Central Drugs Standard Control Organisation (CDSCO) · Biologics Division
Phase III Clinical Trial Data — Summary Filing Extract
Ref: DCGI/BIO/NX7/2025/0424 | Applicant: BioNexus Labs Pvt. Ltd., Hyderabad | Received: 24 April 2025
CompoundNX-7 (nivolumab-x7 analogue) — cancer immunotherapy
Proposed IndicationAdvanced non-small cell lung carcinoma (NSCLC), 2nd line
Filing ReferenceDCGI/BIO/NX7/2025/0424
Applicant SignatoryKavitha Nair, CEO & Managing Director, BioNexus Labs
Regulatory Affairs ContactSanjay Mehta, Head — Regulatory Affairs
Data Cut-off Date (Declared)31 March 2025
EXTRACT: This document is pages 4–11 of the Phase III Clinical Summary Report as filed with DCGI on 24 April 2025. Provided to Telangana State Police under DCGI warrant reference CDL/HYD/W/2025/0509. Redacted sections (pages 1–3, 12–38) contain patient identifiable information and commercially sensitive formulation data — not released.
Phase III Trial Design Summary
| Parameter | Value (as filed) |
|---|
| Trial sites | 7 hospitals across Telangana, Andhra Pradesh, and Tamil Nadu |
| Total enrolled subjects | 847 (combined Batches 1A through 9C) |
| Primary endpoint | Objective Response Rate (ORR) at 12 weeks |
| Secondary endpoints | Progression-free survival, Overall survival, Adverse event profile |
| Statistical methodology | Intent-to-treat (ITT) analysis, RECIST 1.1 criteria |
| Data verification | "All trial data has been independently verified and is consistent with source documentation at participating sites." — Declaration signed by Kavitha Nair and Sanjay Mehta, 24 April 2025 |
Primary Efficacy Results — Filed Data (All Batches Combined)
| Metric | Value (as filed) | Supporting Batch |
|---|
| Overall ORR (all batches) | 74.2% | Batches 1A–9C combined |
| ORR in Batch 7B (n=193 evaluable) | 74.2% | Batch 7B — Hyderabad/Chennai sites, Nov–Dec 2024 |
| Grade 3–4 adverse events (all batches) | 5.7% of evaluable subjects | 11 of 193 evaluable in Batch 7B; aggregate consistent |
| Treatment-related discontinuations | 4.1% overall | Batch 7B: 8 of 193 |
| Primary endpoint met? | Yes — exceeds 65% ORR threshold specified in trial protocol | — |
Batch 7B Specific Notes (as filed)
| Field | Filing Statement |
|---|
| Batch 7B enrollment | 191 enrolled; 193 evaluable (2 subjects enrolled as protocol amendments post-cut) |
| Batch 7B outlier status | No outlier notation. Batch 7B classified as a primary data cohort. |
| CDR cross-reference | Data verified against NX7-CDR/LAB as of data cut 31 March 2025 |
| Missing data handling | Per protocol: last observation carried forward (LOCF). Two subjects with incomplete 12-week assessments were handled via LOCF using 8-week data. |
Regulatory Correspondence — DCGI Review Board
| Date | Action |
|---|
| 24 April 2025 | Filing received; assigned to Biologics Review Committee (BRC/NX7/2025) |
| 30 April 2025 | BRC preliminary review completed; no major deficiencies noted |
| 3 May 2025 | Correspondence received from Dr. Anil Reddy (personal email to DCGI Central Drugs Lab) — flagged internal data concerns regarding Batch 7B. Routed to BRC coordinator for review. |
| 4 May 2025 | BRC coordinator contacted BioNexus Labs for response to Dr. Reddy's communication. Response received from Sanjay Mehta: "The concerns raised have been internally reviewed and are not supported by the verified trial data." BRC coordinator accepted response and proceeded. |
| 6 May 2025 | DCGI approval granted. Letter issued to BioNexus Labs CEO Kavitha Nair. |
DECLARATION OF ACCURACY (reproduced from filed document, p. 4):
"We, the undersigned, certify that the data contained in this Phase III Clinical Trial Summary Report (DCGI/BIO/NX7/2025/0424) is complete, accurate, and consistent with source documentation held at all participating trial sites. All adverse events have been reported in accordance with Schedule Y of the Drugs and Cosmetics Act, 1940."
Signed: Kavitha Nair, CEO, BioNexus Labs Pvt. Ltd. | 24 April 2025
Signed: Sanjay Mehta, Head of Regulatory Affairs, BioNexus Labs Pvt. Ltd. | 24 April 2025
DCGI — Released Under Warrant CDL/HYD/W/2025/0509
Certified extract — Central Drugs Standard Control Organisation, New Delhi
Provided to: Telangana State Police, Homicide Division | 9 May 2025