NovalGen Ltd. (“NovalGen”), a biopharmaceutical company developing breakthrough cancer therapies and HALIX B.V. (“HALIX”), a contract development and manufacturing organisation, today announced a strategic partnership. Within the scope of this partnership, HALIX will provide manufacturing of clinical supply of NovalGen’s therapies.

NovalGen’s innovative platform technology has been successfully deployed at HALIX to manufacture clinical trial material for NovalGen’s first clinical program. The program, NVG-111, is a Receptor Tyrosine Kinase Like Orphan Like Receptor 1 (ROR1) targeting bispecific antibody T cell engager for the treatment of hematologic malignancies and solid tumors, is expected to enter the clinic in the first half of 2021. HALIX has supported NovalGen with the successful completion of GMP manufacture of NVG-111 from drug substance up to drug product and final release. The strategic partnership and collective expertise of both organisations has ensured an efficient technology transfer and further development of the process leading to a successful GMP manufacturing campaign.

“This collaboration with HALIX will ensure high quality, rapid and secure manufacture of clinical supplies for our current and future products. Using cutting-edge manufacturing technologies at our partner’s state-of-the-art cGMP facility, we are progressing to become a clinical stage company,” said Kieran O’Donovan, SVP Chemistry and Manufacturing Controls at NovalGen. “We developed a manufacturing process around the use of transient transfection to accelerate timelines and reduce costs, whilst delivering product of the highest quality. In HALIX we found the ideal partner; experience in transient transfection, modern facilities, strong leadership and a laser focus on delivery to bring NVG-111 from contract signature to vials of clinical drug in less than seven months.”

“The partnership with NovalGen has been a great success,” said Alex Huybens, Chief Operations Officer at HALIX. “Working closely together and utilizing the collective bispecific antibody expertise of both teams has enabled us to meet the ambitious timelines and efficiently transfer the process and deliver the product to be ready to enter the clinic. We look forward to a long and productive collaboration with NovalGen.”

Source: HALIX (Press release)

Drie procent van ons BBP investeren in R&D en meer continuïteit in R&D-beleid. Dat zijn de speerpunten in een vorige week door onderzoeksorganisatie TNO uitgebracht position paper. Hierin bepleit TNO hoe we met innovatie onze economie kunnen aanjagen. Wij herkennen daar onze boodschap van de afgelopen weken in terug: investeer in biotech, investeer je uit de crisis!

Economische wijze(n) uit het oosten

Verhoging van de arbeidsproductiviteit post-corona door middel van gerichte investeringen in onderzoek en ontwikkeling is voor Nederland hét recept voor economische groei, aldus TNO in hun position paper. TNO baseert zich onder meer op het Duitse voorbeeld uit de vorige crisis. Tijdens de bankencrisis van 2008 had Duitsland een Keynesiaanse strategie: In plaats van te korten op R&D-financiering schroefde men de investeringen in private en publieke uitgaven juist op. Meer dan drie procent van het totale BBP werd geïnvesteerd in R&D.

Ook ziet TNO de beleidscontinuïteit als succesfactor. De afspraken om te investeren in R&D stamden al van voor de bankencrisis, het zogenaamde ‘Pact for Research and Innovation’. Ondanks het economische zware weer werd deze afspraak alsnog gehonoreerd. Zo kon de Duitse economie uitgroeien tot een innovatiemotor.

Er is in bij onze oosterburen nog meer af te kijken op innovatiegebied, denken wij. Het Sprind initiatief bijvoorbeeld: De Duitse overheid heeft voor de komende tien jaar €1 miljard vrijgemaakt om innovaties naar de markt te brengen. Een initiatief om gericht innovatie te stimuleren en daadwerkelijk te komen tot impact. Dit soort initiatieven zouden Nederland kunnen helpen om uitvindingen sneller en beter uit het lab en in de samenleving te brengen dan nu.

Investeer in biotech, investeer je uit de crisis

Om het percentage R&D investeringen in Nederland op te stuwen naar drie procent heeft TNO een drietal oproepen aan een nieuw kabinet:

1. Het groeifonds mag niet ten koste gaan van de basisfinanciering van kennisinstellingen.
2. Richt je op gericht onderzoek dat binnen vier jaar tot economische activiteit leidt.
3. Investeer gericht in sleuteltechnologie.

Zeker dat laatste punt zal onze vaste lezers bekend voorkomen. Biotechnologie is namelijk een van de sleuteltechnologieën die onze overheid heeft geïdentificeerd. Wat ons betreft sluit de oproep van TNO dus aan bij wat wij al weken roepen: Investeer in biotech, investeer je uit de crisis!

Forbion, a leading European life sciences venture capital firm, today announces the launch of VectorY, a fully integrated gene therapy company focused on the development of innovative vectorized antibodies for muscular and neurodegenerative disorders. The Company has been operational since October 2020 and has established laboratories and offices at the Amsterdam Science Park.

VectorY develops proprietary and partnered programs based on a novel AAV platform and innovative antibody-based targeted degradation technologies. The Company is creating a pipeline of innovative vectorized antibodies targeting muscular and CNS diseases, aimed at overcoming limitations of current therapies, improving delivery, durability and accessibility of targeted tissues and cells. These novel viral vectors will have enhanced properties of non-immunogenicity, cell type specificity and expression in selected sub-cellular compartments, thus unlocking new treatment opportunities in these disease areas.

This year the Company is setting up its own state-of-the-art GMP manufacturing facilities in Amsterdam. Its technology platform will be developed for scalability and yield, with the aim of significantly lowering the costs of gene therapies.

VectorY has already negotiated its first corporate collaboration agreement, gaining access to a highly relevant neuro-inflammation target to develop a vectorized antibody therapy for treatment of neurological disorders. VectorY will continue to consider further collaborations in parallel to progressing its proprietary programs.

The highly experienced management team will be led by Marco Boorsma, General Partner at Forbion, who is joining as Interim CEO, bringing a proven track record of building and leading biotech companies. Co-founders Carlo Incerti, Pavlina Konstantinova, Anthony Newcombe and Barbara Sanders all bring significant, longstanding experience in gene therapy, vector development, and biopharmaceutical manufacturing expertise. Carlo Incerti, Operating Partner at Forbion and previously Chief Medical Officer of Sanofi Genzyme, will join VectorY’s board as Chairman, together with Sander Slootweg, Managing Partner at Forbion, as board member. Forbion’s principal Dmitrij Hristodorov will join as Observer to the board.

VectorY was seeded by Forbion, following previous investments in successful gene vector companies including bluebird bio (then named Genetix), Biovex, Hookipa, EnGene, Amsterdam Molecular Therapeutics, uniQure and Replimune.

Carlo Incerti, Co-founder and Chairman of the Board of VectorY, and Operating Partner at Forbion, said:
“I have been working in the gene therapy field for over 30 years, and, from experience, know that accurately targeting the right cells with the transgene has always been of paramount importance. Using viral vectors developed at VectorY to deliver the genetic sequence for therapeutic antibody expression in target cells has the potential to address some of the key shortcomings of intravenously injected molecules. Our aim is to create novel treatments for patients.“

Marco Boorsma, Interim CEO of VectorY, said:
“VectorY is developing innovative technologies to create novel, potentiated vectorized antibodies that will target muscle and CNS disorders with substantial unmet medical needs. Our aim is to bring new, powerful treatments to patients suffering from serious diseases. The Company is hitting the ground running, capitalizing on the extensive experience of its co-founders, and the support and expertise from Forbion as longstanding gene therapy investor.”

Source: Forbion (Press release)