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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 [email protected]

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

[email protected]

Investor Enquiries

[email protected]

Media Enquiries

Matt Wright

[email protected]

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.