On April 15, 2021 Clarity Pharmaceuticals, a clinical stage radiopharmaceutical company focused on the treatment of serious disease, reported that the first patient has been treated in the Phase II DISCO trial (Diagnostic Imaging Study of Copper-64 SARTATE Using PET on Patients With Known or Suspected Neuroendocrine Tumors) (Press release, Clarity Pharmaceuticals, APR 15, 2021, View Source [SID1234578042]).

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The DISCO trial (NCT04438304)1 is assessing the performance of 64Cu-SARTATE imaging agent in participants with known or suspected gastroenteropancreatic (GEP) NETs as a potential new way to help diagnose NETs. It is a Phase II study in 63 patients across 3 sites in Australia that compares the diagnostic performance of 64Cu-SARTATE at 4 and 20 hours to the current standard of care 68Ga-DOTATATE at 1 hour.

NETs, also known as well-differentiated neuroendocrine neoplasms or carcinoids, are a heterogeneous group of malignant transformations of cells of the diffuse neuroendocrine system. The most common site of primary NETs is the gastrointestinal tract (GI) (about 60% of all cases), followed by the bronchopulmonary tree (27%). Less frequent sites are the pancreas, biliary tract, liver, ovaries and testes.2 In 2020, the National Cancer Institute (NCI) estimated a prevalence close to 300,000 individuals who had a NET diagnosis and are currently alive in the U.S. Only 15% are survivors of 1 or less years from diagnosis.

A delay in diagnosis or misdiagnosis of NETs is common, such that most NET patients have metastatic disease by the time a diagnosis is confirmed.3 About 30-75% of NETs patients have distant metastases at the time of diagnosis according to the US and European cancer registries.

Clarity’s Executive Chairman, Dr Alan Taylor, commented: "There is a clear unmet need in the diagnosis of NETs with the frightening proportion of people currently being diagnosed when the cancer has already spread in their bodies, limiting treatment options and negatively affecting prognosis.

"Our 64Cu-SARTATE first-in-human diagnostic trial in NETs has demonstrated promising results in the safety and potential effectiveness of the product as a new way to detect neuroendocrine cancers (Hicks, R. et al. 2018)4. The study showed that the longer 12.7 hour half-life of Cu-64, combined with the stability of our proprietary SAR chelator which does not leak copper over time, proved to be advantageous in identifying additional tumour burden as it allows clinicians to have the flexibility to image patients at later time points than products based on Ga-68 or copper-based products that employ inferior chelators," said Dr Taylor.

The longer half-life of Cu-64 also enables product supply benefits. In the DISCO trial, clinical sites across Australia will be supplied 64Cu-SARTATE from a central radiopharmacy. In contrast, Ga-68 based products have to be synthesised on site and require the clinical sites to have local radiopharmacies.

"Our team is very excited to progress the development of 64Cu-SARTATE for NET patients to expand the patient population for SARTATE from neuroblastoma in children. We are also looking forward to capitalising on the many benefits of the "perfect pairing" of Cu-64 and Cu-67 for imaging, therapy, manufacture and logistics in the development of all of our pipeline products with the ultimate goal of improving treatment outcomes for children and adults with cancer," commented Dr Taylor.

Reference List
A Diagnostic Imaging Study of 64Cu-SARTATE Using PET on Patients With Known or Suspected Neuroendocrine Tumors, <View Source>
Modlin, E. et al. 2010, "Gastrointestinal neuroendocrine (carcinoid) tumours: current diagnosis and management", The Medical Journal of Australia, <View Source>
Basuroy, R. et al. 2018, "Delays and routes to diagnosis of neuroendocrine tumours", BMC Cancer, <View Source>
Hicks, R. et al. 2018, "First-in-human trial of 64Cu-SARTATE PET imaging of patients with neuroendocrine tumours demonstrates high tumor uptake and retention, potentially allowing prospective dosimetry for peptide receptor radionuclide therapy", The Journal of Nuclear Medicine, <View Source>

On April 15, 2021 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company developing allogeneic CAR T and in vivo gene correction therapies with its ARCUS genome editing platform, reported that Alan List, M.D. has been appointed as the Company’s Chief Medical Officer and a member of the senior leadership team at Precision BioSciences (Press release, Precision Biosciences, APR 15, 2021, View Source [SID1234578080]). Dr. List is a world-renowned hematologist with extensive academic and clinical experience in the research and development of hematology and oncology products. He has led clinical development programs for multiple FDA-approved drugs to treat hematologic malignancies, including myelodysplastic syndromes, acute leukemia, multiple myeloma, and lymphoma.

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"We are very pleased to welcome Alan to the senior leadership team of Precision BioSciences," said Matt Kane, Chief Executive Officer and Co-Founder of Precision BioSciences. "With three hematology products in the clinic and a fourth entering clinical trials soon, Alan’s deep clinical expertise in hematology and oncology, including pioneering work to develop novel products from the laboratory to the clinic, he will be a strong addition to the Precision team. Over the past 12 months, Alan has been intimately involved in our clinical strategy to develop our lead allogeneic CAR T therapy, PBCAR0191, as well as the design of our clinical program for PBCAR19B, our next generation, stealth cell program. We believe that Alan’s leadership will be critical to the successful execution of our clinical development strategy."

Since April 2020, Dr. List has been a strategic clinical advisor to Precision BioSciences, providing advice to the company and its Board of Directors on its clinical stage and pre-clinical allogeneic CAR T programs. Prior to joining Precision BioSciences, Dr. List served in various roles at the Moffitt Cancer Center, including as President and Chief Executive Officer from 2012 to 2019; Executive VP, Physician in Chief from 2008 to 2012 and Chief of the Malignant Hematology Division from 2003 to 2008. Dr. List is internationally recognized for his many contributions in the development of effective treatment strategies for myelodysplastic syndrome (MDS) and acute myeloid leukemia. His pioneering work led to the development of Revlimid (lenalidomide) a transformational treatment for patients with MDS and multiple myeloma.

Dr. List is the author of more than 425 peer-reviewed articles and books. He previously served as the President for the Society of Hematologic Oncology and a member of the MDS Foundation Board of Directors. Dr. List is an active member of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), the American Society of Hematology (ASH) (Free ASH Whitepaper) and the American Association for Cancer Research (AACR) (Free AACR Whitepaper). He is a Charter Fellow in the National Academy of Inventors, an inductee in the Florida Inventors Hall of Fame, and holds 18 U.S. patents and >45 applications filed. Dr. List was 2016 recipient of the Celgene Career Achievement Award for Clinical Research in Hematology, and other recognitions including the General Motors Cancer Research Foundation Merit Award, the J.P. McCarthy Foundation International Prize, the Emil J. Freireich Award, the Joshua Lederberg Society, and the Aplastic Anemia & MDS International Foundation Leadership in Science Award.

Dr. List received B.S. and M.S. degrees from Bucknell University and earned his M.D. from the University of Pennsylvania. He is board certified in internal medicine, hematology, and medical oncology. He completed his residency in internal medicine at Good Samaritan Medical Center in Phoenix, Arizona and fellowships in

hematology and medical oncology at Vanderbilt University Medical Center. Prior to joining the Moffitt Cancer Center in 2003, Dr. List held academic and clinical appointments at the University of Arizona.

"After advising Precision BioSciences on its clinical trial programs for nearly a year, I’m very excited to join as the Chief Medical Officer as we approach the launch of the first of our stealth CAR T programs. I look forward to working with the management team and the clinical team to advance the development of our potentially breakthrough allogeneic CAR T cell programs, including PBCAR0191 and PBCAR19B. I’m particularly optimistic about the potential opportunity to bring novel cell therapies to patients who suffer from hematologic malignancies, such as non-Hodgkin lymphoma, B-cell acute lymphoblastic leukemia, and multiple myeloma," said Dr. List. "I’m also looking forward to interacting with the clinical investigators who are conducting our clinical trials at leading academic centers across the country."

Dr. List will succeed Chris Heery, M.D., who is leaving Precision BioSciences to pursue other opportunities. Dr. Heery will continue to serve as a consultant to the company to ensure a smooth transition in the conduct of clinical trials underway at Precision.

"During Chris’ time with the company, Precision successfully transitioned PBCAR20A and PBCAR269A into Phase 1 clinical trials and designed the Phase 1 clinical trial for PBCAR19B. We thank Chris for his contributions to Precision BioSciences and wish him success in his future endeavors," added Mr. Kane.

On April 15, 2021 Agilent Technologies, Inc. (NYSE: A) reported it has completed the acquisition of Resolution Bioscience, a leader in the development and commercialization of next-generation sequencing (NGS)-based precision oncology solutions (Press release, Agilent, APR 15, 2021, View Source [SID1234578097]).

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Resolution Bioscience complements and expands Agilent’s capabilities in NGS-based cancer diagnostics and provides the company with innovative technology to further serve the needs of the fast-growing precision medicine market. The addition of Resolution Bioscience’s liquid biopsy-based diagnostic technologies strengthens Agilent’s offerings to biopharma and clinical diagnostics customers and boosts growth opportunities in the company’s diagnostics and genomics business.

"The Resolution Bioscience team and powerful technology are strategic and important additions to Agilent’s growing business in precision oncology solutions," said Mike McMullen, Agilent president and CEO. "This also accelerates our work to more broadly deliver precision oncology testing for patients worldwide with NGS-based diagnostic kits. We’re excited to have Resolution Bioscience joining with us to expand our work in the fight against cancer."

On April 15, 2021 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat genetically defined diseases, reported that the company will host a conference call and live webcast on Thursday, April 29, 2021 at 8:00 a.m. ET to report its first quarter 2021 financial results and other business highlights (Press release, Agios Pharmaceuticals, APR 15, 2021, https://investor.agios.com/news-releases/news-release-details/agios-webcast-conference-call-first-quarter-2021-financial [SID1234578062]).

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A live webcast can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. The conference call can be accessed by dialing 1-877-377-7098 (domestic) or 1-631-291-4547 (international) and referring to conference ID 4497151. The webcast will be archived and made available for replay on the company’s website beginning approximately two hours after the event.

On April 15, 2021 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company developing allogeneic CAR T and in vivo gene correction therapies with its ARCUS genome editing platform, reported that Alan List, M.D. has been appointed as the Company’s Chief Medical Officer and a member of the senior leadership team at Precision BioSciences (Press release, Precision Biosciences, APR 15, 2021, View Source [SID1234578081]). Dr. List is a world-renowned hematologist with extensive academic and clinical experience in the research and development of hematology and oncology products. He has led clinical development programs for multiple FDA-approved drugs to treat hematologic malignancies, including myelodysplastic syndromes, acute leukemia, multiple myeloma, and lymphoma.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We are very pleased to welcome Alan to the senior leadership team of Precision BioSciences," said Matt Kane, Chief Executive Officer and Co-Founder of Precision BioSciences. "With three hematology products in the clinic and a fourth entering clinical trials soon, Alan’s deep clinical expertise in hematology and oncology, including pioneering work to develop novel products from the laboratory to the clinic, will be a strong addition to the Precision team. Over the past 12 months, Alan has been intimately involved in our clinical strategy to develop our lead allogeneic CAR T therapy, PBCAR0191, as well as the design of our clinical program for PBCAR19B, our next generation, stealth cell program. We believe that Alan’s leadership will be critical to the successful execution of our clinical development strategy."

Since April 2020, Dr. List has been a strategic clinical advisor to Precision BioSciences, providing advice to the company and its Board of Directors on its clinical stage and pre-clinical allogeneic CAR T programs. Prior to joining Precision BioSciences, Dr. List served in various roles at the Moffitt Cancer Center, including as President and Chief Executive Officer from 2012 to 2019; Executive VP, Physician in Chief from 2008 to 2012 and Chief of the Malignant Hematology Division from 2003 to 2008. Dr. List is internationally recognized for his many contributions in the development of effective treatment strategies for myelodysplastic syndrome (MDS) and acute myeloid leukemia. His pioneering work led to the development of Revlimid (lenalidomide) a transformational treatment for patients with MDS and multiple myeloma.

Dr. List is the author of more than 425 peer-reviewed articles and books. He previously served as the President for the Society of Hematologic Oncology and a member of the MDS Foundation Board of Directors. Dr. List is an active member of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), the American Society of Hematology (ASH) (Free ASH Whitepaper) and the American Association for Cancer Research (AACR) (Free AACR Whitepaper). He is a Charter Fellow in the National Academy of Inventors, an inductee in the Florida Inventors Hall of Fame, and holds 18 U.S. patents and >45 applications filed. Dr. List was 2016 recipient of the Celgene Career Achievement Award for Clinical Research in Hematology, and other recognitions including the General Motors Cancer Research Foundation Merit Award, the J.P. McCarthy Foundation International Prize, the Emil J. Freireich Award, the Joshua Lederberg Society, and the Aplastic Anemia & MDS International Foundation Leadership in Science Award.

Dr. List received B.S. and M.S. degrees from Bucknell University and earned his M.D. from the University of Pennsylvania. He is board certified in internal medicine, hematology, and medical oncology. He completed his residency in internal medicine at Good Samaritan Medical Center in Phoenix, Arizona and fellowships in hematology and medical oncology at Vanderbilt University Medical Center. Prior to joining the Moffitt Cancer Center in 2003, Dr. List held academic and clinical appointments at the University of Arizona.

"After advising Precision BioSciences on its clinical trial programs for nearly a year, I’m very excited to join as the Chief Medical Officer as we approach the launch of the first of our stealth CAR T programs. I look forward to working with the management team and the clinical team to advance the development of our potentially breakthrough allogeneic CAR T cell programs, including PBCAR0191 and PBCAR19B. I’m particularly optimistic about the potential opportunity to bring novel cell therapies to patients who suffer from hematologic malignancies, such as non-Hodgkin lymphoma, B-cell acute lymphoblastic leukemia, and multiple myeloma," said Dr. List. "I’m also looking forward to interacting with the clinical investigators who are conducting our clinical trials at leading academic centers across the country."

Dr. List will succeed Chris Heery, M.D., who is leaving Precision BioSciences to pursue other opportunities. Dr. Heery will continue to serve as a consultant to the company to ensure a smooth transition in the conduct of clinical trials underway at Precision.

"During Chris’ time with the company, Precision successfully transitioned PBCAR20A and PBCAR269A into Phase 1 clinical trials and designed the Phase 1 clinical trial for PBCAR19B. We thank Chris for his contributions to Precision BioSciences and wish him success in his future endeavors," added Mr. Kane.