Hopefully a milestone of future success in China, and encouragement of adoption row.

https://newswire.iguana2.com/2fee0049d633f441/announcements/imu.asx/3A639894/IMU_Announcement_3A639894.pdf?download=1

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.

Even though I am using IMU to post this link on GLP-1 and potential for lowering cancer risk, this info equally applies to Telix and Clarity Pharmaceuticals. Although it seems ClU6 has seen less volatility than IMU and TLX.

https://www.medicalnewstoday.com/articles/could-glp-1-agonists-be-more-than-just-a-treatment-for-diabetes#GLP-1-drugs-and-Alzheimers,-diabetes-risk

While the article mentions that the drug has potential of lowering cancer risk as a result of treating obesity, it does mention that the drug GLP-1 can lead to the risk of developing thyroid cancer.

Article also mentions the potential of GLP-1 to lower risk of Alzheimers as a result of treating Obesity who are higher risk in getting the disease which may be relevant for CGS holders.

Important milestone, today. IMU has announced that the first patients have received doses in the VAXINIA MAST trial. The Phase 1 MAST (metastatic advanced solid tumours) study evaluating the safety of novel cancer-killing virus CF33-hNIS (VAXINIA) has seen the first patients dosed in the intravenous (IV) and intratumoral (IT) cohorts of CF33-hNIS in combination with Pembrolizumab.

Imugene MD & CEO Leslie Chong said: “Having continued through the monotherapy dose escalation with safety and early positive signals, we’re eager to see VAXINIA used in combination with the well-known drug Pembrolizumab and see the potential benefit this could bring to patients. We’re setting an excellent pace with the trial and look forward to data and results in due course.”

Held in my SMSF

Long letter from Paul Hopper Exec Chairman re: how IMU is in the best shape its ever been and to keep patient re: share price: shorturl.at/rxLV5

I'll admit to feeling more confident for having read the letter in its entirety. I especially like IMU's invite to JPMorgan's prestigious Biotech conference next week, this should give more exposure. Letter also raises, but doesn't answer, questions about a major buyer involved (behind?) the recent 80M raise.

On page 1, a summary of IMU status/activity:

The fundamentals of your company:

• Approx $160m in the bank, which provides us with multiple years of funding runway and one of the strongest cash positions of any ASX biotech;

• Three distinct technology platforms: onCarlytics; Oncolytic viruses & B cell technologies;

• Five unique assets: onCARlytics (CF33-CD19), CHECKvacc (CF33-hNIS-PDL1), Vaxinia (CF33-hNIS), HER-Vaxx, PD1-Vaxx;

• Five clinical trials are currently ongoing;

• Four clinical trials to commence over 2023;

• Four FDA-approved INDs;

• One IND to be submitted in 2023;

• Ten disease areas;

• Three scientific collaborations;

• Two supply agreements with Roche and Merck KGaA/Pfizer.

As cancer has had an impact with one of our family members (luckily not stage 3+) I'm always interested in being aware of the latest cancer treatments.This is especially the case when you need to attend out of hours meetings with oncologists at the expense of your normal life. Note that on the other hand it is unfortunately a different case if the patient can't afford the treatment from experience with another acquaintance who was on Centrelink - even though I was willing to stump up some of the payments. In either case, this does highlight the importance of cancer treatments to the medical sector possibly above all else.

Anyway, back to Imugene. The straws on Imugene by slymeat and slats especially help in giving a overview of the state of play.

Unlike Telix and Clarity, Imugene seems to be taking a more radical path of using immunotherapy to kill cancer cells (one case uses an "engineered virus"). This eliminates the issues in the acquisition and costs of radioisotopes for targeted radiotherapy. Paul Hopper is also on the board and has a large holding.

My only issues are the following:

1. Billions of shares on issue
2. The timeline to get to Phase 3 trials seem to be missing in the AGM presentation (unless I've missed something).
3. The chance Imugene will get booted out of the ASX200. As a reference, the market cap is already below Data#3 and that is not even in the ASX200 yet. Also we have other contenders waiting to dethrone Imugene from the coveted ASX200

Still on my watchlist though. Will be interested to see what happens if Imugene exits the ASX200 and where the price will settle.

@slymeat thanks for the video, I was so intrigued I bought the The Cancer Code book and devoured it over the weekend. It was well researched and fascinating, and medical jargon translated into layman English.

In sum:

• Immunotherapy may be the gamechanger for cancer treatment - ie boosting the immune system to kill out metastic cancer cells
• Cancer drugs and treatment have not changed much over the decades
• Cancer drug industry is prone to 'copycats' that use a winning formula and tweaks them, to be considered a 'new drug'
• FDA classification of efficacy has historically not focused on survival rates, but rather shrinking tumour sizes which may or may not be beneficial depending on the cancer.
• There have been historical FDA mishaps which have approved cancer drugs but have actually yielded no beneficial treatment.
• There's harmful cancer, and non harmful cancer
• Cancer is old as time

Hi Sly and the family Stone

This is in now way meant to be a bubble popper for how great this product could be for impugne, but I thought I would point out a few things I have learnt from painful experience.

these are things I am sure you are aware of, but perhaps lesser experienced investors reading your post might not be aware of.

Cancer therapy trials are complex. It is worth reading up on the structure, cost and probability of success of each particular stage trial any therapeutic agent needs to go through.

this is true for any drug but cancer trials have additional issues to consider.

A drug to treat a simple infection, say tonsillitis, has key advantages to trial in comparison to cancer agents.

Tonsillitis will resolve, or not resolve, in response to a treatment in a week. Trials are short and easy to measure.

cancers are much more complex. Trials will measure things like “disease free interval”, “time to clinical progression” , “tumour volume” and so on. These are quicker to measure (months) but don’t actually measure anything particularly important.

The gold standard outcome is survival. 1 year, 2 year, 5 year survival rates. To measure these tales, well, 1,2 or 5 years!

And big numbers of patients to measure anything meaningful.

So, in summary there might be some intermediate encouraging updates in th coming months but there won’t be anything conclusive for…. you guessed it.

Further, intermediate markers of success that seem really encouraging often do not translate into clinically meaningful outcomes.

good luck to all!