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DOCXbispecific_igg_disclosure.docxOct 6, 2026 at 12:00 AM248 KB
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WorkspaceStatusLast updated
Composition and Method for Bispecific Antibody for Treating Multiple MyelomaIn reviewOct 6, 2026
Lipid Nanoparticle Formulation for mRNA Delivery to HepatocytesFiledOct 6, 2026
CRISPR-Cas12 Guide RNA Library for Multiplexed Gene KnockoutDraft requestedOct 5, 2026
Engineered AAV Capsid with Enhanced Retinal TropismAppraisalOct 5, 2026
Cell Therapy5
Chimeric Antigen Receptor T Cells Targeting CD19 and BCMA3Draft requestedOct 5, 2026
Feeder-Free Expansion of Tumor-Infiltrating Lymphocytes2FiledOct 6, 2026
Allogeneic NK Cell Platform with HLA Class I Knockout for Off-the-Shelf TherapyAppraisalOct 5, 2026
Gamma Delta T Cell Composition for Solid Tumor Immunotherapy and Methods of UseDraft requestedOct 5, 2026
Cryopreservation Medium for Engineered Immune Cell ProductsIn reviewOct 5, 2026
Antibody Engineering3
Diagnostics2
From appraisal to filedFollow each application from appraisal through drafting and review to filing.
StatusBCMA×CD3 bispecific
Appraisal
Draft requested
In review
Filed
Activity
Claims updated from your reviewOct 6
Specification drafted from the disclosureOct 5
Figures generated from the rendersOct 4
Disclosure added from the VaultOct 3
Workspace createdOct 1
Organized by programGroup patents into folders that mirror your pipeline.
Cell Therapy5
Chimeric Antigen Receptor T Cells Targeting CD19 and BCMA3Draft requestedOct 6, 2026
Feeder-Free Expansion of Tumor-Infiltrating Lymphocytes2FiledOct 6, 2026
Antibody Engineering3
Bispecific IgG Format with Common Light ChainIn reviewOct 6, 2026
pH-Dependent Binding Domain for Antibody RecyclingFiledOct 5, 2026
Diagnostics2
Multiplexed cfDNA Assay for Early Cancer DetectionDraft requestedOct 6, 2026
Gene Therapy4
Formulation6
Platform3
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Choose foldersConnected as kevin@halvera.bio
Halvera R&D168 filesToday
Bispecific engineering52 filesToday
Assay results61 filesYesterday
Dosing studies37 files2 days ago
Cell line development18 filesLast week
IPSome folders21 filesLast week
Grants and proposals23 filesSep 30
Board and finance54 filesSep 29
People ops37 filesSep 12
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Reading Bispecific_Construct_Map.pdf0%
In Bispecific engineering
01Index the shared foldersFiles are copied encrypted into your vault and parsed.WaitingIn progressDone
02Scout’s private search agentPulls out the inventive concepts in your files and the documents behind each.WaitingIn progressDone
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Reviewed by SamPatent principal, Fearn LegalHigh noveltySearch report, Oct 6
Step-up dosing schedule for a BCMA×CD3 bispecific
Two step-up doses before the first full dose let T-cell activation ramp up, so cytokine release stays manageable.
What stands out
The 5 → 25 → 200 mg schedule keeps cytokine release low at the first full dose.
Full doses move from weekly to every two weeks once a response holds.
Closest art
Fixed-dose BCMA×CD3 regimens Give the full dose from day one, with cytokine release managed by premedication.
From your DriveStep_Up_Dosing_Cohort_3.xlsxHalvera_Bispecific_Disclosure_v2.docx
Sam: The strongest of the three. Lead the method patent with it.
Novelty unknown
Assay that predicts cytokine release before the first dose
A whole-blood panel run at screening flags the patients likely to need a slower step-up.
What stands out
Predicts the first-dose response from a blood draw at screening.
Ties the step-up schedule to each patient's risk.
Novelty
Unknown until we run a search report on this concept.
Order a search reportFrom your DriveCytokine_Release_Panel.pdf
Sam: Pairs with the dosing patent as a companion method.
Novelty unknown
Fab domain swap that stabilizes CD3 binding
Swapping the constant domains on the CD3 arm keeps each light chain with its own heavy chain.
What stands out
Correct chain pairing without a common light chain.
CD3 binding holds through manufacturing stress.
Novelty
Unknown until we run a search report on this concept.
Order a search reportFrom your DriveBispecific_Construct_Map.pdf
Sam: Its own patent: the constructs are compositions, apart from the dosing method.
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Claims32
1What is claimed is:
2
31. A method of treating multiple myeloma in a human subject, the
method comprising administering to the subject a bispecific antibody
that binds B-cell maturation antigen (BCMA) and CD3, wherein the
administering comprises a first step-up dose of about 5 mg, a second
step-up dose of about 25 mg, and one or more full doses of about 200
mg of the bispecific antibody.
4
52. The method of claim 1, wherein the second step-up dose is
administered about one week after the first step-up dose, and the
first full dose is administered about one week after the second
step-up dose.
6
73. The method of claim 1 or 2, wherein the full doses are
administered once weekly through about week 14 and once every two
weeks thereafter.
8
94. The method of any one of claims 1-3, wherein the bispecific
antibody is administered by intravenous infusion over about 30
minutes.
Figures linked to the specSelect a figure to follow its link to the paragraph that describes it.
FIG. 4Progression-free survival across the dosing cohorts.
FIG. 5BCMA-binding domain in complex with BCMA.
FIG. 6Structure of the CD3-binding fragment.
SpecificationFIG. 4
Detailed description
[0021]The methods described herein treat multiple myeloma with a bispecific antibody that binds B-cell maturation antigen (BCMA) on malignant plasma cells and CD3 on T cells. Bridging the two redirects the subject’s own T cells against the tumor.
[0022]Because T-cell activation is strongest at first exposure, the antibody is given in steps: a first step-up dose of about 5 mg, a second step-up dose of about 25 mg about one week later, and full doses of about 200 mg thereafter.
Examples
[0026]Subjects were assigned to three cohorts: a fixed full dose from day one, a single step-up dose, and the two-step regimen described above. Response was assessed every four weeks.
[0031]As shown in FIG. 4, subjects on the two-step regimen had longer progression-free survival than subjects on a fixed dose, with the curves separating by about month 6 and the gap holding through month 24.
[0033]Grade 2 or higher cytokine release syndrome occurred in fewer subjects on the two-step regimen, and no subject on that regimen needed a dose held after the first full dose.
[0036]The BCMA-binding arm was selected to bind the membrane-proximal region of BCMA, so that soluble BCMA shed into the serum competes less with the target on the cell surface.
[0038]FIG. 5 shows the BCMA-binding domain 502 in complex with the extracellular domain of BCMA 504. The heavy-chain CDR3 contacts the cysteine-rich region of BCMA, which carries most of the binding energy.
[0041]Binding was measured by surface plasmon resonance. The BCMA-binding arm bound with a dissociation constant in the low nanomolar range, while binding to the related receptors TACI and BAFF-R was not detected.
[0044]Referring to FIG. 6, the CD3-binding fragment 602 engages the CD3ε subunit 604 with moderate affinity, so the antibody stays on the tumor cell while it recruits T cells.
[0046]A moderate CD3 affinity also limits activation of T cells away from the tumor, which further reduces cytokine release once full doses begin.
[0049]The full doses can be administered once weekly through about week 14 and once every two weeks thereafter, by intravenous infusion over about 30 minutes.
[0052]In some embodiments, the subject receives a corticosteroid, an antihistamine and an antipyretic before each step-up dose and before the first full dose.
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