Theragnostics, Inc.

Braintree,  MA 
United States
https://theragnostics.com

• Booth: 144

Theragnostics is a radiopharmaceutical company focused on developing new diagnostics and therapeutics for the oncology market.  Our mission is to drive innovation in the fight against cancer by enhancing patients’ lives with precision radiopharmaceuticals.  Our lead drugs are radiolabeled PARP inhibitors where we can bring radioactive decay directly to the DNA.

Our therapeutic is entering a Phase 1 trial later this year where we are combining our PARPi with ¹²³I to use the power of Auger emissions to treat cancers.  Auger emissions have not been used as a therapeutic to date, however, with our drug binding directly to the DNA, we can use the power of Auger emission to kill cancer cells while also having a better safety profile compared to other leading radiopharmaceutical therapeutics that use Alpha or Beta emissions.

Theragnostics received FDA approval in February 2022 for NephroScan^TM, Kit for the Preparation of Technetium Tc 99m Succimer Injection (^99mTc-DMSA).  In 2021, Theragnostics out licensed it’s single step PSMA kit IP to AAA for their product LOCOMETZ®.

Please visit our booth, #144, if you are interested in learning more about Theragnostics, our pipeline or NephroScan^TM.

 Press Releases

• On 18 Feb 2022, FDA approved NephroScan (Tc-99m DMSA) in adults and pediatrics (May 10, 2022)

  Theragnostics Announces US FDA Approval for its Radiodiagnostic Imaging Drug NephroScan^TM (Kit for the Preparation of Technetium Tc 99m Succimer Injection)

  • NephroScan is now US FDA approved for the preparation of Tc-99m DMSA
  • NephroScan aids in the detection of kidney cortical defects in adult and pediatric patients, including term neonates
  • GE Healthcare to commence distribution in the US
  • Manufactured by ROTOP Pharmaka in Germany

  LONDON, UK, 22 February 2022 – Theragnostics announces that NephroScan, its radiodiagnostic imaging drug used as an aid for the evaluation of renal parenchymal disorders in adult and pediatric patients, including term neonates, has received Marketing Approval by the US Food and Drug Administration (“FDA”).

  NephroScan, a proprietary kit for the preparation of technetium Tc 99m succimer injection, is Theragnostics’ first FDA approved drug.  It is manufactured by ROTOP Pharmaka GmbH in Germany.  GE Healthcare, a global leader in molecular imaging, serves as the exclusive distributor of the product in the United States and the product is now available for ordering.

  Greg Mullen, President and Chief Executive Officer of Theragnostics, said: “The FDA approval of NephroScan is a significant milestone for Theragnostics and for patients who are affected by kidney disease. NephroScan enables the detection and diagnosis of kidney disease, enabling physicians, patients, and their families to help make informed treatment decisions. The approval has been a remarkable team effort in collaboration with the regulatory development group at Facet Life Sciences and the specialists for radiopharmaceutical development and manufacturing at ROTOP Pharmaka GmbH.”

  Dr. Ted Treves, Professor of Radiology at Harvard Medical School and former Chief Division of Nuclear Medicine at Boston Children’s Hospital said: “The value of Tc-99m DMSA is well established in the assessment of disorders affecting the kidneys in children and adults. The approval in the US means that Tc-99m DMSA imaging will be brought back as a useful tool for the evaluation of adult and pediatric patients affected by renal diseases. Efforts are underway for renewed education of referring physicians about its value and the Society of Nuclear Medicine and Molecular Imaging (SNMMI) practice guidelines have recently been updated¹.”

• Theragnostics awarded Innovation Passport from UK's MHRA for treatment of Glioblastoma (May 10, 2022)

  Theragnostics Announces that its Radiotherapeutic for Treatment of Glioblastoma Multiforme has been Awarded UK’s MHRA Innovation Passport

  • Promising non-clinical results support Phase 1 clinical study in recurrent GBM
  • Commitment to ensuring I-123 PARPi is available to treat the unmet medical need of patients diagnosed with primary and recurrent GBM

  LONDON, UK, 10 February 2022 – Theragnostics, which is developing radiopharmaceuticals for imaging and treatment of cancer, today announces that its novel I-123 PARPi (THG-009) therapeutic agent has been awarded an Innovation Passport by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of primary and recurrent Glioblastoma Multiforme (GBM). This is provided under the MHRA’s Innovative Licensing and Access Pathway (ILAP) which was launched in January 2021 to accelerate development and access to innovative medicines in the UK.

  Theragnostics is developing I-123 PARPi for the treatment of primary and recurrent glioblastoma. Glioblastoma has a high rate of recurrence in patients of approximately 90% and has a poor overall prognosis of survival of less than 2 years in most patients. There have been no new agents approved for this indication in the last 15 years. Theragnostics’ early non-clinical data have demonstrated promising results which support progression of I-123 PARPi into a Phase 1 clinical study in recurrent GBM.

  The Innovation Passport is awarded to companies developing therapeutics for conditions that are life-threatening or seriously debilitating and has the potential to offer significant benefits to patients. It acts as the gateway to enter the ILAP and is a new medicine designation. The next step in the pathway is the preparation of a target development profile (TDP) document by the MHRA, National Institute for Health and care Excellence (NICE) and the Scottish Medicines Consortium (SMC). The TDP is a ‘living document’ which sets out the regulatory and development milestones, finds potential pitfalls and creates a roadmap to achieving early patient access in the UK. The TDP can aid pharmaceutical companies with clinical trial design and evidence generation.

  Dr Greg Mullen, Chief Executive Officer of Theragnostics, said: “The Innovation Passport will allow us to work closely with the MHRA and its partner agencies to chart out a roadmap for regulatory and key development milestones with the primary goal of achieving early patient access for the treatment of glioblastoma.”