4 open chemical decisions
Lys position
v40.22 (Lys11) vs v40.9 (HomoLys11) head-to-head; v40.24 / v40.25 extra reach reads
Chain length
C16 over-covered. v40.4 reads C18:1. C20 + saturated C18 are KAN gap-fills.
Truncation
Covered on both Nle11 (v40.2 / v40.3) and HomoLys11 (v40.10 / v40.11) scaffolds.
no linked tickets
IND stages at a glance
| Stage | Open | Overdue | Done | Next due |
|---|---|---|---|---|
| Lead optimization | 12 | 0 | 0 | 2026-07-06 |
| Stability + degradation | 1 | 0 | 0 | 2026-08-14 |
| PK (methods · studies · scaling/HED · PK-PD) | 16 | 3 | 0 | 2026-06-26 |
| Safety + immunogenicity | 3 | 0 | 0 | 2026-07-21 |
| GLP / CMC outsourcing | 7 | 0 | 0 | 2026-09-08 |
| Regulatory (AU CTN) | 2 | 0 | 0 | 2026-09-15 |
Active studies (preclin.study)
| Study | Title | Status | Owner | Updated |
|---|---|---|---|---|
STU-olden-dl-dmuo-st0067 | NPSv40.9 1000ug vs. NPSv40.9 500ug vs. NPSv40.9 200ug vs. NPSv40.9 100ug vs. Placebo, subq, 100ul, 0.9% saline, n = 15 | executing | — | 2026-07-01 |
STU-olden-dl-lr5i-st0076 | NPSv41.8 500ug vs. NPSv41.20 500ug vs. Placebo, 0.9% saline, SQ, n = 15 | executing | — | 2026-07-01 |
STU-olden-dl-bnkz-st0003 | NPSv40.2 100ug vs. NPSv40.17 100ug vs. NPSv40.3 100ug vs. NPSv40.5 100ug vs. Placebo, IN, 100ug, 0.25% TMC, 5% HP-beta-cyclodextrin, n = 20 | executing | — | 2026-07-01 |
STU-olden-dl-qmlo-st0075 | NPSv40.9 1000ug vs. NPSv40.9 500ug vs. NPSv41.7 1000ug vs. NPSv41.7 500ug vs. Placebo, subq, n = 15 | executing | — | 2026-07-01 |
STU-olden-dl-nbtc-st0044 | NPSv40.9 25ug vs. NPSv40.9 50ug vs. NPSv40.9 100ug vs. NPSv40.9 200ug vs. Placebo, IN, 0.25% TMC, 10uL, n = 15 | executing | — | 2026-07-01 |
STU-olden-dl-hga4-st0078 | NPSv41.18 500ug vs. NPSv41.13 500ug vs. NPSv40.9 500ug vs. Placebo, SQ, 0.9% saline, n = 15 | executing | — | 2026-07-01 |
STU-olden-dl-fswz-st0077 | NPSv41.21 500ug vs. NPSv41.12 500ug vs. NPSv41.8 500ug vs. Placebo, 0.9% saline, subQ, n = 15 | executing | — | 2026-07-01 |
STU-26-NPS-20260629-001 KAN-87 | Lead-lock same-plate IP1 for NPSR1 107I and 107N coverage | locked | iris | 2026-06-30 |
STU-26-NPS-20260629-003 KAN-89 | Accelerated LC-MS stability triage for NPS lead-lock pair | locked | iris | 2026-06-30 |
STU-26-NPS-20260629-002 KAN-88 | Human albumin functional-shift screen for lipidated NPS leaders | locked | iris | 2026-06-30 |
STU-26-NPS-20260703-003 KAN-123 | Same-plate IP1 and cAMP bridge for the v40 terminal-state comparator pair | draft | iris | 2026-07-03 |
STU-26-NPS-20260703-002 KAN-122 | Fast LC-MS degradation spot-check for NPSv41 hits versus v40 lead-lock comparators | draft | iris | 2026-07-03 |
STU-26-NPS-20260703-001 KAN-121 | Same-plate IP1 and beta-arrestin triage for NPSv41 low-Emax potency hits | draft | iris | 2026-07-03 |
STU-26-NPS-20260702-002 KAN-115 | Same-plate 107I/107N IP1 bridge for full-Emax NPS backups | draft | iris | 2026-07-03 |
STU-26-NPS-20260702-001 KAN-114 | Same-plate 107I/107N IP1 bridge for NPSv41 potency versus Emax ceiling | draft | iris | 2026-07-03 |
STU-260701-NPSv417-PKADME | NPSv41.7 — SQ/IN PK/ADME, acute + day-14 terminal plasma/brain | draft | melissa | 2026-07-02 |
STU-26-NPS-20260630-002 KAN-109 | Same-plate IP1 and beta-arrestin separation screen for v40 leaders | draft | iris | 2026-06-30 |
STU-26-NPS-20260630-001 KAN-108 | Same-plate 107I/107N IP1 bridge for NPSv40.24 lead inclusion | draft | iris | 2026-06-30 |
Overdue across all stages (6)
| Key | Status | Due | Assignee | Vendor | CRO progress | Summary |
|---|---|---|---|---|---|---|
| KAN-20 | Idea | 2026-06-22 | Moaraj Hasan | no vendor | pick vendor (-11d to due) | SPPS synthesis - NPS 40.9 |
| KAN-24 | Idea | 2026-06-26 | Moaraj Hasan | no vendor | pick vendor (-7d to due) | PK study design + AEC (Animal Ethics Committee) protocol (mouse single-dose IV/SC) |
| KAN-21 | Idea | 2026-06-26 | Moaraj Hasan | no vendor | pick vendor (-7d to due) | RP-HPLC purification + lyophilization (NXN + NPS) |
| KAN-16 | Idea | 2026-06-26 | Moaraj Hasan | no vendor | pick vendor (-7d to due) | Peptide Synthesis & Purification |
| KAN-29 | Idea | 2026-06-30 | Moaraj Hasan | no vendor | pick vendor (-3d to due) | Reference standards, IS qualification + stock/working solutions |
| KAN-25 | Idea | 2026-06-30 | Moaraj Hasan | no vendor | pick vendor (-3d to due) | Dose formulation, dose verification, and vehicle bridging |
Compound × complete-assay coverage
"Complete" assay set: 107I IP1 · 107N IP1 · 107I FLIPR · 107N FLIPR · bArr · cAMP — same-plate, same-producer-batch.
Cells show best EC50 in nM and run count. Empty cells (—) are missing reads.
| Compound | Qty | Synth | In-vitro (cell assays) | In-vivo + stability | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IP1 (107I) | IP1 (107N) | FLIPR (107I) | FLIPR (107N) | bArr (107N) | cAMP (107N) | SC actigraphy | EEG | PK plasma | PK CSF/brain | Stability (LC-MS) | |||
NPSv40.9ANCHOR · Lead candidate — HomoLys11, 1-20, -NH2 — in all three head-to-heads SF(Nω-methyl-Arg)N(Sar)VGTG(N-Me-Nle)(HomoLys)-K[(γ-E)-(C16 Pal)]-TSFQRAKS-NH2 | not tracked | through HPLC | 0.00 nM · n=16 | 0.03 nM · n=18 | 0.62 nM · n=1 | 0.17 nM · n=2 | 1.47 nM · n=3 | 0.12 nM · n=4 | 0-6h: -33% sleep (NPSv41.18 500ug) 0-24h: -28% sleep (NPSv41.18 500ug) DL-HGA4-st0078 · 12 Olden runs · latest 2026-06-29 | post-lock | post-lock | post-lock | planned |
NPSv40.22Lys position · Lys11 SF(Nomega-methyl-Arg)N(Sar)VGTG(N-Me-Nle)K-K[(gamma-E)-(C16 Pal)]-TSFQRAKS-NH2 | — | partial | 0.05 nM · n=6 | 0.10 nM · n=7 | — | — | — | 2.79 nM · n=2 | planned | post-lock | post-lock | post-lock | planned |
NPSv40.24Lys position · HomoHomoLys11 (secondary — extra reach) SF(Nomega-methyl-Arg)N(Sar)VGTG(N-Me-Nle)(HomoHomoLys)-K[(gamma-E)-(C16 Pal)]-TS… | not tracked | partial | 0.06 nM · n=6 | 0.07 nM · n=10 | — | — | 1.85 nM · n=1 | 5.42 nM · n=2 | planned | post-lock | post-lock | post-lock | planned |
NPSv40.25Lys position · Ornithine11 (secondary) SF(Nomega-methyl-Arg)N(Sar)VGTG(N-Me-Nle)(Orn)-K[(gamma-E)-(C16 Pal)]-TSFQRAKS-N… | not tracked | through HPLC | 0.12 nM · n=8 | 0.16 nM · n=8 | — | — | 2.75 nM · n=1 | 7.53 nM · n=1 | planned | post-lock | post-lock | post-lock | planned |
NPSv40.10Truncation · 1-13, HomoLys11 scaffold SF(Nω-methyl-Arg)N(Sar)VGTG(N-Me-Nle)(HomoLys)-K[(γ-E)-(C16 Pal)]-T-NH2 | not tracked | SPPS complete; awaiting HPLC/MS | 0.11 nM · n=9 | 0.23 nM · n=3 | — | — | — | — | 0-6h: +22% sleep (EEG NPSv40.10 100ug) 0-24h: +71% sleep (EEG NPSv40.10 100ug) DL-arPA-st0046 · 2 Olden runs · latest 2026-06-01 | — | — | — | — |
NPSv40.11Truncation · 1-12, HomoLys11 scaffold (verify material quantity) SF(Nω-methyl-Arg)N(Sar)VGTG(N-Me-Nle)(HomoLys)-K[(γ-E)-(C16 Pal)]-NH2 | not tracked | through HPLC | 0.09 nM · n=9 | 0.16 nM · n=3 | — | — | — | — | planned | — | — | — | — |
NPSv40.2Truncation · 1-13, Lys11 scaffold SF(Nω-methyl-Arg)N(Sar)VGTGM(Nle)-K[(γ-E)-(C16 Pal)]-T-NH2 | not tracked | SPPS complete; awaiting HPLC/MS | 17.29 nM · n=3 | — | — | — | — | — | 0-6h: +27% sleep (NPSv40.5 100ug) 0-24h: +25% sleep (NPSv40.5 100ug) DL-BNkZ-st0003 · 1 Olden runs · latest 2026-05-01 | — | — | — | — |
NPSv40.3Truncation · 1-12, Lys11 scaffold SF(Nω-methyl-Arg)N(Sar)VGTGM(Nle)-K[(γ-E)-(C16 Pal)]-NH2 | not tracked | through HPLC | — | — | — | — | — | — | 0-6h: +27% sleep (NPSv40.5 100ug) 0-24h: +25% sleep (NPSv40.5 100ug) DL-BNkZ-st0003 · 1 Olden runs · latest 2026-05-01 | — | — | — | — |
NPSv41.1C-terminus · -OH variant of v40.9 — critical for in-vivo effect-life decision SF(Nomega-methyl-Arg)N(Sar)VGTG(N-Me-Nle)(HomoLys)-K[(gamma-E)-(C16 Pal)]-TSFQRA… | not tracked | through HPLC | 0.04 nM · n=5 | 0.17 nM · n=5 | — | — | — | — | 0-6h: -33% sleep (NPSv41.18 500ug) 0-24h: -28% sleep (NPSv41.18 500ug) DL-HGA4-st0078 · 2 Olden runs · latest 2026-06-29 | post-lock | post-lock | post-lock | — |
NPSv40.23Secondary · Nω,Nω-dimethyl-Arg3 — add to cell assays where available (lower priority) SF(Nomega,Nomega-dimethyl-Arg)N(Sar)VGTG(N-Me-Nle)(HomoLys)-K[(gamma-E)-(C16 Pal… | not tracked | partial | 0.05 nM · n=8 | 0.55 nM · n=6 | — | — | 4.99 nM · n=1 | 4.76 nM · n=1 | — | — | — | — | — |
NPSv40.4Chain length · C18:1 analog of v40.22 (Lys11, 1-20) — cell assays + in-vivo pending | not tracked | not in tracker | — | — | — | — | — | — | — | — | — | — | — |
NPSv41.12Chain length · C20 + 1-13 truncation, Lys11, -NH2 — in-vivo data in hand SF(Nomega-methyl-Arg)N(Sar)VGTGMK-K[(gamma-E)-(C20)]-T-NH2 | not tracked | partial | — | 0.14 nM · n=2 | — | — | 15.68 nM · n=1 | — | 0-6h: -82% sleep (NPSv41.8 500ug) 0-24h: -73% sleep (NPSv41.8 500ug) DL-fsWz-st0077 · 1 Olden runs · latest 2026-06-27 | — | — | — | — |
NPSv41.7Chain length · C20 analog of v40.9 — HomoLys11, 1-20, -NH2 — in-vivo data in hand SF(Nomega-methyl-Arg)N(Sar)VGTG(N-Me-Nle)(HomoLys)-K[(gamma-E)-(C20)]-TSFQRAKS-N… | not tracked | partial | 0.06 nM · n=4 | 0.12 nM · n=7 | — | — | — | — | 0-6h: -94% sleep (NPSv40.9 500ug) 0-24h: -77% sleep (NPSv41.7 1000ug) DL-QMLo-st0075 · 2 Olden runs · latest 2026-06-25 | — | — | — | — |
NPSv41.8Chain length · C20 + 1-13 truncation, HomoLys11, -NH2 — in-vivo data in hand SF(Nomega-methyl-Arg)N(Sar)VGTG(N-Me-Nle)(HomoLys)-K[(gamma-E)-(C20)]-T-NH2 | not tracked | partial | 0.11 nM · n=2 | 0.08 nM · n=6 | — | — | — | 1.17 nM · n=1 | 0-6h: -82% sleep (NPSv41.8 500ug) 0-24h: -73% sleep (NPSv41.8 500ug) DL-fsWz-st0077 · 2 Olden runs · latest 2026-06-27 | — | — | — | — |
Planned SC mouse studies (@Jigisha)
| Study | Arms | Status / note |
|---|---|---|
| Lys11 SC study | NPSv40.9 · NPSv40.22 · NPSv40.24 · NPSv40.25 | @Jigisha — n≥20/group, 1-page plan, verify material first |
| Truncation SC study | NPSv40.9 · NPSv40.10 · NPSv40.11 · NPSv40.2 · NPSv40.3 | @Jigisha — n≥20/group, 1-page plan, verify material first |
| C-terminus SC study | NPSv40.9 · NPSv41.1 | @Jigisha — critical for finalising -NH2 vs -OH on in-vivo effect-life |
Synthesis workstream (@Nico, @Hillary)
Chemistry ask (@Nico): one clean ≥95% pure in-house batch each of v40.9, v40.22, v40.24, v40.25, v41.1.
| Key | Status | Due | Assignee | Vendor | CRO progress | Summary |
|---|---|---|---|---|---|---|
| KAN-20 | Idea | 2026-06-22 | Moaraj Hasan | in-house | in-house | SPPS synthesis - NPS 40.9 |
| KAN-21 | Idea | 2026-06-26 | Moaraj Hasan | in-house | in-house | RP-HPLC purification + lyophilization (NXN + NPS) |
| KAN-16 | Idea | 2026-06-26 | Moaraj Hasan | in-house | in-house | Peptide Synthesis & Purification |
Analytical QC workstream (@Mo)
| Key | Status | Due | Assignee | Vendor | CRO progress | Summary |
|---|---|---|---|---|---|---|
| KAN-17 | Idea | 2026-07-03 | Moaraj Hasan | in-house | in-house | Analytical QC / Mass Spec ID |
In-vitro potency workstream (@Stephen)
| Key | Status | Due | Assignee | Vendor | CRO progress | Summary |
|---|---|---|---|---|---|---|
| KAN-23 | Idea | 2026-07-17 | Moaraj Hasan | in-house | in-house | NPSR1 IP1 EC50 assay — NPS 40.9 |
| KAN-18 | Idea | 2026-07-17 | Moaraj Hasan | in-house | in-house | In-vitro Potency (OX2 IP1 / EC50) |
Mechanism + efficacy workstream (in-vitro target engagement, selectivity panel)
| Key | Status | Due | Assignee | Vendor | CRO progress | Summary |
|---|---|---|---|---|---|---|
| KAN-40 | Idea | 2026-07-15 | Moaraj Hasan | in-house | in-house | In-vitro target engagement + selectivity panel |
| KAN-41 | Idea | 2026-08-05 | Moaraj Hasan | in-house | in-house | In-vivo efficacy / target-engagement model (mouse) |
| KAN-42 | Idea | 2026-08-31 | Moaraj Hasan | in-house | in-house | Mechanism-of-action omics readout + brain exposure |
Filed Iris gap-fills (review needed)
Some of these are now redundant with the 2026-06-30 state-of-the-union — see notes.
| KAN | Axis | Status / note |
|---|---|---|
| KAN-90 | Chain length | C20 lipid analog — realized as NPSv41.7 (HomoLys11) and NPSv41.8/v41.12 (truncated); in-vivo data confirmed, compounds promoted to LEAD_OPT_TABLE |
| KAN-91 | C-terminus | Free-acid (-OH) analog — already in flight as NPSv41.1; close as duplicate |
| KAN-92 | Chain length | Saturated C18 analog — DEFER (future-NPS lever) |
| KAN-93 | CMC | CMC + accelerated-degradation — re-scope as external-contractor work (Helena owns) |
Active engagements (38)
Populated from preclin.cro_capability — writes flow from forwarded CRO emails + Slack
@iris cro.| Vendor | Workstream | Status | Owner | CRO progress | Last engagement | Notes |
|---|---|---|---|---|---|---|
| Avance | clinical_phase_1_cro | RFQ sent | melissa | RFQ sent · Being asked whether same batch should support tox | — | Being asked whether same batch should support tox and Phase I for TGA; no contra |
| Novotech | clinical_phase_1_cro | RFQ sent | melissa | RFQ sent · Being asked whether same batch should support tox | — | Being asked whether same batch should support tox and Phase I for TGA; no contra |
| ApiSyn Healthcare | cmc_drug_substance_gmp | MSA | melissa | MSA signed · CDA signed and peptide sequence shared; follow-up | — | CDA signed and peptide sequence shared; follow-up needed for calls. |
| Aurigene Pharmaceutical Services | cmc_drug_substance_gmp | no contract | melissa | no_contract | — | Responsive initial contact; Helena and Nico to meet team once specifications are |
| Biocon | cmc_drug_substance_gmp | no contract | melissa | no_contract | 2026-06-02 | Call completed; judged not suitable due to large scale and fewer drug discovery |
| CPC Scientific | cmc_drug_substance_gmp | quote in | melissa | Quote in · Quoted for drug substance manufacturing but reject | — | Quoted for drug substance manufacturing but rejected because pricing was about 3 |
| Laurus Labs | cmc_drug_substance_gmp | RFQ sent | melissa | RFQ sent · Capable NDA shared; awaiting signature before disc | — | Capable NDA shared; awaiting signature before discussing needs. |
| Piramal Pharma Solutions | cmc_drug_substance_gmp | quote in | melissa | Quote in · Timeline quoted as 18 weeks; awaiting cost, NT to | — | Timeline quoted as 18 weeks; awaiting cost, NT to chase. |
| PolyPeptide Group | cmc_drug_substance_gmp | expired | melissa | expired 2026-02-11 | 2026-02-11 | Selected manufacturing vendor for non-GMP Strasbourg drug substance batch; CDA s |
| Ramshan Lifesciences | cmc_drug_substance_gmp | no contract | melissa | no_contract | — | No response to calls, emails, and website outreach. |
| Sinopep | cmc_drug_substance_gmp | quote in | melissa | Quote in · Quoted or evaluated for drug substance manufacturi | — | Quoted or evaluated for drug substance manufacturing but rejected as over-scoped |
| Syngene | cmc_drug_substance_gmp | quote in | melissa | Quote in · Biocon CDMO; very responsive, quick to call and co | — | Biocon CDMO; very responsive, quick to call and connect. Waiting for quote after |
| VB Shilpa | cmc_drug_substance_gmp | quote in | melissa | Quote in · Chased Shriya, VP BD; non-responsive as of 2026-06 | 2026-06-02 📧 | Chased Shriya, VP BD; non-responsive as of 2026-06-02. |
| Viva Biotech | cmc_drug_substance_gmp | quote in | melissa | Quote in · Quotation DPT-251219 received for Viva CDMO/PPO gr | — | Quotation DPT-251219 received for Viva CDMO/PPO group to produce at least 500 mg |
| VivaBiotech | cmc_drug_substance_gmp | quote in | melissa | Quote in · Quoted tox-only and full manufacturing options, bu | — | Quoted tox-only and full manufacturing options, but tox batch alone was judged i |
| WuXi TIDES | cmc_drug_substance_gmp | expired | melissa | expired | — | Considered for drug substance manufacturing but rejected due to 16-18 week timel |
| PolyPeptide Group | cmc_ich_q1a_stability | expired | melissa | expired 2026-02-11 | 2026-02-11 | Optional non-GMP stability study proposed for the non-GMP batch at -20C, 5C, and |
| Viva Biotech | cmc_ich_q1a_stability | quote in | melissa | Quote in · Viva quotation includes stability study reports am | — | Viva quotation includes stability study reports among documentation deliverables |
| Charles River Laboratories | genotox_ames | quote in | melissa | Quote in · Charles River SOW OPP-423634 includes Bacterial Re | 2026-05-12 📧 | Charles River SOW OPP-423634 includes Bacterial Reverse Mutation Test (Ames) at |
| WuXi AppTec (HongKong) Limited / XenoBiotic Laboratories, Inc | genotox_ames | quote in | melissa | Quote in · Quotation includes a GLP FDA/OECD bacterial revers | — | Quotation includes a GLP FDA/OECD bacterial reverse mutation assay. |
| Charles River Laboratories | genotox_micronucleus | quote in | melissa | Quote in · Charles River SOW OPP-423634 includes In Vitro Mam | 2026-05-12 📧 | Charles River SOW OPP-423634 includes In Vitro Mammalian Cell Micronucleus Test |
| WuXi AppTec (HongKong) Limited / XenoBiotic Laboratories, Inc | genotox_micronucleus | quote in | melissa | Quote in · Quotation includes a GLP FDA/OECD in vivo peripher | — | Quotation includes a GLP FDA/OECD in vivo peripheral blood micronucleus assay in |
| IIT Research Institute | glp_tox_non_rodent | quote in | melissa | Quote in · IITRI provided a cost estimate for 14- and 28-day | 2026-01-05 | IITRI provided a cost estimate for 14- and 28-day GLP repeat-dose intranasal tox |
| Pharmaron, Inc. | glp_tox_non_rodent | quote in | melissa | Quote in · Formal quotation received for non-rodent toxicolog | 2026-01-22 | Formal quotation received for non-rodent toxicology options including dog, prima |
| WuXi AppTec (HongKong) Limited / XenoBiotic Laboratories, Inc | glp_tox_non_rodent | quote in | melissa | Quote in · Quotation covers GLP FDA/OECD repeated intranasal | — | Quotation covers GLP FDA/OECD repeated intranasal dose toxicity and toxicokineti |
| Charles River Laboratories | glp_tox_rodent | no contract | melissa | no_contract | 2026-06-30 📧 | Toxicology decision debrief recommends Sprague-Dawley rats plus Beagle dogs for |
| IIT Research Institute | glp_tox_rodent | quote in | melissa | Quote in · IITRI provided a cost estimate for 14- and 28-day | 2026-01-05 | IITRI provided a cost estimate for 14- and 28-day GLP repeat-dose intranasal tox |
| Pharmaron, Inc. | glp_tox_rodent | quote in | melissa | Quote in · Formal quotation received for GLP rat repeat-dose | 2026-01-22 | Formal quotation received for GLP rat repeat-dose toxicity/TK studies, including |
| WuXi AppTec (HongKong) Limited / XenoBiotic Laboratories, Inc | glp_tox_rodent | quote in | melissa | Quote in · Quotation covers GLP FDA/OECD repeated intranasal | — | Quotation covers GLP FDA/OECD repeated intranasal dose toxicity and toxicokineti |
| IIT Research Institute | histology | quote in | melissa | Quote in · IITRI GLP tox estimates include histology/patholog | 2026-01-05 | IITRI GLP tox estimates include histology/pathology processing and microscopic e |
| Pharmaron, Inc. | histology | quote in | melissa | Quote in · Quotation includes histopathology processing/evalu | 2026-01-22 | Quotation includes histopathology processing/evaluation options by a DACVP patho |
| iHisto Inc. | histology | PO | melissa | PO live · Safety tissues shipped to iHisto Inc. (Salem, MA) | 2026-06-30 📧 | Safety tissues shipped to iHisto Inc. (Salem, MA) via UPS Next Day Air Early on |
| Charles River Laboratories | safety_pharm_ich_s7a | quote in | melissa | Quote in · Quote received for hERG/genotox vendor evaluation. | 2026-06-30 📧 | Quote received for hERG/genotox vendor evaluation. |
| Cyprotex | safety_pharm_ich_s7a | RFQ sent | melissa | RFQ sent · NDA shared from Capable for hERG/genotox vendor ev | — | NDA shared from Capable for hERG/genotox vendor evaluation. |
| IIT Research Institute | safety_pharm_ich_s7a | quote in | melissa | Quote in · IITRI dog repeat-dose GLP tox estimates include ca | 2026-01-05 | IITRI dog repeat-dose GLP tox estimates include cardiovascular/ECG assessments e |
| Pharmalegacy | safety_pharm_ich_s7a | RFQ sent | melissa | RFQ sent · Quote requested for hERG/genotox vendor evaluation | — | Quote requested for hERG/genotox vendor evaluation. |
| Pharmaron, Inc. | safety_pharm_ich_s7a | quote in | melissa | Quote in · Quotation includes safety pharmacology-relevant en | 2026-01-22 | Quotation includes safety pharmacology-relevant endpoints embedded in GLP tox de |
| WuXi AppTec (HongKong) Limited / XenoBiotic Laboratories, Inc | safety_pharm_ich_s7a | quote in | melissa | Quote in · Quotation includes a GLP FDA/OECD hERG assay using | — | Quotation includes a GLP FDA/OECD hERG assay using the manual patch-clamp platfo |
Open gaps (13) — KAN tickets with no contracted vendor
| KAN | Due | Assignee | Summary |
|---|---|---|---|
| KAN-40 | 2026-07-15 | Moaraj Hasan | In-vitro target engagement + selectivity panel |
| KAN-43 | 2026-07-21 | Moaraj Hasan | In-vitro safety pharmacology (hERG, cardiovascular liability) |
| KAN-41 | 2026-08-05 | Moaraj Hasan | In-vivo efficacy / target-engagement model (mouse) |
| KAN-44 | 2026-08-10 | Moaraj Hasan | Immunogenicity / ADA assay strategy + in-silico risk |
| KAN-45 | 2026-08-31 | Moaraj Hasan | GLP tox study design + DART deferral justification |
| KAN-42 | 2026-08-31 | Moaraj Hasan | Mechanism-of-action omics readout + brain exposure |
| KAN-71 | 2026-09-08 | Moaraj Hasan | GMP clinical batch manufacture (API) + batch record + CoA |
| KAN-75 | 2026-09-15 | Moaraj Hasan | Clinical protocol + synopsis (FIH SAD) |
| KAN-69 | 2026-09-15 | Moaraj Hasan | Genotoxicity battery (Ames + in vitro micronucleus) |
| KAN-74 | 2026-09-22 | Moaraj Hasan | Author Investigator's Brochure (IB) |
| KAN-72 | 2026-09-22 | Moaraj Hasan | Drug product CMC: sterile injectable formulation, fill-finish, container-closure |
| KAN-68 | 2026-09-22 | Moaraj Hasan | GLP repeat-dose toxicology study (non-rodent) - execution + report |
| KAN-73 | 2026-09-29 | Moaraj Hasan | ICH Q1A stability program on clinical API + DP lots |
Stability + degradation
CRO progress (Drive): 📁 Manufacturing📁 Formulation
| Key | Status | Due | Assignee | Vendor | CRO progress | Summary |
|---|---|---|---|---|---|---|
| KAN-15 | Idea | 2026-08-14 | Moaraj Hasan | no vendor | pick vendor (42d to due) | Forced degradation study + impurity criteria |
PK (methods · studies · scaling/HED · PK-PD)
CRO progress (Drive): 📁 Preclinical development
| Key | Status | Due | Assignee | Vendor | CRO progress | Summary |
|---|---|---|---|---|---|---|
| KAN-24 | Idea | 2026-06-26 | Moaraj Hasan | no vendor | pick vendor (-7d to due) | PK study design + AEC (Animal Ethics Committee) protocol (mouse single-dose IV/SC) |
| KAN-29 | Idea | 2026-06-30 | Moaraj Hasan | no vendor | pick vendor (-3d to due) | Reference standards, IS qualification + stock/working solutions |
| KAN-25 | Idea | 2026-06-30 | Moaraj Hasan | no vendor | pick vendor (-3d to due) | Dose formulation, dose verification, and vehicle bridging |
| KAN-30 | Idea | 2026-07-08 | Moaraj Hasan | no vendor | pick vendor (5d to due) | Calibration curve + selectivity/specificity (ICH M10) |
| KAN-26 | Idea | 2026-07-10 | Moaraj Hasan | no vendor | pick vendor (7d to due) | In-life dosing + serial plasma collection (0-24 h timecourse) |
| KAN-31 | Idea | 2026-07-18 | Moaraj Hasan | no vendor | pick vendor (15d to due) | Accuracy + precision validation runs (within/between-run) |
| KAN-27 | Idea | 2026-07-18 | Moaraj Hasan | no vendor | pick vendor (15d to due) | Bioanalysis of PK samples on validated 6495D method |
| KAN-32 | Idea | 2026-07-22 | Moaraj Hasan | no vendor | pick vendor (19d to due) | Matrix effect, recovery, dilution integrity, carryover |
| KAN-35 | Idea | 2026-07-28 | Moaraj Hasan | no vendor | pick vendor (25d to due) | Cross-species in-vitro scaling inputs (clearance, binding, stability) |
| KAN-28 | Idea | 2026-07-31 | Moaraj Hasan | no vendor | pick vendor (28d to due) | Non-compartmental PK analysis + IV/SC parameter report |
| KAN-33 | Idea | 2026-08-08 | Moaraj Hasan | no vendor | pick vendor (36d to due) | Stability validation (stock, bench, freeze-thaw, long-term, autosampler) |
| KAN-36 | Idea | 2026-08-10 | Moaraj Hasan | no vendor | pick vendor (38d to due) | Allometric scaling model (CL, Vss) + human PK prediction |
| KAN-38 | Idea | 2026-08-10 | Moaraj Hasan | no vendor | pick vendor (38d to due) | PK/PD biomarker + exposure-response model build |
| KAN-37 | Idea | 2026-08-21 | Moaraj Hasan | no vendor | pick vendor (49d to due) | Human starting dose: MABEL + NOAEL/BSA HED + safety factor |
| KAN-34 | Idea | 2026-08-28 | Moaraj Hasan | no vendor | pick vendor (56d to due) | ICH M10 bioanalytical validation report sign-off |
| KAN-39 | Idea | 2026-08-28 | Moaraj Hasan | no vendor | pick vendor (56d to due) | Clinical dose-escalation scheme + projected exposure margins |
Safety + immunogenicity
CRO progress (Drive): 📁 Tox Studies
| Key | Status | Due | Assignee | Vendor | CRO progress | Summary |
|---|---|---|---|---|---|---|
| KAN-43 | Idea | 2026-07-21 | Moaraj Hasan | no vendor | pick vendor (18d to due) | In-vitro safety pharmacology (hERG, cardiovascular liability) |
| KAN-44 | Idea | 2026-08-10 | Moaraj Hasan | no vendor | pick vendor (38d to due) | Immunogenicity / ADA assay strategy + in-silico risk |
| KAN-45 | Idea | 2026-08-31 | Moaraj Hasan | no vendor | pick vendor (59d to due) | GLP tox study design + DART deferral justification |
GLP / CMC outsourcing
CRO progress (Drive): 📁 Manufacturing📁 Formulation
| Key | Status | Due | Assignee | Vendor | CRO progress | Summary |
|---|---|---|---|---|---|---|
| KAN-71 | Idea | 2026-09-08 | Moaraj Hasan | no vendor | pick vendor (67d to due) | GMP clinical batch manufacture (API) + batch record + CoA |
| KAN-69 | Idea | 2026-09-15 | Moaraj Hasan | no vendor | pick vendor (74d to due) | Genotoxicity battery (Ames + in vitro micronucleus) |
| KAN-67 | Idea | 2026-09-15 | Moaraj Hasan | Charles River Laboratories · no contract 📧 | no_contract | GLP repeat-dose toxicology study (rodent) - execution + report |
| KAN-72 | Idea | 2026-09-22 | Moaraj Hasan | no vendor | pick vendor (81d to due) | Drug product CMC: sterile injectable formulation, fill-finish, container-closure |
| KAN-70 | Idea | 2026-09-22 | Moaraj Hasan | Charles River Laboratories · quote in 📧 | Quote in · Quote received for hERG/genotox vendor evaluation. | Safety pharmacology core battery (ICH S7A: CV, CNS, respiratory) |
| KAN-68 | Idea | 2026-09-22 | Moaraj Hasan | no vendor | pick vendor (81d to due) | GLP repeat-dose toxicology study (non-rodent) - execution + report |
| KAN-73 | Idea | 2026-09-29 | Moaraj Hasan | no vendor | pick vendor (88d to due) | ICH Q1A stability program on clinical API + DP lots |
Regulatory (AU CTN)
CRO progress (Drive): 📁 Phase 1 trial
| Key | Status | Due | Assignee | Vendor | CRO progress | Summary |
|---|---|---|---|---|---|---|
| KAN-75 | Idea | 2026-09-15 | Moaraj Hasan | no vendor | pick vendor (74d to due) | Clinical protocol + synopsis (FIH SAD) |
| KAN-74 | In Progress | 2026-09-22 | Moaraj Hasan | no vendor | pick vendor (81d to due) | Author Investigator's Brochure (IB) |