IsoTherapeutics Group LLC

Illuccix is used for PET imaging to detect PSMA-positive lesions in male prostate cancer patients. Credit: Korawat photo shoot/Shutterstock. Health Canada has expanded the approved use of Telix Pharmaceuticals’ Illuccix for patient selection in prostate-specific membrane antigen (PSMA) targeted radionuclide therapy. This label expansion allows Illuccix, a gallium Ga 68 gozetotide injection kit, to be used for identifying progressive metastatic castration-resistant prostate cancer (mCRPC) patients eligible for lutetium (177Lu) vipivotide tetraxetan treatment, also known as Pluvicto. Since October 2022, Illuccix has been authorised in Canada for staging and re-staging intermediate and high-risk prostate cancer and pinpointing tumour tissue in recurrent cases. The latest approval enhances the clinical applications of Illuccix, which is distributed by Isologic Innovative Radiopharmaceuticals, reaching 265 hospitals and clinics across the country. Telix Precision Medicine CEO Kevin Richardson stated: “We welcome Health Canada’s decision to expand the label for Illuccix. This will further improve access to advanced prostate cancer imaging and provide doctors with critical information to help make treatment decisions with confidence. See Also: NUHS’s CD7 CAR-T cell therapy shows promise for leukaemia Editas trades part of Vertex CRISPR therapy licencing rights deal for $57m “This reflects Telix’s ongoing commitment to supporting patients with cancer and empowering the doctors who care for them across more stages of the patient journey.” Illuccix, post radiolabelling with gallium (68Ga), is indicated for positron emission tomography (PET) imaging of PSMA-positive lesions in men with prostate cancer. The indications include cases with suspected metastasis who are candidates for initial definitive therapy, suspected recurrence based on elevated serum prostate specific antigen (PSA) levels, and now, for identifying mCRPC patients for whom PSMA-targeted therapy is indicated. Isologic president André Gagnon stated: “PSMA-targeted theranostics are widely considered to be the future of prostate cancer treatment. It is therefore tremendous that we can now offer Illuccix in this additional setting, for patients who are candidates for PSMA-targeted therapy, through our national network.” In February 2024, Telix reached an agreement to buy US-based speciality radiopharmaceutical development and bioconjugation company IsoTherapeutics.

The acquisition expands Telix’s North American manufacturing footprint. Credit: Pixels Hunter via Shutterstock. Telix Pharmaceuticals has bought US-based radioisotope manufacturer RLS Radiopharmacies to expand its manufacturing footprint in the US. The acquisition will cost the Australian radiopharma company $230m upfront, with an additional $20m tied to milestone payments. In return, Telix will gain 31 of RLS’s licensed radiopharmacies across the US, establishing a radiometal production and distribution network for key therapeutic and diagnostic isotopes, along with last-mile delivery of finished doses to target markets. Telix plans on deploying its isotope production platform, QUANTM Irradiation System (QIS) cyclotron, across its new radiopharmacies. Telix inherited the technology from Canadian company ARTMS, which it acquired in March 2024. The system produces medical isotopes used in Telix’s drug candidates such as zirconium-89 (89Zr), copper-64 (64Cu), and gallium-68 (68Ga). One of Telix’s lead candidates is the US Food and Drug Administration (FDA)-approved Illuccix (gallium-68 gozetotide), used for prostate cancer imaging. Telix was in the news last quarter when it abandoned a proposed listing on Nasdaq , citing “market conditions” at the time as the reason. The company first shared its IPO plans in January 2024 and was predicted to increase up to $232m via American depository shares (ADSs), as per a SEC filing. Despite Telix’s U-turn, 2024 has seen a slow increase in the number of biotechs going public. This includes drugmakers Bicara Therapeutics , Zenas BioPharma, and MBX Biosciences, who all went public on Nasdaq this month. The radiopharma arena is gaining interest, with several high-profile deals spotlighting its therapeutic promise. Eli Lilly sealed its interest in the space with a $1.4bn acquisition of POINT Biopharma in October 2023. The pharma giant also acquired radiopharmaceutical company Radionetics Oncology in July 2024 for $140m, reinforcing its status in the space. See Also: Takeda’s FRUZAQLA approved in Japan for advanced colorectal cancer FDA approves UCB’s BIMZELX for multiple inflammatory conditions The largest deal was seen by Bristol Myers Squibb in December 2023 when it signed a definitive agreement for the acquisition of all of the outstanding shares of common stock of RayzeBio, costing nearly $4.1bn . Novartis is also a major player in the field, making its own radiopharma acquisition of Mariana Oncology for $1.75m in May 2024. As the space continues to boom, experts in the space have raised challenges in the manufacture and logistics of this drug class. The short half-lives of isotopes mean that sophisticated infrastructure is required for development. Telix’s CEO Christian Behrenbruch said: “Our vision is to build a radiometal production and distribution network fit for the future. By combining the ARTMS platform and the RLS network, we can scale up the production of key isotopes and build a stable and consistent supply of PET and SPECT diagnostic tracers, along with therapeutic radiopharmaceuticals across the US for the benefit of Telix, our partners and the patients we serve.” The acquisition is expected to close in Q1 2025. After that, RLS will operate independently under Telix Manufacturing Solutions (TMS), which includes other brands such as IsoTherapeutics and Optimal Tracers. Telix acquired speciality radiopharmaceutical development and bioconjugation company IsoTherapeutics in February 2024.

Australian radiopharma company Telix Pharmaceuticals is acquiring radioisotope manufacturer RLS Radiopharmacies in another move to expand its presence in the US. Telix is budgeting $230 million up front for the purchase and potentially another $20 million in milestone payments. In exchange, Telix will take on RLS’ 31 radiopharmacies, designed to make and distribute clinical and commercial radiotherapies, located across 18 US states. Telix will also acquire RLS’ 100,000 square feet of space for future expansions, according to a Monday release. The acquisition is set to close in the first quarter of 2025, after which RLS will still operate and serve its existing customers as a standalone business. Wall Street analysts believe this is a move for Telix to solidify its identity as a radiopharma manufacturer and expect the company to further boost its capacity for isotope production. By combining Telix’s manufacturing platform and RLS’ radiopharmacy network, Telix is aiming to scale up production of isotopes and radiotherapies, as well as improve the supply of diagnostic devices such as PET scans, Telix’s CEO Christian Behrenbruch said in a statement. Telix plans on integrating a technology platform for rare metal and isotope production across each of the 31 radiopharmacies. Telix just bought such technology when it acquired the Canadian company ARTMS in March. RLS has a range of radiopharma-related services. It recently expanded into gallium-68 production for PET scans via a partnership with Eckert & Ziegler announced in April. RLS also has CDMO services, recently expanding its in-house manufacturing at eight of its 31 sites in October last year. When Telix’s purchase is closed, RLS will operate independently under Telix Manufacturing Solutions, an umbrella brand that includes other manufacturers like IsoTherapeutics. Telix acquired radiochemistry and bioconjugation manufacturer IsoTherapeutics in April this year. As a part of Telix’s recent spending spree, in May it also snapped up the cancer radiopharma company QSAM Biosciences and its clinical pipeline. QSAM’s lead radiopharma asset is called samarium-153-DOTMP for pain management in patients with bone metastases and osteosarcoma. The radiopharma space is heating up with many players making moves to increase their pipelines and manufacturing capacity. Earlier this month, Sanofi spent $110 million in licensing deals with RadioMedix and Orano Med. Novartis allocated $1 billion to buy Mariana Oncology, according to a May announcement. Other pharma companies like AstraZeneca , Bristol Myers Squibb and Eli Lilly have also expanded their respective stakes in radiotherapies.