Gallium Dotatate Ga-68

Telix already has an FDA-approved imaging agent, a gallium-68 gozetotide injection marketed under the brand name Illuccix. Image credit: Shutterstock / Ezume Images. A day after announcing a $400m convertible bond offering, Telix Pharmaceuticals has had a new drug application (NDA) accepted by the US Food and Drug Administration (FDA) for prostate cancer imaging agent TLX007-CDx. The agency has set a prescription drug user fee act (PDUFA) goal date of 24 March 2025, as per a 24 July press release. Radiopharmaceutical specialist Telix said its objective is to further enhance patient access to prostate-specific membrane antigen (PSMA) PET imaging. PSMA is a protein specific to prostate cancer cells, and the test can detect increased areas of its uptake in cells by linking it with a radioisotope. The technique is seen as superior to conventional imaging methods for prostate cancer tracking, but issues with accessibility and regulatory requirements mean many prostate cancer patients do not undergo the scan. Telix’s TLX007-CDx is a so-called “cold kit” to prepare PSMA-PET imaging. The Australia-based company said the kit can help with PSMA imaging product utilisation at locations that are not close to a nuclear pharmacy, a requirement for many current gallium-68 agents. See Also: Agilent agrees to acquire BIOVECTRA for $925m Ergomed sees highest patent filings and grants during May in Q2 2024 There are currently around 350-450 certified nuclear pharmacists in the US. Cardinal Health operates the largest radiopharmaceutical network in the country. The kit is designed to facilitate more flexible production and includes higher activity gallium-68. Telix already has an FDA-approved imaging agent, a gallium-68 gozetotide injection marketed under the brand name Illuccix. The company’s group CEO Dr Christian Behrenbruch said the filing acceptance for the cold kit is a step towards “improving equity of access”. Behrenbruch added: “We now look forward to working with the FDA to bring TLX007-CDx to American men living with prostate cancer, including those residing in underserved communities and regions where access to state-of-the-art imaging remains limited.” As Telix waits for the FDA review, it has set its sights on label expansions for its other diagnostic imaging agents. On 23 July, Telix offered $398m in convertible bonds , which will be used to fund the necessary studies and pivotal trials for kidney and brain cancer therapy programmes. Currently listed on the Australian Securities Exchange, Telix had been planning on going public on Nasdaq earlier this year. The company U-turned on the IPO , however, citing market conditions at the time. Eli Lilly has joined Telix in the growing radiopharmaceutical space, acquiring POINT Biopharma in a $1.4bn deal in October 2023. The drugmaker then partnered with Radionetics Oncology in a $140m deal earlier this month, which included an exclusive option to acquire the partner for $1bn. Bristol Myers Squibb and Novartis have also conducted their own radiopharma acquisitions for $4.2bn and $1.75bn respectively in the past year.

Evotec, LegoChem Biosciences and Daiichi Sankyo have all signed up to collaborate with Glycotope. Radiopharmaceutical company Pentixapharm is picking up fellow Germany-based Glycotope's target discovery unit for an undisclosed sum in order to double its pipeline courtesy of a portfolio of preclinical cancer antibodies. The assets are aimed at various oncology targets and could be turned into radiopharmaceuticals, Pentixapharm said in a July 3 release. The deal will also see the company take ownership of Glycotope’s labs, cell banks and tumor target database as well as “the equipment needed to exploit the discovery platform, along with a range of patents, licenses, and other tangible assets.” “In total, Pentixapharm will be able to add an integrated team of 40 seasoned executives, R&D specialists, and administrators to its staff,” Pentixapharm said. The release made no mention of the financial terms of the deal. Pentixapharm’s current therapeutic pipeline consists solely of PentixaTher, a CXCR4 cytokine receptor in a phase 1/2 trial for patients with lymphoma affecting the central nervous system. The biotech also has a gallium-68 PET imaging agent being tested in non-Hodgkin B-cell lymphoma and a hypertension-related condition called primary aldosteronism. “The acquisition will broaden Pentixapharm’s intellectual property portfolio beyond the one built around the CXCR4 receptor,” Pentixapharm CEO Hakim Bouterfa said in today’s release. “Glycotope’s pipeline comprises several candidates that can be used immediately for proof-of-concept studies as next generation radiopharmaceuticals,” Bouterfa added. “We look forward to maximizing the synergy of Pentixapharm’s know-how and Glycotope’s target discovery for the benefit of patients in both diagnostics and therapeutic applications.” Pentixapharm is owned by Eckert & Ziegler (EZAG), a specialist in isotope-related components used for nuclear medicine and radiation therapy. But the company’s plans involve detaching from its parent company and listing on the Frankfurt Stock Exchange. “The transaction provides Pentixapharm not just with a chance to build a clinical pipeline beyond the company’s current CXCR4-ligand based programs, but also substantially strengthens its administrative and managerial capacities,” Andreas Eckert, chairman of the supervisory board of both Pentixapharm and EZAG, said in the same release. “The offices and laboratories included in the deal are large enough to allow a consolidation of all Berlin-based activities into one location.” As part of the acquisition, Bouterfa will move across to the biotech’s supervisory board, with current Chief Medical Officer Dirk Pleimes, M.D., taking on the CEO role. Glycotope’s chief scientific officer Patrik Kehler will take up the same role at Pentixapharm. At Glycotope, Kehler and his team have been working on tumor-associated carbohydrate structures, so-called GlycoTargets. Due to the greater ability to target tumors when compared to conventional antibodies, the company’s hope had been to “close the treatment gap that exists for the majority of solid tumors,” Kehler said in the release. The radiopharma space has seen a frenzy of dealmaking since the end of last year, with Eli Lilly making its latest move earlier this week via a $140 million partnership with Radionetics Oncology. Pentixapharm is far from the first company to see potential in Glycotope’s tech. Evotec, LegoChem Biosciences and Daiichi Sankyo have all signed up to collaborate with the German biotech.