramanan, Pitchaipillai Sankar Ganesh, Renganathan Senthil*, Jeyachandran Akshay, Arumugam Veera Ravi, Kulanthaivel Langeswaran, Jamuna Vadivelu, Samuthira Nagarajan, Kaliaperumal Rajendran, Esaki Muthu Shankar, 2020. Inhibition of Quorum Sensing and Biofilm Formation in Chromobacterium violaceum by Fruit Extracts of Passiflora edulis. ACS Omega.5(40):25605-25616.doi: 10.1021/acsomega.0c02483.

V).Subrata Pramanik, Manisha Thaker, Ananda Gopu Perumal*, Rajasekaran Ekambaram, Naresh Poondla, Markus Schmidt, Pok‐Son Kim, Arne Kutzner, Klaus Heese, 2020. Proteomic Atomics Reveals a Distinctive Uracil‐5‐Methyltransferase. Molecular Informatics. Vol. 39, Issue 5,doi:10.1002/minf.201900135 .