Randomized, Open-Label, Phase 3 Clinical Trial Of ANKTIVA Plus NIVOLUMAB And DOCETAXEL Versus DOCETAXEL Monotherapy In Participants With Advanced Or Metastatic Non-Small Cell Lung Cancer Who Have Acquired Resistance To Immune Checkpoint Inhibitor Therapy

This is a randomized, open-label, phase 3 clinical trial to compare the efficacy and safety of ANKTIVA plus nivolumab and docetaxel (experimental arm) versus docetaxel monotherapy (control arm). Enrolled participants will be randomized 2:1 to treatment in the experimental arm or the control arm. Participant randomization will be stratified by geographical region (North America vs Europe vs ASIA), NSCLC histology (squamous vs nonsquamous), and actionable genomic alteration (AGA); (epidermal growth factor receptor [EGFR]/anaplastic lymphoma kinase [ALK] reactive oxygen species [ROS] vs OTHER AGA vs No AGA).

Start Date01 Jan 2025

Sponsor / Collaborator

ImmunityBio, Inc.

NCT05642195 / SuspendedPhase 1/2IIT

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 Date25 Dec 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 Date25 Dec 2024

Sponsor / Collaborator

National Cancer Institute

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 Dec 2024·European Urology Oncology

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

Review

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

BACKGROUND AND OBJECTIVE:

Therapeutic 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.

METHODS:

We 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 LIMITATIONS:

To 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 IMPLICATIONS:

Novel 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 SUMMARY:

We 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.

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

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.

News (Medical) associated with Nogapendekin alfa inbakicept-pmln

11 Dec 2024

·www.businesswire.com

ImmunityBio, Inc. Announces Pricing of Public Offering of Common Stock

CULVER CITY, Calif.--( BUSINESS WIRE )--ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced the pricing of its previously announced underwritten public offering of an aggregate of 33,333,334 shares of its common stock at a price to the public of $3.00 per share. ImmunityBio has granted the underwriters a 30-day option to purchase up to an additional 5,000,000 shares of its common stock at the public offering price, less underwriting discounts and commissions. All of the shares were sold by ImmunityBio. Before deducting the underwriting discount and offering expenses payable by ImmunityBio, ImmunityBio expects to receive gross proceeds of approximately $100.0 million, assuming no exercise of the underwriters’ option to purchase additional shares. The offering is expected to close on or about December 12, 2024 subject to satisfaction of customary closing conditions. Jefferies and Piper Sandler are acting as joint book-running managers and representatives of the underwriters for the offering. BTIG and H.C. Wainwright & Co. are acting as co-lead managers with D. Boral Capital acting as co-manager for the offering. ImmunityBio currently intends to use the net proceeds from this offering to progress its continued commercialization of ANKTIVA ® for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (“NMIBC”) with carcinoma in situ (“CIS”) with or without papillary tumors, to fund its trials in BCG-naïve NMIBC and non-small cell lung cancer (“NSCLC”), toward further research and development, for working capital needs, and for other general corporate purposes. A shelf registration statement on Form S-3ASR relating to the common stock offered in the public offering was filed with the Securities and Exchange Commission (the “SEC”) on April 17, 2024 and became automatically effective on April 17, 2024. The offering is being made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC on December 10, 2024 and is available on the SEC’s website at www.sec.gov . A final prospectus supplement and accompanying prospectus relating to the offering will also be filed with the SEC and will be available on the SEC’s website at www.sec.gov . When available, copies of the final prospectus supplement and the accompanying prospectus may also be obtained from: Jefferies LLC, by mail at Attn: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, New York 10022, by telephone at (877) 821-7388 or by email at Prospectus_Department@Jefferies.com , or Piper Sandler & Co. by mail at Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402 or by email at prospectus@psc.com . This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. The offering was made only by means of a prospectus supplement and accompanying prospectus. About ImmunityBio, Inc. ImmunityBio is a vertically-integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company’s range of immunotherapy platforms, alone and together, act to drive an immune response with the goal of creating durable immune memory generating 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. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements concerning expectations with respect to the completion of the public offering, and the anticipated use of the net proceeds from the offering. Risks and uncertainties related to these endeavors include, but are not limited to, risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the public offering. 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. Investors should review the risks and uncertainties contained in ImmunityBio’s filings with the SEC, including the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the SEC on November 12, 2024, in the preliminary prospectus supplement related to the public offering filed with the SEC on December 10, 2024, and in the final prospectus supplement to be filed with the SEC, as well as other risks set forth in the Company’s other filings with the SEC. ImmunityBio cautions you that the forward-looking information presented in this press release is not a guarantee of future events, and that actual events may differ materially from those described in or suggested by the forward-looking information contained in this press release. 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. Any forward-looking information presented herein is made only as of the date of this press release, and the Company does not undertake any obligation to update or revise any forward-looking information to reflect changes in assumptions, the occurrence of unanticipated events, or otherwise, except to the extent required by law.

ImmunotherapyClinical StudyBreakthrough TherapyVaccine

10 Dec 2024

·www.businesswire.com

ImmunityBio, Inc. Announces Proposed Public Offering of Common Stock

CULVER CITY, Calif.--( BUSINESS WIRE )--ImmunityBio, Inc. (NASDAQ: IBRX), a leading immunotherapy company, today announced that it intends to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering. In addition, ImmunityBio expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the offering at the public offering price, less underwriting discounts and commissions. ImmunityBio currently intends to use the net proceeds from this offering to progress its continued commercialization of ANKTIVA ® for treatment of BCG-unresponsive non-muscle invasive bladder cancer (“NMIBC”) with carcinoma in situ (“CIS”) with or without papillary tumors, to fund its trials in BCG-naïve NMIBC and non-small cell lung cancer (“NSCLC”), toward further research and development, for working capital needs, and for other general corporate purposes. All of the shares are being offered by ImmunityBio. There can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering. Jefferies and Piper Sandler are acting as joint book-running managers and representatives of the underwriters for the offering. BTIG and H.C. Wainwright & Co. are acting as co-lead managers for the offering. A shelf registration statement on Form S-3ASR relating to the common stock offered in the public offering described above was filed with the Securities and Exchange Commission (“SEC”) on April 17, 2024 and became automatically effective on April 17, 2024. The proposed offering is being made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov . Copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering, when available, may also be obtained from Jefferies LLC, by mail at Attn: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, New York 10022, by telephone at (877) 821-7388 or by email at Prospectus_Department@Jefferies.com , or Piper Sandler & Co. by mail at Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402 or by email at prospectus@psc.com . This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. The offering may be made only by means of a prospectus supplement and accompanying prospectus. About ImmunityBio, Inc. ImmunityBio is a vertically-integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company’s range of immunotherapy platforms, alone and together, act to drive an immune response with the goal of creating durable immune memory generating 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. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements concerning expectations with respect to the completion, timing and size of the proposed public offering, the grant to the underwriters of an option to purchase additional shares, and the anticipated use of the net proceeds from the proposed offering. Risks and uncertainties related to these endeavors include, but are not limited to, risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the proposed public offering. 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. Investors should review the risks and uncertainties contained in ImmunityBio’s filings with the SEC, including the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the SEC on November 12, 2024, in the preliminary prospectus supplement related to the public offering filed with the SEC on December 10, 2024, and in the final prospectus supplement to be filed with the SEC, as well as other risks set forth in the Company’s other filings with the SEC. ImmunityBio cautions you that the forward-looking information presented in this press release is not a guarantee of future events, and that actual events may differ materially from those described in or suggested by the forward-looking information contained in this press release. 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. Any forward-looking information presented herein is made only as of the date of this press release, and the Company does not undertake any obligation to update or revise any forward-looking information to reflect changes in assumptions, the occurrence of unanticipated events, or otherwise, except to the extent required by law.

ImmunotherapyClinical StudyDrug ApprovalBreakthrough Therapy

05 Dec 2024

·endpts.com

CG Oncology’s bladder cancer treatment shows durability potential in Phase 3

CG Oncology says its immunotherapy candidate that could help patients avoid surgery may deliver lasting responses in a certain form of bladder cancer based on late-stage trial data. The California biotech’s oncolytic virus therapy, named cretostimogene grenadenorepvec, has not yet reached median duration of response in a Phase 3 study in people with high-risk non-muscle invasive bladder cancer (NMIBC) who are unresponsive to the Bacillus Calmette-Guérin vaccine, which is usually part of a first-line regimen. That said, the median DOR exceeded 27 months at the Sept. 30 data cutoff, according to data presented Thursday at the Society of Urologic Oncology annual meeting in Dallas. For context, Merck’s Keytruda, which is often used in the second line, has a median DOR of around 16 months, CG Oncology CEO Arthur Kuan told Endpoints News in an interview. CG also reported that 97.3% of patients did not progress to muscle-invasive disease at 12 months. Also, just over half of the enrolled patients remained responsive to treatment at 24 months or more based on Kaplan-Meier estimations. Thursday’s durability data add to an interim readout in May that showed the asset cleared tumors in 75% of the 112 patients in the trial. The latest safety results were also consistent with the May data, with no reports of grade 3 or higher adverse events or treatment-related discontinuation. The most common side effects included bladder spasm, frequent urination and urgent urination. Cretostimogene “basically spares normal cells” because they don’t harbor RB/E2F1 mutations, Kuan said. Cretostimogene has the potential to become a “backbone bladder-sparing therapeutic” if it secures US approval, CG’s chief operating officer Ambaw Bellete said in a company release. Most patients in the Phase 3 did not have surgery to remove all or part of their bladder before joining the study. The biotech plans to file the treatment with the FDA in the second half of 2025. CG went public via a $380 million upsized listing on the Nasdaq in January. The company plans to launch cretostimogene alone in most markets, although it has a partnership with Kissei Pharmaceutical for Japan, South Korea, Taiwan and a number of other Asian countries except China. It had $540.7 million in cash and equivalents at the end of September, which should support it through 2027. Elsewhere, the biotech is also testing the treatment in the Phase 3 PIVOT-006 trial in intermediate-risk NMIBC. Market competition for NMIBC is steadily growing after the FDA greenlit ImmunityBio’s Anktiva plus BCG for a subgroup of patients in April. Johnson & Johnson is advancing a drug-device combination that it calls the “pretzel” for people with high- and intermediate-risk NMIBC.

Phase 3Clinical ResultASCOVaccine

100 Deals associated with Nogapendekin alfa inbakicept-pmln

External Link

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.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Non-small cell lung cancer stage III	Phase 3	-	ImmunityBio, Inc.	01 Jan 2025
metastatic non-small cell lung cancer	Phase 3	US	ImmunityBio, Inc.	18 May 2018
Bladder Cancer	Phase 3	US	ImmunityBio, Inc.	02 Jun 2017
Platinum-Resistant Ovarian Carcinoma	Phase 2	US	ImmunityBio, Inc.	01 Dec 2024
Recurrent Platinum-Resistant Ovarian Carcinoma	Phase 2	US	ImmunityBio, Inc.	01 Dec 2024
Glioblastoma	Phase 2	US	ImmunityBio, Inc.	07 Aug 2024
Head and neck cancer metastatic	Phase 2	US	ImmunityBio, Inc.	16 Feb 2024
Recurrent Head and Neck Carcinoma	Phase 2	US	ImmunityBio, Inc.	16 Feb 2024
Recurrent Squamous Cell Carcinoma of the Head and Neck	Phase 2	US	ImmunityBio, Inc.	16 Feb 2024
Squamous cell carcinoma of head and neck metastatic	Phase 2	US	ImmunityBio, Inc.	16 Feb 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03329248 (QUILT-3.060, CTgov)	Phase 1/2	Pancreatic Cancer	6	SBRT+GI-4000+lovaza+Leucovorin+ETBX-011+fluorouracil+ALT-803+nab-paclitaxel+cyclophosphamide+haNK for infusion+Bevacizumab+Oxaliplatin+Capecitabine	rpafnocvlq(yxofqhgihs) = pknongyoqc drfwebvwxv (uwfswsdczp, nqklprqxjj - amxakjggsz) View more	-	12 Dec 2024
NCT03563157 (CTgov)	Phase 1/2	Metastatic Colorectal Carcinoma	2	SBRT+Aldoxorubicin Hydrochloride+GI-6301+GI-4000+ETBX-061+Cetuximab+ETBX-051+Leucovorin+ETBX-011+5-Fluorouracil+ALT-803+ETBX-021+nab-paclitaxel+CYCLOPHOSPHAMIDE+Avelumab+haNK+GI-6207+Regorafenib+Oxaliplatin+Capecitabine (NANT Colorectal Cancer (CRC) Vaccine)	ussnzgucrx(qrcnkqroqy) = lncugslurb dxiotvdnbx (ykirkcbxua, jkzfruymby - ejnzvwgtfx) View more	-	11 Dec 2024
NCT03563157 (CTgov)	Phase 1/2	Metastatic Colorectal Carcinoma	2	Regorafenib (Regorafenib)	hrjniaewvr(vsgfvmkcwg) = ekvjckphar ijbxdotlfh (ltxhqdbnil, swjcwtbcbw - hlvihhcmrw) View more	-	11 Dec 2024
NCT02099539 (CTgov)	Phase 1	Relapse multiple myeloma \| Refractory Multiple Myeloma	19	N-803 (Cohort 1: N-803 - IV 1 ug/kg)	vmoqibcvyk(lphfqhvpng) = joccqklkph igigosdqun (nfeehgioie, wqcqldysvj - yvnzqujfpa) View more	-	26 Sep 2024
NCT02099539 (CTgov)	Phase 1	Relapse multiple myeloma \| Refractory Multiple Myeloma	19	N-803 (Cohort 2: N-803 - IV 3 ug/kg)	vmoqibcvyk(lphfqhvpng) = hdivuekjdf igigosdqun (nfeehgioie, pnnnajcewj - jlcwgnlili) View more	-	26 Sep 2024
NCT03228667 (QUILT 3.055, WCLC2024) Manual	Phase 2	Non-Small Cell Lung Cancer Second line \| Last line \| Third line PDL1+	86	Anktiva 15mcg/knivolumabvolupembrolizumab	pwfaytjcqn(iyfjvbynzi) = injection site reaction 78 (91%), fatigue 46 (53%), chills 36 (42%). qezpxcunzp (rvgoqnpwxf )	Positive	08 Sep 2024
NCT03228667 (QUILT 3.055, WCLC2024) Manual	Phase 2		86	Anktiva + CPI (nivolumab or pembrolizumab)pembrolizumab) (failure of CPI + 3rd line)		Positive	08 Sep 2024
NCT04385849 (CTgov)	Phase 1	COVID-19	1	N-803 (Experimental Arm)	oiwxchdtwv(aaunfssvzz) = ukmdcqxmtq mmhkbruyey (emglajwjwc, puwpptsrla - otbmvzzvec) View more	-	05 Sep 2024
NCT04385849 (CTgov)	Phase 1	COVID-19	1	Saline (Placebo Arm)	oiwxchdtwv(aaunfssvzz) = fiffidtzpt mmhkbruyey (emglajwjwc, bpovfzzvuw - fanacqlfwr) View more	-	05 Sep 2024
NCT03586869 (QUILT-3.080, CTgov)	Phase 1/2	Pancreatic Cancer	3	Avelumab+Aldoxorubicin HCl+GI-6301+GI-4000+ETBX-061+ETBX-051+Leucovorin+ETBX-011+fluorouracil+ALT-803+ETBX-021+nab-paclitaxel+cyclophosphamide+haNK for infusion+GI-6207+bevacizumab+Oxaliplatin+Capecitabine	uaixhythzb(giqilxdtti) = moytmgqiyn gobaemdhpc (fbquumhqqz, jfxpxbujuy - jzqjovswkd) View more	-	27 Aug 2024
NCT03853317 (QUILT-3.063, CTgov)	Phase 2	Metastatic Merkel Cell Carcinoma \| Merkel Cell Carcinoma	9	N-803+Avelumab+haNK™	lfofzzmdur(qtautyvxey) = yvbohiwugx rlndcggume (ntqflhiqyw, sqwouaneyx - gmwyrqzevd) View more	-	09 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+Leucovorin+ETBX-011+5-Fluorouracil+N-803+nab-paclitaxel+CYCLOPHOSPHAMIDE+Avelumab+haNK for Infusion+GI-6207+cisplatin+Bevacizumab+Capecitabine	rskystwebj(pvfsgxrywh) = lrgvxxncry nncweccnax (ugxakzgbex, drrbguovgo - frjjhtwqyy) View more	-	09 Aug 2024
NCT03127098 (CTgov)	Phase 1/2	Lung Cancer \| Ovarian Cancer \| Colonic Cancer ... View more	3	ALT-803+ETBX-011	cumheqdjom(mbnefgzphh) = qneaplswpz oryzozbqvt (tuzjyyiezv, qssfhifogx - kgsatrckhc) 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+Leucovorin+ETBX-011+Necitumumab+fluorouracil+N-803+ETBX-021+nab-paclitaxel+Cyclophosphamide+Avelumab+haNK for infusion+GI-6207+cisplatin+Bevacizumab+Capecitabine	vzjvvvmgsd(rojqeygidu) = iivtzvttkq apdtisdqny (nwocuaawkt, dchukjvgag - hbjybhsiwb) View more	-	05 Aug 2024

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