Theralase Technologies Inc. V.TLT

Sesen (Vicineum) was disqualified on that

[ScienceFirst]

In July 2021, SESEN's Vicinium was rejected by the FDA

FDA Slams Sesen Bio with CRL for Bladder Cancer Drug

the U.S. Food and Drug Administration rejected its lead candidate, Viceneum (oportuzumab monatox-qqrs) as a treatment for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

In its Complete Response Letter, the FDA said it is unable to approve the company's Biologics License Application for Vicineum in its present form. The regulatory agency recommended additional clinical and statistical data analyses, as well as issues related to the company's Chemistry, Manufacturing and Controls (CMC). 

The FDA also expressed concern about drug substance and drug product manufacturing, cell bank, characterization, resin reuse, reference standards, methods, specifications, stability, and microbiology, the company said in a conference call on Monday.

In that call, Sesen chief executive officer Tomas Cannell expressed his disappointment in the FDA's decision adding that the company will seek a Type A meeting with the regulatory agency to discuss the next steps regarding potential approval. Cannell said they anticipate the meeting will take place during the fourth quarter of this year.

The CEO also discussed that the Type A meeting would be twofold. In addition to addressing the CMC concerns, Sesen will need to confirm the primary endpoints of clinical data. He said the endpoints should be Complete Response and Duration of Response. 

[DJDawg]

Quick question. I know biologic agents have different production challenges and concerns with safety and contamination in the manufacturing process. Can we confirm that TLD-1433 has a more straightforward, non BLA production process? If so that probably reduces some of the Vicineum issues above around production. I think it does but thought I would confirm. More chance to satisfy FDA requirements

[enriquesuave]

I believe that we will have to apply with an NDA rather than a BLA.  Much easier IMO as TLD-1433 is an Organometallic substance ( pretty much like a salt) which is dissolved in saline when ready to be administered.  Already have shown 3 years of shelf life stability.   BLA is for a biological substance and much harder to produce and show consistency.  Manufacturing is very

[enriquesuave]

All of the competition that TLD-1433 faces are Biological drugs, hence much harder to get approval and riskier. IMO  N-803, Vicinium, CG0070, Keytruda etc.  That is one heck of a key advantage.  They already proved safety, efficacy is in the process and Manufacturing is a joke vs the competition.  IMHO  "While, biologics and drugs are both used for the same

[enriquesuave]

After reading this over again, we have one major heck of an advantage when it will come to file for FDA approval.  TLD-1433 being a small molecule drug will go through the NDA pathway, vs BLA.  This says it all.   Manufacturing of Biological Products is Inherently Riskier than Production of Drugs. The manufacturing processes for biological products are different than processes&

[LaserStock29]

We've answered every single objection to why pdt was dropped in 1993....... and they know it.  From manufacturing to storage/shelflife to preserving the organ  to multiple doses of administration. All the risk has been eliminated from the table......  The table is clear.. the chairs are set...... Now are we gonna sit down and make a deal or what.