CAMBRIDGE, Mass., January 11, 2021 / PRNewswire / – Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage company bringing transformative potential from synthetic biology to medicine, today presented important clinical milestones for 2021 and provided an overview of recent progress.

“With three programs in clinical trials, multiple proof-of-concept opportunities, and a rapidly advancing preclinical portfolio into the clinic, Synlogic is poised to be successful with a number of data reads coming in 2021,” said Aoife Brennan, MB Ch.B., President and CEO of Synlogic. “2020 has been a year we will not forget. Despite the external challenges, the Synlogic team has moved our programs forward with courage and resilience. We enter 2021 with momentum and the opportunity to truly see the potential of newcomers. synthetic biotic drugs to make a significant difference in the lives of patients. “

Synlogic expects clinical proof of concept data in 2021 in two metabolic programs, SYNB1618 for the treatment of phenylketonuria (PKU) and SYNB8802 for the treatment of enteric hyperoxaluria, as well as the continued advancement of SYNB1891 for the treatment of tumors. solids and lymphomas.

Running through the clinical pipeline: metabolic programs

  • Progression of a Phase 2 clinical trial of the proof of concept of SYNB1618 for the treatment of Phenylketonuria (PKU)
    • SYNB1618 is an investigational drug consisting of a synthetic biotic drug designed to consume phenylalanine (Phe) in the gastrointestinal (GI) tract for the treatment of PKU in patients of any age or type of disease.
    • A solid oral formulation of SYNB1618 has been shown to metabolize Phe in the gastrointestinal tract in a study in healthy volunteers.
    • The SynPheny-1 study evaluates the decrease in plasma Phe of SYNB1618 in adult PKU patients who do not benefit from or tolerate existing therapies such as Kuvan or Palynziq.
    • Synlogic expects data from SynPheny-1 to be available in mid-2021.
  • Progress of a Phase 1 clinical study of SYNB8802 for the treatment of enteric hyperoxaluria
    • SYNB8802 is an investigational drug consisting of a synthetic biotic drug designed to consume oxalate in the gastrointestinal tract and reduce urinary oxalate levels, potentially reducing kidney damage due to enteric hyperoxaluria.
    • In data presented at the American Society of Nephrology (ASN) Kidney Week 2020, SYNB8802 was shown to reduce urinary oxalate in two animal models of hyperoxaluria.
    • The phase 1 clinical study is evaluating the safety, tolerability and lowering potential of urinary oxalate in healthy volunteers and patients.
    • The study has two parts: Part A is a multiple dose escalation study in healthy volunteers; Part B is a placebo-controlled crossover design study in patients with enteric hyperoxaluria after Roux-nY gastric bypass surgery, which provides the opportunity to demonstrate the proof of concept.
    • Synlogic expects data from Part B of the study to be available in mid-2021.

Execution through the clinical pipeline: immunomodulation programs

  • Progress of SYNB1891 in the dosing arm combined with checkpoint inhibitor PDL1 in the ongoing phase 1 study
    • SYNB1891 is an investigational drug consisting of a synthetic biotic drug administered intratumorally designed to produce a STING agonist and act as an innate dual immune activator for the treatment of advanced solid tumors and lymphoma.
    • SYNB1891 is currently being evaluated in a Phase 1 study that has two parts:
      • Part A is a monotherapy arm that has recruited four dose cohorts to date.
        • A maximum tolerated dose has not been reached and dose escalation continues.
      • Part A of the study demonstrated target engagement and activation of the STING pathway.
      • Part B of the study will combine escalating doses of SYNB1891 with a fixed dose of aezolizumab, a PD-L1 checkpoint inhibitor, to establish a recommended Phase 2 dose for the combination regimen.
    • Synlogic predicts that additional data from cohorts in both arms will be available between mid to late 2021.

Preclinical roadmap

  • Synlogic continues to advance preclinical programs, including additional effectors for immuno-oncology; immune regulatory targets for the treatment of inflammatory bowel disease and other inflammatory disorders; and other rare, undisclosed metabolic diseases.
  • Further updates on these programs will be shared as they progress into the clinic.

2020 corporate milestones

  • Synlogic strengthened its leadership with the following appointments:
    • Synlogic has appointed Dr. David Hava, Ph.D., as Scientific Director. Dr. Hava brings to Synlogic over a decade of senior research and development experience, including in-depth academic expertise in the pillars of synthetic biology.
    • Synlogic has promoted Antoine ‘Tony’ Awad to the position of COO. Mr. Awad brings over 15 years of experience in the biotechnology and pharmaceutical industry with considerable experience in the development and manufacture of new therapies, from pre-IND studies to global commercialization.
    • Synlogic named Michel heffernan, seasoned entrepreneur and biopharmaceutical leader, and Dr. Michael burgess, scientific doctor and expert in translational development, to its board of directors.
  • Synlogic and Ginkgo Bioworks have advanced their long-term strategic platform collaboration that provides extensive synthetic biology capabilities to Synlogic.
    • Ginkgo and Synlogic are collaborating on multiple efforts, including metabolism and immunomodulation programs, and the evaluation of the potential application of synthetic biotics for vaccine development.
  • Synlogic closed the third quarter of 2020 with $ 102.0 million in cash, cash equivalents, and short- and long-term investments and expects this to fund the company’s operations through 2022 as part of its current plan.

Learn more about Synlogic’s programs and pipeline by visiting https://www.synlogictx.com/.

About Synlogic
Synlogic ™ brings the transformative potential of synthetic biology to medicine. With a leading synthetic biology platform that leverages a reproducible and modular approach to microbial engineering, Synlogic designs synthetic biotic drugs that target the underlying biology validated to treat disease in new ways. Synlogic’s proprietary pipeline includes synthetic biotics for the treatment of metabolic disorders including phenylketonuria (PKU) and enteric hyperoxaluria (HOX). The company is also in the process of building a portfolio of assets that can be the subject of partnerships in immunology and oncology.

Forward-looking statements
This press release contains “forward-looking statements” that involve substantial risks and uncertainties for the safe harbor purposes of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, included in this press release regarding strategy, future operations, clinical development plans, future financial condition, future revenues, projected expenses, outlook, plans and objectives of management are forward-looking statements. In addition, when or if they are used in this press release, the words “could”, “could”, “should”, “anticipate”, “believe”, “estimate”, “” ‘expect to “,” Predict “and similar expressions and variations thereof, with respect to Synlogic, may identify forward-looking statements. Examples of forward-looking statements include, but are not limited to, statements regarding the potential of Synlogic’s platform to develop therapies to treat a wide range of diseases, including: cancer, inborn errors of metabolism and disorders inflammatory and immune systems; the future clinical development of synthetic biotic drugs; the approach adopted by Synlogic to discover and develop new therapies using synthetic biology; and the anticipated timing of Synlogic’s clinical trials, including the Phase 1 study for SYNB1891 and SYNB8802 and the Phase 2 study for SYNB1618, and the availability of clinical trial data from this and other studies.

Actual results could differ materially from those contained in any forward-looking statement due to various factors, including: uncertainties inherent in the clinical and preclinical development process; Synlogic’s ability to protect its intellectual property rights; and legislative, regulatory, political and economic developments, as well as the risks identified under the heading “Risk Factors” in the documents filed by Synlogic with the SEC. The forward-looking statements contained in this press release reflect Synlogic’s current views with respect to future events. Synlogic expects subsequent events and developments to change its point of view. However, although Synlogic may choose to update these forward-looking statements in the future, Synlogic specifically disclaims any obligation to do so. These forward-looking statements should not be taken as representing the views of Synlogic as of a date subsequent to the date hereof.

SOURCE Synlogic, Inc.

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