(Total Views: 592)
Posted On: 02/06/2020 4:32:10 PM
Post# of 154857
06 02 2020 CC Notes (First draft)
> Update on cancer studies, BTD etc.
3 options for enrollment: (1) TNBC Phase 1b/2: if inclusion criteria met; (2) Compassionate use or expanded access if criteria non met; (3) single emergency IND
Currently enrolled: six patients; results for four patients
No. 1: Sept 27 2019; in 2 weeks CTC 5 to 0; CTC zero the following months; shrinking of primary tumour
No. 2 (MIL): Her2+, metastasis to lung, brains, liver; lesions in brain shrunk by 56%; radiation stopped
No. 3: Jan 7, 2 weeks later: CTC 9 to 2
No. 4: TO BE ADDED
Enrollment: patients 5-6 enrolled; 4 screened that could be enrolled during the next 2-3 weeks.
BTD filing: Jan 10; updated FDA with patients, might re-start clock
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
> Update on Coronavirus: Licensing of leronlimab for cancer in China
> Signed a non-binding agreement for cancer and coronavirus with a large biopharma group in China.
> Idea: adjunct to CAR-T therapy; leronlimab on its own; MOA of leronlimab against corona (.e.g. inhibiting macrophages into the coronavirus lesions); partner went through channels in Chinese FDA.
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
> Update on basket trial
- Few weeks to get IRB on board; by end of this month everyone should be able to enroll; number of interested patients increased to 70.
- „Naysayers can stop their activities after these data hit“ (lol)
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
> BLA
- BLA clinical part delayed until end of February; manufacturing delayed until February too.
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Communication with BPs
> for PrEP
> in Europe
> Thai Red Cross study funded, going forward
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Fundraising
> Balance of debt and stock financing
> Notes have been fully retired
> Warrants have been exercised
> Update on cancer studies, BTD etc.
3 options for enrollment: (1) TNBC Phase 1b/2: if inclusion criteria met; (2) Compassionate use or expanded access if criteria non met; (3) single emergency IND
Currently enrolled: six patients; results for four patients
No. 1: Sept 27 2019; in 2 weeks CTC 5 to 0; CTC zero the following months; shrinking of primary tumour
No. 2 (MIL): Her2+, metastasis to lung, brains, liver; lesions in brain shrunk by 56%; radiation stopped
No. 3: Jan 7, 2 weeks later: CTC 9 to 2
No. 4: TO BE ADDED
Enrollment: patients 5-6 enrolled; 4 screened that could be enrolled during the next 2-3 weeks.
BTD filing: Jan 10; updated FDA with patients, might re-start clock
–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
> Update on Coronavirus: Licensing of leronlimab for cancer in China
> Signed a non-binding agreement for cancer and coronavirus with a large biopharma group in China.
> Idea: adjunct to CAR-T therapy; leronlimab on its own; MOA of leronlimab against corona (.e.g. inhibiting macrophages into the coronavirus lesions); partner went through channels in Chinese FDA.
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
> Update on basket trial
- Few weeks to get IRB on board; by end of this month everyone should be able to enroll; number of interested patients increased to 70.
- „Naysayers can stop their activities after these data hit“ (lol)
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
> BLA
- BLA clinical part delayed until end of February; manufacturing delayed until February too.
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Communication with BPs
> for PrEP
> in Europe
> Thai Red Cross study funded, going forward
––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––
Fundraising
> Balance of debt and stock financing
> Notes have been fully retired
> Warrants have been exercised
(6)
(0)
