Shilpa Medicare Ltd's CDMO customer receives Fast-Track Designation for its investigational drug candidate

One of Shilpa Medicare Limited ("SML")'s, NASDAQ listed US based, CDMO customers has announced that its investigational drug candidate for treatment of Glioblastoma (GBM) has been granted Fast Track Designation by the USFDA. The drug is currently in a Phase 1A clinical trial designed to evaluate the safety and tolerability of the synthetically lethal investigational drug candidate in a broad range of solid tumors, including GBM. A phase 1b/2a clinical trial for recurrent GBM is targeted to start in late 2024/early 2025.

GBM affects nearly 13,000 patients annually in the US and approximately 300,000 globally, with a mortality rate of 94%. Current standard of care therapies result in a life expectancy in GBM patients of less than 15 months. A major limitation to development of new drugs in the treatment of GBM is the need for potential drugs to have the ability to cross the blood brain barrier (BBB) as well as the ability to counteract the inherent and adaptive resistance of GBM cancer cells to the current standard of care in GBM. This resistance is largely derived from the expression of the DNA repair enzyme MGMT. The activity of drug under development is agnostic to MGMT expression, meaning it does not depend on the under or over-expression of MGMT in GBM and has shown in-vivo, preclinical activity in both types of GBM models.

No new drug for GBM has been approved in over two decades. The drug under development demonstrates synthetic lethality when combined with agents that cause DNA damage repair deficiency. Additionally, the drug under development has shown that it causes double-stranded breaks in the DNA of recurrent GBM (rGBM) cancer cells in multiple in-vivo models and is currently being advanced in early clinical stage studies.

SML has partnered with the customer to provide end-to-end solution for development of API and formulation for this challenging drug where no drug of choice has been developed for over two decades. SML along with its 100% subsidiary Shilpa Pharma Lifesciences Limited ("SPL") has already completed the developmental quantities and are now working on GMP grade material. SML is currently the only partner with whom the customer is working on the project.

For Shilpa, this is the second CDMO contract where the partner has received Fast Track Designation for its product review, showcasing Shilpa's capabilities of developing difficult molecules addressing un-met patient needs. The FDA's Fast Track process is designed to facilitate development and expedite the review of therapies intended to treat serious conditions and address unmet medical needs to potentially bring important new medicines to patients sooner.

Shares of Shilpa Medicare Limited was last trading in BSE at Rs. 887.35 as compared to the previous close of Rs. 859.05. The total number of shares traded during the day was 11510 in over 809 trades.

The stock hit an intraday high of Rs. 890.45 and intraday low of 853.00. The net turnover during the day was Rs. 10047283.00.

Source : Equity Bulls

Keywords

ShilpaMedicare INE790G01031 CDMO Customer GBM FastTrackDesignation USFDA