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AMN Healthcare to Host Fourth Quarter and Full Year 2019 Earnings Conference Call on Thursday, February 13, 2020

On January 14, 2020 AMN Healthcare Services, Inc. (NYSE: AMN), healthcare’s leader and innovator in workforce solutions and staffing services, has reported a conference call to discuss its fourth quarter and full year 2019 financial results on Thursday, February 13, 2020 at 5:00 p.m. Eastern Time (Press release, AMN Healthcare Services, JAN 14, 2020, View Source [SID1234553200]). The same day, the Company also expects to issue an earnings news release after market close at approximately 4:15 p.m. Eastern Time.

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A live webcast of the call can be accessed through AMN Healthcare’s website at View Source Please log in at least 10 minutes prior to the conference call in order to download the applicable audio software. Interested parties may participate live via telephone by dialing (844) 721-7241 in the U.S. or (409) 207-6955 for international callers. Following the conclusion of the call, a replay of the webcast will be available at the Company’s website. Alternatively, a telephonic replay of the call will be available beginning at 6:30 p.m. Eastern Time on February 13, 2020, and can be accessed until 11:59 p.m. Eastern Time on February 27, 2020 by calling (866) 207-1041 in the U.S. or (402) 970-0847 internationally, with access code 2857669.

Quantum Leap Healthcare Collaborative and G1 Therapeutics Announce the Selection of Trilaciclib in the I-SPY 2 TRIAL for Breast Cancer

On January 14, 2020 Quantum Leap Healthcare Collaborative and G1 Therapeutics, Inc. (Nasdaq: GTHX) reported a collaboration to evaluate trilaciclib, an investigational therapy designed to improve outcomes for people with cancer treated with chemotherapy, in a new randomized, investigational treatment arm for the ongoing I-SPY 2 TRIAL for neoadjuvant treatment of locally advanced breast cancer (Press release, QuantumLeap, JAN 14, 2020, View Source [SID1234553199]).

The I-SPY 2 TRIAL (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2) is squarely focused on early stage breast cancers that have a high risk of recurrence. (PRNewsfoto/Quantum Leap Healthcare Collabo)
The I-SPY 2 TRIAL (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2) is squarely focused on early stage breast cancers that have a high risk of recurrence. (PRNewsfoto/Quantum Leap Healthcare Collabo)
"The I-SPY 2 TRIAL is designed to evaluate agents with the goal of accelerating the pace of promising effective and potentially less toxic treatments to patients who are most likely to benefit quickly. We are excited to include trilaciclib in I-SPY 2, with the goal of determining whether adding trilaciclib to neoadjuvant chemotherapy-based treatment, either with or without an immune checkpoint inhibitor, increases the probability that the tumor will disappear prior to surgery, signaling a much better outcome and survival. The study will also measure how much chemotherapy lowers red and white blood cell levels (myelosuppression) to assess whether trilaciclib reduces any of these negative side effects, which have a significant impact on patient care and quality of life," stated Dr. Laura J. Esserman, MD, MBA, Principal Investigator of I-SPY 2 and Director of the Carol Franc Buck Breast Care Center at the UCSF Helen Diller Family Comprehensive Cancer Center. "As with other arms, the I-SPY 2 TRIAL, has the ability to evaluate the drug across an array of biomarker signatures to learn the chance of how it will benefit patients and predict success in a confirmatory phase 3 trial."

"The I-SPY 2 program is recognized as a leading breast cancer research initiative, and we are excited about the opportunity to evaluate the potential of trilaciclib to improve outcomes for a range of breast cancer subtypes. In our Phase 2 trial of women with triple negative breast cancer, patients who received trilaciclib plus chemotherapy showed significant improvement in overall survival, and reductions in the rate of red blood cell transfusions versus patients treated with chemotherapy alone," said Raj Malik, M.D., Chief Medical Officer and Senior Vice President, R&D at G1. "The I-SPY 2 study will allow us to evaluate trilaciclib for the first time in combination with several broadly-used chemotherapy classes. It will provide important data regarding which patients may benefit from treatment with trilaciclib and inform our future development plans."

The I-SPY 2 TRIAL, sponsored by Quantum Leap, is a standing Phase 2 randomized, controlled, multicenter platform with an innovative Bayesian adaptive randomization design aimed to rapidly screen and identify promising new treatments in specific subgroups of adults with newly-diagnosed, high-risk (high likelihood of recurrence), locally-advanced breast cancer (Stage II/III). G1 Therapeutics will provide funding and trilaciclib and Quantum Leap will be responsible for running the trial.

Trilaciclib will be evaluated across all high-risk, early stage breast cancer subtypes (including HR+, HER2+ and triple negative breast cancer). All patients will receive standard neoadjuvant treatment, including chemotherapy (and anti-HER2 Mab for HER2+ disease) prior to surgical resection of breast tissue. Patients in two arms of the study will also receive an anti-PD-1 immunotherapy in combination with paclitaxel prior to surgery. Biomarker data to evaluate the impact of trilaciclib on the tumor immune microenvironment, as well as pre-specified endpoints to evaluate anti-tumor efficacy and myelopreservation will be collected.

About Trilaciclib

Trilaciclib is a first-in-class investigational therapy designed to improve outcomes for people with cancer treated with chemotherapy. Based on results from three randomized trials in patients with small cell lung cancer, trilaciclib has received Breakthrough Therapy Designation, and G1 Therapeutics expects to submit marketing applications in the U.S. and Europe for myelopreservation in small cell lung cancer in 2020. In a randomized trial of women with metastatic triple-negative breast cancer, trilaciclib improved overall survival when administered in combination with chemotherapy compared with chemotherapy alone. In 2020, the company plans to initiate a Phase 3 clinical trial in colorectal cancer and begin a neoadjuvant trial in breast cancer as part of the I-SPY 2 TRIAL.

About the I-SPY TRIALs

The I-SPY 2 TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis) was designed to rapidly screen promising experimental treatments and identify those most effective in specific patient subgroups based on molecular characteristics (biomarker signatures). The trial is a unique collaborative effort by a consortium that includes the Food and Drug Administration (FDA), industry, patient advocates, philanthropic sponsors, and clinicians from more than 20 major U.S. cancer research centers. Under the terms of the collaboration agreement, Quantum Leap Healthcare Collaborative is the trial sponsor and manages all study operations. For more information, visit www.ispytrials.org.

John Theurer Cancer Center Investigators Report Transformative Results of CAR T-Cell Therapy in Relapsed/Refractory Mantle Cell Lymphoma (MCL)

On January 14, 2020 John Theurer Cancer Center (JTCC) at Hackensack University Medical Center in New Jersey reported that were part of the 15-site international ZUMA-2 trial, a phase II study of CAR T-cell therapy in a heavily pretreated patient population who had exhausted all standard treatment options for mantle cell lymphoma (MCL) (Press release, John Theurer Cancer Center, JAN 14, 2020, View Source [SID1234553198]).

After a single infusion of KTE-X19, 93% of patients with relapsed/refractory MCL responded and 67% achieved a complete response (CR) rate (i.e., no remaining disease). These unprecedented results were presented at the 2019 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, held in December in Orlando, Florida — the world’s leading conference for hematologic cancers and blood disorders.

With CAR T-cell therapy, white blood cells called T cells are removed from the patient, modified in the laboratory to make them recognize a protein (CD19) on lymphoma cells, then expanded to much larger numbers and returned to the patient intravenously, where they can expand further to detect and destroy cancer cells anywhere in the body. Two forms of CAR T-cell therapy — aci-cell (Yescarta) and tisa-cell (Kymriah) — are currently approved by the U.S. Food and Drug Administration to treat recurrent and persistent B-cell lymphoma in adults, as well as acute lymphoblastic leukemia in children and young adults up to age 25. However, CAR T-cell therapy is not yet approved to treat MCL, an aggressive type of non-Hodgkin lymphoma which becomes resistant to therapy over time and is associated with very poor outcomes.

The ZUMA-2 study included MCL patients who had failed to respond to both chemoimmunotherapy and BTK inhibitors, such as ibrutinib or acalabrutinib. The 93% response rate and 67% CR rate were observed regardless of the number of prior therapies or extent of disease. Interestingly, 40% of patients who initially had a partial response or stable disease achieved a CR within 3 to 12 months, showing the effectiveness of a "living drug" that continues to work over time.

Responses were also durable, with one-year estimates of progression-free survival (the time before the cancer continued to grow) and overall survival being 71% and 86%, respectively. At the time of analysis, the median duration of response had not yet been reached, and for those who achieved a CR, 78% of patients remained in remission. For the first 28 patients who were treated with axi-cel and had the longest follow-up time (median 27 months), 43% of the responders remained in remission — a rate totally unprecedented for this population.

"This will be a true game-changer in the management of patients with mantle cell lymphoma," said Andre Goy, M.D., M.S., Chairman and Director of JTCC, Lymphoma Division Chief, and a renowned lymphoma expert who led JTCC’s participation in the ZUMA-2 study.

Side effects were generally manageable and as expected with CAR T-cell therapy, including low blood cell counts, cytokine release syndrome (a release of inflammatory proteins associated with the immune response), and nervous system side effects that were all reversible.

John Theurer Cancer Center Investigators Report Poor Colorectal Cancer Biomarker Testing Rates

On January 14, 2020 John Theurer Cancer Center (JTCC) at Hackensack University Medical Center in New Jersey are reported the first to report poor adherence to genomic profiling guidelines for four biomarkers of metastatic colorectal cancer used to predict response to therapy, choose the most effective treatment, and improve outcomes — showing that only 40% of patients had their tumors tested (Press release, John Theurer Cancer Center, JAN 14, 2020, View Source [SID1234553197]). The study was published online in the December 6, 2019 issue of JCO Precision Oncology, a publication of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).

"Despite guidelines that recommend testing for four common biomarkers in patients with metastatic colorectal cancer, overall testing rates were suboptimal," noted hematologist-oncologist Stuart L. Goldberg, M.D., Chief, Division of Outcomes and Value-Based Care at JTCC, Associate Professor of Medicine at Seton Hall School of Medicine, and senior author of the study. "We expected there to be better awareness of the guidelines with time and increased testing rates over the years, but that did not turn out to be the case."

Genomic testing is recognized in national guidelines as essential to guide appropriate therapy selection in metastatic colorectal cancer. The presence or absence of mutations in genes such as RAS (KRAS and NRAS) and BRAF and genetic changes called microsatellite instability (MSI) can predict how well a patient will respond to metastatic colorectal cancer therapies such as cetuximab, panitumumab, and immunotherapy with pembrolizumab. Starting in 2009 and over the ensuing decade, ASCO (Free ASCO Whitepaper) and the National Comprehensive Cancer Network (NCCN) began publishing guidelines recommending routine genomic testing for KRAS, NRAS, BRAF, and MSI status in patients with metastatic colorectal cancer.

Studies published earlier have reported that adherence to testing guidelines was suboptimal, but current testing rates have not been assessed. Investigators at John Theurer Cancer Center retrospectively reviewed the COTA Real World Data database to identify patients with metastatic colorectal cancer diagnosed between 2013 and 2017. Among the 1,497 patients identified, testing for biomarkers according to the guidelines for RAS, BRAF, and MSI were 41%, 43%, and 51%, respectively. RAS and BRAF testing were more likely to be done in academic medical centers compared with community hospitals. Of 177 patients who received cetuximab or panitumumab — drugs indicated for the treatment of people with normal RAS genes — only 28% had undergone tumor testing for RAS status.

"When biomarker testing is underutilized, it places patients at risk of receiving ineffective therapies and may delay or prevent them from receiving appropriate therapeutic options," explained lead author Martin E. Gutierrez, M.D., Chief of Thoracic Oncology and Director of Drug Discovery and the Phase I Unit at JTCC. "Adherence to guideline-recommended biomarker testing would potentially reduce exposure to expensive and ineffective therapies, resulting in more rationale care and improved patient outcomes."

The investigators noted that possible barriers to biomarker testing may include availability of tumor tissue, turnaround time, physician knowledge, cost and insurance issues, patient preferences, and patient eligibility for therapy based on overall health.

AIVITA Biomedical to Present at Biotech Showcase 2020

On January 14, 2020 AIVITA Biomedical, Inc., a biotech company specializing in innovative stem cell applications, reported that it will be featured as a presenting company at the annual Biotech Showcase conference taking place January 13-15 at the Hilton San Francisco Union Square in San Francisco, California (Press release, AIVITA Biomedical, JAN 14, 2020, View Source [SID1234553196]). Dr. Hans S. Keirstead, AIVITA’s Chairman and CEO, will present at the following time and location:

Date: Tuesday, January 14, 2019
Time: 10:00 AM
Track: Franciscan D (Ballroom Level)

Biotech Showcase is an annual investor and networking conference that provides private and public biotechnology and life science companies with an opportunity to present and meet with investors and pharmaceutical executives.

Dr. Keirstead will be presenting details on AIVITA’s platform cancer technology, a next generation immunotherapy targeting the tumor-initiating stem cells, with strong clinical data evidencing 72% survival at 2-years, and 54% survival at 5-years post-treatment. AIVITA is currently conducting three clinical studies investigating its platform immunotherapy in patients with ovarian cancer, glioblastoma and melanoma.

CLINICAL TRIAL DETAIL

OVARIAN CANCER

AIVITA’s ovarian Phase 2 double-blind study is active and enrolling approximately 99 patients who are being randomized in a 2:1 ratio to receive either the autologous tumor-initiating cell-targeting immunotherapy or autologous monocytes as a comparator.

Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient monocytes were obtained, (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), and (5) who have completed primary therapy. The trial is not open to patients with recurrent ovarian cancer.

For additional information about AIVITA’s AVOVA-1 trial patients can visit: www.clinicaltrials.gov/ct2/show/NCT02033616

GLIOBLASTOMA

AIVITA’s glioblastoma Phase 2 single-arm study is active and is enrolling approximately 55 patients to receive the tumor-initiating cell-targeting immunotherapy.

Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a Karnofsky Performance Status of > 70 and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC). The trial is not open to patients with recurrent glioblastoma.

For additional information about AIVITA’s AV-GBM-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03400917

MELANOMA

AIVITA’s melanoma Phase 1B open-label, single-arm study will establish the safety of administering anti-PD1 monoclonal antibodies in combination with AIVITA’s tumor-initiating cell-targeting immunotherapy in patients with measurable metastatic melanoma. The study will also track efficacy of the treatment for the estimated 14 to 20 patients. This trial is not yet open for enrollment.

Patients eligible for treatment will be those (1) for whom a cell line has been established, (2) who have undergone leukapheresis from which sufficient monocytes were obtained, (3) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), (4) who have either never received treatment for metastatic melanoma or were previously treated with enzymatic inhibitors of the BRAF/MEK pathway because of BRAF600E/K mutations and (5) are about to initiate anti-PD1 monotherapy.