Phase I/II Evaluation of a Cancer Lysate Vaccine and Montanide(R) ISA-51 VG With or Without the IL-15 Super-Agonist N-803 as Adjuvant Therapy for PD-L1 Negative Non-Small Cell Lung Cancer

Background:
Surgery is the primary treatment for non-small cell lung cancer (NSCLC) that is diagnosed in its earlier stages. But the tumors often return. Radiation and chemotherapy can improve survival in some people who have had surgery for NSCLC, but these treatments also cause serious side effects. A new approach, called immunotherapy, may be a better way to stop NSCLC tumors from coming back.
Objective:
To test a new treatment (H1299 lung cancer cell vaccine combined with the drug N-803) in people who received surgery for NSCLC.
Eligibility:
Adults aged 18 years or older with no sign of disease after surgery for NSCLC.
Design:
Participants will be screened. They will have a physical exam with blood tests. They will have tests of their heart and lung function. They will have imaging scans.
Study treatment will be given in 28-day cycles. Participants will visit the clinic on the first day of each cycle. They will receive 2 treatments at each visit:
The study vaccine is given as 2-4 small shots under the skin of the thigh or arm.
N-803 is given as a shot under the skin of the abdomen.
Treatment will continue for 6 cycles. Blood tests and imaging scans will be repeated throughout the study.
Participants will have a blood test 1 month after receiving the 6th vaccine. Some participants may then resume taking N-803; they may also receive 2 more vaccinations at 3 and 6 months after their previous treatment.
Follow-up visits will continue for up to 5 years.

Start Date21 Nov 2024

Sponsor / Collaborator

National Cancer Institute

NCT06161545 / Not yet recruitingPhase 2IIT

A Phase II Sequential Window of Opportunity Trial of Pembrolizumab + N-803 Alone or in Combination With PD-L1 t-haNK Cells for Resectable Head and Neck Squamous Cell Carcinoma

Background:
Squamous cell carcinoma is a type of cancer that can cause tumors on the head and neck (HNSCC). Even with treatment, less than 50% of people with certain types of HNSCC survive for 5 years.
Objective:
To test a new drug treatment (N-803 and pembrolizumab, with or without PD-L1 t-haNK cells) in people with HNSCC. These drugs may help the immune system to fight cancer.
Eligibility:
People aged 18 years and older who have HNSCC that is not linked to human papillomavirus infection. They must not yet have received any treatment and be scheduled for surgery to remove the tumors.
Design:
Participants will be screened. They will have a physical exam with blood and urine tests. They will have imaging scans and a test of their heart function. They will have a biopsy: A sample of tissue will be removed from the tumor.
Pembrolizumab is given through a tube attached to a needle inserted into a vein in the arm (intravenous infusion). N-803 is injected under the skin of the abdomen. All participants will receive these 2 treatments on day 1. They will have follow-up visits on days 8 and 15.
Some participants will also receive PD-L1 t-haNK cells by intravenous infusion. These are cells that attack cancer cells. These participants will receive this treatment on days 1, 5, 8, 12, and 15.
All participants will have a clinic visit on day 21. They will have a second biopsy.
Follow-up visits will occur on days 49 and 105. Visits will continue by phone or email every 9 weeks for 2 years....

Start Date21 Nov 2024

Sponsor / Collaborator

National Cancer Institute

NCT05618925 / RecruitingPhase 1

Open-label, Phase 1 Study of CD19 t-haNK as a Single Agent and in Combination With an IL-15 Superagonist (N-803) and Rituximab in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma.

Open-label, Phase 1 Study of CD19 t-haNK as a Single Agent and in Combination With an IL-15 Superagonist (N-803) and Rituximab in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma. Up to 20 subjects will be enrolled and randomized 1:1 to 1 of 2 cohorts, as outlined below. The initial 3 subjects will be sequentially enrolled in a staggered fashion, with a 7 day interval between each subject to enable the capture and monitoring of any acute and subacute toxicities.

Start Date01 Nov 2024

Sponsor / Collaborator

ImmunityBio, Inc.

100 Clinical Results associated with Nogapendekin alfa inbakicept-pmln

100 Translational Medicine associated with Nogapendekin alfa inbakicept-pmln

100 Patents (Medical) associated with Nogapendekin alfa inbakicept-pmln

Literatures (Medical) associated with Nogapendekin alfa inbakicept-pmln

01 Oct 2024·Future Oncology

N-803 Plus BCG Treatment for BCG-Naïve or -Unresponsive Non-Muscle Invasive Bladder Cancer: A Plain Language Review

Review

Author: Sender, Lennie ; Rosser, Charles J. ; Soon-Shiong, Patrick ; Chang, Sam S. ; Reddy, Sandeep ; Gonzalgo, Mark L. ; Kramolowski, Eugene ; Sexton, Wade J. ; Chamie, Karim ; Spilman, Patricia

WHAT IS THIS SUMMARY ABOUT?This is a summary of two studies that looked at the safety and effectiveness of a potential new treatment, N-803 (Anktiva), in combination with a standard treatment bacillus Calmette-Guerin (BCG) for people with non-muscle invasive bladder cancer (NMIBC).One study was a Phase 1b study that tested increasing doses of N-803 in combination with the same dose of BCG in people with NMIBC who had never received BCG previously (BCG-naive). The other study is a Phase 2/3 study of N-803 and BCG in people with NMIBC whose cancer wasn't eliminated by BCG alone (BCGunresponsive).WHAT HAPPENED IN THE STUDIES?In the Phase 1b study, the nine participants were split into three groups of 3 participants who received a dose of 100, 200, or 400 μg N-803 along with a standard 50 mg dose of BCG. In the Phase 2/3 study, one group (cohort A) of participants with carcinoma in situ (CIS) disease and another group (cohort B) with papillary disease were treated with 400 μg N-803 plus 50 mg BCG. There was also a cohort C that received only 400 μg N-803. Treatments were delivered directly into the bladder once a week for 6 weeks in a row.WHAT WERE THE KEY TAKEAWAYS?N-803 plus BCG eliminated NMIBC in all nine BCG-naive participants and the effects were long-lasting, with participants remaining NMIBC-free for a range of 8.3 to 9.2 years.As reported in 2022, cancer was eliminated in 58 of 82 (71%) participants with BCG-unresponsive CIS disease and the effect was also long-lasting. Importantly, approximately 90% of the successfully treated participants avoided surgical removal of the bladder. In cohort B participants with papillary disease, 40 of 72 (55.4%) were cancer-free 12 months after treatment. N-803 used alone was only effective in 2 of 10 participants. In both studies, the combination of N-803 and BCG was found to be associated with very few adverse events.Based on results from the Phase 2/3 study, the U.S. Food and Drug Association (FDA) approved the use of N-803 plus BCG for the treatment of BCG-unresponsive bladder CIS with or without Ta/T1 papillary disease.Clinical Trial Registration: NCT02138734 (Phase 1b study), NCT03022825 (Phase 2/3 study).

01 Jul 2024·Drugs

Nogapendekin alfa Inbakicept: First Approval

Review

Author: Keam, Susan J

Nogapendekin alfa inbakicept (ANKTIVA^®; nogapendekin alfa inbakicept-pmln) is a recombinant interleukin-15 (IL-15) superagonist protein complex being developed by Altor BioScience, LLC, an indirect wholly owned subsidiary of ImmunityBio, Inc., for the treatment of solid and haematological cancers and HIV infection. In April 2024, nogapendekin alfa inbakicept was approved for use with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours in the USA. This article summarizes the milestones in the development of nogapendekin alfa inbakicept leading to this first approval for the treatment of cancer.

01 Jun 2024·European Urology Oncology

Novel Delivery Systems and Pharmacotherapeutic Approaches for the Treatment of Non–muscle-invasive Bladder Cancer

Review

Author: Gontero, Paolo ; Rouprêt, Morgan ; Daneshmand, Siamak ; Vilaseca, Antoni ; Shariat, Shahrokh F ; Guerrero-Ramos, Félix ; Kamat, Ashish M ; Boormans, Joost L

BACKGROUND AND OBJECTIVETherapeutic options for patients with non-muscle-invasive bladder cancer (NMIBC) have traditionally been limited to intravesical immunotherapy or chemotherapy. A considerable number of new options have been investigated in recent years. Our aim was to review the efficacy and toxicity of novel therapeutic options (results already reported or currently under investigation) for patients with NMIBC.METHODSWe assessed the efficacy of various novel therapeutic options by examining key endpoints in diverse settings, including recurrence, progression, overall survival, disease-specific survival, and complete response. We identified the principal advantages and limitations for each option. Safety was predominantly evaluated as the incidence of grade ≥3 adverse events. Our investigation focused on evidence from scientific articles and congress abstracts published in English within the past 5 yr.KEY FINDINGS AND LIMITATIONSTo date, pembrolizumab, nadofaragene firadenovec, and the combination of BCG with N-803 have received US Food and Drug administration approval for the treatment of BCG-unresponsive carcinoma in situ of the bladder (with or without papillary tumours). Five phase 3 trials are recruiting BCG-naïve patients with high-risk NMIBC. There is increasing interest in an ablative rather than an adjuvant approach for patients with intermediate-risk NMIBC.CONCLUSIONS AND CLINICAL IMPLICATIONSNovel drugs and device-assisted drug delivery systems are on the verge of changing the treatment of NMIBC. Novel intravesical options seem to have the same efficacy with fewer adverse events in comparison to systemic therapies.PATIENT SUMMARYWe reviewed new therapy options for non-muscle-invasive bladder cancer. Two agents (pembrolizumab and nadofaragene firadenovec) have been approved to date. Ongoing trials are assessing direct delivery of drugs in solution into the bladder. This route seems to have similar efficacy and fewer side effects than intravenous immunotherapy.

News (Medical) associated with Nogapendekin alfa inbakicept-pmln

14 Nov 2024

·www.prnewswire.com

Biotech Companies' Q3 Updates: Promising Cancer Treatments on the Horizon

USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Nov. 14, 2024 /PRNewswire/ -- USA News Group News Commentary – As many biotech companies within the oncology space begin to roll out their end-of-quarter results, the American Medical Association is pointing out the alarming trend of rising cancer rates, especially with younger people. According to data released from the National Cancer Institute (NCI), a division of the National Institutes of Health (NIH), a map shared by Newsweek showed that the prevalence of cancer varies significantly from state to state. Thankfully, there are plenty of new breakthroughs in the fight against cancer that the World Economic Forum recently highlighted, which are giving hope. Behind the scenes, biotech companies are making strides, with several touting their recent wins in their Q3 2024 financial results, including developments from O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), ImmunityBio, Inc. (NASDAQ: IBRX), Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), Syndax Pharmaceuticals, Inc. (NASDAQ: SNDX), and SpringWorks Therapeutics, Inc. (NASDAQ: SWTX). The article continued: As reported by The Guardian, a new study is raising hopes of treating aggressive cancers by zapping rogue DNA that helps tumors thrive and become resistant to chemotherapy. Showing the shifting market, researchers at Statista recently released a report showing the Top 5 Oncology Products Worldwide by Market Share in 2017 and 2024. Oncolytics Biotech® Reports Third Quarter 2024 Financial Results and Operational Highlights Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, recently reported their Q3 2024 financial results and operational highlights. Among these highlights included impressive overall survival benefit results from BRACELET-1 data in HR+/HER2- metastatic breast cancer affirming its pelareorep + paclitaxel combination should be evaluated in a registrational study. "With positive BRACELET-1 results, we have two randomized phase two studies confirming pelareorep's potential in HR+/HER2- metastatic breast cancer," said Wayne Pisano, Chair of Oncolytics' Board of Directors and Interim CEO of Oncolytics. "After discussions with regulators and key opinion leaders and based on an estimated overall survival benefit of more than a year provided by pelareorep-based therapy, a registration-enabling study that is designed to support an accelerated approval is the next logical step for the development of pelareorep." In the BRACELET-1 study, pelareorep combined with paclitaxel significantly improved outcomes for patients with advanced HR+/HER2- breast cancer. Patients receiving this treatment lived without cancer progression for an average of 12.1 months, compared to just 6.4 months with paclitaxel alone—showing a benefit of nearly six months. Additionally, 64% of patients treated with pelareorep and paclitaxel lived for at least two years, compared to only 33% for paclitaxel alone. Median overall survival could not be calculated because over half of the patients on pelareorep were still alive at the study's end, but if they only lived to their next follow-up, their survival would average 32.1 months, notably higher than the 18.2 months for paclitaxel alone. Oncolytics also highlighted upcoming milestones in its GOBLET study to include efficacy data from the anal cancer cohort and safety run-in data from the modified FOLFIRINOX pancreatic cancer cohort. "We continue to develop our gastrointestinal cancer program and look forward to presenting updated efficacy data from our anal cancer cohort and safety data from our new modified FOLFIRNOX pancreatic cancer cohort," continued Pisano. "Both of these indications represent a significant unmet medical need, and we have shown pelareorep provides the potential to meaningfully improve patient outcomes. This coming year will be critical for pelareorep, as well as for Oncolytics, and I've never been more confident in the potential pelareorep can deliver to cancer patients in need." Also, as of September 30, 2024, Oncolytics had a cash position of $19.6 million, providing a cash runway through key milestones and into 2025. Looking ahead, in H1 2025, Oncolytics is set to finalize the master protocol for the adaptive registration-enabling trial for pelareorep, gemcitabine, nab-paclitaxel, and atezolizumab in first-line pancreatic ductal adenocarcinoma (PDAC) with the Global Coalition for Adaptive Research (GCAR) and submit it to the FDA. Oncolytics also expects in H1 2025: safety run-in data from cohort 5 of the GOBLET study, investigating pelareorep and modified FOLFIRNOX (mFOLFIRINOX) with or without atezolizumab in newly diagnosed pancreatic cancer; and updated efficacy data from cohort 4 of the GOBLET study, investigating pelareorep and atezolizumab in second-line or later anal cancer. As well, mid 2025 should see the first patient enrolled in registration-enabling study evaluating pelareorep and paclitaxel in metastatic HR+/HER2- breast cancer, and H2 2025 should see initial efficacy results from cohort 5 of the GOBLET study, investigating pelareorep and mFOLFIRINOX with or without atezolizumab in newly diagnosed pancreatic cancer. CONTINUED… Read this and more news for Oncolytics Biotech at: In other industry developments and happenings in the market this week include: ImmunityBio, Inc. (NASDAQ: IBRX), an immunotherapy innovator, recently reported its Q3 2024 financial results, which included highlights such as its ANKTIVA® receiving a J-code (HCPCS Level II Code) effective January 1, 2025, and becoming widely accessible to patients through commercial and government insurance programs (VA, DoD, Medicare), leading ImmunityBio to secure coverage for over 200 million medical lives through medical reimbursement policies. "The U.S. launch of ANKTIVA for [non-muscle invasive bladder cancer with carcinoma in situ] (NMIBC CIS) continues to gain momentum, and we are pleased to see the clinical impact for patients," said Richard Adcock, President and CEO of ImmunityBio. "Our permanent J-code has been issued by Centers for Medicare and Medicaid Services and will be effective January 1, 2025. Our submission of ANKTIVA for NMIBC CIS to the MHRA in the UK for potential approval demonstrates our plans for global expansion. Further, we anticipate an EU submission this quarter." The financial results came just weeks after ImmunityBio announced that the first patients had been dosed in an initial trial studying the potential of the company's CAR-NK cell therapy targeting CD-19 in the treatment of non-Hodgkin's lymphoma (NHL). Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, recently reported its Q3 2024 financial results and corporate updates. Among the highlights were the reporting that significant demand for Amtagvi™ (Lifileucel) continues with $58.6M in Total 3Q24 Product Revenue and Iovance reaffirming guidance of $160-$165 million for FY 2024 and $450-$475 million for FY 2025 of total product revenue. " Iovance is executing a successful U.S. commercial launch of Amtagvi™ for patients with previously treated advanced melanoma," said Frederick Vogt, Ph.D., J.D., Interim President and CEO of Iovance. "Robust demand for Amtagvi and Proleukin® continues to grow as our expanding network of authorized treatment centers (ATCs) and outreach to community oncologists broaden the utilization of Amtagvi, driving a higher volume of patient referrals. Demand trends are expected to accelerate growth throughout the remainder of the year and over the following years. As a fully integrated company, Iovance is well positioned to remain the global leader in innovating, developing, and delivering current and future generations of TIL cell therapy for patients with cancer." Syndax Pharmaceuticals, Inc. (NASDAQ: SNDX), a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies, recently reported its Q3 2024 financial results and business update. Within the highlights were the mention that new revumenib and Niktimvo™ clinical data will be highlighted at the 66th ASH Annual Meeting and that mNPM1 AML topline data from AUGMENT-101 is expected in Q4 2024, with a potential sNDA filing in H1 2025. "This has been a historic period for Syndax as we transitioned to a commercial-stage company with the approval of Niktimvo," said Michael A. Metzger, CEO of Syndax. "We have a very exciting quarter ahead with the anticipated FDA approval and U.S. launch of revumenib for adults and pediatrics with R/R KMT2Ar acute leukemia, as well as the expected readout of topline pivotal data from patients with R/R mNPM1 AML. Our commercial organization is well-prepared to launch revumenib and leverage our first-to-market position to drive long-term value creation." SpringWorks Therapeutics, Inc. (NASDAQ: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, recently reported their Q3 2024 financial results and provided an update on recent company developments that included achieving $49.3 million in OGSIVEO® (nirogacestat) net product revenue in the quarter, and being granted FDA Priority Review on NDA and received validation of EU Marketing Authorization Application for mirdametinib for the treatment of adults and children with NF1-PN. "As we approach nearly one full year on market, we are very encouraged by the metrics we are seeing regarding the breadth of physician prescribing, the number of patients on OGSIVEO, and the number of patients identified who may stand to benefit in the future from our medicine," said Saqib Islam, CEO of SpringWorks. "Our focus for the remainder of the year is to continue building on OGSIVEO's momentum in the U.S. while working to also bring it to patients in Europe, to advance our commercial preparations for mirdametinib in anticipation of serving patients with NF1-PN in the U.S. and Europe, and to progress our emerging portfolio." Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCE USA News Group WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyFinancial Statement

25 Oct 2024

·pipelinereview.com

First Patients Dosed in Phase 1 Clinical Study of ImmunityBio’s CAR-NK Cell Therapy for the Treatment of Relapsed B-Cell Non-Hodgkin Lymphoma

CULVER CITY, CA, USA I October 24, 2024 I Immunotherapy innovator ImmunityBio, Inc. ( NASDAQ: IBRX ), announced today that the first patients have been dosed in an initial trial studying the potential of the company’s CAR-NK cell therapy targeting CD-19 in the treatment of non-Hodgkin’s lymphoma (NHL). In the QUILT 106 trial, CD19-targeted high-affinity natural killer (t-haNK) cells are being tested initially as a single agent, and after demonstrating safety, then in combination with standard NHL treatment rituximab, in participants with selected CD19+ and CD20+ relapsed/refractory B-cell NHL. The phase 1, open label clinical study is designed to enroll up to 10 participants and is being conducted in Johannesburg, Pretoria, and Bloemfontein, South Africa. This is the first cellular-targeted natural killer (NK) cell therapy study ever to be conducted in South Africa, and is designed to provide important clinical information on a cancer with a significant rate of diagnosis in the region, but with few treatment options. Non-Hodgkin’s lymphoma is the 6 th most common malignancy among people in Sub-Saharan Africa and it is the 4 th most diagnosed cancer in men and the 5 th most diagnosed cancer in women in South Africa, according to the Cancer Association of South Africa. “This trial is important for ImmunityBio as our first clinical study of our CAR-NK, CD19 t-haNK cell line, as well as one of our first studies in liquid tumors,” said Patrick Soon-Shiong, M.D., Executive Chairman, Founder and Global Chief Scientific and Medical Officer at ImmunityBio. “We have chosen to undertake this trial because Sub-Saharan African and, in particular, South African populations are often overlooked when it comes to advanced clinical research, despite the need for innovative immunotherapies in the region.” Full patient enrollment in this Phase 1 study of CD19 t-haNK is currently expected in the first quarter of calendar year 2025 with topline data readout expected in the second half of the calendar year 2025. This study, being conducted in South Africa, is similar to ImmunityBio’s U.S.-based trial QUILT 3.092, a phase 1 open-label study of CD19 t-haNK as a single agent and in combination with the company’s IL-15 superagonist (N-803; ANKTIVA®) and rituximab in participants with relapsed or refractory NHL. About the QUILT 106 Study The Phase 1, first-in-human (FIH), open-label study is designed to enroll up to 10 participants at sites in Johannesburg, Pretoria, and Bloemfontein, South Africa with the primary endpoint of the trial to evaluate the safety and preliminary efficacy of CAR-NK, CD19 t-haNK as a single agent and in combination with rituximab in participants with selected CD19+ and CD20+ R/R B-cell non-Hodgkin lymphoma (NHL). Participants will initially receive a single 3-week cycle of the CD19 t-haNK as a single-agent regime. Following a 1-week safety pause, participants will then receive a 3-week cycle of CD19 t-haNK in combination with rituximab. Patients will undergo multiple assessments of safety and efficacy to help evaluate the safety of CD19 t-haNK as a single agent and in combination with rituximab in participants with R/R NHL, who have active disease after completing ≥ 2 lines of cytotoxic chemotherapy. About CAR-NK, CD19 t-haNK CD19 t-haNK is a human, allogeneic, stable clonal NK cell line generated from the parental activated NK (aNK) cell line (NK-92). Based on the demonstrated therapeutic efficacy of chimeric antigen receptor (CAR) targeting and on the important role of FcγR-mediated antibody-dependent cellular cytotoxicity (ADCC) in the effectiveness of therapeutic IgG1 monoclonal antibodies, it was hypothesized that modification of the parental aNK cell line to stably express both a CD19-targeted CAR and the high-affinity variant of CD16 would result in potent and selective antitumor activity. Therefore, the novel CD19 t-haNK cells have been genetically engineered to stably express 3 main proteins: (1) a human CD19-targeted CAR; (2) the high-affinity variant of the human Fcγ receptor (FcγRIIIa/CD16a 158V) for enhanced ADCC; and (3) endoplasmic reticulum-retained version of human interleukin-2 (ERIL-2) for independent growth. Non-Hodgkin Lymphoma Non-Hodgkin lymphoma (NHL) is a heterogeneous disease that most commonly originates in B lymphocytes. In 2020, according to the South Africa National Cancer Registry ( SANCR 2020 ), it is estimated that 1 in 174 men and 1 in 288 women will develop NHL. According to Global Cancer Observatory ( Sung 2021 ), the incidence of NHL is 4.1% of all cancers. A comparative study of the distribution of NHL subtypes in South Africa reported that Southern Africa had a significantly lower proportion of low-grade B cell NHL (34.3%) and a higher proportion of high-grade B cell NHL (51.5%) compared to Western Europe (54.5% and 36.4%) and North America (56.1% and 34.3%) ( Perry 2015 ). About ImmunityBio ImmunityBio is a vertically-integrated biotechnology company developing next-generation therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases. The company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA ® is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates natural killer cells, T cells, and memory T cells for a long-duration response. The company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. For more information, visit www.immunitybio.com and connect with us on X (Twitter), Facebook , LinkedIn , and Instagram . SOURCE: ImmunityBio

ImmunotherapyPhase 1Cell TherapyVaccineBreakthrough Therapy

24 Oct 2024

·www.biospace.com

First Patients Dosed in Phase 1 Clinical Study of ImmunityBio’s CAR-NK Cell Therapy for the Treatment of Relapsed B-Cell Non-Hodgkin Lymphoma

Company’s first clinical trial studying CAR-NK (CD19 t-haNK) cellular therapy in liquid tumors First natural killer cell-based cellular therapy study conducted in the continent of Africa Complete enrollment currently expected in Q1 2025 CULVER CITY, Calif.--(BUSINESS WIRE)--Immunotherapy innovator ImmunityBio, Inc. ( NASDAQ: IBRX ), announced today that the first patients have been dosed in an initial trial studying the potential of the company’s CAR-NK cell therapy targeting CD-19 in the treatment of non-Hodgkin’s lymphoma (NHL). In the QUILT 106 trial, CD19-targeted high-affinity natural killer (t-haNK) cells are being tested initially as a single agent, and after demonstrating safety, then in combination with standard NHL treatment rituximab, in participants with selected CD19+ and CD20+ relapsed/refractory B-cell NHL. The phase 1, open label clinical study is designed to enroll up to 10 participants and is being conducted in Johannesburg, Pretoria, and Bloemfontein, South Africa. This is the first cellular-targeted natural killer (NK) cell therapy study ever to be conducted in South Africa, and is designed to provide important clinical information on a cancer with a significant rate of diagnosis in the region, but with few treatment options. Non-Hodgkin’s lymphoma is the 6 th most common malignancy among people in Sub-Saharan Africa and it is the 4 th most diagnosed cancer in men and the 5 th most diagnosed cancer in women in South Africa, according to the Cancer Association of South Africa. “This trial is important for ImmunityBio as our first clinical study of our CAR-NK, CD19 t-haNK cell line, as well as one of our first studies in liquid tumors,” said Patrick Soon-Shiong, M.D., Executive Chairman, Founder and Global Chief Scientific and Medical Officer at ImmunityBio. “We have chosen to undertake this trial because Sub-Saharan African and, in particular, South African populations are often overlooked when it comes to advanced clinical research, despite the need for innovative immunotherapies in the region.” Full patient enrollment in this Phase 1 study of CD19 t-haNK is currently expected in the first quarter of calendar year 2025 with topline data readout expected in the second half of the calendar year 2025. This study, being conducted in South Africa, is similar to ImmunityBio’s U.S.-based trial QUILT 3.092, a phase 1 open-label study of CD19 t-haNK as a single agent and in combination with the company’s IL-15 superagonist (N-803; ANKTIVA®) and rituximab in participants with relapsed or refractory NHL. About the QUILT 106 Study The Phase 1, first-in-human (FIH), open-label study is designed to enroll up to 10 participants at sites in Johannesburg, Pretoria, and Bloemfontein, South Africa with the primary endpoint of the trial to evaluate the safety and preliminary efficacy of CAR-NK, CD19 t-haNK as a single agent and in combination with rituximab in participants with selected CD19+ and CD20+ R/R B-cell non-Hodgkin lymphoma (NHL). Participants will initially receive a single 3-week cycle of the CD19 t-haNK as a single-agent regime. Following a 1-week safety pause, participants will then receive a 3-week cycle of CD19 t-haNK in combination with rituximab. Patients will undergo multiple assessments of safety and efficacy to help evaluate the safety of CD19 t-haNK as a single agent and in combination with rituximab in participants with R/R NHL, who have active disease after completing ≥ 2 lines of cytotoxic chemotherapy. About CAR-NK, CD19 t-haNK CD19 t-haNK is a human, allogeneic, stable clonal NK cell line generated from the parental activated NK (aNK) cell line (NK-92). Based on the demonstrated therapeutic efficacy of chimeric antigen receptor (CAR) targeting and on the important role of FcγR-mediated antibody-dependent cellular cytotoxicity (ADCC) in the effectiveness of therapeutic IgG1 monoclonal antibodies, it was hypothesized that modification of the parental aNK cell line to stably express both a CD19-targeted CAR and the high-affinity variant of CD16 would result in potent and selective antitumor activity. Therefore, the novel CD19 t-haNK cells have been genetically engineered to stably express 3 main proteins: (1) a human CD19-targeted CAR; (2) the high-affinity variant of the human Fcγ receptor (FcγRIIIa/CD16a 158V) for enhanced ADCC; and (3) endoplasmic reticulum-retained version of human interleukin-2 (ERIL-2) for independent growth. Non-Hodgkin Lymphoma Non-Hodgkin lymphoma (NHL) is a heterogeneous disease that most commonly originates in B lymphocytes. In 2020, according to the South Africa National Cancer Registry ( SANCR 2020 ), it is estimated that 1 in 174 men and 1 in 288 women will develop NHL. According to Global Cancer Observatory ( Sung 2021 ), the incidence of NHL is 4.1% of all cancers. A comparative study of the distribution of NHL subtypes in South Africa reported that Southern Africa had a significantly lower proportion of low-grade B cell NHL (34.3%) and a higher proportion of high-grade B cell NHL (51.5%) compared to Western Europe (54.5% and 36.4%) and North America (56.1% and 34.3%) ( Perry 2015 ). About ImmunityBio ImmunityBio is a vertically-integrated biotechnology company developing next-generation therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases. The company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA ® is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates natural killer cells, T cells, and memory T cells for a long-duration response. The company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. For more information, visit and connect with us on X (Twitter), Facebook , LinkedIn , and Instagram . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements regarding clinical trial plans and timing, patient enrollment and treatment, timing of data read outs, market and prevalence data, the regulatory review process and timing thereof, the development of therapeutics for cancer and infectious diseases, potential benefits to patients, potential treatment outcomes for patients, the described mechanism of action and results and contributions therefrom, potential future uses and applications of ANKTIVA and use in cancer vaccines and across multiple tumor types, and ImmunityBio’s approved product and investigational agents as compared to existing treatment options, among others. Statements in this presentation that are not statements of historical fact are considered forward-looking statements, which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “goal,” “could,” “estimates,” “scheduled,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “indicate,” “projects,” “is,” “seeks,” “should,” “will,” “strategy,” and variations of such words or similar expressions. Statements of past performance, efforts, or results of our preclinical and clinical trials, about which inferences or assumptions may be made, can also be forward-looking statements and are not indicative of future performance or results. Forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of ImmunityBio’s management as well as assumptions made by and information currently available to ImmunityBio. Such information may be limited or incomplete, and ImmunityBio’s statements should not be read to indicate that it has conducted a thorough inquiry into, or review of, all potentially available relevant information. Such statements reflect the current views of ImmunityBio with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about ImmunityBio, including, without limitation, (i) risks and uncertainties regarding clinical trial patient enrollment and timing and potential results, including with respect to the trial described herein, (ii) risks and uncertainties related to the regulatory submission and review process, (iii) the ability of ImmunityBio to fund its ongoing and anticipated clinical trials, (iv) whether clinical trials will result in registrational pathways and the risks and uncertainties regarding the regulatory submission, review and approval process, (v) the ability of ImmunityBio to continue its planned preclinical and clinical development of its development programs through itself and/or its investigators, and the timing and success of any such continued preclinical and clinical development, patient enrollment and planned regulatory submissions, (vi) potential delays in product availability and regulatory approvals, (vii) ImmunityBio’s ability to retain and hire key personnel, (viii) ImmunityBio’s ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (ix) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (x) ImmunityBio’s ability to successfully commercialize its approved product and product candidates, (xi) ImmunityBio’s ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, and (xii) ImmunityBio’s ability to obtain, maintain, protect and enforce patent protection and other proprietary rights for its product candidates and technologies. More details about these and other risks that may impact ImmunityBio’s business are described under the heading “Risk Factors” in the Company’s Form 10-K filed with the U.S. Securities and Exchange Commission (“SEC”) on March 19, 2024 and the Company’s Form 10-Q filed with the SEC on August 12, 2024, and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC’s website at . ImmunityBio cautions you not to place undue reliance on any forward looking statements, which speak only as of the date hereof. ImmunityBio does not undertake any duty to update any forward-looking statement or other information in this press release, except to the extent required by law. Contacts Investors Hemanth Ramaprakash, PhD, MBA ImmunityBio, Inc. +1 858-746-9289 Hemanth.Ramaprakash@ImmunityBio.com Media Sarah Singleton ImmunityBio +1 415-290-8045 Sarah.Singleton@ImmunityBio.com

ImmunotherapyPhase 1Drug ApprovalCell Therapy

100 Deals associated with Nogapendekin alfa inbakicept-pmln

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KEGG	Wiki	ATC	Drug Bank
D12888	-	-	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Non-Muscle Invasive Bladder Neoplasms	US	Altor BioScience Corp.	22 Apr 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
metastatic non-small cell lung cancer	Phase 3	US	ImmunityBio, Inc.	18 May 2018
Breast Cancer	Phase 2	US	ImmunityBio, Inc.	26 Jun 2017
Colonic Cancer	Phase 2	US	ImmunityBio, Inc.	26 Jun 2017
Ovarian Cancer	Phase 2	US	ImmunityBio, Inc.	26 Jun 2017
Thyroid Cancer	Phase 2	US	ImmunityBio, Inc.	26 Jun 2017
Bladder Cancer	Phase 2	US	ImmunityBio, Inc.	02 Jun 2017
Merkel Cell Carcinoma	Phase 2	US	ImmunityBio, Inc.	24 Sep 2015
Indolent B-Cell Non-Hodgkin Lymphoma	Phase 2	US	Altor BioScience Corp.	17 Apr 2015
Refractory Indolent Non-Hodgkin Lymphoma	Phase 2	US	Altor BioScience Corp.	17 Apr 2015
Non-Muscle Invasive Bladder Neoplasms	Phase 2	CN	Shenzhen Beike Biotechnology Co., Ltd.	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02099539 (CTgov)	Phase 1	Relapse multiple myeloma \| Plasma cell myeloma refractory	19	N-803 (Cohort 1: N-803 - IV 1 ug/kg)	jlexhnzahl(upllrinfsr) = mdwnptnluc ffuamkbzpn (kvwhyiatrn, fjzbsnspyh - lfgvgfgafw) View more	-	26 Sep 2024
				N-803 (Cohort 2: N-803 - IV 3 ug/kg)	jlexhnzahl(upllrinfsr) = psvdmwpyux ffuamkbzpn (kvwhyiatrn, myremyynyz - lzxitkcgaq) View more
NCT03228667 (QUILT 3.055, WCLC2024) Manual	Phase 2	Non-Small Cell Lung Cancer Second line \| Last line \| Third line PDL1+	86	Anktiva + CPI (nivolumab or pembrolizumab) (failure of CPI)	(byvpdttion) = injection site reaction 78 (91%), fatigue 46 (53%), chills 36 (42%). pywztljhww (ncdkscaqay )	Positive	08 Sep 2024
				Anktiva + CPI (nivolumab or pembrolizumab) (failure of CPI + 3rd line)
NCT04385849 (CTgov)	Phase 1	COVID-19	1	N-803 (Experimental Arm)	gywtwbsbfp(hpjgmnjxlj) = dfqntxdtwi fyrhszggyw (tkqoikoacd, yvjpvcqhzd - plmymyustc) View more	-	05 Sep 2024
				Saline (Placebo Arm)	gywtwbsbfp(hpjgmnjxlj) = twqvxtmtwb fyrhszggyw (tkqoikoacd, qsytepilli - oiipljtzuw) View more
NCT03586869 (QUILT-3.080, CTgov)	Phase 1/2	Pancreatic Cancer	3	Avelumab+Aldoxorubicin HCl+GI-6301+GI-4000+ETBX-061+ETBX-051+ETBX-011+fluorouracil+ALT-803+ETBX-021+nab-paclitaxel+Cyclophosphamide+haNK for infusion+Leucovorin+GI-6207+bevacizumab+Oxaliplatin+Capecitabine	cbtezrfkur(icejkoxohi) = bzcxhrjmuk zwhezpznki (zpgjjgsgnz, ohlghppvzn - vtflymchwj) View more	-	27 Aug 2024
NCT03387085 (QUILT-3.067, CTgov)	Phase 1/2	Triple Negative Breast Cancer	9	SBRT+Aldoxorubicin HCl+GI-6301+GI-4000+ETBX-061+ETBX-051+ETBX-011+5-fluorouracil+N-803+nab-paclitaxel+CYCLOPHOSPHAMIDE+Avelumab+haNK for Infusion+Leucovorin+GI-6207+Cisplatin+Bevacizumab+Capecitabine	yzgxlqijcg(cosxtgajfq) = fnkidxssuj ldrgibcuol (uybooffhjn, xccqwsigqz - dnueeauwho) View more	-	09 Aug 2024
NCT03853317 (QUILT-3.063, CTgov)	Phase 2	Merkel Cell Carcinoma	9	N-803+Avelumab+haNK™	obpepdaowd(fxknlvgcsl) = whloqchmta otgnyyhtmm (ctuuzstiik, swfqcraltf - amelnrgovr) View more	-	09 Aug 2024
NCT03127098 (CTgov)	Phase 1/2	Lung Cancer \| Ovarian Cancer \| Colonic Cancer \| Breast Cancer \| Pancreatic Cancer \| Thyroid Cancer	3	ALT-803+ETBX-011	itwdtvrhlw(ngtftekcei) = flkfudgxam bsjblothxb (cfwwsyluoi, omvugtoxmg - mwfwxypnwz) View more	-	06 Aug 2024
NCT03387111 (CTgov)	Phase 1/2	Squamous Cell Carcinoma	4	SBRT+Aldoxorubicin HCl+GI-6301+GI-4000+cetuximab+ETBX-061+ETBX-051+ETBX-011+Necitumumab+fluorouracil+N-803+ETBX-021+nab-paclitaxel+Cyclophosphamide+Avelumab+haNK for infusion+Leucovorin+GI-6207+Cisplatin+Bevacizumab+Capecitabine	pfvxlvyavi(jwdvepsnuj) = mvaorjojtv fuzdqdfclx (mdwxgsywmo, qflctzthhz - hjevzngrge) View more	-	05 Aug 2024
NCT02384954 (CTgov)	Phase 1/2	Refractory Indolent Non-Hodgkin Lymphoma \| Indolent B-Cell Non-Hodgkin Lymphoma	43	N-803+Rituximab (Phase 1 Cohort 1: N-803 - IV 1 ug/kg)	yjzfxehzeo(zawrfwistk) = cvqixwsmwp iedxbtdjvy (qnaoqoofqq, opygymdnxj - ilcpdhnipn) View more	-	03 Jul 2024
				N-803+Rituximab (Phase 1 Cohort 2: N-803 - IV 3 ug/kg)	yjzfxehzeo(zawrfwistk) = erlhtmuyvi iedxbtdjvy (qnaoqoofqq, zcthbzpxgi - wwzabvfrnu) View more
NCT02138734 \| NCT03022825 (Pubmed \| Future Oncol)	Not Applicable	-	-	N-803 plus BCG	(rubmlkiguz) = vbetrecbwb fehhuuhisa (khdxffdyhu )	Positive	02 Jul 2024
				BCG	(rubmlkiguz) = uckdutswfq fehhuuhisa (khdxffdyhu )

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