NPS IND dashboard

4 open chemical decisions

Lys position

Lys11HomoLysHomoHomoLysOrnithineLys12

v40.22 (Lys11) vs v40.9 (HomoLys11) head-to-head; v40.24 / v40.25 extra reach reads

KAN-87 KAN-88

Chain length

C16C18 satC18:1C20

C16 over-covered. v40.4 reads C18:1. C20 + saturated C18 are KAN gap-fills.

KAN-90 KAN-92

Truncation

1-201-131-12

Covered on both Nle11 (v40.2 / v40.3) and HomoLys11 (v40.10 / v40.11) scaffolds.

no linked tickets

C-terminus

-NH2-OH (free acid)

Only -NH2 in current queue. -OH gap-fill filed.

KAN-91

IND stages at a glance

Stage	Open	Overdue	Next due
Lead optimization	12	0	2026-07-06
Stability + degradation	1	0	2026-08-14
PK (methods · studies · scaling/HED · PK-PD)	16	3	2026-06-26
Safety + immunogenicity	3	0	2026-07-21
GLP / CMC outsourcing	7	0	2026-09-08
Regulatory (AU CTN)	2	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
Compound	Qty	Synth	IP1 (107I)	IP1 (107N)	FLIPR (107I)	FLIPR (107N)	bArr (107N)	cAMP (107N)	SC actigraphy	EEG	PK plasma	PK CSF/brain	Stability (LC-MS)
`NPSv40.9` ANCHOR · 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
`NPSv40.22` Lys 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
`NPSv40.24` Lys 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
`NPSv40.25` Lys 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
`NPSv40.10` Truncation · 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	—	—	—	—
`NPSv40.11` Truncation · 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	—	—	—	—
`NPSv40.2` Truncation · 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	—	—	—	—
`NPSv40.3` Truncation · 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	—	—	—	—
`NPSv41.1` C-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	—
`NPSv40.23` Secondary · 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	—	—	—	—	—
`NPSv40.4` Chain length · C18:1 analog of v40.22 (Lys11, 1-20) — cell assays + in-vivo pending	not tracked	not in tracker	—	—	—	—	—	—	—	—	—	—	—
`NPSv41.12` Chain 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	—	—	—	—
`NPSv41.7` Chain 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	—	—	—	—
`NPSv41.8` Chain 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

1 open 0 done

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)

16 open 3 overdue 0 done

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

3 open 0 done

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

7 open 0 done