Cancer therapies, competition nd Imugene
The race to make a dent in the huge unmet need facing cancer patients is heating up. Leading the charge in recent years has been Pfizer, who are now firmly focused on cancer drugs, having purchased the cancer drugmaker Seagen for $43 billion USD and going on to perform an internal restructure to prioritise their cancer drugs. One cancer indication Pfizer are concentrating on is Non Small Cell Lung Cancer (NSCLC), the most common type of lung cancer. A Pfizer drug of particular interest is Lorbrena, expected to be successful in the Chinese market, where lung cancer is prevalent. Lorbrena, like Pfizer's Xalkori, is designed to treat cancer with a mutation of a specific gene called anaplastic lymphoma kinase, or ALK. While 4% of non-small cell lung cancer (NSCLC) patients globally have ALK-positive tumors, up to 7% of patients in China do.
In Pfizers most recent Lobrena study sixty percent of ALK-positive patients with advanced lung cancer treated had no disease progression after five years, according to follow-up results from the company's Phase 3 CROWN trial unveiled at the American Society of Clinical Oncology meeting in Chicago. That compared with five-year progression-free survival of just 8% of patients treated with Xalkori. About 53% of Lorbrena patients whose cancer had spread to the brain at the start of the trial were alive without disease progression after five years, the data also showed.
But others targeting lung cancer are not having as much luck. Reuters reported today that Gilead’s Trodelvy failed to make a significant impact in its 603-patient lung cancer trial for the drug. On Friday, trial data presented at the American Society of Clinical Oncology meeting in Chicago showed that Trodelvy improved survival by just 1.3 months more than chemotherapy for patients with advanced lung cancer, a difference that was not statistically significant.
Imugene (IMU ASX) entered the race to target lung cancer some years ago. The company licensed Professor Pravin Kaumaya’s PD1 Vaxx, a drug designed to treat tumours such as lung and colorectal cancer by interfering with the PD-1/PD-L1 pathway, and in doing so produce an anti-cancer effect similar to Tecentiq, Keytruda and Opdivo. Having proven successful in a Phase 1 Melbourne Trial for participants with NSCLC more recently Imugene commenced a Phase 1/1b Trial for the disease in which 24 patients are currently enrolled across a number of sites in Australia and the US (See https://www.clinicaltrials.gov/study/NCT04432207 for more). Imugene’s website highlights the fact the monotherapy arm of the trial is now complete (See https://www.imugene.com/clinical-trials) with the trial set to expand into a combination with Roche’s Tercentriq. With the first patient dosed over 11 months ago now surely initial data feeds are not too far away for beleaguered IMU holders, many of whom were buoyed by PD1 Vaxx’s initial Phase 1 results in 2022.Given Trodelvy’s recent miss in the lung cancer indication there is perhaps even more riding on PD1 Vaxx’s Phase 1/1b results than there was a few months prior.
But PD1 Vaxx isn’t the only drug Imugene have licensed that is capable of treating lung cancer patients. Professor Yuman Fong has long espoused the virtues of his 33rd Virus CF33 as being one that could potentially treat “any type of cancer,” including lung cancer.
CF33 is not yet proven in humans to any large extent and still in dose escalation mode in a Phase 1 clinical trial of its own. That said the potent parental strain of the oncolytic virus known as Vaxinia, has resulted in a large number of stable disease conditions in patients suffering from a broad array of advanced, late stage cancers that had metasticized prior to enrolling in the trial. Professor Yuman Fong is of the opinion his drug may perform better at higher doses, therefore with the trial recently advancing to a dosage rate of 10 parts to the 8, there is an expectation results in the Vaxinia Trial could remain fruitful for those on the trial still receiving treatment.
Whilst Imugene does have many trials underway at present it is not in a position to fund large clinical trials such as those being performed by the likes of Gilead and Pfizer. Though if the science is promising in these ongoing trials for PD1 Vaxx and Vaxinia there is sure to be interest given the markets continued focus on cancer therapies. There are a number of reasons interest from Big Pharma could play into the hands of Imugene. Not least the fact that lung, colorectal and the gastrointestinal cancers being treated by drugs such as PD1 Vaxx and Vaxinia respectively, are swimming in the same pool as blockbuster drugs such as Opdivo and Keytruda, both of whom are soon to run out of patent life in 2028. The downside for IMU holders has been the company's inability thus far to convert their presence in this lucrative market to either sales of their shares to large players, or a licensing deal with the likes of Pfizer or Gilead. Maybe a further FDA fast track designation for a gastrointestinal indication in the current Vaxinia Trial, or strong interim results in the aforementioned PD1 Vaxx Imprinter Trial, may turn the tide for this underperforming biotech stock. If Imugene's clinical trial pipeline is anything to go by, we may have the answer as early as H2, 2024.
DYOR
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