- The collaboration will evaluate the safety and efficacy of
Tessa's armored human papillomavirus-specific T cell (HPVST)
therapy combined with Merck's KEYTRUDA® (pembrolizumab)
to address the limited number of effective treatment options for
metastatic or recurrent cervical cancer
SINGAPORE, April
15, 2019 /PRNewswire/ -- 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 Merck (known
as MSD outside the US and Canada),
through a subsidiary, to evaluate Tessa's armored human
papillomavirus-specific T cell (HPVST) therapy, or TT12, in
combination with KEYTRUDA® (pembrolizumab), Merck'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 Merck to evaluate the
potential of KEYTRUDA® 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-β 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 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® 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-β
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
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