Orchid Pharma Ltd.

The funding will support the commercial launch of the company’s Phase III lead candidate, ITM-11, for cancer. Credit: Lightspring / Shutterstock. ITM Isotope Technologies Munich (ITM) has secured an investment of €188m ($204.6m) aimed at bolstering its radiopharmaceutical pipeline. Recommended Buyer's Guides Buyer's Guide Leading Guide to Compliance Software for the Pharmaceutical Industry Buyer's Guide Leading Guide to Clinical Packaging Companies in contract Manufacturing for the Pharmaceutical Industry Global investment company Temasek spearheaded the funding round with contributions from entities managed by BlackRock , the Qatar Investment Authority (QIA), ATHOS and Carbyne. The funding will be channelled towards advancing and broadening ITM’s radiopharmaceutical pipeline, supporting the development platform and commercially launching its Phase III lead candidate, ITM-11 (n.c.a. 177 Lu-edotreotide). The asset is currently under evaluation in two Phase III trials, COMPETE and COMPOSE, for the treatment of gastroenteropancreatic neuroendocrine tumours. The investment will enable ITM to bolster its manufacturing capabilities for Lutetium-177 ( 177 Lu) and expand its production to include other high-value medical radioisotopes such as Actinium-225 ( 225 Ac). See Also: FDA recommends updated Covid-19 vaccines targeting JN.1 India’s DCGI approves Orchid Pharma’s API Enmetazobactam As part of the expansion, the company will also supply the in-demand medical radioisotopes to its extensive global network and utilise them to diversify its radiopharmaceutical therapy pipeline. This strategy is designed to address a variety of challenging cancer indications. ITM CEO Steffen Schuster stated: “The additional equity and continued collaboration with our existing, industry-specialised investors emphasises their confidence in our ability to drive value for the radiopharmaceutical field through our unmatched manufacturing capabilities and innovative precision oncology pipeline. “We have reached key milestones since our last financing round including advancing our pipeline with novel targets in multiple oncology indications, opening our NOVA facility, launching Actineer with CNL for the joint production of Actinium-225 and entering several high-value supply agreements for Lutetium-177. “As we continue growing as an organisation, our focus remains on bringing the significant therapeutic benefits of radiopharmaceutical therapy to as many patients worldwide as possible and we are thankful for the additional financing which will support us on this path.”

The treatment is indicated for use in adults with low to intermediate-1 risk myelodysplastic syndromes with transfusion-dependent anaemia. Credit: LindseyRN / Shutterstock. The US Food and Drug Administration (FDA) has granted approval for Geron ’s RYTELO (imetelstat) for adults with low to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anaemia. Recommended Buyer's Guides Buyer's Guide Leading Guide to Packaging Materials, Containers and Containment Services for the Pharmaceutical Industry Buyer's Guide Top Guide for Drug Delivery Systems The approval marks a significant milestone for patients requiring red blood cell transfusions four or more times over eight weeks and who are unresponsive to, have lost response to, or are not eligible for erythropoiesis-stimulating agents. The FDA’s decision is grounded in the positive results from the IMerge Phase III clinical trial. RYTELO demonstrated a significant increase in red blood cell transfusion independence compared to placebo. The trial’s primary and key secondary endpoints were met, showcasing RYTELO’s ability to provide durable and sustained responses for patients with MDS. See Also: FDA recommends updated Covid-19 vaccines targeting JN.1 India’s DCGI approves Orchid Pharma’s API Enmetazobactam In the trial, the safety profile of RYTELO was well-characterised with the most common adverse reactions being manageable cytopenias. Neutropenia and thrombocytopenia were the most frequent Grade 3/4 side effects, typically resolving within a short timeframe Geron chairman and CEO John Scarlett stated: “With the approval and availability of RYTELO, we believe eligible patients with lower-risk MDS can potentially experience meaningful clinical benefit, particularly the potential for greater than 24 weeks of freedom from the burden of red blood cell transfusions and symptomatic anaemia. “The approval of RYTELO as the first telomerase inhibitor is a testament to the power of our science and the passion of our people to innovate in the field of blood cancer. As we celebrate the momentous milestone, I would like to thank the patients and families, advocates, clinicians, study coordinators, site personnel, scientists and Geron employees and collaborators past and present whose participation was integral to this achievement and to supporting our transformation into a commercial company.” In March 2024, advisers to the US Food and Drug Administration (FDA) defended Geron‘s imetelstat, saying that the benefits outweighed the risks associated with the treatment , based on data from Phase III IMerge trial in MDS patients.

Osteal antibiotic joint spacer aims to treat periprosthetic joint infection. Image credit: Shutterstock / Kateryna Kon. Osteal Therapeutics has raised $50m in Series D financing, as the orthopaedic infection treatment specialist turns its eyes to a regulatory submission for its lead candidate VT-X7. Recommended Buyer's Guides Buyer's Guide Leading Guide to Packaging Materials, Containers and Containment Services for the Pharmaceutical Industry Buyer's Guide Leading Guide to Clinical Packaging Companies in contract Manufacturing for the Pharmaceutical Industry Medtech giant Zimmer Biomet led the round with participation from existing investors, including Johnson & Johnson Innovation, among others. The funds, which follow $23m raised in Series C financing in late 2023, will be used for a new drug application (NDA) to the US Food and Drug Administration (FDA) for VT-X7. Proceeds will also go towards advancing the US-based company’s musculoskeletal portfolio , according to a 5 June press release. Osteal has designed VT-X7 for the treatment of periprosthetic joint infection. The condition is a complication of joint replacement surgery in which bacteria infiltrate the joint implant. This causes biofilms, a layer of microorganisms that are hard to treat. VT-X7 is a drug/device combination product, consisting of antibiotic drugs vancomycin hydrochloride and tobramycin sulfate for irrigation and the VT-X7 irrigation system. The therapy works by placing a spacer connected to an irrigation pump. Antibiotics are then administered into the joint space through the spacer for seven days of treatment. See Also: FDA recommends updated Covid-19 vaccines targeting JN.1 India’s DCGI approves Orchid Pharma’s API Enmetazobactam Osteal says the product can deliver high antibiotic concentrations at the infection site and is effective against both gram-negative and gram-positive bacteria. The company’s candidate has breakthrough therapy, orphan drug, fast track, and qualified infectious disease product designations, indicating that the company is eligible for a range of benefits on expedited regulatory pathways. VT-X7 recently demonstrated positive results in a Phase III trial, named APEX-2 (NCT05607030). The trial, which enrolled 76 patients scheduled for a two-stage exchange arthroplasty due to hip or knee periprosthetic joint infection, met its primary endpoint of treatment success after 180 days. The trial is expected to end in late 2024, at which point Osteal said it will seek FDA approval. Osteal’s CEO David Thompson said: “This round of financing represents an inflection point in the company’s progress towards introducing VT-X7 to the market.”