Telix Pharmaceuticals (ASX:TLX) has announced new collaborations and studies of its investigational technologies.
The company announced a pan-cancer clinical collaboration with German-based global biopharmaceutical company Merck KGaA.
The companies will conduct combination studies with one of Merck’s investigational proprietary DNA Damage Response Inhibitor (DDRi) molecules in combination with each of Telix’s TLX591 (177Lu-rosopatamab) and TLX250 (177Lu-girentuximab) molecularly-targeted radiation (MTR) therapeutic programs.
TLX591 and TLX250 are late-stage products in development for prostate and renal cancer therapy. Telix said that under the terms of the collaboration, and based on encouraging preclinical data derived from the initial strategic research collaboration, the two companies have agreed to investigate the synergy of these investigational assets with Merck’s DDRi compound across a wide variety of oncology indications in the clinic.
Telix also announced an extension to its partnership with AusHealth on the novel theranostic APOMAB that is being investigated in lung and ovarian cancers.
Telix said it has exercised an option granted in 2019 to in-licence the antibody. Its decision was based on encouraging preliminary clinical data from a Phase 1 imaging study that forms part of the current academic collaboration.
APOMAB is an antibody targeting the La/SSB protein that is expressed by cancer cells treated with chemotherapy and/or radiation. It is the subject of an ongoing clinical study being conducted by the Central Adelaide Local Health Network, led by Royal Adelaide Hospital Cancer Clinical Trials Unit Head, Professor Michael Brown.
This proof-of-concept study is initially using zirconium-89 labelled antibody (89Zr-APOMAB) to evaluate the biological properties and safety of the agent using positron emission tomography imaging.
Telix has also announced a number of new studies.
The London-based Great Ormond Street Hospital (GOSH) has received UK research ethics approval to commence a Phase 2 academic study of Telix’s investigational product, TLX66 (90Y-DTPA-besilesomab), in children with high-risk leukaemia.
The open-label study will evaluate the safety and efficacy of TLX66 as part of a reduced toxicity conditioning regimen in children and adolescents undergoing allogeneic haematopoietic stem cell transplantation.
Two investigator-led studies will be launched to evaluate the potential utility of the company’s late-stage imaging portfolio in women’s health, initially in two sub-types of breast cancer with a significant unmet medical need.
The company said both TLX591-CDx and TLX250-CDx have potential utility in breast cancer imaging, particularly for specific phenotypes that are not consistently well imaged using existing techniques.
A first patient has been dosed in a proof-of-concept study using TLX591-CDx (Kit for the preparation of 68Ga-PSMA-11 injection) for the detection of occult metastases of lobular breast cancer (also called invasive lobular carcinoma, or ILC). The study is led by Dr David Schuster at Winship Cancer Institute of Emory University and will recruit 20 patients over two years.
The Phase 2 OPALESCENCE study will evaluate Telix’s TLX250-CDx (89Zr-DFO-girentuximab) in patients with triple-negative breast cancer (TNBC).
The objective is to evaluate the feasibility of using TLX250-CDx PET/CT to detect CA9 expression as the basis of a potential future therapeutic strategy for TNBC. The study will be led by Dr Caroline Rousseau at the Institut de Cancérologie de l’Ouest in St Herblain, France, and will recruit 12 patients.
The company also announced two ancillary studies under the ProstACT program, including a Phase 2 study in collaboration with GenesisCare, that will evaluate TLX591 into areas of unmet medical need across the full prostate cancer treatment journey.
The two additional studies will run alongside the Phase 3 ProstACT GLOBAL study. Telix said the expanded ProstACT study program scope will enable it to evaluate the efficacy and safety of prostate-specific membrane antigen targeted lutetium therapy in early-stage, localised disease all the way through to advanced metastatic disease.