From pilot cohort to Phase II in 84 months

1. Phase 0Months 0–4

   Governance, regulatory & logistics

   • JV Committee set up and SOPs adopted
   • Sequencing services and material transfer agreement with the US sequencing partner
   • Ethics committee approvals and patient consent documents at all enrolling sites
   • Cold-chain validation on the India–New York lane (−150 °C / −80 °C shippers, continuous temperature monitoring, chain of custody)
   • Export/import permits and a secure data-transfer protocol

   M0 · Month 4

   Go / no-go gate

   All approvals in place, logistics lane validated, sequencing agreement signed

2. Phase 1Months 4–10

   Pilot cohort & sequencing validation

   • Enrolment of about 15–30 patients with Stage I–III triple-negative breast cancer (TNBC)
   • Fresh frozen tissue and liquid biopsy collection
   • Single-cell sequencing on the proprietary gene panel with TNBC supplements
   • HLA class I typing and IHC panel (PD-L1, AR, Trop-2)
   • End-to-end validation of the raw data pipeline

   M1 · Month 10

   Go / no-go gate

   At least 20 samples sequenced and QC-passed; data pipeline validated end to end

3. Phase 2Months 10–18

   Analytics, neoantigen selection & vaccine design

   • AI-based clonal-architecture and neoantigen-ranking analytics
   • DC-NK vaccine platform confirmed: neoantigen peptide-loaded autologous dendritic-cell vaccine, optionally combined with NK cell therapy
   • Personalised vaccine designs for the first patient cohort
   • Process development started with a CDMO under the manufacturing IP licence

   M2 · Month 18

   Go / no-go gate

   Vaccine platform locked; first-cohort vaccine designs frozen

4. Phase 3Months 16–26

   Preclinical development & CMC

   • In-vitro / ex-vivo immunogenicity and potency assay development
   • Stability studies
   • GMP manufacturing process defined and characterised
   • Manufacture and release of the GMP clinical batch

   M3 · Month 26

   Go / no-go gate

   GMP clinical batch released; preclinical package complete

5. Phase 4Months 22–28

   Regulatory submissions

   • Clinical trial application to CDSCO (India)
   • IND to the US FDA if a US cohort is included
   • Regulator interactions and responses, in parallel with Phase 3

   M4 · Month 28

   Clinical trial authorisation obtained

6. Phase 4AMonth 28 onwards

   Compassionate / special access

   • Parallel per-patient program for eligible patients who do not meet trial criteria or have no satisfactory standard therapy left
   • Under NDCT Rules 2019 (incl. Rule 96), with ethics committee and Central Licensing Authority permission for each patient
   • Not-for-profit supply; adverse events reported within the project pharmacovigilance framework

   Parallel track

   Runs alongside the clinical phases, subject to JV Committee approval and regulatory permission for each patient.

7. Phase 5Months 28–48

   Phase I first-in-human study

   • Dose-escalation and schedule-optimisation study in 10–20 patients
   • Post-neoadjuvant minimal residual disease (MRD) setting
   • Endpoints: safety, tolerability and neoantigen-specific T-cell responses
   • MRD monitoring with ctDNA / CTC liquid biopsy

   M5 · Month 48

   Go / no-go gate

   Phase I readout; go/no-go decision for Phase II

8. Phase 6Months 48–84

   Phase II efficacy signal

   • Expansion or randomised cohort
   • Evaluation of MRD clearance and relapse-free survival

   M6 · Month 84

   Phase II interim analysis and commercialisation decision

Detailed capital and operating budgets for each phase, plus the funding mix, are in the investor data room.