Like many of you I have been bored and somewhat annoyed at the persistent commentary pertaining to the IMU share price, the focus on shorting and ancillary notion that Imugene has “nothing to offer”. For those of us who chose to live in the real world, when it comes Imugene, the facts are as follows:
Her Vaxx
The median OS for patients receiving HER-Vaxx plus chemotherapy was 13.9 months, compared to 8.3 months in patients treated with chemotherapy alone. Median duration ofresponse was 30 vs 19 weeks in favour of the HER-Vaxx arm.
Her Vaxx Founder Professor Ursula Wiedermann
Photo courtesy of https://loop.frontiersin.org
This data demonstrates that in patients with HER2 over-expressing gastric/GEJ cancer active HER2 immunization with HER-Vaxx is safe and provides relevant clinical benefit over standard of care chemotherapy.
PD1 Vaxx
Pravin Kaumaya says of his B cell vaccine “First, PD1-Vaxx activates both B- and T-cell functions to promote tumor clearance. Second, the treatment is targeted to block signaling pathways that are crucial for tumor growth and maintenance.
“By giving this vaccine in combination with an immunotherapy drug,” he explains, “we are supercharging and directing the immunesystem to target and kill cancer cells.”
Pd1 Vaxx Found Professor Pravin Kaumaya
Photo courtesy of https://cancer.osu.edu
Pravin Kaumaya says of his B cell vaccine “First, PD1-Vaxx activates both B- and T-cell functions to promote tumor clearance. Second, the treatment is targeted to block signaling pathways that are crucial for tumor growth and maintenance.
“By giving this vaccine in combination with an immunotherapy drug,” he explains, “we are supercharging and directing the immune system to target and kill cancer cells.”
In PD1 Vaxx’s first in human trial the results were as follows:
Four patients were in the 10 ug/dose cohort, 6 patients in 50 ug/dose cohort, and 4 patients in the 100 ug/dose cohort
In the 10 ug/dose cohort, one patient achieved a CR
In the 50 ug/dose cohort, two patients achieved SD
In the 100 ug/dose cohort, one patient achieved PR and two patients achieved SD
Three patients remain on study
CF33 Check Vacc
CF33’s novel oncolytic virus is currently in a City of Hope Phase 1 Trial into late stage TNBC patients. Triple-negative breast cancer (TNBC) is an aggressive subtype of breast cancer with high recurrence rate and poor prognosis. Here, we describe a novel, chimeric orthopoxvirus (CF33) that efficiently kills TNBC. Cytotoxicity was assayed in vitro in four TNBC cell lines. Viral replication was examined through standard plaque assay.The research from the trial highlights CF33 was effective in vitro against several different TNBC cell lines.There was evidence of necrosis i.e., cell death in recent CF33 publications from trial supervisors
Vaxinia
Vaxinia Founder Professor Yuman Fong
Photo Courtesy of Imugene
Vaxinia is CF33 potent parental oncolytic virus. By the end of October 2023 By the end of last month, the entire cohort had received VAXINIA during a continuing dose escalation phase where 16 patients had IT-administered doses and 18 had doses intravenously as monotherapy or in combination with pembrolizumab.
Of these, 25 patients were able to receive their first evaluation scan at day 42, with results showing that 16 had achieved stable disease (SD) status while eight registered progressive disease (PD) as measured by standard approaches including iRECIST ([immune] response evaluation criteria in solid tumours) and RECIST (response evaluation criteria in solid tumours).
Oncarlytics
Oncarlytics Co Founder Saul Priceman
Photo Courtesy www.aiche.org
OnCARlytics is a novel and effective combination immunotherapy utilizing the CF33 oncolytic virus to deliver de novo cell surface expression of CD19 antigen (CF33-CD19) promoting CD19-CAR T cell anti-tumor responses against solid tumors. In 2022 City of Hope Research Facility presenters illustrated how the CF33-CD19t oncolytic virus (onCARlytics) targets hepatocellular carcinoma (HCC) and in combination with CD19- Redirected ARTEMIS® T cells results in significant tumor killing. At the time it was noted "The data supports the potential benefit of the 'Mark-and-Kill' approach in addressing the lack of tumour- specific targets in treating solid tumours with T-cell therapies,” said Dr. Cheng Liu, President of Estrella Biopharma.
Azer Cel
Azer-cel is an off-the-shelf CD19 CAR T, a type of cell therapy which is being manufactured and supplied from Imugene’s state-of-the-art facility in North Carolina.
Azer-cel has demonstrated clinically-meaningful activity with an acceptable safety profile for patients with non-Hodgkin’s lymphoma (NHL) and acute lymphocytic leukemia (ALL). In a recent clinical trial with 84 patients Notably, the Azer-cel data were found to be especially strong in patients with diffuse large B cell lymphoma (DLBCL) who had relapsed following auto CAR T therapy. In summary Azer-cel achieved an 83% overall response rate, a 61% complete response rate with 55% durable response greater than or equal to six months in this difficult to treat auto CAR T relapse setting.
All Imugene’s vaccines and viruses have exhibited exemplary safety parameters with little or no patient side effects. All drugs have the potential to achieve strong revenue figures in arenas where a huge unmet need exists. Existing players are facing patent expiration for many of their blockbuster drugs, presenting even more opportunities of Imugene’s cost effective, safe and efficacious cancer treatments.
All of the aforementioned vaccines, viruses, Oncarlytics and allogeneic therapies are currently being trialled in both late stage, and more recently earlier stage cancer patients. News is imminent in Imugene’s ongoing PD1 Vaxx, Oncarlytics and most importantly Vaxinia trials.
DYOR Research Seek Investment advice as and when required Opinions only