News

Xinnate AB partners with Destum Partners, Inc. a leading global, advisory firm

Lund, Sweden – Xinnate AB today announced a strategic collaboration with Destum Partners, Inc., a leading global, advisory firm specializing in the life sciences sector. Under the agreement, Destum Partners will act as the exclusive advisor to Xinnate AB for identifying and developing partnership opportunities for TCP-25 gel, the company’s innovative drug candidate for the treatment of Epidermolysis Bullosa (EB). EB is a group of rare, often very severe inflammatory disorders which causes fragile, blistering skin, resulting in recurring and chronic wounds.

“Following our positive Phase 1 data, including patients with Dystrophic EB, we sought the expertise of Destum Partners to support our mission of finding the right partner to advance TCP-25 gel and bring this much-needed treatment to patients,” said Helene Hartman, CEO of Xinnate AB. “With Destum Partners’ guidance, we are now ramping up our partnering activities, including introducing TCP-25 to potential strategic partners at the upcoming JP Morgan Healthcare Conference in January.”

“TCP-25 is an exciting drug candidate that has already attracted significant interest,” added Tom Filipczak, Managing Director and Partner at Destum Partners. “We are thrilled to collaborate with the Xinnate team and contribute to their efforts to unlock the full potential of TCP-25 through strategic partnerships.”

For more information
Helene Hartman, CEO of Xinnate AB
Helene.hartman@xinnate.com
Phone: +46 (0)72-512 03 12

About Destum Partners, Inc.
Destum Partners, Inc. (www.destumpartners.com) is a global, advisory and consultancy firm specializing in the biopharmaceutical and life sciences industries. For more than 18 years, Destum Partners has worked with clients ranging from large, multinational Fortune 500 companies through mid-sized/early-stage companies, globally completing transactions and providing customized market research and valuations. Destum Partners is therapeutically agnostic and has completed over USD $5.15B in deal value.

by Elin Hartman

Xinnate presents TCP-25 data at international dermatology congress

Xinnate AB, a biotech company developing therapies based on a pioneering immune-modulating peptides technology, targets dysfunctional healing, including treatment of the genetic disorder Epidermolysis Bullosa, is pleased to present clinical study results at the ongoing 2024 Annual Meeting of the European Society for Dermatological Research (ESDR).

 The ESDR 2024 annual meeting, taking place in Lisbon, Portugal from September 4-7, is a major four-day event, with international attendance from over 1000 skin scientists. ESDR will feature a presentation titled "Randomized Controlled Trial of TCP-25 Gel: Dual-Action for Bacteria and Inflammation Control in Epidermal Wounds." This work was generated in Xinnate´s initial phase I study, part I, which included healthy volunteers with induced blister wounds, and will be presented by Professor Artur Schmidtchen, Professor of Dermatology at Lund University.

Key findings from the study demonstrate that TCP-25 gel not only significantly reduces bacterial levels in and around wounds but also selectively preserves beneficial commensal bacteria. Additionally, the gel was found to downregulate key inflammatory proteins and cytokines, resulting in reduced wound exudation and preventing excess protein leakage.

-This is the first study to explore the effects of TCP-25 gel in human epidermal wounds, and the results are very promising for the further clinical development of TCP-25 for treatment of Epidermolysis Bullosa wounds, said Professor Schmidtchen.

by Anna-Karin Lindqvist

Xinnate reports positive results from Phase 1 study with TCP-25, in patients with Epidermolysis Bullosa

Xinnate AB, today announced the headline read-out from the third and final part of the 1 a/b study with TCP-25, in patients with Epidermolysis Bullosa (EB), showing positive safety, tolerability and pharmacokinetic data as well as signs of wound healing efficacy.

The primary objective of this three-part Phase 1a/b study was to evaluate the safety of TCP-25 gel, Xinnate’s drug candidate, for the treatment of Epidermolysis Bullosa (EB). EB is a group of rare, often very severe disorders which causes fragile, blistering skin, resulting in recurring and chronic wounds. In the final third part of the study, patients with EB were included and treated with TCP-25 gel for 4 weeks.
The results now show a good safety and tolerability of TCP-25 gel, when administered topically in this patient population. As previously announced no SAE were reported in the study. The pharmacokinetic analysis shows, as expected, no detectable systemic uptake of TCP-25 in plasma. Additionally, wound healing trends are demonstrated in this cohort of EB patients.
“This data gives us additional confidence for our ongoing development of TCP-25 gel. We are currently preparing for the Phase 2 study by producing drug product and selecting participating sites”, said Xinnate´s CEO Helene Hartman.
More information about the completed Phase 1a/b study can be found at clinicaltrials.gov. ID: NCT05378997.

About Xinnate
Xinnate is a pharmaceutical development company that develops novel, pharmaceutical therapies based on a pioneering technology of immune modulating peptides, that targets dysfunctional healing by controlling presence of microbes and the complex interplay of inflammatory responses. Xinnate runs an ambitious development program to transform lives for patients with high unmet medical need in inflammatory skin conditions, wounds and surgical procedures. The company´s first drug candidate TCP-25 gel, is a novel pharmaceutical based on a synthetically manufactured peptide, TCP-25.

For more information
Helene Hartman, CEO
Helene.hartmann@xinnate.com
Phone: +46 (0)72-512 03 12

by Helene Hartman

Xinnate completes Phase 1a/b study with TCP-25

PRESS RELEASE March 18, 2024:  

Xinnate AB, a pharmaceutical development company that develops novel, pharmaceutical therapies that targets dysfunctional healing in inflammatory skin conditions, today announced the completion of its clinical Phase 1 a/b study with TCP-25.

The primary objective of this three-part Phase 1a/b study is to evaluate the safety of TCP-25, Xinnate’s drug candidate, for the treatment of Epidermolysis Bullosa (EB). EB is a group of rare, often very severe disorders which causes fragile, blistering skin, resulting in recurring and chronic wounds.

In Part I of the study healthy volunteers with acute epidermal wounds formed by the suction blister technique were included and in Part II patients with non-healing leg ulcers were enrolled. In the final third part, patients with EB were included and treated with TCP-25 for 4 weeks. In total, the study included 35 participants, and they have now all completed the study.

“We have used a step-wise approach in our phase 1 program, continuously implementing our learnings from the previous parts. I am especially delighted about the generation of data with TCP-25 in our target indication EB”, said Xinnate´s CEO Helene Hartman.

“I would like to extend our gratitude to all patients and their families who participated in the study, as well as the clinicians and CRO staff for their excellent work”, continued Helene Hartman.

No serious adverse events (SAEs) have been reported in the study. The next step is to process and evaluate data, including biomarkers and clinical assessments. Thereafter, Xinnate plans to start a clinical Phase 2 study in patients with EB.

More information about the completed Phase 1a/b study can be found at clinicaltrials.gov. ID: NCT05378997. The method for part I of the study is published in in BMJ Open by Dr. Sigrid Lundgren et al¹

¹Lundgren S, Wallblom K, Fisher J, et al. Study protocol for a phase 1, randomised, double-blind, placebo-controlled study to investigate the safety, tolerability and pharmacokinetics of ascending topical doses of TCP-25 applied to epidermal suction blister wounds in healthy male and female volunteers. BMJ Open. 2023 Feb 22;13(2):e064866. doi: 10.1136/bmjopen-2022-064866. https://pubmed.ncbi.nlm.nih.gov/36813496/

by Helene Hartman

Xinnate secures 100 million SEK in financing and applies for a patent for the treatment of Epidermolysis Bullosa

Lund, Sweden, February 7, 2024

PRESS RELEASE

Xinnate conducted a new share issue of 100 million SEK from private investors last year. The funding enables an upcoming phase-2 study for the company's first drug—a gel for topical treatment of dysfunctional healing in wounds or inflammatory skin conditions. A phase-1 study in three parts is currently underway, including one part with patients suffering from the rare and severe disease Epidermolysis Bullosa. Planning for a multi-site phase-2 study with EB patients is ongoing.

– It is incredibly powerful that we can support the patent application with existing results from our clinical study. We aim to develop a drug that reduces harmful inflammation, improves the healing process, and reduces the risk of serious complications, says Helene Hartman, CEO of Xinnate.

Read full press release here

by Helene Hartman

Xinnate appoints Anna-Karin Lindqvist as new COO

We are delighted to welcome Anna-Karin Lindqvist to our team as our new COO.

With extensive experience in the pharmaceuticals industry, Anna-Karin has proven expertise in bringing pharmaceutical products from discovery through to market authorization approval and launch. Her arrival marks a significant milestone for our team as we prepare for the next phase of development. Please join us in welcoming Anna-Karin to our team!

by Helene Hartman

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.

by Helene Hartman

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.

by Helene Hartman

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.

by Helene Hartman