all the initiatves from webcast:
1) mss ongoing trial
> rollover amendment was just submitted
> amendment also includes extension study beyond the original 12 months dosing
2) mss pilot front line with HAI via city of hope
> about to submit protocol to fda
> will include ctDNA data of leron as monotherapy prior to HAI
3) mss another 3rd party might initiate a pilot specifically combining leron and ICI in earlier lines of treatment
4) tnbc p1 and p2 collaboration with the breast cancer network
> PRE-I-SPY and I-SPY 2 programs to facilitate a well-designed and accelerated pathway to a p3 trial
> phase 1 is dose escalation / phase 2 is ICI. i think he said phase 2b/3.
> phase 1 is "weeks to months" away. that was his favorite phrase today.
5) tnbc EAP underway,
> we are "measuring PD-L1" he said.
6) tnbc a monotherapy neo-adjuvant (prior to surgery) trial collaboration with breast cancer network again
***** NOTE THAT'S 3 TRACKS IN MSS AND ALSO 3 TRACKS IN TNBC *****
***** MSS 1) combo in heavily treated w SOC and perhaps also adding ICI, 2) mono neoadjuvant to HAI, 3) earlier lines (front line?) w ICI *****
***** TNBC 1) combo in heavily treated with ICI, 2) EAP measuring PD-L1 and i guess(?) followed by ICI?, 3) mono neoadjuvant to surgery
7) GBM preclinical
GBM pilot
> rough draft of protocol
9) alzheimers is screening
10) stroke preclinical
*****
***** 11) 12) other potential pilots in TWO OTHER CANCERS, different from those cancers above *****
*****
13) fast track and or BTD application process will take place throughout 2026
14) MSS data update this summer
15) ESMO spain in october (this is the biggie as far as oncology conferences)
16) ASCO-GI january - MSS "final data" perhaps - that means ORR for 60 patients.
> dosing continues, more data well into 2027
X) dose-finding was one of the more interesting aspects of the webcast
1) mss ongoing trial
> rollover amendment was just submitted
> amendment also includes extension study beyond the original 12 months dosing
2) mss pilot front line with HAI via city of hope
> about to submit protocol to fda
> will include ctDNA data of leron as monotherapy prior to HAI
3) mss another 3rd party might initiate a pilot specifically combining leron and ICI in earlier lines of treatment
4) tnbc p1 and p2 collaboration with the breast cancer network
> PRE-I-SPY and I-SPY 2 programs to facilitate a well-designed and accelerated pathway to a p3 trial
> phase 1 is dose escalation / phase 2 is ICI. i think he said phase 2b/3.
> phase 1 is "weeks to months" away. that was his favorite phrase today.
5) tnbc EAP underway,
> we are "measuring PD-L1" he said.
6) tnbc a monotherapy neo-adjuvant (prior to surgery) trial collaboration with breast cancer network again
***** NOTE THAT'S 3 TRACKS IN MSS AND ALSO 3 TRACKS IN TNBC *****
***** MSS 1) combo in heavily treated w SOC and perhaps also adding ICI, 2) mono neoadjuvant to HAI, 3) earlier lines (front line?) w ICI *****
***** TNBC 1) combo in heavily treated with ICI, 2) EAP measuring PD-L1 and i guess(?) followed by ICI?, 3) mono neoadjuvant to surgery
7) GBM preclinical
GBM pilot > rough draft of protocol
9) alzheimers is screening
10) stroke preclinical
*****
***** 11) 12) other potential pilots in TWO OTHER CANCERS, different from those cancers above *****
*****
13) fast track and or BTD application process will take place throughout 2026
14) MSS data update this summer
15) ESMO spain in october (this is the biggie as far as oncology conferences)
16) ASCO-GI january - MSS "final data" perhaps - that means ORR for 60 patients.
> dosing continues, more data well into 2027
X) dose-finding was one of the more interesting aspects of the webcast
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