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 | 0 | 0 | 0 | — |
| PK (methods · studies · scaling/HED · PK-PD) | 0 | 0 | 0 | — |
| Safety + immunogenicity | 0 | 0 | 0 | — |
| GLP / CMC outsourcing | 4 | 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-20260703-004 KAN-165 | Same-plate Gq and beta-arrestin bias gate for v40.9 and v41 challengers | draft | iris | 2026-07-03 |
STU-26-NPS-20260703-003 KAN-164 | Same-plate truncation check for v40.22-v40.25 versus v40.9 | draft | iris | 2026-07-03 |
STU-26-NPS-20260703-002 KAN-158 | Rapid LC-MS stability add-on for v41 challengers versus v40.9 | draft | iris | 2026-07-03 |
STU-26-NPS-20260703-001 KAN-157 | Same-plate 107I/107N IP1 triage of v41 challengers against v40.9 | 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 |
Overdue across all stages (0)
| Key | Status | Due | Assignee | Vendor | CRO progress | Summary |
|---|---|---|---|---|---|---|
| none | ||||||
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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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=16IP1 · hNPSR1 Ile107
| 0.03 nM · n=18IP1 · hNPSR1 Asn107
| 0.62 nM · n=1Ca2+ · hNPSR1 Ile107
| 0.17 nM · n=2Ca2+ · hNPSR1 Asn107
| 1.47 nM · n=3bArr · hNPSR1 Asn107
| 0.12 nM · n=4cAMP · hNPSR1 Asn107
| 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=6IP1 · hNPSR1 Ile107
| 0.10 nM · n=7IP1 · hNPSR1 Asn107
| — | — | — | 2.79 nM · n=2cAMP · hNPSR1 Asn107
| 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=6IP1 · hNPSR1 Ile107
| 0.07 nM · n=10IP1 · hNPSR1 Asn107
| — | — | 1.85 nM · n=1bArr · hNPSR1 Asn107
| 5.42 nM · n=2cAMP · hNPSR1 Asn107
| 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=8IP1 · hNPSR1 Ile107
| 0.16 nM · n=8IP1 · hNPSR1 Asn107
| — | — | 2.75 nM · n=1bArr · hNPSR1 Asn107
| 7.53 nM · n=1cAMP · hNPSR1 Asn107
| 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=9IP1 · hNPSR1 Ile107
| 0.23 nM · n=3IP1 · hNPSR1 Asn107
| — | — | — | — | 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=9IP1 · hNPSR1 Ile107
| 0.16 nM · n=3IP1 · hNPSR1 Asn107
| — | — | — | — | 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=3IP1 · hNPSR1 Ile107
| — | — | — | — | — | 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=5IP1 · hNPSR1 Ile107
| 0.17 nM · n=5IP1 · hNPSR1 Asn107
| — | — | — | — | 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=8IP1 · hNPSR1 Ile107
| 0.55 nM · n=6IP1 · hNPSR1 Asn107
| — | — | 4.99 nM · n=1bArr · hNPSR1 Asn107
| 4.76 nM · n=1cAMP · hNPSR1 Asn107
| — | — | — | — | — | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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=2IP1 · hNPSR1 Asn107
| — | — | 15.68 nM · n=1bArr · hNPSR1 Asn107
| — | 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=4IP1 · hNPSR1 Ile107
| 0.12 nM · n=7IP1 · hNPSR1 Asn107
| — | — | — | — | 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=2IP1 · hNPSR1 Ile107
| 0.08 nM · n=6IP1 · hNPSR1 Asn107
| — | — | — | 1.17 nM · n=1cAMP · hNPSR1 Asn107
| 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 |
|---|---|---|---|---|---|---|
| no tickets | ||||||
Analytical QC workstream (@Mo)
| Key | Status | Due | Assignee | Vendor | CRO progress | Summary |
|---|---|---|---|---|---|---|
| no tickets | ||||||
In-vitro potency workstream (@Stephen)
| Key | Status | Due | Assignee | Vendor | CRO progress | Summary |
|---|---|---|---|---|---|---|
| no tickets | ||||||
Mechanism + efficacy workstream (in-vitro target engagement, selectivity panel)
| Key | Status | Due | Assignee | Vendor | CRO progress | Summary |
|---|---|---|---|---|---|---|
| no tickets | ||||||
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 (57)
Populated from preclin.cro_capability — writes flow from forwarded CRO emails + Slack
@iris cro. Default order: furthest along the funnel first; click a column header to re-sort.| Vendor | Workstream | Status | Owner | CRO progress | Last engagement | Notes |
|---|---|---|---|---|---|---|
| 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 2026-06-30, tracking 1Z99F400A003060964. Shipped from Bonneville Labs. Hazardous materials, adult signature required. Moaraj noted significant team effort to get tissues out. |
| 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. |
| CPC Scientific | cmc_drug_substance_gmp | quote in | melissa | Quote in · Detailed quote provided for CAPABLE-001 Phase I AP | 2026-01-22 📄 | Detailed quote provided for CAPABLE-001 Phase I API manufacturing: $286K, non-GMP in March or full GMP in April-May. Put on hold because too expensive and unable to meet the Feb/March target for Phase I-ready material. |
| 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. |
| Sinopep | cmc_drug_substance_gmp | quote in | melissa | Quote in · Quote received for CAPABLE-001 Phase I API manufac | 2026-01-22 📄 | Quote received for CAPABLE-001 Phase I API manufacturing at $200K. Scope included end-to-end peptide CMC plus cGMP capability and 15 g for analytical development, which was over-scoped for the 500 mg need. |
| Syngene | cmc_drug_substance_gmp | quote in | melissa | Quote in · Syngene proposal CD/Tides/01072026/47287/1.0/NC co | 2026-07-01 📄 | Syngene proposal CD/Tides/01072026/47287/1.0/NC covers process familiarization, ~5 g lab/PoC synthesis with ~500 mg shipped to Capable, and ~200 g non-GMP 49-mer peptide synthesis for $651,940 with 27-week lead time including ~5 weeks raw material procurement. Project starts upon WO/PO execution. Deliverables include analytical method development and analytical test report; tentative purity NLT 95% to be confirmed. Offer valid 30 days from proposal date. Payment terms are 50% invoiced upon project start and 50% upon completion. Delivery terms are Ex-works, Bangalore; other Incoterms can be supported with freight passed through at actuals. Storage beyond 7 days after completion is out of scope and would require separate pricing. |
| 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 from Viva CDMO/PPO covers pro | 2026-01-22 📄 | Quotation DPT-251219 from Viva CDMO/PPO covers production of at least 500 mg CAPABLE-001 peptide API, cGMP or GMP-like, for Phase I clinical use and Australia IND-enabling filing. Deliverables include tox batch and GMP batch product, process optimization report, reference material characterization report and CoAs, toxicity/GMP batch production report, analytical method validation reports, stability study reports, and IND filing documentation. Payment terms are 50% due within 5 business days after contract signing and 50% upon delivery; cold-chain shipping billed at actual cost. Quote notes Capable should verify the listed peptide sequence before proceeding. |
| VivaBiotech | cmc_drug_substance_gmp | quote in | melissa | Quote in · VivaBiotech remains a possible secondary/tox-only | — 📄 | VivaBiotech remains a possible secondary/tox-only option at $62K for tox batch in 5 weeks or $676K for full package in 25 weeks, but tox-only material is not adequate for Phase I human material and would require bridging analytics to show representativeness of the clinical batch. Preferred approach is one batch unless PolyPeptide slips or MIT/HMS in-house tox is not viable. |
| WuXi TIDES | cmc_drug_substance_gmp | quote in | melissa | Quote in · CAPABLE-001 Phase I API manufacturing option liste | 2026-01-22 📄 | CAPABLE-001 Phase I API manufacturing option listed as viable at $120K with 7-8 week timeline; fastest viable option with AU Phase I experience and ability to ship under quarantine. Status was active with Monday call scheduled; needed clarification whether validated release meant full ICH Q2 or phase-appropriate qualification. |
| Viva Biotech | cmc_ich_q1a_stability | quote in | melissa | Quote in · Quotation DPT-251219 includes stability study repo | — 📄 | Quotation DPT-251219 includes stability study reports as part of the IND package documentation deliverables for CAPABLE-001. No executed contract is evidenced; payment obligations begin after contract signing. |
| WuXi AppTec (HongKong) Limited / XenoBiotic Laboratories, Inc | genotox_ames | quote in | melissa | Quote in · WuXi quotation V3 includes a GLP FDA/OECD bacteria | 2026-05-08 📄 | WuXi quotation V3 includes a GLP FDA/OECD bacterial reverse mutation assay (Ames). |
| WuXi AppTec (HongKong) Limited / XenoBiotic Laboratories, Inc | genotox_micronucleus | quote in | melissa | Quote in · WuXi quotation V3 includes a GLP FDA/OECD in vivo | 2026-05-08 📄 | WuXi quotation V3 includes a GLP FDA/OECD in vivo peripheral blood micronucleus assay in rats using FCM with SEND. |
| WuXi AppTec (HongKong) Limited / XenoBiotic Laboratories, Inc | glp_tox_non_rodent | quote in | melissa | Quote in · WuXi quotation V3 covers a GLP FDA/OECD 14-day rep | 2026-05-08 📄 | WuXi quotation V3 covers a GLP FDA/OECD 14-day repeated intranasal dose toxicity and toxicokinetics study in Beagle dogs with a 14-day recovery period. |
| WuXi AppTec (HongKong) Limited / XenoBiotic Laboratories, Inc | glp_tox_rodent | quote in | melissa | Quote in · WuXi quotation V3 covers a GLP FDA/OECD 14-day rep | 2026-05-08 📄 | WuXi quotation V3 covers a GLP FDA/OECD 14-day repeated intranasal dose toxicity and toxicokinetics study in rats with a 14-day recovery period. |
| 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 evaluation, including detailed nasal cavity evaluation, with additional-cost target-tissue evaluation where applicable. |
| 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 pathologist for rodent and non-rodent tox studies. |
| Charles River Laboratories | safety_pharm_ich_s7a | quote in | melissa | Quote in · Avance Gap Analysis review found standalone hERG r | 2026-06-30 📧 📄 | Avance Gap Analysis review found standalone hERG recommended on pages 8 and 13; dog ECG alone may not satisfy the hERG requirement. |
| WuXi AppTec (HongKong) Limited / XenoBiotic Laboratories, Inc | safety_pharm_ich_s7a | quote in | melissa | Quote in · WuXi quotation V3 includes a GLP FDA/OECD hERG ass | 2026-05-08 📄 | WuXi quotation V3 includes a GLP FDA/OECD hERG assay in a manual patch-clamp platform. |
| 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 contract detail in document. |
| 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 contract detail in document. |
| AmbioPharm | cmc_drug_substance_gmp | RFQ sent | melissa | RFQ open 162d · Discussed for CAPABLE-001 Phase I API manufacturin | 2026-01-22 📄 | Discussed for CAPABLE-001 Phase I API manufacturing as a fast GMP peptide option at gram-kg scale; no response to inquiry. |
| BCN Peptides | cmc_drug_substance_gmp | RFQ sent | melissa | RFQ open 162d · Discussed for CAPABLE-001 Phase I API manufacturin | 2026-01-22 📄 | Discussed for CAPABLE-001 Phase I API manufacturing as an EU GMP peptide option; first response took 4 days and status was slow response. |
| Catalent | cmc_drug_substance_gmp | RFQ sent | melissa | RFQ open 162d · Discussed for CAPABLE-001 Phase I API manufacturin | 2026-01-22 📄 | Discussed for CAPABLE-001 Phase I API manufacturing as a large CDMO network option; no response to inquiry. |
| CordenPharma | cmc_drug_substance_gmp | RFQ sent | melissa | RFQ open 162d · Discussed for CAPABLE-001 Phase I API manufacturin | 2026-01-22 📄 | Discussed for CAPABLE-001 Phase I API manufacturing as a GMP network EU/US option; no response to inquiry. |
| Eurogentec | cmc_drug_substance_gmp | RFQ sent | melissa | RFQ open 162d · Discussed for CAPABLE-001 Phase I API manufacturin | 2026-01-22 📄 | Discussed for CAPABLE-001 Phase I API manufacturing as a GMP peptide manufacturing option; no response to inquiry. |
| 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. |
| 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. |
| Pharmalegacy | safety_pharm_ich_s7a | RFQ sent | melissa | RFQ sent · Quote requested for hERG/genotox vendor evaluation | — 📄 | Quote requested for hERG/genotox vendor evaluation. |
| CMAX | clinical_phase_1_cro | no contract | melissa | no_contract | — 📄 | Listed in the Phase 1 CRO assessment with Adelaide noted as location; no contract or contact details shown. |
| GLG | clinical_phase_1_cro | no contract | melissa | no_contract | 2026-05-15 📄 | Indication debrief calls for arranging 3 Sleep KOL interviews through GLG to confirm unmet need/current clinical practice and discuss Kleine Levin Syndrome before drafting the Phase 1 protocol, then circling back with KOLs after protocol completion. |
| Guidepoint | clinical_phase_1_cro | no contract | melissa | no_contract | 2026-05-27 📄 | Discussed as an option for sourcing additional consultants or expert-network support for Australian clinical trial resourcing; no active contract or direct engagement stated in the excerpt. |
| Linear Clinical Research | clinical_phase_1_cro | no contract | melissa | no_contract | — 📄 | Listed as a Phase 1 clinical CRO assessment option; no contract or contact details shown. |
| Novotrials | clinical_phase_1_cro | no contract | melissa | no_contract | — 📄 | Listed in the Phase 1 CRO assessment; Newcastle location, brand new 30-bed unit, Phase 2/3/4 experience, and best cost noted. No contract or contact details shown. |
| Nucleus Network | clinical_phase_1_cro | no contract | melissa | no_contract | — 📄 | Listed as a Phase 1 clinical CRO assessment option; Brisbane and Melbourne noted as locations. No contract or contact details shown. |
| Scientia Clinical Research | clinical_phase_1_cro | no contract | melissa | no_contract | — 📄 | Listed as a Phase 1 clinical CRO assessment option; no contract or contact details shown. |
| SSR | clinical_phase_1_cro | no contract | melissa | no_contract | — 📄 | Phase 1 CRO assessment notes SSR will review the intranasal device/medicine; CRO-contract-to-dosing timeline estimated at 3 months; recruitment noted as 30 patients in 2-4 months with 20% dropout allowed; usually one site; communication plan needed; experience with biotech sponsors noted as 80-90%; 2 medical monitors; emergency response via GP/ex-GP; FDA/EMA audit track record noted as good so far with last audit in 2019. |
| Aurigene Pharmaceutical Services | cmc_drug_substance_gmp | no contract | melissa | no_contract | — 📄 | Responsive initial contact; Helena and Nico to meet team once specifications are confirmed. |
| 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 capabilities. Referred Capable to Syngene. |
| Chinapeptides | cmc_drug_substance_gmp | no contract | melissa | no_contract | 2026-01-22 📄 | Declined for CAPABLE-001 Phase I API manufacturing because Chinapeptides could not establish GMP-like capability on the required timeline and quoted $700K for facility setup. |
| Ramshan Lifesciences | cmc_drug_substance_gmp | no contract | melissa | no_contract | — 📄 | No response to calls, emails, and website outreach. |
| Sai | cmc_drug_substance_gmp | no contract | melissa | no_contract | — 📄 | Listed in India CROs manufacturing tracker; no response to outreach by calls, emails, and website. |
| Charles River Laboratories | genotox_ames | no contract | melissa | no_contract | 2026-04-05 📧 📄 | Debrief identifies genotoxicity as a hard regulatory gap and action item; Charles River is one of three vendors to contact for AMES plus chromosomal aberration plus micronucleus, estimated around $100K and 8-12 weeks, to run in parallel with in vivo tox. |
| Covance | genotox_ames | no contract | melissa | no_contract | 2026-04-05 📄 | Debrief identifies genotoxicity as a hard regulatory gap and action item; Covance is one of three vendors to contact for AMES plus chromosomal aberration plus micronucleus, estimated around $100K and 8-12 weeks, to run in parallel with in vivo tox. |
| Eurofins | genotox_ames | no contract | melissa | no_contract | 2026-04-05 📄 | Debrief identifies genotoxicity as a hard regulatory gap and action item; Eurofins is one of three vendors to contact for AMES plus chromosomal aberration plus micronucleus, estimated around $100K and 8-12 weeks, to run in parallel with in vivo tox. |
| Charles River Laboratories | genotox_micronucleus | no contract | melissa | no_contract | 2026-04-05 📧 📄 | Debrief identifies genotoxicity as a hard regulatory gap and action item; Charles River is one of three vendors to contact for AMES plus chromosomal aberration plus micronucleus, estimated around $100K and 8-12 weeks, to run in parallel with in vivo tox. |
| Covance | genotox_micronucleus | no contract | melissa | no_contract | 2026-04-05 📄 | Debrief identifies genotoxicity as a hard regulatory gap and action item; Covance is one of three vendors to contact for AMES plus chromosomal aberration plus micronucleus, estimated around $100K and 8-12 weeks, to run in parallel with in vivo tox. |
| Eurofins | genotox_micronucleus | no contract | melissa | no_contract | 2026-04-05 📄 | Debrief identifies genotoxicity as a hard regulatory gap and action item; Eurofins is one of three vendors to contact for AMES plus chromosomal aberration plus micronucleus, estimated around $100K and 8-12 weeks, to run in parallel with in vivo tox. |
| 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 GLP repeat-dose intranasal toxicology studies supporting AU TGA CTN Phase I submission of Capable 101, with a recommended 14-day toxicology duration because comparable Phase 1 MAD dosing timelines were 14 days. |
| PolyPeptide Group | cmc_drug_substance_gmp | expired | melissa | expired 2026-02-11 | 2026-02-11 📄 | PolyPeptide proposal QT-15449 dated 2026-02-11 covers non-GMP manufacture of 500 mg-1 g Axonic Peptide 1/PPL4166 for Phase I clinical trials in Australia. Scope includes sequence assessment, scalable process development using PeptiSystem Flow, 2 g non-GMP demonstration batch, delivery of 500 mg-1 g non-GMP grade peptide and CoA. Price is $95,000 with ~4-6 week timeline, subject to raw material and suite availability at PO receipt. Analytical method development by RP-HPLC/UPLC is offered for identification, impurity/purity measurement, forced degradation/LC-MS, robustness, impurity MW ID, and peak purity by LC-MS at $45,000 per method with ~12 week timeline. Proposal valid for 90 days; no contractual relationship exists until mutual written Work Order execution, though an MSA can be negotiated. |
| PolyPeptide Group | cmc_ich_q1a_stability | expired | melissa | expired 2026-02-11 | 2026-02-11 📄 | Optional non-GMP stability study in PolyPeptide proposal QT-15449 dated 2026-02-11 would be performed on each non-GMP batch at -20C +/-5C, 5C +/-3C, and 25C +/-2C/60% RH +/-5% RH through 24 months, testing appearance, water content, and purity at scheduled timepoints. Pricing: $15,000 initiation, $25,000 at 12 months, $10,000 at 24 months. Proposal valid for 90 days; no contractual relationship exists until mutual written Work Order execution. |
| IIT Research Institute | glp_tox_non_rodent | expired | melissa | expired 2026-04-05 | 2026-04-05 📄 | Tox CRO debrief says no final CRO decision has been made. IITRI dog non-rodent path is speed-favored but must document the scientific dogs-vs-monkeys rationale because Avance flagged NPSR1 conservation is higher in monkeys; quote expired Mar 5, 2026 and must be reconfirmed before PO. |
| Pharmaron, Inc. | glp_tox_non_rodent | expired | melissa | expired 2026-04-05 | 2026-04-05 📄 | Pharmaron quoted dogs as the non-rodent species for the cheaper minimum viable tox package; monkey pricing was noted as about $1.05M for 2-week GLP alone and considered a non-starter on speed and price. Quote expired Feb 21, 2026 and pricing is stale. |
| IIT Research Institute | glp_tox_rodent | expired | melissa | expired 2026-04-05 | 2026-04-05 📄 | Tox CRO debrief says no final CRO decision has been made. IITRI remains the speed-favored path because it avoids China logistics and saves an estimated 2-4 weeks versus Pharmaron, but quote CA01.05.2026 expired Mar 5, 2026 and pricing/slot availability must be reconfirmed with Todd Bucciarelli before PO. Debrief also flags high method-development cost and need to confirm method development starts immediately at PO; weekly formulation prep assumes 7-day intranasal formulation stability data exists. |
| Pharmaron, Inc. | glp_tox_rodent | expired | melissa | expired 2026-04-05 | 2026-04-05 📄 | Pharmaron remains a cheaper alternative for the minimum viable rat/dog GLP tox package, estimated around $530K for 14-day studies versus about $1.16M at IITRI, but loses 2-4 weeks to China logistics and its Jan 22, 2026 quote expired Feb 21, 2026. Reconfirmation required before comparison or PO. |
| IIT Research Institute | safety_pharm_ich_s7a | expired | melissa | expired 2026-04-05 | 2026-04-05 📄 | Debrief says IITRI dog GLP includes ECG/in vivo CV under ICH S7A, but standalone in vitro hERG patch clamp under ICH S7B may still be required. Capable should confirm with Avance or Novotech whether dog ECG suffices or standalone hERG is needed. |
| Pharmaron, Inc. | safety_pharm_ich_s7a | expired | melissa | expired 2026-01-22 | 2026-01-22 📄 | Pharmaron toxicology quotation includes safety-pharmacology-relevant endpoints embedded in GLP toxicology designs: rat FOB and respiratory evaluations, plus dog blood pressure and ECG monitoring around Tmax. Quote validity was 30 days from issuance. |
Open gaps (5) — KAN tickets with no contracted vendor
| KAN | Due | Assignee | Summary |
|---|---|---|---|
| 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-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-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 |
|---|---|---|---|---|---|---|
| no tickets | ||||||
PK (methods · studies · scaling/HED · PK-PD)
CRO progress (Drive): 📁 Preclinical development
| Key | Status | Due | Assignee | Vendor | CRO progress | Summary |
|---|---|---|---|---|---|---|
| no tickets | ||||||
Safety + immunogenicity
CRO progress (Drive): 📁 Tox Studies
| Key | Status | Due | Assignee | Vendor | CRO progress | Summary |
|---|---|---|---|---|---|---|
| no tickets | ||||||
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-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 · Avance Gap Analysis review found standalone hERG r | Safety pharmacology core battery (ICH S7A: CV, CNS, respiratory) |
| 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) |