Microbiome Report for Week Ending 6/22/19

June 24, 2019

Axial Biotherapeutics Announces $10M Investment from Taiho Ventures to Access Axial’s Expertise in the Gut-Brain Axis
Axial Biotherapeutics, announced on 6/20/19 a direct investment of $10 million from Taiho Ventures, LLC to fund the discovery and development of novel gut-targeted, small molecule approaches in oncology.

“Axial has built, and continues to build, an exciting and innovative discovery platform that targets the gut-brain axis but we also believe that additional diseases and disorders outside of CNS can stem from the gut microbiome,” said David H. Donabedian, Ph.D., co-founder and CEO of Axial Biotherapeutics. “We are pleased that Taiho Ventures sees the potential of this discovery platform, and we are honored to have their support as we look to progress the breadth and depth of our scientific platform. Just as we have done with the CNS space, we look to reshaping the scientific understanding of oncology with gut-targeted therapies.”

The $10 million investment from Taiho Ventures is an extension of Axial’s previously closed Series B round in February 2019. With this investment, Axial has raised a total of $35 million in its Series B financing. In conjunction with this investment, Axial will maintain control of the new oncology programs and Taiho Ventures will have a first right to negotiate for an exclusive license related to the new programs. Axial retains all of its rights to its existing CNS programs.

EnteroBiotix secure key additional MHRA license and announces regulatory milestones
EnteroBiotix, a leading clinical stage microbiome therapeutics company headquartered in Aberdeen, Scotland, announced on 6/20/19 that it has secured a Manufacturer’s Authorisation for Investigational Medicinal Products MIA (IMP) license from the Medicines and Healthcare Products Regulatory Agency (MHRA). The Manufacturers Authorisation for IMPs is an EU requirement for the production of material for patient use in clinical trials. The license enables EnteroBiotix to manufacture intestinal microbiome derived medicinal products for use in EnteroBiotix-sponsored and investigator-led clinical trials. On the back of this success, the Company plans to announce its clinical trial pipeline and distribute products to trial participants towards the end of this year.

In August 2018, EnteroBiotix announced that the Company had been awarded a manufacturer’s specials license from the MHRA. Since then, EnteroBiotix has distributed products to hospitals in the UK and the EU on a named patient basis. The announcement of this additional IMP license, which follows a substantial seed-extension investment announced in May, will catalyse the launch of a number of pioneering clinical trials later this year.

EnteroBiotix is also announcing that the company has made significant progress with regulatory authorities and its product development pipeline. Last month, Dr James McIlroy MBChB, Founder and President of EnteroBiotix, delivered a presentation and led discussions on behalf of the company at an Innovation Task Force meeting held at the European Medicines Agency (EMA) in Amsterdam. Dr McIlroy was supported by Nicolas Robinson CSci, Director of Production at EnteroBiotix, Professor Dilip Nathwani OBE, Clinical Advisor to EnteroBiotix, and a team of regulatory specialists. The ITF is a multidisciplinary group that includes scientific, regulatory and legal competencies. It was set up to ensure coordination across the Agency and to provide a forum for early dialogue with applicants on innovative aspects in medicines development.

In parallel with these developments, the company is also announcing that, EnteroBiotix, Caelus Health, Ferring Pharmaceuticals, and MaaT Pharma, in coordination with the Pharmabiotic Research Institute (PRI), have established a joint collaboration focused on creating a proposal with recommendations for a common European regulatory framework for human intestinal microbiome ecosystem-based therapeutics. Through this new collaboration, IMM-ETG hopes to gain valuable insight and feedback from the competent authorities with the aim of establishing a harmonised regulatory landscape for related products across the European Union.

Seres Therapeutics, Inc. Announces Proposed Public Offering of Common Stock 
Seres Therapeutics, Inc. (Nasdaq: MCRB) (“Seres”), a leading microbiome therapeutics platform company developing a novel class of biological drugs that are designed to treat disease by restoring the function of a dysbiotic microbiome, announced on 6/12/19 that it is commencing an underwritten registered public offering of $60.0 million of shares of its common stock. As part of this offering, Seres intends to grant the underwriters a 30-day option to purchase up to an additional $9.0 million of shares of its common stock. All of the shares in the proposed offering are to be sold by Seres.

Goldman Sachs & Co. LLC and Cowen and Company, LLC are acting as joint book-running managers for the offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The common stock described are being offered by Seres pursuant to a shelf registration statement on Form S-3 (No. 333-216735), including a prospectus, which was declared effective by the Securities and Exchange Commission (“SEC”) on March 24, 2017. A preliminary prospectus supplement to the prospectus describing the terms of the offering was filed with the SEC on June 5, 2019, and a final prospectus supplement will be filed with the SEC. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the effective registration statement. Copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering may be obtained, when available, by contacting: Goldman Sachs & Co. LLC by mail at Prospectus Department, 200 West Street, New York, New York 10282, Attention: Prospectus Department, by telephone at (866) 471-2526, by fax at (212) 902-9316, or by email at prospectus-ny@ny.email.gs.com or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, or by telephone at (631) 592-5973.

Synlogic and Ginkgo Bioworks Establish Transformational Platform Collaboration for the Accelerated Development of Novel Synthetic Biotic Medicines
Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage company applying synthetic biology to beneficial microbes to develop novel, living medicines and Ginkgo Bioworks, the organism company, announced on 6/12/19 a platform collaboration to accelerate expansion and development of Synlogic’s pipeline of Synthetic Bioticmedicines using Ginkgo’s cell programming platform.

The agreement provides an $80.0 million equity investment at a premium in Synlogic by Ginkgo and entry into a long-term strategic platform collaboration. Synlogic will use Ginkgo’s cell programming platform for building and testing thousands of microbial strains to accelerate progression of early preclinical leads to drug candidates optimized for further clinical development.

Ginkgo has purchased 6,340,771 shares of Synlogic common stock as well as pre-funded warrants to purchase up to 2,548,117 shares of Synlogic common stock, both at a price of $9.00 per share. Gross proceeds to Synlogic are approximately $80 million. The transactions were executed and closed on June 11, 2019. At the closing, under the foundry services agreement, Synlogic paid $30.0 million to Ginkgo for synthetic biology services to be provided over an initial period of five years which can be extended. Synlogic has exclusive rights to any Synthetic Biotic medicines that it develops as part of the collaboration and to intellectual property covering such products.

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