On May 3, 2021 EXINI Diagnostics AB, a subsidiary of Lantheus Holdings, Inc. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence (AI) solutions to Find, Fight and Follow serious medical conditions, reported that it has received CE Mark clearance for aPROMISE in Europe (Press release, EXINI Diagnostics, MAY 3, 2021, View Source [SID1234579025]).

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aPROMISE is artificial intelligence-based, deep learning-enabled, medical device software that allows healthcare professionals and researchers to perform quantitative assessment of prostate-specific membrane antigen (PSMA) PET/CT in oncology. aPROMISE includes a solution for automated body segmentation and marking, quantifying and reporting suspicious lesions in their anatomical context.1,2 The AI tool provides enhanced consistency in quantitative analysis and is intended to increase efficiency, accuracy and reproducibility of PSMA PET/CT image assessments.

In a prospectively planned independent analysis of the PyL OSPREY trial, aPROMISE demonstrated a high reproducibility with an intraclass correlation coefficient (ICC) of 0.99 (95%CI 0.99 – 0.99). In metastatic prostate cancer patients, the sensitivity of aPROMISE in a pre-selection of lesions was 92% for regional lymph nodes, 91% for distant lymph nodes, and 87% for bone.

"The Prostate Cancer Molecular Imaging Standardized Evaluation (PROMISE) criteria has proposed a uniform language for objective reporting to assist physicians in assessing a patient’s tumor burden and also provides clinically meaningful information to physicians for developing therapeutic plans," said Matthias Eiber, Department of Nuclear Medicine, Klinikum Rechts der Isar, Technical University of Munich, Munich, Germany. "With the introduction of automation to the PROMISE criteria, the software is able to facilitate adherence to standardized reporting in clinical practice by reducing reporting time and limitations of manual assessment."

"The aPROMISE CE Mark clearance is an exciting milestone for Lantheus on the path to possible U.S. approval later this year," said Etienne Montagut, Sr. Vice President, Corporate Development. "We believe aPROMISE is a unique offering that could complement and strengthen our PSMA assets portfolio by improving their value and ease of use while assisting treating clinicians in their patient management decisions."

About Prostate Cancer

Prostate cancer is the second most common form of cancer affecting men in the United States – an estimated one in eight men will be diagnosed with prostate cancer in their lifetimes. The American Cancer Society estimates that in 2021, 248,530 new cases of prostate cancer will be diagnosed, and 34,130 men will die of the disease. Approximately 3.1 million men in the United States currently count themselves as prostate cancer survivors.3

About PyL

PyL (also known as 18F-DCFPyL) is an investigational fluorinated PSMA-targeted PET imaging agent that enables visualization of localized prostate cancer both localized as well as metastatic to lymph nodes, bone and soft tissue to detect and localize recurrent and/or metastatic prostate cancer. On September 29, 2020, Lantheus submitted a new drug application (NDA) for PyL which was accepted and granted priority review and assigned a Prescription Drug User Fee Act (PDUFA) action date of May 28, 2021.

OSPREY Phase 2/3 Trial

The OSPREY trial was designed to assess the diagnostic performance of PyL to detect prostate cancer in pelvic lymph nodes in subjects with high-risk prostate cancer (Cohort A) and confirm distant metastases in subjects with metastatic or recurrent prostate cancer (Cohort B). The primary endpoints for the trial were sensitivity and specificity of PyL PET/CT imaging to detect metastatic prostate cancer within the pelvic lymph nodes relative to histopathology in Cohort A. A key secondary endpoint of the trial was the sensitivity of PyL PET/CT imaging to detect prostate cancer within sites of metastasis or local recurrence relative to histopathology in Cohort B.

In the trial, the diagnostic performance of PyL in detecting disease in pelvic lymph nodes (Cohort A) was compared with histopathology. PyL showed specificity of 96-99%, sensitivity of 31-42%, and PPV of 78-91% meeting the specificity but not the pre-established sensitivity co-primary endpoint. In the metastatic or recurrent prostate cancer setting (Cohort B), PyL exhibited sensitivity of 93-99% and PPV of 81-88% in detecting metastatic lesions. Overall, PyL demonstrated high diagnostic performance in reliably detecting nodal and distant metastatic prostate cancer.

Safety results showed PyL was well tolerated. The most frequent adverse events reported were dysgeusia (2.6%), headache (1.8%), and fatigue (1.3%).

On May 3, 2021 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the appointment of Craig Eagle, MD as the company’s new Chief Medical Officer (CMO) (Press release, Guardant Health, MAY 3, 2021, View Source [SID1234579024]).

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As CMO, Dr. Eagle will play a vital role in furthering Guardant Health’s mission of transforming cancer care by unlocking data that will accelerate precision oncology for patients at all stages of the disease. "I am thrilled to welcome Dr. Craig Eagle, a respected leader in oncology, as our Chief Medical Officer," said AmirAli Talasaz, Guardant Health President. "Craig has a wealth of experience driving medical affairs, clinical development, and clinical trial operations at leading pharmaceutical companies, and he will undoubtedly make a great impact as we continue to develop and commercialize first-in-class products and scale the company for the future."

"I look forward to contributing to the ground-breaking work Guardant Health is doing to serve unmet medical needs by applying precision oncology across the continuum of cancer care," said Craig Eagle, MD. "Guardant Health is uniquely positioned to serve cancer patients at all stages of the disease, from advanced to early-stage cancers. I look forward to joining the team as the company continues to increase patient access to potentially life-changing diagnostics and testing."

Prior to joining Guardant Health, Dr. Eagle has most recently served as Vice President of Medical Affairs Oncology for Genentech where he oversaw the medical programs across the oncology portfolio, and developed innovative cancer trials and strategies in personalized health care. Prior to Genentech, Dr. Eagle has held several positions in the U.S. and internationally over his 19-year career at Pfizer including global head of the Oncology Medical and Outcomes Group. In this role, he oversaw the worldwide medical programs and development of numerous commercially successful drugs. Dr. Eagle currently serves on the Board of Directors for Generex Biotechnology and NuGenerex Immuno-Oncology.

Dr. Eagle attended medical school at the University of New South Wales in Sydney, Australia and received his general internist training at Royal North Shore Hospital in Sydney. Dr. Eagle completed his specialist training in hemato-oncology and laboratory hematology at Royal Prince Alfred Hospital in Sydney and was granted Fellowship in the Royal Australasian College of Physicians (FRACP) and the Royal College of Pathologists Australasia (FRCPA).

On May 3, 2021 Synthekine Inc., an engineered cytokine therapeutics company, reported that it has appointed Naiyer Rizvi, M.D., as Chief Medical Officer, effective today (Press release, Synthekine, MAY 3, 2021, View Source [SID1234579023]). Dr. Rizvi is an internationally recognized leader in cancer immunotherapy drug development whose clinical research has helped deliver FDA approvals of several landmark immunotherapies, including nivolumab in squamous lung cancer and pembrolizumab in non-small cell lung cancer. He will lead Synthekine’s efforts in advancing its maturing pipeline through clinical investigation.

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"Naiyer is a physician scientist with a track record of success in the development of breakthrough oncology treatments. We are thrilled to have him join as our CMO as we move our first cytokine therapeutics into clinical development later this year," said Debanjan Ray, CEO of Synthekine. "Naiyer’s leadership and exceptional track record in immuno-oncology clinical development complement our deep cytokine expertise and will enable Synthekine to advance our broad pipeline of cytokine therapeutics and cytokine enabled cell therapies to clinical proof of concept."

As a medical oncologist and expert in clinical immuno-oncology, Dr. Rizvi’s research into mechanisms of sensitivity and resistance to immunotherapy has laid the foundation to the understanding of clinical responses to immune checkpoint inhibitors. Dr. Rizvi conducted clinical studies of novel immunotherapy drugs and immunotherapy combinations, including the landmark study to demonstrate a correlation between mutations and neoantigens with durable benefit to immune-checkpoint blockade. His work has been published in leading journals including Science, Nature, and the New England Journal of Medicine.

"Synthekine has assembled an impressive portfolio of cytokine therapeutic candidates that has the potential to address a spectrum of diseases, and I look forward to leading our clinical development and strategy to advance these promising medicines," said Dr. Rizvi. "I’ve treated patients with cytokine drugs and understand both the promise but also the toxicity that these potent therapeutics can deliver. Synthekine’s two lead programs, an IL-2 partial agonist (STK-012) and a CD-19 CAR-T with orthogonal IL-2 (SYNCAR-001 + STK-009), have demonstrated compelling efficacy, safety, and selectivity in preclinical models and I look forward to advancing them to clinical studies."

Dr. Rizvi most recently served as the Price Family Professor of Medicine, Director of Thoracic Oncology and Co-Director of Cancer Immunotherapy at Columbia University Medical Center. In addition, Dr. Rizvi was recently Research Director of the Price Family Comprehensive Center for Chest Care at New York-Presbyterian Hospital. Dr. Rizvi received his medical doctorate from the University of Manitoba Faculty of Medicine and completed his residency training at the University of Manitoba Affiliated Hospital and fellowship at Beth Israel Deaconess Medical Center/Harvard Medical School. He was a co-founder of Gritstone Oncology.

On May 3, 2021 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company enabled by its proprietary synthetic lethality (SL) approach to the discovery and development of novel therapeutics, reported the first patient has been dosed in the Company’s Phase 1 clinical trial of RP-6306, a first-in-class small molecule product candidate targeting PKMYT1, which is a novel target that Repare discovered to be synthetic lethal with CCNE1 amplification and other genomic mutations to treat CCNE1-amplified, FBXW7-altered and other PKMYT1 inhibitor-sensitive cancers (Press release, Repare Therapeutics, MAY 3, 2021, View Source [SID1234579022]).

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"The dosing of the first patient in this RP-6306 trial marks a key milestone in Repare’s development of targeted cancer therapeutics. We are pleased to have initiated this trial six months ahead of what we projected at our IPO launch last June," said Lloyd M. Segal, President and Chief Executive Officer of Repare. "Patients with tumors carrying CCNE1, FBXW7 and certain other genetic alterations we have identified as sensitive to PKMYT1 inhibition have few treatment options available, and the incidence of these cancers is rising. This Phase 1 trial will assess the safety and tolerability of RP-6306, as well as dosing schedule, to inform Repare’s planned Phase 2 program."

The Phase 1 multi-center clinical trial is expected to enroll approximately 70 patients with recurrent tumors characterized by specific genomic alterations predicted by Repare’s SNIPRx platform to render sensitivity to RP-6306. The primary goal of the Phase 1 clinical trial is to assess preliminary safety and tolerability in patients and to establish the recommended Phase 2 dose and dosing schedule for RP-6306 for evaluation in further trials. Subject to completion and review of the Phase 1 clinical trial, the Company expects to advance RP-6306, both as monotherapy and in combination with chemotherapies and other treatment modalities, into proof-of-concept studies in 2022, targeting a variety of patient populations, including those with tumors with CCNE1 amplification, FBXW7 loss or other alterations identified through Repare’s proprietary STEP2 screens.

About RP-6306

RP-6306 is a first-in-class, selective, orally available inhibitor of PKMYT1 that was discovered and developed entirely in-house by Repare. Through Repare’s SNIPRx screen campaign for targets that are SL with CCNE1 amplification, the Company identified and validated this novel SL gene that has the characteristics of a therapeutic target. Repare has developed novel and selective inhibitors against PKMYT1, which demonstrated compelling pre-clinical anti-tumor activity alone and in combination with certain anticancer agents, and subsequently announced the advancement of a clinical candidate to this potential, first-in-class program.

On May 3, 2021 Vivacitas Oncology, Inc. ("Vivacitas" or the "Company"), a clinical stage biopharmaceutical company focused on tough to treat cancers, and Image Analysis Group ("IAG"), a leading global medical imaging company, reported that iare collaborating to apply Artificial Intelligence (AI) technology and advanced imaging strategies to further the development of AR-67, a third generation Camptothecin, in patients with recurrent glioblastoma multiforme (reGBM) (Press release, Vivacitas Oncology, MAY 3, 2021, View Source [SID1234579021]).

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Advanced imaging techniques could play a critical role in response assessment in developing new and innovative cancer therapies. Multiparametric magnetic resonance imaging (mpMRI) provides quantitative non-invasive imaging markers of early therapy-related changes. IAG is deploying its proprietary, cloud-based imaging approach to provide scientific evidence of early therapy response.

Tina Runk, Vivacitas co-founder and Executive Vice President of Clinical Operations stated, "Working with IAG, we performed a retrospective analysis of imaging data from our Phase 2 clinical study of AR-67 activity in recurrent GBM, in which their technology was applied to assess pseudoprogression from true progression of disease. This assessment capability demonstrates the benefit of potentially including this technology in future pivotal clinical trials and treatment regimens to ensure patient retention based on more detailed and objective criteria."

Dr. Diana Dupont-Roettger, the Chief Scientific Alliance Officer at IAG stated, "We are excited to bring the latest and most impactful imaging strategies to Vivacitas to ensure a scientific excellence and efficient drug development process."