Global Roundup: Iceland's Alvotech Hits Mark with Biosimilar to Janssen's Stelara

Gene therapy research

Iceland is known for the beauty of its rugged landscape, but the land of fire and ice also has a growing pharma industry that includes Alvotech Holdings S.A., a biosimilar manufacturer developing AVT04, a proposed biosimilar to Janssen's Stelara (ustekinumab).

Alvotech, which has partnered with Teva Pharmaceuticals on AVT04, announced positive results from a confirmatory clinical study. The confirmatory clinical trial, AVT04-GL-301, was designed to demonstrate equivalent efficacy and compare safety and immunogenicity between AVT04 and Stelara in patients with moderate to severe chronic plaque-type psoriasis. The study met its primary endpoint, with results demonstrating therapeutic equivalence between Alvotech's biosimilar candidate and Stelara. Additionally, there were no clinically meaningful differences in safety observed through week 28.

"The progress of our proposed biosimilar to Stelara® highlights the advantage of our global, vertically integrated platform," Robert Wessman, founder and chairman of Alvotech said in a statement. "Completing this clinical milestone, less than one year since we recruited the first subject, truly demonstrates the success of our clinical development and integrated approach to rapidly advancing multiple high-quality biosimilar candidates."

In 2021, Stelara's worldwide net sales exceeded $9 billion. Ustekinumab is a human IgG1κ monoclonal antibody that binds with specificity to the p40 protein subunit present in the IL-12 and IL-23 cytokines. Stelara is prescribed to treat a variety of inflammatory conditions, including psoriatic arthritis, Crohn's disease, ulcerative colitis, and plaque psoriasis. 

Earlier this month, Alvotech announced positive top-line results from a pharmacokinetic (PK) similarity study for AVT04.

Across the rest of the world:

Ilya Pharma: Sweden's Ilya Pharma announced the Indian Patent Office issued a patent covering ILP100 for the treatment of diseases of skin and mucosa in humans and animals. The patent covers the general use of a plasmid expressing the protein CXCL12 in Lactobacillus reuteri.

Ilya is currently developing a portfolio of three first-in-class immunotherapies for skin and mucosal diseases, including ILP100-Topical for treatment of surgical wounds in diabetic, prediabetic and obese patients, especially at risk, ILP100-Topical for diabetic ulcers and ILP100-Oral for patients with immune mediated enterocolitis resulting from cancer treatment with checkpoint inhibitors.

Biotage: Also based in Sweden, Biotage launched Biotage Select Enkel, a dedicated purification workhorse with a modular design that facilitates application customization. Biotage Selekt Enkel introduces a digitized approach to instrument design with a novel modular construction. Laboratories can decide whether they wish to add optional features, such as automated handling of purified sample collection racks or an extended collection bed, thus tailoring the system to suit their workflow.

Centogene N.V.: Germany-based Centogene released updated recommendations for Whole Genome Sequencing (WGS) in the rare disease diagnostic setting. The report, published in the European Journal of Human Genetics, promotes the standardized application of WGS – minimizing diagnostic delay to promote better health outcomes.

The original guidelines for diagnostic Next Generation Sequencing were published in 2016. At that time, the guidelines predominantly focused on Whole Exome Sequencing and gene panels to identify Single Nucleotide Variants (SNVs) and insertions/deletions. Since then, WGS has been increasingly proven as an emerging and comprehensive genetic testing technology to avoid diagnostic delays and stepwise testing.

Elsevier: Based in London, Elsevier forged an agreement with the Slovenian ScienceDirect Consortium of universities, institutes and hospitals, which is expected to benefit the member institutions through access to Elsevier's extensive collection of journals. The Slovenian ScienceDirect Consortium was founded in 2001 and represents sixteen public institutions across Slovenia. It

Recce Pharmaceuticals: In the land Down Under, Recce Pharmaceuticals announced data from a single cohort of a study of its Phase I anti-infective, R327. Cohort five has seen promising safety and tolerability data in 10 healthy male subjects who received a 2,000 mg dose. An Independent Safety Committee has unanimously approved cohort six to commence at 4,000mg, with subjects recruited and dosing underway.

The Phase I trial is an ascending dose, randomized, placebo-controlled, parallel, double-blind, single-dose study being conducted at Adelaide's CMAX clinical trial facility. The study is on track to have all Phase I dosing complete by the end of the second quarter of this year. According to PEW Charitable Trusts global antibiotic pipeline review, R327 is the only clinical-stage new class of antibiotics in the world being developed for sepsis, the largest unmet medical need in human health.

Ascendis Pharma A/S: Based in Denmark, Ascendis announced results from a Phase III study conducted by Visen Pharmaceuticals, assessing once-per-week. TransCon hGH in children with growth hormone deficiency (GHD) in China saw consistent results in a Phase III study conducted by Ascendis Pharma.

Visen Pharmaceuticals' Phase III trial achieved its primary endpoint, with pediatric GHD patients treated with once-weekly TransCon hGH demonstrating greater annualized height velocity at 52-weeks compared to patients treated with daily growth hormone. Pediatric GHD is a serious orphan disease characterized by short stature and metabolic abnormalities that affect overall physical and mental health.

In both Ascendis Pharma's and Visen Pharmaceuticals' Phase III trials, TransCon hGH, which has been approved in both the United States and European Union, demonstrated statistical non-inferiority and superiority on the primary endpoint with comparable safety and tolerability to daily growth hormone.

Vectorius Medical Technologies: Israel's Vectorius announced results from the VECTOR-HF I study demonstrated the safety and accuracy of the pioneering V-LAP novel wireless system. The V-LAP system is implanted permanently in the left atrial wall of the heart to remotely calculate left atrial pressure (LAP).

Data from the study was presented at the European Society of Cardiology (ESC) Heart Failure 2022 conference. The V-LAP system is the first device to directly measure pressure data generated from the left atrium. Remote access to left atrium pressure readings has the potential to be more personalized, accurate and timely, beginning even before physiological symptoms appear. Lessons learned from VECTOR-HF II will be incorporated into VECTOR-HF III, a larger pivotal study scheduled to start in the U.S. in 2023 with the goal of achieving FDA approval.

Pierre Fabre: Pierre Fabre and the European Organisation for Research and Treatment of Cancer (EORTC) opened a large Phase III clinical study in the adjuvant setting of stage IIB-C melanoma. The first patient, who has a resected stage II BRAF-mutant melanoma, was screened for the Phase III COLUMBUS- study.

The Columbus-AD trial is a pioneering study designed to evaluate whether the combination of BRAF and MEK inhibitors encorafenib and binimetinib can prolong recurrence-free survival (RFS) and improve distant metastasis-free survival and overall survival compared to placebo in participants with surgically resected stage IIB-C BRAF V600E/K-mutant cutaneous melanoma. It is estimated that 18% of stage IIB and 25% of stage IIC patients die from melanoma within 10 years. Approximately 815 patients will be enrolled in Columbus-AD. More than 160 sites in about 25 countries will participate in the study.

Osivax: France's Osivax announced an update on the clinical development of its lead candidate, OVX836, T-cell based influenza candidate developed using the company's proprietary oligoDOM nanoparticle technology platform and designed to produce immune responses against the nucleoprotein. Based on positive safety data from the ongoing Phase Ia trial, the company has initiated two additional Phase II clinical trials: a dose-escalation study in elderly subjects and a combination trial with a seasonal quadrivalent influenza vaccine (QIV), to broaden the scope of OVX836's application in an effort to provide improved protection against influenza across strains.

Achiko AG: Switzerland-based Achiko secured $1.3 million in financing from strategic investors Buranto AG and Negma Group.

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