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Posted On: 09/28/2020 7:39:39 PM
Post# of 148908
RE: Revised version of the Intro to Leronlimab: MOU, Steps in Clinical Trial Process, and Resources (Is a short intro for a friend with cancer and her oncologist.)
Sorry to post (almost) the same thing twice- but a couple folks had asked for it and I wanted to make sure to replace the previous version.
Dr. Jay, the clinical trial coordinator- as busy as he is- checked out the doc and made a great clarification. (He is awesome.) To paraphrase: they are working on proof of concept and efficacy in patients with cancer versus it being a done deal.
So the doc was edited; new version is below.
____________________________
Leronlimab Cancer Clinical Trial: Next Generation Monoclonal Antibody Therapy
Leronlimab (PRO 140) is a monoclonal antibody CCR5 receptor antagonist, to be used as a platform drug for a variety of indications.
How it Works: Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).
In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab has shown reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting several human clinical trials to establish proof of concept and efficacy in patients with cancer. This includes a Phase 2 compassionate use study in metastatic triple-negative breast cancer (being granted Fast Track designation in May 2019) and a Phase 2 basket study on patients with CCR5 locally advanced or metastatic sold tumor.
• Taken Along with Current Treatment: The study treatment, Leronlimab (PRO 140), is a once per week subcutaneous injection. It can be used along with one’s current cancer treatment.
• Impeccable Safety Profile: Lack of SAEs, well tolerated, in more than one thousand patients over five years, in a population as fragile as HIV patients.
• Rapid Results:
o Drops CTC and reduction of EMT cells and putative metastic cells.
o Leronlimab may absolutely help even in advanced TNBC. Blocking CCR5 is being found to possibly reduce metastasis and reduce the ability of tumor cells to maintain the micro-environment that enables them to avoid other chemotherapies and the body's immune system.
• Main Resources:
o Recent Advances Targeting CCR5 for Cancer and Its Role in Immuno-Oncology- in Cancer Research/ American Association of Cancer Research: Article available at: https://cancerres.aacrjournals.org/content/79/19/4801.long and https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6810651/.
o Leronlimab’s Interaction with Cancer- Video (3 minutes):
https://www.dropbox.com/s/3kpf69r21u7vasf/ler...2.mp4?dl=0
o The Role of the CCL5/CCR5 Axis in Cancer Progression
https://res.mdpi.com/d_attachment/cancers/can...-01765.pdf
• Clinical Trials including:
o Basket Study of Leronlimab (PRO 140) in Patients With CCR5+ Locally Advanced or Metastatic Solid Tumors
o A Compassionate Use Study of Leronlimab in Breast Cancer
https://clinicaltrials.gov/ct2/results?cond=&...&dist=
Steps in the Clinical Trial Process
Quest Clinical Research, coordinating the study, reviews slides to will tell them whether or not the individual may benefit from the study treatment and is a candidate (i.e., positive for CCR5). If a candidate and if agreeable, Quest has indicated they would like to connect with the patient’s oncologist re: enrollment in the study.
Once they receive the CCR5 test results, and if she tests positive for CCR5, they request a brief summary of the cancer diagnosis and treatment history, and/or recent progress notes, scan reports, and recent laboratory results (CBC with differential, complete chemistry panel, urinalysis) to be reviewed by their medical team.
After they receive the medical history and recent labs, they will set up a zoom conference call with the patient and the Oncologist Dr. Dolezal for an additional screening before making arrangements for the patient to travel (a one-time trip) to San Francisco for an initial treatment.
After that, they will need blood samples (4 tubes) every 4 weeks. The blood can be taken by the oncologist or a qualified nurse and then shipped (no charge to the patient) to their lab. The weekly injections can be administered at home between visits by the patient or a trusted friend or caregiver.
They will be asking for copies of monthly safety lab reports (CBC with differential, complete chemistry panel, urinalysis, and urine pregnancy), as well as the results of future imaging/scans once enrolled.
Trial Contacts
Quest Clinical Research
2300 Sutter Street, Suite 208
San Francisco, CA 94115
TEL: 415-353-0800
FAX: 415-353-0801
WEB QUEST: QUESTCLINICAL.COM
Clinical Research Coordinator
Jay Lalezari, MD <drjay@questclinical.com>
Emily Jennings <emily@questclinical.com>
Additional Resources
Global Health Leaders Join CytoDyn's Scientific Advisory Board
Leading experts in the fields of HIV, Oncology, Rheumatology, and NASH join together to facilitate the best approaches to utilize multiple opportunities for leronlimab.
https://www.cytodyn.com/investors/news-events...c-advisory
Mechanism of Action Animation for leronlimab in Immuno-Oncology
Potential of leronlimab to positively influence the tumor microenvironment by inhibiting T-reg infiltration, conversion of M2 macrophages (protumor macrophages) into M1 macrophages (antitumor macrophages), decreasing tumor angiogenesis, and inhibiting metastasis through CCR5 overexpression.
https://www.youtube.com/watch?v=uxkc6Ql1C-U
Leronlimab Moving Toward Breakthrough Designation With Positive mTNBC Data
(Targeted Oncology)
The FDA has recommended that a preliminary meeting for a potential Breakthrough Therapy designation be requested for leronlimab as a treatment of patients with metastatic triple-negative breast cancer, based on positive data from a phase Ib/II study.
https://www.targetedonc.com/view/leronlimab-m...mtnbc-data
A review of antibody-based therapeutics targeting G protein-coupled receptors: an update
Expert Opinion on Biological Therapy: Journal (Volume 20, 2020 - Issue
There are currently two approved GPCR-targeting mAbs; these are mogamulizumab and erenumab which target CCR4 and CGRP type 1 receptor, respectively. One other mAb is at an advanced stage of clinical development, namely leronlimab (or PRO140) that targets CCR5 and has now reached pre-registration. Summary case studies are presented. https://www.tandfonline.com/doi/full/10.1080/...20.1745770
CCR5's Role in Cancer Metastasis, Leronlimab and Cancer
https://www.cytodyn.com/pipeline/cancer
Useful Links on this website (with links):
CCR5 Antagonist Blocks Metastasis of Basal Breast Cancer Cells
Link: Read Article
CCR5 Receptor Antagonists Block Metastasis to Bone of v-Src Oncogene-Transformed Metastatic Prostate Cancer Cell Lines
Link: Read Article
The CCL5/CCR5 Axis Promotes Metastasis in Basal Breast Cancer
Link: Read Article
CCR5 Governs DNA Damage Repair and Breast Cancer Stem Cell Expansion
Link: Read Article
Tumoral Immune Cell Exploitation in Colorectal Cancer Metastases Can Be Targeted Effectively by Anti-CCR5 Therapy in Cancer Patients
Link: Read Article
CytoDyn aims to be ‘paradigm-shifting’ in cancer management with its platform drug Leronlimab (PRO 140)
Link: Watch Video
How Leronlimab (PRO 140) Combats HIV
Link: Watch Video
Sorry to post (almost) the same thing twice- but a couple folks had asked for it and I wanted to make sure to replace the previous version.
Dr. Jay, the clinical trial coordinator- as busy as he is- checked out the doc and made a great clarification. (He is awesome.) To paraphrase: they are working on proof of concept and efficacy in patients with cancer versus it being a done deal.
So the doc was edited; new version is below.
____________________________
Leronlimab Cancer Clinical Trial: Next Generation Monoclonal Antibody Therapy
Leronlimab (PRO 140) is a monoclonal antibody CCR5 receptor antagonist, to be used as a platform drug for a variety of indications.
How it Works: Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).
In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab has shown reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting several human clinical trials to establish proof of concept and efficacy in patients with cancer. This includes a Phase 2 compassionate use study in metastatic triple-negative breast cancer (being granted Fast Track designation in May 2019) and a Phase 2 basket study on patients with CCR5 locally advanced or metastatic sold tumor.
• Taken Along with Current Treatment: The study treatment, Leronlimab (PRO 140), is a once per week subcutaneous injection. It can be used along with one’s current cancer treatment.
• Impeccable Safety Profile: Lack of SAEs, well tolerated, in more than one thousand patients over five years, in a population as fragile as HIV patients.
• Rapid Results:
o Drops CTC and reduction of EMT cells and putative metastic cells.
o Leronlimab may absolutely help even in advanced TNBC. Blocking CCR5 is being found to possibly reduce metastasis and reduce the ability of tumor cells to maintain the micro-environment that enables them to avoid other chemotherapies and the body's immune system.
• Main Resources:
o Recent Advances Targeting CCR5 for Cancer and Its Role in Immuno-Oncology- in Cancer Research/ American Association of Cancer Research: Article available at: https://cancerres.aacrjournals.org/content/79/19/4801.long and https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6810651/.
o Leronlimab’s Interaction with Cancer- Video (3 minutes):
https://www.dropbox.com/s/3kpf69r21u7vasf/ler...2.mp4?dl=0
o The Role of the CCL5/CCR5 Axis in Cancer Progression
https://res.mdpi.com/d_attachment/cancers/can...-01765.pdf
• Clinical Trials including:
o Basket Study of Leronlimab (PRO 140) in Patients With CCR5+ Locally Advanced or Metastatic Solid Tumors
o A Compassionate Use Study of Leronlimab in Breast Cancer
https://clinicaltrials.gov/ct2/results?cond=&...&dist=
Steps in the Clinical Trial Process
Quest Clinical Research, coordinating the study, reviews slides to will tell them whether or not the individual may benefit from the study treatment and is a candidate (i.e., positive for CCR5). If a candidate and if agreeable, Quest has indicated they would like to connect with the patient’s oncologist re: enrollment in the study.
Once they receive the CCR5 test results, and if she tests positive for CCR5, they request a brief summary of the cancer diagnosis and treatment history, and/or recent progress notes, scan reports, and recent laboratory results (CBC with differential, complete chemistry panel, urinalysis) to be reviewed by their medical team.
After they receive the medical history and recent labs, they will set up a zoom conference call with the patient and the Oncologist Dr. Dolezal for an additional screening before making arrangements for the patient to travel (a one-time trip) to San Francisco for an initial treatment.
After that, they will need blood samples (4 tubes) every 4 weeks. The blood can be taken by the oncologist or a qualified nurse and then shipped (no charge to the patient) to their lab. The weekly injections can be administered at home between visits by the patient or a trusted friend or caregiver.
They will be asking for copies of monthly safety lab reports (CBC with differential, complete chemistry panel, urinalysis, and urine pregnancy), as well as the results of future imaging/scans once enrolled.
Trial Contacts
Quest Clinical Research
2300 Sutter Street, Suite 208
San Francisco, CA 94115
TEL: 415-353-0800
FAX: 415-353-0801
WEB QUEST: QUESTCLINICAL.COM
Clinical Research Coordinator
Jay Lalezari, MD <drjay@questclinical.com>
Emily Jennings <emily@questclinical.com>
Additional Resources
Global Health Leaders Join CytoDyn's Scientific Advisory Board
Leading experts in the fields of HIV, Oncology, Rheumatology, and NASH join together to facilitate the best approaches to utilize multiple opportunities for leronlimab.
https://www.cytodyn.com/investors/news-events...c-advisory
Mechanism of Action Animation for leronlimab in Immuno-Oncology
Potential of leronlimab to positively influence the tumor microenvironment by inhibiting T-reg infiltration, conversion of M2 macrophages (protumor macrophages) into M1 macrophages (antitumor macrophages), decreasing tumor angiogenesis, and inhibiting metastasis through CCR5 overexpression.
https://www.youtube.com/watch?v=uxkc6Ql1C-U
Leronlimab Moving Toward Breakthrough Designation With Positive mTNBC Data
(Targeted Oncology)
The FDA has recommended that a preliminary meeting for a potential Breakthrough Therapy designation be requested for leronlimab as a treatment of patients with metastatic triple-negative breast cancer, based on positive data from a phase Ib/II study.
https://www.targetedonc.com/view/leronlimab-m...mtnbc-data
A review of antibody-based therapeutics targeting G protein-coupled receptors: an update
Expert Opinion on Biological Therapy: Journal (Volume 20, 2020 - Issue
There are currently two approved GPCR-targeting mAbs; these are mogamulizumab and erenumab which target CCR4 and CGRP type 1 receptor, respectively. One other mAb is at an advanced stage of clinical development, namely leronlimab (or PRO140) that targets CCR5 and has now reached pre-registration. Summary case studies are presented. https://www.tandfonline.com/doi/full/10.1080/...20.1745770
CCR5's Role in Cancer Metastasis, Leronlimab and Cancer
https://www.cytodyn.com/pipeline/cancer
Useful Links on this website (with links):
CCR5 Antagonist Blocks Metastasis of Basal Breast Cancer Cells
Link: Read Article
CCR5 Receptor Antagonists Block Metastasis to Bone of v-Src Oncogene-Transformed Metastatic Prostate Cancer Cell Lines
Link: Read Article
The CCL5/CCR5 Axis Promotes Metastasis in Basal Breast Cancer
Link: Read Article
CCR5 Governs DNA Damage Repair and Breast Cancer Stem Cell Expansion
Link: Read Article
Tumoral Immune Cell Exploitation in Colorectal Cancer Metastases Can Be Targeted Effectively by Anti-CCR5 Therapy in Cancer Patients
Link: Read Article
CytoDyn aims to be ‘paradigm-shifting’ in cancer management with its platform drug Leronlimab (PRO 140)
Link: Watch Video
How Leronlimab (PRO 140) Combats HIV
Link: Watch Video
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