RE:RE:Pfizer terminated NMIBC trial due to strategic considerationOnly a new release would confirm such jv with TLT but the timing of all this is quite intriguing, to say the least.
It doesn't preclude to anything but it could, given the sequence of events that could resemble one of late negociations (a big pharma finally stepping in at the last minute):
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Pfizer has a presence in NSCLC, one of our next 2 indications
- Both TLT
and Pfizer are targetting the bladder indication
- Both TLT
and Pfizer have engaged in a clinical trial against NMIBC
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Pfizer already won this in 2021:
FDA Approves BAVENCIO as First-Line Maintenance Treatment for Patients with Locally Advanced or Metastatic Urothelial Carcinoma - TLT has confirmed it can also treat MIBC, on top of NMIBC.
- TLT is well 50% into its Ph. 2 BCG-Unresponsive trial
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Pfizer initially launched its NMIBC Ph. 1 trial Feb. 2022
- TLT's milestone to be able to apply for FDA Breakthrough Therapy is p#25 450-days
- TLT's p#25 450-days expected date is mid-Nov. to mid-December
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August 29 - TLT publishes interim Ph. 2 data that includes 45 patients (3+42) with 24 evaluable patients @450-days
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Sept. 22. - TLT closes 1st pp of 2.5M$ in which the management participated in (
Related Party Transactions An aggregate of 2,400,000 Units, representing gross proceeds of $600,000, were issued to certain insiders of the Corporation).
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Oct. 3 - TLT launches a 2nd TLT pp, initially aiming for 2.5M$ and expected to close within 14 days
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Oct. 24 -
Pfizer updates its clinical trial record with this reason:
"Pfizer has decided to terminate Study C4661001 due to strategic considerations" -
Nov. 17 - The 2nd pp is closed. 1 month after the expected closing. 250K$ (instead of 2.5M$), with 127K$ to management (
Related Party Transactions An aggregate of 511,000 Units, representing gross proceeds of $127,750, were issued to certain insiders of the Corporation.).
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Nov. 21 - Theralase Grants Stock Options
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Nov. 30 - TLT publishes interim Ph. 2 data that includes 54 patients (3+51), with 29 evaluable patients @450-days (so p#25 @450-days, so triggering the possibility to finally apply for FDA Breaktrhough Therapy desingation)
So it's a bit like if Pfizer would have decided, after Oct. 3rd, to finally step in, before it's too late, or already convinced that the data is stellar enough to trigger FDA designation like Accelerated Approval. An informal agreement could have been discussed, where Pfizer would make the first move of terminating its NMIBC trial on Oct. 24, to show good faith to TLT. To then allow TLT to lower its 2nd pp to minimum on Nov. 17 and then grant stock options to management on Nov. 21. Then wait the FDA decision regarding Breakthrough Therapy and/or Accelerated Approval before officially announcing a jv with TLT. Pfizer would then pay upfront payment, would also advance our treatment to early-stage setting of NMIBC, in order to disrout the 17B$ market of BCG, on top of grabbing the BCG-Unresponsive market.
All plauside. Clearly possible scenario. Only a news release can confirm though.
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ScienceFirst - (12/22/2022 11:51:41 AM)
RE:Pfizer terminated NMIBC trial due to strategic consideration
For participants with high-grade Ta/ T1 disease only Remember that one that succeeds in BCG-Unresponsive, would logically be in a position to displace BCG in early-stage setting. Knowing that BCG sales is a 17B$US market, it's a no brainer that a big pharma would want to jv with a BCG-Unresponsive winner to advance such treatment in early-stage setting, completely displacing BCG.
These are the types of deals that Boards of big pharmas can envision. And if we get FDA recognition for BCG-Unresponsive, then everything becomes possible.
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ScienceFirst - (12/22/2022 11:43:33 AM)
Pfizer terminated NMIBC trial due to strategic consideration
Interesting ...
Pfizer has decided to terminate Study C4661001 due to strategic considerations PF-07225570 Alone or in Combination With an Anti-PD-1 Antibody in Recurrent Non-muscle Invasive Bladder Cancer (NMIBC) | ClinicalTrials.gov Identifier: NCT05259397 |
Recruitment Status : Withdrawn (Pfizer has decided to terminate Study C4661001 due to strategic considerations. This decision is not due to any specific safety reasons or requests from any regulatory authorities. No participants have been enrolled in this study.) First Posted : February 28, 2022 Last Update Posted : October 24, 2022 |