The Australian Securities Exchange (ASX) has a burgeoning life sciences cohort that is doing some great work in a range of major diseases: here are four very interesting cancer fighters.
- Immutep (IMM, 34 cents)
Market capitalisation: $494 million
12-month total return: 5.6%
Three-year total return: –10.4% a year
Analysts’ consensus valuation: 95 cents (Stock Doctor/Refinitiv, five analysts)
Immutep focuses on immuno-oncology, which is the field of developing immune-based therapies that enable the body’s immune system to selectively recognise and attack cancer cells. The company owns the LAG-3 (lymphocyte activation gene 3) molecule, a crucial mediator of the immune system, discovered by Immutep’s executive director and chief scientific officer, Frédéric Triebel, in 1990.
LAG-3 is an immune control mechanism that is considered one of the most promising targets in immuno-oncology. It is a protein molecule that can identify cancer cells to regulate immune responses, allowing patients to fight the disease using their own cells. Immutep has a portfolio of products that exploits this molecule’s unique ability to stimulate or suppress the immune response.
Immutep’s lead drug candidate, eftilagimod alpha, or Efti, is currently undergoing clinical trials in five different oncology indications. Efti is being evaluated for a variety of solid tumours, including non-small cell lung cancer (NSCLC), the most common type of lung cancer; head and neck squamous cell carcinoma (HNSCC); and metastatic breast cancer. Efti has received “Fast Track” designation from the United States Food & Drug Administration (FDA) in first-line HNSCC and in first-line NSCLC: fast track designation speeds up the review of drugs to treat serious diseases with unmet needs.
Efti’s favourable safety profile enables it to be used in various combinations of treatments, including with other drugs, and chemotherapy, to amplify a patient’s immune response. Efti has been through several successful Phase 2 trials and is now proceeding to a Phase 3 trial in metastatic non-small cell lung cancer (NSCLC), a disease in which cancer cells form in the tissues of the lung, in combination with Merck’s Keytruda (pembrolizumab) drug and chemotherapy. Success in the Phase 3 trial would clear the way for Efti’s commercialisation: it is the first of four LAG-3 product candidates from Immutep to move through clinical trials.
Immutep recently raised $100 million to finalise the late-stage lung cancer trials. The company says it is less than three years away from a potential “blockbuster” drug.
- Imugene (IMU, 5.5 cents)
Market capitalisation: $403 million
12-month total return: –38.2%
Three-year total return: –45% a year
Analysts’ consensus valuation: 42 cents (Stock Doctor/Refinitiv, two analysts)
Imugene works in immuno-oncology, the anti-cancer field in which the body’s immune system is artificially stimulated to boost its natural ability to fight the disease (it is sometimes called “cancer immuno-therapy.”) Imugene is developing four new treatments that activate the immune system of cancer patients to identify and eradicate tumours; all four cancer treatments are in clinical trials.
By effectively harnessing a patient’s own immune system, malignant tumours can potentially be eradicated. The company is investigating its treatments as sole therapies (monotherapies), and in combination with other marketed drugs.
Imugene has been busy with all of its lead candidates.
Azer-cel: Azer-cel is a chimeric antigen receptor T-cell (CAR-T) therapy, a revolutionary type of treatment in which a patient’s T-cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells: it is all about re-programming the body’s own immune system to kill cancer cells. Azer-cel is an allogeneic cell therapy, in that it uses cells from a healthy donor other than the patient: azer-cel targets the CD19 protein so your immune system can recognise them. to treat blood cancers. It is currently in a Phase 1b trial dosing diffuse large B cell lymphoma (DLBCL) patients who have failed autologous CAR T therapy (that is, using their own cells.) DLBCL is an aggressive type of cancer that develops from the B-cells in the lymphatic system, which are responsible for producing antibodies typically to fight infectious disease; DLBCL develops when some of your B-cells become cancerous. They grow uncontrollably, are abnormal, and do not die when they should. Azer-cel is a supercharged allogeneic T cell designed to identify and kill malignant cells expressing CD19; it is designed for immediacy, potency, and cost-effectiveness compared to existing autologous treatments.
The VAXINIA MAST Trial: Imugene’s VAXINIA, an engineered virus that targets tumour cells, has demonstrated promising preliminary results. Currently, in a Phase 1 dose-escalation study, VAXINIA has been administered alone or in combination with pembrolizumab to 47 heavily pre-treated patients. Nearly half of the evaluable patients showed substantial disease control, remaining on treatment for over three months. Highlights include a complete response in one bile tract cancer patient and partial responses in melanoma patients. The trial has now moved to higher dose cohorts and opened a bile tract cancer expansion trial. This trial, which was granted Fast Track Designation by the FDA, is expected to provide preliminary data in the second half of 2024.
OnCARlytics (CF33-CD19): The innovative onCARlytics therapy, using a CD19-expressing oncolytic virus, has shown promising safety profiles in early-phase trials and is now moving into combination studies with a targeted cancer drug called blinatumomab (marketed by Amgen). This approach could potentially extend CD19-targeted therapies, traditionally used for blood cancers, to treat solid tumours.
PD1-Vaxx: PD1-Vaxx is a B-cell immunotherapy, which are cancer vaccines that vaccinate and induce the body to produce antibodies against validated oncology targets. PD1-Vaxx is currently in the development stage of a bid to target colo-rectal (bowel) cancer and NSCLC (see the Immutep entry). It works by preventing cancer cells from using programmed death-1 (PD-1) to stay undetected by the immune system. PD1-Vaxx has been designed to treat tumours like lung cancer by inhibiting the PD-1 protein and generating an anti-cancer effect.
HER-Vaxx: Also, a B-cell immunotherapy, HER-Vaxx has been designed to treat tumours that overexpress the HER-2 receptor. These receptors are essential in controlling cell growth and differentiation; over-expression of the HER-2 receptor is associated with cancers including gastric cancers. During pre-clinical studies, HER-Vaxx was seen to stimulate a potent polyclonal antibody response to HER-2 receptors. Clinical results from a phase 2 study involving a combination of HER-Vaxx and chemotherapy was undertaken in patients with HER-2 overexpressing metastatic or advanced gastric cancer: the combination of HER-Vaxx and chemotherapy increased overall survival in study participants compared to treatment with chemotherapy alone. Further trials using HER-Vaxx in combination with other therapies are in progress.
- Race Oncology (RAC, $1.605)
Market capitalisation: $274 million
12-month total return: 21.6%
Three-year total return: –23.8% a year
Analysts’ consensus valuation: n/a
Race Oncology is developing its anti-cancer drug called Zantrene (also known by its generic name, bisantrene dihydrochloride). Zantrene is used both as a low-dose targeted precision oncology agent as well as a cardio-protective chemotherapy drug; the drug is aimed at melanoma and clear cell renal cell carcinoma, as well as acute myeloid leukaemia (AML), breast, and ovarian cancers, which is in Phase 2/3 clinical trial. It has a pre-clinical research program with the University of Newcastle for investigating Zantrene.
Race announced two big milestones in June. In the first, it appointed contract research organisation (CRO) George Clinical International to support development of its lead drug candidate RC220 (reformulated bisantrene, to enable easy clinical use through standard infusion through arm or leg veins). George Clinical International will help Race in the refinement and efficient execution of the proposed Phase Ia/1b study of intravenous RC220 in combination with a standard-of-care treatment using the chemotherapy drug doxorubicin in patients with advanced solid tumours, to explore the drug’s anticancer and cardio-protective properties alongside the known standard of care. The Phase 1 trial will be conducted in two stages across multiple sites in Australia, Hong Kong and South Korea: it is expected to complete recruitment during 2026.
In the second, RC220 received Rare Paediatric Disease Designation (RPDD) from the FDA for the treatment of childhood (paediatric) subtypes of AML. RPDD is a designation designed to incentivize drug development for rare paediatric diseases; it is granted for new treatments of serious or life-threatening diseases which affect fewer than 200,000 people in the US and which primarily affect people under 18 years of age. Approximately 70 per cent of rare diseases are exclusively paediatric in onset, with 95 per cent of rare diseases having no approved treatments.
Race has also been in talks with Associate Professor Dr. Himalee Sabnis from the Department of Pediatrics at Emory University School of Medicine in Atlanta, and a large international paediatric oncology cooperative group, to undertake a sponsored (or ‘investigator-initiated’ trial) of RC220 bisantrene as a ‘salvage treatment’ for paediatric AML patients. Salvage treatment is given after a disease, such as cancer, fails to respond to other standard therapy treatments. Race says Dr Sabnis is a world-leading key opinion leader (KOL) in the treatment of AML in paediatric patients. The company says several proposals from the international paediatric cooperative oncology group and Dr Sabnis have been received and possible options for conducting the trial have been discussed.
- Noxopharm (NOX, 7.2 cents)
Market capitalisation: $21 million
12-month total return: 84.6%
Three-year total return: –51.3% a year
Analysts’ consensus valuation: n/a
Australian biotech Noxopharm has two main technology platforms, one called Sofra, and one called Chroma, from which it is developing drug candidates. While the Sofra platform relates to inflammation and is involved in potential Messenger RNA (mRNA) vaccine treatments – creating vaccine “enhancers” that significantly reduce mRNA-driven inflammation – the Chroma platform relates to cancer. The lead drug candidate out of Chroma is the pancreatic cancer drug, CRO-67.
CRO-67 targets a market where few new drugs have been introduced over recent decades, and pancreatic cancer patients urgently require innovative approaches to help mitigate this lethal disease. For this reason, regulatory authorities tend to look favourably at companies that are trying to tackle this considerable problem; last October, Noxopharm was granted orphan drug designation (ODD) status by the FDA for CRO-67. ODD status is granted to drugs designed to prevent, diagnose or treat rare diseases or conditions; an ‘orphan drug’ is one that would not be profitable to produce without government assistance, because of the small population of patients affected by the conditions.
CRO-67 takes a new approach to treat pancreatic cancer. This cancer is particularly difficult to treat because of the hard shell-like outer layer that usually surrounds the tumour, called fibroblast, which not only nurtures the tumour, it also protects external drugs from entering and attacking the tumour. Noxopharm describes CRO-67 as having “dual cell activity,” in that it kills the cancer cells, but it also breaks-up the fibroblast barrier cells by softening them up, with the effect of depriving the tumour of its nurturing.
Next up from the Chroma platform is encouraging pre-clinical work on a novel first-in-class drug candidate for glioblastoma, the most frequent and lethal type of brain cancer. There are very few treatment options for glioblastoma, and after initial treatment, recurrence of it is almost inevitable. The global glioblastoma market was worth around US$2.5 billion in 2022 and is expected to grow at an annual rate of 9.3 per cent. Noxopharm is working with the University of South Australia to further develop its understanding of this asset.
Noxopharm’s dual focus is attractive, because while the Chroma platform delivers candidates for testing, so does its Sofra counterpart – including the SOF-VAC mRNA vaccine enhancer and the SOF-SKN potential lupus medication.
Noxopharm is quite some way away from commercialisation but is doing very interesting things in two major disease areas.
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