Immuno-oncology company Imugene (ASX: IMU) is set to advance its PD1-Vaxx cancer immunotherapy by trialling the treatment in patients with non-small cell lung cancer.
In an update to the market, the company said it plans to conduct a new study later this year at up to six sites across North America and Australia under an FDA investigational new drug application.
The upcoming phase 1 study has now met pre-clinical milestones including GMP manufacturing standards including sterile fill and finish.
Imugene has also confirmed that all pre-clinical toxicology studies have also been completed.
Final filled and finished vials of PD1-Vaxx have completed non-human primate safety toxicology studies in the US with “high levels of PD1-targeting polyclonal antibodies” generated.
The oncology company tested three different doses and confirmed that all three were well tolerated with no adverse findings.
Moreover, given the high antibody generation, Imugene declared its preclinical results serve as a strong indicator that PD1-Vaxx will break tolerance in humans, generate antibodies, and may produce an anti-cancer effect similar to high-profile PD-1 inhibitor drugs such as Keytruda and Opdivo.
Both Opidvo and Keytruda are used to treat different cancers including lung, head, neck and melanomas with Imugene hoping to emulate these market leaders by developing its own version.
Made by US pharma giant Merck, Keytruda sales have mushroomed from $55 million in 2014 to $7.2 billion in 2018, registering an average annual growth of 334%. Meanwhile, Opdivo made by Bristol-Myers Squibb pulled in $4.24 billion in US sales in 2018.
Given the strong growth of immunotherapies within oncology, backed up by rapidly growing sales of PD-1 inhibitors, Imugene is developing a product pipeline including multiple immunotherapy B-cell vaccine candidates and an oncolytic virotherapy aimed at treating a variety of cancers in combination with standard of care drugs and emerging immunotherapies.
Imugene also wants to develop a selection of B-cell therapies that can stimulate the patient’s immune system to produce polyclonal antibodies, and very importantly, introduce a slew of benefits including lower costs, better efficacy and lower cancer recurrence rates.
“We are pleased to reach both the toxicology and GMP drug product manufacturing milestones with such positive results, enabling us to progress PD1-Vaxx into phase 1 trials in 2020 as an important next step in bringing a much-needed new therapeutic option to cancer patients,” said Ms Leslie Chong, managing director and chief executive officer of Imugene.
Earlier this month, Imugene announced that it had scooped a patent for its HER-Vaxx cancer immunotherapy, currently undergoing phase II development for HER-2+ gastric cancer.
The patent protects Imugene’s IP for the next 16 years.
Imugene designed HER-Vaxx as a B-cell immunotherapy to treat tumours that overexpress the HER-2/neu receptor including gastric, breast, ovarian, lung and pancreatic cancers.