Treos Bio Announces FDA Approval of IND of Its First PolyPEPI™ Precision Cancer Vaccine for Metastatic Colorectal Cancer

SAN FRANCISCO and LONDON, Jan. 24, 2018 -- Treos Bio Limited, an immuno-oncology company developing next-generation, off-the-shelf precision cancer vaccines coupled with companion diagnostics, today said that the U.S. Food and Drug Administration has accepted its Investigational New Drug (IND) Application for PolyPEPI™ 1018, its investigational precision cancer vaccine for patients with metastatic colorectal cancer (mCRC), and has provided authorization to proceed with the Phase 1 study in mCRC patients.

This Phase 1 study will be conducted at Mayo Clinic in Rochester, Minnesota and University of Pisa in Pisa, Italy. Treos Bio ZRT, an operating subsidiary of Treos Bio Limited, submitted the IND to the FDA on December 21, 2017 and clearance was received on January 19, 2018.

“Our goal is to address the needs of metastatic colorectal cancer patients, who today face a grim prognosis with an urgent need for new therapeutic options,” said Dr. Menghis Bairu, Executive Chairman of Treos Bio. “This is an important milestone achieved by the Treos’ team.”

“Treos’ IND is based on the qualification of novel predictive models of the therapeutic effects of cancer vaccines in human subjects,” said Dr. Julianna Lisziewicz, the founder and Chief Scientific Officer of Treos Bio. “Our proprietary biomarkers not only support the development of companion diagnostics but also decreases the risk and time of cancer vaccine development.”

“We have spent years studying the mechanism how to stimulate the human immune system to destroy tumor cells but not attack healthy cells. We have analyzed large amount of genetic and clinical data from patients and developed proprietary algorithms to precisely identify the epitopes that stimulate immune responses in human subjects,” said Dr. Franco Lori, Chief Medical Officer. “We are one step closer to induce tumor specific immune responses in patients who cannot benefit from current immunotherapies.”

Clinical Study Details
The phase I clinical trial will investigate the safety, tolerability, and immunogenicity of a single dose of PolyPEPI1018 CRC Vaccine as an add-on treatment to the standard-of-care maintenance therapy in patients with metastatic colorectal cancer. Vaccine induced effector and memory T cell responses will be determined by bioassays and the correlation with the predicted T cell responses will be assessed in each study subject.

About PolyPEPI^TM 1018 CRC Vaccine
The vaccine contains six synthetic polypeptides that are precisely selected to induce T cell responses against 12 epitopes from seven cancer testis antigens (CTAs) most frequently expressed in colorectal cancers. These polypeptides are optimized with the PEPI biomarker to induce robust and lasting CRC specific T cell responses.

About Colorectal Cancer
Colorectal cancer is the third most common cancer worldwide, accounting for 9.7 percent of all cancers apart from non-melanoma skin cancers with nearly 700,000 deaths in 2012 from colorectal cancer worldwide, according to GLOBOCAN. While improvements in cancer care have boosted survival rates for all stages of colorectal cancer in the past two decades, the prognosis for patients with metastatic colorectal cancer remains grim. The five-year relative survival rate for patients with metastatic colon cancer is just 11 percent. For patients with metastatic rectal cancer, the five-year relative survival rate is just 12 percent, according to the American Cancer Society. 

About Treos Bio Limited
Treos Bio is headquartered in London, with operational subsidiaries in Budapest, Hungary and San Francisco, USA. More information can be found at www.treosbio.com.

Treos Bio uses data science and proprietary biomarkers to develop its precision cancer vaccines, with substantially shortened development timelines and at lower costs. Treos Bio’s off-the-shelf cancer vaccines are designed to exclude autoimmunity and induce tumor specific immune responses to be safer and more effective in patients who cannot benefit from current immunotherapies. Treos Bio’s novel biomarkers will support the development of in vitro companion diagnostic tests to identify patients who most likely to respond to treatment.

Treos Bio has completed preclinical development of additional members of the PolyPEPI cancer vaccine family with companion diagnostics to select likely responders. These patient specific off-the-shelf vaccines are designed for a general population of patients with ovarian-, breast-, lung cancers, glioma, melanoma, and leukemia. Treos Bio patient focused vaccine design also support the development of vaccines for single individuals and population of individuals with specific genetic background, including specific vaccines most effective in ethnic populations.

Contact
Daniel Levine
Levine Media Group
[email protected]
(510) 280-5405