PharmaLogic Successfully Delivers First Dose for Novel Radiopharmaceutical in Sarcoma Study

PharmaLogic's Milestone in Radiopharmaceutical Supply for Sarcoma Treatment

PharmaLogic Holdings Corp., a prominent player in the contract development and manufacturing organization (CDMO) sector specializing in radiopharmaceuticals, has recently achieved a significant milestone. The company announced the successful supply of the first dosing cohort of Ratio Therapeutics' investigational FAP-targeted radiopharmaceutical [Ac-225]-RTX-2358 for the ATLAS trial, a clinical study aimed at treating late-stage aggressive sarcomas. This achievement underscores PharmaLogic's commitment to advancing innovative cancer treatments and improving patient outcomes.

The ATLAS Trial: Objectives and Methodologies

The ATLAS trial, identified with the clinicaltrials.gov number NCT07156565, is structured as a Phase 1/2 open-label clinical trial. It aims to evaluate the safety, tolerability, dosimetry, biodistribution, pharmacokinetics, and initial anti-tumor activity of the FAP-targeted radiopharmaceutical in patients suffering from relapsed or refractory soft tissue sarcomas that express fibroblast activation protein (FAP).

The trial is divided into two main phases: an ascending administered activity phase (Phase 1) and an expansion phase (Phase 2). Initially, participants eligible for treatment will undergo assessments of FAP expression using a [Cu-64]-LNTH-1363S PET scan. Those found to be FAP positive will receive intravenous injections of [Ac-225]-RTX-2358 every eight weeks for up to six treatment cycles spanning a year. The design follows a standard 3+3 dose escalation model, wherein participants are assigned to one of three groups, with each group receiving progressively higher dose levels. This strategy aims to determine the maximum tolerated dose and establish a recommended dosage for the subsequent expansion phase.

During Phase 1, a maximum of 10 patients can be treated in each cohort, with 26 patients planned for evaluation. This careful approach allows for thorough characterization of both safety and tolerability while also assessing preliminary efficacy. Importantly, the safety data from each group will be reviewed by an independent Safety Review Committee before proceeding with dose escalations.

In Phase 2, the study will evaluate the efficacy and safety of [Ac-225]-RTX-2358 in up to 50 patients.

PharmaLogic's Commitment to Innovation

Etienne Montagut, the President and CEO of PharmaLogic, expressed pride in the successful collaboration with Ratio Therapeutics and the advancement of [Ac-225]-RTX-2358 into clinical trials. The first cohort doses delivered from their Bronx facility mark a significant step in their commitment to supporting the development and accessibility of innovative radiopharmaceutical therapies globally. PharmaLogic is dedicated to ensuring that patients have access to cutting-edge treatment options and collaborating with industry innovators in the field.

About PharmaLogic Holdings Corp.

PharmaLogic is recognized as a premier global CDMO focusing on diagnostic and therapeutic radiopharmaceuticals. The company boasts decades of experience and a vast network consisting of over 45 facilities across the United States, Puerto Rico, Canada, and Norway. These resources enable PharmaLogic to deliver comprehensive solutions that span development, manufacturing, and distribution of both clinical and commercial-stage radiopharmaceutical products, always adhering to the highest quality and regulatory standards. Their expanding diagnostics arm leverages state-of-the-art technologies to enhance how patients access advanced diagnostics in oncology, cardiology, and neurology. Furthermore, PharmaLogic, as the only cGMP-compliant CDMO worldwide, currently produces and distributes a commercial radiopharmaceutical therapeutic to more than 30 countries.

Conclusion

With the ATLAS trial underway and efforts to enhance patient access to groundbreaking therapies, PharmaLogic's latest achievement reflects its ongoing commitment to reshaping the future of oncology treatments. As the company continues its research and collaborations, it remains poised to play a crucial role in advancing radiopharmaceuticals and addressing critical medical needs.

For further information, visit their website at radiopharmacy.com or connect with them on LinkedIn.