The Australian share market is home to a growing cohort of life sciences stocks, and it is a very interesting area to research. From the 140-plus biotechs that are beavering away on various diseases, here are three of the ASX’s top cancer fighters.
1. Imugene (IMU, 5.2 cents)
Market capitalization: $380 million
12-month total return: –72.1%
Three-year total return: –1.2% a year
Analysts’ consensus valuation: 46 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. Imugene is developing a range of new treatments that activate the immune system of cancer patients to identify and eradicate tumours.
The lead candidate is the cancer-killing virus CF33-hNIS (Vaxinia), which was developed by Professor Yuman Fong, at the prestigious City of Hope Comprehensive Cancer Center in Los Angeles. Vaxinia comes out of the field of oncolytic virotherapy, a form of cancer treatment that uses naturally occurring or genetically modified viruses to infect, replicate in, and kill cancer cells, while sparing healthy cells. Vaxinia is aimed at treating a variety of cancers, in combination with standard-of-care drugs and emerging immunotherapies such as CAR Ts for solid tumours.
(CAR Ts is one of the most exciting areas of medical research. This immune therapy transforms T-cells – natural disease-fighting cells in the human immune system – into cancer fighters by extracting them from patients. In the lab, clinicians then insert structures called chimeric antigen receptors (CARs); the combined CAR-T cells produce a protein that allows them to recognise and destroy cancer cells throughout the body.)
Vaxinia has demonstrated promising results in pre-clinical laboratory and animal models, effectively shrinking tumours associated with colon, lung, breast, ovarian and pancreatic cancers. Imugene is evaluating the safety of Vaxinia in a Phase 1 trial it calls MAST, for ‘metastatic advanced solid tumours.’ The company is testing Vaxinia on its own, and also as a ‘combination treatment’ that also includes Merck’s global best-seller drug, Keytruda, which is used to try and stop cancer cells from suppressing the immune system, allowing it to attack and kill the cancer cells.
At City of Hope, doctors combined an oncolytic virus developed by Imugene with CAR-T cell therapy to create a combination immunotherapy, called onCARlytics, to infiltrate solid tumours. (CAR-T therapies have been successful in blood cancers, but solid tumours are proving much more difficult to crack.) In May, the US Food and Drug Administration (FDA) gave. onCARlytics an Investigational New Drug (IND) clearance: subsequently, Imugene has begun a Phase 1 trial evaluating onCARlytics to target and eradicate solid tumours that are otherwise difficult to treat with CAR T therapy alone. The first patient, suffering from ovarian cancer, was dosed at City of Hope’s Comprehensive Cancer Center last month.
Imugene also has in trials:
- the oncolytic virotherapy CF33, known as CHECKvacc, in patients with triple negative breast cancer (TNBC);
- the HER-Vaxx candidate, which is a B-cell peptide cancer immunotherapy designed to treat tumours in gastric, breast, ovarian, lung and pancreatic cancers, in gastric cancer patients; and
- PD1-Vaxx, a B-cell immuno-therapy, in trials in patients with non-small-cell lung cancer (NSCLC).
Imugene is well-funded, following an $80 million institutional placement in September 2022, and an institutional placement that raised $35 million in August 2023, and $18.2 million brought in by a shareholder purchase plan in the same month.
US biotech research firm ROTH MKM has a price target of 46 cents on Imugene, while fellow American firm Diamond Equity Research has a target of 54 cents.
2.Chimeric Therapeutics (CHM, 2.8 cents)
Market capitalisation: $16 million
12-month total return: –65%
Three-year total return: n/a (listed January 2021)
Analysts’ consensus valuation: n/a
Melbourne-based cell therapy development company Chimeric Therapeutics is making good progress with its lead candidate CHM 2101 – a CAR T therapy – aimed at treating gastro-intestinal cancers. In March, Chimeric announced it had completed a pre-investigational new drug (IND) meeting with the FDA and had received positive feedback from the regulator on the development plan for CHM 2101: the FDA cleared the company’s IND application late last month.
The first-in-class therapy will now go into a Phase 1 clinical trial for patients with advanced colorectal, gastric and neuroendocrine tumours. The company plans to begin patient enrolments in the new year.
CHM 2101 was invented at the world- renowned cell therapy centre at the University of Pennsylvania. Preclinical evidence for CHM 2101 was published in March 2022 in the journal Nature Cancer, demonstrating complete eradication of tumours in seven types of cancer. CHM 2101 (CDH17 CAR T) is currently in preclinical development with a planned phase 1A clinical trial in gastrointestinal and neuroendocrine tumours.
The secondary candidate, CHM 1101, is also a novel and promising CAR T therapy, developed for the treatment of patients with solid tumours. CHM 1101 is currently being studied in a phase 1B clinical trial in patients suffering from glioblastoma, which is the deadliest form of brain cancer. Earlier this month, Chimeric announced that the first patient in its Phase 1B clinical trial in glioblastoma had received CHM 1101 CAR T cell treatment. The new trial follows positive survival results in the previous phase of testing.
From its proprietary cell platform, Chimeric also has a range of assets being developed across multiple different disease areas in oncology.
Chimeric Therapeutics’ January 2021 IPO was priced at 20 cents a share. The shares opened at 36 cents – representing an 80 per cent gain – but it has been a long slide since, to the current price of 2.8 cents. But for investors prepared to research the technology and prospects, and stomach the risk, it could be a rewarding entry.
3.Immutep (IMM, 31 cents)
Market capitalization: $369 million
12-month total return: –1.6%
Three-year total return: 5.9% a year
Analysts’ consensus valuation: 93.5 cents (Stock Doctor/Refinitiv, five analysts)
Named after the Egyptian god of medicine Imhotep, Immutep (the former Prima BioMed) also works in the immuno-oncology area. Its lead product candidate, efti (also known as IMP321), is being developed for the treatment of cancer and auto-immune disease.
Efti is a soluble LAG-3 protein, based on the LAG-3 immune control mechanism, which is Immutep’s intellectual property. LAG-3 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.
Efti is being evaluated for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. The drug has received Fast Track Designation from the FDA, in 1st line HNSCC and in 1st line NSCLC.
In October, Immutep reported excellent results from the Phase 2 TACTI-002 trial of efti – used in combination with Merck’s blockbuster drug KEYTRUDA – in NSCLC, delivering an overall survival benefit in patients with of 35.5 months: a median 12 months of additional survival compared to historical data from the current best-option drug-and-chemotherapy treatment. On top of the substantial survival benefit, the combination in Immutep’s trial is chemotherapy-free, meaning that patients can enjoy a better quality of life without the harsh side effects.
Immutep expects the global market for NSCLC to nearly double to US$48 billion by 2031 making it an attractive cancer market to enter. The company says success in this market alone could see efti become a significant drug alongside other major drugs such as Keytruda. Immutep will continue to evaluate efti in first-line lung cancer through the Phase 3 trial, known as TACTI-004.
This month, the company also reported the “safety lead-in” and opening of the Phase 2 part of its AIPAC-003 Phase 2/3 trial of efti in patients with metastatic breast cancer, in which the drug is being taken in combination with paclitaxel, the current standard-of-care drug. There were no safety or tolerability issues in the first six patients, so the trial will now be broadened to up to 58 evaluable patients.
Within the cohort of international biotech research firms that cover Immutep, there are current price targets in the range of $7.00–$8.30.
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