Approved clinical trial application for BioC gel on complex wounds

The CTA (Clinical Trial Application) has been approved by the Swedish Medical Products Agency (Läkemedelsverket) and the Ethics committee. The study will include patients with large complex wounds and the aim is to show safety and tolerability.


Excellent results from phase I study shows that the BioC gel is safe and well tolerated.

The first part of the phase I study has now been unblinded. The result shows that BioC gel is both safe and well tolerated. There were no adverse events reported and no systemic effect detected.


Funding secured for the next step of BioC clinical plan

The interest was very high and a new issue of 14M SEK was oversubscribed. The money will be used for the clinical phase Ib study on patient with complex wounds and for preparation of the clinical trial phase II.


Xinnate is awarded a prestigious grant from the US Department of Defense

Xinnate is awarded prestigious grant from the US Department of Defense (DoD) of 1,77M USD over three years. The grant was issued by US Army Medical Research Acquisition Activity (USAMRAA) and will be used for development of a BioC based formulation in the project entitled ”Prevention and Treatment of Infection and Inflammation in Pressure Ulcers”. The project will run in parallel with the clinical work on acute wounds.
Martin Malmsten, Professor in Biopharmaceuticals, Biophysics and Drug Delivery at the University of Copenhagen and the Director of LEO Foundation Center for Cutaneous Drug Delivery, has taken on the role as Sr advisor and will support the project.


Approved clinical trial application for First in Human study on BioC gel

The Swedish Medical Products Agency (Läkemedelsverket), and the Ethics committee have approved the Clinical Trial Application of the Phase I, a First in Human study on BioC gel. They study will be run at Lund University Hospital and will include healthy volunteers and treatment of epidermal skin wounds. The aim of the study is to show safety and tolerability.


New publication: BioC-coated dressing shows promising effect on both infection and inflammation

A BioC-coated dressing showed promising effect on both infection and inflammation in vivo. The results were recently published in Acta Biomaterialia, “Peptide-coated polyurethane material reduces wound infection and inflammation”. These are commercially important findings illustrating that the peptide can be coated on biomaterials such as dressings, meshes and sutures.


Funding secured for the first clinical study of BioC wound gel

A rights issue has been completed and successfully raised 14.5 million SEK for Xinnate to fund the first clinical study of BioC wound gel. We plan to begin the study in the fourth quarter of 2021 and will evaluate the safety and antimicrobial and anti-inflammatory effects of BioC in wounds.


Xinnate has received a prestigious Swedish Research Council grant

Xinnate co-founder Artur Schmidtchen has received 9.5 MSEK in funding from the Swedish Research Council – the largest grant awarded in the field of medicine in this round. The application received the highest possible rating in all assessment categories. The money will go to in-depth basic research on mechanisms related to wound healing, which will be commercialized by Xinnate.


Xinnate is looking for a Chief Operating Officer

Chief Operating Officer  - An opportunity to be part of a highly collaborative, international team, turning groundbreaking world class science into clinical applications.

Xinnate is an innovative startup company with the aim to develop and commercialize product concepts for applications in the areas skin, wound, surgery and biomaterials. We specialize in the development of proprietary peptide-based drugs for prevention and treatment of inflammatory diseases and infections. We are in pre-clinical phase, starting clinical trials later this year.

Xinnate is a member of SmiLe incubator at Medicon Village in Lund and we work in close collaboration with the founder prof Artur Schmidtchen and his team at Lund University, BMC.

We are now looking for Chief Operating Officer and the position is a 12 months temporary employment with an option to prolong. Full or part time can be discussed.

Role description

Your main role is to act as on overall project leader directing and coordinating the consultants, CRO’s and the partner involved in the development of the first product. You are responsible for the overall budget and time plan and together with the team you challenge and define the strategic way forward taking into account the regulatory options and the product strategy.

You will also take an active role in developing the documentation needed for the regulatory approval and funding and you will take part in the overall management of the company.

Personal skills and requirements

You have a university degree in life science (MSc) and a PhD or research experience in areas of inflammation and/or infections would be an advantage.

You have a good understanding for pre-clinical project work, and you have previous experience in project coordination. You are skilled in scientific writing and experience from regulatory documentation (IB, IMPD, IND/CTA Application Form, Label design…) would be a benefit.

As a person you are highly motivated, you have a strong drive and you like new challenges. You are structured and take pride in delivering results on time. You are a passionate team player and you are fluent in English with good communication skills.

Application

Pls send you application to Helene.hartman@xinnate.com no later than 2020-02-08.

If you are an applicant and if you have any questions, pls contact Helene Hartman 0725-120312.