NeoImmuneTech Announces First Patient Dosed in Phase 2 Study of NT-I7 (efineptakin alfa) with PD-L1 Checkpoint Inhibitor in High-Risk Skin Cancers

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.

Agendia Study Demonstrates MammaPrint® and BluePrint® Capture Full Spectrum of Early Breast Cancer Biology, Providing Opportunity for Highly Individualized Treatment

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.

Fortress Biotech to Participate in the 2nd Annual Winter Wonderland Best Ideas Virtual Investor Conference

On February 7, 2022 Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), an innovative revenue-generating company focused on acquiring, developing and commercializing or monetizing promising biopharmaceutical products and product candidates cost-effectively, reported that Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer, will present a corporate update at the 2nd Annual Winter Wonderland Best Ideas Virtual Investor Conference on Wednesday, February 9, 2022, at 9:30 a.m. ET and will participate in one-on-one meetings during the conference (Press release, Fortress Biotech, FEB 7, 2022, View Source [SID1234607802]).

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A live webcast of the presentation will be available on the Events page under the News & Media section of Fortress’ website: www.fortressbiotech.com, for approximately 30 days after the meeting.

Aeterna Zentaris to Present at the 2022 BIO CEO & Investor Conference

On February 7 2022 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) ("Aeterna" or the "Company"), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, reported that Dr. Klaus Paulini, Chief Executive Officer of Aeterna Zentaris, will present at the BIO CEO & Investor Conference being held in New York, NY and virtually, February 14-17, 2022 (Press release, AEterna Zentaris, FEB 7, 2022, View Source;id=223115&p=2218793&I=1206939-c7Z3G6f3m8 [SID1234607801]).

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In addition to the presentation, management will be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information about the conference, please visit the conference website.

A video webcast of the presentation will be available for viewing on-demand for those registered for the event.

Horizon Therapeutics plc to Release Fourth-Quarter and Full-Year 2021 Financial Results and Host Webcast on March 1, 2022

On February 7, 2022 Horizon Therapeutics plc (Nasdaq: HZNP) reported that it will release its fourth-quarter and full-year 2021 financial results on Tuesday, March 1, 2022 (Press release, Horizon Therapeutics, FEB 7, 2022, View Source [SID1234607800]). Following the announcement, Horizon’s management will host a live webcast at 8 a.m. Eastern Time to review the Company’s financial and operating results.

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The live webcast and a replay may be accessed at View Source Please connect to the Company’s website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. A replay of the webcast will be available approximately two hours after the live webcast.