Why IMU is a multi multi bagger, page-12650

Thiis is a month old but it is good to see that IMU is getting some media coverage. Apologies if previously posted.

Imugene progresses novel cancer-killing virus with first patients dosed in combination trial (*********.com.au)

Imugene progresses novel cancer-killing virus withfirst patients dosed in combination trial

By

Lorna Nicholas

-

March 6, 2023

Imugene isdeveloping a range of therapies to activate a cancer patient’s immune system tohelp it fight its malignant cells.

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Immuno-oncology company, Imugene (ASX: IMU) has begun dosing the first patients of its combination study evaluating its novel cancer-killing virus (CF33 oncolytic virotherapy) in metastatic advanced solid tumours (MAST).

Imugene is developing a range of therapies that aredesigned to activate a cancer patient’s immune system to help it fight itsmalignant cells.

By essentially harnessing a patient’s own immunesystem, malignant tumours can potentially be eradicated.

The company is investigating its treatments as soletherapies (monotherapies), and in combination with other marketed drugs.

Imugene’s portfolio includes multiple immunotherapyB-cell vaccine candidates, an oncolytic virotherapy (VAXINIA or CF33), andemerging technologies, including onCARlytics (CF33 CD19) in combination withCAR-Ts ,or bispecifc antibody targeting CD19 for solid tumours.

VAXINIA MAST trial progresses

The company is progressing its novel cancer-killingvirus CF33-hNIS (VAXINIA or CF33), which is delivered to patients viaintravenous (IV) and intra-tumoral methods (IT).

Imugene is evaluating VAXINIA as a monotherapy andin combination with pembrolizumabin in patients with MAST.

In early March, the first patients in the IV and ITcohorts received VAXINIA in combination with pembrolizumab.

Last month, Imugene reported it was on its thirdcohort of three-to-six patients evaluating VAXINIA as a monotherapy atescalating doses.

All patients have had at least two prior lines ofstandard of care treatment.

Patients treated to-date have received the lowestdoses of VAXINIA and have shown what Imugene describes as “acceptable safety”,which allowed for escalating monotherapy doses and evaluation of the virus incombination with immunotherapy pembrolizumab.

These studies kicked-off in May 2022 and areexpected to take 18-24 months to complete. All-up, the company hopes to recruitup to 100 patients across 10 trial sites in the US and Australia.

CF33 oncolytic virotherapy platform

Imugene licenced the CF33 oncolytic virus platformin 2019 from Prof Yuman Fong, who is the chair of the Department of Surgery atCity of Hope in the United States.

City of Hope is an independent research andtreatment centre for cancer, diabetes and other life-threatening diseases basednear Los Angeles.

Imugene describes Dr Fong as a world-renownedcancer researcher, physician and surgeon.

In pre-clinical laboratory research and mousemodels, CF33 was able to shrink malignant colon, lung, breast, ovarian andpancreatic tumours.

The virus effectively works by finding, infectingand killing only cancer cells.

Imugene managing director and chief executiveofficer Leslie Chong said the company was “incredibly eager” to unlock thepotential of CF33 and the oncolytic virotherapy platform for cancer patients.

CHECKvacc and onCARlytics

Also, under development within Imugene’s portfolioare its CHECKvacc and onCARlytics therapeutics.

CHECKvacc, also known as CF33-hNIS-antiPD-L1, is anarmed chimeric vaccinia poxvirus, which is designed to selectively kill tumourcells while also activating the immune system.

The immunotherapy is undergoing a phase 1 trial inpatients with metastatic triple negative breast cancer – targeting the PD-L1protein and activating the local tumour microenvironment.

CHECKvacc was injected into the tumour and wasfound to be safe and well-tolerated in all patients in cohort two and initialresults also showed immune activation in response to the therapy. The study iscurrently in cohort three.

onCARlytics combines CF33 and CD19 with CD19directed therapeutics to include CAR-T (chimeric antigen receptor) therapies.

To-date CAR-T, alone, has limited activity in solidtumours. According to Imugene, this is because of a lack of selectively andhighly expressed surface antigens such as the blood B cell transmembraneprotein CD19 present on solid tumours.

CD19 is present in both normal and abnormal Bcells. Because of this, it is expressed in most B-cell malignancies and at anearly stage.

Imugene has designed onCARlytics to express CD19 onsolid tumours following infection of the cancer cell by the CF33-CD19 virus –enabling them to be “seen” by targeted therapies.

PD1-Vaxx

In February, Imugene revealed it has been grantedthe patent for its PD1-Vaxx, which is a B-cell activating immunotherapy fortreating non-small cell lung cancer.

It essentially works by preventing cancer cellsfrom using programmed death-1 (PD-1) to stay undetected by the immune system.

PD-1 is a protein that is found on T-cells, whichis a type of immune cell. Unfortunately, when PD-1 is bound to another proteinPD-L1, it can prevent T-cells from killing other cells including cancer.

Imugene’s PD1-Vaxx is under clinical developmentand the recent patent protects the company’s intellectual property through to2038.

Ms Chong said it is vital to the company tocontinue “locking-in” its IP across its portfolio.

“With the US being the largest healthcare market inthe world, this is a particularly important patent to protect our PD1-Vaxxtechnology as we continue its development,” Ms Chong added.

Anti-cancer effect

PD1-Vaxx has been designed to treat tumours likelung cancer by interfering with the PD-1 checkpoint target and generate ananti-cancer effect.

By inhibiting the PD-1 protein, Imugene’s PD1-Vaxxboosts the ability of its T-cells in killing the cancer cells.

Imugene has completed the final preparations for anew trial evaluating PD1-Vaxx in combination with immune checkpoint inhibitoratezolizumab (Tecentriq).

HER-Vaxx

Another of Imugene’s B-cell immunotherapies is itsclinically advanced HER-Vaxx, which has been designed to treat tumours thatoverexpress the HER-2 receptor.

These receptors are essential in controlling cellgrowth and differentiation. Overexpression of the HER-2 receptor is associatedwith adenocarcinomas, including gastric cancers.

During pre-clinical studies, HER-Vaxx was seen tostimulate a potent polyclonal antibody response to HER-2 receptors.

Clinical results from a phase 2 study involving acombination of HER-Vaxx and chemotherapy was undertaken in patients with HER-2overexpressing metastatic or advanced gastric adenocarcinoma.

The combination of HER-Vaxx and chemotherapyincreased overall survival in study participants to 14 months compared to 8.3months with chemotherapy alone.

Further trials using HER-Vaxx in combination withother therapies have begun.