INT-2104

Plus, news about Interius BioTherapeutics, Hope Medicine, PMV Pharmaceuticals, Epitopea, Alyssum Therapeutics and a new dementia trial accelerator in the UK: Bayer exercises option to develop heart drug with Dewpoint Therapeutics : The companies, which first teamed up in 2019, now plan to develop a therapy for dilated cardiomyopathy, a heart muscle disease. Bayer is paying $424 million in upfront and milestone payments. — Jaimy Lee Viking Therapeutics is already thinking about an obesity launch: The company plans to meet with the FDA before the end of the year to discuss Phase 3 plans for its subcutaneous GLP-1/GIP receptor agonist, VK2735, according to remarks made by CEO Brian Lian on Wednesday’s earnings call. Viking is already in conversation with manufacturers, and Lian said he’s confident the company will be able to supply “a blockbuster-sized product at the appropriate time.” Viking is also launching a Phase 2 trial this quarter for an oral version of VK2735. Lian described the experimental oral medicine as more of an “add-on” to the portfolio, while the subcutaneous version would be the “anchor piece.” — Nicole DeFeudis Interius BioTherapeutics doses first ever patient with in vivo CAR-T: The biotech gave an in vivo CAR-T therapy to a patient enrolled in a Phase 1 study of INT2104, which it’s developing for B cell cancers. The trial, which is being run in Australia, is the first test of its kind. Umoja Biopharma has said it plans to dose a patient in its US-based study of its own in vivo CAR-T therapy by the end of this year . — Lei Lei Wu Hope Medicine touts interim data for endometriosis treatment: The company’s monoclonal antibody, dubbed HMI-115 , demonstrated statistically significant improvement in endometriosis pain at 12 weeks. The Phase 2 trial enrolled 142 female patients in the US, Poland and China. The mean dysmenorrhea pain score was reduced by 42%, and non-menstrual pelvic pain score was reduced by 50%. Hope CEO Nathan Chen said the company plans to “move quickly” toward global Phase 3 trials. — Katherine Lewin PMV Pharmaceuticals discontinues early-stage cancer trial: Citing toxicities and limited clinical benefit, the company abandoned its Phase 1b study assessing rezatapopt and Merck’s Keytruda. It had been testing the combo in patients with advanced solid tumors harboring a TP53 Y220C mutation. PMV said enrollment for a Phase 2 trial evaluating rezatapopt as a monotherapy for patients with TP53 Y220C and KRAS wild-type advanced solid tumors is still on track. — Katherine Lewin Epitopea closes $31M pre-Series A: With today’s round, the cancer biotech has raised more than $45 million. The funds are set to go toward its preclinical discovery work in solid tumors and clinical development plans for its RNA-based immunotherapies. — Katherine Lewin Alyssum Therapeutics emerges from stealth with $26M Series A: The Cambridge, MA-based biotech’s lead asset is AT-1965, a clinical-stage small molecule CMTR2 inhibitor. This round was led by co-founder Patrick Soon-Shiong and Accel, Famy and Navam Capital. — Katherine Lewin UK government pours £20M into dementia trial accelerator: The new initiative aims to increase the number of participants in late-stage dementia studies to the tens of thousands and “address pharma-identified roadblocks” to running the trials. The Dementia Trials Accelerator’s objectives include creating a biomarker toolbox and extending trial enrollment to community settings. — Ayisha Sharma

INT2104 is a novel in vivo chimeric antigen receptor (CAR) gene therapy designed to generate CAR-T and CAR-NK cells in the patient’s body to target CD20-expressing malignant B cells Interim safety and proof-of-concept data to be presented at a scientific meeting in 1H 2025 PHILADELPHIA, PA, USA I October 23, 2024 I Interius BioTherapeutics , a clinical-stage company engineering targeted, programmable vectors for the precision delivery of genetic medicines, today announced that the first study participant has been dosed in INVISE, its first-in-human Phase 1 clinical trial of INT2104, a first-in-class gene therapy that delivers a CAR transgene to generate effector CAR-T and CAR-NK cells in vivo for the targeting of CD20-positive B cells for the treatment of B-cell malignancies. “Interius was founded with a sense of urgency to provide patients with a new therapeutic option that does not require preconditioning or long manufacturing and wait times. Interius’s breakthrough technology allows precise targeting of gene therapies to specific cells via intravenous administration,” said Interius President and CEO, Phil Johnson, M.D. “This milestone marks the first time that a durable in vivo CAR therapy has been used in the clinic. INT2104 has the potential to overcome ex vivo CAR therapy challenges with a single-dose, off-the-shelf, widely accessible therapy for the treatment of B cell malignancies enabled by Interius’s programmable platform. In our preclinical studies, we achieved successful B cell depletion in small and large animal models without chemotherapy and observed no signs of cytokine release syndrome (CRS) or neurotoxicity. We look forward to sharing interim clinical safety and proof-of-concept data at a scientific meeting next year.” Dr. Michael Dickinson, MBBS, FRACP, Lead of the Aggressive Lymphoma Disease Group at Peter MacCallum Cancer Centre and Royal Melbourne Hospital and INVISE Principal Investigator, added, “The need for new, accessible treatment options for patients with cancer is critical. Innovative approaches, like in vivo CAR gene therapies, have the potential to transform how we treat cancer, offering faster, single-dose solutions that are less burdensome on patients and treatment centres.” About INVISE INVISE (INjectable Vectors for In Situ Engineering) is a first-in-human Phase 1 clinical trial evaluating the safety of INT2104 intravenous infusion in adults with refractory/relapsing B cell malignancies. The study is a global, two-part, multicenter, open-label, single dose design with a dose escalation portion designed to inform the dose of INT2104 to be used in the dose confirmation part of the trial and future studies. INVISE has been granted Human Research Ethics Committee (HREC) approval and Clinical Trial Notification (CTN) clearance by the Australian Therapeutic Goods Administration (TGA). Additional information and enrollment criteria may be found on clinicaltrials.gov ( NCT06539338 ). About INT2104 INT2104 is a wholly-owned investigational gene therapy candidate, which specifically targets CD7-positive T and NK cells and delivers a CAR transgene to create effector CAR-T and CAR-NK cells in vivo . The CAR cells target CD20-positive B cells for the treatment of B cell malignancies. Unlike ex vivo CAR-T therapies, INT2104 is an off-the-shelf, single dose treatment, administered systemically through intravenous infusion without the need for lymphodepletion or for any special equipment or training. About Interius BioTherapeutics Interius BioTherapeutics is a clinical stage biotechnology company engineering targeted, programmable vectors for the precision delivery of genetic medicines to treat an array of challenging diseases in oncology, autoimmunity and beyond. Leveraging a proprietary platform, Interius has created a differentiated off-the-shelf therapeutic modality designed for broad patient access. The Company’s lead programs aim to overcome the current limitations of ex vivo chimeric antigen receptor (CAR) T-cell therapy by creating therapeutic CAR cells directly in the patient’s body, avoiding preconditioning chemotherapy, manufacturing bottlenecks, and high costs. For more information, visit www.interiusbio.com and follow us on LinkedIn . SOURCE: Interius BioTherapeutics