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Lantheus Holdings Announces Submission of Drug Master File for NM-01 in the U.S.

On January 12, 2021 Lantheus Holdings, Inc. (NASDAQ: LNTH) (Lantheus), the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, reported that it has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for NM-01, a PD-L1 imaging biomarker, and will begin making the biomarker available to academic centers and pharmaceutical companies for use in immuno-oncology (I/O) clinical trials in 2021 (Press release, Lantheus Medical Imaging, JAN 12, 2021, View Source [SID1234573919]).

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NM-01 is a proprietary radiopharmaceutical biomarker using a camelid single-domain antibody and a technetium-99 radioisotope that has demonstrated a high affinity for PD-L1 protein. NM-01 could provide a specific, non-invasive approach to patient assessment, including use in whole-body imaging, or virtual biopsy. NM-01 potentially allows detection of PD-L1 expression in tumors and could be used to evaluate patients before, during, or after treatment with I/O agents, including checkpoint inhibitors, in clinical trials. The market for checkpoint inhibitors is expected to grow from $25B in 2019 to $68B in 2026.1 Lantheus licensed NM-01 from NanoMab Technology Limited in 2019 and plans to provide NM-01 as a clinical research tool, together with support and analytics, to pharmaceutical companies and the largest academic centers conducting clinical research in I/O.

"Evaluation of patients for I/O therapy is a key challenge for companies developing new therapeutics in this high-growth field," said Etienne Montagut, Senior Vice President of Corporate Development at Lantheus. "With the filing of the DMF, Lantheus is pleased to take an important step forward in providing a novel clinical research tool with the potential to provide new information to optimize the use of I/O therapy."

NanoMab has completed a Phase 1 study using NM-01 in 30 non-small cell lung cancer (NSCLC) patients, and preliminary data of the first 16 patients were published in the February 22, 2019 issue of Journal of Nuclear Medicine (Xing et al.). Separately, an investigator-led clinical trial involving 30 patients with either NSCLC or melanoma is in progress at King’s College London and Guy’s and St Thomas’ NHS Trust (NCT04436406); the study aims to monitor treatment response. A clinical trial authorization (CTA) was also granted by the Medicines Healthcare Products Regulatory Agency (MHRA) in November 2020 for a Phase 2 clinical study on NM-01 in NSCLC patients.

"We are very encouraged by the results of the Phase I study, which validated our innovative nanobody platform and demonstrated strong correlation with tissue-based biomarker," said Dr. H.H. Ting, Chief Executive Officer of NanoMab. "We are pleased that leading cancer research centers are progressing with the use of NM-01 in I/O clinical trials."

About a Drug Master File (DMF)

A Drug Master File (DMF) is a submission to the Food and Drug Administration that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.2

Imago BioSciences to Present at the 39th Annual J.P. Morgan Healthcare Conference

On January 12, 2021 Imago BioSciences, Inc., a clinical-stage biopharmaceutical company developing innovative treatments for myeloproliferative neoplasms, reported that Hugh Young Rienhoff, Jr., M.D., CEO, will present at the 39th Annual J.P. Morgan Healthcare Conference at 4:55 p.m. EST on Thursday, January 14, 2021 (Press release, Imago BioSciences, JAN 12, 2021, View Source [SID1234573918]). An archived replay of the presentation will be available on the company’s website, www.imagobio.com, for 30 days.

Primmune Therapeutics Announces Close of Series A Financing

On January 12, 2021 Primmune Therapeutics reported the close of its Series A financing round with the addition of $4.0 million from Bioqube Ventures, a European life sciences venture capital firm (Press release, Primmune Therapeutics, JAN 12, 2021, View Source [SID1234573917]). This brings the total of the Series A financing raise to $31.4 million. These funds will be used to support the development of PRTX007, a novel orally-administered, small molecule toll-like receptor 7 (TLR7) agonist as a therapeutic-adjuvant for acute viral diseases and cancer.

Concurrently, Debbie Dumont, Co-founder and Managing Partner at Bioqube Ventures has joined Primmune’s Board of Directors as an observer. Elina Zuniga, Ph.D., Professor of Molecular Biology at the University of California, San Diego has joined the company’s scientific advisory board.

"We are excited to have Bioqube Ventures join our investor syndicate because of their expertise and experience in establishing European operations. Bioqube Ventures will facilitate the establishment of our Belgium subsidiary to complement our Australian presence and enable us to effectively partner and run clinical studies in the European Union as well as in the United States and Australia," said Charlie McDermott, Chairman and Chief Executive Officer of Primmune Therapeutics. "Dr. Elina Zuniga will be important in guiding our TLR7 agonist strategy as part of our scientific advisory board given her deep knowledge regarding the interplay between toll-like receptor signaling, endogenous poly-interferon antiviral responses, and host innate immune modulation."

ARTMS and Telix Pharmaceuticals Announce Successful Production of PSMA-11 with Cyclotron Produced 68Ga from a Solid Target

On January 12, 2021 ARTMS Inc. (‘ARTMS’) and Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’) reported that they have successfully produced Telix’s prostate cancer imaging product, TLX591-CDx (Kit for the preparation of 68Ga-PSMA-11)1, using multi-Curie quantities of cyclotron-produced Gallium-68 (68Ga) via ARTMS’ proprietary Quantum Irradiation System (QIS) solid target system (Press release, Telix Pharmaceuticals, JAN 12, 2021, View Source [SID1234573916]).

The testing demonstrated an impressive six-hour stability of TLX591-CDx, a radiopharmaceutical targeting Prostate-Specific Membrane Antigen (PSMA) for the imaging of prostate cancer using Positron Emission Tomography (PET). Testing exceeded all relevant quality control standards for both low- (50 mCi and 100 mCi) and mid-level output (over 2,500 mCi) 68Ga production runs. The "cold kit" format of TLX591-CDx enables rapid radiolabelling at room temperature with high radiochemical purity and production consistency, ideally suited for the radiopharmacy setting.

ARTMS Chief Executive Officer, Charles S. Conroy, stated, "This collaboration and successful testing represents a significant step forward for the diagnosis of prostate cancer globally. The combination of Telix’s user friendly, high quality PSMA-11 kit along with robust production of 68Ga using our solid targetry approach moves us closer to having a PET diagnostic agent on demand for clinicians. Our goal at ARTMS is to ensure that the 68Ga supply is able to meet the substantial projected clinical demand for this isotope."

Telix USA President, Dr Bernard Lambert, added, "When the Telix-ARTMS collaboration was announced in April 2020, we were confident that ARTMS’ proprietary technology to produce 68Ga from specialized solid 68Zn targets using low-energy cyclotrons would be valuable to the Molecular Imaging and Oncology community. ARTMS’ work represents a significant development in how 68Ga is able to be supplied to the market for large-scale production and, as a result, will contribute to the reliability of access to all men living with prostate cancer who require advanced prostate imaging. This outcome is a testament to both the ARTMS technology and Telix’s proprietary formulation of PSMA-11"

ARTMS will continue the development of cyclotron-produced 68Ga with a focus on optimizing production potential and satisfying regulatory requirements for use in radiopharmaceutical kits such as TLX591-CDx.

About Prostate Cancer

Prostate cancer is the second most common cancer in men following skin cancer and, in 2018, 1.3 million men were diagnosed with prostate cancer for the first time.2 Despite advances in treatment, prostate cancer still accounts for a large number of deaths and in 2018 more than 365,000 men died from their disease. Rates of diagnosis are increasing, with the highest incidences of prostate cancer occurring in the United States, Europe, and Australia and New Zealand.

New Treatment for Central Nervous System Tumors Enters Phase I Clinical Trials

On January 12, 2021 OX2 Therapeutics, Inc., a privately held Minneapolis company, reported that they treated their first patient in a phase one human trial of a new treatment developed to combat recurrent high-grade brain tumors (Press release, OX2 Therapeutics, JAN 12, 2021, View Source [SID1234573915]).

"This is a first-of-its kind immunotherapy that works to treat one of the most aggressive and deadly cancers today," said Christopher Moertel, MD, OX2 Therapeutics, Inc. "Central nervous system cancers are the number one cause of cancer related mortality in children, and a major cause of morbidity and mortality in adults."

OX2 Therapeutics developed the first immune checkpoint peptide platform targeting the immune system to attack solid tumors. Focusing on high-grade gliomas, OX2 Therapeutics has been treating dogs diagnosed with spontaneous high-grade glioma in a canine clinical trial at the University of Minnesota, Veterinary hospital. "This is the first therapy Dr. Olin and I have used to significantly extend the life of dogs with high-grade gliomas with no adverse events," said G. Elisabeth Pluhar, DVM, PhD, director of canine brain tumor program.

The OX2 peptide, known as CD200AR-L, is a single peptide that has the potential to replace the toxic antibody therapies that are currently used to block immune checkpoints," stated Michael Olin, PhD, OX2 Therapeutics, Inc. "CD200AR-L provides a one-two punch in the fight against cancer through the activation of the immune system while simultaneously protecting it against tumor induced suppression allowing the immune system to both reach the cancer cells and then fight them."

The FDA approved the treatment for an adult phase one human trial in June 2020. OX2 Therapeutics treated their 1st patient January 6th in a phase one single center, open-label, dose-escalation clinical trial for recurrent glioblastoma under the direction of Elizabeth Neil, MD at the University of Minnesota. This will be followed by a pediatric trial for recurrent malignant brain tumors based on its safety and pharmacokinetic profile led by Emily Greengard, MD.

The phase one human trial of this potentially groundbreaking treatment is an important milestone for OX2 Therapeutics and the Brain Tumor Program at the Masonic Cancer Center, University of Minnesota.