Tessa Therapeutics Announces Collaboration with MSD Investigating the Combination of KEYTRUDA (R) (pembrolizumab) and Virus-Specific T Cell Therapy Targeting Human Papillomavirus in Cervical Cancer

PR78333

SINGAPORE, April 16, 2019 /PRNewswire=KYODO JBN/ --

The collaboration will evaluate the safety and efficacy of Tessa's armored

human papillomavirus-specific T cell (HPVST) therapy combined with MSD's

KEYTRUDA (R) (pembrolizumab) to address the limited number of effective

treatment options for metastatic or recurrent cervical cancer

Tessa Therapeutics, a clinical-stage immunotherapy company focused on

autologous and off-the-shelf, allogeneic therapies targeting solid tumors,

today announced that it has entered into an agreement with MSD (tradename of

Merck & Co., Inc., Kenilworth, N.J., USA), through a subsidiary, to evaluate

Tessa's armored human papillomavirus-specific T cell (HPVST) therapy, or TT12,

in combination with KEYTRUDA (R) (pembrolizumab), MSD's anti-PD-1 (programmed

death receptor-1) therapy, in patients with recurrent or metastatic HPV 16 and

18-positive cervical cancer.

Under the agreement, Tessa will conduct a multi-center Phase 1b/2 trial to

evaluate the safety and efficacy of the combination. The trial is planned for

initiation in the United States, Singapore and South Korea.

"We are very excited to work with MSD to evaluate the potential of KEYTRUDA (R)

in combination with Tessa's VST therapy for cervical cancer," said Mr. Andrew

Khoo, Tessa Therapeutics CEO and Co-Founder.  "Cervical cancer is a major cause

of death in women, especially in some of the most vulnerable parts of the

world. Furthermore, the current prognosis and treatment options for patients

with metastatic cervical cancer are poor. We look forward to developing this

novel combination further, which has the potential to bring more effective

treatment options for such patients."

Tessa's TT12 is an autologous cell therapy product composed of HPVSTs that have

been trained to target HPV 16/18 antigens and genetically modified with a decoy

TGF-â receptor to overcome the suppressive tumor microenvironment. The safety

and optimal dose selection of armored HPVSTs in combination with another

anti-PD-1 antibody is currently being evaluated in a separate, ongoing

investigator-sponsored Phase 1 trial(http://tinyurl.com/y5ed6mab) in the United

States, in patients with relapsed HPV-associated cancers. Preliminary results

from this trial show that armored HPVSTs and its combination with anti-PD-1 are

well-tolerated, have minimal toxicities and early signs of efficacy.

Dr. Ivan D. Horak, M.D., Tessa Therapeutics President of Research and

Development said, "Tessa's TT12 Phase 1 study has shown encouraging results,

supporting the effectiveness of armoured HPVSTs in targeting HPV-positive

tumors and the addition of anti-PD-1 may remove potential immune inhibition

that can hamper the tumor-killing activity of the HPVSTs. Bringing this therapy

into a Phase 1b/2 trial and the expansion of clinical sites into Asia reflect

our desire to bring novel therapies to more cancer patients globally, as well

as our belief in the therapy's potential to improve the clinical outcomes of

patients with advanced stages of HPV-positive tumors."

KEYTRUDA (R) is a registered trademark of Merck Sharp & Dohme Corp., a

subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.

About Cervical Cancer and Armored HPVST Immunotherapy

According to the World Health Organization, cervical cancer is the fourth most

common cancer in women worldwide and second most common in less developed

regions. Cervical cancer is caused by sexually acquired infection with certain

types of human papillomavirus (HPV), with two HPV types (16 and 18) accounting

for 70% of cervical cancers and pre-cancerous cervical lesions.

Various studies have reported poor outcome of patients with metastatic cervical

cancer. Currently, the median survival time for metastatic cervical cancer is

only 8 to 13 months[1] and the 5-year survival rate is 16.5% compared to 91.5%

for localized cervical cancer[2]. Contrary to patients with early-stage

cervical cancer and locally advanced cervical cancer who have access to

conventional treatments including surgery, chemotherapy, or radiotherapy,

patients with metastatic cervical cancer have no standard treatment because of

its heterogeneous manifestations.

T cells are a critical part of the body's immune system that play a central

role in fighting virus infections and cancers. Virus-Specific T cells (VSTs),

in particular, have the ability to recognize and kill infected cells while

activating other parts of immune system for a coordinated response.

HPVSTs are produced by collecting patient's blood and selectively expanding T

cells which recognize HPV 16/18 antigens. To increase durability in the tumor

microenvironment, the HPVSTs are armored by modifying the cells to express a

decoy TGF-â receptor. The armored HPVSTs are expanded before undergoing strict

quality control prior to infusion back into the patient.

[1] van Meir H, Kenter GG, Burggraaf J, Kroep JR, Welters MJ, Melief CJ, et al.

The need for improvement of the treatment of advanced and metastatic cervical

cancer, the rationale for combined chemo-immunotherapy. Anticancer Agents Med

Chem. 2014;14:190–203.

[2] Shen G, Zhou H, Jia Z, Deng H. Diagnostic performance of diffusion-weighted

MRI for detection of pelvic metastatic lymph nodes in patients with cervical

cancer: a systematic review and meta-analysis. Br J Radiol. 2015;88:20150063.

About Tessa Therapeutics

Tessa Therapeutics is a clinical-stage immunotherapy company focused on the

development of autologous and off-the-shelf, allogeneic therapies targeting

solid tumors. Tessa's Virus-Specific T cell (VST) platform harnesses the body's

potent anti-viral immune response and has shown compelling results in the

treatment of solid tumors.

Tessa is building a portfolio of innovative, next-generation therapies by

combining the qualities of VSTs with other immuno-oncology technologies. This

includes a rapidly growing pipeline of clinical and pre-clinical autologous

programs that target a wide range of cancers, including nasopharyngeal

carcinoma, cervical cancer, oropharyngeal cancer, lung cancer, breast cancer,

bladder cancer, as well as head and neck cancer. In addition, Tessa is

leveraging its platform to develop an allogeneic therapy to address

Epstein-Barr virus-associated lymphomas.

Tessa has built up robust operational and supply chain capabilities to

successfully deliver T cell therapy treatments to a large patient pool

worldwide. Together with the Company's academic, clinical, and commercial

research partners, Tessa has created a fully-integrated approach to the

treatment of cancer with immunotherapy.

For more information on Tessa, please visit www.tessatherapeutics.com.

Tessa Therapeutics Media Contacts

Gladys Wong

gladyswong@tessatherapeutics.com

+65 6384 0755

Brunswick Group

Will Carnwath, Ben Fry

TessaTherapeutics@brunswickgroup.com  

+65 6426 8188

Source: Tessa Therapeutics