"Novartis will reveal VISION data at ASCO on 7 June. Median survival of about 14 months (which accords with earlier trials) will surely lead to FDA approval, but patients may decide that they cannot justify the very high cost of treatment for a relatively small extension of life over Cabazitaxel......If NOX66 has patent protection, Novartis might try to lock up the drug through a Licence, but Noxopharm can afford to wait until results from IONIC, DARRT-2 and CEP-2 are known."

Two things: First, since these are all separate and independent programs, Veyonda can be licensed separately in each case, so the totality of each possible license agreement needs to be considered within a risk-adjusted probability-based framework in order to properly value Noxopharm. Sure, a takeover or M&A could be on the table, but if Veyonda works exceptionally well in all four pillars then the buy out price will be insanely high.

Second, i'm of the firm view that Novartis are going to want to move quickly to license Veyonda for use with 177Lu-PSMA-617 once we get those patents. The reason for this is because it appears that you see a similar mOS irregardless of which radioligand you attach to PSMA-617, so Novartis are going to need to find a way to differentiate themselves from all of the competition who are nipping at their heels.

https://www.urologytimes.com/view/fda-authorizes-trial-of-novel-psma-theranostics-in-mcrpc

FDA authorizes trial of novel PSMA theranostics in mCRPC

Jason M. Broderick

6-8 minutes

The FDA has authorized the launch of the phase 1/2a SECURE trial exploring 2 novel PSMA theranostic products in patients with metastatic castration-resistant prostate cancer (mCRPC), according to Clarity Pharmaceuticals, the company developing the investigational agents.¹

The open-label, single-arm, dose-escalation SECURE trial (NCT04868604) is specifically exploring the PSMA PET imaging product ⁶⁴Cu-SAR-bisPSMA and the PSMA targeted therapy ⁶⁷Cu-SAR-bisPSMA.² The basic design of the trial is that ⁶⁴Cu-SAR-bisPSMA will be used for the selection of appropriate patients to receive treatment with ⁶⁷Cu-SAR-bis-PSMA. The study aims to enroll 44 patients at multiple locations in the United States.

To enroll on the trial, patients must have mCRPC that has progressed despite being treated with androgen-deprivation therapy and at least 1 second-generation androgen receptor pathway inhibitor, such as abiraterone acetate (Zytiga) or enzalutamide (Xtandi). Patients are required to have an ECOG performance status of 0 to 2, and a castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L). Individuals with brain metastases are not eligible to enroll.

"The FDA response suggests not only the importance of developing novel treatments for men with late-stage prostate cancer, whose prognosis is currently very poor, but also validates Clarity's copper pairing paradigm and the centralized manufacturing concept, which differentiates it from the competitor products and enables product supply to the levels suitable for use in large patient indications," Dr Alan Taylor, executive chairman of Clarity, stated in a press release.

"We are very excited to commence the SECURE trial in mCRPC patients and have engaged a world class group of key opinion leaders in the prostate cancer space to support the development of ^64/67Cu SAR-bisPSMA. Clarity's Global Clinical Development Group has unrivalled experience in the commercialization of the only currently approved radiotherapeutic for prostate cancer. The FDA response is a crucial milestone in the development of SAR-bisPSMA theranostics and we are looking forward to progressing this trial at some of the leading cancer centers in the United States as part of our ultimate goal of developing better treatments for children and adults with cancer," added Taylor.

PSMA-PET imaging has emerged as a new frontier in prostate cancer diagnosis and treatment. In December 2020, the FDA approved Gallium 68 PSMA-11 as the first product for PET imaging of PSMA-positive lesions in men with prostate cancer. Other PSMA products, such as the PSMA-targeted radiopharmaceutical 177Lu-PSMA-617, are now rapidly moving through the pipeline in prostate cancer.