Perspective Announces Presentation of Positive Early Clinical Data for VMT-α-NET at the 36th Annual Congress of the European Association of Nuclear Medicine

Rhea-AI Summary

Perspective Therapeutics presents encouraging early clinical results for [212Pb]VMT-α-NET therapy in patients with neuroendocrine tumors and medullary thyroid carcinomas. Initial response seen in 7 out of 9 evaluable patients. Responses observed in both PRRT-naïve and PRRT-refractory disease. No significant adverse events observed. Potential for expansion into other indications.

Positive

• Encouraging initial response rate of [212Pb]VMT-α-NET therapy in patients with neuroendocrine tumors and medullary thyroid carcinomas
• Improvements in patients' symptoms and quality of life
• No significant adverse events observed

Negative

• None.

• Ten patients received therapy, with an initial response seen in 7 out of 9 evaluable patients to date.
• Responses observed in both peptide receptor radionuclide therapy-naïve and peptide receptor radionuclide therapy-refractory disease.
  
  

SEATTLE, Wash., Sept. 12, 2023 (GLOBE NEWSWIRE) --  Perspective Therapeutics, Inc. (“Perspective” or “the Company”) (NYSE AMERICAN: CATX), today announced the presentation of encouraging early clinical results from an open-label, single-arm, investigator-initiated study investigating the safety and efficacy of [²¹²Pb]VMT-α-NET, ​a targeted alpha therapy (TAT), in patients with metastatic neuroendocrine tumors (NETs) and medullary thyroid carcinomas. The results were presented at the 36th Annual Congress of the European Association of Nuclear Medicine (EANM), held in Vienna, Austria, from September 9-13, 2023.

Highlights of the presented results include:

• Ten patients who failed at least 1 prior line of standard of care therapy have received [²¹²Pb]VMT-α-NET therapy to date, with initial responses observed in 7 of 9 evaluable patients. Responses were observed across both peptide receptor radionuclide therapy (PRRT)-naïve and PRRT-refractory disease. Of the 10 patients enrolled in the study, 3 presented with gastrointestinal NETs, 5 presented with pancreatic NETs, and 2 presented with medullary thyroid carcinoma. Four patients (1 with gastro-intestinal NETs; 3 with pancreatic NETs) were previously treated with [¹⁷⁷Lu]DOTATATE PRRT, one of which also received 3 prior administrations of [²²⁵Ac]DOTATATE.
  
  
• Improvements in patients’ symptoms and quality of life trended strongly positive with consecutive [²¹²Pb]VMT-α-NET doses.
  
  
• No significant renal or hepatic function adverse events have been observed to date​. Most adverse events were mild and included Grade 1 anemias, alopecia, and fatigue, which usually resolved within 1 week of [²¹²Pb]VMT-α-NET administration. Two patients experienced serious adverse events (SAEs) that were deemed unrelated to [²¹²Pb]VMT-α-NET treatment. One patient who developed myelodysplastic syndromes (MDS) discontinued treatment and the other patient, who was heavily pre-treated, died (patient was deemed not evaluable).
  

“We have safely administered a total of 25 doses of [²¹²Pb]VMT-α-NET across the 10 patients enrolled in the trial, with two of these patients having received all 4 doses to date,” commented Dr. Dharmender Malik, Consultant Nuclear Medicine and PET-CT, MBBS, DNB, FANMB & RSO-II, at the Fortis Memorial research institute (FMRI), Gurugram India. “[²¹²Pb]VMT-α-NET shows encouraging initial efficacy and safety across different neuroendocrine and medullary thyroid tumor types in patients who failed prior lines of therapy, including standard of care [¹⁷⁷Lu]DOTATATE, and [²²⁵Ac]DOTATATE.”

"While still early, these initial high objective response rates are promising in light of the 13% response rate for LUTATHERA® (www.novartis.com/us-en/sites/novartis_us/files/lutathera.pdf, Table 8). We are especially encouraged by the responses at low [²¹²Pb]VMT-α-NET activity doses as these are in the starting range of our IND-enabled dose escalation study which is currently screening patients in the US,” said Thijs Spoor, Chief Executive Officer at Perspective. “Additionally, these early responses among multiple tumor types suggest the potential to expand into other indications including small cell lung cancers, meningiomas, pheochromocytomas, paragangliomas, and neuroblastomas – especially given the compelling preclinical neuroblastoma [²¹²Pb]VMT-α-NET therapy data presented at EANM on Sunday. We will continue to monitor patients’ progress, and we look forward to providing a more extensive data readout in the upcoming quarters.”

About the study
Ten adult subjects with histologically confirmed NETs and metastatic medullary thyroid carcinomas who failed at least one prior line of treatment were treated as part of a compassionate use program. All patients were planned to receive [²¹²Pb]VMT-α-NET peptide at intervals of 8 weeks up to 4 doses or until evidence of radiographic progression, unacceptable toxicity or the patient’s decision to discontinue. ​All patients were to be co-infused with an amino acid solution for renal protection. The primary objective of the study is to evaluate the safety of low doses of [²¹²Pb]VMT-α-NET in this patient population. Secondary assessments will include objective response rate measured by RECIST 1.1 criteria, and the number of patients with treatment-related adverse events as assessed by CTCAE v.4.0​. Both will be measured at 24 months after the last administered dose of [²¹²Pb]VMT-α-NET. Isotope was provided using Perspective’s proprietary VMT-α-GEN generator.

About VMT-α-NET
VMT-α-NET is being developed for the treatment and diagnosis of somatostatin receptor subtype 2 (SSTR2) expressing neuroendocrine tumors, which are a rare and difficult-to-treat type of cancer. The dosed patients were diagnosed with confirmed-advanced somatostatin expressing NETs. In early December 2022, VMT-α-NET, the Company’s lead drug for the treatment of neuroendocrine tumors was administered to patients in India on a compassionate use basis, independent of a planned U.S. trial.

About Perspective Therapeutics, Inc.
Perspective Therapeutics, Inc., is a diversified medical technology and radiopharmaceutical company that is pioneering advanced treatment applications for cancers throughout the body. The Company has a proprietary technology that utilizes the alpha emitting isotope Lead-212 to deliver powerful radiation specifically to cancer cells via specialized targeting peptides. The Company is also developing complementary imaging diagnostics that incorporate the same targeting peptides which provide the opportunity to personalize treatment and optimize patient outcomes. This “theranostic” approach enables the ability to see the specific tumor and then treat it to potentially improve efficacy and minimize toxicity associated with many other types of cancer treatments.

The Company’s melanoma (VMT01) and neuroendocrine tumor (VMT-α-NET) programs have entered Phase 1/2a imaging and therapy trials for the treatment of metastatic melanoma and neuroendocrine tumors at several leading academic institutions in the United States. The Company has also developed a proprietary Lead-212 generator to enable isotope supply for clinical trial and commercial operations.

In addition to its targeted alpha therapy programs, Perspective is the sole producer of Cesium-131 brachytherapy seeds which are commercially available in the United States for the treatment of prostate cancer and other solid tumors.

For more information, please visit the Company’s website at www.perspectivetherapeutics.com.

  
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