Touchlight Genetics Ltd.

Hercules’s loan is expected to hold Arcus up as the company continues to run at a net loss. Image: Shutterstock/ Tada Images Arcus Biosciences has announced a loan from financer Hercules Capital valued at as much as $250m, contingent on the advancement of the company’s therapeutic candidates. Arcus released the news after the markets closed yesterday (27 August), outlining an initial $50m granted at the deal’s close, with another $100m available at Arcus’s discretion. Provided Hercules Capital approves, a further $100m can be drawn. The five-year loan and four-year interest-only period may each be extended another year should Arcus initiate Phase III trials for its cancer therapies, a HIF-2α inhibitor casdatifan and the CD73 inhibitor quemlicustat, and meet regulatory milestones, respectively. The deal comes as the company continues its financial recovery. Arcus’s share price dropped from a high of $49.1 in November 2021 to $13.10 in November 2023. When the market opened today (28 August), the share price stood at $17.3; the company is valued at $1.6bn. Arcus CEO Dr. Terry Rosen said, “This non-dilutive facility enhances our already strong cash position and enables us to expand and accelerate our development program for casdatifan across multiple settings in ccRCC (clear cell renal cell carcinoma).” If approved, the HIF-2α inhibitor is projected to enter the market in 2028 potentially earning annual global revenues of $64m, increasing to $69m by 2030. Arcus plans to present data from their Phase I/Ib casdatifan trial ARC-20 (NCT05536141) later this year. See Also: AstraZeneca may pull plug on UK vaccine manufacturing plans Touchlight to supply GMP dbDNA for UK Zika vaccine study GlobalData is the parent company of Pharmaceutical Technology . The loan will contribute to the $1bn in cash reserves held by Arcus as of 30 June this year. Much of this funding comes from the company’s 10-year deal signed with Gilead Sciences in 2020. As per Arcus’s Q2 2024 report, Gilead may purchase up to 35% of Arcus stock , of which it owned 32.9% at the end of Q2 2024, and appoint three Arcus board members. Gilead has done so, and appointed Gilead CEO Johanna Mercier among others. Arcus also secured funding from other partnerships, including through an exclusive licence to quemliclustat in Asian markets , excluding China, to Taiho Pharmaceuticals. Despite this, Arcus reported net losses of $93m in Q2 2024 compared to $75m in Q2 2023. Another group of investigational drugs for the company is the checkpoint inhibitors domvanalimab and zimberelimab. Both target programmed cell death protein 1 and are being developed in non-small cell lung cancer under a collaboration between Arcus and Gilead in an active Phase III trial (NCT05502237). GlobalData estimates domvanalimab plus zimberelimab to yield $1.37bn in sales in 2030, including profit shares and royalties.

An ultra-rare, sight-threatening corneal infection, acanthamoeba keratitis causes intense pain and photophobia. Credit: Jo Panuwat D/Shutterstock. Italian ophthalmic company SIFI has received European Commission (EC) approval for AKANTIOR (polihexanide) to treat acanthamoeba keratitis (AK), a rare and severe corneal infection. The asset is the first therapy approved for AK in Europe. AKANTIOR targets both adults and children aged 12 years and above. Its commercial launch is set to begin in Germany in the fourth quarter of 2024, with subsequent rollouts in France, Italy, Romania, Spain, Türkiye and the UK. The launches are contingent on each country’s regulatory and reimbursement processes. See Also: AstraZeneca may pull plug on UK vaccine manufacturing plans Touchlight to supply GMP dbDNA for UK Zika vaccine study SIFI has also partnered with Avanzanite to introduce AKANTIOR in other European markets. AKANTIOR (polihexanide 0.08%) is an anti-amoebic polymer effective against both the trophozoites and cysts stages of acanthamoeba. It can be used as a monotherapy in the form of single-dose eye drops. The US Food and Drug Administration (FDA) granted orphan drug designation for AKANTIOR. An ultra-rare, sight-threatening corneal infection, AK causes intense pain and photophobia. The infection primarily affects those who wear contact lenses and is caused by the acanthamoeba protozoan. SIFI chairman and CEO Fabrizio Chines stated: “The approval represents an important step towards delivering a new global standard of care for patients with AK and builds on 15 years of research and development. “For the first time in Europe, AK patients have an approved therapy, marking a new era in the treatment of this disease, which may lead to blindness. AKANTIOR is the first and only approved medicine for AK, and our team is committed to developing polihexanide in other corneal infectious diseases, such as fungal keratitis, where we obtained orphan drug designation from the European Medicines Agency and the FDA.”

Clinical data confirmed that SteQeyma is highly similar to Stelara, without any significant differences in efficacy and safety. Credit: pedro7merino/Shutterstock. The European Commission (EC) has approved Celltrion ‘s SteQeyma (CT-P43), a biosimilar to Stelara (ustekinumab), for treating various chronic inflammatory conditions. This approval, which encompasses gastroenterology, dermatology, and rheumatology indications, follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June this year. SteQeyma, previously known as CT-P43, acts as an antagonist to human IL-12 and IL-23, addressing multiple immune-mediated diseases. It is available in subcutaneous and intravenous formulations, with the subcutaneous injection offered in 45mg/0.5ml or 90mg/1ml strengths in a single-dose, prefilled syringe. The intravenous infusion is available as a 130mg/26ml (5mg/ml) solution in a single-dose vial. Stelara, the reference product for SteQeyma, is a biologic therapy targeting interleukin (IL)-12 and IL-23 cytokines, crucial in inflammatory and immune responses. See Also: AstraZeneca may pull plug on UK vaccine manufacturing plans Touchlight to supply GMP dbDNA for UK Zika vaccine study The EC’s decision is grounded on comprehensive evidence, including a Phase III trial in adults with moderate to severe plaque psoriasis. The study’s primary endpoint was the change rate in the Psoriasis Area and Severity Index (PASI) for skin symptoms. Clinical data confirmed that SteQeyma is highly similar to Stelara, without any significant differences in efficacy and safety. SteQeyma is claimed to be the seventh biosimilar of Celltrion to receive EU approval, joining a portfolio that includes Remsima SC, Remsima, Truxima, Herzuma, Yuflyma, Vegzelma, and Omlyclo. In May this year, the EC approved Omlyclo, a omalizumab biosimilar for reference product Xolair, to treat allergic conditions. Celltrion Europe Division senior vice-president and head Taehun Ha said: “The EC approval of SteQeyma brings an important new therapeutic option to patients and we’re excited to launch this innovative therapy, with a proven track record in Crohn’s and other immune diseases. “This approval, alongside those of Remsima SC and Yuflyma, marks a key milestone in our strategy to strengthen Celltrion’s immunology offering, and with the recent approval of Omlyclo in May, we are looking forward to expanding our portfolio into the dermatology sector. We believe the approval demonstrates our unwavering commitment to expanding patient access to affordable, high-quality biologic medicines.”