On March 10, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported the U.S. Preventive Services Task Force (USPSTF) for its new, revised recommendations that expand eligibility for lung cancer screening (Press release, Veracyte, MAR 10, 2021, View Source [SID1234576406]). The updated recommendations lower the age for current and former smokers to begin screening from 55 to 50 years and reduces smoking intensity – from a 30 "pack-year" history to 20. The independent expert panel’s final recommendations appear online in the Journal of the American Medical Association and are expected to increase the number of people in the United States who are eligible for annual screening with low dose CT (LDCT) scans to nearly 15 million.

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"We commend the USPSTF for their new lung cancer screening recommendations, which will help ensure that more lives are saved through early detection," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "Lung cancer is the leading cause of cancer death in the United States because too often the disease is found after it has spread and is less treatable. Expanding screening eligibility – as well as the number of people who actually undergo screening – will be key to saving lives.

"Much work remains in the fight against lung cancer, including ensuring that physicians have optimal tools to help guide patient care when potentially cancerous lung nodules are found through screening. We are proud to be part of the healthcare sector that is utilizing novel genomic science to improve lung cancer early detection, diagnosis and treatment."

Veracyte’s Percepta Genomic Sequencing Classifier is available to improve the diagnosis of potentially cancerous lung nodules found on CT scans. The company is developing a first-of-its-kind, noninvasive nasal swab test to help determine which patients with lung nodules should undergo additional diagnostic procedures and which can simply be monitored. Additionally, the company is developing a comprehensive genomic profiling test to inform treatment decisions at the time of diagnosis. Both tests are scheduled for introduction in the second half of 2021.

About Lung Cancer

Lung cancer is the deadliest cancer globally, killing more than 1.75 million people worldwide each year, according to the World Health Organization. Early detection is key, with a five-year survival rate of nearly 60 percent when the cancer is found early, compared to six percent when it is found at a later stage, according to the American Lung Association. Lung nodules are typically the first sign of lung cancer. While the vast majority of lung nodules ultimately prove to be benign, physicians currently lack clear diagnostic tools to determine which patients have cancer and which do not. This can lead to unnecessary invasive biopsies, which are costly and risky, as well as to delayed diagnosis and treatment.

On March 10, 2021 ImmunityBio, Inc. (NASDAQ: IBRX) reported it has begun trading as a large cap company with approximately 398 million fully diluted shares outstanding following its merger with NantKwest (Press release, ImmunityBio, MAR 10, 2021, View Source [SID1234576422]). The combined company begins trading today on the Global Select Market of the Nasdaq exchange under the IBRX ticker.

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ImmunityBio is a leading late-clinical-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancers and infectious diseases. The company’s immunotherapy platform activates both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term "immunological memory."

The company’s broad-based platforms are based on the foundation of four separate modalities: Antibody cytokine fusion proteins, synthetic immunomodulators, second-generation human adenovirus (hAd5) and yeast vaccine technologies, and state-of-the-art, off-the-shelf natural killer cells, including autologous and allogenic cytokine-enhanced memory NK cells.

ImmunityBio has a broad immunotherapy clinical pipeline of over 40 clinical trials in Phase I, II and III development across 19 indications in solid and liquid cancers and infectious diseases. The clinical-stage pipeline and intellectual property portfolio spans 17 first-in-human antibody cytokine fusion proteins, chemo immuno-modulators, vaccine vectors, and cell therapies in 25 Phase II and III clinical trials. Anktiva (ImmunityBio’s lead cytokine infusion protein) is a novel interleukin-15 (IL-15) superagonist complex and has received Breakthrough Therapy and Fast Track Designations from the U.S. Food and Drug Administration (FDA) for BCG-unresponsive CIS non-muscle invasive bladder cancer (NMIBC).

On March 10, 2021 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, pancreatic cancer, castrate-resistant prostate cancer and leukemias, reported the publication of two abstracts that will be presented as electronic posters during Week 1 of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, taking place virtually from April 10-15, 2021 (Press release, Cardiff Oncology, MAR 10, 2021, View Source [SID1234576440]).

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Details on the electronic posters and corresponding abstracts are shown below.

Title: Expanded access program of the PLK1 inhibitor onvansertib for treatment of patients with KRAS-mutant metastatic colorectal cancer
Session Type: E-Poster Session
Session Category: Clinical Research (Excluding Trials)
Session Title: Clinical Outcomes Research
Abstract Number: 425

This abstract includes findings from Cardiff Oncology’s Expanded Access Program (EAP) for onvansertib in KRAS-mutated metastatic colorectal cancer (mCRC). The findings show that of the 13 patients with a KRAS mutation detected in circulating tumor DNA (ctDNA) at baseline, 8 had a decrease of greater than 50% in KRAS mutant allelic frequency (MAF) following two treatment cycles of onvansertib (15 mg/m2, Days 1 to 5 of a 14-day cycle) in combination with FOLFIRI and bevacizumab (Day 1 of each cycle). Additional observations regarding clinical benefit and correlations between KRAS MAF and treatment response will be featured as part of the upcoming electronic poster presentation at the AACR (Free AACR Whitepaper) annual meeting.

Title: The selective polo-like kinase (Plk1) inhibitor onvansertib and the antiandrogen abiraterone synergistically kill cancer cells through disruption of mitosis independently of androgen receptor signaling
Session Type: E-Poster Session
Session Category: Experimental and Molecular Therapeutics
Session Title: Cell Cycle Mechanisms of Anticancer Drug Action
Abstract Number: 973

This abstract describes preclinical studies that aim to identify the mechanisms driving onvansertib-abiraterone synergy by treating prostate cancer cell lines showing, or not showing, synergy between these drugs with vehicle, abiraterone, enzalutamide, or onvansertib prior to RNA sequencing and Gene Set Variation Analysis (GSVA). In synergistic cells, a group of mitosis and mitotic spindle related gene sets were significantly upregulated by both abiraterone and onvansertib. These gene sets were not upregulated in non-synergistic cells, or by enzalutamide, indicating that abiraterone may target mitosis related genes or processes in an androgen receptor-independent manner. Data also suggested that baseline differences in mitotic arrest and spindle assembly checkpoint dependent cell death pathways may be predictive of synergy and patient response to the onvansertib-abiraterone combination. This hypothesis is currently being evaluated in an ongoing Phase 2 trial evaluating the all-oral regimen of onvansertib, abiraterone and prednisone in metastatic castrate-resistant prostate cancer patients showing initial abiraterone resistance.

The full texts of the published abstracts are currently available on the AACR (Free AACR Whitepaper) Annual Meeting 2021 website. The corresponding posters will be available for on-demand viewing on the AACR (Free AACR Whitepaper) Annual Meeting 2021 e-poster website starting at 8:30 am ET on April 10, 2021 and will also be posted to the "Scientific Presentations" section of the Cardiff Oncology website at View Source

About the Phase 2 Trial of Onvansertib in Metastatic Castrate-Resistant Prostate Cancer

This trial is a Phase 2 open-label study of onvansertib in combination with abiraterone and prednisone, all administered orally, in patients with metastatic castration-resistant prostate cancer showing signs of early progressive disease (demonstrated by two rising prostate-specific antigen values separated by at least one week with no or minimal symptoms) while on Zytiga/prednisone therapy. The primary efficacy endpoint is the proportion of patients achieving disease control after 12 weeks of study treatment, as defined by a lack of prostate-specific antigen (PSA), radiographic, or symptomatic progression. The trial is being conducted by Beth Israel Deaconess Medical Center (BIDMC), Dana-Farber Cancer Institute (Dana-Farber), and Massachusetts General Hospital Cancer Center (MGH). David Einstein, M.D., Genitourinary Oncology Program at BIDMC, is the principal investigator for the trial. For more information on the trial, please visit View Source

About the Expanded Access Program (EAP) for Onvansertib in KRAS-mutated mCRC

Sometimes called "compassionate use", expanded access is a potential pathway for a patient with a serious or life-threatening disease to gain access to an investigational drug for treatment outside of a clinical trial, particularly when no comparable or satisfactory alternative therapy options are available. The Cardiff Oncology EAP in KRAS-mutated mCRC is using the same combination treatment regimen (onvansertib 15 mg/m2 + FOLFIRI/bevacizumab) and dosing schedule as the ongoing Phase 1b/2 clinical trial and is intended for patients that have progressed on prior therapy and do not meet the eligibility criteria for enrollment in the clinical trial. For more information on the expanded access program, please visit View Source

On March 9, 2021 GeneCentric Therapeutics, a company making precision medicine more precise, reported the granting of Patent No. 10,934,595 by the United States Patent and Trademark Office (USPTO), protecting another one of its novel RNA-based lung cancer gene signatures (Press release, GeneCentric Therapeutics, MAR 9, 2021, View Source [SID1234576311]). This new patent provides further demonstration of the novel RNA-based technology achievements of the GeneCentric team and its growing pipeline of predictive response signatures developed using its Tumor and Immune Micro-Environment (T(I)ME) Explorer platform.

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The patent covers the use of reduced RNA gene sets to characterize tumors from patients diagnosed with non-squamous non-small cell lung cancer (NSCLC), which are foundational to the development of the company’s predictive response signatures and diagnostics for this important patient population. The use of RNA-based gene signatures allows for a deeper understanding of the T(I)ME than DNA mutations alone, often allowing for the identification of a broader patient population that may benefit from targeted therapy compared to use of traditional DNA mutation analysis.

"Those of us who study the genomics of lung cancer have known for more than a decade that there is a rich and reproducible story to be told though gene expression assays," said Neil Hayes, MD, GeneCentric co-founder, and Scientific Director, University of Tennessee West Institute for Cancer Research. "The signatures inherent to clinically relevant subgroups are opaque to the microscope but revealed through the genome. We are thrilled to open the door to applications applicable to prognosis and response for traditional cytotoxic chemotherapy, targeted therapies, and emerging immune-oncologic approaches."

GeneCentric continues to make significant progress with its growing pipeline of RNA-based predictive response signatures and molecular diagnostics, with the lung cancer program as its cornerstone. Further updates will be provided as the company presents additional data validating its novel RNA-based signatures and diagnostic tests across multiple tumor types at upcoming scientific meetings and in peer-reviewed publications.

"This is an important time for GeneCentric as we clinically validate and prepare to launch this diagnostic test," said Dr. Mike Milburn, President, and CEO of GeneCentric Therapeutics. "The granting of this latest lung cancer patent by the USPTO demonstrates the utility and uniqueness of our growing pipeline of RNA-based diagnostics,"

On March 9, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX) reported the publication of results from the UNITY-NHL Phase 2b trial evaluating UKONIQ (umbralisib), the Company’s inhibitor of PI3k-delta and CK1-epsilon, in patients with relapsed or refractory indolent non-Hodgkin Lymphoma (NHL) in the Journal of Clinical Oncology (JCO) (Press release, TG Therapeutics, MAR 9, 2021, View Source [SID1234576327]).

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Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, "We are extremely pleased that the results of the UNITY-NHL trial which supported the recent approval of umbralisib, now called UKONIQ, in relapsed or refractory marginal zone and follicular lymphoma, have been published in the prestigious Journal of Clinical Oncology. The data published yesterday, and previously presented at the ASH (Free ASH Whitepaper) 2020 conference, highlight the utility of UKONIQ across these diseases. As the first and only inhibitor of both PI3K-delta and CK1-epsilon, which is now commercially available, we believe UKONIQ offers an important new treatment option for patients."

Pier Luigi Zinzani, MD, PhD, Professor, Institute of Hematology, "L. e A. Seràgnoli", University of Bologna, and Global Chair of the UNITY-NHL Phase 2b study stated, "The data published yesterday as well as the recent U.S. FDA approval of umbralisib in relapsed or refractory marginal zone lymphoma and follicular lymphoma, are encouraging for patients suffering from these diseases, especially given the lack of a standard of care in these settings. As we see from the UNITY-NHL publication, umbralisib offers meaningful clinical activity across both marginal zone and follicular lymphoma and a manageable safety profile with relatively low rates of immune mediated toxicities and discontinuations due to adverse events."

The manuscript includes data from 208 patients with relapsed or refractory iNHL, including 69 marginal zone lymphoma (MZL), 117 follicular lymphoma (FL), and 22 small lymphocytic lymphoma (SLL) patients who were unresponsive to prior treatments (≥1 MZL; ≥2 FL/SLL), including anti-CD20–based therapy. Patients were administered umbralisib 800 mg orally once-daily until disease progression, unacceptable toxicity, or study withdrawal. The primary end point was overall-response-rate (ORR) as assessed by an independent review committee (IRC) based on the Lugano classification.

Key highlights from this manuscript include:

The ORR was 47.1% across all relapsed or refractory iNHL patients treated (n=208)
At a median follow-up of 27.8 months patients with relapsed or refractory MZL demonstrated:
• 49.3% ORR with 16% Complete response (CR) rate (IRC assessed)
• Median duration of response (DOR) was not reached (95% CI, 10.3 – not estimable) and
• Median Progression Free Survival (PFS) was not reached (95% CI, 12.1 – not estimable)
At a median follow-up of 27.5 months patients with relapsed or refractory FL demonstrated:
• 45.3% ORR with 5.1% achieving a CR (IRC assessed)
• Median DOR of 11.1 months (95% CI, 8.3–15.6)
• Median PFS was 10.6 months
Grade ≥3 treatment emergent adverse events (TEAEs) reported in ≥10% of patients included: neutropenia (11.5%) and diarrhea (10.1%). Increased ALT/AST (grade ≥3) occurred in 6.7%/7.2% of patients.
Other AEs of special interest included pneumonitis (1.4%; grade >3 1.0%) and non-infectious colitis (1.9%; grade >3 0.5%).
A total of 31 patients (14.9%) discontinued due to a treatment-related adverse event.
These data are described further in the manuscript entitled, "Umbralisib, a Dual PI3Kδ/CK1ε Inhibitor in Patients with Relapsed/Refractory Indolent Lymphoma," which was published online yesterday in the Journal of Clinical Oncology. The online version of the article can be accessed at View Source