Global Roundup: Galapagos NV Wins European Approval for Ulcerative Colitis Therapy


Belgium-based Galapagos NV won European approval for Jyseleca for the treatment of adult patients with moderately to severely active ulcerative colitis (UC).

This is an additional approval for Jyseleca, an oral, once-daily, JAK1 preferential inhibitor, for adult patients with moderately to severely active UC who have had an inadequate response or were intolerant to conventional therapies. The European Commission based its approval on data from the Phase IIb/III SELECTION program, which evaluated Jyseleca as an induction and maintenance therapy in the patient population now included in the label. Data from the SELECTION trial was published in The Lancet.

“We are very pleased that the European Commission has approved Jyseleca as a treatment for people with UC. This decision further supports the efficacy and safety profile of Jyseleca, which was studied in over 1,250 UC patients. Our focus now is on making this treatment available as rapidly as possible to physicians and UC patients across the European Union,” Onno van de Stolpe, chief executive officer of Galapagos said in a statement.

Ulcerative colitis is characterized by inflammation of the mucosal lining of the colon and rectum. There are more than two million people across Europe who are affected by ulcerative colitis.

Elsewhere around the globe:

Tokyo Institute of Technology – Researchers at the Tokyo Institute of Technology have uncovered a novel role of nascent protein chains in stabilizing translating ribosomes. They suggest that longer peptide sequences spanning the ribosomal exit tunnel and bulky amino acid residues in the tunnel entry help stabilize the ribosome by bridging its subunits, ensuring uninterrupted translation. The findings indicate an intrinsic regulatory mechanism wherein the nascent peptide in collaboration with the ribosomal tunnel helps maintain ribosomal stability and continuity in translation elongation.

Cellenion – France’s Cellenion, a BICO company, formerly known as CELLINK, forged an agreement with Thermo Fisher Scientific to advance single cell proteomics analyses. The goal of the partnership is to combine Cellenion’s cellenONE and proteoCHIP with Thermo Fisher’s TMT multiplexing technologies and Thermo Scientific Orbitrap mass spectrometers to deliver complete solutions, from single cell isolation and automated sample preparation through to mass spectrometry (MS)-based proteomics analysis on single cells.

Pierre Fabre – Also based in France, Pierre Fabre and Switzerland’s EspeRare Foundation partnered to initiate the EDELIFE study assessing ER004, a prenatal treatment for XLHED (X-linked Hypohidrotic Ectodermal Dysplasia), a rare and debilitating congenital disease. If positive, the study could lead to the first approved treatment for XLHED by 2026, the companies said in the announcement. XLHED is a rare disease which affects approximately four of every 100,000 male births every year. This genetic disorder is a dermatologic-related condition that leads to abnormal development of the skin, sweat glands, sebaceous glands, hair, oral cavity and respiratory mucosal glands resulting in serious clinical manifestations such as hyperthermia, craniofacial anomalies and recurrent respiratory infections. ER004 received Breakthrough Therapy designation from the U.S. Food and Drug Administration in 2020.

Cytovation AS – Norway-based Cytovation AS has dosed its first patients in the Phase I/IIa CICILIA clinical trial assessing CyPep-1 in combination with Merck’s Keytruda in patients with solid tumors.

CARMAT – Artificial heart company CARMAT, which is based in France, announced the first implant of the Aeson artificial heart in The Netherlands. The implant procedure was performed by the Heart Team at the University Medical Center in Utrecht, The Netherlands.

LabCorp – Labcorp opened a new, integrated bioanalytical laboratory in Singapore. The laboratory features new capabilities that enhance the substantial array of bioanalytical services, which will allow the company to meet increased demand from pharmaceutical and biotechnology companies.

Entos Pharmaceuticals – Canada-based Entos and BioMarin Pharmaceutical entered into an agreement that will see Entos apply its Fusogenix nucleic acid delivery technology to promising gene therapy candidates in the BioMarin pipeline. Entos will apply the Fusogenix platform to formulate BioMarin product candidates aimed at the treatment of genetic diseases. Entos’ most advanced clinical program is Covigenix VAX-001, a COVID-19 DNA vaccine that is the subject of an ongoing Phase II clinical trial in South Africa.

SOTIO Biotech – Czech Republic-based SOTIO entered into a target-specific license and option agreement with LegoChem Biosciences Inc. to deploy that company’s ADC technology for up to five therapeutic programs targeting distinct tumor-associated antigens. The deal enables SOTIO to combine its proprietary antibodies with LCB’s ADC technology platform in order to deliver novel therapeutics for the treatment of solid tumors and includes LCB’s proprietary conjugation technology ConjuAll and potent linker-payload platform including multiple different payloads.

Affibody AB – Sweden’s Affibody forged an agreement with Acelyrin, Inc. to develop and commercialize izokibep, a bispecific molecule targeting interleukin-17A (IL-17), for multiple autoimmune diseases. Izokibep is a unique, antibody mimetic, IL-17A inhibitor designed to overcome the limitations of monoclonal antibodies. Affibody will receive $25 million in an upfront payment and the deal could swell to as much as $280 million when regulatory milestones are included.

CRISPR Therapeutics – With an office in Switzerland, CRISPR Therapeutics and ViaCyte, Inc. announced that Health Canada has approved the companies’ Clinical Trial Application for VCTX210, an allogeneic, gene-edited, immune-evasive, stem cell-derived therapy for the treatment of type 1 diabetes (T1D). Patient enrollment is expected to begin by the end of 2021. The Phase 1 trial of VCTX210 is designed to assess its safety, tolerability, and immune evasion in patients with T1D.

OncoOne – Austria’s OncoOne and GenScript ProBio entered into an agreement for the cell line development, drug substance and drug product manufacturing of therapeutic and diagnostic monoclonal antibodies (mAbs) directed against the promising immuno-oncology target, oxidized macrophage migration inhibitory factor (oxMIF). The companies will combine their respective expertise in drug discovery and manufacturing to bring the resulting mAb candidates into the clinic. Further terms of the agreement have not been disclosed.

GenSight Biologics – Based in France, GenSight reported that a second patient with late-stage retinitis pigmentosa (RP) partially recovered visual function after treatment with GS030 optogenetic therapy. The GS030 optogenetic treatment, which combines gene therapy with the use of light-stimulating goggles, led to the patient being able to perceive and count objects one year after injection with GS030’s gene therapy component. The patient is a participant in the ongoing PIONEER Phase I/II clinical trial of GS030. Data on a previous patient who exhibited a partial recovery was published earlier this year in Nature Medicine.

Saniona – Denmark’s Saniona initiated a Phase IIb study of Tesomet in patients with hypothalamic obesity (HO). Tesomet is an investigational fixed-dose combination therapy of tesofensine, a triple monoamine reuptake inhibitor, and metoprolol, a beta-1 selective blocker. Data from the trial are expected in the second half of 2023.

Sofinnova Partners – European venture capital firm Sofinnova Partners has raised €150 million in capital for its early-stage environmental impact fund, bringing the firm’s total assets under management to €2.5 billion across its platform of investment strategies. Sofinnova Industrial Biotech II is part of the venture capital firm’s pioneering sustainability strategy initiated over a decade ago with the launch of the Sofinnova Green Seed Fund. The fund will continue to finance early-stage companies harnessing biotechnology to develop sustainable solutions across the food, agriculture, chemical and materials sectors.

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