Evelo Biosciences to Present Clinical Data from Phase 1/2 Trial of EDP1503 at the ESMO World Congress on Gastrointestinal Cancer Virtual Meeting
Evelo Biosciences (Nasdaq: EVLO) has announced the presentation of clinical data from its Phase 1/2 study of EDP1503, combined with pembrolizumab, for advanced metastatic colorectal carcinoma, triple-negative breast cancer, and checkpoint inhibitor relapsed tumors, at the ESMO World Congress from July 1-4, 2020. The study revealed a 25% overall response rate in 8 TNBC patients receiving a high dose of EDP1503, significantly above the historic 5-10% rate for anti-PD-1 monotherapy. Further data on TNBC patients is anticipated in Q4 2020.
- EDP1503 shows a 25% overall response rate in high-dose TNBC patients.
- The study's ORR of 25% is significantly higher compared to the historic 5-10% for anti-PD-1 monotherapy.
- Further clinical data is expected in Q4 2020, indicating ongoing research progress.
- The overall response rate (ORR) in TNBC patients is based on a small sample size (11 patients).
- Continued enrollment may indicate the need for more data and understanding in ongoing trials.
CAMBRIDGE, Mass., July 01, 2020 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (Nasdaq:EVLO), a clinical stage biotechnology company developing a new modality of orally delivered, systemically acting biologics, today announced that clinical data from the Phase 1/2 open-label study of EDP1503, in combination with pembrolizumab, in patients with advanced metastatic microsatellite stable colorectal carcinoma (MSS CRC), triple-negative breast cancer (TNBC), and checkpoint inhibitor relapsed tumors, will be presented at the ESMO World Congress on Gastrointestinal Cancer Virtual Meeting being held July 1 - 4, 2020.
In addition to data in MSS CRC patients, the poster reported preliminary data on 11 TNBC patients (8 on high dose and 3 on low dose EDP1503). An overall response rate (ORR) of
Details of the poster are as follows:
Title: EDP1503 induces antitumor responses via gut-mediated activation of both innate and adaptive immunity
Poster Session Date: July 1-4, 2020
Abstract ID: P-325
Category: Clinical Colon Cancer
Authors: Loise Francisco-Anderson, PhD; Shamira Shariffudin; Humphrey Gardner, MD; Michael Goldberg, PhD; Shubhra Kashyap, MS; Mary Abdou; Chris Davitt, PhD; Shannon Argueta, PhD; Pooja Parameswaran, MS; Peter Sandy, PhD; Holly Ponichtera, PhD; Mark Carlson; Maria Sizova, PhD; Valeria Kravitz; Erin Troy, PhD; Sam Andrewes, MS; Johanna C. Bendell, MD; Judy S. Wang, MD; Susanna V. Ulahannan, MD; Michael Chisamore, PhD; Mark Bodmer, PhD; and Duncan McHale, MD
The poster is available online on the ESMO conference website, as well as on the Evelo website, under the “publications” tab.
About Evelo Biosciences
Evelo Biosciences is a clinical stage biotechnology company developing oral biologics that act on SINTAX™, the small intestinal axis, with systemic therapeutic effects. SINTAX plays a central role in governing the immune, metabolic and neurological systems. The company’s first product candidates are pharmaceutical preparations of single strains of microbes selected for defined pharmacological properties. Evelo’s therapies have the potential to be effective, safe, and affordable medicines to improve the lives of people with inflammatory diseases and cancer.
Evelo currently has four product candidates in development: EDP1815, EDP1867, and EDP2939 for the treatment of inflammatory diseases including psoriasis, atopic dermatitis, and COVID-19, and EDP1503 for the treatment of cancer. Evelo is advancing additional product candidates in other disease areas.
For more information, please visit www.evelobio.com and engage with Evelo on LinkedIn.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements concerning the development of EDP1503 for the treatment of cancer, the promise and potential impact of any of our monoclonal microbials or preclinical or clinical trial data, the timing of and plans for clinical studies of EDP1503, and the timing and results of any clinical studies or readouts.
These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the impact of the COVID-19 pandemic on our operations, including our preclinical studies and clinical trials, and the continuity of our business; we have incurred significant losses, are not currently profitable and may never become profitable; our need for additional funding; our limited operating history; our unproven approach to therapeutic intervention; the lengthy, expensive, and uncertain process of clinical drug development, including potential delays in completing clinical trials or in seeking or obtaining regulatory approval; our reliance on third parties and collaborators to expand our microbial library, conduct our clinical trials, manufacture our product candidates, and develop and commercialize our product candidates, if approved; our lack of experience in manufacturing, selling, marketing, and distributing our product candidates; failure to compete successfully against other drug companies; protection of our proprietary technology and the confidentiality of our trade secrets; potential lawsuits for, or claims of, infringement of third-party intellectual property or challenges to the ownership of our intellectual property; our patents being found invalid or unenforceable; risks associated with international operations; our ability to retain key personnel and to manage our growth; the potential volatility of our common stock; our management and principal stockholders have the ability to control or significantly influence our business; costs and resources of operating as a public company; unfavorable or no analyst research or reports; and securities class action litigation against us.
These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Contact
Evelo Biosciences
Jessica Cotrone, 978-760-5622
jcotrone@evelobio.com
FAQ
What are the clinical results of EDP1503 in the EVLO study?
When will more data from the EDP1503 trial be released?
What is the significance of the EDP1503 study results for EVLO shareholders?
In which cancers is EDP1503 being tested?
