Clinical trials, communication and those who only read what they want to hear
@davybabyk I clearly do not believe Imugene should post ongoing data and results ad infinitum, at the beck and call of shareholders. It is simply not cost effective, sound time management or necessary to provide regular updates in the interim stages of clinical trials. Nor @taureanull do I believe the Imugene BOD were aware of the Vaxinia results prior to making the decision to raise capital for azer cel.
Though @Taureanbull and @Hawkbar33 I wouldn’t be so quick to throw stones @tenacity&patience. Whilst there may be a mountain of information available on the Imugene website, and open lines of communication for investors to the company, the bottom line is when it comes to Imugene, often the nuts and bolts of clinical trial development are left to the imagination. The overall progression of the group has been outstanding, their investor relations sound, but their failure to produce clear and concise numbers, figures and results with respect to clinical trial development is a topic requires further investigation, if @tenacity&patience is to be given a right of reply.
Taking firstly Imugene’s primary B Cel candidate, that being Her Vaxx, I note Clinicaltrials.gov
states Imugene commenced a trial on August 17, 2022, with the primary completion date estimated to be March 31 this year, in approximately 2 months time.
Her Vaxx with Keytruda as per clinicaltrials.gov
A Study of IMU-131 (HER-Vaxx) in Combination With Chemotherapy or Pembrolizumab in Patients With Metastatic HER2/ Neu Over-Expressing Gastric Cancer (nextHERIZON) (nextHERIZON)
Study Start (Actual 2022-08-17)
Primary Completion (Estimate 2024-03-31)
Enrolment (Estimated)
30
Locations - Australia now Taiwan and Taipei
At the time this clinical trial was announced I remember LC being most excited and exuberant about this trial, for their number one B cell candidate, to be trialed alongside Mercks blockbuster Keytruda. Yet where on the company website are investors made aware of this clinical trials progression? And incidentally what was the rationale behind enrolling only 30 patients? What was the desired outcome of the trial? I note clinicaltrial.gov states the study is designed to generate safety data and efficacy signals to support further development of HER-Vaxx in ≥2L mGC/GEJ cancer after progression with trastuzumab. Can you tell me if the trial has been successful to date? Oh and while you are where on the website does it state how many patients have been enrolled thus far? It’s been close to 18 months now, what is the status of this trial?
Taking secondly the PD1 Vaxx Trial with Tercentriq, I note clinicaltrials.gov has this trial starting on 30th, November 2020, over three years ago now. LC was again very excited and exuberant about the pending trial in combination with her former employee Roche. From what I remember the first patient wasn’t dosed until June 1, 2023. Wonder what happened with the 2 and a half years in between, clearly a long time between drinks. Oh and btw where on the Imugene website does it state how many of the 88 patients have been dosed in this trial?
PD1 Vaxx with Tercentriq as per clinicaltrials.gov
A Study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy, in Adults With Non-Small Cell Lung Cancer
Study Start Actual
2020-11-30
Study Completion (Estimated)
2026-03
Enrolment (Estimated)
88
Locations - US Australia
What about the CF33 City of Hope Trial for CF33 commencing in October 2021 (see information herein)? Where on the Imugene website does it state the ongoing data from the said 9 patients? I note on January 4 last week a note was made on clinicaltrials.gov the trial is no longer recruiting. As such has the trial supervisor determined the optimal biological dose rate yet? I note there was a dose escalation announced way back on March 24 last year. Where on the Imugene website can I find details and information on the trials progression today?
CF33 as per clinicaltrials.gov
CF33-hNIS-antiPDL1 for the Treatment of Metastatic Triple Negative Breast Cancer
First Posted : October 18, 2021
Actual enrolment 9 participants
Actual start date 18 October 2021
Estimated completion date September 2024
Locations - City of Hope Cancer Research Facility US
Let’s call a spade a spade. Aside from the significant progress made in Imugene’s Vaxinia Trial, and more recently Oncarlytics and azer cel, the company has been tardy in releasing clear and coherent communication with respect to many of their pipeline assets, including Her Vaxx, PD1 Vaxx and CF33. Hence at times the innuendos, speculation and unknowns surrounding the company’s product development. In short LC has done herself no favours by coming out of the gates with such enthusiasm, only to years down the track have been found wanting when it comes to delivering solid data on the trials which yielded so much promise when initially announced. The Her Vaxx combination with Pfizer and Merck Germany, the potential to move forward and grow with such collaborators as Celularity, the prospect of one day putting their “big pants” on and entering the Nasdaq. What about that Her Vaxx sale or out licensing deal often discussed when it comes to Imugene. How’s that travelling? Can I find out somewhere on the Imugene website what the company’s stance on that is? Is it actually for sale? Waiting to be out licensed? Or are we awaiting the results of the Her Vaxx Keytruda Trial?
It’s easy to be critical I know, but tenacity&patience has a point. As patient as Imugene investors are Imugene’s strategy surrounding both clinical trials and the development of their B cell platform leaves a bit to be desired. If everyone was better informed in the last few years, since proof of concept for the platform was attained, perhaps there would be no need for scepticism. Their competitors have raced ahead due to their superior levels of cash, resources and positioning in the market. Larger trial numbers, access to regulatory experts and existing IP all contribute to BP’s preeminence and ability to overtake Imugene in the latter stages of drug development. Hence as @fourdollars has suggested it was probably unwise of LC to not pursue the out licensing or commercialisation of Her Vaxx in the latter stages of 2021 if not 2022.
But speaking of @fourdollars and those of his/her ilk commenting on this thread, no one discourages balanced if not contrarian viewpoints. What readers are disdainful of is those espousing a negative standpoint without providing solutions to the problem or issue they are scrutinising. Simply being negative for negatives sake is the modus operandi of many posters including @fourdollars, who seek to attain a rise from those contributing posts of substance. They tend to be anti posters who are “liked,” anti management, and anti product development, without providing viable alternatives, substantial opinions and evidence to support potential replacement strategies. It is easy to criticise, but not so easy to afford your audience with realistic options and road maps forward, to avoid making the same mistakes over and over again. That said I find posters such as @fourdollars not really worth reading. To suggest I have not written of Imugene’s demise from 60 cents to 5 is clearly a nonsense, reiterating what it is I have always said of these half smart interpreters, “They only read what they want to hear.” I've written of the topic more times than I care to mention. But of perhaps greater concern is the fact they post negative comments about a clearly safe and efficacious drug such as Her Vaxx, which has demonstrated extension of life close to six months over and above the standard of care (chemotherapy). By inference for anyone in their right mind to suggest the families of those administered with Her Vaxx were disappointed their relatives and close kin lived an extra six months than they otherwise would have, had they not taken Her Vaxx, is not left of centre, but an attempt to defy reality. Just to reassure Imugene investors, despite the flaws outlined herein pertaining to the company’s subsequent development of Her Vaxx, and to a lesser extent PD1 Vaxx, these B cell exponents are clearly vaccines with huge potential that are still 100% owned by Imugene, taking part in ongoing trials and presenting a low cost, safe, alternate choice for those suffering with cancer.
While on the topic of the cynical, negative, sarcastic posters on this thread, who I am enjoying calling out for who they are, I must admit to enjoying their terminology. Terms such as Hopping on the Vaxinia bus, and the like brigade or fanbase. Because aside from detesting those who are indeed liked by the community on these threads, they must feel so unhappy about the fact Vaxinia is shaping up to be all that was promised pre clinically. I can only imagine the shock if not anger they are to feel if Vaxinia does one day become human therapy. If Paul Hopper is one day to become one of Australia’s richest men. If, heaven forbid, my “IMU Story” were to be published? What if IMU were to one day soared into the $$ stratosphere? Now can you imagine how depressed these characters would be….
WMHB
DYOR Seek investment advice as and when requires Opinions only
Thanks to @davybabyk, @Taureanbull, @Footmax, @Outlander2, @owlvfox, @Kluck, Wells, Sooky, @justin75 @odds&evens, @Steini, @onetonne, wasi, @trite42 and all those who I have missed for contributing to make this the vibrant community it is…
