Hi KolbeB,
Attempting something similar (i.e., MOA, benefits and resources) for a skeptical friend and her more-than-skeptical oncologist. Unfortunately, only things I have expertise in are related to the logistic hurdles and human fears/suspicions of clinic trials. . . . so a lot of cut and past. (Have received some wonderful -very appreciated- guidance and words of wisdom from a few folks on this board.)
Not a pretty version- and the links don't work in this format- but below is my initial draft I am working on if/when we get word from Dr. L and Quest Research that she is a candidate for the LL cancer clinical trial. (If you would like the pretty version with links- glad to send you my email address via PM.)
Best of luck for your friend's sister, CGC
_________________________________
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. 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). The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses.
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 reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019. (They are also – as I understand it- working on a solid tumor cancer trial in addition to their triple negative trials for those showing CCR5.)
• Taken Along with Current Treatment: The study treatment, Leronlimab (PRO 140), is a once per week subcutaneous injection. It is not a monotherapy, and is 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. (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/.
• Leronlimab’s Interaction with Cancer- Video (3 minutes):
https://www.dropbox.com/s/3kpf69r21u7vasf/ler...2.mp4?dl=0
Steps in the Clinical Trial Process
Quest Clinical Research, coordinating the study, is reviewing slides to will tell them whether or not she 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 Mary’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 Mary and the Oncologist Dr. Dolezal for an additional screening before making arrangements for Mary 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
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
Attempting something similar (i.e., MOA, benefits and resources) for a skeptical friend and her more-than-skeptical oncologist. Unfortunately, only things I have expertise in are related to the logistic hurdles and human fears/suspicions of clinic trials. . . . so a lot of cut and past. (Have received some wonderful -very appreciated- guidance and words of wisdom from a few folks on this board.)
Not a pretty version- and the links don't work in this format- but below is my initial draft I am working on if/when we get word from Dr. L and Quest Research that she is a candidate for the LL cancer clinical trial. (If you would like the pretty version with links- glad to send you my email address via PM.)
Best of luck for your friend's sister, CGC
_________________________________
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. 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). The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses.
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 reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019. (They are also – as I understand it- working on a solid tumor cancer trial in addition to their triple negative trials for those showing CCR5.)
• Taken Along with Current Treatment: The study treatment, Leronlimab (PRO 140), is a once per week subcutaneous injection. It is not a monotherapy, and is 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. (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/.
• Leronlimab’s Interaction with Cancer- Video (3 minutes):
https://www.dropbox.com/s/3kpf69r21u7vasf/ler...2.mp4?dl=0
Steps in the Clinical Trial Process
Quest Clinical Research, coordinating the study, is reviewing slides to will tell them whether or not she 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 Mary’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 Mary and the Oncologist Dr. Dolezal for an additional screening before making arrangements for Mary 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
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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