NorthWest Biotherapeutics Inc (NWBO)

[ae kusterer]

dstock07734

Re: None

Tuesday, July 23, 2024 2:43:30 PM

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707777
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This project with Dr. Robert Prins as the PI is up for renewal the end of this month. The research has been going on for over five years. Will UCLA start running a clinical trial using the technology licensed from NWBO in the coming new budget year?

Project 1: Targeting immunotherapy-induced resistance with DC vaccination and PD-1/CSF-1R inhibition

https://reporter.nih.gov/search/aoyfNLfFVUq2O5ILmmPMMQ/project-details/10673749

Abstract Text
PROJECT SUMMARY/ABSTRACT – Project 1 The lack of effective treatments for glioblastoma (GBM) patients remains a significant health problem and highlights the need for novel and innovative approaches. Immunotherapy is an appealing strategy because of the potential ability for immune cells to traffic to and destroy infiltrating tumor cells in the brain. For the past 15 years, our group and others have been testing active vaccination strategies, such as dendritic cells (DC) pulsed with tumor lysate, to induce antitumor immunity in glioblastoma patients. From the interim results of the clinical trial we initiated in our current SPORE funding period, we found that in addition to inducing T-cell infiltration into brain tumors, DC vaccination + anti-PD1 blockade may also create a pro-inflammatory environment within the tumor that induces the immigration of immunosuppressive myeloid cells (TIM). These cells are phenotypically similar to the myeloid cells that dominantly attenuate the T-cell response to chronic viral infections, and may counteract the effective anti-tumor T-cell responses induced by DC vaccination within the tumor microenvironment. Therapies that target myeloid cells within the tumor microenvironment represent a promising new strategy. As such, inhibition of these myeloid cells using a CSF-1R inhibitor, in conjunction with autologous tumor lysate-pulsed DC vaccination (ATL-DC) and PD-1 mAb blockade, resulted in significantly prolonged survival in tumor-bearing animals with large, well-established intracranial (i.c.) gliomas. Our hypothesis is that myeloid cells mediate adaptive immune resistance in response to T cell activation induced by immunotherapy. In this SPORE Project renewal, we have planned a series of novel pre-clinical studies to re- polarize myeloid cells, to optimize how the timing and sequence of immunotherapy can influence ant-tumor immunity, and a new clinical trial to test the first-in-human combination of a new brain penetrant CSF-1R inhibitor (CSF-1Ri; PLX3397, Daiichi-Sankyo) with DC vaccination and PD-1 mAb blockade (Pembrolizumab, Merck) in patients with newly diagnosed GBM. A better understanding of the biology of these cellular interactions will provide insight into more effective ways to induce therapeutic anti-tumor immune responses for this deadly type of brain tumor. These studies span the continuum of translational research in brain tumor immunotherapy, and will likely provided informative new insights for the development of new, rational immune-based strategies for brain tumor patients.Re: dstock07734 post# 707805

Tuesday, July 23, 2024 6:10:16 PM

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“Leidos
https://www.highergov.com/idv/75N95022D00022/

Battelle Memorial Institute
https://www.highergov.com/idv/75N95022D00021/

Battelle, AmplifyBio, Andelyn Biosciences Win Research Contract for National Institute of Neurological Disorders and Stroke
https://www.battelle.org/insights/newsroom/press-release-details/battelle-amplifybio-andelyn-biosciences-win-research-contract-for-national-institute-of-neurological-disorders-and-stroke “

Interesting note: Louis Von Thaer, President & CEO of Battelle, joined Battelle in 2017 and had been a senior executive with Leidos; currently he is Chairman of the Board of AmplifyBio.




Re: None

Tuesday, July 23, 2024 2:17:59 PM

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707758
of 707875
A hypothetical question:

Assuming the collaboration trial between Merck and NWBO is real, can Merck file for FDA approval for the combination on colorectal cancer?

A multi-center, Phase II clinical trial evaluating DCVax-L (autologous dendritic cells pulsed with tumor lysate antigen) and pembrolizumab (an anti–PD-1 monoclonal antibody) for subjects with liver metastases of primary colorectal carcinoma
https://www.rlp-forschung.de/public/facilities/2807/research_projects/22146

Merck filed for FDA approval of an ADC based on a phase 2 trial which was solely run by Daiichi Sankyo. But Merck did sign a deal with Daiichi about this specific ADC last October. That's why I was wondering whether Merck can for FDA approval based on the results from the collaboration trial.

Patritumab Deruxtecan BLA Submission Receives Complete Response Letter from FDA Due to Inspection Findings at Third-Party Manufacturer
https://www.merck.com/news/patritumab-deruxtecan-bla-submission-receives-complete-response-letter-from-fda-due-to-inspection-findings-at-third-party-manufacturer/

HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer
https://clinicaltrials.gov/study/NCT04619004

https://daiichisankyo.us/press-releases/-/article/patritumab-deruxtecan-demonstrated-clinically-meaningful-and-durable-responses-in-patients-with-egfr-mutated-metastatic-non-small-cell-lung-cancer-in-

https://www.merck.com/news/daiichi-sankyo-and-merck-announce-global-development-and-commercialization-collaboration-for-three-daiichi-sankyo-dxd-adcs/




Re: manibiotech post# 707761

Tuesday, July 23, 2024 2:30:58 PM

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707764
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Poly-iclc must be bonded with DCVax-L to have efficacy. I simply cannot see how poly-iclc alone without any efficacy data from all the previous clinical trials can convince all the RAs all over the world to grant the approval.

https://gritdaily.com/cancer-therapy-oncovirs-hiltonol/

“We have a drug master file with the FDA, and we have been in front of many of the world’s tier 1 regulatory agencies including the European Union Countries including France and Switzerland, in addition to Canada, Japan, Brazil and Thailand. Our product is going to be able to be used around the world. Our big push is to get funding so that we can support the development of Hiltonol with our partners and get commercialized in one therapeutic area.”

For fighting a devious enemy in immunotherapy settings, Oncovir’s Hiltonol is a knight in shining armor ready to do battle as a standalone drug product and as a potent vaccine adjuvant in oncology and infectious diseases.dstock07734

Re: Steady_T post# 707795

Tuesday, July 23, 2024 8:02:47 PM

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707866
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I didn't finish the list of all the acquisitions of ADCs by BPs in the past three years. I think the list is long enough. I see big money incoming soon.

AbbVie to Acquire ImmunoGen, including its Flagship Cancer Therapy ELAHERE® (mirvetuximab soravtansine-gynx), Expanding Solid Tumor Portfolio
https://investor.immunogen.com/news-releases/news-release-details/abbvie-acquire-immunogen-including-its-flagship-cancer-therapy

Orum Therapeutics Announces Acquisition of ORM-6151 Program by Bristol Myers Squibb
https://www.orumrx.com/news/orum-orm-6151-acquisition-by-bms

Tubulis Announces Strategic License Agreement with Bristol Myers Squibb to Develop Next Generation ADCs for the Treatment of Cancer Patients
https://tubulis.com/news/tubulis-announces-strategic-license-agreement-with-bristol-myers-squibb-to-develop-next-generation-adcs-for-the-treatment-of-cancer-patients-2/

Daiichi Sankyo and Merck Announce Global Development and Commercialization Collaboration for Three Daiichi Sankyo DXd ADCs
https://www.merck.com/news/daiichi-sankyo-and-merck-announce-global-development-and-commercialization-collaboration-for-three-daiichi-sankyo-dxd-adcs/

Merck Snaps Up Small Startup in $208M Deal, Seeks to Improve Safety of ADCs
https://www.biospace.com/merck-snaps-up-small-startup-in-208m-deal-seeks-to-improve-safety-of-adcs


GSK enters exclusive license agreement with Hansoh for HS-20089
https://www.gsk.com/en-gb/media/press-releases/gsk-enters-exclusive-license-agreement-with-hansoh-for-hs-20089/


LaNova Medicines Announces Global Exclusive License Agreement with AstraZeneca for LM-305, a Novel GPRC5D-Targeting Antibody Drug Conjugate
https://www.prnewswire.com/news-releases/lanova-medicines-announces-global-exclusive-license-agreement-with-astrazeneca-for-lm-305-a-novel-gprc5d-targeting-antibody-drug-conjugate-301823364.html


Eli Lilly expands ADC scope with Mablink Bioscience acquisition
https://www.pharmaceutical-technology.com/news/eli-lilly-expands-adc-scope-with-mablink-bioscience-acquisition/

Genmab buys ProfoundBio for $1.8B, adding to ADC dealmaking flurry
https://www.biopharmadive.com/news/genmab-profoundbio-adc-acquisition-buyout-seagen/712097/


Johnson & Johnson to Acquire Ambrx, Advancing Next Generation Antibody Drug Conjugates to Transform the Treatment of Cancer
https://www.janssen.com/johnson-johnson-acquire-ambrx-advancing-next-generation-antibody-drug-conjugates-transform-treatment

dstock07734

Re: None

Tuesday, July 23, 2024 3:33:33 PM

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707792
of 707874
ABL Awarded $Multimillion Contract to Provide Manufacturing and Nonclinical Services to Support Development of Promising Therapeutics for the NINDS
https://ablinc.com/about-abl/news/news-item/abl-awarded-multimillion-contract-to-provide-manufacturing-and-nonclinical-services-to-support-development-of-promising-therapeutics-for-the-ninds/

Rockville, Maryland (US), November 4, 2022 Advanced BioScience Laboratories (ABL), a global Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) to the U.S. Government and biopharmaceutical industry, announced it is one of three contractors awarded an Indefinite Delivery, Indefinite Quantity (IDIQ) contract for “Manufacturing and Nonclinical Studies support for Development of Therapeutic Biotechnology Products (Biologics) for Neurological-related Disorders” by the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health (NIH) of the U.S. Department of Health and Human Services (HHS), contract number 75N95022D00023.

ABL & NINDS Partnership

The eight-year, multiple-award-IDIQ contract has a total potential funding value of $149.2M million. ABL, as an awardee of the IDIQ contract pool will provide NINDS current Good Manufacturing Practices (cGMP) manufacturing and Good Laboratory Practice (GLP) nonclinical (preclinical) services to support translational development of therapeutic biotechnology (biologics) products of various modalities for NIH’s drug discovery and development programs. This contract supports the NIH Biologics development projects for the NIH Blueprint Neurotherapeutics Network Biologics (BPN-Biologics) program, the NINDS Ultra-Rare Gene Therapy (URGenT) program, the Helping to End Addiction Long-term Pain Therapeutics Development Program (HEAL-PTDP), and other extramural or intramural NIH drug discovery and development programs. ABL’s portfolio of services includes feasibility studies, process and assay development, cGMP manufacturing, IND-enabling GLP safety, pharmacokinetic and efficacy studies, stability studies, and product release testing. These services are provided either at ABL facilities or at one of the 42 companies that formed the ABL Collaboratory to support this contract.

ABL’s scientists have been supporting NIH’s mission since the 1980s. Our Government Solutions staff has worked hand-in-hand with government and industry key opinion leaders (KOLs) for many years to develop novel biomedical products.

“We look forward to continuing to serve the mission of the NIH through this contract with NINDS and in support of the most innovative investigators in the field who are developing cutting-edge products that prevent, treat, and cure neurological disorders, stroke, and ultrarare genetic disease” said Marykay Marchigiani, COO of ABL.