Vaxinia - Is the fast track fast enough?It would appear Imugene...

Vaxinia - Is the fast track fast enough?

It would appear Imugene now has a number of vaccines successful in delivering positive outcomes for late stage cancer patients. Their safe vaccine PD1 Vaxx, is but one of them. The announcement recently Imugene is preparing to commence a bowel cancer trial in both Australia and the UK utilising PD1 Vaxx for earlier stage participants, is encouraging. Onlookers can ascertain how the company’s B Cell candidate PD1 Vaxx performs on individuals who have not as yet undergone surgery. These patients may well have stronger immune systems than those compromised through both surgery and prior treatment. Given their early diagnosis and potentially stronger immune system, hopefully they are in a position to respond more favourably to PD1 Vaxx than later stage recipients, as the drug is designed to stimulate one’s immune system in the fight against cancer.

Primary objective is to determine major pathological response rates, a measurement of tumour size, after treating with PD1-Vaxx before surgery to remove any residual tumour also known as neoadjuvant in operable CRC cancer patients.

Imugene clearly holds out hope PD1 Vaxx can assist these suffering cancer patients, due to the a results of their Phase 1 trial in Melbourne Australia, which produced a both a complete and partial responses when administered to late stage lung cancer patients. I say this as the company is not only forecast to trial PD1 Vaxx on 44 bowel cancer patients in Australia and the UK, they are already trialling the drug in lung cancer patients both in Australia and the US. PD1 Vaxx’s inventor Professor Pravin Kauyama suggested in 2022 his vaccines may perform successfully when administered in combination with other drugs. Imugene have since taken the step of combining PD1 Vaxx with the Roche Therapeutic drug Tercentriq, with their trial into lung cancer patients already well underway. The first patient was dosed in the NSCLC Trial on June 1, 2023. The Phase 1/1b Imprinter Trial as it is known, is studying responses to PD1 Vaxx in up to 88 patients with lung cancer, in contrast to the aforementioned Phase 2 Trial, studying up to 44 patients with colorectal (i.e., bowel cancer.)

PD1 Vaxx is now being trialled at its Optimal Biological Dose Rate following on from the December 2020 Phase 1 trial in Melbourne. At present Imugene’s Phase 1 Vaxinia (MAST) Trial is being conducted to ascertain the same thing, that being to determine the Optimal Biological Dose Rate for Vaxinia. But in the interim signs of efficacy are appearing at relatively low dose rates. In fact many late stage cancer patients with limited life expectancy are seeing their disease stabilise, as opposed to progress, having been administered with Vaxinia. What is perhaps of even greater significance, as noted by @davybabyk here on HC is the possibilty that some of these patients may even realise an improvement in prognosis, as time marches forward. As @davybabyk points out some of the patients who were SD and PR as of 31 October (and maybe some of the Progressive Disease patients) may indeed improve their results by the time another data cut is analysed, because of the whole "pseudo-progression thing." ie. in the short term their tumour may grow and look like Progressive Disease, or just look like Stable Disease, but really this is because they are being attacked by the immune system and are inflamed by that, and then later as the immune attack becomes successful, they shrink.

With the initial doses in the Vaxinia Trial being at relatively low levels, i.e.,10 to the 6, there is an expectation Yuman Fongs potent and parental CF33 virus (i.e., Vaxinia) may produce stronger immune responses at increased dosage rates. Which I suppose brings me to the essence of this article, that being, Are we doing enough to distribute what appears to be a safe and now effective drug to the broader population? PD1 Vaxx has taken years now to progress to Phase 1/1b and Phase 2 Trials. Given the existing constraints faced by cancer drug developers such as Imugene this is understandable. But from a sick patients perspective are these strict regulatory guidelines proving to be in their best interests? Back in March when at lunch the conversation between YF , LC and those at the table drifted toward the companys desire to prove consistency when it came to Vaxinia’s efficacy within specific cancer indications. Although YF stated Vaxinia has been developed to cure “any type of cancer’, and that “all cancers are acceptable” within the current Vaxinia (MAST) Trial, there is clearly a need to satisfy the FDA through the presence of a number of SD, PR or CR’S within a specific cancer indication. Hence the recent directive of Imugene to enrol an additional 10 patients with late stage bile duct cancer, that being an indication with positive early results.

In order to progress cancer drug development faster and appease regulatory authorities in the US burdened with the high cost of cancer drugs coupled with the extensive side effects attributable to existing standard of care, Joe Bidens Cancer Moonshot Project was incepted. This government initiative has empowered the FDA to take positive steps toward assisting those drug developers successful in treating cancer indications where there is a huge unmet need. Some of this energy has been passed onto Imugene in the form of a Fast Track Designation and Priority Review status for Vaxinia in the existing MAST Trial for the indication of bile duct cancer. This may enable patients with that condition to receive Vaxinia somewhat earlier than would otherwise have been the case had such a pathway been unavailable to them.

But to cut to the chase what are we waiting for? Like many on these threads who have hugged loved ones only to see them pass far too early from this insidious disease, I feel I am letting the side down. It perhaps shouldn’t be up to Biden, the FDA, Imugene, the Morrison Government or existing governments to rally around and throw their hat in the ring for the fast track of Vaxinia. Okay so Imugene does benefit from R&D tax concessions available to them through Federal Government initiatives. But there is significant red tape governments themselves could remove to enable increaed patient participation. Someone asked me the other day would the patients treated at 10 to the 6 be in a position to turn back up and be administered with Vaxinia at te now trial dosage rate of 10 to the 8? To the best of my knowledge the answer is no, given the current trial format. Wow I thought later, what if you were one of the unlucky ones administered at the lower dose. It reminds of sitting in the car when one of our employees told my father he had been conscripted to go to Vietnam. Both his brothers, who passed through the system a few months before him were free from fighting, but he was required to head off to Nam. Bloody hell how unlucky can you be I thought at the time. So as Imugene progresses through the current trial to ascertain the optimal biological dose rate for Vaxinia, additional patients with Bile Duct Cancer are to be treated. Alongside them a random number of patients with other indications are to be treated, at lower numbers, and those treated earlier on in the peace are unable to receive a higher dose of the drug. At least thats my understanding of the lay of the land to this point in time.

I just think, reading between the lines, YF, LC and the team at Imugene supervising the trial were aware back in March 2023, that Vaxinia was yielding some of the results produced pre clinically, wherein it killed cancer indications against the NCI 60. At that juncture management took the correct step of prioritising the Vaxinia Trial. But is there not more they, we, governments and cancer lobbysits can do to fast track the existing trial? Why should such a trial now be focused primarily on bile duct cancer patients, at the behest of the FDA, given their stringent parameters? Pancreatic and liver cancer patients like bile duct sufferers have limited life expectancy as well, when their tumours have metasticised. What about other cancer indications, are they not worthy of Vaxinia, if their oncologist recommends it? Bureacratic red tape is required to ensure patient safety in clinical trials, in addition to eliminating the risk of long term ramifications arising from adverse treatment programs. You cannot just go off “willy nilly” and treat all and sundry in sight, irrespective of how confident you are in your vaccines ability to deliver effective results. I comprehend the need for rational reasoning at the medical coal face. But surely in instances such as this where patients have very limited life expectancy, as pointed out by Dave earlier today, where only a few percent of individuals are expected to live two years, can we not draw a line in the sand? Governments have bent the rules when it comes to allowing euthanasia in certain states. They bent the rules somewhat when it came to approving COVID vaccines.

I feel uneasy about the time taken to develop drugs such as Vaxinia. YF cannot believe how fast the existing trial is progressing. He himself has praised Imugene for the speed in which they have delivered the trial. But Imugene aside, if money is an obstacle, let us find more of it. If government regulations are holding back the participation of additional patients, let’s talk to the governments. If the FDA can and could fast track the administraion of Vaxinia to a more extensive list of cancer indications, pressure should be exerted publicly to ensure they do so. Are petitions of any use? Is lobbying your local member a solution? Is utilisng your influence as an Imugene shareholder enough to persuade Imugene to do everything in their power to make it happen.

Imugene’s goal is to see their drugs in patients arms as quickly as possible. They are striving passionately to this end. But realistically speaking they are a relatively small biotech outfit with novel technologies in down town OZ. At least until Vaxinia came along that is. Look at the November results for heavens sake. Taking nothing away from PD1 Vaxx, which threatens to shoot the lights out the world over in huge market segments such as lung and bowel cancer, Vaxinia is a serious drug when one considers 16 of 25 late stage cancer patients, who had failed on all prior treatments lines, with metasticised solId tumours, experienced a stabilisation in their disease having taken Vaxinia. And many of these via IV, that’s right, intravenously. To coin a much over used phrase, SHUT UP AND TAKE MY MONEY.

In conclusion I think when the forthcoming data is cut, if it proves to be as promising as that released in November, a round table needs to be convened to ensure Vaxinia reaches the arms of as many patients as is humanly possible, irrespective of their solid tumour indication. Imugene is doing the right thing in paying for advertising and media to spread the word. But perhaps Vaxinia is bigger than Imugene. At least it appears that way, IMO.

DYOR Seek investment advice as and when required Opinions only