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Five Prime Presents First Preclinical Data on Anti-CCR8 Antibody FPA157

·5 min read
  • Preclinical data support evaluation of FPA157 as a novel immunomodulator with the potential to remove Treg-mediated immune suppression in solid tumors

  • FPA157 is an anti-CCR8 antibody engineered to enhance antibody-dependent cell-mediated cytotoxicity to preferentially eliminate CCR8+ Treg cells in the tumor microenvironment

  • Data presented today at The Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting & Pre-Conference Programs (SITC 2020) show investigational immunotherapy FPA157 elicits anti-tumor activity in multiple preclinical models

  • FPT157 is undergoing IND-enabling studies

Five Prime Therapeutics, Inc. (NASDAQ: FPRX) today presented the first preclinical data from its anti-CCR8 FPA157 program at The Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting & Pre-Conference Programs (SITC 2020).

The poster, "Development of FPA157, an anti-CCR8 depleting antibody engineered to preferentially eliminate tumor-infiltrating T regulatory cells," was presented in a late-breaker live Q&A session and is available here.

Key highlights from the poster included:

  • CCR8 expression is highly restricted to T regulatory (Treg) cells within the tumor

  • Preclinical efficacy studies demonstrate that anti-CCR8 antibody treatment depletes CCR8+ Tregs in the tumor microenvironment while sparing peripheral Treg subsets

  • Anti-CCR8 treatment elicits the development of robust anti-tumor memory responses

  • FPA157 leads to potent natural killer (NK) cell-dependent killing of CCR8+ target cells

"Preclinical data for FPA157 suggest that selective depletion of regulatory T cells within the tumor— without affecting peripheral Tregs—is a promising and exciting therapeutic pathway to pursue," said Andrew Rankin, PhD, Vice President of Research. "This is the first time we are publicly sharing information about the CCR8 inhibitor antibody in the Five Prime immuno-oncology pipeline and to do so at SITC is very rewarding. We are eager to further investigate the potential of FPA157 in the clinic."

There will be two live Q&A sessions with poster author Edwina Naik, PhD, Associate Director, Immuno-Oncology Research. The first is today, November 11, 2020 from 5:15-5:45pm EST and the second is on November 13, 2020 from 4:40-5:10pm EST.

About FPA157

FPA157 is a monoclonal antibody targeting CCR8 that is designed to enhance antibody-dependent cell-mediated cytotoxicity (ADCC) and deplete the T regulatory cell (Treg) population in the tumor microenvironment. Tregs inhibit anti-tumoral immune responses and act through multiple suppressive mechanisms.1,2 FPA157 is part of the Five Prime immuno-oncology antibody pipeline and is undergoing IND-enabling studies.

About Five Prime Therapeutics

Five Prime Therapeutics, Inc. discovers and develops innovative protein therapeutics to improve the lives of patients with serious diseases. Five Prime’s product candidates have innovative mechanisms of action and address patient populations in need of better therapies. The company focuses on researching and developing immuno-oncology and targeted cancer therapies paired with companion diagnostics to identify patients who are most likely to benefit from treatment with Five Prime’s product candidates. Five Prime has entered into strategic collaborations with leading global pharmaceutical companies and has promising product candidates in clinical and preclinical development. For more information, please visit www.fiveprime.com.

Cautionary Note on Forward-looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Five Prime's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Forward-looking statements contained in this press release include statements regarding (i) Five Prime’s expectations regarding the potential safety, efficacy or clinical utility of FPA157; and (ii) the potential use of FPA157 to treat certain patients. Actual results may differ materially from these forward-looking statements. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during research, preclinical or clinical studies, changes in expected or existing competition, changes in the regulatory, pricing or reimbursement environment, and unexpected litigation or other disputes. In addition, while the company expects the COVID-19 pandemic to adversely affect its business operations and financial results, the extent of the impact on the company’s ability to advance its manufacturing, clinical development and regulatory efforts and business and corporate development and other objectives and the value of and market for its common stock will depend on future developments that are highly uncertain, and the company cannot predict with confidence the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the U.S. and in other countries and the effectiveness of actions taken globally to contain and treat COVID-19. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Five Prime’s filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" contained therein. Except as required by law, Five Prime assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

References

  1. Teng MW, Ngiow SF, von Scheidt B, McLaughlin N, Sparwasser T, Smyth MJ. Conditional regulatory T-cell depletion releases adaptive immunity preventing carcinogenesis and suppressing established tumor growth [published correction appears in Cancer Res. 2010; 70(23):10014]. Cancer Res. 2010; 70(20):7800-7809. doi:10.1158/0008-5472.CAN-10-1681

  2. Simpson TR, Li F, Montalvo-Ortiz W, et al. Fc-dependent depletion of tumor-infiltrating regulatory T cells co-defines the efficacy of anti-CTLA-4 therapy against melanoma. J Exp Med. 2013; 210(9):1695-710. doi:10.1084/jem.20130579

Source: Five Prime Therapeutics, Inc.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201111005832/en/

Contacts

Media and Investor Contact

Martin Forrest
VP, Investor Relations & Corporate Communications
Five Prime Therapeutics, Inc.
415-365-5625
martin.forrest@fiveprime.com