Thanks Bio and Thanks Hoops !!! If you don't mind, I will copy-and-paste below. Very powerful statements by Dr. J !!!
In this Q&A, CEO Jay Lalezari and CFO Robert E. Hoffman discuss the company’s clinical programs and how CytoDyn balances patient needs with the requirements of drug development.
Clinical Leader: You've implemented an amendment to the CLOVER study providing a checkpoint inhibitor to patients with clinical progression. How does that work?
Jay Lalezari, MD: We have evaluated three doses of leronlimab: 350 mg, 525 mg, and 700 mg. It's given subcutaneously once a week. Patients administer it themselves, and there are no safety issues with this drug, which is not something you can say about any other cancer drug candidate.
We initiated the CLOVER study in patients with third line mCRC, evaluating two doses of leronlimab (350 mg vs 700 mg) on top of the standard-of-care backbone of Avastin and Lonsurf. We initially envisioned increasing everyone’s dose up to 700 mg and adding a checkpoint inhibitor as quickly as possible. However, we observed decreases in circulating tumor DNA in 100% of patients, which indicated potent anti-tumor activity with just leronlimab and the backbone regimen, even at the lowest dose of 350 mg.
As a result, we decided to further evaluate leronlimab's activity across the assigned dose cohorts before introducing a checkpoint inhibitor. We are now continuing to follow patients at their assigned dose level to better understand the activity of leronlimab without the confounding effects of adding a checkpoint inhibitor.
More recently, we submitted an amendment that allows patients who reach week 52 on their assigned dose and are doing well to continue treatment at that dose. In addition, we’re offering a rollover option that allows patients who experience clinical progression to increase their dose of leronlimab to 700 mg and add the checkpoint inhibitor.
You’re also expanding access to TNBC patients. Why did you decide to offer the Expanded Access Protocol?
Lalezari: In discussions with potential big pharma partners, one of the things they asked for was prospective confirmation that leronlimab would induce PDL1 and turn cold tumors hot — enabling treatment with an immune checkpoint inhibitor in a tumor with little to no immune cell infiltration. What that does is open up a huge market because most solid tumors are cold. When you use a checkpoint inhibitor, it often works, but it's only a small fraction of patients who are even eligible. If we can make those cold tumors hot, many patients with solid tumors suddenly become candidates.
Patients were also calling us wanting access. So, the two lines converged. The current path for access is through an emergency IND application, which requires a lot of paperwork and each individual physician is now the sponsor of an IND with the FDA. It’s really meant to discourage anyone from doing it.
However, the Expanded Access Protocol served both the patients’ and CytoDyn’s needs to give patients access to the drug, get readouts around their induction of PDL1, and then provide that information to doctors so they can try to get checkpoint inhibitor reimbursements from insurance companies.
How do you ensure that you're understanding patients' needs when preparing for or running trials?
Lalezari: I am still the medical director at Quest Clinical Research and we are involved with a number of cancer studies. I get reminded on a daily basis about patient perspectives and what they want and need.
For example, we have this ongoing colorectal cancer study, and we had a screening requirement that sometimes took up to six weeks to confirm that a patient’s tumor was CCR5+. At some point we realized that 100% of screened patients were coming back CCR5+, so we eliminated that screening requirement which enabled patients to start on treatment as soon as possible.
In this Q&A, CEO Jay Lalezari and CFO Robert E. Hoffman discuss the company’s clinical programs and how CytoDyn balances patient needs with the requirements of drug development.
Clinical Leader: You've implemented an amendment to the CLOVER study providing a checkpoint inhibitor to patients with clinical progression. How does that work?
Jay Lalezari, MD: We have evaluated three doses of leronlimab: 350 mg, 525 mg, and 700 mg. It's given subcutaneously once a week. Patients administer it themselves, and there are no safety issues with this drug, which is not something you can say about any other cancer drug candidate.
We initiated the CLOVER study in patients with third line mCRC, evaluating two doses of leronlimab (350 mg vs 700 mg) on top of the standard-of-care backbone of Avastin and Lonsurf. We initially envisioned increasing everyone’s dose up to 700 mg and adding a checkpoint inhibitor as quickly as possible. However, we observed decreases in circulating tumor DNA in 100% of patients, which indicated potent anti-tumor activity with just leronlimab and the backbone regimen, even at the lowest dose of 350 mg.
As a result, we decided to further evaluate leronlimab's activity across the assigned dose cohorts before introducing a checkpoint inhibitor. We are now continuing to follow patients at their assigned dose level to better understand the activity of leronlimab without the confounding effects of adding a checkpoint inhibitor.
More recently, we submitted an amendment that allows patients who reach week 52 on their assigned dose and are doing well to continue treatment at that dose. In addition, we’re offering a rollover option that allows patients who experience clinical progression to increase their dose of leronlimab to 700 mg and add the checkpoint inhibitor.
You’re also expanding access to TNBC patients. Why did you decide to offer the Expanded Access Protocol?
Lalezari: In discussions with potential big pharma partners, one of the things they asked for was prospective confirmation that leronlimab would induce PDL1 and turn cold tumors hot — enabling treatment with an immune checkpoint inhibitor in a tumor with little to no immune cell infiltration. What that does is open up a huge market because most solid tumors are cold. When you use a checkpoint inhibitor, it often works, but it's only a small fraction of patients who are even eligible. If we can make those cold tumors hot, many patients with solid tumors suddenly become candidates.
Patients were also calling us wanting access. So, the two lines converged. The current path for access is through an emergency IND application, which requires a lot of paperwork and each individual physician is now the sponsor of an IND with the FDA. It’s really meant to discourage anyone from doing it.
However, the Expanded Access Protocol served both the patients’ and CytoDyn’s needs to give patients access to the drug, get readouts around their induction of PDL1, and then provide that information to doctors so they can try to get checkpoint inhibitor reimbursements from insurance companies.
How do you ensure that you're understanding patients' needs when preparing for or running trials?
Lalezari: I am still the medical director at Quest Clinical Research and we are involved with a number of cancer studies. I get reminded on a daily basis about patient perspectives and what they want and need.
For example, we have this ongoing colorectal cancer study, and we had a screening requirement that sometimes took up to six weeks to confirm that a patient’s tumor was CCR5+. At some point we realized that 100% of screened patients were coming back CCR5+, so we eliminated that screening requirement which enabled patients to start on treatment as soon as possible.
13
