NorthWest Biotherapeutics Inc (NWBO)

[ae kusterer]

Excellent post by antihama:
Don't think that's accurate. Here are 6 trials that are better candidates, IMO, including one previously described. Three of the trials are listed but recruiting estimated to start this year which I assume counts when the PR states "The technologies are already in Phase 2 clinical trials"
Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma
http://ClinicalTrials.gov ID NCT04093323
Sponsor Roswell Park Cancer Institute
Information provided by Roswell Park Cancer Institute (Responsible Party)
Last Update Posted 2024-05-30
Study Start (Estimated) 2024-06-20

Study Overview
Brief Summary
This phase II trial studies how well polarized dendritic cell (aDC1) based therapy, interferon alpha-2, rintatolimod, and celecoxib work together in treating patients with HLA-A2 positive (+) melanoma that has not responded to previous treatment (refractory). The aDC1 cell-based treatment contains white blood cells (dendritic cells or DCs) that stimulates the immune system. Interferon alpha-2 can improve the body's natural response to infections and other diseases. It can also interfere with the division of cancer cells and slow tumor growth. Rintalolimid may stimulate the immune system. Celecoxib is a drug that reduces pain. This study is being done to find out if the combination of the study cell-based treatment (aDC1 dendritic cells) and interferon alpha-2, rintatolimod, and celecoxib can prevent the growth and/or progression of melanoma.

Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast Cancer
http://ClinicalTrials.gov ID NCT04348747
Sponsor Roswell Park Cancer Institute
Information provided by Roswell Park Cancer Institute (Responsible Party)
Last Update Posted 2024-06-14
Study Start (Actual) 2022-12-19

Study Overview
Brief Summary
This phase IIa trial studies how well dendritic cell vaccines against Her2/Her3 and pembrolizumab work for the treatment of triple negative breast cancer or HER2+ breast cancer that has spread to the brain (brain metastasis). Dendritic cell vaccines work by boosting the immune system (a system in the body that protect against infection) to recognize and destroy the cancer cells. . Pembrolizumab is an "immune checkpoint inhibitor" which is designed to either "unleash" or "enhance" the cancer immune responses that already exist by either blocking inhibitory molecules" or by activating stimulatory molecules. Giving dendritic cell vaccines and pembrolizumab may shrink the cancer.

Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma
http://ClinicalTrials.gov ID NCT04093323
Sponsor Roswell Park Cancer Institute
Information provided by Roswell Park Cancer Institute (Responsible Party)
Last Update Posted 2024-05-30
Study Start (Estimated) 2024-06-20

Study Overview
Brief Summary
This phase II trial studies how well polarized dendritic cell (aDC1) based therapy, interferon alpha-2, rintatolimod, and celecoxib work together in treating patients with HLA-A2 positive (+) melanoma that has not responded to previous treatment (refractory). The aDC1 cell-based treatment contains white blood cells (dendritic cells or DCs) that stimulates the immune system. Interferon alpha-2 can improve the body's natural response to infections and other diseases. It can also interfere with the division of cancer cells and slow tumor growth. Rintalolimid may stimulate the immune system. Celecoxib is a drug that reduces pain. This study is being done to find out if the combination of the study cell-based treatment (aDC1 dendritic cells) and interferon alpha-2, rintatolimod, and celecoxib can prevent the growth and/or progression of melanoma.

Pembrolizumab and Autologous Dendritic Cells for the Treatment of Refractory Colorectal Cancer (CRC)
http://ClinicalTrials.gov ID NCT05518032
Sponsor Roswell Park Cancer Institute
Information provided by Roswell Park Cancer Institute (Responsible Party)
Last Update Posted 2024-04-12
Study Start (Estimated) 2024-10-01

Study Overview
Brief Summary
The phase II trial tests whether pembrolizumab and dendritic cell-based treatment works to shrink tumors in patients with colorectal cancer that does not respond to treatment (refractory). Pembrolizumab, also referred to as an immune checkpoint inhibitor drug, works by targeting molecules that act as a check and balance system for immune responses. Immune checkpoint inhibitor drugs are designed to either "unleash" or "enhance" the cancer immune responses that already exist by either (1) blocking inhibitory molecules or by (2) activating stimulatory molecules. Dendritic cell-based treatment works by boosting the immune system (a system in our bodies that protects us against infection) to recognize and destroy the cancer cells. This investigational treatment targets cancer cells and is made from the patient's own blood cells. Giving pembrolizumab and dendritic cell-based treatment may help shrink tumors in patients with colorectal cancer.

Dendritic Cell-Based Treatment Plus Immunotherapy for the Treatment of Metastatic or Unresectable Triple Negative Breast Cancer
http://ClinicalTrials.gov ID NCT05539365
Sponsor Roswell Park Cancer Institute
Information provided by Roswell Park Cancer Institute (Responsible Party)
Last Update Posted 2024-04-12
Study Start (Estimated)
2024-10-01
Study Overview
Brief Summary
This phase II trial tests the safety, side effects, and whether dendritic cell-based treatment and pembrolizumab work in treating patients with triple negative breast cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). The term triple-negative breast cancer refers to the fact that the cancer cells don't have estrogen or progesterone receptors (ER or PR) and also don't make any or too much of the protein called HER2 (the cells test "negative" on all 3 tests). Dendritic cell-based treatment works by boosting the immune system (a system in our bodies that protects us against infection) to recognize and destroy the cancer cells. Pembrolizumab, is an immune checkpoint inhibitor drug, that works by targeting molecules that act as a check and balance system for immune responses. Immune checkpoint inhibitor drugs are designed to either "unleash" or "enhance" the cancer immune responses that already exist by either blocking inhibitory molecules or by activating stimulatory molecules. Giving dendritic cell-based therapy and pembrolizumab may decrease symptoms and improve quality of life in patients with triple negative breast cancer.

Autologous Dendritic Cell Vaccine in Kidney Cancer
http://ClinicalTrials.gov ID NCT05127824
Sponsor Jodi Maranchie
Information provided by Jodi Maranchie, University of Pittsburgh (Responsible Party)
Last Update Posted 2024-06-14
Study Start (Actual) 2023-07-06
Study Overview
Brief Summary
The purpose of this study is to estimate the probability of immune response for the combination treatment of dendritic cell vaccine with oral cabozantinib and characterize the safety profile of interventional therapy.
Detailed Description
Participants with newly diagnosed, non-metastatic, histologically confirmed, clear cell renal cell carcinoma (ccRCC) who have elected to undergo surgical resection, will receive neoadjuvant autologous Tumor Blood Vessel Antigen (TBVA)-Dendritic Cell Vaccine intradermally every 2 weeks x 2 (days 7(+/-3) and 21(+/-3)) prior to surgery on day 31(+7) with oral cabozantinib 20 mg daily for 10 days. We hypothesize that treated renal tumors will demonstrate maturation and organization of the tumor endothelium with normalization of endothelial markers and formation of tertiary lymphoid structure capable of promoting specific T-cell induction.

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3:55 AM · Jun 18, 2024
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University of Chicago Ovarian Cancer SPORE Clinical Trials
RESEARCH
Roswell Park - University of Chicago Ovarian Cancer SPORE
SPORE Overview
History of the Ovarian Cancer SPORE
Information for Patients
Clinical Trials
Faculty and Staff
Upcoming clinical trials
A Phase I/II study to investigate the safety, biologic and anti-tumor activity of oncolytic vaccinia virus armed with a CXCR4 antagonist in combination with pembrolizumab in patients receiving liposomal doxorubicin for recurrent or treatment refractory ovarian, fallopian tube or primary peritoneal cancer (expected early 2024).

A Phase I/II trial of patient-specific neoepitope-loaded autologous dendritic cells and PD-1 blockade in advanced ovarian cancer (expected late 2024).

View a list of all ovarian cancer clinical trials offered by cancer centers across the United States.

Fabulous post! Three immunosuppressive characteristics and MDSC is one of them. Plx3397 can take care of TAM. Seems like Pawel Kalinski can help to tackle MDSC.


#dcvax $nwbo #gbm

Specializing In:

Biology of dendritic cells (DC) and DC vaccines Biology of T cells and T cell targeting therapies of cancer Biology of natural killer (NK) cells Biology of human myeloid-derived suppressor cells (MDSC) Regulation of chemokine production in tumor microenvironment (TME) TME and tumor-associated immune suppression In vitro modeling of human immune system Design and implementation of early phase clinical trialsSpecializing In:

Development and clinical evaluation of new cancer involving the modulation of patients' immune system Role of the immune system in the effectiveness of chemo- and radiotherapy Promoting interactions between clinical and laboratory researchers Development and clinical evaluation of therapeutic vaccines involving different subsets of “polarized” DCs (colorectal cancer, ovarian cancer, prostate cancer, melanoma, hematologic malignancies) Development and clinical evaluation of adoptive T cell therapies (ACT) using ex vivo-induced polyclonal CTLs (ovarian- & colorectal cancers and melanoma) Development and clinical evaluation of combinatorial approaches to enhance the effectiveness of vaccines, ACT an checkpoint blockers, but reprogramming tumor microenvironments for enhanced CTL infiltration and modulating intratumoral expression of PD-L1, Development of combinatorial adjuvants to modulate DC functions in situ Counteracting cancer-related immunosuppressive mechanisms and their use in transplantation and autoimmunity Role of the immune system in the effectiveness of oncolytic virotherapies Role of the immune system in the effectiveness of chemotherapy and radiotherapy of cancer Interplay between stress and cancer immunityResearch Interests:

About Pawel Kalinski
Biography:
The overall goal of my research is to advance the integration of immunotherapy within comprehensive cancer care, as a complementary modality to surgery, chemo and radiotherapy. My group develops new methods of using ex vivo-educated dendritic cells, DC-activated T cells, combinatorial adjuvants and checkpoint blockers, to promote selectively accumulation of type-1 immune cells (CTLs, Th1 and NK cells) in tumor lesions, without amplifying pre-existing Treg- and MDSC responses, in order to enhance local immune surveillance and enhance overall therapeutic outcomes. Our current projects include:Development and clinical evaluation of therapeutic vaccines involving different subsets of “polarized” DCs (colorectal cancer, ovarian cancer, prostate cancer, melanoma, hematologic malignancies)
Development and clinical evaluation of adoptive T cell therapies (ACT) using ex vivo-induced polyclonal CTLs (ovarian- & colorectal cancers and melanoma)
Development and clinical evaluation of combinatorial approaches to enhance the effectiveness of vaccines, ACT and checkpoint blockers, but reprogramming tumor microenvironments for enhanced CTL infiltration and modulating intratumoral expression of PD-L1, PD-L2 and other checkpoints (colorectal cancer, ovarian cancer, prostate cancer, melanoma, bladder cancer, HPV-associated cancers)
Development of combinatorial adjuvants to modulate DC functions in situ
Counteracting cancer-related immunosuppressive mechanisms and their use in transplantation and autoimmunity
Role of the immune system in the effectiveness of oncolytic virotherapies
Role of the immune system in the effectiveness of chemotherapy and radiotherapy of cancer
Interplay between psychologic stress and cancer immunity These interdisciplinary projects involving multiple clinical and laboratory teams, have been advanced as parts of the as multiple NIH-, DOD-, pharma and biotech-funded grants and program projects (single- and multi-institution P01s and P50/SPOREs; where I have been serving as the overall PI, overall co-PI or a Project Leader) and focusing on the therapy of melanoma, colon cancer, prostate cancer, ovarian cancer, and hematologic malignancies. Our current work includes phase I/II and phase II clinical testing of the resulting paradigms and methods in cancer patients, and development of similar treatments for patients with premalignant lesions and chronic infections resistant to standard forms of treatment.

https://roswellpark.org/pawel-kalinski



#dcvax $nwbo #gbm

Excellent post by Brightboy:

People, People, People!!! THIS A BIG, BIG ,TERRIFIC DEAL!!!!! How do you build a Franchise???? Well, the "Instruction Sheet" is in the PRESS RELEASE!!! For a "Song"($2.3 million and a 4% royalty on treatment sales for the 2 NEW and possibly a third cancer treatment, the company has now expanded its Franchise value from one treatment for GBM pending approval in the UK to 2 active clinical trials with one pending for 3 new cancers AND in doing so, has firmly established DCVax Technology as the "Go TO" technology for every dendritic cell based immunotherapy company in the world!!!! Not to mention the FACT that the company has the only manufacturing process that can make the product and scale to demand for every CI company in biotech to dramatically improve their treatment. Shoot, we have already become the "XEROX" of dendritic cell based immunotherapy or in the words of a company supporter, Northwest has "APPELIZED" healthcare!!!! BUT ALSO!!!! as is apparent in the PR, the company ain't stopping there!!! No, No, NO 111 The company's going for "All the marbles"!!! AND every CEO in big biotech knows that they have to license the DCVax Platform Technology to be competitive!! Hell, this deal is making "Screaming Kitty" or whatever the hell that guys name is, drool with envy. This ain't no flash in the pan like GME, this a "FLASHBULB, LIGHTING UP THE FUTURE OF THE ENTIRE HEALTHCARE LANDSCAPE!!!!!" Dudes and Dudettes, this deal has got legs!!!!!

AND by the way, Linda Powers and her band of experts have not been sittin on their ass like many have claimed, they've been workin their butts off for the last 2 years to pull this off!!! and BRAVO to them!!!! How much do you think the value of getting in on 3 clinical trials is??? Millions and millions!!!! THAT'S THE FRANCHISE VALUE THAT NORTHWEST HAS ADDED. Hundreds of millions in cost savings and billions in sales revenue!!!!!

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8:48 AM · Jun 17, 2024
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Northwest Biotherapeutics Announces Exclusive In-License of Portfolio of Dendritic Cell Technology and Intellectual Property
Complementary to Technology & IP Already Owned or In-Licensed; Significant Step in Building a Leading Dendritic Cell Franchise

BETHESDA, MD, June 17, 2024 – Northwest Biotherapeutics (OTCQB: NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that on June 12, 2024 it entered into an exclusive license from Roswell Park Comprehensive Cancer Center for a portfolio of dendritic cell technologies and intellectual property (IP). The technologies are already in Phase 2 clinical trials, and the Company plans to collaborate with the lead scientist-clinician, Dr. Pawel Kalinski, on the further development of the technologies. The license is the culmination of more than 2 years of discussions and negotiations.

The license includes 5 new patent families that were just filed in 2023 and hence have their full potential patent life ahead of them. The technologies include enhanced versions of dendritic cells (DCs) and DC based therapies, as well as conditioning regimens designed to enhance patient responses and approaches to reprogram the tumor microenvironment to boost immune therapies and help overcome resistance to checkpoint inhibitors.

The DC based therapies include versions with tumor antigens loaded into the DCs and versions for intra-tumoral administration without pre-loading of antigens. Phase 2 trials involving the licensed technologies for two different cancers opened for enrollment earlier this year and are currently under way, and a third Phase 2 trial for a third cancer is pending. The trials are fully funded by grant funding and are being conducted as investigator led trials. The Company does not anticipate having to provide any funding or undertake any operational role for these trials.

As previously reported, over time the Company has been quietly in-licensing various technologies and IP from various institutions and entities which it believes can be valuable in building a leading franchise in dendritic cell therapies.

The portfolio in-licensed from Roswell Park is complementary to, and builds upon, a portfolio which the Company exclusively licensed from another institution last year. Together, the two portfolios encompass more than 20 years of work by one of the foremost groups of dendritic cell experts, led by Dr. Kalinski.

The portfolio in-licensed last year includes the foundational technologies and IP, and positive early-stage clinical trial results, developed by the Kalinski group over 17 years before coming to Roswell. The portfolio in-licensed now includes the further work during the last 7 years at Roswell. Taken together, the Company believes that the two portfolios comprise a whole that is greater than the sum of its parts and offer compelling synergies with the Company’s own portfolio. The Company plans to collaborate with Dr. Kalinski on the further clinical development of the combined technologies.

The Company believes that the infrastructure and systems it has developed, and experience it has gained, in producing and delivering personalized living-cell DC based therapies for large numbers of patients make it uniquely positioned to help accelerate the late-stage development of the licensed DC technologies. The Company’s 331-patient Phase 3 clinical trial remains one of the largest personalized cell therapy trials conducted to date, and the Company’s extensive experience treating compassionate use patients has added valuable ongoing “real world” experience.

“We are excited to join forces with Dr. Kalinski, one of the foremost experts on dendritic cell biology and therapies,” commented Linda Powers, the Company’s CEO. “We also greatly appreciate the supportiveness of the institutions throughout the long process of working out the arrangements to keep the Kalinski portfolios intact and to license them to NWBio. In the immediate term, we will continue to focus intensively on pursuing the approval and commercialization of DCVax®-L for glioblastoma, but we are excited to begin working on growth opportunities with the licensed technologies as well.”

The terms of the Roswell license include standard provisions for an upfront license fee and milestones related to the first Phase 2 trial, first Phase 3 trial, first product approval and first commercial sale. If all of the milestones are met, the payments would be approximately $2.3 million. The license terms also include royalties of 4% on product sales (potentially reduced to 3% in the event of royalty stacking).

ABOUT NORTHWEST BIOTHERAPEUTICS
Northwest Biotherapeutics is a biotechnology company focused on developing personalized immunotherapy products that are designed to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis. The Company has a broad platform technology for DCVax® dendritic cell-based vaccines. The Company’s lead program involves DCVax®-L treatment for glioblastoma (GBM). GBM is the most aggressive and lethal form of primary brain cancer, and is an “orphan disease.” The Company has completed a 331-patient Phase III trial of DCVax-L for GBM, presented the results in scientific meetings, published the results in JAMA Oncology and submitted a MAA for commercial approval in the UK. The Company has also developed DCVax®-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial and, as resources permit, plans to pursue Phase II trials. The Company previously conducted a Phase I/II trial with DCVax-L for advanced ovarian cancer together with the University of Pennsylvania.

DISCLAIMER
Statements made in this news release that are not historical facts, including statements concerning plans for DCVax are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “expect,” “believe,” “intend,” “design,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those projected in any forward-looking statement. Readers should not rely upon forward-looking statements. There are a number of important factors that could cause actual results to differ materially from those anticipated, including, without limitation, risks related to delays or uncertainties in regulatory processes and decisions, risks related to the Company’s ability to achieve timely performance of third parties, risks related to whether the Company’s products, including products involving in-licensed intellectual property, will be viewed as demonstrating safety and efficacy, risks relating to funding or implementation of clinical trials, including trials involving in-licensed intellectual property, risks related to the Company’s ongoing ability to raise additional capital, and other risks included in the Company’s Securities and Exchange Commission (“SEC”) filings. Additional information on the foregoing risk factors and other factors, including Risk Factors, which could affect the Company’s results, is included in its SEC filings. Finally, there may be other factors not mentioned above or included in the Company’s SEC filings that may cause actual plans, results or timelines to differ materially from those projected in any forward-looking statement. The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.

*****

CONTACTS
Northwest Biotherapeutics

Dave Innes
804-513-4758
[e-mail]

Les Goldman
240-234-0059
[e-mail]




#dcvax $nwbo #gbm

Excellent post by beartrap:

About Dr. Pawel Kalinski from 2020 research found at: [url][/url][tag]https://onclive.com/view/roswell-parks-dr-pawel-kalinski-to-lead-145m-ncifunded-immunotherapy-effort[/tag]

Obviously, I don't know if this is the technology that NWBO in-licensed.

A team led by Pawel Kalinski, MD, PhD, of Roswell Park Comprehensive Cancer Center has earned a five-year, $14.54 million award from the National Cancer Institute (NCI) to expand a promising immunotherapy platform. Funded through the NCI’s Program Project Grant program, this prestigious five-year grant will fund five clinical trials, all focused on a strategy for making some of the most common immunotherapies work for more cancer patients.

"Our goal with this project is to convert cancers that are traditionally checkpoint-resistant into treatable, 'hot' tumors so that more patients will be able to benefit from some of the most commonly prescribed immunotherapies," says Dr. Kalinski, who is Vice Chair for Translational Research, the Rustum Family Professor for Molecular Therapeutics and Translational Research and Director of Cancer Vaccine and Dendritic Cell Therapies at Roswell Park.

"This five-year National Cancer Institute grant continues a long tradition of groundbreaking immunotherapy research at Roswell Park Comprehensive Cancer Center," says Congressman Brian Higgins. "The research the clinicians at Roswell are conducting represents the next generation of transformational care for cancer patients."
"Cancer touches every family in one way or another," says Congressman Tom Reed. "We are pleased to see this critical grant funding delivered to right here in our backyard to promote innovative breakthroughs for cancer treatment. We will continue to be a constant advocate for Roswell Park in the halls of Congress."

Currently, depending on their cancer type and the genetic characteristics of their tumors, only about 20% of cancer patients are good candidates for a newer class of treatments called checkpoint inhibitors — drugs such as pembrolizumab (Keytruda), nivolumab (Opdivo) and ipilimumab (Yervoy). Even among those patients who are likely to respond initially to treatment with a checkpoint inhibitor, 60% to 70% are likely to have their cancers recur or progress.

"Dr. Kalinski and colleagues have built a compelling case in support of their out-of-the-box approach to cancer immunotherapy," says Kunle Odunsi, MD, PhD, FRCOG, FACOG, Deputy Director and Executive Director of the Center for Immunotherapy at Roswell Park Comprehensive Cancer Center. "All of us in the field will be eagerly following this elegant work, which involves combinations that would uniquely harness previously untapped properties of the human immune system, and accompanied by innovative translational science that should yield greater understanding of immune responses to solid tumors."
Dr. Kalinski has spent the last 15 years developing a unique approach to cancer immunotherapy, or cancer treatment strategies that engage the immune system — first as a faculty member at University of Pittsburgh Medical Center (UPMC), and more recently at Roswell Park.

The NCI grant, which involves partners from both UPMC and The Tisch Cancer Institute at Mount Sinai, will enable five new phase II or phase IIA clinical trials to assess the efficacy of this multipronged approach — two studies in patients with metastatic colorectal cancer, one in patients with checkpoint-resistant advanced melanoma and two in advanced ovarian cancer. Three of the five studies will be conducted at Roswell Park, with the two ovarian cancer studies to be led at UPMC’s Hillman Cancer Center, with participation from Roswell Park.

Chemokines are a type of signaling protein with the ability to control the movements and growth of many immune cells, including cancer-fighting cells called cytotoxic T lymphocytes (CTLs). Together, the trials will explore three complementary strategies for targeting chemokines to alter the tumor microenvironment, or cells surrounding cancer cells, to promote the attraction and activation of CTLs, the key antitumor immune cells.
"Based on our earlier studies both in the lab and in early-phase clinical trials, we have evidence that we can selectively promote entry of antitumor killer cells into tumor microenvironments and reduce local accumulation of suppressive cells in order to sensitize 'cold' tumors to immune checkpoint-inhibition therapy," notes Dr. Kalinski.

The clinical trials will employ a chemokine-modulating regimen targeting three separate pathways of immune response — the toll-like receptor-3, type-1 interferon and prostaglandin networks — as well as specialized dendritic-cell therapeutic vaccines.

The team will also work to assess the immunologic and clinical efficacy of this new therapeutic strategy; identify the biomarkers of response; and develop optimized treatment combinations for many patients with hard-to-treat ovarian and colorectal tumors. The program will also address the pressing challenge of determining the best treatment for patients with melanoma whose tumors recur or persist despite treatment with immunotherapy.

OmniSeq Inc. will conduct advanced molecular diagnostic testing on participating patients’ tumor cells as part of the studies. AIM ImmunoTech Inc. has agreed to provide rintatolimod (brand name Ampligen), the chemokine-modulating agent to be incorporated into these studies.

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8:58 AM · Jun 17, 2024
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