Pepscan’s GMP production capacity has doubled. Pepscan is an all-in-one partner in peptides, building on 25 years of experience in advancing and applying peptide expertise to facilitate clients in the development and production of peptides. The doubled GMP production capacity enables Pepscan to guarantee short production timelines. It also gives clients the benefit of collaborating with a single expert partner on the way from R&D to the clinic, resulting in maximum efficiency while also saving time. Specifically, researchers active in personalized peptide medicine, where both timelines and flexibility are key, will benefit from these new developments.

Hans de Backer, CEO of Pepscan, explains the new capacity additions. “Earlier this year, we started producing GMP peptides for clinical studies phases 1 and 2, which made it possible to provide peptides for purposes beyond R&D: directly for the benefit of patients. Our new production line, consisting of a new synthesizer, a preparative HPLC and lyophilizer in our cleanroom, and the strengthened QMS and process documentation that were put in place for this, have proven to facilitate the efficient execution of the process. Using this proven concept, we have now doubled the complete production line.” Current production includes both therapeutic peptide projects as well as personalized peptide medicine projects (e.g. neoantigen vaccines).

“Given our role in the field of personalized medicine, short and reliable delivery times are crucial,” adds Hanne Kho, Chief Operations Officer of Pepscan. “This demands a set of rigorous processes and a certain level of flexibility that we, together with outstanding product quality, are able to deliver. I’m very proud that the recent GMP customer audits that were conducted have confirmed this.”

De Backer continues, “Doubling our GMP production capacity is a major milestone that transforms our newly developed GMP capabilities into a solid pillar of our peptide services portfolio. In the last 25 years, we have built extensive knowledge and a reputation for our expertise in developing and producing peptides, specifically constrained peptides.  I’m glad that we are now able to use this expertise to provide peptides for purposes beyond R&D: directly for the benefit of patients.”

Source: Pepscan

Every year, an estimated 300.000 hemodialysis patients worldwide die as they run out of medical alternatives. One of the main reasons for these deaths is failure of the vascular access site, the blood vessel where blood is removed, filtered and returned to the body during dialysis. To solve this problem, a medical device was developed that enables a patient’s body to create blood vessels using the patient’s own cells. Vacis, the company commercializing this technology, has successfully closed a further funding round to set up GMP production, execute clinical trials and obtain CE certification.

The company received funding from Netherlands-based Brightlands Venture Partners and LIOF through their Limburg Business Development Fund (LBDF), as well as the German High-Tech Gründerfonds (HTGF). This was supplemented with a so-called Innovation Credit from RVO (the Netherlands Enterprise Agency). “The financing and support of the investors will enable us to quickly scale up the clinical trial and accelerate the route to market by at least a year”, says Ken Messier.

“Vacis combines elegant science with a solid management team. Brightlands truly is the ecosystem in which Vacis can validate its technology in patients and go to market fast.”, says Casper Bruens – Director at Brightlands Venture Partners. Tys van Elk, Director at LIOF adds: “Vacis is an exciting addition to the local community of regenerative medicine and realizing this consortium fits perfectly with LIOF’s increasing cross border ambition in the Euregio.”

The medical device is a synthetic rod with a specialized surface that is inserted under the skin. This induces the body to form a tissue capsule, which in the right environment, further matures into a functional blood vessel that is used as a vascular access site for hemodialysis. “We found the simplicity of the solution and the biocompatibility data very convincing and are delighted to support Vacis” adds Anke Cassing, Investment Manager at HTGF.

The team has been expanded with two seasoned biotech managers, Ken Messier and Josephine Brackman. Ken brings a wealth of clinical development and regulatory expertise, with over 30 years’ experience in Biotech. He has held various Director and Sr. Program Management positions within biotech companies such as Genzyme and DSM Biomedical. Josephine brings a broad expertise that covers (project) management, intellectual property and R&D. She has over 25 years’ experience in materials and biotech and has held several senior positions within DSM. They both join Dominik Klump, the Chief Technology Officer of Vacis, in the management team at the location in Geleen.

Leiden University Medical Center and Maastricht University played a key role in the development of the technology. The project was also supported by The Dutch Kidney Patients Association and the Biomedical Materials Program (BMM), a public-private partnership of leading industrial and academic players and the Dutch government.

Source: Vacis

SeraNovo has signed a License Agreement with Carna Biosciences, a company engaged in drug development specializing in the development of kinase inhibitors. Under the agreement, the companies will expand their existing collaboration and jointly continue to develop an oral formulation with an increased bioavailability for auto-immune diseases. Utilizing its proprietary Deep Eutectic Solvent (DES) formulation platform, SeraNovo is formulating Carna’s proprietary drug to increase its oral bioavailability. This advanced formulation enables the drug to progress into the clinical phase of development. The DES formulation platform is based on constituents that are for oral administration or broadly used in the industry. The final formulation includes an optimized combination of a DES, one or more polymeric precipitation inhibitors and Carna’s leading BTK inhibitor AS-0871.

Niall Hodgins, Chief Executive Officer of SeraNovo commented: “We are very excited that we have set up this important partnership with Carna Biosciences. We are confident this is just the first step in a long and fruitful partnership with an industry leader. As a startup company, this partnership represents excellent validation for our breakthrough formulation technology.

Source: SeraNovo (press release)

Een samenwerkingsverband van Regenerative Medicine Crossing Borders (RegMed XB) en de Dutch CardioVascular Alliance (DCVA) krijgt van de rijksoverheid een investeringsbedrag van 8 miljoen euro voor een nieuw valorisatieplatform. Dit faciliteert effectieve translatie vanuit toponderzoekers en bedrijven met als doel nieuwe oplossingen uit de velden van regeneratieve en cardiovasculaire geneeskunde sneller bij de patiënt te brengen.

Door te investeren in valorisatie-expertise en -capaciteit bouwen we aan een uniek valorisatie-ecosysteem op het gebied van regeneratieve en cardiovasculaire geneeskunde ter versterking van de regio’s. Als onderdeel hiervan wordt er een seed-fonds gecreëerd dat investeert in innovatieve cases, die vaak door het grote risico in deze vroege fase nog moeilijk investeringen aantrekken. We bouwen hiermee aan betaalbare oplossingen voor patiënten door middel van opschaalbare bedrijven die daarna door bestaande fondsen uitgebouwd kunnen worden.

Prof. dr. Marianne van der Steen, directeur van RegMed XB en penvoerder van het plan: ‘Belangrijk van deze investering is dat we de huidige kloof tussen innovatief concept, validatie en eerste klinische studies overbruggen, hierdoor wordt het concept aantrekkelijker voor durfinvesteerders. We gaan hiervoor proactief scouten bij al onze partners om impactvolle oplossingen voor patiënten zo snel mogelijk te valoriseren. Dat is de eerste stap naar de ontwikkeling van nieuwe medische oplossingen die dan via opschaling betaalbaar beschikbaar komen voor een grote groep patiënten. En dat is ons doel: chronische ziekten genezen en voorkomen’.

RegMed XB en de DCVA hebben de gedeelde missie om nieuwe oplossingen versneld te ontwikkelen om chronische ziekten te voorkomen en genezen. Met het oog daarop brengen RegMed XB en de DCVA de beste onderzoekers en ondernemers in Nederland samen in consortia om ‘patiënt-gedreven’ te werken aan de bestrijding van nierziekten, hart- en vaatziekten, diabetes type 1 en artrose. De partners van RegMed XB en de DCVA zijn, (technische) universiteiten, universitair medische centra, gezondheidsfondsen, overheden & provincies en private partijen. BioGeneration Ventures (BGV) zal nauw betrokken zijn bij het implementeren van het nieuwe fonds.

Prof. dr. Wiek van Gilst, bestuurder van de DCVA: ‘Dankzij de goede samenwerking van alle partners, samengebracht binnen RegMed XB en de DCVA, hebben we niet alleen de rijksoverheid kunnen overtuigen van de impact van onze missie, maar weten we ook zeker dat we daadwerkelijk in de komende jaren nieuwe en betere oplossingen voor patiënten gaan creëren.’

De impuls van 8 miljoen euro maakt deel uit van een investeringsprogramma van 24 miljoen waarmee de ministeries van OCW en EZK kennis uit onderzoek beter naar de samenleving en markt willen brengen. Hiermee worden investeerders gestimuleerd om geld te steken in startups die gebruik maken van kennis ontwikkeld binnen onderzoeksorganisaties. Het geld is afkomstig van de subsidieregeling Thematische Technology Transfer (TTT) en wordt verdeeld over drie consortia van onderzoeksorganisaties en durfinvesteerders. De consortia rond de thema’s regeneratieve en cardiovasculaire geneeskunde, smart systems en circulaire oplossingen krijgen ieder 8 miljoen euro.

Bron: RegMed XB