Why IMU is a multi multi bagger, page-16015

Over the next seven weeks Imugene will be presenting trial updates at three conferences

11/9/2023 World Lung Cancer Conference 2023 in Singapore
P2.08-05IMRPrinter: A Phase 1/1b Trial of IMU‑201 (PD1-Vaxx) as Monotherapy or in Combination with Atezolizumab +/- Chemotherapy in NSCLC

20/10/2023 ESMO 2023 in Madrid
Induction of an Inflammatory Tumor Microenvironment with Oncolytic Virus CF33-hNIS-antiPD-L1 Intratumoral Injection in Patients with Metastatic Triple Negative Breast Cancer (mTNBC)

1/11/2023 Society for Immunotherapy of Cancer (SITC) 2023 in San Diego
A Phase I Safety and Tolerability Study of VAXINIA (CF33-hNIS), a Novel Chimeric Oncolytic Poxvirus, Administered Intratumorally or Intravenously in Adults with Metastatic or Advanced Solid Tumors

There has been much discussion and anticipation as to the release of efficacy data for our two oncolytic viral therapies CHECKvacc (CF33-hNIS-antiPD-L1) and VAXINIA (CF33-hNIS).

Professor Yuman Fong's CHECKvacc is a first in human trial conducted at the City of Hope.
The first patient was dosed on 20th October 2021 exactly two years before the ESMO 2023 conference.


The most recent update of the CHECKvacc data was reported at AACR 2023 in April in a presentation titled hNIS Imaging Data from a First-in-Human Trial of the Oncolytic Virus CF33-hNIS-antiPD-L1 in Patients with Triple Negative Breast Cancer

RESULTS
•From October 2021 to October 2022, 8 patients were enrolled in this ongoing study and received at least 1 dose of CF33-hNIS-antiPD-L1 injection at one of the first 3 dose levels (1 x 10 5 , 3 x 10 5 , or 1 x 10 6 PFU), and all patients underwent 99mTc SPECT imaging for virus tracking at C1D8.
• The IT CF33-hNIS-anti-PD-L1 injections were well tolerated and no DLTs were observed. Treatment related AEs included: fatigue, injection site reaction, lymphocyte count decrease, and injection site pain or discoloration (Table 2).
• 75% of patients (6/8) had uptake at the site of injection on 99mTc SPECT imaging.
• Of these, 4/4 (100%) patients with injection sites at metastatic subcutaneous nodules, intramuscular masses, or axillary lymph nodes had uptake at the injection site. Figure 2 shows imaging from 2 representative patients.
• 2/4 patients (50%) with injection sites at matted dermal metastatic lesions had uptake on SPECT imaging • Multiplex immunofluorescence shows an increase in CD8+ T-cells and PD-L1 expression

https://static1.squarespace.com/sta...2d/1681895764090/AACR 2023 FINAL 4-6-2023.pdf

In the recent July 2023 Webinar, YF commented "The FDA made me start really really low at 10^5 ...
we are now 3 cohorts cleared - it is well tolerated and we are seeing a lot of the biologic activities"

Given that the dose escalation into the fourth cohort (10^7) was recently announced in July 2023, the ESMO 2023 update will be limited to the results from the first three cohorts. And IMO will demonstrate how CF33 activates the tumor microenvironment by
- enhancing the expression of check-point targets to enhance activity of CPI
- helping antigen presenting cells to establish long lasting immunity and
- recruiting CD8+, CD4+ and NK cells

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