Microbiome Report for Week Ending 4/6/19

April 12, 2019

C3J Therapeutics Receives Patent Covering Synthetic Bacteriophage
C3J Therapeutics, Inc. (C3J) a private clinical stage biotechnology company focused on the development of novel targeted antimicrobials based on bacteriophage,  announced on 4/2/19 that the United States Patent and Trademark Office (USPTO) has issued patent No. 10,221,398, entitled “Compositions of and Methods for In Vitro Viral Genome Engineering.” The patent, which covers the composition of a synthetically engineered Pseudomonas aeruginosa phage, is an important addition to C3J’s expanding patent estate, and the Company’s first issued patent covering its proprietary technology platform that enhances natural bacteriophage through genetic engineering. The patent includes claims intended to improve host range and increase the antimicrobial activity of wild type (natural) phage, including activity against biofilm. C3J possesses a significant library of naturally occurring phage and other biological materials that are critical for the creation of synthetic phage via the C3J phage engineering platform.

Todd Patrick, President and Chief Executive Officer of C3J, said, “This is an important patent for our company. Not only does it strengthen our program in Pseudomonas aeruginosa but it also exemplifies our strategy of protecting each individual phage that is created using our synthetic biology-based phage engineering platform.”

On January 4, 2019, C3J and AmpliPhi Biosciences Corporation (“AmpliPhi”) (NYSE American: APHB), a clinical-stage biotechnology company focused on the development of precisely targeted bacteriophage therapeutics for antibiotic-resistant infections, announced that the companies have agreed to merge. The consummation of the merger transaction will result in a combined company that has a diverse clinical-stage pipeline, including a Phase 1/2-ready natural phage candidate targeting Staphylococcus aureus, as well as a synthetic phage candidate targeting Pseudomonas aueriginosa respiratory infections poised to enter Phase 1 development later this year. In addition, the combined company will have an extensive natural phage library and the capability to develop synthetic phage against a wide range of microbial agents.

C3J currently has 3 candidates in development in their medical pipeline and 2 in their dental pipeline. In February of 2018, C3J acquired Synthetic Genomics engineered bacteriophage platform.

Enterome Adds Industry Veterans to its Management Team
ENTEROME SA, a clinical-stage biopharmaceutical company leveraging its unique knowledge of the key functional and molecular interactions between the gut microbiome and the human body to develop targeted therapeutics, today announces the appointment of two new members to its management team: Jan Fagerberg M.D., Ph.D. as Chief Medical Officer and Catherine Mathis, Pharm.D. as Chief Development Officer.

“We are pleased that Jan and Catherine are joining us to complement our team,” said Pierre Belichard, CEO of Enterome. “We believe their extensive clinical and regulatory experience across biotech and big pharma will be key assets as we prepare to initiate clinical trials with EO2401, an innovative, immunotherapy developed using our molecular mimicry approach, for glioblastoma multiforme (GBM). We also believe the collective and in-depth expertise of our expanded management team and across the organization will allow us to capitalize on the potential of our microbiome-based approach to further develop the company and its portfolio of novel therapeutics.”

Jan Fagerberg M.D., Ph.D.
Dr. Jan Fagerberg is a board-certified clinical oncologist with more than 25 years of experience in cancer drug development. He gained an M.D. and a Ph.D. (in immuno-oncology) from the Karolinska Institute (Sweden), and subsequently spent ten years in oncology practice and academic translational immuno-oncology research at the Karolinska Hospital. He joined Roche in 1999, working both in Europe and the United States in various positions of increasing responsibility, ultimately serving as Therapeutic Area Expert Oncology at Hoffmann-La Roche in Switzerland. After Roche, Dr. Fagerberg served as the Medical Director at TopoTarget A/S and as the Senior Vice President and Chief Medical Officer at Micromet A/G. After this, he served as Vice President, Global Development and Managing Director at Amgen Research GmbH, and subsequently as Chief Medical Officer at SOTIO a.s. Prior to joining the Company, Dr. Fagerberg served as Senior Adviser at Fagerberg Oncology SA. Dr. Fagerberg has published more than 60 articles related to immuno-oncology/oncology in peer-reviewed journals.

Catherine Mathis, Pharm.D.
Catherine Mathis has over 25 years of experience in clinical research and regulatory affairs in the pharmaceutical and biotech industries, particularly in the fields of immunology and oncology. During this time, she has gained significant experience in product development and regulatory strategy and conducted interactions with the health authorities in Europe (European Medicines Agency and National Competence Authority) and in the United States (Food and Drug Administration). Prior to joining Enterome, Ms. Mathis served as Chief Operating Officer and Head of Regulatory Affairs at ElsaLys Biotech.
She also served for nearly 20 years as Head of Regulatory Affairs at Transgene, a French biotech company developing virus-based immunotherapies against cancers, and before this was at Sanofi-Pasteur and Ipsen. Ms. Mathis gained a Pharm.D. and then earned a Master’s degree in applied and basic toxicology from the Paris Diderot University.

Seres Therapeutics Presents New Preclinical Data Supporting the Development of SER-401 for Immuno-Oncology
Seres Therapeutics, Inc. (Nasdaq: MCRB) announced on 4/2/19 that new preclinical data supporting the development of microbiome therapeutics for immuno-oncology (poster title “Leveraging gut microbiota networks to impact tumor immunotherapy”) will be presented by Sceneay et al. at the 2019 American Association for Cancer Research Annual Meeting (AACR) in Atlanta, Georgia. The data presented provide new insights on the potential mechanism by which Seres’ microbiome therapies, including the Company’s SER-401 program, could improve outcomes of cancer patients treated with immune checkpoint inhibitors.

“The novel data presented at AACR provide mechanistic insights into the biological activity of our microbiome therapeutic candidates to augment immune checkpoint inhibitors,” said Matthew Henn, Ph.D., Chief Scientific Officer and Executive Vice President at Seres. “The valuable learnings obtained from this work have informed the development of SER-401, which is being evaluated in combination with an FDA approved immunotherapy in the ongoing MCGRAW Phase 1b study in patients with metastatic melanoma.”
Seres presented preclinical results evaluating the impact of various consortia of bacterial species on the anti-tumor immune response in murine models following treatment with an anti-PD-1 checkpoint inhibitor. Results demonstrated that germ-free or antibiotic-treated mice lacking a functional gastrointestinal microbiome failed to mount an effective anti-tumor response when administered anti-PD-1 checkpoint inhibitor treatment. The response to anti-PD-1 treatment was restored by the introduction of a specific consortia of commensal bacteria rationally designed using insights from both in vivo and human microbiome signatures of response and the functional properties of specific bacterial strains in Seres’ strain library of gastrointestinal bacteria.

These data provide support for the continued development of SER-401, an oral microbiome therapeutic candidate sourced from screened healthy individuals who have been identified to have a microbiome bacterial signature similar to that observed in responders to cancer immunotherapy. The therapeutic aim of SER-401 is to modify the microbiome of cancer patients to increase the efficacy of immunotherapy. SER-401 is being evaluated in a Phase 1b clinical study (NCT03817125) conducted in collaboration with The University of Texas MD Anderson Cancer Center and the Parker Institute for Cancer Immunotherapy in patients with metastatic melanoma. In addition, Seres has an ongoing collaboration with AstraZeneca to advance the mechanistic understanding of the microbiome in augmenting the efficacy of cancer immunotherapy, including in combination with agents in AstraZeneca’s oncology pipeline.

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