NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

biosectinvestor,

see my post Monday 11/09/2020. https://investorshub.advfn.com/boards/read_msg.aspx?message_id=159380673

Lykiri Monday, 11/09/20 12:09:56 PM
Re: Lykiri post# 328421 0
Post #
328443
of 331815
Quote:
MDNA: PLANNING FOR INNOVATIVE HYBRID REGISTRATION TRIAL FOR MDNA55…
10/20/2020
By David Bautz, PhD

NASDAQ:MDNA

Business Update

Phase 3 Plan for MDNA55 Program

On October 15, 2020, Medicenna Therapeutics Corp. (NASDAQ:MDNA) provided an update for the MDNA55 program following an ‘End-of-Phase 2’ meeting with the U.S. FDA. The FDA has guided for the company to proceed with a Phase 3 registration trial of MDNA55 in patients with recurrent glioblastoma (rGBM) that harbor no IDH1/IDH2 mutations. There are two noteworthy points regarding the proposed trial:

1) The trial will utilize a matched external control group for 2/3rd of the control arm.

2) Patients will be randomized 3:1 to receive MDNA55 or standard of care (SOC). SOC will consist of physician’s choice (temozolomide, bevacizumab, lomustine, etc.)

This is the first instance we are aware of where a company has been encouraged to utilize a substantial external control arm for a cancer trial and could represent a paradigm shift in the way trials are conducted for diseases that have a significant unmet need for improved therapeutics. In addition, the use of a sizeable external control arm will decrease the number of patients required in the trial, which will help to defray costs and could expedite the time to complete the trial. With a 3:1 randomization it will also allow for more patients to receive MDNA55 than would be possible with a standard 1:1 randomization.

We estimate a total of approximately 150 patients will be enrolled in the treatment arm, with approximately 50 patients enrolled in the control arm. Another 100 patients will be enrolled into the external control arm, with records for those patients derived from previous clinical trials that have been conducted since January 2016. Patients included in the external control arm will have characteristics similar to those enrolled in the treatment and control arms and will be identified in a manner similar to that used for the company’s analysis of the Phase 2 clinical trial that utilized a synthetic control arm (discussed below).

We expect that the positive ‘End-of-Phase 2’ meeting with the FDA will invigorate Medicenna’s efforts to identify a suitable partner to advance the program, as we do not anticipate the company initiating a Phase 3 program for MDNA55 without a collaboration agreement with a larger pharmaceutical company in place.

https://scr.zacks.com/News/Press-Releases/Press-Release-Details/2020/MDNA-Planning-for-Innovative-Hybrid-Registration-Trial-for-MDNA55-article/default.aspx