On February 7, 2022 Agendia, Inc., a commercial stage company focused on enabling optimized decision-making by providing physicians with next-generation diagnostic and information solutions that can be used to help improve outcomes for breast cancer patients worldwide, reported new data published in Genes, Chromosomes and Cancer (Genes) that show MammaPrint and BluePrint gene signatures represent and capture all of the original 10 hallmarks of cancer (HoCs), recognized as the biological capabilities acquired during the multi-step development of human cancer, as defined by Hanahan and Weinberg.1,2 (Press release, Agendia, FEB 7, 2022, View Source [SID1234607803])

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Previous data demonstrated the association of the 70 MammaPrint genes with the initial six HoCs, which represent characteristics acquired during the multistep development of cancer cells to survive, proliferate, disseminate, and metastasize.3 In updating the annotation of MammaPrint and BluePrint genes related to the subsequently established HoCs, the data published in Genes underscores the biological relevance in, and the comprehensive nature of, the MammaPrint signature extending beyond tumor proliferation genes.

"This study further unlocks new insights that MammaPrint and BluePrint are accurately aligned with the 10 hallmarks of cancer, which are considered the underlying biological processes," said Frédérique Penault-Llorca, MD, PhD, Professor of Pathology in the Department of Pathology and Molecular Pathology, Centre Jean Perrin, Clermont-Ferrand, France. "With this validation, the updated annotations show the clinical utility of MammaPrint and BluePrint as comprehensive genomic tools to provide more precise insights for women with breast cancer."

Additionally, the peer-reviewed data highlights MammaPrint’s ability to further stratify High Risk breast cancer tumors based on their underlying biological processes into High 1 or High 2 sub-groups, offering physicians more specific insights as they guide treatment decisions for women with early-stage breast cancer. Previous data from the ISPY trial demonstrated that MammaPrint can identify separate High 1 and High 2 sub-groups, with different responses to treatment. These data show that the High 2 Risk sub-group is biologically different from High 1 but also from the other extreme end of the spectrum: Ultra Low. The biological features may explain differences in the prognosis and therapy responses of these tumors. Through the discovery and validation of more specific stratifications in the High Risk category, providers can more precisely treat these biologically differentiated tumors that have higher pathologic response rates to treatment combinations, including chemotherapy and immunotherapy.

"This latest study illustrates with elegant biology, the comprehensive nature of the genomic information provided by MammaPrint and BluePrint. It also confirms our expectation that the MammaPrint High Risk category further identifies clinically important distinctions in breast cancer biology, reflecting the evolving knowledge in the field," said William Audeh, MD, Chief Medical Officer at Agendia. "These findings highlight today’s opportunity to stratify MammaPrint signatures beyond Low and High Risk, which allows patients and physicians to better understand the genomic complexity of breast cancer and provides new insights at the time of diagnosis that may impact the course of treatment."

Agendia is committed to continuing research to validate additional datasets evaluating the precise tumor stratification by MammaPrint and molecular subtyping by BluePrint to inform refined, personalized treatment planning decisions for women with breast cancer and their providers.

On February 7, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company developing next-generation products to address the growing needs in oncology, reported that it has received a confirmation from the US Food and Drug Administration (FDA) that the diagnostic 64Cu SAR-bisPSMA trial (COBRA) may proceed (Press release, Clarity Pharmaceuticals, FEB 7, 2022, View Source [SID1234607769]).

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Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are excited to be progressing this stand-alone diagnostic trial following a Study May Proceed letter from the US FDA as we head towards registering this product in the US. Following this exciting news, we are now planning to commence recruitment in the trial in the second quarter of CY2022."

COBRA (Copper-64 SAR-BisPSMA in Biochemically Recurrent prostAte cancer) is a Phase I/II Positron Emission Tomography (PET) trial of participants with biochemical recurrence (BCR) of prostate cancer following definitive therapy. It is a multi-centre, single arm, non-randomised, open-label trial of 64Cu-labelled SAR-bisPSMA in up to 50 participants. The primary objectives of the trial are to investigate safety and tolerability of 64Cu-SAR-bisPSMA as well as its ability to correctly detect recurrence of prostate cancer.

Prostate cancer is a key focus of Clarity’s Targeted Copper Theranostics (TCT) program where COBRA is the third clinical trial of the optimised SAR-bisPSMA agent in prostate cancer. The US-based theranostic 64Cu/67Cu SAR-bisPSMA trial, SECuRE (NCT04868604)1, has already demonstrated utility in patients with metastatic castrate resistant prostate cancer with imaging from 1 hour to 72 hours post-injection. The diagnostic 64Cu SAR-bisPSMA trial in Australia, PROPELLER (NCT04839367)2, is well underway, having reached its 50% recruitment milestone in untreated, confirmed prostate cancer patients (i.e. pre-radical prostatectomy) in December 2021. Clarity has previously received advice from the FDA that its prostate diagnostic clinical program with 64Cu SAR-bisPSMA is addressing the two relevant patient populations for registration: pre-prostatectomy/pre-definitive treatment as well as patients with suspected biochemical recurrence.

Dr Alan Taylor further commented, "The preliminary data from our SAR-bisPSMA trials in Australia and the US look very promising and the high uptake and retention of SAR-bisPSMA shown in preclinical and clinical trials to date may lead to improved detection in patients with prostate cancer, particularly those with low PSA levels. Our team and our collaborators are excited to commence the COBRA trial, generating more data to progress the development of SAR-bisPSMA as we move this product closer to registration in the US.

"We also look forward to further validating our on-demand distribution model as the trial sites will be supplied with ready-to-use cGMP 64Cu-SAR-bisPSMA product. Clarity’s vision is to move the diagnostic field towards centrally manufactured products that can be delivered on demand, shifting away from the supply constraints of the first generation of PET agents such as gallium-68 and fluorine-18 and the burdensome challenges of short-lived radionuclides. But most importantly, on-demand central manufacture of radiopharmaceuticals could potentially improve patient care by focusing on the needs of patients and their treating staff, delivering critical treatments that are safe and efficacious, on time and at any treatment centre with a PET camera."

Dr Neal Shore MD, FACS (CMO – Urology/Surgical Oncology, GenesisCare, US and the Medical Director of Carolina Urologic Research Centre), Principal Investigator in the COBRA trial, commented, "I am impressed by the images seen to date and look forward to working together with Clarity on the COBRA trial, exploring the clinical benefits of 64Cu SAR-bisPSMA in patients with BCR of prostate cancer. Higher uptake of the product in tumours may offer improvements in diagnosis of disease, which is particularly relevant for patients with suspected recurrence of prostate cancer. The ability to diagnose the disease earlier offers the potential to provide better treatment options earlier. When these benefits are combined with the ability to supply the products on demand and in large scale, this may be a game changer for prostate cancer management."

This announcement has been authorised for release by the Executive Chairman.

On February 7, 2022 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported that Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics, will present a company overview during the BIO CEO & Investor Conference on Monday, February 14, 2022 at 1:15 p.m. ET, at the New York Marriott Marquis (Press release, Cytori Therapeutics, FEB 7, 2022, View Source;Investor-Conference/default.aspx [SID1234607786]).

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The Company’s live presentation will be made available through the BIO CEO & Investor Conference website and available on-demand to registered participants during the conference at View Source Investors interested in arranging a meeting with the Company’s management for this conference should contact the conference coordinator.

On February 7, 2022 NeoImmuneTech, Inc. (KOSDAQ: 950220), a clinical-stage T cell-focused biopharmaceutical company, reported that the first patient has been dosed in the Phase 2a portion of a study evaluating NT-I7 (efineptakin alfa), a novel long-acting human interleukin-7 (IL-7), in combination with the PD-L1 targeting drug atezolizumab (Tecentriq), in patients with advanced high-risk skin cancers including melanoma, merkel cell carcinoma (MCC), and cutaneous squamous cell carcinoma (cSCC) (Press release, NeoImmuneTech, FEB 7, 2022, View Source [SID1234607804]).

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All three of these skin cancers can grow rapidly and have the potential to be fatal if left untreated. While cSCC is considered a more treatable form of skin cancer, it affects millions of patients per year in the U.S. alone and represents up to 50% of all skin cancer cases. Melanoma and MCC are less common forms of skin cancer, but they are notable for spreading rapidly and carrying a high risk for recurrence. Skin cancer is the most common form of cancer in the U.S., accounting for more diagnoses than all other cancers combined1.

"We are excited to move into the Phase 2 portion of this important clinical trial, now that the safety and tolerability of the combination has been demonstrated," said Se Hwan Yang, Ph.D., President and CEO of NIT. "NT-I7’s established ability to amplify T cells coupled with its excellent safety profile gives us great confidence that combinations with checkpoint inhibitor therapies like atezolizumab could improve clinical outcomes. We look forward to watching this next phase of the trial unfold and potentially set the foundation for a new immunotherapeutic option for the many patients living with these forms of skin cancer."

This open-label, multicenter Phase 2a study will evaluate the safety, tolerability and anti-tumor effect of the combination therapy. Roche will supply NeoImmuneTech with atezolizumab for the clinical trial. More information can be found at www.neoimmunetech.com or www.clinicaltrials.gov, identifier: NCT03901573.

Tecentriq (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

About NT-I7

NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T cell amplification and enhanced functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). In clinical trials to date, NT-I7 has exhibited favorable PK/PD and safety profiles, both as a monotherapy and in combination with other anticancer treatments. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

On February 7, 2022 Emergent BioSolutions Inc. (NYSE: EBS) reported that it will host a conference call on Thursday, February 24, 2022 at 5:00 pm eastern time to discuss the financial results for the fourth quarter 2021, recent business developments, financial outlook for full year 2022, and revenue guidance for the first quarter of 2022 (Press release, Emergent BioSolutions, FEB 7, 2022, View Source [SID1234607787]).

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This conference call can be accessed live by telephone or by webcast:

Webcast Information:
Visit View Source for the live webcast.

A replay of the call can be accessed from the Investors page of the Emergent website.