Hemogenyx Pharmaceuticals PLC (LSE:HEMO, OTC:HOPHF) CEO Dr. Vladislav Sandler talked with Proactive about the company’s recent milestone—the first human dose of its proprietary CAR-T cell therapy, HG-CT-1, for treating relapsed refractory acute myeloid leukemia (AML) in adults. This is a significant development in tackling one of the deadliest blood cancers, which has a low remission rate with current frontline therapies.
Dr. Sandler explained, “We are trying to cure a very deadly disease which is called acute myeloid leukemia... This is one of the worst blood cancers in existence.” He highlighted that only 30% of newly diagnosed patients respond to frontline therapies, leaving a significant need for more effective treatments.
The therapy uses third-generation chimeric antigen receptor (CAR) technology, which, according to Dr. Sandler, offers the same efficacy as the current second-generation CARs but with enhanced safety. The company is poised to accelerate its clinical trials, pending resource availability, with the potential to infuse patients every 14 days after the fourth patient.
With the first patient showing no adverse effects so far, Hemogenyx is hopeful about the progress of HG-CT-1 and is ready to scale up manufacturing as new patients are identified.
Proactive: Vladik, it's very good to speak with you. You’ve announced the first human dose of your CAR-T cell therapy, HG-CT-1. So a big milestone for the company?
Dr. Vladislav Sandler: Hi Stephen, thank you. Thank you for inviting me again. Good to talk to you. Yes, you are absolutely right. We just injected our first patient with our proprietary CAR-T cell therapy for the treatment of relapsed refractory acute myeloid leukemia in adults. This is a true milestone for our company. As you correctly pointed out. And I'm ready to answer your questions regarding this treatment.
Proactive: Well, maybe to take a step back. Vladik, who’s the treatment targeted at, and what does it do?
Dr. Vladislav Sandler: So we are trying to cure a very deadly disease which is called acute myeloid leukemia. This is cancer of myeloid cells. And this is one of the worst blood cancers in existence. So typically, only 30% of all newly diagnosed patients, when they're treated using the frontline therapy, respond to this frontline therapy and go into remission.
70% of all patients, newly diagnosed patients, including the patient that we currently injected, they typically either fail to respond to the frontline therapy or the disease, AML, comes back very fast. So when they fail to respond, as the patient that we're dealing with right now, these patients are called refractory. And when the disease comes back fast, they are called relapsed acute myeloid leukemia patients. These are the patients, these are adult patients that we are targeting right now. Adult meaning from 18 to infinity, basically, for pretty much any age.
Proactive: What exactly is CAR-T cell therapy?
Dr. Vladislav Sandler: CAR stands for chimeric antigen receptor. So in our case, this chimeric antigen receptor is the receptor of the third generation. So this is an advanced CAR that we developed inside our company ourselves. The third generation CAR has certain advantages compared to the second generation, which is used in every single approved CAR-T cell therapy as of today. Our third generation has about the same efficacy based on research from other groups, clinical research from other groups. However, it is much safer as it has been shown in clinical trials.
Proactive: With the first patient now injected, what are the next steps?
Dr. Vladislav Sandler: According to the protocol that was approved by the FDA, we have to have 28 days between the injection of the first patient, the second patient, the third patient, and the so-called lymphoid depletion of the next patient. Lymphoid depletion is the procedure that allows the physicians to remove T cells and B cells from the patient's blood to prepare the patient for the infusion of modified T cells.
In practice, we can start manufacturing for the next patient literally today, however, we are waiting for the hospital to find that next patient. The research is ongoing already. From this point on, we expect acceleration of the process and the acceleration of the clinical trial.
Proactive: Any updates on the first patient’s condition?
Dr. Vladislav Sandler: After the infusion of any patient, there are 28 days designated as the so-called official safety trial. During these 28 days, the patient is tested several times for adverse effects of this cell therapy. As a secondary readout, we also look at the efficacy or potential efficacy of this treatment. At this point, after a few days post-infusion, we did not have bad news, which is good news. Anything adverse happening must be reported to us, and if it is a severe adverse side effect, it must be reported to the FDA. So far, we assume everything is in line, and everything is good.