This is very early data but exciting from a humanitarian perspective. Upper GI cancers including cholangiocarcinoma are some of the most deadly and least treatable so even one (heavily pre-treated ie we've thrown everything else at it) patient with a complete response for over a year is massive news.
As with all biotechs experimenting with early stage drugs this will require some patience as an investor and I'm coming to the conclusion it's better to follow and jump on board later but... Big opportunity and I hope they're successful
IMUGENE LIMITED ACN 009 179 551 WWW.IMUGENE.COM info@imugene.com
ASX Announcement
Phase 1 CF33-hNIS (VAXINIA) Study Update
Positive Early Signals
• CF33-hNIS administered alone, or in combination with pembrolizumab and either
dosed intravenously (IV) or intratumourally (IT)
• 38 heavily pre-treated patients dosed to date with CF33-hNIS virus
• All treatments to date have been determined to be safe and tolerable
• 1 Complete Response (CR)* in biliary tract cancer treated at a mid-dose; patient
has been in remission for over 430 days
• 2 Partial Response (PRs)* in melanoma in a mid-dose level
• In the IT cohorts, 47% of injected lesions had a reduction in tumour burden, 3
lesions were completely eradicated; In IV cohorts, 53% of patients achieved
stable disease as their best response, among the efficacy evaluable patients
• 7 patients with gastrointestinal cancers who received CF33-hNIS alone during
dose escalation achieved a disease control rate (CR, PR or SD) of 86% presented
this week at the American Society of Clinical Oncology - Gastrointestinal Cancer
Symposium (ASCO-GI)
Sydney, Australia, 17 January 2024: Imugene Limited (ASX: IMU), a clinical stage
immuno-oncology company, is pleased to provide a clinical trial update of its Phase 1
MAST (Metastatic Advanced Solid Tumours) trial evaluating the safety and efficacy of
novel cancer-killing virus CF33-hNIS (VAXINIA).
• As of 12 January 2024, 38 patients have been dosed with VAXINIA during the
continuing dose escalation phase, comprised of 19 patients dosed intratumourally
and 19 patients dosed intravenously as either monotherapy or in combination with
pembrolizumab.
• 31 patients were evaluable for efficacy (received at least their first scan at day 42).
In the IT cohorts (14 patients), 7 of 15 (47%) injected lesions had a reduction in
IMUGENE LIMITED ACN 009 179 551 2
tumour burden, 3 lesions were completely eradicated. 3 patients (21%) had an
objective response: 1 complete response by iRECIST in a patient with
cholangiocarcinoma (a type of biliary tract cancer); and 2 partial responses in
patients with melanoma (skin cancer) by RECIST. In IV cohorts (17 patients), 53% of
patients achieved stable disease as their best response.
• Patients who received prior checkpoint blockade therapy derived clinical benefit
with and without pembrolizumab.
• Trial expansion is planned for 10-20 patients with biliary tract cancers.
• Early results presented this week at the annual ASCO-GI Symposium in San
Francisco, California, show that 7 patients with gastrointestinal cancers who
received CF33-hNIS alone including 3 colorectal, 2 biliary tract, 1 pancreatic and 1
liver cancer showed positive treatment effects, with a disease control rate (all CR,
PR and SD) of 86%. Importantly, in these patients, changes in tumour burden
correlated with systemic immunological changes known to promote anti-tumour
immunity. The poster "Oncolytic Virus CF33-hNIS Monotherapy for the Treatment of
Gastrointestinal Malignancies" will be presented on 18 January 2024 during Session
A: Cancers of the Esophagus and Stomach and Other GI Cancers from 11:45 AM-1:15
PM.
Imugene MD & CEO Leslie Chong said: “This latest data reinforces the early positive
responses we’ve seen in gastrointestinal cancers and in particular for cholangiocarcinoma
(bile duct cancer). It provides an excellent platform to investigate the impact of VAXINIA
at higher dose levels as we also expand the trial to additional patients with hard-to-treat
biliary tract cancers. It is a proud moment for us to be able to present these results at
ASCO-GI, and promote the potential of VAXINIA and CF33 more broadly.”
Notably, 1 patient with biliary tract cancer, treated IT with mid-dose level displayed
pseudoprogression (see below) with a 49% increase in tumour burden after 2 cycles of
therapy. However, by the 4th cycle they achieved a Complete Response (iCR) with no
known recurrence in over 430 days. A second patient with bile duct cancer, who
IMUGENE LIMITED ACN 009 179 551 3
previously progressed on prior drug therapies, achieved Stable Disease (SD) for > 4
months upon receiving IV-administered CF33-hNIS.
About Biliary Tract Cancers
Bile duct cancers are difficult to treat and typically respond modestly to immunotherapy
drugs. Pseudoprogression is a phenomenon in which the cancer initially appears to be
growing, largely due to the cancer cells being infected by the virus then followed by
infiltration of cancer fighting immune cells. However, it is usually followed by a decrease in
tumour burden when the therapy takes effect. This phenomenon can benefit patients
receiving immunotherapy but often leads to premature discontinuation of treatment
owing to the false impression the cancer is growing.
About the MAST Trial
The multicenter Phase 1 MAST trial commenced by delivering a low dose of VAXINIA to
patients with metastatic or advanced solid tumours who have had at least two prior lines
of standard of care treatment. The City of Hope-developed oncolytic virus has been
shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumours in preclinical
laboratory and animal models¹. Overall, the study aims to recruit cancer patients across
approximately 10 trial sites in the United States and Australia.
The clinical trial is titled “A Phase I, Dose Escalation Safety and Tolerability Study of
VAXINIA (CF33- hNIS), Administered Intratumourally or Intravenously as a Monotherapy or
in Combination with Pembrolizumab in Adult Patients with Metastatic or Advanced Solid
Tumours (MAST).” The trial commenced in May 2022 and is anticipated to run for
approximately 24 months while being funded from existing budgets and resources.
Full study details can also be found on clinicaltrials.gov under study ID: NCT05346484.
*iRECIST and RECIST: (immune) Response evaluation criteria in solid tumours
*PFU: Plaque Forming Unit
References
¹ Warner SG, Kim SI, Chaurasiya S, O'Leary MP, Lu J, Sivanandam V, Woo Y, Chen NG, Fong Y. A Novel Chimeric Poxvirus
Encoding hNIS Is Tumor-Tropic, Imageable, and Synergistic with Radioiodine to Sustain Colon Cancer Regression. Mol
Ther Oncolytics. 2019 Apr 11;13:82-92. doi: 10.1016/j.omto.2019.04.001. PMID: 31061881; PMCID: PMC6495072.
IMUGENE LIMITED ACN 009 179 551 4
For more information please contact:
Leslie Chong
Managing Director and Chief Executive Officer
info@imugene.com
Investor Enquiries
shareholderenquiries@imugene.com
Media Enquiries
Matt Wright
matt@nwrcommunications.com.au
Connect with us on LinkedIn @Imugene Limited
Follow us on Twitter @TeamImugene
Watch us on YouTube @ImugeneLimited
Join us on InvestorHub; investorhub.imugene.com
About Imugene (ASX:IMU)
Imugene is a clinical stage immuno-oncology company developing a range of new and
novel immunotherapies that seek to activate the immune system of cancer patients to
treat and eradicate tumours. Our unique platform technologies seek to harness the body’s
immune system against tumours, potentially achieving a similar or greater effect than
synthetically manufactured monoclonal antibody and other immunotherapies. Our
pipeline includes an off-the-shelf (allogeneic) cell therapy CAR T drug azer-cel
(azercabtagene zapreleucel) which targets CD19 to treat blood cancers. Our pipeline
also includes multiple immunotherapy B-cell vaccine candidates and an oncolytic
virotherapy (CF33) aimed at treating a variety of cancers in combination with standard of
care drugs and emerging immunotherapies such as CAR T’s for solid tumours. We are
supported by a leading team of international cancer experts with extensive experience in
developing new cancer therapies with many approved for sale and marketing for global
markets.
Our vision is to help transform and improve the treatment of cancer and the lives of the
millions of patients who need effective treatments. This vision is backed by a growing
IMUGENE LIMITED ACN 009 179 551 5
body of clinical evidence and peer-reviewed research. Imugene is well funded and
resourced, to deliver on its commercial and clinical milestones. Together with leading
specialists and medical professionals, we believe Imugene’s immuno-oncology therapies
will become foundation treatments for cancer. Our goal is to ensure that Imugene and its
shareholders are at the forefront of this rapidly growing global market.
Release authorised by the Managing Director and Chief Executive Officer Imugene Limited.
