NANTKWEST INC. DL-,0001 Forum: Community User: Ibt2

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Dieser Part ist wohl der Wichtigste: John Lee, M.D., Clinical Senior Vice President at NantKwest, said, “We are highly encouraged by the early safety results with PD-L1.t-haNK in a patient population with advanced, difficult to treat solid tumors. All patients were able to be infused in the outpatient setting without any reported cytokine toxicities or immune related adverse events. NantKwest’s approach has been designed to overcome the challenges and limitations typically seen when treating solid tumors with CAR-T and other immunotherapy approaches and I look forward to progressing our studies to advance this innovative new approach to cancer therapy

NantKwest (NK) Reports Phase 1 Results for First-in-Human PD-L1 Tumor-Targeted Natural Killer Cells (PD-L1.t-haNK) December 2, 2019 4:14 PM NantKwest, Inc. (NASDAQ: NK) today announced promising safety data generated from the first six patients in its QUILT-3.064 trial. The first-in-human study evaluated the safety and preliminary efficacy of the Company’s first-in-class, tumor-targeted PD-L1.t-haNK cell therapy in patients with locally advanced or metastatic solid tumors. “The unique dual-targeting of PD-L1.t-haNK to both PD-L1 expressing tumors and therapeutic monoclonal antibodies has the potential to be transformative to the treatment of advanced solid tumors with cell-based therapies,” said Dr. Patrick Soon-Shiong, the Chairman and CEO of NantKwest. “PD-L1.t-haNK is a cryopreserved, off-the-shelf product that can rapidly deliver treatment to patients in an outpatient setting while avoiding the extensive manufacturing delays associated with autologous CAR-T therapies. We look forward to reporting full study results from the phase 1 cohort and moving toward a recommended phase 2 dose. We continue to advance our innovative cell therapies such as PD-L1.t-haNK in combination with ImmunityBio’s N-803, an IL-15 superagonist that is designed to stimulate the activation and proliferation of the patient’s own NK cells to maximize the potential of immunogenic cell death to treat cancer,” continued Soon-Shiong. NantKwest and a wholly owned subsidiary of ImmunityBio have entered into an exclusive collaboration agreement to co-develop NantKwest’s proprietary off-the-shelf NK platforms in combination with N-803. On December 2, 2019 at the NantKwest Key Opinion Leader and Investors conference, Dr. Soon-Shiong described the clinical development plans for two of NantKwest’s first-in-class NK products: haNK, which was developed to target binding to approved monoclonal therapies such as Trastuzumab, Rituximab and Cetuximab; and PD-L1.t-haNK, which was also designed to target these approved therapies plus directly target PD-L1-expressing tumor cells. PD-L1.t-haNK cells are a human-derived, allogeneic, natural killer cell *** engineered to express a chimeric antigen receptor (CAR) targeting PD-L1, whose origins arise from NantKwest’s proprietary NK-92 (aNK) master cell bank. In addition to targeting PD-L1, PD-L1.t-haNK is engineered to produce intracellular IL-2 for enhanced CD16-targeted antibody-dependent cellular cytotoxicity capabilities. John Lee, M.D., Clinical Senior Vice President at NantKwest, said, “We are highly encouraged by the early safety results with PD-L1.t-haNK in a patient population with advanced, difficult to treat solid tumors. All patients were able to be infused in the outpatient setting without any reported cytokine toxicities or immune related adverse events. NantKwest’s approach has been designed to overcome the challenges and limitations typically seen when treating solid tumors with CAR-T and other immunotherapy approaches and I look forward to progressing our studies to advance this innovative new approach to cancer therapy.” Study Design The QUILT-3.064 study is an open-label, Phase 1 study of PD-L1.t-haNK in subjects with locally advanced or metastatic solid cancers to evaluate safety, preliminary efficacy, determine maximum tolerated dose (MTD) or highest tolerated dose (HTD) and designate the recommended Phase 2 dose (RP2D). The study is being conducted in two parts: the first is evaluating dose escalation using a 3 + 3 design and the second part will evaluate the expansion of the recommended Phase 2 dose (RP2D) to further assess the safety and efficacy of PD-L1.t-haNK therapy. In part one, six subjects were sequentially enrolled, starting at dose level 1 and assessed for dose-limiting toxicities. The primary study objectives are to determine the MTD or HTD, RP2D (recommended phase 2 dose), and safety. The secondary endpoints include objective response rate (ORR), progression free survival (PFS) and overall survival (OS). More information can be found at ClinicalTrials.gov, Identifier: NCT04050709

Scheint als ob am 2 Dezember irgendwas Gutes zur Pipeline und zum Fortschritt der Forschung oder Forschungsergebnisse veröffentlicht werden.

Am 2. Dezember 2019 wurde in New York City ein KOL - Treffen zum Thema "Behandlung von Krebs, Infektionskrankheiten und anderen Krankheiten" angekündigt , dreifach negativem Brustkrebs, soliden Tumoren und der Behandlung auf dem neuesten Stand der Technik bei der Induktion des immunogenen Zelltods. Diese Veranstaltung wird Präsentationen von KOLs, George Ansstas, MD, der Washington University of Medicine in St. Louis, Chaitali Nangia, MD, dem Chan Soon-Shiong Institut für Medizin, und Clint Allen, MD, dem Johns Hopkins Kimmel Cancer Center, sowie von Dr Patrick Soon-Shiong, Vorstandsvorsitzender und Vorsitzender von NantKwest. Das Managementteam von NantKwest wird auch Pipeline-Updates für seine Programme haNK und PD-L1.t-haNK bereitstellen, die die Zellplattform Activated Natural Killer (aNK) des Unternehmens zur Bekämpfung dieser Krankheiten nutzen. Diese Plattform nutzt die Kraft des angeborenen Immunsystems und ist einzigartig positioniert, um allgemein verfügbare, handelsübliche Zelltherapien bereitzustellen, die ambulant verabreicht werden können.

CULVER CITY, Calif.--(BUSINESS WIRE)--NantKwest, Inc. (Nasdaq: NK), a 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, today announced that on Monday, December 2, 2019, it will host a key opinion leader (KOL) meeting in New York City on the current treatment landscapes and unmet medical needs of patients with Merkel cell carcinoma, triple-negative breast cancer, solid tumors and the state-of-the-art treatment in the induction of Immunogenic Cell Death. This event will feature presentations from KOLs George Ansstas, MD, Washington University of Medicine in St. Louis, Chaitali Nangia, MD, Chan Soon-Shiong Institute for Medicine, and Clint Allen, MD, Johns Hopkins Kimmel Cancer Center, as well as Dr. Patrick Soon-Shiong, Chief Executive Officer and Chairman of NantKwest. NantKwest’s management team will also provide pipeline updates on their haNK and PD-L1.t-haNK programs utilizing the Company’s Activated Natural Killer (aNK) cell platform to target these diseases. This platform harnesses the power of the innate immune system and is uniquely positioned to provide broadly available, off-the-shelf cell therapies capable of being administered in the outpatient setting. Clint Allen, MD is an Associate Professor of Otolaryngology-Head and Neck Surgery at the Johns Hopkins School of Medicine, Principal Investigator of the Translational Tumor Immunology Program, National Institute on Deafness and Other Communication Disorders, NIH. His research focuses on understanding how the immune system responds to squamous cell carcinoma of the head and neck, and how this can be enhanced therapeutically. He leads a large pre-clinical and clinical laboratory program focused on translational pre-clinical studies in syngeneic models of squamous cell carcinoma and the assessment of clinical trial specimens. He is the director of the inpatient Otolaryngology consultation service at the NIH Clinical Center and maintains a surgical practice for the Johns Hopkins School of Medicine based out of Suburban Hospital in Bethesda, MD. George Ansstas, MD is an Assistant Professor of Medicine, Section of Medical Oncology, Division of Oncology at Washington University School of Medicine. Dr. Ansstas's clinical expertise includes brain tumors, neuro-oncology, skin cancer, and melanoma. He received his medical degree from University of Tishreen, Latakia, Syria in 2001. Dr. Ansstas completed a fellowship in hematology and oncology at Washington University, St. Louis. Chaitali Nangia, MD is an Hematologist/Oncologist based in Costa Mesa, California and is affiliated with Hoag Hospital System. She received her medical degree from Lady Hardinge Medical College in New Delhi, India and completed her residency in Internal Medicine at Resurrection Westlake Medical Center in Illinois. She then completed her Fellowship in Hematology/Oncology at the Henry Ford Hospital in Michigan. She worked as an Associate Professor at University of California-Irvine and as an Associate Program Director at University of California-Irvine Hematology/Oncology Fellowship Program prior to her current role. She acted as the principal investigator for several clinical trials and has been an author of several publications. This event is intended for institutional investors, sell-side analysts, and business development professionals only. Please RSVP in advance if you plan to attend, as space is limited. Members of the media and the public are invited to participate via the live webcast, which can be accessed through our company website at https://nantkwest.com/nantkwest-key-opinion-leader-event/. The event is expected to start at noon EST on Monday, December 2, 2019.

NantKwest Announces Presentation of Positive Phase 2 Clinical Data of Natural Killer Cell Therapy in Metastatic Merkel Cell Carcinoma at SITC 2019 Durable Responses Demonstrated in 2 of 7 Patients with Refractory Metastatic MCC Data Supportive of Planned Off-the-Shelf Clinical Trial to Confirm Activity and Safety November 07, 2019 04:15 PM Eastern Standard Time CULVER CITY, Calif.--(BUSINESS WIRE)--NantKwest Inc. (Nasdaq: NK), a 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, today announced the presentation of results from their Phase 2 trial investigation using aNK, NantKwest’s off-the-shelf natural killer cell-based therapeutic, in combination with N-803, ImmunityBio’s IL-15 superagonist, in patients with advanced refractory metastatic Merkel cell carcinoma (MCC) (NCT03853317) at The 34th Annual Meeting of the Society for Immunotherapy for Cancer (SITC 2019) on November 8, 2019 in National Harbor, Maryland. ImmunityBio is an affiliate company of NantKwest. “We believe the results of this Phase 2 study are testament to the potential of our natural killer cell-based therapeutics to change the cancer treatment paradigm” Dr. Shailender Bhatia, Associate Professor of Medical Oncology at the University of Washington/Fred Hutchinson Cancer Research Center, will make an oral presentation entitled “Final results from a phase 2 study using off-the-shelf activated natural killer (aNK) cells in combination with N-803, an IL-15 superagonist, in patients with metastatic Merkel cell carcinoma (MCC).” That study demonstrated long term, durable responses in 2 of 7 patients with advanced refractory MCC. One of these patients achieved a radiologic complete response, and the second a durable partial response with more than 75% tumor regression and no subsequent therapy (response ongoing to date). Both patients with responses in the trial remain alive to date, 29 and 44 months after the initiation of treatment. Results from this study provide evidence that treatment with aNK cell therapy can stimulate immune responses to checkpoint inhibitors, even in patients that have previously failed treatments using these types of therapies. One heavily pretreated subject refractory to pembrolizumab was rechallenged with this checkpoint inhibitor subsequent to receiving aNK cell therapy resulting in a durable complete response (CR) that is ongoing at this time, 44 months after receipt of first aNK cell infusion. “We believe the results of this Phase 2 study are testament to the potential of our natural killer cell-based therapeutics to change the cancer treatment paradigm,” said Dr. Patrick Soon-Shiong, Chairman and CEO of NantKwest. “Long term responses in patients with refractory metastatic disease is a remarkable achievement and is supportive of our upcoming trial, which will evaluate NantKwest’s off-the-shelf CD16-targeted haNK cells in combination with N-803 and Pfizer’s avelumab in patients with advanced MCC who are refractory to immune checkpoint inhibitors. We are particularly enthusiastic about the potential of aNK and N-803 to induce sensitization to checkpoint inhibitors, and thus, are evaluating this in our upcoming trial. We remain deeply committed to harnessing the power of immunogenic cell death across a wide range of indications to provide innovative treatments to patients with serious unmet need.” Other presentation highlights include: Overall response rate of 29% (2 of 7 patients) Evidence that aNK cell treatment may induce sensitivity to immune checkpoint inhibitors with a patient previously refractory to pembrolizumab demonstrating an ongoing complete response to the checkpoint inhibitor after completing aNK cell therapy aNK cell therapy resulted in increased levels of tumor-infiltrating lymphocytes and increased immune response-related gene expression within tumor tissue aNK cells in combination with N-803 were well-tolerated, with no treatment-related serious adverse events or grade ≥3 adverse events Infusions all safely administered in the outpatient setting without observed immune related adverse events Dr. Bhatia said, “Merkel cell carcinoma (MCC) is an aggressive skin cancer that is estimated to be three times more deadly than melanoma. PD-1 blockade works well for around 50 percent of patients with metastatic disease, but a significant proportion do not respond or progress later. Innate immunotherapy approach using aNK cells can potentially overcome resistance mechanisms in PD-1 refractory tumors. I am particularly enthusiastic about the preliminary results of the MCC study, with two complete responses in patients with very advanced metastatic disease.”

Many brokerage firms have already submitted their reports for NK stocks, with Citigroup repeating the rating for NK shares by setting it to “Sell”. The predicted price for NK stocks in the upcoming period according to Citigroup is $21 based on the research report published on May 31, 2019.

Many investors like to check how much of a company is owned by insiders. A high insider ownership often makes company leadership more mindful of shareholder interests. It’s great to see that NantKwest insiders own 65% of the company, worth about US$67m. I like to see this level of insider ownership, because it increases the chances that management are thinking about the best interests of shareholders.

Aber sie stehen genau wie alle Konkurenten noch am Anfang also abwarten und Teetrinken

5 von 35/ Patienten (14%) kann man einen Teilerfolg nennen, mehr leider nicht.

5 out of 35 Durable Complete Responses Observed in Patients with Relapsed Third-*** Advanced Solid Tumors with Duration Ranging 4 to 24 Months Patrick Soon-Shiong, MD, Chairman and CEO of NantKwest (NK), a leading clinical-stage, natural killer cell based therapeutics company today presented a clinical data update in patients who have received off-the-shelf aNK and/or haNK natural killer cell therapy in combination with immunotherapeutic agents in advanced solid tumors. These results demonstrated durable complete responses in 5 out of 35 patients with highly refractory late stage cancers across multiple tumor types. Data presented at the Jefferies Healthcare Conference demonstrated complete responses across phase I combination studies of aNK/haNK with or without N-803, ImmunityBio, Inc.’s IL-15 fusion superagonist in solid tumor cancer patients with highly refractory disease. ImmunityBio, Inc. (formerly known as NantCell, Inc.) is an affiliated company of NantKwest. These combinations enhance NK and T cell activity and proliferation, and resulted in 14% complete responses across multiple indications, while demonstrating positive safety profiles. In patients with highly refractory and relapsed diseases who have failed multiple rounds of standard-of-care therapy, the responses were durable. All five patients with complete responses remain alive to date, ranging from 4 to 24 months from the onset of response. “We are excited by the durable complete responses seen in patients with highly refractory disease safely treated with off-the-shelf haNK or aNK -- to date over 511 infusions of haNK cell therapy have been administered, without any patient requiring hospitalization or resulting in cytokine release syndrome,” said Patrick Soon-Shiong, M.D. “These early signals of efficacy have now provided us a pathway to the development of registration trials across triple negative breast cell and Merkel cell carcinoma.” In addition, Dr. Soon-Shiong also announced the FDA authorization of a trial utilizing the first in class CD19 T-haNK for treatment of refractory diffuse large B-Cell Lymphoma and the IND filing of the first in class PD-L1 T-haNK for refractory solid tumors.

Und was sagst du persönlich dazu?

cryopreserved, off-the-shelf, bi-specific NK cell therapy to enter human clinical trials targeting CD16 and CD19 in patients with lymphoma NantKwest Inc. (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, today announced 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. 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.comor www.clinicaltrials.gov/.