On November 24, 2020 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that management will participate in a fireside chat at the 2020 Piper Sandler Healthcare Conference, which is scheduled to take place from December 1 – 3, 2020 (Press release, Bicycle Therapeutics, NOV 24, 2020, View Source [SID1234571645]). The conference will be held in a virtual meeting format.

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A recording of the fireside chat will be accessible in the Investors & Media section of Bicycle’s website at www.bicycletherapeutics.coma at 9:00 a.m. ET on Tuesday, December 1. An archived replay of the webcast will be available for 90 days following the fireside chat date.

On November 24, 2020 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that it will be hosting a virtual investor event to provide a review of the Company’s oral, potent and selective menin inhibitor, KO-539, following the oral presentation of preliminary clinical data at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, Kura Oncology, NOV 24, 2020, View Source [SID1234571664]). The event will feature members of the Kura management team along with two of the investigators from KOMET-001, an ongoing Phase 1/2A clinical trial of KO-539. The virtual event will take place at 2:00 p.m. ET / 11:00 a.m. PT on Saturday, December 5, 2020.

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A live video webcast of the event will be available in the Investors section of Kura’s website at www.kuraoncology.com, with an archived replay available shortly after the conclusion of the event.

On November 24, 2020 Celularity, Inc., a clinical-stage cell therapeutics company focused on the development of innovative allogeneic placenta-derived cellular therapies, reported that the first patient was dosed in its Phase 1 clinical study of human placental hematopoietic stem cell-derived natural killer cells (CYNK-001) in adults with recurrent glioblastoma multiforme (Press release, Celularity, NOV 24, 2020, View Source [SID1234571688]).

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"Celularity is committed to the development of innovative therapeutic tools to treat serious diseases, particularly targeting diseases with unmet medical needs that have a devastating impact on patients and families. As testimony to this commitment, we are extremely excited to announce the dosing of our first patient in our first clinical trial for, glioblastoma multiforme (GBM). Through the study team’s diligent efforts, we were able to rapidly complete the start-up activities and to accelerate the commencement of patient screening, enrollment, and first dosing in this important study," said Robert J. Hariri, M.D., Ph.D., Celularity’s Founder, Chairman and Chief Executive Officer.

This study (ClinicalTrials.gov Identifier: NCT04489420) will determine the maximum safe dose (MSD) of CYNK-001 which are culture-expanded NK cells derived from human placental CD34+ cells. The intravenous (IV) cohort will receive repeat administration of CYNK-001 cells after lymphodepleting chemotherapy. The intratumoral (IT) cohort will not receive lymphodepletion. The safety of this treatment will be evaluated, as researchers investigate the role of NK cells in the treatment of recurrent glioblastoma.

"Glioblastoma patients have poor survival and novel treatments are urgently needed for this patient population," said Nazanin Majd, M.D., Ph.D., assistant professor of Neuro-Oncology at The University of Texas MD Anderson Cancer Center and principal investigator of the study. "Placental-derived NK cells are a promising approach in treatment of GBM patients as these cells have been shown to kill GBM tumor cells in pre-clinical animal studies. This trial offers an innovative immunotherapy approach where exogenously manufactured NK cells will be administered to GBM patients with the goal of shrinking the tumor and improving outcomes."

In a related development, the Company also announced that its abstract highlighting the details of this Phase 1 study was accepted for a poster presentation at the 25th Annual Meeting and Education Day of the Society for Neuro-Oncology (SNO) which will occur November 19-21, 2020.

Presentation Details

Poster #:

RTID-07

Title:

HUMAN PLACENTAL HEMATOPOIETIC STEM CELL DERIVED NATURAL KILLER CELLS (CYNK-001) FOR TREATMENT OF RECURRENT GLIOBLASTOMA

Session:

Randomized Trials in Development

Authors:

Nazanin Majd, Maha Rizk, Solveig Ericson, Kris Grzegorzewski, Sharmila Koppisetti, Junhong Zhu, Lin Kang, Shawn He, Tanel Mahlakoiv, William van Der Touw, Xiaokui Zhang, Nassir Habboubi, Robert Hariri, Kathy Hunter, Kristin Alfaro-Munoz, Amy Heimberger, John de Groot, Linda Chi, Samer Srour

Dates:

Available November 19-21, 2020

Link:

View Source

About CYNK-001
CYNK-001 is an investigational cryopreserved allogeneic, off-the-shelf NK cell therapy developed from placental hematopoietic stem cells. CYNK-001 is being investigated as a potential treatment option in adults with COVID-19, as well as for various hematologic cancers and solid tumors. NK cells are a unique class of immune cells, innately capable of targeting cancer cells and interacting with adaptive immunity. CYNK-001 cells derived from the placenta are currently being investigated as a treatment for acute myeloid leukemia (AML), multiple myeloma (MM), and glioblastoma multiforme (GBM).

On November 24, 2020 Blue Earth Diagnostics, a leading molecular imaging diagnostics company, reported that their manufacturing partner Nucleis (Liege, Belgium) has manufactured and shipped their first patient doses of rhPSMA-7.3 (18F), an investigational Prostate-Specific Membrane Antigen (PSMA)-targeted radiohybrid PET imaging agent, currently under evaluation in clinical trials in men with newly diagnosed prostate cancer and suspected prostate cancer recurrence (Press release, Blue Earth Diagnostics, NOV 24, 2020, View Source [SID1234571646]).

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Prostate cancer is a leading cause of cancer death in men. Accurate staging of newly diagnosed prostate cancer assists in directing appropriate initial treatment strategies. After initial treatment, recurrence occurs in up to one-third of patients, typically detected by a rise in prostate-specific antigen (PSA) levels. However, in both settings, conventional imaging is limited in detecting the location and extent of the disease. Of those who suffer biochemical recurrence, approximately one-third develop metastatic prostate cancer.

Blue Earth Diagnostics has been working closely with Nucleis Radiopharmaceuticals, formerly part of the Cyclotron Research Centre (University of Liege in Belgium), to establish them as a contract manufacturer able to supply clinical trial sites. Nucleis is now qualified to supply rhPSMA-7.3 (18F) as part of a clinical trials programme in the Netherlands where the first patients have been scanned.

Blue Earth Diagnostics has two Phase 3 studies underway to investigate the use of rhPSMA-7.3 (18F) PET imaging in prostate cancer. The SPOTLIGHT study is designed to evaluate its safety and diagnostic performance in men with suspected prostate cancer recurrence based on elevated PSA following prior therapy. The LIGHTHOUSE trial is designed to evaluate the safety and diagnostic performance of rhPSMA-7.3 (18F) PET imaging in men with newly diagnosed prostate cancer. Further information, including a current list of clinical trial sites, can be found on www.clinicaltrials.gov (LIGHTHOUSE at NCT04186819, and SPOTLIGHT at NCT04186845).

Dr. Jonathan Allis, Chief Executive Officer of Blue Earth Diagnostics said, "Our collaboration with Nucleis Radiopharmaceuticals and supply of our first rhPSMA-7.3 (18F) doses from their site in Liege is a great development in our R&D programme. This will enable us to bring more European sites into our clinical trials programme as part of our work to bring new products to clinicians and their patients."

Fabrice Giacomelli, Chief Executive Officer of Nucleis Radiopharmaceuticals said, "We are pleased to have been chosen by a global leader in diagnostic imaging, Blue Earth Diagnostics, to manufacture and supply rhPSMA-7.3 (18F) doses for these two Phase 3 studies. This collaboration is fully aligned with the Nucleis mission of delivering innovative PET tracers and improving patient care."

About rhPSMA

rhPSMA-7.3 (18F) is an investigational agent that consists of a radiohybrid Prostate-Specific Membrane Antigen (PSMA)-targeted receptor ligand which attaches to and is internalized by prostate cancer cells, and is labeled with the 18F radioisotope for PET imaging. rhPSMA compounds can also be labeled with radioisotopes such as 177Lu and 225Ac for therapeutic use. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA imaging technology from Scintomics in 2018, with an option to therapeutic rights. rhPSMA originated from the Technical University of Munich, Germany, and has been utilised clinically under German legislation at the Department of Nuclear Medicine there for the diagnostic imaging of men with both primary and recurrent prostate cancer. rhPSMA compounds have not received regulatory approval.

This press release is intended to provide information about Blue Earth Diagnostics’ business in Europe.

On November 24, 2020 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel products for serious rare and ultra-rare genetic diseases, reported that Emil D. Kakkis, M.D., Ph.D., the company’s Chief Executive Officer and President, will present at the following upcoming investor conferences (Press release, Ultragenyx Pharmaceutical, NOV 24, 2020, View Source [SID1234571667]):

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Piper Sandler’s 32nd Annual Healthcare Conference on Tuesday, December 1, 2020. The pre-recorded presentation is currently available on the company’s website.

Evercore ISI HealthCONx Conference on Wednesday, December 2, 2020 at 1:00 PM ET.
The live and archived webcast of the presentation will be accessible from the company’s website at View Source The replay of the webcast will be available for 90 days.