See what’s in our product pipeline

We're investing in research and development to offer more solutions to challenges in transplant. Get to know our product pipeline and see our investment in the future.

product pipeline
PRODUCT PIPELINE

Our future (in development)

We’re living up to our commitment to transform transplant medicine by leveraging our research and development capabilities to discover new therapies.

Veloxis Corporate PipelineVeloxis Corporate Product Pipeline
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Veloxis Pipeline & Investments:

VEL101

  • Therapeutic Area: Transplantation (Immunology)
  • Name: VEL101
  • Indication: SOT
  • Type/Region: License/Global
  • Phase: Phase 1

*T-Guard®

  • Therapeutic Area: Transplantation (Immunology)
  • Name: T-Guard
  • Indication: HSCT aGvHD
  • Type/Region: VC & Call Option/Global
  • Phase: Phase 3

Asahi Kasei Pipeline:

ART-123 – CIPN

  • Therapeutic Area: Critical Care
  • Name: ART-123
  • Indication: CIPN
  • Type/Region: In-house/Global
  • Phase: Phase 1

AK1820 (isavuconazole)

  • Therapeutic Area: Critical Care
  • Name: AK1820 (isavuconazole)
  • Indication: anti-fungal
  • Type/Region: License/Japan
  • Phase: Filed/Market

AK1830

  • Therapeutic Area: Musculoskeletal
  • Name: AK1830
  • Indication: OA pain
  • Type/Region: License/Japan
  • Phase: Phase 2

HE-69 (mizoribine)

  • Therapeutic Area: Nephrology
  • Name: HE-69 (mizoribine)
  • Indication: lupus nephritis
  • Type/Region: In-house/China
  • Phase: Filed/Market
*T-Guard is a registered trademark of Xenikos B.V. Veloxis obtained options to acquire Xenikos B.V. in connection with its provision of financing to the company. Please see the full press release here.
Joint development program for ART-123 in US and Japan.

SOT=solid organ transplant; HSCT=hematopoietic stem cell transplant; aGvHD=acute graft-versus-host disease; CIPN=chemotherapy-induced peripheral neuropathy; OA=osteoarthritis
*T-Guard is a registered trademark of Xenikos B.V. Veloxis obtained options to acquire Xenikos B.V. in connection with its provision of financing to the company. Please see the full press release here.
Joint development program for ART-123 in US and Japan.

SOT=solid organ transplant; HSCT=hematopoietic stem cell transplant; aGvHD=acute graft vs host disease; CIPN=chemotherapy-induced peripheral neuropathy; OA=osteoarthritis.

VEL-101 Clinical Program

VEL-101, a novel investigational immunosuppressant formerly known as FR104, is a monoclonal antibody fragment that inhibits costimulation via direct CD28 blockade.1 VEL-101 will be developed as a subcutaneous, at-home self-administration medication that may eliminate many of the toxicities seen with current standard of care immunosuppression.2

CD28 plays an essential role in T-cell activation, while CTLA-4 plays a key role in preventing or regulating T-cell activation.1,3,4 As a direct blocker of CD28 on the T cell, VEL-101 has a unique mechanism of action. Direct blockade of CD28 on the T cell with VEL-101 preserves vital CTLA-4 inhibitory functions.1,3,4 As a result of VEL-101's unique mechanism of action, it will be studied for prevention of acute rejection, preservation of regulatory T-cell function, and inhibition of donor-specific antibody production.3,4

Animal and initial human studies have been completed with VEL-101, and based on the results, the development program is continuing.1,3

See study publication
DEVELOPMENT PARTNERSHIPS

Clinical investments

Veloxis is proud to partner with Xenikos B.V. on the development of T-Guard®, a novel investigational immunotherapy with potential future applications in transplant medicine.

Person wearing glasses looking into a microscope.

T-Guard® Clinical Program

T-Guard is a first-of-its kind investigational medicine infused intravenously to treat and prevent steroid-resistant acute graft-versus-host disease (aGvHD). T-Guard has the potential for opportunities in solid organ transplantation such as acute rejection treatment or prevention, and in certain autoimmune conditions.5

By combining two toxin-conjugated anti-CD3 and anti-CD7 monoclonal antibodies, T-Guard acts on T cells and natural killer cells to reset the immune response. T-Guard is designed to target the mature, activated T cells that are primarily implicated in aGvHD. By preventing the synthesis of new proteins in T cells, T-Guard induces apoptosis and cell death. Its rapid and self-limiting effect is believed to reduce patients’ vulnerability to opportunistic infection, in contrast to broad immunosuppressive treatments.5,6

T-Guard has been studied in a Phase 1 dose-escalation trial and a Phase 1/2 trial in patients who received an allogeneic stem cell transplant for myeloid or lymphoid malignancies and had grades 2 to 4 steroid-resistant aGvHD.7

Learn more about T-Guard
References
1. Poirier N, Blancho G, Hiance M, et al. First-in-human study in healthy subjects with FR104, a pegylated monoclonal antibody fragment antagonist of CD28. J Immunol. 2016;197(12):4593-4602. 2. US National Institutes of Health, National Library of Medicine. A Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VEL-101 [NCT05238493]. https://clinicaltrials.gov/ct2/show/NCT05238493. 3. Poirier N, Mary C, Dilek N, et al. Preclinical efficacy and immunological safety of FR104, an antagonist anti-CD28 monovalent Fab' antibody. Am J Transplant. 2012;12(10):2630-2640. 4. Poirier N, Dilek N, Mary C, et al. FR104, an antagonist anti-CD28 monovalent fab' antibody, prevents alloimmunization and allows calcineurin inhibitor minimization in nonhuman primate renal allograft. Am J Transplant. 2015;15(1):88-100. 5. Xenikos.com. Characteristics. Accessed November 4, 2021. https://www.xenikos.com/characteristics/ 6. Groth C, van Groningen LFJ, Matos TR, et al. Phase I/II trial of a combination of anti-CD3/CD7 immunotoxins for steroid-refractory acute graft-versus-host disease. Biol Blood Marrow Transplant. 2019;25:712-719. 7. Xenikos.com. Development Plan. Accessed November 4, 2021. https://www.xenikos.com/development-plan/

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