Lantheus announces the first patient treated in clinical phase 2
NORTH BILLERICA, Mass., May 13, 2022 (GLOBE NEWSWIRE) — Lantheus Holdings, Inc. (“the Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapies and artificial intelligence solutions to detect, combat and track serious medical conditions, today announced that the first patient has received a dose in a Phase 2 trial evaluating NM-01, its proprietary SPECT imaging agent in technetium 99m used to assess PD-L1 expression in cancer cells, for its potential to identify patients who will respond to checkpoint inhibitor treatments.
The PELICAN trial (NCT04992715) is a single-arm, open-label trial in patients with non-small cell lung cancer (NSCLC). The primary endpoint is assessment of PD-L1 expression in primary tumor and metastatic lesions by NM-01 versus immunohistochemistry. Other objectives will aim to quantify the intra- and inter-tumor heterogeneity of PD-L1 expression by NM-01, as well as to establish a correlation with other diagnostic procedures. The trial is being conducted by Lantheus partner NanoMab Technology Limited (NanoMab) at King’s College London. Lantheus obtained an NM-01 license from NanoMab in 2019.
“While checkpoint inhibitor therapies targeting PD1 or PD-L1 have improved the prognosis of patients with NSCLC, these therapies often present with unpredictable patient outcomes,” said Gary Cook, MD, King’s College London. and principal investigator of the trial. “PELICAN will help us determine if NM-01 can help select responders to checkpoint inhibitor treatments, providing the right treatments to the right patients while sparing non-responders from side effects, procedures and costs. unnecessary.
Current assessment of PD-L1 expression is performed on tumor biopsy specimens by immunohistochemistry. The discrepancies in response to checkpoint inhibitor treatment highlighted potential shortcomings in the current method of assessing PD-L1 expression in a clinical setting. Immunohistochemical evaluation of tumor samples obtained by needle biopsy is often unable to capture the heterogeneity and dynamic nature of PD-L1 expression in the tumor and its microenvironment. NM-01, an imaging agent targeting PD-L1 receptors, can provide whole-body imaging assessment in a single exam and may overcome these issues and represent an alternative to multiple biopsies. NM-01 potentially allows the detection of PD-L1 expression in tumors and could be used in the management of patients before, during or after treatment with checkpoint inhibitors. NM-01 could also be used in immuno-oncology clinical trials to improve patient selection and monitor treatment response.
“The future potential of targeted imaging agents, like NM-01, to inform clinical decision-making in oncology is very exciting,” said Jean-Claude Provost, MD, interim medical director of Lantheus. “We are excited to take this important step in the development of a novel imaging agent designed to provide new insights to optimize the use of checkpoint inhibitor therapies, improve patient outcomes and to limit the need for multiple biopsies during the process. checkpoint inhibitor therapy.
“This is an important step in our development of NM-01 as a non-invasive in vivo imaging and patient screening tool for immune checkpoint drugs,” said Dr Hong Hoi. Ting, co-founder and CSO, NanoMab. “We are excited about the potential to address an unmet clinical need in oncology, and know that Lantheus, a leader in the development and commercialization of imaging agents, is the ideal partner for this program.
About Lantheus Holdings, Inc.
Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc., Progenics Pharmaceuticals, Inc. and EXINI Diagnostics AB and an established leader and fully integrated provider engaged in innovative imaging diagnostics, targeted therapies and solutions of artificial intelligence to follow® serious medical conditions. Lantheus offers a wide range of products, including the DEFINITY echocardiography agent® Vial for suspension for injection (Perflutren Lipid Microsphere); PYLARIFY®, a PSMA PET imaging agent for the detection of suspected recurrent or metastatic prostate cancer; PYLARIFY AI™, an artificial intelligence platform that helps in the evaluation of PET PSMA images; TechLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumours; and RELISTOR® for the treatment of opioid-induced constipation, which is in partnership with Bausch Health Companies, Inc. The company is headquartered in North Billerica, Massachusetts, with offices in New Jersey, Canada and Sweden. For more information, visit www.lantheus.com.
Safe Harbor for Forward-Looking Statements and Cautions
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, which are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of the Section 27A of the Securities Act of 1933, as amended; and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements can be identified by their use of terms such as “may”, “continue”, “could”, “future”, “potential”, “will” and other similar terms. These forward-looking statements are based on current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The inclusion of forward-looking statements should not be taken as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. The risks and uncertainties that could cause our actual results to differ materially from those described in the forward-looking statements include (i) the timing and potential results of clinical studies, including PELICAN, evaluating the use of NM-01 to evaluate PD-L1 expression in cancer cells; (ii) our ability to develop NM-01 as a SPECT imaging agent; and (iii) the risks and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section of our annual reports on Form 10-K and our quarterly reports on Form 10-Q) .
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