Company Directory

Single-Patient EA Policies/Criteria

Taiho Oncology, Inc. (“Taiho”) is committed to helping patients with cancer obtain access to new treatments. While we believe this is best accomplished through participation in clinical trials, we recognize that this is not always possible for every cancer patient. In such situations, Taiho may be able to provide pre‑approval access to an investigational drug through our Expanded Access Program. Expanded Access, also known as Compassionate Use, is the use of an investigational medical product intended to diagnose, monitor or treat a patient's disease or condition, prior to FDA approval and outside of use in a clinical trial. Taiho accepts requests for pre‑approval access to investigational cancer medicines from physicians only.

To be eligible for access to an investigational medicine, a physician must apply and certify that the patient for whom the application is being submitted meets the following criteria*:

• The patient is suffering from a serious or life‑threatening malignancy and has received available standard treatments without success
• The patient is not eligible to participate in any ongoing clinical study of the Taiho investigational agent
• The medicine requested is part of an active ongoing clinical development program at Taiho Oncology (US) as described on our website: www.taihooncology.com/us under the tab for ‘Our Science’
• Provision of the investigational agent will not interfere with the ongoing Taiho development program, and the potential benefits to the patient outweigh the potential risks

A physician may click here to obtain an application form, submit the completed form, or submit questions about Taiho's Expanded Access Program, via email to ExpandedAccess@taihooncology.com. (For futibatinib specific requests, click here to obtain the application form).

* Note that meeting these criteria does not guarantee access to any investigational product.

Disease/Category-Specific EA Policies/Criteria

EXPANDED ACCESS TO INVESTIGATIONAL DRUGS

https://www.takedaoncology.com/medicines/expanded-access-to-investigational-drugs/

Available Therapies via Single-Patient EA

At this time, TenNor will not provide investigational drug outside of clinical studies and will reevaluate when sufficient preliminary safety and efficacy information has been obtained in clinical trials.

Rifasutenizol (formerly known as TNP-2198) is currently under clinical development for the treatment of Helicobacter pylori infection. Rifaquizinone (formerly known as TNP-2092) is currently under clinical development for the treatment of Prosthetic Joint infection (PJI) and Acute Bacterial Skin and Skin Structure Infections (ABSSSI).

At this time, TenNor will not provide investigational drug outside of clinical studies and will reevaluate when sufficient preliminary safety and efficacy information has been obtained in clinical trials.

 

Single-Patient EA Policies/Criteria

Tetra Therapeutics is dedicated to developing new therapies that have a positive impact on patient health, and to serving patients, patient families and patient communities.
Consistent with Tetra Therapeutic’s mission to bring innovative medicines to patients with serious or life-threatening illnesses or conditions, we are focused on enrolling and conducting the clinical trials necessary to gain regulatory approvals to make our medicines available to patients as quickly as possible. We are privileged to collaborate with clinical investigators and with patients who participate in our studies to develop new, safe and effective therapies. We understand that there are patients who will not be eligible for our clinical trials and may not have options for alternative therapies. In these circumstances, Tetra Therapeutics will consider providing a requesting physician with pre-approval access to a specific Tetra Therapeutics investigational drug, for the treatment of an individual patient outside of a clinical trial, when certain conditions are met and in accordance with the local regulatory process. These conditions include the following:
- The patient has a serious or life-threatening illness or condition;
- The investigational drug is in active clinical development with sufficient data available to determine an appropriate dose and schedule for the patient’s specific condition;
- A benefit-risk analysis, based on both the available clinical data as well as the requesting physician’s assessment of the individual patient’s condition and history, supports making the investigational drug available;
- Making the investigational drug available will not negatively impact or delay the conduct of clinical trials or regulatory review or approval of the investigational drug for broader patient access; and
- Adequate supply of the investigational drug is available.
We continually evaluate the benefit-risk profile of each of our investigational drugs based on evolving clinical data. Each compound under development is different and the fact that one investigational drug is made available for the treatment of a particular patient does not mean it will be made available in response to other requests on behalf of other patients whose circumstances and medical histories may be different, or that a different investigational drug will be made available under our policy. Requests will be considered on a case-by-case basis.
Tetra Therapeutics is committed to evaluating all requests in a fair and equitable manner. All requests must be submitted by the patient’s treating physician; Tetra Therapeutics may require more detailed information in order to fully evaluate a request. The requesting physician must agree to obtain appropriate regulatory and ethics committee approvals and comply with regulatory obligations, including obtaining patient consent, patient monitoring and safety reporting. Each request will be given careful consideration by Tetra Therapeutics, whose decisions are final.
Physicians seeking pre-approval access for patients with no alternative treatment options should submit their requests to info@tetratherapeutics.com. All requests will be acknowledged within five business days if received during regular business hours and reviewed in a timely manner.
For further information on current clinical trials please see https://tetratherapeutics.com/clinical-trials/ and https://clinicaltrials.gov.

 

Available Therapies via Single-Patient EA

Zatolmilast

 

Single-Patient EA Policies/Criteria

Voriconazole Inhalation Powder for Pulmonary Aspergillosis and other voriconazole-sensitive pulmonary fungal infections

 

Available Therapies via Single-Patient EA

TFF Pharmaceuticals is developing its two lead drug candidates, Voriconazole Inhalation Powder and Tacrolimus Inhalation Powder, through the conduct of clinical trials. We understand that in some cases, patients may have exhausted other therapeutic options and/or may not qualify for participation in clinical trials. In such cases, treating physicians may request the use of an investigational drug on an expanded access or compassionate use basis. It is important to remember that the potential risks of an investigational drug are not yet established and therefore the treating physician must weigh the potential risks of an investigational drug against its potential benefits before considering the use of an investigational drug.

At this point, TFF Pharmaceuticals will consider providing a requesting physician with access to a specific TFF Pharmaceuticals investigational drug on an expanded access/compassionate use basis when certain conditions are met.

TFF Pharmaceuticals will consider requests for expanded access to Voriconazole Inhalation Powder:
• The patient is deemed by the patient’s physician to have a serious or life-threatening condition, with no satisfactory alternative therapies available, or has had an unfavorable response to adequate standard of care therapy.
• The patient’s physician believes that the use of Voriconazole Inhalation Powder is in the patient’s best interest.
• If provided, the investigational drug will be used in accordance with applicable laws and regulatory requirements of the country where the patient is treated.
• The patient is ineligible for or otherwise unable to participate in a clinical trial.
• Making the investigational drug available to a patient will not negatively impact or delay the conduct of ongoing clinical trials or regulatory review or approval of the investigational drug for broader patient access.

The treating physician must submit a formal request for expanded access to TFF Pharmaceuticals at expandedaccess@tffpharma.com. The treating physician is responsible for obtaining local regulatory and/or ethics/IRB approval for the investigational use. The request for expanded access must include at a minimum the requesting physician’s name and contact information, the indication, and rationale for request. Product specific eligibility criteria may apply and the treating physician will be requested to provide additional information.
The medical reviewers at TFF Pharmaceuticals will evaluate each request based on the criteria above, and the overall assessment of potential benefits and risks in the given patient.

TFF Pharmaceuticals may require more detailed information in order to fully evaluate a request. Every effort will be made to provide a response to an expanded access request within 3 business days of the formal request, with approval, non-approval or a request for additional information.

Additional information on Expanded Access for Voriconazole Inhalation Powder

Indications:

Invasive Pulmonary Aspergillosis
Chronic Pulmonary Aspergillosis

Allergic Bronchopulmonary Aspergillosis
Aspergillus Tracheobronchitis
Aspergillus bronchial anastomotic infection

Other voriconazole-sensitive pulmonary fungal infections

Eligibility Criteria:

Inclusion Criteria:

1. Male or female aged 18 years or older at screening.
2. Diagnosed with pulmonary aspergillosis including Invasive Pulmonary Aspergillosis (IPA), Chronic Pulmonary Aspergillosis (CPA), Allergic Bronchopulmonary Aspergillosis (ABPA), Aspergillus tracheobronchitis and Aspergillus bronchial anastomotic infection. Pulmonary infections with voriconazole sensitive fungi other than Aspergillus such as but not limited to scedosporium and fusarium are also allowed.
3. Patient has limited or no treatment options due to documented or anticipated intolerance, toxicity, contraindications, or lack of clinical response to SOC antifungal therapy, as advocated by the relevant regional treatment guidelines.
4. The treating clinician considers that the potential advantage of using Voriconazole Inhalation Powder outweighs the potential risks. In patients with disseminated fungal infection in addition to pulmonary infection, Voriconazole Inhalation Powder must be used as add-on therapy to the current SOC.
5. The Sponsor agrees that the benefit:risk assessment is favorable for the use of Voriconazole Inhalation Powder in the patient.
6. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test (UPT) prior to first dose. Sexually active WOCBP and male patients must agree to use highly effective birth control or abstinence until 3 months after last dose.
7. Patient succeeds in meeting training criteria on the use of the dry powder inhaler (DPI) and is willing and able to perform adequate inhalation technique for treatment duration in the opinion of the treating clinician or designee.
8. Patient provides informed consent and agrees to follow the treatment regimen and safety and outcomes assessments.

Exclusion Criteria:

1. Infection with fungi not responsive to voriconazole.
2. Pregnant or breastfeeding.
3. History or presence of hypersensitivity or idiosyncratic reaction to voriconazole or excipients in Voriconazole Inhalation Powder.
4. Patients with severe liver disease as defined by Child-Pugh Class C.
5. Patients who are eligible and are able to participate in a clinical trial of Voriconazole Inhalation Powder.

Single-Patient EA Policies/Criteria

TG Therapeutics is committed to bringing our investigational therapies for B-cell malignancies and autoimmune diseases to patients as fast as possible. We believe the best way for patients to access our investigational therapies is through participation in clinical trials, with the goal of obtaining regulatory approval of our products and allowing access to the broadest group of patients possible.

At this time, TG Therapeutics does not have a program to provide its investigational therapies to patients on an expanded access basis pursuant to section 561(b) of the U.S. Federal Food, Drug, and Cosmetic Act (FDCA). Because we do not currently have an expanded access program, we have not yet established procedures for making such requests or criteria for evaluating them. TG Therapeutics will update this policy if the company decides to make its investigational therapies available on an expanded access basis.

Patients may be able to access TG Therapeutics investigational therapies by participating in ongoing clinical trials. Whether or not a patient is eligible to enroll in any of our trials depends on a number of factors, including the specific requirements of each trial and the status of that trial. For more information about our trials, please visit Our Trials Overview or https://clinicaltrials.gov/ct2/results?cond=&term=%22tg+therapeutics%22&cntry=&state=&city=&dist.

TG is committed to responding to questions about its expanded access policy within five (5) business days of receipt. As noted above, at this time, we are not providing our investigational therapies on an expanded access basis.

Single-Patient EA Policies/Criteria

TheRas, Inc. (d/b/a BridgeBio Oncology Therapeutics) (“BBOT”) is passionate about developing advanced therapies and delivering transformative medicines to treat patients who suffer from advanced cancers. BBOT provides access to our investigational therapies through enrollment in our ongoing clinical trials. For ongoing clinical trials on BBOT’s investigational therapies currently in development, please visit https://clinicaltrials.gov.
BBOT also recognizes the importance of utilizing the applicable regulatory and legal pathways for providing access to our investigational therapies when patients with life-threatening diseases have exhausted all available treatment options and are not eligible for clinical trials. At certain point when efficacy and safety profile of specific molecule is reasonably established to allow BBOT for risk/benefit assessment, BBOT may be able to provide patients access to its investigational medicines outside of a clinical trial if certain conditions are met.
The use of investigational medicines outside of a clinical trial is known under various terms such as Pre-approval Access, Expanded Access, or Named Patient Programs (also widely referred to as compassionate use). Requests for access to investigational products under these circumstances must be made by treating physicians directly to BBOT. Upon receipt of an unsolicited request by a prescribing healthcare professional, when permitted by local regulations, BBOT may consider access requests from treating physicians for patients with no viable therapeutic alternatives.

Single-Patient EA Policies/Criteria

Purpose:

Theriva Biologics, is dedicated to developing innovative treatments for patients with cancer. We have developed this Expanded Access Policy to provide a pathway for patients who may benefit from treatment with our investigational product VCN-01 outside of clinical trials. As provided by the 21st Century Cures Act, we may revise this policy at any time.

Criteria for Expanded Access:

• Patient must have a confirmed diagnosis of a serious or life-threatening illness for which our investigational product is being investigated.
• Patient must have exhausted all standard treatment options and have no other viable treatment alternatives including participation in clinical trials.
• Patient must meet any additional criteria established by our Company to ensure the safe and appropriate use of our investigational product.
• There is sufficient evidence that the potential clinical benefit to the Patient of treatment with our investigational product outweighs the potential risks.

Process for Access:

• The Patient’s healthcare provider must submit a request for Expanded Access to our Company, including all relevant medical information and rationale for requesting access to our investigational product.
• Our medical team will review each request on a case-by-case basis to determine if the patient meets the criteria for expanded access.
• If approved, the Patient must provide written informed consent and our Company will work with the patient’s healthcare provider to facilitate access to our investigational product, including providing necessary information and support for administration of the drug.
• We will monitor the Patient’s response to treatment and report any adverse events to regulatory authorities as required.
• Expanded access does not guarantee a positive outcome and the patient must be informed of the potential risks and benefits of our investigational product.

Limitations:

• Expanded access may only be considered in circumstances where VCN-01 is available, and such expanded access will not compromise the scientific validity of broader development programs, or interfere with or delay current clinical trials or regulatory filings that are designed to make the therapy available to many more patients.
• Our company reserves the right to make final decisions on granting expanded access based on medical necessity and available supply of the drug.

Contact Information:

For more information on our Expanded Access Policy or to request access to our oncolytic adenovirus therapy, please contact our medical team at medicalmonitor@therivabio.com.

Approval:

This Expanded Access Policy has been approved by our Company’s executive team and will be reviewed periodically to ensure compliance with regulatory requirements and ethical standards.

Available Therapies via Single-Patient EA

VCN-01

Single-Patient EA Policies/Criteria

Expanded Access to Investigational Drugs Policy:
1. Purpose and philosophy behind the policy
Throne Biotechnologies (Throne) is a clinical-stage therapeutic company with a disruptive stem cell technology that can fundamentally reverse type 1 diabetes (T1D), alopecia areata (AA) and other autoimmune diseases through immune education of Stem Cell Educator therapy (Gleukocellä) at the root causes. Over last 12 years, international multicenter clinical trials in the United States, China, and Spain have demonstrated the clinical safety and efficacy of Stem Cell Educator therapy. Throne is committed to bring this innovative therapy to help patients with serious and life-threatening diseases in medical need before it is fully approved by FDA for clinical use on prescription.
2. Approach to requests for access to Stem Cell Educator therapy
It is the first and most preferable route for patients to participate Throne’s ongoing clinical trials by using Stem Cell Educator therapy to treat type 1 diabetes and alopecia areata. If patients do not meet the criteria of clinical trials, their treating physician, who is able to comply with the requirements that are stated in this document, may request information about how to apply for access to Throne's investigational products by contacting the Company.

3. Policy
3.1. Patient Eligibility Criteria: To be eligible for accessing to the investigational product, patients must meet following criteria:
• The patient has a serious or life-threatening condition with no satisfactory alternative.
• Assessment that benefits outweigh the risks to the patient.
• Adequate venous access for blood cell separation (apheresis).
• Ability to provide informed consent.
• Must agree to comply with all study requirements and be willing to complete all study visits.

3.2. Investigational Product Criteria:

• The product is under clinical investigation in one or more clinical trials, with high safety profiles.
• Assessment that the company has an adequate supply of the investigational product.
• A determination that expanded access will not interfere with the company's ability to complete clinical trials in a timely fashion or which might otherwise delay marketing approval and ultimately availability to all patients.

3.3. Treating Physician Criteria and Responsibility: The physician must agree in writing to comply with:
• Physician(s) is (are) properly licensed.
• Physician(s) meet the applicable country-specific legal and regulatory requirements related to providing the investigational products under the Expanded Access.
• Any Throne’s requirements in terms of safety reporting and protection of intellectual properties.
• A treating physician may submit questions and requests regarding to the Expanded Access to email: connect@thronebio.com. We will do our best efforts to acknowledge each submitted request within 5 business days.

Single-Patient EA Policies/Criteria

Early (Expanded) Access Policy

Tiziana Life Sciences is dedicated to developing new therapies that have a positive impact on patient health, and to serving patients, patient families and patient communities through education, empathy, and awareness.

Consistent with Tiziana Life Sciences’ mission to bring innovative medicines to patients with serious or life-threatening illnesses or conditions, we are focused on enrolling and conducting the clinical trials necessary to gain regulatory approvals to make our medicines available broadly to patients as quickly as possible. We are privileged to collaborate with clinical investigators and with patients who participate in our studies to develop new, safe and effective therapies. We believe this approach will serve patients who could be helped by the therapies we are developing. At the same time, we understand that there are seriously ill patients who will not be eligible for our clinical trials and may not have options for alternative therapies, including investigational therapies in trials being conducted by other sponsors. In these circumstances, Tiziana Life Sciences will consider providing a requesting physician with pre-approval access to a specific Tiziana Life Sciences investigational drug, for the treatment of an individual patient outside of a clinical trial, when certain conditions are met. These conditions include the following:



The patient has a serious or life-threatening illness or condition and is either no longer responsive to or no longer able to tolerate any available treatment option;
The investigational drug is in active clinical development with sufficient data available to determine an appropriate dose and schedule for the patient’s specific condition;
A benefit-risk analysis, based on both the available clinical data as well as the requesting physician’s assessment of the individual patient’s condition and history, supports making the investigational drug available;
Making the investigational drug available will not negatively impact or delay the conduct of clinical trials or regulatory review or approval of the investigational drug for broader patient access; and
Adequate supply of the investigational drug is available.



We continually evaluate the benefit-risk profile of each of our investigational drugs based on evolving clinical data. Each compound under development is different and the fact that one investigational drug is made available for the treatment of a particular patient does not mean it will be made available in response to other requests on behalf of other patients whose circumstances and medical histories may be different, or that a different investigational drug will be made available under our policy. Requests will be considered on a case-by-case basis.

Tiziana Life Sciences is committed to evaluating all requests in a fair and equitable manner. All requests must be submitted by the patient’s treating physician; Tiziana Life Sciences may require more detailed information in order to fully evaluate a request. The requesting physician must agree to obtain appropriate regulatory and ethics committee approvals and comply with regulatory obligations, including obtaining patient consent, patient monitoring and safety reporting. Each request will be given careful consideration by Tiziana Life Sciences, whose decisions are final.



Physicians seeking pre-approval access for patients with no alternative treatment options should submit their requests to ea@tizianalifesciences.com. We regularly monitor this mailbox and will use our best efforts to acknowledge each submitted request within 5 business days after receipt.


 

Single-Patient EA Policies/Criteria

At this time, TME Pharma is not offering Expanded Access for NOX-A12 (olaptesed pegol). Access to NOX-A12-based therapies is currently available only through participation in our clinical trials which allows us to allocate available supply to study the drug’s effectiveness and safety in a controlled and evaluable setting. For more information on our clinical trials that may be recruiting new patients, please consult www.clinicaltrials.gov. We understand the interest of patients in accessing NOX-A12 outside of clinical trials and prior to regulatory approval but we believe investigational products should be studied within the context of a clinical trial and encourage patients to enroll in a clinical trial wherever possible. We recognize the need for Expanded Access programs, and we will re-evaluate the status of our policy based on data from ongoing and future clinical trials.

 

Single-Patient EA Policies/Criteria

The objective of our development program is to conduct clinical trials and to obtain marketing approval by the FDA and other regulatory authorities. Participation in clinical trials is the first and most preferable route. If participation in clinical trials is not an option, physicians may consider a single-patient expanded access IND. Requests are considered on an individual basis. The general criteria used to evaluate such requests for individual patients are as follows: 1) The patient is diagnosed with PJI; 2) Assessment that the company has an adequate supply of the investigational medicine; and 3) A determination that expanded access will not interfere with the company’s ability to complete clinical trials in a timely fashion or which might otherwise delay marketing approval and ultimately availability to all patients. The company may request additional information, including patient history, in order to fully evaluate the request. If the physician will be the sponsor for the IND, he or she is required to obtain necessary ethical and regulatory clearances, including informed consent, as well as provide reporting on treatment outcomes.

Available Therapies via Single-Patient EA

Prosthetic joint infection.

Available Therapies via Single-Patient EA

G207 for pediatric high grade gliomas

Single-Patient EA Policies/Criteria

Trevi Therapeutics, Inc. is currently unable to offer Expanded Access.

Available Therapies via Single-Patient EA

Currently, Trevi Therapeutics, Inc. does not have any investigational products available for Expanded Access.

Disease/Category-Specific EA Policies/Criteria

https://www.trevitherapeutics.com/patients-2/

Single-Patient EA Policies/Criteria

Trinomab is dedicated to discovering and developing novel native human monoclonal antibody (mAb) drug. Trinomab’s lead product, TNM002 injection, is the first recombinant native human mAb against tetanus toxin and is indicated for prophylaxis against tetanus. Currently, TNM002 has completed phase I clinical trials. A phase II clinical trial is ongoing. The results of clinical trials show that TNM002 has excellent safety and efficacy profiles, with low risk of immunogenicity. At Trinomab, we focus on conducting clinical trials aimed at gaining regulatory approval, making TNM002 available to patients as early as possible. Trinomab understands the interest of patients in accessing TNM002 outside of clinical trials and prior to regulatory approval for potentially life threatening diseases, however we do not currently offer any Expanded Access Programs for TNM002. Trinomab recognizes the need for Expanded Access Programs and will continue to evaluate of our policy based on data from ongoing and future clinical trials and the clinical development plan in the U.S.

Single-Patient EA Policies/Criteria

Trinomab is dedicated to discovering and developing novel native human monoclonal antibody (mAb) drug. Trinomab’s lead product, TNM002 injection, is the first recombinant native human mAb against tetanus toxin and is indicated for prophylaxis against tetanus. Currently, TNM002 has completed phase I clinical trials. A phase II clinical trial is ongoing. The results of clinical trials show that TNM002 has excellent safety and efficacy profiles, with low risk of immunogenicity. At Trinomab, we focus on conducting clinical trials aimed at gaining regulatory approval, making TNM002 available to patients as early as possible. Trinomab understands the interest of patients in accessing TNM002 outside of clinical trials and prior to regulatory approval for potentially life threatening diseases, however we do not currently offer any Expanded Access Programs for TNM002. Trinomab recognizes the need for Expanded Access Programs and will continue to evaluate of our policy based on data from ongoing and future clinical trials and the clinical development plan in the U.S.

Single-Patient EA Policies/Criteria

Triumvira Immunologics, Inc. is dedicated to developing new therapies that have a positive impact on patient health, and to serving patients, patient families and patient communities through education, empathy, and awareness. Consistent with Triumvira, Inc.’s mission to bring innovative medicines to patients with serious or life-threatening illnesses or conditions, we are focused on enrolling and conducting the clinical trials necessary to gain regulatory approvals to make our medicines available broadly to patients as quickly as possible. We are privileged to collaborate with clinical investigators and with patients who participate in our studies to develop new, safe and effective therapies. We believe this approach will serve patients who could be helped by the therapies we are developing.

At the same time, we understand that there are seriously ill patients who will not be eligible for our clinical trials and may not have options for alternative therapies, including investigational therapies in trials being conducted by other sponsors. In these circumstances, Triumvira, Inc. will consider providing a requesting physician with pre-approval access to a specific investigational drug, for the treatment of an individual patient outside of a clinical trial, when certain conditions are met. These conditions include the following:

• The patient has a serious or life-threatening illness or condition and is either no longer responsive to or no longer able to tolerate any available treatment option;
• The investigational drug is in active clinical development with sufficient data available to determine an appropriate dose and schedule for the patient’s specific condition;
• A benefit-risk analysis, based on both the available clinical data as well as the requesting physician’s assessment of the individual patient’s condition and history, supports making the investigational drug available;
• Making the investigational drug available will not negatively impact or delay the conduct of clinical trials or regulatory review or approval of the investigational drug for broader patient access; and
• Adequate supply of the investigational drug is available.

We continually evaluate the benefit-risk profile of each of our investigational drugs based on evolving clinical data. Each compound under development is different and the fact that one investigational drug is made available for the treatment of a particular patient does not mean it will be made available in response to other requests on behalf of other patients whose circumstances and medical histories may be different, or that a different investigational drug will be made available under our policy. Requests will be considered on a case-by-case basis.

Triumvira is committed to evaluating all requests in a fair and equitable manner. All requests must be submitted by the patient’s treating physician; Triumvira may require more detailed information in order to fully evaluate a request. The requesting physician must agree to obtain appropriate regulatory and ethics committee approvals and comply with regulatory obligations, including obtaining patient consent, patient monitoring and safety reporting. Each request will be given careful consideration by Triumvira whose decisions are final. Physicians seeking pre-approval access for patients with no alternative treatment options should submit their requests to Partners@Triumvira.com. We regularly monitor this mailbox and will use our best efforts to acknowledge each submitted request within 3 business days after receipt.

Available Therapies via Single-Patient EA

TAC01-CD19, autologous TAC (T cell antigen coupler) T cells, single infusion, multiple dosage levels.

Indication: B-Cell Lymphoma

Single-Patient EA Policies/Criteria

The FDA has developed a guidance whereby patients who have no treatment alternatives and cannot participate in a clinical trial may receive investigational treatments from companies.  This program is called Expanded Access.  In order to be eligible, patients must demonstrate that they have exhausted all available medications to treat their disorder, meaning they have taken available medications and have no further benefit, are intolerant to other medications, or have contraindications to other medications.  They must also demonstrate that there are either no clinical trials available in their locale, or that they are not eligible to participate in other clinical trials. The key decision for physicians and patients is whether they believe the benefits of treatment outweigh the risks.

TrueBinding has prepared an expanded access protocol for which treating physicians can apply on behalf of their patients.  Once enrolled in the protocol, patients receive monthly (every 28 days) IV infusions of TB006.  Treatment may continue indefinitely, however it may be discontinued whenever desired.  The protocol contains some patient monitoring suggestions, however other than adverse events there are no data to report to TrueBinding.

You may receive a copy of the protocol and the Investigator’s Brochure by contacting us.  A Confidentiality Disclosure Agreement will be sent to you.  Once executed, the documents will be sent.  If you have a patient who qualifies and is interested, you may apply for the program by accessing the application.  You will be notified of approval within 7 days of the application.  If the application is approved, you must participate in a short training session.  This covers preparation of the IV drug product, collection and reporting of adverse events, and other elements of Good Clinical Practices (GCPs).

When this is complete, drug will be sent to you.  You must provide IV administration supplies, including saline, tubing, and administration equipment. 

You may receive a copy of the protocol and the Investigator’s Brochure by contacting us.  A Confidentiality Disclosure Agreement will be sent to you.  Once executed, the documents will be sent.  If you have a patient who qualifies and is interested, you may apply for the program by accessing the application.  You will be notified of approval within 7 days of the application.  If the application is approved, you must participate in a short training session.  This covers preparation of the IV drug product, collection and reporting of adverse events, and other elements of Good Clinical Practices (GCPs).

When this is complete, drug will be sent to you.  You must provide IV administration supplies, including saline, tubing, and administration equipment. 

Available Therapies via Single-Patient EA

TrueBinding, Inc. is pleased to offer their lead pipeline compound, TB006, on a compassionate use basis to patients with Alzheimer’s disease (AD) and related dementias.  TB006 is a humanized monoclonal antibody which targets galectin-3 (Gal-3), an endogenous protein involved in a number of neurological and metabolic disorders.  There are two antibodies approved for AD, aducanumab (Aduhelm^Ò) and lecanemab (Leqembi^Ò).  TB006 differs from these antibodies in two important ways.  First, the two approved antibodies are direct inhibitors of beta amyloid, the protein involved in the formation of neurofibrillary tangles and amyloid plaques in the brain.  TB006, by blocking the action of Gal-3, inhibits not only beta amyloid but precursors of other oligomers and neurofibrillary tangles such as tau, alpha-synuclein, and apolipoprotein E4.  Secondly, the two approved antibodies are indicated in AD patients who are in their early phase (MCI-early AD) and have PET imaging evidence of amyloid plaques.  TB006 is being studied in patients with established disease on the mild-moderate-severe (Mini Mental Status Exam score range of 24 or less) regardless of their amyloid status.

Single-Patient EA Policies/Criteria

TVAX Biomedical, Inc. (TVAX) is committed to developing immunotherapies for patients with serious cancers. Our goal is to provide access to our investigational therapies primarily through clinical trials. At this time, TVAX does not have any investigational immunotherapy product available for expanded access.

“Expanded Access” refers to the use of an investigational therapy outside of a clinical trial for potential treatment of a serious condition in a patient. The US Food and Drug Administration has set forth guidelines when considering expanded access.

TVAX is not currently making its investigational immunotherapy product candidates available on an expanded access basis anywhere in the world. Requests for expanded access to TVAX Biomedical’s investigational immunotherapy product candidates must come from the patient’s treating physician because only physicians can enroll patients in a clinical trial or the expanded access program.

Certain therapies, like TVAX Immunotherapy, are made through complex manufacturing processes. TVAX seeks to retain the ability to make and supply product in a fair and equitable manner and in a volume that assures adequate manufacturing capacity for clinical trials and development programs. TVAX believes that participation in one of its’ clinical trials is the most appropriate way to access these investigational therapies.

At this time, TVAX is not currently making its unapproved therapies available on an expanded access or right to try basis. In the event TVAX decides to consider expanded access or right to try use, TVAX will evaluate and respond to each request that it receives on a case-by-case basis.

If you have questions, please speak with your physician or contact TVAX at info@tvaxbiomedical.com.

Consistent with the 21st Century Cures Act, TVAX may revise this policy at any time.