News, Infos & good to know Forum: Community User: Lirumlarum1

Dr. Pat Soon-Shiong @DrPatSoonShiong Woweee. Out the gate!!! FDA green light for us to begin trials on first Covid Vaccine that can be given by injection and orally to drive T cells and Antibodies for long term immunity. #COVID19 #hAd5 #Tcell

Interesting point from article which could indicate a January 2021 phase 2 or 2/3 combined: Phase 1, typically lasting about two months, is the earliest point at which humans are injected with vaccine candidates. If the FDA allows ImmunityBio to proceed to Phase 2 and Phase 3 trials with increasing number of participants, the company may begin to get a signal as to whether the vaccine is effective. Soon-Shiong said he hoped to begin Phase 2 — or a combined Phase 2 and 3 — by the first quarter of 2021. https://www.latimes.com/california/story/2020-10-15/immunitybio-soon-shiong-phase-1-clinical-trial-coronavirus-vaccine

Phase 1 Study of the Safety of Therapeutic Tx With Immunomodulatory MSC in Adults With COVID-19 Infection Requiring Mechanical Ventilation: Data is coming out soon!!! Time frame from randomization: 30 and 60 days (Right about now!) https://clinicaltrials.gov/ct2/show/NCT04397796

From 10Q pg 41: "We recently announced FDA authorization of our IND for BM‑Allo‑MSC and have initiated the Phase Ib trial at regional hospitals in Southern California, with our first patient anticipated to be dosed in August 2020" https://www.sec.gov/ix?doc=/Archives/edgar/data/1326110/000156459020038096/nk-10q_20200630.htm

"Data from SARS-CoV-2 Convalescent Serum and T Cells Demonstrating Immune Recall to hAd5-COVID-19 Vaccine: ImmunityBio is in the process of publishing the study demonstrating that COVID-19 convalescent antibodies and T cells recognize human cell-expressed hAd5 S+N vaccine antigens, with rapid immune T cell recall." https://ir.nantkwest.com/news-releases/news-release-details/fda-authorizes-phase-1-trial-immunitybios-novel-covid-19-vaccine?field_nir_news_date_value[min]=

FDA Authorizes Phase 1 Trial of ImmunityBio’s Novel COVID-19 Vaccine Candidate hAd5; Dual Construct is Designed to Drive Both T Cell and Antibody Immunity Thu, October 15, 2020, 12:00 PM First human adenovirus (hAd5) vector vaccine candidate to deliver both outer spike (S) and inner nucleocapsid (N) antigens from SARS-CoV-2, offering potential long-term T cell and antibody immunity to the SARS-CoV-2 virus Second-generation adenoviral vector platform designed to generate immune response even in patients with pre-existing adenovirus immunity Ongoing development proceeding for oral, inhalational and intranasal administration of hAd5 Phase I trial recruitment to begin at Hoag Hospital Irvine in Orange County, Calif. this month https://finance.yahoo.com/news/fda-authorizes-phase-1-trial-100000557.html

Piper Sandler’s 32nd Annual Healthcare Conference (virtual) December 1-3, 2020 New York, NY NantKwest Chairman and CEO Dr. Patrick Soon-Shiong will be presenting a business update. Note this conference is for Piper Sandler clients only. However, we will make the presentation available to all shareholders via the Investor Relations section of the NantKwest website.

here is response-pay attention to last part: "I can’t comment on individual patients, which are being treated by our clinical partners. We are focused on activating sites for and enrolling patients in our larger pancreatic trial. The COVID program remains a priority and ImmunityBio hopes to receive FDA authorization for its vaccine candidate in the coming week (NantKwest is involved in the manufacturing of the vaccine). Unfortunately, we’re at the mercy of the FDA on the timing of this. Best, -Sarah"

CytRx hebt die Verwendung des zugelassenen Arzneimittels Aldoxorubicin bei der Behandlung des Bauchspeicheldrüsenkrebses des ehemaligen Mehrheitsführers des Senats, Harry Reid, hervor 7. Oktober 2020, 14:00 Uhr Reids Bauchspeicheldrüsenkrebs im Stadium IV befindet sich Berichten zufolge in einer "vollständigen Remission" nach einer kombinierten Immuntherapie, zu der NantKwest's PD-L1 t-haNK, ImmunityBios N-803 und Aldoxorubicin gehörten https://finance.yahoo.com/news/cytrx-highlights-licensed-dru…

EL SEGUNDO, Calif. & CULVER CITY, Calif.--( BUSINESS WIRE )--NantKwest, Inc. (NASDAQ: NK), a clinical-stage, natural killer cell-based therapeutics company, and ImmunityBio, a privately-held immunotherapy company, today announced they have added a third cohort to their ongoing Phase 2 trial of a novel immunotherapy for locally advanced or metastatic pancreatic cancer. The third cohort enables pancreatic cancer patients who have failed all approved standards of care to participate in the trial. The randomized, open-label study is evaluating safety and efficacy of a combination immunotherapy comprising NantKwest’s PD-L1 t-haNK, ImmunityBio’s IL-15 superagonist Anktiva (N-803), and aldoxorubicin, plus standard of care. The results will be compared to standard-of-care chemotherapy for first- and second-line treatment; the third-line cohort is a single arm, with no comparator. Each cohort will be studied independently to provide more precise comparative data for each disease stage. “Pancreatic cancer is one of the deadliest forms of cancer, with a five-year survival rate of just five percent, so new and more effective therapies are desperately needed,” said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of NantKwest and ImmunityBio. “By adding the third cohort to this important study, we’re able to enroll patients at all stages of the disease, even those who experience disease progression after the first- or second-line treatment.” Trial Sites and Enrollment Currently, three trial sites have been activated: Hoag Memorial Hospital Presbyterian in Orange County, Calif., The Chan Soon-Shiong Institute for Medicine in Los Angeles County, Calif., and Avera McKennan Hospital and University Health Center in Sioux Falls, South Dakota, which will serve patients in the tri-state area (Iowa, Nebraska and South Dakota). Forty patients are currently enrolled in or being evaluated for the trial. NantKwest and ImmunityBio’s combination immunotherapy is designed to harness the body's immune system to target, kill, and "remember" cancer cells. The agents in this trial are designed to find pancreatic cancer cells and initiate a large immune response against them. This may allow the body to develop its own antibodies to fight the cancer. “Our research in pancreatic cancer, as well as many other forms of cancer, is focused on how we can recruit and amplify the power of the human body’s own immune system to target and destroy even the most difficult cancer cells,” said Dr. Soon-Shiong. “Our goal is to attack the disease aggressively so that we can provide more time and a higher quality of life to patients who today have a very poor prognosis.” Study Details This Phase 2, randomized, three-cohort, open-label study will evaluate the comparative efficacy and overall safety of standard-of-care chemotherapy versus standard-of-care chemotherapy, in combination with PD-L1 t-haNK, Anktiva (N-803), and aldoxorubicin in subjects with locally advanced or metastatic pancreatic cancer (QUILT-88, NCT04390399). Each treatment setting, as well as each first- and second-line or later maintenance treatment, will be evaluated independently as Cohort A, Cohort B, and Cohort C, respectively, with cohorts A and B having independent experimental and control arms. The study will initially enroll 298 subjects across all three cohorts. The primary objective of cohorts A and B is progression-free survival (PFS) and the objective of cohort C is overall survival (OS) per RECIST V1.1. Secondary objectives include initial safety and additional efficacy measures, including overall response rate (ORR), complete response (CR) rate, durability of response (DoR), disease control rate (DCR), and overall survival (OS). Pancreatic cancer is the fourth leading cause of cancer-related death in the US, with an estimated 47,050 deaths and 57,600 new cases expected in 2020. 1. It is the 12th most common cancer worldwide, with around 338,000 new cases diagnosed in 2012 (2% of all cancer diagnoses).

Ich habe mir mal die Mühe gemacht und eine Mail eines Investors von Bild in Text zu wandeln, da dieser nur einen Screenshot online gestellt hat. Dies ist eine Antwort seitens NantKwests auf die Frage wann mit Neuigkeiten zu rechnen ist: We will issue press releases when we have trial updates. We are still on track to have data readouts for pancreatic cancer and MCC trials in Q1 2021. However, we'll likely issue press releases on our patient accrual and site activation progress in the coming weeks. We should have information on our MSC therapeutic for severaly ill Covid-19 patients in Q4. Immunity Bio will announce when they recieve FDA authorization for their vaccine candidate. Zudem empfehle ich im 10-Q Bericht vom 07.08.20 die bevorstehenden Updates zur Pipeline auf Seite 35 anzuschauen. https://ir.nantkwest.com/financial-information/sec-filings Anfang nächsten Jahres sollten dann ganz andere Kurse zu erwarten sein, vorrausgesetzt die Ergebnisse bleiben und werden wieder so gut.

NantKwest to Present at the 7th Annual Jefferies Cell Therapy Summit September 21, 2020, 3:00 pm NantKwest, Inc. (NASDAQ: NK), a clinical-stage, natural killer cell-based therapeutics company, today announced that Patrick Soon-Shiong, M.D., Chairman and CEO, will present at the virtual Jefferies Cell Therapy Summit on Tuesday, October 6, 2020 at 12:50 PM ET. The conference presentation will be available on the NantKwest website, NantKwest.com. An archived replay will be available on the website for approximately 30 days.

Brink Biologics Announces License Agreement with Global Healthcare Company Fresenius Kabi SwissBioSim GmbH SAN DIEGO--(BUSINESS WIRE)--Sep. 10, 2020-- Brink Biologics, Inc. (“Brink”), a NantKwest, Inc. (NASDAQ: NK) affiliate and exclusively-licensed distributor of NantKwest’s proprietary off-the-shelf NK-92® natural killer cells in certain fields, announces the licensing of its next-generation natural killer-based bioanalytical testing solution to Fresenius Kabi SwissBioSim GmbH (“Fresenius”), a Switzerland-based global healthcare company focusing on autoimmune diseases and oncology. Brink Biologics offers a variety of GLP and research-grade NK-92® based cell lines as part of its Neukopanel® portfolio of products for laboratory testing applications. Neukopanel® includes discovery, translational and developmental research as well as commercial lot release testing of clinical products. Brink products are utilized widely by large pharmaceuticals and biotechnology companies to support products ranging from anti-viral and dendritic cell vaccines, therapeutic monoclonal antibodies and biosimilars, bi- and tri-specific fusion proteins, cytokines, natural killer cell checkpoint inhibitors and other biologic products. The laboratory use of live natural killer cell cultures for functional assays, such as antibody dependent cellular cytotoxicity, antibody-dependent cell-mediated viral inhibition and cytokine release assays, most closely approximates what one would actually see in target patient populations. Of all the sources of natural killer cells, Brink’s NK-92® natural killer cells are considered to be the gold standard when it comes to providing greater assay consistency and reproducibility, testing scalability, and reduced labor time and costs for laboratory scientists and technicians. These features give a competitive edge to companies licensed to use Brink’s NK-92® products. Fresenius has joined the growing list of leading biotechnology companies that are using Brink’s NK-92® cell line for laboratory based bioanalytical testing. “Since our proprietary NK-92® cell line provides unique advantages to commercial and academic researchers as well as commercial manufacturers, we are committed to making our bioanalytical testing solutions widely available to the public through standard licensing agreements using market-driven terms and conditions,” said Barry Simon, M.D., CEO of Brink Biologics and President of NantKwest. “A growing number of commercial large pharma, biotech and device companies are joining scores of academic researchers who have accessed our NK-92 based cell lines to facilitate their internal activities. Our affiliate, NantKwest, has manufactured more than three trillion GMP-grade NK-92® cells and hundreds of doses of clinical product have been administered to patients in clinical trials since 2017. This positions NK-92® well to grow as a leading functional cell-based testing platform to complement its role as a leading immunotherapy platform, currently under development. We are pleased to make our testing solution available to Fresenius to facilitate their research and development endeavors.” https://ir.nantkwest.com/news-releases/news-release-details/brink-biologics-announces-license-agreement-global-healthcare?field_nir_news_date_value[min]=

Ich gehe stark davon aus, dass sich der Kurs spätestens im Frühjahr 2021 richtung 21$ Marke entwickeln wird, man muss sich nur mal im 10-Q Bericht vom 07.08.20 die bevorstehenden Updates zur Pipeline anachauen. Zu finden auf: https://ir.nantkwest.com/financial-information/sec-filings Hier mal grob dargestellt: Current status and expected Milestones: Q3: Sars CoV-2 PD-L1 t-haNK Non small lung cancer read read out Q4: IND Filings - ceNK/t-heNK: Multiple Myeloma/Ovarian/ Leukemia/Breast Cancer/ Gastric Cancers/ Cell Carcinom Q1 2021: Status Update Pipeline Merkell Cell Carcinom 2L/Pancreatic Cancer 1L, 2L, 3L Zudem dürften vorher mindestens noch News zum Genesungszustand von Alex Trebek kommen, welcher ja bekanntlich schon wieder arbeitet und das mit der Diagnose Bauchspeicheldrüsenkrebs Stadium 4, eigentlich ein sicheres Todesurteil. Aber NantKwest hat bei Harry Reid, Ex Senator von Nevada, schon gezeigt was möglich ist, der hatte die gleiche Diagnose und ist nun seit 8 Monaten in Remission. Sobald die Ergebnisse von Alex Trebek und anderen Patienten bestätigt werden, wird es hier nur noch eine Richtung geben - steil nach Oben!

Patrick Soon Shiong about Gates Foundation: The Gates Foundation has analyzed our adenovirus approach and we are in negotiations for their support, for which we are very grateful. But this will not go far enough to manage the potential billion-dollar cost to see this all the way through and manufacture billions of doses for the world. https://www.pharmexec.com/view/tackling-a-genius-virus

Soon-Shiong about Covid:  By January 2020, we had undertaken the sequence. By March, we had confirmed that the antibodies recognized our protein construct. By April, we created finished dosage form of both constructs; we submitted our IND (investigational new drug) and went immediately into scale-up. We have a magnificent facility already activated that has a capacity now of 100 million doses by the end of the year. And so, in Q3 we will do first-in-human studies, and then we’re off to the races with everybody else, and we will hopefully be on the path to the billion doses. https://www.pharmexec.com/view/tackling-a-genius-virus