Our Company

OUR COMPANY

Our Company

In a nutshell

Da Volterra is a private clinical-stage biopharmaceutical company which innovates for better health and care for people worldwide.

Our team is composed of 45 people with an extensive experience in science and in the industrial development of medical products. Together, we are dedicated to developing novel and safe therapeutic options for patients.

Our expertise focuses on the protection of the intestinal microbiome during antibiotic treatments.

  • Based in Paris, France
  • 45 collaborators,
    14 PhD
  • 81M€ funds raised
  • Lead Microbiome Protector in Phase 3

Our goal

Da Volterra’s goal is to develop and commercialize innovative healthcare solutions to preserve the intestinal microbiome of patients worldwide and help prevent and cure life-threatening diseases.

As new insights into the human intestinal microbiome are fundamentally reshaping how we understand and treat a wide range of diseases, Da Volterra is a pioneer in understanding and harnessing the microbiome capacity to help prevent and cure diseases, notably in cancer patients.

Our mission & vision

Da Volterra’s vision is to be a trusted and acknowledged leader of drug and medical device development in the microbiome field.

Our mission is to discover and develop up-to-market safe and novel therapeutic options, preserving patients’ microbiome to prevent and cure life-threatening diseases.

We strive to serve patients by transforming the promise of science into innovative treatments which have the power to restore health and save lives.

History

Da Volterra was created by Professor Antoine Andremont whose life-long research has been dedicated to understanding the impact of antibiotics on the intestinal microbiome and antibiotic resistance.

2000

Company inception

Prof. Antoine Andremont, a medical microbiologist, creates Da Volterra based on concepts originating from his work on the impact of antibiotics on the intestinal microbiome.

2000 – 2008

Early academic collaboration and technology patent filling

Academic collaborations are set-up to explore early research work. First patents are granted on innovative microbiome protection technologies to spare patients from life-threatening bacterial infections. Further innovations are developed with new patent applications filed regularly by the R&D team.

2009

Company structuration

The team is building up and takes foot in its facilities and laboratories of the rue de Charonne in Paris. Florence Séjourné, co-founder and then member of the board of Genfit, is appointed CEO. The management team is formed and 10 employees are recruited.

2010 – 2013

Preclinical proof of concept of DAV132

DAV132 composition is developed and optimized: associated patents are filed.
The company pipeline is structured and the first preclinical proofs of concept are obtained with DAV132. First grants are obtained from bpifrance and the European Commission.

2014

Clinical proof of concept of DAV132

The proof-of-concept of DAV132 is achieved in humans treated with antibiotics in a series of phase 1 clinical studies:

  • – Delivery of the active substance in the ileo-caecal region
  • – No impact of DAV132 on the efficacy of antibiotics
  • – Free antibiotic faecal concentrations decreased by 99%
  • – Very good protection of the microbiome diversity

2015

Major regulatory milestones

CE mark granted in Europe (ISO13485) and Pre-IND meeting with the FDA clears the development path as a drug in the USA.

2017

€20 million financing agreement with the European Investment Bank (EIB) as part of the European Union’s InnovFin program

2018

First publications showing the importance of the gut microbiome in immuno-oncology

First publications highlighting the impact of antibiotics and of the gut microbiome on the efficacy of immune checkpoints inhibitors and on the survival of cancer patients.

2019

DAV132 Investigational New Drug (IND) application approved by the US FDA

2019

Completion of the phase 2 clinical trial
evaluating DAV132 in patients

Success of the phase 2 clinical trial (SHIELD) evaluating DAV132 in patients.

The SHIELD trial showed that DAV132 was safe for use in hospitalized elderly patients with several comorbidities and taking concomitant medications. It also demonstrated that DAV132 was able to protect the intestinal microbiome from antibiotic damage.

It is the first phase 2 clinical trial assessing DAV132 safety and ability to protect the intestinal microbiome in patients.

May 2020

Da Volterra becomes coordinator
of the COMBACTE-NET consortium
and receives approval of co-financing
of the MICROCARE Phase 3 study

COMBACTE-NET is a European public-private research and development consortium funded by the IMI (Innovative Medicine Initiative).
Da Volterra has been a member of the consortium since 2016.

December 2020

Early meeting with NICE (National Institute for Health and Care Excellence) in the United Kingdom to discuss the Phase 3 protocol and pharmaco-economic models for DAV132

March 2021

DAV132 granted FDA Fast-Track Designation

Da Volterra receives FDA Fast-Track designation for DAV132 in the prevention of C. difficile infections in high-risk patients. This designation intends to facilitate the development and review of drug candidates for treating or preventing serious conditions that demonstrate the potential to address unmet medical needs.

July 2021

Recruitment of the first patient in the Phase 3 clinical trial evaluating DAV132 in patients with hematologic malignancies

The overarching objective of the MICROCARE Phase 3 trial is to demonstrate that DAV132 contributes to decrease the occurrence of life-threatening complications and to reduce the mortality of patients with hematologic malignancies undergoing several cycles of chemotherapies. 900 patients will be enrolled.