Coherus BioSciences Releases Positive Results for Casdozokitug (IL-27)
Coherus BioSciences Releases Positive Results for Casdozokitug (IL-27)
Taking a Look at Coherus BioSciences (CHRS), Weekly Activity, & Portfolio Update.
This week, I'm excited to dive into one of my top investment picks in the biotech field, Coherus BioSciences (CHRS). Recently, they announced promising phase 2 clinical data for Casdozokitug (IL-27), a key product in their pipeline. Despite their consistent execution, Coherus BioSciences seems to remain overlooked by Wall Street, which I find intriguing. I want to take this opportunity to discuss the significance of these recent results and what they could mean for the company's future.
What is Casdozokitug?
Before we get into the results, we need to know what this product does. Casdozokitug, a groundbreaking anti-IL-27 antibody part of the Surface Oncology acquisition, is carving a new path in the treatment of solid tumors, particularly in lung and liver cancer. This innovative therapy is currently under rigorous evaluation in clinical trials.
At the heart of Casdozokitug's mechanism is its target, the immune regulatory cytokine Interleukin-27 (IL-27). IL-27 plays a pivotal role in modulating the immune system, particularly in how it controls the intensity and duration of immune responses. It achieves this by inducing the expression of immunoregulatory receptors and diminishing the production of inflammatory cytokines. However, IL-27 is also implicated in suppressing immune mechanisms, particularly those that combat tumor growth. By inhibiting the anti-tumor immune responses, IL-27 emerges as a critical target in the realm of cancer treatment.
Casdozokitug's potential lies in its ability to bolster the immune system. It does so by neutralizing the immune-suppressing effects of IL-27, thereby paving the way for more effective anti-tumor activity. This opens up possibilities for its use in conjunction with other cancer therapies. As a human anti-IL-27 antibody, Casdozokitug is specifically designed to inhibit the activity of IL-27. Its development is particularly focused on tumor types where IL-27, secreted from macrophages, plays a substantial role in creating an immunosuppressive environment within tumors. This environment is often responsible for resistance to treatment, especially treatments involving immune checkpoint inhibitors. Preclinical studies have demonstrated that Casdozokitug effectively blocks the immunosuppressive biological effects of IL-27. This results in the activation of immune cells and exhibits anti-tumor effects, especially when used in combination with other cancer therapies, including anti-PD-1 therapy (Are you still with me?).
Casdozokitug's journey in clinical trials has been promising. It has shown efficacy in inhibiting tumor growth as a monotherapy and has induced partial responses in patients with non-small cell lung cancer (NSCLC) and renal cell carcinoma (RCC). Its potential is further being explored in combination therapies, particularly with PD-1/PD-L1 pathway blockers in NSCLC and hepatocellular carcinoma (HCC). The significance of Casdozokitug in cancer treatment is further underscored by its receipt of Orphan Drug and Fast Track designations from the FDA for the treatment of refractory hepatocellular carcinoma, highlighting its potential as a first-of-its-kind therapy in the clinic. The innovative approach of Casdozokitug marks a significant stride in cancer treatment, offering a new avenue for patients with solid tumors, particularly those where conventional therapies have shown limited effectiveness. As trials continue, the medical community eagerly anticipates further developments, hoping for breakthroughs that could transform cancer therapy.
Orphan Drug Designation is a special status granted by the FDA to a drug or biological product to treat a rare disease or condition, typically affecting fewer than 200,000 individuals in the United States. This designation provides certain benefits, including tax credits, grant funding, assistance with clinical trial design, and seven years of market exclusivity upon FDA approval.
Fast Track Designation, also by the FDA, is aimed at expediting the development and review of drugs which treat serious conditions and fill an unmet medical need. This designation facilitates more frequent meetings and communications with the FDA, and potentially eligibility for accelerated approval and priority review if relevant criteria are met.
Phase 2 Clinical Results
CHRS shared encouraging results from their recent Phase 2 clinical trial involving the novel anti-IL-27 antibody, Casdozokitug, in combination with atezolizumab and bevacizumab for treating hepatocellular carcinoma (HCC). They were presented at the 2024 ASCO Gastrointestinal Cancers Symposium in San Francisco.
The Phase 2 clinical trial's lead-in portion involved evaluating casdozokitug with atezo and bev in 30 treatment-naïve patients with unresectable HCC. The primary endpoint was safety and tolerability, with key secondary endpoints including progression-free survival (PFS) and ORR. The results showed an ORR of 38% per RECIST v1.1 criteria, with a median PFS of 8.1 months. The disease control rate was also noteworthy. Further clinical development is planned to evaluate casdozokitug in combination with toripalimab and bevacizumab. Or, in other words…
Phase 2 clinical trial: This is a stage of research where a new treatment (in this case, casdozokitug) is tested on a group of patients to see if it's effective and to further evaluate its safety. It's one of the steps before a drug can be approved for widespread use.
Lead-in portion: This refers to an initial part of the trial. It's like a preliminary round to gather early information.
Casdozokitug with atezo and bev: These are the names of drugs. Casdozokitug (the new drug being tested), atezolizumab (often called atezo), and bevacizumab (bev) are combined to see how well they work together in treating patients.
Treatment-naïve patients: These are patients who haven't received treatment for their condition yet.
Unresectable HCC: HCC stands for hepatocellular carcinoma, a type of liver cancer. Unresectable means the cancer can't be removed with surgery.
Safety and tolerability: The trial is checking to see if the drug combination is safe to use and if patients can tolerate it without severe side effects.
Progression-free survival (PFS) and ORR: These are ways to measure how well the treatment works. PFS is the time during and after the treatment when the patient's cancer does not get worse. ORR stands for Objective Response Rate, which is the percentage of patients whose cancer shrinks or disappears after treatment.
Results showed an ORR of 38% per RECIST v1.1 criteria, with a median PFS of 8.1 months: This means that in 38% of the patients, the cancer shrank or disappeared according to a standardized way of measuring this (RECIST v1.1 criteria). Also, on average, the patients went 8.1 months without their cancer getting worse.
Disease control rate: This refers to the percentage of patients who have benefited from the treatment, including those whose cancer has shrunk or remained stable.
Further clinical development with toripalimab and bevacizumab: The researchers plan more studies to see how well casdozokitug works when combined with two other drugs, toripalimab and bevacizumab, in treating this type of liver cancer.
Daneng Li, M.D., from the City of Hope Comprehensive Cancer Center, highlights the potential of casdozokitug in liver cancer treatment, especially in its ability to enhance the effectiveness of standard care. The data showing the relationship between IL-27 biology and casdozokitug's response are particularly promising, indicating a potential for identifying biomarkers that could benefit liver cancer patients.
Rosh Dias, M.D., CHRS’ Chief Medical Officer, emphasizes the significant early clinical results and immune activation data from the trial. With an objective response rate (ORR) of 38%, including three complete responses and a favorable safety profile, casdozokitug demonstrates considerable promise as a novel target in combination therapy for advanced solid tumors. CHRS' comprehensive clinical development program aims to further investigate casdozokitug in combination with their anti-PD-1 antibody, toripalimab-tpzi, focusing on overcoming immune suppression in the tumor microenvironment.
These results underscore the potential of casdozokitug in combination with VEGF and PD-(L)1 pathway inhibitors in treating HCC. CHRS plans to continue this exploration in future clinical trials, with the goal of extending survival and improving outcomes for patients.
Weekly Activity (Jan 15th-19th)
Nothing.
Portfolio Update
