On June 3, 2019 NantKwest Inc. (Nasdaq:NK), a pioneering, next generation, clinical-stage immunotherapy company focused on harnessing the unique power of our immune system using natural killer (NK) cells to treat cancer, infectious diseases and other diseases, reported that the company’s t-haNK investigational new drug application (IND) has cleared FDA review and the program has now transitioned to a first-in-human clinical trial targeting CD19 t-haNK in advanced B-cell lymphoma (Press release, NantKwest, JUN 3, 2019, View Source [SID1234536841]).

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CD19 is a transmembrane protein expressed in B cells and overexpressed in a large percentage of advanced leukemia and lymphoma representing a well validated therapeutic target. The CD19 t-haNK cell therapy is a novel, NK cell based immuno-oncology therapy that includes a CD19-based Chimeric Antigen Receptor (CAR) that has been engineered to create an NK cell that includes the high affinity CD16 (Fc receptor), which enhances an NK cell’s ability to bind and enhance monoclonal antibody activity. Use of a targeted, bi-specific NK cell is intended to enhance the cancer cell killing ability of this novel NK cell therapy.

"Based on extensive and encouraging preclinical results, we have enhanced our ability to modularly combine this proprietary off-the-shelf t-haNK-based therapy with a wide range of monoclonal antibodies using this multi-targeted approach," commented Dr. Patrick Soon-Shiong, Chairman and CEO of NantKwest. Dr. Soon-Shiong continued, "We are now ready to transition this innovation in NK cell based therapeutics to a Phase I human clinical trials designed to assess the safety, tolerability and efficacy of CD19 t-haNK cell therapy in advanced b-cell lymphoma. Upon completion of the safety phase, NantKwest intends to combine this CD19 t-haNK cell therapy with other synergistic, immunomodulatory agents as part of an integrative, combination therapy approach that we describe as the NANT Cancer Vaccine to further enhance the synergistic effectiveness of this novel therapeutic intervention."

CD19 t-haNK

NantKwest’s CD19-t-haNK cell therapy is designed to provide precise tumor-cell specificity through the use of a CAR construct that utilizes a CD19-specific scFv (single chain antibody fragment) engineered into the company’s proprietary NK cell that includes the CD16 (Fc high affinity receptor).

In pre-clinical studies, cytotoxicity of these GMP-grade, cryopreserved CD19 t-haNK cells were comprehensively evaluated against a panel of cancer cell lines with different levels of CD19 expression in vitro and in vivo, with these studies showing increased activity and selective cytotoxicity towards CD19-expressing tumor cells of various b-cell origins including leukemia.

To better inform routine patient care, these clinical trials will incorporate a state-of-the-art, biomarker analysis using GPS Cancer, which is an integrated, multi-omics, whole genome, transcriptomic platform, both provided by NantHealth, an affiliated company. These comprehensive molecular analysis tools are designed to provide critical information to the clinical study team regarding the unique molecular alterations associated with the patient’s cancer and response rates, potentially enhancing patient management.

Additional information regarding the CD19 t-haNK clinical study can be found at www.nantkwest.com or www.clinicaltrials.gov/.

About NantKwest

NantKwest, a member of the NantWorks ecosystem of companies, is an innovative clinical-stage immunotherapy company focused on harnessing the power of the innate immune system by using the natural killer cell to treat cancer and virally induced infectious diseases.

On June 3, 2019 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it filed an application for ALK Inhibitor, Alecensa capsule 150 mg (generic name: alectinib) to MHLW for an additional indication of recurrent or refractory ALK fusion gene-positive anaplastic large cell lymphoma (ALK-positive ALCL) (Press release, Chugai, JUN 3, 2019, View Source [SID1234536788]). Alecensa obtained an orphan drug designation from the MHLW on May 30.

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"While chemotherapy is known to be effective for ALCL, there is a strong need for development of new therapeutic options since recurrent ALCL often carries a poor prognosis," said Dr. Yasushi Ito, Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management Unit. "We hope that we can contribute to improving prognosis of these patients with the use of Alecensa that has the possibility of becoming a promising molecular target drug for ALK-positive ALCL."

This filing is based on the results from the investigator initiated study (the ALC-ALCL study) started in May 2015. The study has been conducted as a part of "Research Project on Practical Application of Innovative Cancer Therapy" by Japan Agency for Medical Research and Development. The ALC-ALCL study was a phase II multicenter clinical study in which the response rate (primary endpoint) was assessed by the central review committee and safety was investigated in 10 patients with recurrent or refractory ALK-positive ALCL. It was conducted in three sites, led by Nagoya Medical Center, National Hospital Organization.

As a leading pharmaceutical company in the oncology field in Japan, Chugai will work to provide Alecensa as a new treatment option for ALK-positive ALCL as soon as possible.

About ALK-positive ALCL
ALCL is one of four subtypes of peripheral T-cell lymphoma classified as malignant lymphoma, which is non-Hodgkin’s lymphoma originated in T-cells in lymphocytes. The malignancy is categorized as "intermediate-grade," in which disease progression is observed on a monthly basis. In Japan, the percentage of ALCL in malignant lymphomas is from 1.5 to 2.0%1, 2), about half of which have been reported as ALK-positive.3,4) Considering that the 5-year survival rate with successful treatment has been reported to be 60% in patients with ALK-positive ALCL who received chemotherapy in another global study, the percentage of recurrent and refractory cases is estimated to be 40%.3)

Trademarks used or mentioned in this release are protected by law.

Lymphoma Study Group of Japanese Pathologists. The World Health Organization classification of malignant lymphomas in Japan: Incidence of recently recognized entities. Pathol Int. 2000 Sep; 50(9): 696-702
Aoki R, Karube K, Sugita Y, Nomura Y, Shimizu K, Kimura Y, et al. Distribution of malignant lymphoma in Japan: Analysis of 2260 cases. 2001-2006. Pathol Int. 2008 Mar; 58(3): 174-82
Savage KJ, Harris NL, Vose JM, Ullrich F, Jaffe ES, Connors JM, et al. ALK- anaplastic large-cell lymphoma is clinically and immunophenotypically different from both ALK+ ALCL and peripheral Tcell lymphoma, not otherwise specified: report from the International Peripheral T-Cell Lymphoma Project. Blood. 2008 Jun 5; 111(12): 5496-504
Sibon D, Fournier M, Brière J, Lamant L, Haioun C, Coiffier B, et al. Long-Term Outcome of Adults With Systemic Anaplastic Large-Cell Lymphoma Treated Within the Groupe d’Étude des Lymphomes de l’Adulte Trials. J Clin Oncol. 2012 Nov 10; 30(32): 3939-46

On June 3, 2019 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported that it entered into securities purchase agreements with certain institutional investors in connection with a registered direct offering of an aggregate of 1,170,000 shares of common stock and, in a concurrent private placement, warrants to purchase 760,500 shares of common stock (Press release, DelMar Pharmaceuticals, JUN 3, 2019, View Source [SID1234536805]). The combined purchase price for one share of common stock and each warrant will be $3.10, for aggregate gross proceeds of $3.6 million. The warrants have an exercise price of $3.10 per share, are immediately exercisable and have a term of exercise of five years. The offering and concurrent private placement are expected to close on or about June 5, 2019, subject to the satisfaction of customary closing conditions.

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Maxim Group LLC is acting as the lead placement agent and Dawson James Securities, Inc. is acting as co-placement agent in connection with the offering and concurrent private placement.

DelMar currently intends to use the net proceeds of the offering and concurrent private placement for its clinical trials and for general corporate purposes, which may include working capital, capital expenditures, research and development and other commercial expenditures. In addition, DelMar may use the net proceeds for investments in businesses, products or technologies that are complementary to its business.

The shares are being offered pursuant to an effective shelf registration statement on Form S-3, as amended (File No. 333-213601), that was previously filed with the Securities and Exchange Commission ("SEC") and declared effective on September 27, 2016. A prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. The offering is being made only by means of a prospectus and related prospectus supplement, copies of which may be obtained, when available, from Maxim Group LLC, 405 Lexington Avenue, New York, NY 10174, Attention: Syndicate Department, or via email at [email protected] or telephone at (212) 895-3745.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor may there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On June 3, 2019 Genomic Health, Inc. (NASDAQ: GHDX) reported that its Oncotype DX Breast Recurrence Score test and the TAILORx results have been recommended to guide chemotherapy treatment use in patients with node-negative early-stage breast cancer by the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in its 2019 Guidelines for Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy (Press release, Genomic Health, JUN 3, 2019, View Source [SID1234536824]). Using the strong and highest level of evidence from TAILORx, the updated ASCO (Free ASCO Whitepaper) guidelines increase the proportion of women who can be effectively treated without chemotherapy based on the Oncotype DX results, highlighting the importance of testing all medically eligible patients as standard of care.

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"We are pleased that the ASCO (Free ASCO Whitepaper) guidelines have been updated to reflect the findings from the landmark TAILORx trial, the practice-changing results of which demonstrated that the Oncotype DX Recurrence Score result can be used to guide chemotherapy decision-making for all medically eligible women with the most common form of early-stage, invasive breast cancer," said Steven Shak, M.D., chief scientific officer, Genomic Health. "The TAILORx results have influenced positive treatment guideline recommendations from ASCO (Free ASCO Whitepaper) and other organizations around the world, elevating the Oncotype DX test to a new global standard of care."

TAILORx, sponsored by the National Cancer Institute (NCI) and conducted by the ECOG-ACRIN Cancer Research Group, involved 10,273 women across 1,100 trial sites in six participating countries. The study results, which were presented during the Plenary Session at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting last June and simultaneously published in The New England Journal of Medicine, demonstrated that the Oncotype DX Breast Recurrence Score test definitively identifies the vast majority of women with early-stage breast cancer who receive no benefit from chemotherapy, and the important minority of women for whom chemotherapy benefit can be life-saving. Patients with an Oncotype DX Breast Recurrence Score result of 25 or less – up to about 80 percent of patients – may be safely spared chemotherapy and its well-known side effects, while those with scores of 26 to 100 may receive a life-saving benefit from chemotherapy.

"The updated ASCO (Free ASCO Whitepaper) breast cancer treatment guidelines based on the TAILORx results will provide physicians with clarity and confidence that they are selecting the right treatment for each of their breast cancer patients," said Harold A. Burstein, M.D., Ph.D., medical oncologist at the Dana-Farber Cancer Institute. "Having guidelines that reflect the latest ground-breaking research is critical in ensuring that physicians incorporate standard-of-care technology, such as the Oncotype DX test, when making clinical decisions about treatment for their patients with breast cancer."

New TAILORx Data Analysis at 2019 ASCO (Free ASCO Whitepaper) Annual Meeting
New analysis of a secondary endpoint of the TAILORx trial will be presented in the "Breast Cancer—Local/Regional/Adjuvant" oral abstract session at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting. The presentation, titled "Impact of clinical risk category on prognosis and prediction of chemotherapy benefit in early breast cancer (EBC) by age and the 21-gene recurrence score (RS) in TAILORx," will take place on Monday, June 3. The abstract (#503) can be accessed here.

About Oncotype DX
The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. The company’s flagship product, the Oncotype DX Breast Recurrence Score test, is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. In prostate cancer, the Oncotype DX Genomic Prostate Score test predicts disease aggressiveness and further clarifies the current and future risk of the cancer prior to treatment intervention, and the Oncotype DX AR-V7 Nucleus Detect test helps determine which patients with metastatic castration-resistant prostate cancer (mCRPC) are resistant to androgen receptor (AR)-targeted therapies. The Oncotype DX AR-V7 Nucleus Detect test is performed by Epic Sciences at its centralized, CLIA-certified laboratory in San Diego and offered exclusively by Genomic Health. With more than 1 million patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatment.org.

On June 3, 2019 Brooklyn ImmunoTherapeutics, a biopharmaceutical company focused on exploring the role that cytokine-based therapy can have in treating patients with cancer, reported the presentation of an ongoing trial poster at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on May 31 – June 4, 2019 at the McCormick Place in Chicago, IL (Press release, Brooklyn ImmunoTherapeutics, JUN 3, 2019, View Source [SID1234536842]). The poster describes a Phase 1b study to evaluate the safety, determine the recommended Phase 2 dose and investigate the biologic and clinical activity of IRX-2 in combination with nivolumab in solid tumor indications (NCT03758781).

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IRX-2 is an allogeneic, cell-derived biologic with multiple active cytokine components, including IL-2, that act on various parts of the immune system associated with activation of the entire tumor microenvironment.

"Anti-PD-1 therapy in oncology has been demonstrated to be a safe and effective therapeutic approach in treating certain cancers and increased lymphocyte infiltration has been associated with improved patient outcomes," said Rohit K Jain, M.D. M.P.H., principal investigator on the Phase 1b trial and Assistant Member in Moffitt Cancer Center Department of Genitourinary Oncology. "In data collected to date, IRX-2 has demonstrated an increase immune activation in the tumor microenvironment and was correlated with greater progression free survival and overall survival in a Phase 2 study in head and neck cancer. This clinically observed increased immune activation suggests the combination of IRX-2 therapy with PD-1 blockade with nivolumab could enhance outcomes compared to PD-1 blockade alone. This robust Phase 1b trial in up to five different indications will help us better understand the potential role of IRX-2 in oncology immunotherapy."

The Phase 1b clinical trial is taking place at Moffitt Cancer Center in Tampa, Florida and is currently recruiting patients.

"IRX-2 has been well-tolerated to date in clinical trials while demonstrating encouraging activity in squamous cell cancer of the head and neck," said Mark Leuchtenberger, interim President and CEO of Brooklyn ImmunoTherapeutics. "We believe the mechanism of action as well as the safety and clinical activity shown to date provides a strong rationale for combining IRX-2 with checkpoint inhibitors such as nivolumab for the treatment of solid tumor cancers. We look forward to the results of this important trial as well as the results of other ongoing studies, including the Phase 2B INSPIRE trial and an investigator-sponsored trial in squamous cervical intraepithelial neoplasia 3 or vulvar intraepithelial neoplasia 3."

About the Phase 1b Trial
Patients with recurrent or metastatic renal cell carcinoma, urothelial carcinoma, non-small cell lung cancer, HNSCC and melanoma are eligible. Patients who have received prior anti-PD-1/PD-L1 antibodies are eligible. The IRX-2 regimen consists of cyclophosphamide 300mg/m2 (Day 1) and subcutaneous IRX-2 injections for 10 days every 3 months. Nivolumab is administered at 240 mg once every two weeks. Planned total enrollment of approximately 100 patients. The study will include cohorts of the 5 different diseases. Each cohort will include two groups: 1) anti-PD-1/PD-L1 antibody naïve tumors, and 2) progressed during or after anti-PD-1/PD-L1 antibodies.

The primary study objective is to determine safety and tolerability of combination therapy. Secondary objectives are to evaluate the objective response rate, progression-free survival, and overall survival. The study is actively accruing patients.