EXPANDED ACCESS

EXPANDED ACCESS POLICY

VIPER-101 (Senza5 CART5), investigational CAR T-cell therapy | Effective date: November 9, 2026

1. General Policy Statement

The U.S. Food and Drug Administration (FDA) and other health authorities have established criteria under which an investigational medicine may be made available to patients outside of a clinical trial. This is referred to as Expanded Access, and may also be called compassionate use, early access, pre-approval access, or emergency use. Patients may seek Expanded Access when standard treatments have failed, when they cannot tolerate approved medicines, when they are unable to participate in a clinical trial, or when no comparable or satisfactory alternative therapy is available.

Vittoria Biotherapeutics, Inc. (“Vittoria”) publishes this policy in accordance with Section 561A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-0), as added by the 21st Century Cures Act. This policy applies to the product VIPER-101 (Senza5 CART5), investigational CAR T-cell therapy.

2. About VIPER-101

VIPER-101 (also referred to as Senza5 CART5) is Vittoria’s investigational, autologous, gene-edited, dual-population chimeric antigen receptor (CAR) T-cell therapy directed against CD5. VIPER-101 is produced using Vittoria’s Senza5 platform, which uses gene editing to delete CD5 from the patient’s own T cells, with a five-day manufacturing process.

VIPER-101 was evaluated in a first-in-human, open-label Phase 1 dose-escalation study (ClinicalTrials.gov identifier NCT06420089; study acronym VIPER101) in adults with relapsed or refractory CD5-positive nodal peripheral T-cell lymphoma and other CD5-positive aggressive mature T-cell non-Hodgkin lymphomas. The study, sponsored by Vittoria in collaboration with the University of Pennsylvania, was designed to determine the safety, tolerability, manufacturing feasibility, preliminary efficacy, and recommended Phase 2 dose of a single intravenous infusion of VIPER-101.

VIPER-101 has not been approved by FDA or any other health authority, and its safety and efficacy have not been established.

3. Policy

Vittoria Expanded Access to VIPER-101

Vittoria believes the best route to broad patient access to VIPER-101 is approval by FDA and other health authorities and subsequent commercial availability. Before approval, participation in a Vittoria clinical trial is the preferred way for patients to access VIPER-101, because well-controlled clinical trials generate the data needed to establish safety and efficacy and support regulatory approval. Expanded Access is an option only when a patient cannot participate in a Vittoria clinical trial and the conditions below are met.

Because VIPER-101 is manufactured individually from each patient’s own cells, Vittoria does not maintain a standing supply of product, and manufacturing capacity exists only while Vittoria is actively producing VIPER-101 for participants enrolled in a clinical trial. Accordingly, Vittoria will consider requests for Expanded Access to VIPER-101 only during periods of active manufacturing in support of an actively enrolling Vittoria-sponsored clinical trial (“Eligible Period”). Outside of an Eligible Period, Vittoria cannot consider Expanded Access requests. During an Eligible Period, all available manufacturing capacity is reserved first for enrolled trial participants. All VIPER-101 products provided through Expanded Access will be manufactured, evaluated, and released under applicable Quality standards and Vittoria’s established manufacturing and Quality oversight procedures.

Requests for Expanded Access must be submitted by the patient’s treating physician by emailing expandedaccess@vittoriabio.com or by calling Vittoria at +1 (215) 600-1380. Requests should include the physician’s name, credentials, institution, and contact information; a de-identified summary of the patient’s diagnosis, CD5 expression status, prior therapies, and current clinical condition; the reason the patient cannot participate in a Vittoria clinical trial; and confirmation that the patient can travel to a participating clinical site for treatment and monitoring.

Vittoria cannot accept requests directly from patients or caregivers; patients should discuss Expanded Access with their physician. Patients and caregivers with general questions about Vittoria’s clinical trials may contact ClinOps@vittoriabio.com.

For Vittoria to consider providing VIPER-101 under Expanded Access, each of the following criteria must be met:

  • Vittoria is in an Eligible Period of active manufacturing of VIPER-101 for an actively enrolling Vittoria-sponsored clinical trial, and sufficient manufacturing, starting-material, and release-testing capacity is available to produce product for the requesting patient without delaying or displacing manufacturing for any enrolled trial participant.
  • The patient’s diagnosis, disease characteristics (including CD5 expression), and prior treatment history are sufficiently consistent with the population being studied to support a scientifically and medically justified benefit-risk assessment. Patients who do not meet specific clinical trial eligibility criteria may be considered on a case-by-case basis, provided the reasons for ineligibility do not introduce unacceptable safety risks.
  • Sufficient clinical data exist to suggest that the potential benefit of VIPER-101 justifies its potential risks for the patient and that those risks are not unreasonable in the context of the patient’s disease.
  • The patient has a serious or immediately life-threatening disease or condition.
  • The patient has no appropriate, comparable, or satisfactory alternative therapy, including approved products and other enrolling clinical trials, or has tried available alternatives without success.
  • The patient is unable to participate in a Vittoria clinical trial for the condition, as confirmed by the treating physician.
  • The patient can travel for treatment-related procedures to a participating clinical site.
  • Providing Expanded Access would not significantly jeopardize Vittoria’s clinical development program, including by interfering with the initiation, conduct, or completion of a clinical trial (such as participant availability and enrollment), by diverting the specialized expertise needed to conduct clinical trials, or by delaying regulatory submissions.
  • The patient’s treating physician:
    • Determines, as FDA regulations require, that the probable risk to the patient from VIPER-101 is not greater than the probable risk from the disease.
    • Practices at a site capable of managing cytokine release syndrome, neurologic toxicities, and the other known risks of CAR T-cell therapy.
    • Agrees to comply with all applicable Expanded Access laws and regulations, including submitting an individual patient Expanded Access IND to FDA, obtaining Institutional Review Board approval, and obtaining informed consent.
    • Agrees to monitor the patient and report adverse events and other safety information to Vittoria and to FDA as required.
  • The patient agrees to participate in long-term safety follow-up after VIPER-101 infusion for the time period Vittoria specifies (expected to be up to 15 years, consistent with FDA recommendations for genome-edited products), and the treating physician agrees to support that follow-up.
  • Expanded Access is permitted under the laws and regulations of the country in which the patient would be treated. Vittoria currently considers requests only for patients who would be treated in the United States of America.

Vittoria provides VIPER-101 under Expanded Access at no charge for the drug product. Vittoria does NOT cover the costs of related care (such as apheresis, lymphodepleting chemotherapy, hospitalization, and management of side effects). The treating physician and treatment institution are responsible for discussing anticipated treatment-related costs and potential insurance coverage with the patient before proceeding with Expanded Access.

Vittoria will evaluate each request for Expanded Access on a case-by-case basis, applying the criteria above consistently to all requests, and will acknowledge receipt of a request within five (5) business days. Where Vittoria is not in an Eligible Period of active manufacturing for an actively enrolling clinical trial, the acknowledgement of receipt will state that Expanded Access is not available at that time. Acknowledgement of receipt does not indicate that a request has been or will be approved. Following acknowledgement, Vittoria will communicate with the treating physician regarding any additional information needed to complete its evaluation. The timing of a final decision will depend on the clinical circumstances, available information, manufacturing feasibility, and applicable regulatory requirements. Vittoria will inform the treating physician of its decision. Decisions are made at Vittoria’s sole discretion.

Closing of Expanded Access

Vittoria may close or decline to continue Expanded Access to VIPER-101 at any time. Reasons for closure may include, without limitation:

  • The end of an Eligible Period, including completion of enrollment in the relevant trial.
  • Commercial availability of VIPER-101 in the relevant country.
  • A negative decision by a health authority, or a decision by Vittoria to discontinue clinical development or commercialization of VIPER-101.
  • New safety, efficacy, or other information that substantially changes the benefit-risk profile of VIPER-101.
  • Limited product or starting-material supply, or manufacturing issues.

Patients who have already received VIPER-101 under Expanded Access at the time of such a decision will continue to be followed for safety, including long-term follow-up, in accordance with the applicable individual patient Expanded Access IND.

4. Clinical Trial Information

VIPER-101 was studied under ClinicalTrials.gov identifier NCT06420089. Physicians and patients can review the study design at https://clinicaltrials.gov/study/NCT06420089. If Vittoria makes VIPER-101 available under Expanded Access, it will register an Expanded Access record on ClinicalTrials.gov and provide the registration link here.

5. Disclaimer

This policy may be revised by Vittoria at any time without notice, including to reflect changes in its clinical development program, manufacturing capacity, available data, or applicable law. This policy does not create a contract or any other legally enforceable obligation, and the posting of this policy does not guarantee Expanded Access to VIPER-101 for any individual patient.