Pipeline

We have an advanced clinical pipeline of autologous and allogeneic therapies that combine VSTs with other immune-oncology approaches to target multiple tumor indications.

Autologous Therapies
Allogeneic Therapy

TT12, TT16 and TT11x are Investigator-initiated trials sponsored by Tessa. All of Tessa’s programmes are not yet being offered for sale and are currently undergoing investigation. Accordingly, Tessa makes no claim as to their safety and effectiveness for the purposes for which they are under investigation.

Product Candidates

Epstein-Barr Virus-Specific T Cells (EBVSTs) for Nasopharyngeal Cancer (NPC)

Using our proprietary Virus-Specific T cell (VST) platform, we are able to target specific Epstein-Barr Virus (EBV) proteins that are present on EBV-positive tumors.

Our EBVSTs extracted from patient’s blood are enhanced for anti-tumor potency, selectively activated and expanded ex vivo before infusion back into the patient

Trial Name:

A Phase III Trial Evaluating Chemotherapy and Immunotherapy for Advanced Nasopharyngeal Carcinoma (NPC) Patients

Indication: Nasopharyngeal cancer (NPC)
US FDA Orphan Drug and Fast Track Designation

Enrollment Status: Recruiting

Trial Number: NCT02578641

A Multicentre, Randomized, Open-Label, Phase III Clinical Trial of Gemcitabine and Carboplatin Followed by Epstein-Barr Virus-Specific Autologous Cytotoxic T Lymphocytes Versus Gemcitabine and Carboplatin as First Line Treatment for Advanced Nasopharyngeal cancer Patients.

Learn more at Clinicaltrials.gov

Locations

United States

  • California, United States
  • Massachusetts, United States
  • Texas, United States

Malaysia

Singapore

Taiwan

Thailand

CD30-Directed Genetically Modified Autologous T cells (CD30.CAR-T) in Adult and Pediatric Patients with Relapsed or Refractory CD30 Positive Classical Hodgkin Lymphoma

Tessa is initiating a pivotal Phase II clinical study to investigate an autologous CD30.CAR-T cell therapy program targeting relapsed or refractory classical Hodgkin Lymphoma. CD30-targeting CAR enables the recognition and elimination of CD30-positive lymphoma cells.

This therapy is developed based on encouraging clinical data from two independent CD30.CAR-T Phase I/II studies conducted by Baylor College of Medicine (BCM, Houston, Texas) and the University of North Carolina (UNC, Chapel Hill, North Carolina), for patients with relapsed or refractory CD30-positive Hodgkin Lymphoma. CD30.CAR-T were administered after lymphodepletion with either bendamustine alone, bendamustine and fludarabine, or cyclophosphamide and fludarabine.

In the study conducted by Baylor College of Medicine (trial number: NCT02917083), preliminary data demonstrated an overall response rate of 66% among 12 patients evaluated at 6 weeks post infusion, with 7 complete responses lasting up to >15 months observed¹. A separate Phase I/II study conducted by the University of North Carolina (trial number: NCT02690545) demonstrated an overall response rate of 63% among 19 patients and 10 complete responses observed².

¹ Ramos, C., et al. 2019 CD30‐Chimeric Antigen Receptor (Car) T Cells For Therapy Of Hodgkin Lymphoma (HL). Hematol Oncol, 37: 168-168. doi:10.1002/hon.125_2629.
2 Grover, Natalie S. et al. 2019. A Phase Ib/II Study of Anti-CD30 Chimeric Antigen Receptor T Cells for Relapsed/Refractory CD30+ Lymphomas. Biology of Blood and Marrow Transplantation, Volume 25, Issue 3, S66.

Trial Name:

CD30-Directed Genetically Modified Autologous T cells (CD30.CAR-T) in Adult and Pediatric Patients with Relapsed or Refractory CD30 Positive Classical Hodgkin Lymphoma

Indication: CD30-positive Hodgkin Lymphoma

About Hodgkin Lymphoma

CD30 is universally expressed in classical Hodgkin Lymphoma (cHL). Patients with relapsed or refractory cHL have limited treatment options and poor outcomes despite recently approved immune-checkpoint inhibitors indicated for patients who have relapsed after 3 or more lines of therapy.

Allogeneic CD30-Chimeric Antigen Receptor (CAR) Epstein-Bar Virus-Specific T cells (EBVSTs) for CD30-Positive Lymphomas

Tessa is developing a next-generation, allogeneic VST therapy targeting CD30-Positive Lymphomas. EBVST cell lines derived from healthy donors are modified with a CD30 Chimeric Antigen Receptor (CAR) and matched to suitable patients to target CD30+ cancer cells within their bodies.

This therapy is developed based on an ongoing Phase 1 clinical study (Trial Number: NCT02287311) conducted by Baylor College of Medicine, which investigates the feasibility and safety of allogeneic EBVSTs in EBV-associated lymphomas.

Trial Name:

Most Closely Matched 3rd Party Rapidly Generated LMP, BARF1 And EBNA1 Specific CTL, EBV-Positive Lymphoma (MABEL) (MABEL)

Indication: EBV-associated lymphomas and PTLD

Enrollment Status: Recruiting

Trial Number: NCT02287311

Most Closely Matched 3rd Party Rapidly Generated LMP, BARF1 And EBNA1 Specific CTL, EBV-Positive Lymphoma (MABEL)

Learn more at Clinicaltrials.gov

Locations

Texas, United States

Human Papillomavirus-Specific T Cells (HPVSTs) for HPV-Associated Cancers

We have extended our proprietary VST platform to treat other virus-associated cancers. Tessa’s TT12 is an autologous T cell therapy product composed of HPVSTs that have been trained to target HPV 16/18 antigens and genetically modified with a decoy TGF-β receptor to overcome the immuno-suppressive tumor microenvironment.The safety and optimal dose selection of armored HPVSTs in combination with an anti-PD-1 antibody is currently being evaluated in an ongoing investigator-sponsored Phase 1 trial (NTC02379520) in the United States, in patients with relapsed/resistant HPV-associated cancers.

In collaboration with MSD (tradename of Merck & Co., Inc., Kenilworth, N.J., USA), Tessa will conduct a separate, multi-center Phase 1b/2 trial to evaluate the safety and efficacy of our autologous HPVST therapy in combination with MSD’s anti-programmed death receptor-1 (PD-1) antibody, Pembrolizumab (KEYTRUDA®), following pre-conditioning lymphodepletion chemotherapy, in patients with recurrent/refractory or metastatic HPV 16/18-positive cervical cancer. More details here.

Overview of HPVST therapy

Trial Name:

HPV-16/18 E6/E7-Specific T Lymphocytes, Relapsed HPV-Associated Cancers, HESTIA (HESTIA)

Indication: HPV-associated cancers

including oropharyngeal cancer, cervical cancer, anal cancer, vulvar cancer and penile cancer

Enrollment Status: Recruiting

Trial Number: NCT02379520

Study evaluating HPV-16/18 E6/E7-Specific T Lymphocytes in patients with Relapsed HPV-Associated Cancers

Learn more at Clinicaltrials.gov

Locations

Texas, United States

HER2-CAR Ts + Oncolytic & Helper-Dependent Adenovirus for HER2-positive solid tumors

Human Epidermal Growth Factor Receptor 2 (HER2) is over expressed in multiple solid tumors, including breast cancer, bladder cancer, lung, colorectal, gastric carcinoma, and head and neck. The overexpression of HER2 is an indicator of poor prognosis, increased recurrence and decreased OS. Our therapy is a two-way process, firstly the adenoviruses are administered locally into the tumor, followed by infusion of HER2-CAR Ts.

Oncolytic Adenovirus

Selectively replicates and kills tumor cells to promote inflammation

Helper-dependent Adenovirus

Expresses IL-12 and checkpoint inhibitor anti-PD-L1. Modulating the tumor microenvironment to promote a strong anti-tumor response

HER2-specific CAR T Cell

Targets and specifically kills HER2 expressing tumor cells

Multi CAR VSTs for Pediatric Gliomas

Tessa in collaboration with St Jude, is developing a novel CAR approach targeting multiple tumor antigens expressed in pediatric gliomas. The multi-CAR VSTs will help address the problem of resistance through antigen loss, a common escape strategy for glioma¹

¹ O’Rouke D.M., et al. Sci Transl Med. 2017