System for verifying the accuracy of a plurality of drug modules connected in series of a combination drug delivery device

Abstract

To provide a system for verifying accuracy of serially-connected drug modules in a combinatorial drug delivery device.SOLUTION: Each of a plurality of drug modules 12 includes a drug reservoir accommodating a liquid drug. The system includes: a machine-readable code 44 located on each of the plurality of drug modules; application software 48 on a user's mobile device 46, a transmitter on the user's mobile device; a flow controller on the drug delivery device and selectively activatable to a use state to allow flow of liquid drug from the drug delivery device; and a control unit on the drug delivery device, the control unit including a computing processing unit having an associated memory in which an authentication code is stored, and a receiver.SELECTED DRAWING: Figure 1

Description

Background Art

[0001] Combination drug delivery devices and systems are disclosed and described in U.S. Provisional Patent Application 62 / 670,266 (filed May 11, 2018), International Application PCT / US2019 / 031727 (filed May 10, 2019), International Application PCT / 2019 / 031762 (filed May 10, 2019), and International Application PCT / US2019 / 031791 (filed May 10, 2019). All of the above patent applications are by the same assignee as this application. As shown in the above patent applications, multiple drug modules of different liquid drugs can be provided in various combinations to provide different (person-tailored) combinations of drugs. The multiple drug modules are housed, i.e., connected, in series or in parallel on a tray or other base structure. Alternatively, the multiple drug modules can be directly connected to each other in series (vertically and / or horizontally). U.S. Provisional Patent Application 62 / 670,266, International Application PCT / US2019 / 031727, International Application PCT / 2019 / 031762, and International Application PCT / US2019 / 031791 are incorporated herein by reference in their entireties.

[0002] A series-connected combination system has the advantage in terms of components and thus supply chain efficiency in that it does not require separate tray parts to form fluid connections as compared to a housing-type design.

[0003] In a housing-type system, the tray design can "hold" information regarding the configuration of multiple modules through its unique design and layout. For example, the tray can provide a configuration (e.g., a mechanically cooperating mechanism such as a "lock" mechanism) that ensures that only the correct drug module can be inserted into the housing part of the tray and that the correct drug modules are arranged in the correct order. This functions as a safety check when preparing the drug modules for use. In contrast, a series-connected system does not have a tray-type element and thus does not have a function for safety checks based on this.

[0004] This is because when connected in series, tray-based mechanical means for preventing errors cannot be utilized. It is desirable to implement another means for detecting configuration errors in a series connection system, thereby preventing the occurrence of dosing errors.

Summary of the Invention

[0005] In one aspect, the subject invention provides a system for verifying the accuracy of a plurality of serially connected drug modules of a combination drug delivery device. Each of the plurality of drug modules includes a drug reservoir containing a liquid drug. The system includes a machine-readable code disposed on each of the plurality of drug modules, application software on the user's mobile device, a transmitter on the user's mobile device, a flow controller on the drug delivery device that is selectively activatable to an operating state that permits liquid drug to flow from the drug delivery device, and a control unit having a computing processing unit and a receiver on the drug delivery device, the computing processing unit having an associated memory in which an authentication code is stored. The application software is configured to read a plurality of machine-readable codes in a captured digital image of the plurality of serially connected drug modules. The application software is configured to generate an activation code based on the plurality of machine-readable codes and the order of the plurality of machine-readable codes. The transmitter is configured to transmit the activation code. The receiver is configured to receive the activation code transmitted by the transmitter. The computing processing unit is configured to compare the activation code with the authentication code. The computing processing unit is configured to activate the flow controller to an operating state that permits liquid drug to flow from the drug delivery device if the authentication code matches the activation code.

[0006] In a further aspect, the subject invention provides a system for verifying the accuracy of a plurality of drug modules connected in series of a combination drug delivery device. Each of the plurality of drug modules includes a drug reservoir containing a liquid drug. The system includes a machine-readable code disposed on each of the plurality of drug modules, application software on the user's mobile device, a transmitter on the user's mobile device, a flow controller on the drug delivery device that is selectively activatable to an in-use state that permits the flow of liquid drug from the drug delivery device, and a control unit on the drug delivery device having a computing processing unit and a receiver. The application software is configured to read a plurality of machine-readable codes in a captured digital image of the plurality of drug modules connected in series. The application software is configured to generate an activation code based on the plurality of machine-readable codes and the order of the plurality of machine-readable codes. The application software includes an application programming interface that calls a remote server to obtain an authentication code associated with the drug delivery device. The application software is configured to compare the activation code with the authentication code and generate an approval message if the authentication code and the activation code match. The transmitter is configured to transmit the approval message. The receiver is configured to receive the approval message transmitted by the transmitter. The computing processing unit is configured to activate the flow controller to an in-use state that permits the flow of liquid drug from the drug delivery device based on the approval message.

[0007] In a further aspect, the subject invention provides a system for verifying the accuracy of a plurality of drug modules connected in series of a combination drug delivery device. Each of the plurality of drug modules includes a drug reservoir containing a liquid drug. The system includes a machine-readable code for each drug module disposed on each of the plurality of drug modules, application software on the user's mobile device, a transmitter on the user's mobile device, a flow controller on the drug delivery device that is selectively activatable to an in-use state that permits the flow of liquid drug from the drug delivery device, and a control unit on the drug delivery device having a computing processing unit and a receiver. The application software is configured to read the machine-readable codes of the plurality of drug modules in the captured digital image of the plurality of drug modules connected in series and to read a second machine-readable code representing an authentication code. The application software is configured to generate an activation code based on the plurality of drug module machine-readable codes and the order of the plurality of drug module machine-readable codes. The application software is configured to compare the activation code with the authentication code and to generate an approval message if the authentication code and the activation code match. The transmitter is configured to transmit the approval message. The receiver is configured to receive the approval message transmitted by the transmitter. The computing processing unit is configured to activate the flow controller to an in-use state that permits the flow of liquid drug from the drug delivery device based on the approval message.

[0008] In yet a further aspect, the subject invention provides a system for verifying the accuracy of a plurality of serially connected drug modules of a combinatorial drug delivery device. Each of the plurality of drug modules includes a drug reservoir containing a liquid drug. The system includes a machine-readable code disposed on each of the plurality of drug modules, application software on the user's mobile device, a transmitter on the user's mobile device, a remote server storing an authentication code associated with the drug delivery device, a flow controller on the drug delivery device selectively activatable to an in-use state that permits flow of liquid drug from the drug delivery device, and a control unit on the drug delivery device having a computing processing unit and a receiver. The application software is configured to read a plurality of machine-readable codes within a captured digital image of the plurality of serially connected drug modules. The application software is configured to generate an activation code based on the plurality of machine-readable codes and the order of the plurality of machine-readable codes. The transmitter is configured to transmit the activation code. The remote server is configured to receive the activation code transmitted by the transmitter. The remote server is configured to compare the activation code with the authentication code. The remote server is configured to generate an approval message and transmit the approval message if the authentication code matches the activation code. The transmitter on the user's mobile device transmits the approval message upon receiving the approval message. The receiver is configured to receive the approval message transmitted by the transmitter on the user's mobile device. The computing processing unit is configured to activate the flow controller to an in-use state that permits flow of liquid drug from the drug delivery device based on the approval message.

[0009] These and other features of the invention will be better understood through a consideration of the detailed description and the accompanying drawings.

Brief Description of the Drawings

[0010]

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BRIEF DESCRIPTION OF THE DRAWINGS

[0011] Referring to FIG. 1, a system 10 is shown that can be used to verify the accuracy of a plurality of serially connected drug modules 12 of a combination drug delivery device 14. Each of the plurality of drug modules 12 includes a drug reservoir 16 for containing a liquid drug 18. The plurality of drug reservoirs 16 may be defined as part of the plurality of drug modules 12 or, alternatively, may be defined by components such as vials inserted into the plurality of drug modules 12. The combination drug delivery device 14 (including any aspect thereof) can be formed in accordance with any of the embodiments disclosed in U.S. Provisional Patent Application 62 / 670,266, International Application PCT / US2019 / 031727, International Application PCT / 2019 / 031762, and International Application PCT / US2019 / 031791. For illustrative purposes, exemplary features of the combination drug delivery device 14 are described herein. As will be appreciated by those skilled in the art, the subject invention can be used with any of the combination drug delivery devices and with any of their components (e.g., system 10, plurality of drug modules 12, manner of connection of the plurality of drug modules 12, flow controller 34, etc.) disclosed in any of the above-described patent applications.

[0012] As shown in FIG. 2, a plurality of drug modules 12 are connected in series to define a single flow path for a drug delivery device 14 through a column of the plurality of drug modules 12 from which the liquid drug 18 of each of the plurality of drug modules 12 can be withdrawn. As shown in FIG. 2, inlet and outlet tubes 20, 22 may be provided to each of the plurality of drug modules 12 such that the liquid drug 18 can be continuously withdrawn from each of the plurality of drug modules 12. As shown in FIG. 3, the inlet and outlet tubes 20, 22 may be continuously formed between the plurality of drug reservoirs 16 such that each tube functions as both an outlet of one of the plurality of drug reservoirs 16 and an inlet of the next drug reservoir 16. FIG. 2 shows six drug modules 12 (12A - 12F). As will be understood by those skilled in the art, any number of drug modules 12 may be utilized. The outlet 13 may be provided at the end of the flow path (the most distal drug module).

[0013] It should be noted that one or more bypass drug modules 12BY may be required to be provided in the column to provide a location in the column but contain no liquid drug. As shown in FIG. 2A, the bypass drug module 12BY may have a bypass tube 24 extending from its inlet to its outlet to allow a flow that does not pass through the drug reservoir. Alternatively, as shown in FIG. 3, the bypass tube 24 may be provided in place of one of the plurality of drug modules 12 to connect two of the plurality of drug modules 12 or two components of the drug delivery device 14 such as a controller housing described below.

[0014] The plurality of liquid drugs 18 contained in the plurality of drug modules 12 can have different types and concentrations. Some of the liquid drugs 18 in the module 12 can be diluents that do not have a pharmaceutical or biological active agent. The plurality of drug modules 12 can include one or more solid components that are prepared by the inflow of a diluent therein to form a liquid drug. The ability of the plurality of serially connected drug modules 12 containing various drug types and concentrations enables the drug delivery device 14 to be a combination drug delivery device 14 and provides for the mixing of various liquid drugs. The plurality of liquid drugs 18 targeted for a special combination for a patient are prescribed by a doctor. The subject invention provides for the inclusion of a specific plurality of drug modules 12 within the drug delivery device 14 and for the verification of the accuracy regarding the order of the plurality of drug modules 12. The order of the plurality of drug modules 14 can be important and can affect the efficacy of the resulting combination ultimately.

[0015] The drug delivery device 14 preferably includes a controller housing 26 to which a plurality of serially connected drug modules 12 are connected. The outflow tube 22 of the first drug module 12A (closest to the controller housing 26) leads to an inlet 28 formed in the controller housing 26 through which liquid drug 18 can flow in from the plurality of drug modules 12. The delivery tube 30 extends from the inlet 28 to carry the liquid drug 18 through the controller housing 26 to an outlet 32. A tube or transport medium can be fixed to the outlet 32 to move the liquid drug 18 to a storage device (e.g., an IV bag, syringe, etc.) or to a drug delivery device (e.g., a winged needle) connected to the patient.

[0016] The flow controller 34 is provided in the controller housing 26 and selectively controls the flow through the delivery tube 30. In one embodiment, the flow controller 34 may include an activatable negative pressure source 36, such as a pump, provided in the controller housing 26 for withdrawing the liquid drug 18 through the inlet 28 and discharging the liquid drug 18 through the outlet 32 via the delivery tube 30 (which may not be connected). In the rest state, the negative pressure source 36 does not generate negative pressure and thus does not withdraw the liquid drug 18. In a further embodiment, the flow controller 34 may include one or more adjustable valves 38 provided in the controller housing 26 and configured to selectively control the flow through the delivery tube 30, particularly configured to be selectively adjustable between open and closed states. By using the valve 38, a negative pressure source configured to apply negative pressure outside the controller housing 26 at the outlet 32 and withdraw the liquid drug 18 therefrom can be utilized.

[0017] The control unit 40 may be provided in the controller housing 26 and includes a computing processing unit (CPU) 42. The flow controller 34 is preferably electrically powered to be controlled by the CPU 42. For example, an electric motor or actuator having a switch configured to be controlled by the CPU 42 may be provided. Activating the motor activates the negative pressure source 30 (e.g., the pump is turned on), while activating the actuator adjusts one or more valves 38 to the open state (e.g., the valve stem rotates to the open state). The switch may be adjusted to the off position by the CPU 42 to turn off the motor or close one or more valves.

[0018] It is envisioned that the plurality of drug modules 12 will be connected in series when made ready for use. The assembly of the plurality of drug modules 12 is required to be performed by the user or on behalf of the user. As a fail-safe mechanism, as shown in FIG. 4, in order to ensure that the plurality of drug modules 12 are properly included in the drug delivery device 14 and arranged in the correct order, each of the plurality of drug modules 12 is provided with a machine-readable code 44 corresponding to the liquid drug 18 when filled with the liquid drug 18. The machine-readable code 44 is preferably permanently fixed to the drug module 12 (e.g., by a strongly adhesive sticker, adhesive, etching, etc.) so that the machine-readable code 44 does not separate from the drug module 12 during storage or transportation. The machine-readable code 44 can be in any form, including, for example, barcode form and QR code form. The machine-readable code 44 is prepared to specify the type of drug and, if possible, the concentration or strength of the drug. The liquid drug 18 can be filled into the drug module 12 at a manufacturing facility or pharmacy, and at the same time, the machine-readable code 44 is fixed. Care must be taken to ensure that the correct machine-readable code 44 is attached to the drug module 12.

[0019] The plurality of specific liquid drugs 18 (type, concentration) can be specified by a prescription. The plurality of drug modules 12 can be prepared to accommodate the plurality of specified liquid drugs 18. The number of the plurality of drug modules 12 used is at least equal to the number of drug components specified by the prescription. The plurality of drug modules 12, together with the controller housing 26, can be delivered as a kit for assembly to the user or a location associated with the user. Instructions can be provided regarding the assembly of the plurality of drug modules 12, including the order of the plurality of drug modules 12 at the first position (closest to the controller housing 26), the second position, etc.

[0020] Once a plurality of drug modules 12 are assembled as a drug delivery device 14 together with the controller housing 26, the drug delivery device 14 must be made ready for use. In preparing the device, a digital image of the entire row of serially connected drug modules 12, particularly one that includes all the machine-readable codes 44 of the plurality of drug modules 12, is captured by a digital camera or a device 46 (smartphone, tablet, notebook, mobile phone) equipped with a digital camera. The digital image can be captured by the device 46 under the control of the user 45 or through automated means where the digital camera is placed at the facility preparing the drug delivery device 14.

[0021] Preferably, the device 46 includes application software 48 configured to read the machine-readable codes 44 to generate an activation code based on the content and their order of the plurality of machine-readable codes 44. For example, the device 46 may be a mobile device such as a smartphone equipped with a digital camera and accessible to the application software 48. Any graphical user interface (GUI) can be provided on the device 46 to enable interaction with the user. As understood by those skilled in the art, software for the recognition and reading of barcodes and QR codes is well-known and can be used for the application software 48. The application software 48 can be stored in a non-transitory memory associated with the device 46 as a set of instructions. All or part of the application software 48 may be resident on the device 46 and can be called as needed through a network as described later.

[0022] Alternatively, device 46 may be linkable to a second device or computer processing unit 47 (which may be a remote server) associated with application software 48. Here, the digital image captured by device 46 is transmitted to the second device or CPU 47 so that it can be read by application software 48. Device 46 may be linked to the second device or CPU 47 through any network 49 (wired, wireless, Internet, local area network (LAN), wide area network (WAN)). The second device or CPU 47 generates an activation code based on reading the machine-readable code 44 in the captured image. The second device or CPU 47 may be associated with a non-transitory memory 50 in which all or part of the application software 48 may be stored as a set of instructions.

[0023] As shown in FIG. 4A, the machine-readable code 44 of each of the plurality of drug modules 12 can be used to generate a combined alphanumeric data string CDS. In this case, the individual data strings DS of each of the plurality of drug modules 12 are combined with each other in the order of the plurality of drug modules 12 to produce an activation code.

[0024] The activation code can be used for comparison with an authentication code to determine its accuracy. In one embodiment, the authentication code may be stored in a non-transitory memory 41 associated with the CPU 42 of the controller housing 26. The application software 48 may be configured such that the generated activation code is transmitted to the CPU 42 (e.g., through the transmitter T1 on device 46 and the receiver R1 on the controller housing 26), whereupon the CPU 42 performs a comparison to determine a match. If there is a match, the CPU 42 may activate the flow controller 34 to enable delivery of the liquid drug 18.

[0025] The transmitter T1 and the receiver R1 can each be formed as a receiver and a transmitter, respectively. Any wireless network protocol can be used for wireless communication, and is not particularly limited, but includes protocols obtained from an 802.11-compliant network, a Bluetooth (registered trademark) network, a cellular digital packet data (CDPD) network, a high speed circuit switched data (HSCSD) network, a packet data cellular (PDC-P) network, a general packet radio service (GPRS) network, a 1x radio transmission technology (1xRTT) network, an IrDA network, a multichannel multipoint distribution service (MMDS) network, a local multipoint distribution service (LMDS) network, and a worldwide interoperability for microwave access (WiMAX) network.

[0026] In another embodiment, the application software 48 on the device 46 may be configured to call the second device or the CPU 47, for example, through the network 49, using an application programming interface (API), to obtain an authentication code therefrom. Alternatively, the device 46 may obtain the authentication code from another information source, for example, from a machine-readable code provided in the drug module 12. Thereafter, the application software 48 may compare the activation code with the authentication code on the device 46. If they match, the application software 48 may generate an approval message. The approval message is transmitted to the CPU 42, for example, using the transmitter T1. The approval message may be stored in the memory 41. If they match, the CPU 42 may activate the flow controller 34 to enable the delivery of the liquid drug 18. This embodiment eliminates the need to store the authentication code in the controller housing 26.

[0027] In a further embodiment, the application software 48 on the device 46 may transmit the activation code through the network 49, for example, to the second device or the CPU 47, for comparison with the authentication code. If they match, the second device or the CPU 47 transmits an approval message to the application software 48 through the network 49, for example, and then the application software 48 transmits the approval message to the CPU 42, for example, using the transmitter T1. The resulting approval message may be stored in the memory 41. If they match, the CPU 42 may activate the flow controller 34 to enable the delivery of the liquid drug 18. This embodiment eliminates the need to store the authentication code in the controller housing 26.

[0028] The flow controller 34 can be provided to have a storage (i.e., unused) state in which one or more adjustment valves 38 are closed so as not to flow to the outlet 32 through the delivery tube 30. Additionally, or alternatively, in the storage state, the negative pressure source 36 is in a resting state. When the activation code and the authentication code match, as described above, the CPU 42 may activate the flow controller 34, thereby enabling the flow controller 34 to be in a use state. When the flow controller 34 is in a use state, the delivery of the liquid drug 18 from the drug delivery device 14 can be achieved. In particular, one or more adjustment valves 38 are opened so as to flow to the outlet 32 through the delivery tube 30. Additionally, the negative pressure source 36 is activated. Alternatively, the negative pressure source 36 can be in an activation state waiting for activation (by a switch in the controller housing 26 and / or through the application software 48 using the device 46).

[0029] As will be understood by those skilled in the art, the system 10 enables various functions. For example, a user account can be established and stored, for example, in the memory 50 in the form of a database. Access to the user account can be permitted by various entities including, for example, the prescribing physician P, the dispensing pharmacy Ph, and / or the manufacturing site M that prepares one or more components of the drug delivery device 14. When accessible to the user account through the network 49, the details of the prescription are verified and / or updated if necessary. This information can be used for the selection of the liquid drug 18 used in the drug delivery device 14. The user 45 can access their account according to the GUI through the network 49 using a device 46 such as a mobile device, for example, to access the details as needed.

[0030] When the drug delivery device 14 has a receiver R1 that is also configured as a transmitter, details of the administration of the drug by the drug delivery device 14 (time, date, confirmation of completion) can be transmitted through the network 49 to the relevant user account. A healthcare provider, e.g., a prescribing physician P, can access this data to confirm compliance with the dosing schedule.

[0031] The system 10 also enables the provision of the patient's medical information that can be used to determine a prescription. For example, information based on the patient's tests can be uploaded to a user account that can be referenced to determine a prescription. Various physiological parameters and / or biomarkers can be tested and the results uploaded. This enables, for example, remote confirmation by a prescribing physician P to realize a prescription, followed by confirmation of the prescription by a pharmacy Ph and / or a manufacturing site M. A kit of a plurality of drug modules 12 and a controller housing 26 prepared can be sent to the place of use for assembly by a user or an assistant. The kit may be sent to a facility, such as a pharmacy Ph or a clinic, where the kit is assembled for the patient.

[0032] Referring to FIGS. 6 to 15, a non-limiting example of a processing flow of the application software 48 is presented, which includes a GUI that can be presented to the device 46 at different stages of the processing. Referring to FIG. 6, a processing flow 100 that can be used is depicted, which starts from a home page or a splash screen 102. The processing flow 100 is followed by a startup screen 104 and a package scan subroutine having an image reader or a capture screen 106 (the camera on the device 46 can be activated) for reading a machine-readable code on a package associated with a kit of a plurality of drug modules 12 before assembly. This subroutine enables identification of an authentication code associated with the package kit of the plurality of drug modules 12. This subroutine requires returning to the startup screen 104 to enable a restart when the time runs out.

[0033] After the package scan subroutine has completed successfully, an interstitial screen 108 is provided to prompt the user that the assembly of the plurality of drug modules 12 has been completed. If the user indicates completion (e.g., by pressing button 110), the drug module scan subroutine is launched with an image reader, or a capture screen 112, to read, or acquire, all machine-readable codes arranged in the order of the assembled plurality of drug modules 12 with the camera of device 46. The application software 48 is configured to generate an activation code based on the machine-readable codes, including their content and order. If the activation code is generated as shown in the processing flow 100, the scan is considered successful (step 114). If the activation code is not successfully generated, for example, if the scan times out without proper data capture (e.g., see screen 117), the processing flow of step 116 returns to the startup screen 104 to repeat the package scan subroutine.

[0034] The application software 48 compares the generated activation code with the acquired authentication code and determines whether they match. If they match, as shown in step 118, it is determined that the plurality of drug modules 12 are appropriate and, further, in the appropriate order. This may launch a screen 120 that includes a list of drugs, dosages, and their order.

[0035] If the activation code and the authentication code do not match, the reason for the mismatch can be determined by the application software 48 and can be shown as an error. For example, the application software 48 may determine that, as indicated by the error message 122, although the plurality of drug modules 12 are appropriate, the order is incorrect. Alternatively, the application software 48 may determine that, as indicated by the error message 124, one or more of the plurality of drug modules 12 are incorrect. Further, the application software 48 may determine that one or more of the plurality of drug modules 12 are not found, and accordingly provide an incomplete order, as indicated by the error message 126. It is possible to restart by returning to the startup screen 104.

[0036] In one embodiment, for the benefit of patients suffering from any of a wide range of diseases or conditions such as, for example, cancer, autoimmune diseases, inflammatory diseases, cardiovascular diseases, fibrosis, etc., any of the combination drug delivery devices of the present disclosure can deliver two or more drugs. In one embodiment, one or more of the plurality of drug modules 12 may contain a single drug. In one embodiment, one or more of the drug modules 12 may contain a drug formulated into two or more agents. In one embodiment, one or more of the drug modules 12 may contain a solid drug (e.g., tablet, capsule, powder, lyophilized product, spray-dried product) that is prepared by the inflow of a diluent to form a liquid drug.

[0037] In one embodiment, one or more drugs of the combination drug delivery device of the present disclosure are immune checkpoint inhibitors. In certain embodiments, the immune checkpoint inhibitor is a programmed death 1 ( "PD-1") pathway inhibitor, a cytotoxic T lymphocyte antigen 4 ( "CTLA-4") antagonist, a lymphocyte activation gene 3 ( "LAG3") antagonist, a CD80 antagonist, a CD86 antagonist, a T cell immunoglobulin-mucin domain ( "Tim-3") antagonist, a T cell immunoreceptor with Ig and ITIM domains ( "TIGIT") antagonist, a CD20 antagonist, a CD96 antagonist, an indoleamine 2,3-dioxygenase ( "IDO1") antagonist, an interferon gene stimulator ( "STING") antagonist, a repetitive dominant glycoprotein A (GARP) antagonist, a CD40 antagonist, an adenosine A2A receptor ( "A2aR") antagonist, a carcinoembryonic antigen-related cell adhesion molecule 1 (CEACAM1) (CD66a) antagonist, a carcinoembryonic antigen (CEA) antagonist, a CD47 antagonist, a receptor-associated immunoglobulin domain protein ( "PVRIG") antagonist, a tryptophan 2,3-dioxygenase ( "TDO") antagonist, a V domain immunoglobulin T cell activation inhibitor ( "VISTA") antagonist, or a killer cell immunoglobulin-like receptor ( "KIR") antagonist.

[0038] In one embodiment, the PD-1 pathway inhibitor is an anti-PD-1 antibody or an antigen-binding fragment thereof. In certain embodiments, the anti-PD-1 antibody is pembrolizumab (Keytruda; MK-3475), pidilizumab (CT-011), nivolumab (Opdivo; BMS-936558), PDR001, MEDI0680 (AMP-514), TSR-042, REGN2810, JS001, AMP-224 (GSK-2661380), PF-06801591, BGB-A317, BI754091, or SHR-1210.

[0039] In one embodiment, the PD-1 pathway inhibitor is an anti-PD-L1 antibody or an antigen-binding fragment thereof. In certain embodiments, the anti-PD-L1 antibody is atezolizumab (Tecentriq; RG7446; MPDL3280A; RO5541267), durvalumab (MEDI4736), BMS-936559, avelumab (Bavencio), LY3300054, CX-072 (Proclaim-CX-072), FAZ053, KN035, or MDX-1105.

[0040] In one embodiment, the PD-1 pathway inhibitor is a small molecule drug. In certain embodiments, the PD-1 pathway inhibitor is CA-170. In other embodiments, the PD-1 pathway inhibitor is a cell-based therapy. In one embodiment, the cell-based therapy is a MiHA-added PD-L1 / L2 expression-suppressing dendritic cell vaccine. In other embodiments, the cell-based therapy is an anti-programmed cell death protein 1 antibody-expressing pluripotent T lymphocyte, an autologous PD-1-targeted chimeric switch receptor-modified T lymphocyte, or a PD-1 knockout autologous T lymphocyte.

[0041] In one embodiment, the PD-1 pathway inhibitor is an anti-PD-L2 antibody or an antigen-binding fragment thereof. In another embodiment, the anti-PD-L2 antibody is rHIgM12B7.

[0042] In one embodiment, the PD-1 pathway inhibitor is a soluble PD-1 polypeptide. In certain embodiments, the soluble PD-1 polypeptide is a fusion polypeptide. In some embodiments, the soluble PD-1 polypeptide comprises a ligand-binding fragment of the PD-1 extracellular domain. In other embodiments, the soluble PD-1 polypeptide comprises a ligand-binding fragment of the PD-1 extracellular domain. In other embodiments, the soluble PD-1 polypeptide further comprises an Fc domain.

[0043] In one embodiment, the immune checkpoint inhibitor is a CTLA-4 antagonist. In certain embodiments, the CTLA-4 antagonist is an anti-CTLA-4 antibody or an antigen-binding fragment thereof. In some embodiments, the anti-CTLA-4 antibody is ipilimumab (Yervoy), tremelimumab (ticilimumab; CP-675,206), AGEN-1884, or ATOR-1015. In one embodiment, any of the combination drug delivery devices of the present disclosure includes a CTLA-4 antagonist such as ipilimumab (Yervoy), and a PD-1 pathway inhibitor such as nivolumab (Opdivo) or pembrolizumab (Keytruda).

[0044] In one embodiment, the immune checkpoint inhibitor is a LAG3 antagonist. In certain embodiments, the LAG3 antagonist is an anti-LAG3 antibody or an antigen-binding fragment thereof. In certain embodiments, the anti-LAG3 antibody is relatlimab (BMS-986016), MK-4280 (28G-10), REGN3767, GSK2831781, IMP731 (H5L7BW), BAP050, IMP-701 (LAG-5250), IMP321, TSR-033, LAG525, BI754111, or FS-118. In one embodiment, any of the combination drug delivery devices of the present disclosure comprises a LAG3 antagonist such as relatlimab or MK-4280, and a PD-1 pathway inhibitor such as nivolumab (Opdivo) or pembrolizumab (Keytruda). In one embodiment, any of the combination drug delivery devices of the present disclosure comprises a LAG3 antagonist such as relatlimab or MK-4280, and a CTLA-4 antagonist such as ipilimumab (Yervoy). In one embodiment, any of the combination drug delivery devices of the present disclosure comprises a LAG3 antagonist such as relatlimab or MK-4280, a CTLA-4 antagonist such as ipilimumab (Yervoy), and a PD-1 pathway inhibitor such as nivolumab (Opdivo) or pembrolizumab (Keytruda).

[0045] In one embodiment, the immune checkpoint inhibitor is a KIR antagonist. In certain embodiments, the KIR antagonist is an anti-KIR antibody or an antigen-binding fragment thereof. In some embodiments, the anti-KIR antibody is lirilumab (1-7F9, BMS-986015, IPH2101), or IPH4102.

[0046] In one embodiment, the immune checkpoint inhibitor is a TIGIT antagonist. In one embodiment, the TIGIT antagonist is an anti-TIGIT antibody or an antigen-binding fragment thereof. In certain embodiments, the anti-TIGIT antibody is BMS-986207, AB154, COM902 (CGEN-15137), or OMP-313M32.

[0047] In one embodiment, the immune checkpoint inhibitor is a Tim-3 antagonist. In certain embodiments, the Tim-3 antagonist is an anti-Tim-3 antibody or an antigen-binding fragment thereof. In some embodiments, the anti-Tim-3 antibody is TSR-022 or LY3321367.

[0048] In one embodiment, the immune checkpoint inhibitor is an IDO1 antagonist. In another embodiment, the IDO1 antagonist is indoximod (NLG8189; 1-methyl-D-tryptophan), epacadostat (INCB-024360, INCB-24360), KHK2455, PE-06840003, navoximod (RG6078, GDC-0919, NLG919), BMS-986205 (F001287), or a pyrrolidine-2,5-dione derivative.

[0049] In one embodiment, the immune checkpoint inhibitor is a STING antagonist. In certain embodiments, the STING antagonist is a 2' or 3'-monofluoro-substituted cyclic-di-nucleotide, a 2'3'-difluoro-substituted mixed-bond 2',5'-3',5' cyclic-di-nucleotide, a 2'-fluoro-substituted, bis-3',5' cyclic-di-nucleotide, a 2',2''-diF-Rp,Rp, bis-3',5' cyclic-di-nucleotide, or a fluorinated cyclic-di-nucleotide.

[0050] In one embodiment, the immune checkpoint inhibitor is a CD20 antagonist. In some embodiments, the CD20 antagonist is an anti-CD20 antibody or an antigen-binding fragment thereof. In one embodiment, the anti-CD20 antibody is rituximab (RITUXAN; IDEC-102; IDEC-C2B8), ABP798, ofatumumab, or obinutuzumab.

[0051] In one embodiment, the immune checkpoint inhibitor is a CD80 antagonist. In certain embodiments, the CD80 antagonist is an anti-CD80 antibody or an antigen-binding fragment thereof. In one embodiment, the anti-CD80 antibody is galiximab or AV1142742.

[0052] In one embodiment, the immune checkpoint inhibitor is a GARP antagonist. In some embodiments, the GARP antagonist is an anti-GARP antibody or an antigen-binding fragment thereof. In certain embodiments, the anti-GARP antibody is ARGX-115.

[0053] In one embodiment, the immune checkpoint inhibitor is a CD40 antagonist. In certain embodiments, the CD40 antagonist is an anti-CD40 antibody for its antigen-binding fragment. In some embodiments, the anti-CD40 antibody is BMS3h-56, lucatumumab (HCD122 and CHIR-12.12), CHIR-5.9, or dacetuzumab (huS2C6, PRO64553, RG3636, SGN14, SGN-40). In another embodiment, the CD40 antagonist is soluble CD40 ligand (CD40-L). In one embodiment, the soluble CD40 ligand is a fusion polypeptide. In one embodiment, the soluble CD40 ligand is CD40-L / FC2 or monomeric CD40-L.

[0054] In one embodiment, the immune checkpoint inhibitor is an A2aR antagonist. In some embodiments, the A2aR antagonist is a small molecule. In one embodiment, the A2aR antagonist is CPI-444, PBF-509, istradefylline (KW-6002), preladenant (SCH420814), tozadenant (SYN115), vipadenant (BIIB014), HTL-1071, ST1535, SCH412348, SCH442416, SCH58261, ZM241385, or AZD4635.

[0055] In one embodiment, the immune checkpoint inhibitor is a CEACAM1 antagonist. In some embodiments, the CEACAM1 antagonist is an anti-CEACAM1 antibody or an antigen-binding fragment thereof. In one embodiment, the anti-CEACAM1 antibody is CM-24 (MK-6018).

[0056] In one embodiment, the immune checkpoint inhibitor is a CEA antagonist. In one embodiment, the CEA antagonist is an anti-CEA antibody or an antigen-binding fragment thereof. In one embodiment, the anti-CEA antibody is cergutuzumab amunaleukin (RG7813, RO-6895882), or RG7802 (RO6958688).

[0057] In one embodiment, the immune checkpoint inhibitor is a CD47 antagonist. In some embodiments, the CD47 antagonist is an anti-CD47 antibody or an antigen-binding fragment thereof. In one embodiment, the anti-CD47 antibody is HuF9-G4, CC-90002, TTI-621, ALX148, NI-1701, NI-1801, SRF231, or Effi-DEM.

[0058] In one embodiment, the immune checkpoint inhibitor is a PVRIG antagonist. In certain embodiments, the PVRIG antagonist is an anti-PVRIG antibody or an antigen-binding fragment thereof. In one embodiment, the anti-PVRIG antibody is COM701 (CGEN-15029).

[0059] In one embodiment, the immune checkpoint inhibitor is a TDO antagonist. In one embodiment, the TDO antagonist is a 4-(indol-3-yl)-pyrazole derivative, a 3-indole substituted derivative, or a 3-(indol-3-yl)-pyridine derivative. In another embodiment, the immune checkpoint inhibitor is a dual IDO and TDO antagonist. In one embodiment, the dual IDO and TDO antagonist is a small molecule.

[0060] In one embodiment, the immune checkpoint inhibitor is a VISTA antagonist. In some embodiments, the VISTA antagonist is CA-170 or JNJ-61610588.

[0061] In one embodiment, any one or more of the drugs of the combination drug delivery device of the present disclosure is an immune checkpoint enhancer or stimulator.

[0062] In one embodiment, the immune checkpoint enhancer or stimulator is a CD28 agonist, a 4-1BB agonist, an OX40 agonist, a CD27 agonist, a CD80 agonist, a CD86 agonist, a CD40 agonist, an ICOS agonist, a CD70 agonist, or a GITR agonist.

[0063] In one embodiment, the immune checkpoint enhancer or stimulator is an OX40 agonist. In certain embodiments, the OX40 agonist is an anti-OX40 antibody or an antigen-binding fragment thereof. In some embodiments, the anti-OX40 antibody is tavolixizumab (MEDI-0562), pogalizumab (MOXR0916, RG7888), GSK3174998, ATOR-1015, MEDI-6383, MEDI-6469, BMS986178, PF-04518600, or RG7888 (MOXR0916). In another embodiment, the OX40 agonist is a cell-based therapy. In certain embodiments, the OX40 agonist is GINAKIT cells (iC9-GD2-CD28-OX40-expressing T lymphocytes).

[0064] In one embodiment, the immune checkpoint enhancer or stimulator is a CD40 agonist. In some embodiments, the CD40 agonist is an anti-CD40 antibody or an antigen-binding fragment thereof. In one embodiment, the anti-CD40 antibody is ADC-1013 (JNJ-64457107), RG7876 (RO-7009789), HuCD40-M2, APX005M (EPI-0050), or Chi Lob 7 / 4. In another embodiment, the CD40 agonist is soluble CD40 ligand (CD40-L). In one embodiment, the soluble CD40 ligand is a fusion polypeptide. In certain embodiments, the soluble CD40 ligand is trimeric CD40-L (AVREND (registered trademark)).

[0065] In one embodiment, the immune checkpoint enhancer or stimulator is a GITR agonist. In certain embodiments, the GITR agonist is an anti-GITR antibody or an antigen-binding fragment thereof. In one embodiment, the anti-GITR antibody is BMS-986156, TRX518, GWN323, INCAGN01876, or MEDI1873. In one embodiment, the GITR agonist is a soluble GITR ligand (GITRL). In some embodiments, the soluble GITR ligand is a fusion polypeptide. In another embodiment, the GITR agonist is a cell-based therapy. In one embodiment, the cell-based therapy is an anti-CTLA4 mAb RNA / GITRL RNA transfected autologous dendritic cell vaccine or a GITRL RNA transfected autologous dendritic cell vaccine.

[0066] In one embodiment, the immune checkpoint enhancer or stimulator is a 4-1BB agonist. In some embodiments, the 4-1BB agonist is an anti-4-1BB antibody or an antigen-binding fragment thereof. In one embodiment, the anti-4-1BB antibody is urelumab or PF-05082566.

[0067] In one embodiment, the immune checkpoint enhancer or stimulator is a CD80 agonist or a CD86 agonist. In some embodiments, the CD80 agonist or CD86 agonist is a soluble CD80 or CD86 ligand (CTLA-4). In certain embodiments, the soluble CD80 or CD86 ligand is a fusion polypeptide. In one embodiment, the CD80 or CD86 ligand is CTLA4-Ig (CTLA4-IgG4m, RG2077, or RG1046) or abatacept (Orencia, BMS-188667). In other embodiments, the CD80 agonist or CD86 agonist is a cell-based therapy. In one embodiment, the cell-based therapy is MGN1601 (allogeneic renal cell carcinoma vaccine).

[0068] In one embodiment, the immune checkpoint enhancer or stimulator is a CD28 agonist. In some embodiments, the CD28 agonist is an anti-CD28 antibody, or an antigen-binding fragment thereof. In one embodiment, the anti-CD28 antibody is TGN1412.

[0069] In one embodiment, the CD28 agonist is a cell-based therapy. In one embodiment, the cell-based therapy is JCAR015 (anti-CD19-CD28-zeta modified CAR CD3+ T lymphocytes), CD28CAR / CD137CAR-expressing T lymphocytes, allogeneic CD4+ memory Th1-like T cells / microparticle-bound anti-CD3 / anti-CD28, anti-CD19 / CD28 / CD3 zeta CAR gamma-retroviral vector-transduced autologous T lymphocytes KTE-C19, anti-CEA IgCD28TCR-transduced autologous T lymphocytes, anti-EGFRvIII CAR-transduced allogeneic T lymphocytes, autologous CD123CAR-CD28-CD3 zeta-EGFRt-expressing T lymphocytes, autologous CD171-specific CAR-CD28 zeta-4-1-BB-EGFRt-expressing T lymphocytes, autologous CD19CAR-CD28-CD3 zeta-EGFRt-expressing Tcm-enriched T cells, autologous PD-1-targeted chimeric switch receptor-modified T lymphocytes (chimeric with CD28), CD19CAR-CD28-CD3 zeta-EGFRt-expressing Tcm-enriched T lymphocytes, CD19CAR-CD28-CD3 zeta-EGFRt-expressing Tn / mem-enriched T lymphocytes, CD19CAR-CD28 zeta-4-1BB-expressing allogeneic T lymphocytes, CD19CAR-CD3 zeta-4-1BB-CD28-expressing autologous T lymphocytes, CD28CAR / CD137CAR-expressing T lymphocytes, CD3 / CD28 co-stimulatory vaccine-stimulated autologous T lymphocytes, or iC9-GD2-CD28-OX40-expressing T lymphocytes.

[0070] In one embodiment, the immune checkpoint enhancer or stimulator is a CD27 agonist. In some embodiments, the CD27 agonist is an anti-CD27 antibody, or an antigen-binding fragment thereof. In one embodiment, the anti-CD27 antibody is varlilumab (CDX-1127).

[0071] In one embodiment, the immune checkpoint enhancer or stimulator is a CD70 agonist. In some embodiments, the CD70 agonist is an anti-CD70 antibody or an antigen-binding fragment thereof. In one embodiment, the anti-CD70 antibody is ARGX-110.

[0072] In one embodiment, the immune checkpoint enhancer or stimulator is an ICOS agonist. In certain embodiments, the ICOS agonist is an anti-ICOS antibody or an antigen-binding fragment thereof. In some embodiments, the anti-ICOS antibody is BMS986226, MEDI-570, GSK3359609, or JTX-2011. In other embodiments, the ICOS agonist is a soluble ICOS ligand. In some embodiments, the soluble ICOS ligand is a fusion polypeptide. In one embodiment, the soluble ICOS ligand is AMG750.

[0073] In one embodiment, any one or more of the drugs of the combination drug delivery device of the present disclosure is an anti-CD73 antibody or an antigen-binding fragment thereof. In certain embodiments, the anti-CD73 antibody is MEDI9447.

[0074] In one embodiment, any one or more of the drugs of the combination drug delivery device of the present disclosure is a TLR9 agonist. In one embodiment, the TLR9 agonist is agatrimod sodium.

[0075] In one embodiment, any one or more of the drugs of the combination drug delivery device of the present disclosure is a cytokine. In certain embodiments, the cytokine is a chemokine, interferon, interleukin, lymphokine, or a member of the tumor necrosis factor family. In some embodiments, the cytokine is IL-2, IL-15, or interferon-gamma.

[0076] In one embodiment, one or more drugs of any of the combination drug delivery devices of the present disclosure are TGF-β antagonists. In some embodiments, the TGF-β antagonist is fresolimumab (GC-1008), NIS793, IMC-TR1 (LY3022859), ISTH0036, trabedersen (AP12009), recombinant transforming growth factor-beta-2, autologous HPV-16 / 18 E6 / E7 specific TGF-beta resistant T lymphocytes, or TGF-beta resistant LMP specific cytotoxic T lymphocytes.

[0077] In one embodiment, one or more drugs of any of the combination drug delivery devices of the present disclosure are iNOS antagonists. In some embodiments, the iNOS antagonist is N-acetyl-cysteine (NAC), aminoguanidine, L-nitroarginine methyl ester, or S,S-1,4-phenylene-bis(1,2-ethanediyldi)bis-isothiourea).

[0078] In one embodiment, one or more drugs of any of the combination drug delivery devices of the present disclosure are SHP-1 antagonists.

[0079] In one embodiment, one or more drugs of any of the combination drug delivery devices of the present disclosure are colony stimulating factor 1 receptor (“CSF1R”) antagonists. In certain embodiments, the CSF1R antagonist is an anti-CSF1R antibody, or an antigen-binding fragment thereof. In some embodiments, the anti-CSF1R antibody is emactuzumab.

[0080] In one embodiment, one or more drugs of any of the combination drug delivery devices of the present disclosure are agonists of members of the TNF family. In some embodiments, the agonist of a member of the TNF family is ATOR1016, ABBV-621, or adalimumab.

[0081] In one embodiment, one or more drugs of the combination drug delivery devices of the present disclosure are Interleukin-2 (IL-2) such as aldesleukin. Preferably, IL-2 or conjugated IL-2 (e.g., PEGylated) may be modified to selectively activate effector T cells through regulatory T cells, such as in the case of bempegaldesleukin (referred to as "T-eff IL-2"). In one embodiment, any of the combination drug delivery devices of the present disclosure includes a modified IL-2 such as bempegaldesleukin that selectively activates effector T cells through regulatory T cells, and a PD-1 pathway inhibitor such as nivolumab (Opdivo) or pembrolizumab (Keytruda). In one embodiment, any of the combination drug delivery devices of the present disclosure includes a modified IL-2 such as bempegaldesleukin that selectively activates effector T cells through regulatory T cells, and a LAG3 antagonist such as relatlimab or MK-4280. In one embodiment, any of the combination drug delivery devices of the present disclosure includes a modified IL-2 such as bempegaldesleukin that selectively activates effector T cells through regulatory T cells, a PD-1 pathway inhibitor such as nivolumab (Opdivo) or pembrolizumab (Keytruda), and a LAG3 antagonist such as relatlimab or MK-4280. In one embodiment, any of the combination drug delivery devices of the present disclosure includes a modified IL-2 such as bempegaldesleukin that selectively activates effector T cells through regulatory T cells, and a CTLA-4 antagonist such as ipilimumab (Yervoy). In one embodiment, any of the combination drug delivery devices of the present disclosure includes a modified IL-2 such as bempegaldesleukin that selectively activates effector T cells through regulatory T cells, a PD-1 pathway inhibitor such as nivolumab (Opdivo) or pembrolizumab (Keytruda), and a CTLA-4 antagonist such as ipilimumab (Yervoy).In one embodiment, any of the combination drug delivery devices of the present disclosure includes a modified IL-2 such as bempegaldesleukin that selectively activates effector T cells through regulatory T cells, a CTLA-4 antagonist such as ipilimumab (Yervoy), and a LAG3 antagonist such as relatlimab or MK-4280. In one embodiment, any of the combination drug delivery devices of the present disclosure includes a modified IL-2 such as bempegaldesleukin that selectively activates effector T cells through regulatory T cells, a PD-1 pathway inhibitor such as nivolumab (Opdivo) or pembrolizumab (Keytruda), a CTLA-4 antagonist such as ipilimumab (Yervoy), and a LAG3 antagonist such as relatlimab or MK-4280.

[0082] In one embodiment, one or more drugs of any of the combination drug delivery devices of the present disclosure are CD160 (NK1) agonists. In certain embodiments, the CD160 (NK1) agonist is an anti-CD160 antibody or an antigen-binding fragment thereof. In one embodiment, the anti-CD160 antibody is BY55.

[0083] In one embodiment, one or more of the drug modules 12 may include a soluble CTLA-4 polypeptide. The soluble CTLA-4 polypeptide may be useful, for example, in the treatment of cell-mediated autoimmune diseases such as rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, graft-versus-host disease, transplant rejection, and the like. In one embodiment, the soluble CTLA-4 polypeptide is abatacept (Orencia), belatacept (Nulojix), RG2077, or RG-1046. In certain embodiments, one or more of the drug modules 12 of the combination drug delivery device of the present disclosure include a soluble CTLA-4 polypeptide such as abatacept (Orencia) and a Bruton's tyrosine kinase inhibitor such as branebrutinib. In certain embodiments, one or more of the drug modules 12 of the combination drug delivery device of the present disclosure include a soluble CTLA-4 polypeptide such as abatacept (Orencia) and a tyrosine kinase 2 inhibitor such as BMS-986165. In certain embodiments, one or more of the drug modules 12 of the combination drug delivery device of the present disclosure include a soluble CTLA-4 polypeptide such as abatacept (Orencia) and an "IL-2 for T-reg" such as BMS-986326 and NKTR-358 that selectively activates regulatory T cells that oppose effector T cells or interleukin-2 (IL2).

Claims

1. 1. A method of preparing a combination drug delivery device for a patient, the combination drug delivery device being comprised of a plurality of serially connected drug modules, comprising: providing a plurality of serially connectable medication modules, each containing a medication component or a diluent for said patient; fixing to each of said plurality of medication modules a machine readable code representing an alphanumeric data string associated with said medication ingredient or diluent contained in a corresponding medication module; associating an authentication code with said plurality of medication modules; Including, the authentication code is based on a combination of the alphanumeric data strings combined with one another in a predefined order of the medication modules for the patient such that the authentication code can be used to determine whether the medication modules are in the correct and proper order when serially connected. method.

2. Further comprising providing a flow controller selectively actuable to a use state permitting liquid drug to flow from the drug delivery device.

2. The method of claim 1.

3. providing a control unit having a computing processing unit configured to initiate the flow controller. The method of claim 2.

4. storing the authentication code in a non-transitory memory associated with the computing processing unit. The method of claim 3.

5. The computing processing unit is i. receiving a remotely generated activation code based on the machine readable codes of the plurality of serially connected medication modules; ii. comparing the activation code with the authentication code; iii. if the activation code matches the authentication code, activating the flow controller to the use state; iv. if the activation code does not match the authentication code, generating an error message; It is configured as follows: The method of claim 4.

6. The computing processing unit is configured to activate the flow controller to the usage state based on an acknowledgement message received by the computing processing unit; the authorization message is generated remotely from the computing processing unit based on a match between an activation code based on the machine readable code of the plurality of serially connected medication modules and the authentication code; The method of claim 3.

7. The flow controller and the control unit are contained in a controller housing. The method of claim 3.

8. and delivering the plurality of medication modules and the controller housing to an assembly site. The method of claim 7.

9. The machine-readable code is selected from one or more of the group consisting of a QR code and a barcode.

2. The method of claim 1.

10. the machine readable code represents the type of drug ingredient or diluent contained in the corresponding drug module; 2. The method of claim 1.

11. the machine readable code represents a concentration of the drug component contained in the corresponding drug module; The method of claim 10.

12. the plurality of medication modules are prepared for the patient based on a prescription for the patient; 2. The method of claim 1.

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