Johnson & Johnson

Pictured: 3D illustration of a T cell attacking a cancer cell/iStock, Meletios Verras Interius BioTherapeutics announced Tuesday that it has secured a regulatory go-ahead to conduct a first-in-human Phase I trial for its potentially first-in-class in vivo CAR-T therapy for B cell malignancies. The Philadelphia-based biotech will conduct its trial in Australia after the Human Research Ethics Committee for the country’s Therapeutic Goods Administration granted the company its Clinical Trial Notification clearance. Interius expects to initiate the Phase I study in the fourth quarter of 2024, with the expected delivery of key milestones “as early as the first quarter of 2025,” according to Tuesday’s announcement. STAT News reported that Interius is looking to enroll up to 30 patients from various sites globally. The early-stage trial is primarily designed to evaluate the safety of a single infusion of the investigational in vivo cell therapy, dubbed INT2104. The study will not be blinded and will include a dose-escalation part to determine the optimal dose of INT2104 for future trials. The decision to start trials outside the U.S. was informed by the FDA’s overly cautious approach to the in vivo therapy, Interius CEO Phil Johnson told STAT. The regulator wanted a study that could be stopped when a grade 3 safety event occurred. An FDA spokesperson in a statement to STAT said that it would be “unusual” for grade 3 events to cause an automatic pause in a study. Regardless of where the study is conducted, Johnson in a statement said that the regulatory clearance for a Phase I trial for INT2014 is a “significant milestone” for Interius and “recognizes the potential of our novel in vivo targeted gene therapy candidate.” Currently available CAR-T treatments—such as Johnson & Johnson and Legend’s Carvykti (ciltacabtagene autoleucel) and Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel)—are ex vivo therapies. Doctors collect patients’ T cells and engineer them outside of the body, typically in specialized laboratories, to produce the CAR proteins on their surface. The modified cells are reintroduced into the patients, where the CAR proteins seek out and target antigens on cancer cells causing their destruction. Interius’ approach hopes to replicate this process—but entirely inside the patient’s body. INT2104 targets CD7-positive T and natural killer cells to deliver a CAR transgene, allowing these effector cells to bind to the CD20 antigen which is commonly found on malignant B cells. INT2104 distinguishes itself from current CAR-T therapies by providing an off-the-shelf, single-dose intravenous treatment and by eliminating the need for lymphodepletion, according to the biotech. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

After securing approval last week for Alzheimer’s drug Kisunla, Eli Lilly was back in the news Monday with the $3.2 billion acquisition of immunology biotech Morphic Holding. This represents another deal in the lucrative immunology and inflammation (I&I) space, which saw $12.3 billion in M&A activity last year, with analysts predicting this momentum would carry over into 2024. Investment continues to pour into another hot therapeutic space: antibody-drug conjugates (ADCs). British biopharma company Myricx Bio netted a £90 million ($115.5 million) Series A round to expand its ADC platform and advance its pipeline into the clinic. Several other pharmaceutical companies are looking to capitalize on the potential of the ADC market—which is estimated to reach nearly $30 billion by 2028—including Johnson & Johnson, Genmab and Ipsen, who have all struck M&A deals in the space this year. Still others, including Sutro Biopharma and Mersana Therapeutics, are hoping to supercharge their potential via the immune system with immunostimulatory ADCs. And GLP-1s continue to make headlines, with one study linking semaglutide to an optic nerve condition that can cause sudden vision loss, and another showing the drug class could significantly lower the risk of 10 obesity-related cancers in diabetes patients. Novo Nordisk’s Wegovy has successfully expanded into China, where its patent will expire in less than two years, paving the way for biosimilar competition, and Lilly’s Mounjaro elicited greater weight loss than Novo’s Ozempic in a new observational study. Greg Slabodkin is the news editor at BioSpace. You can reach him at greg.slabodkin@biospace.com. Follow him on LinkedIn.  Heather McKenzie is a senior editor at BioSpace. You can reach her at heather.mckenzie@biospace.com. Follow her on LinkedIn. Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn. > Listen on Spotify > Listen on Apple Podcasts > Listen on Amazon Music > Listen on iHeart

Around 5.2 million adults in the UK have moderate to severe atopic dermatitis. Image credit: Shutterstock / Kmpzzz. England’s National Institute for Health and Care Excellence ( Nice ) has recommended Almirall ’s Ebglyss (lebrikizumab) for patients with moderate to severe atopic dermatitis, giving NHS patients another biological therapy option. In line with NICE guidelines, the NHS will now have 90 days to make the treatment available to patients. Patients over 12 years of age who have not responded to or are not able to take systemic immunosuppressants will be eligible for the therapy, as per a 10 July press release. Monoclonal antibody Ebgylss will join Sanofi / Regeneron’s Dupixent (dupilumab) and Leo Pharma ’s Adbry (tralokinumab) as interleukin-targeting options for treating the skin condition. The Janus kinase (JAK) inhibitors Cibinqo (abrocitinib), Olumiant (baricitinib), and Rinvoq (upadacitinib) developed by Pfizer , Eli Lilly, and AbbVie , respectively, are also recommended by NICE. Atopic dermatitis, also known as atopic eczema, is an inflammatory skin condition characterised by intense itching. It has an estimated prevalence of up to 4.4% among adults in the EU. In the UK alone, around 5.2 million adults have moderate to severe atopic dermatitis. See Also: Dupixent “addresses current gap” in COPD biologics landscape Peltopepimut-s by ISA Pharmaceuticals for Cervical Cancer: Likelihood of Approval Ebglyss, which was approved in Europe in October 2023, and then two months later in the UK, works by inhibiting interleukin-13 (IL-13) signalling. IL-13 pathways play an important role in inflammation, driving the type-2 inflammatory loop in the skin. Adbry similarly targets IL-13 while Dupixent inhibits IL-13 and IL-4. The National Eczema Society’s chief executive Andrew Proctor said: “It’s important we have a range of treatment options, so patients have the chance to access a treatment that works well for them.” Almirall licensed the rights to develop and commercialise Ebglyss in dermatology indications, including atopic dermatitis, in Europe from Dermira in 2019. Dermira was then acquired by Eli Lilly, the latter retaining drug rights in the US and the rest of the world. Ebglyss is forecast to reach blockbuster status by 2026, according to GlobalData’s Pharma Intelligence Centre. By 2030, the drug is predicted to generate nearly $3.4bn in global sales. GlobalData is the parent company of Pharmaceutical Technology. Amid Sanofi and Regeneron’s Dupixent dominance , Johnson & Johnson (J&J) made a play for the atopic dermatitis space earlier this year when it spent $1.25bn to acquire Numab Therapeutics’ antibody NM26 in May.