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Re caravon
We knew before that these vaccines most likely could only be effective short term, and that infection gives a broader immunity including long lasting partial T-cell immunity to virus mutants inner proteins.
What happens to CEL-SCI ? Phase III success ?
https://finance.yahoo.com/quote/CVM/community?p=CVM
RE caravon - influenza vaccination
It is NOT optimal to vaccinate almost whole populations each year. The flu itself creates both an antibody AND T-cell immunity. The latter lasts longer (against flu virus inner proteins) and you get partially protected against other type A flu where the inner proteins usually are conserved to a high degree.
A flu vaccine generally only induce an antibody response against a virus surface protein.
So even just regarding seasonal flu there is no advantage if you vaccinate the (almost) whole country. You deprive the population of natural broader immunity.
You should limit the vaccination to the high risk group of usually elderly and/or with some underlying conditions that constitute a high risk to die if you get the flu.
MOS will be 5-11 months higher in Immunicum's MERECA study for the ilixadencel-group compared to the control group.
Today was announced that the MOS of the control group will be just over 25 months. And the figures show that the ilixadencel group will reach a MOS of 30-37 months. Follow up continues every 6 months.
All of the 5 patients with complete response are still alive in the ilixadencel-group. The only patient with CR in the control group has died.
This was ilixadencel + sunitinib in mRRC, but ilixadencel + check point inhibitors have a potential in practically all solid tumors. The ongoing ILIAD study will hopefully prove this.
Ilixadencel has recently received RMAT designation of FDA.
Immunicum should get a nice deal with Big Pharma within a reasonable time I believe...
https://immunicum.se/wp-content/uploads/2020/08/20200818_Immunicum-Company-Presentation.pdf
https://immunicum.se/investors/press-releases/press/?xml_id=2079626
Re vinmantoo "Death is a lagging indicator and Europe's infection cycle is about 2-3 weeks or more ahead of the US. Sadly, a lot more death is coming to the US."
The graph I posted a link to actually do consider that since it beginns with the day when deaths reached 50 per million inhabitants. So it is neutral in that respect. USA lies steadily well below the others and will most likely continue to do so the coming months.
https://www.bildtagg.se/bild/jc1ie2ahjdbxgg0cjrnje23f
Re "so the U.S. with approx. 5% of the global population and the highest of standard medical facilities is experiencing 29% of SARS-CoV-2 related deaths?"
USA is so far "better" than for example Spain, Italy, United Kingdom regarding deaths per capita.
https://www.bildtagg.se/bild/jc1ie2ahjdbxgg0cjrnje23f
Re swampboots. "
I assume then that you support the idea that environmental exposure to any infectious agents (non-specific to Covid-19), bacteria, viruses, fungi, and parasites. can not boost immune responses to Covid-19?"
Yes, but you can get a partial immune respons against SARS-CoV-2 if you have already been infected by another coronavirus that share some inner proteins with SARS-CoV-2. SARS-CoV-1 but also some corona viruses that cause common cold are examples of that.
This might be an explanation factor for all those infected with SARS-CoV-2 but who show no symtoms or only mild symtoms.
-----------
In the influenza case the same principle is true. Several influenza A viruses have conserved inner proteins. It is an explanation why many, including elderly, people had so called cellmediated immunity against the not so lethal swine flu.
Immunicum AB (publ) Receives Regenerative Medicine Advanced Therapy
Designation from FDA for Ilixadencel in Kidney Cancer
"Immunicum AB (publ; IMMU.ST) announced today that it has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for the Company’s lead candidate, ilixadencel, a cell-based, off-the-shelf immune primer for the treatment
of metastatic Renal Cell Carcinoma (mRCC). The FDA’s decision was made based on the previously communicated results from the Phase II MERECA clinical trial that evaluated the safety and efficacy of ilixadencel in combination with Sutent® (sunitinib) in patients with newly diagnosed
mRCC. Advantages of the RMAT designation include all the benefits of the Fast Track and Breakthrough Therapy Designation programs including guidance and early interactions with the FDA to discuss potential surrogate or intermediate endpoints to support accelerated approval as
well as potential ways to satisfy post-approval requirements."
https://ml-eu.globenewswire.com/Resource/Download/9252cc88-cb63-4f90-a0de-af1085cc54fb
Re "The Lockdowns Were the Black Swan"
"Novel pandemic diseases are not a black swan. Our lockdown response was a black swan."
Unfortunately at least I couldn't imagine such (crazy) devasting lockdowns of nearly the whole world economy before the stockmarkets already had crushed.
But at least we have nearly full freedom of movements in Sweden in spite of similar evolvement of deaths per capita as for example USA so far (Sweden is a short time ahead in its evolution of the pandemic). I left Spain after a week of quarantine in March and that was really day of liberation.
The whole world will suffer from an economic(and maybe health) crisis that is much much worse than the lockdown itself could reduce the negative effects of the pandemic.
Re vinmantoo
"So you want shutdowns and isolation in the immigrant group as an effective containment strategy but not in the general population. That undercuts the whole don't shutdown argument."
No that does not logically follow of my statement.
But obviously there is an overpresentation of the risk group among noneuropean immugrants in Sweden.
They should have identified the people belonging to the risk group and protected/isolated them, not shut down the economy.
The big difference in Sweden compared with the other Nordic countries is the much higher proportion of obviously vulnerable noneuropean immigrants.
The lockdown of the nearly whole world is the biggest mistake in the world since many many decades.
Re vinmantoo
"So it looks like they MIGHT have stabilized at a high level for now with regards to both infections and deaths whereas the other Nordic countries are showing large drops of infected people and death, and the overall deaths remains far lower than in Sweden. Great job there Brownie"
Sweden has far more immigrants than the other Nordic countries, which explains a substantial part of the difference in deaths per capita. Noneuropean immigrants are very overpresented and accounted for around half of all deaths recently in covid-19 in Sweden.
Sweden though has failed in effective protection/isolation of the risk group. They could have done better focusing on that.
So far Sweden is not doing significantly worse than for example United States regarding deaths per capita and much better than Spain, Italy, United Kingdom, Belgium, Netherlands et al.
The quarantine and lockdown countries are not only risking to destroy the world economy but also creating another health problem from a quarantine itself and the worse economy.
Covid-19: Hydroxychloroquine + Zinc + azithromycin are worth studying I think.
"The rationale for my treatment plan is as follows. I combined the data available from China and South Korea with the recent study published from France (sites available on request). We know that hydroxychloroquine helps Zinc enter the cell. We know that Zinc slows viral replication within the cell. Regarding the use of azithromycin, I postulate it prevents secondary bacterial infections. These three drugs are well known and usually well tolerated, hence the risk to the patient is low"
"https://www.globalresearch.ca/report-successful-treatment-coronavirus/5708056"
https://techstartups.com/2020/03/28/dr-vladimir-zelenko-now-treated-699-coronavirus-patients-100-success-using-hydroxychloroquine-sulfate-zinc-z-pak-update/
Re vinmantoo
Yes of course, but the fatality rate that the italian statistics indicate, 5 %, is most likely a huge overestimation and the South Korean example of 0.7 % much more relevant.
Re DewDiligence
This web site updated the Italian figures a couple of hours ago or so.
https://www.worldometers.info/coronavirus/
Re vinmantoo
"The bad news a wider spread means more overall deaths."
All things equal yes, but not necessarily in reality.
If the fatality rate rather is around 0.7 % then most likely the total number of deaths in the world will be lower than if it really was 5 %.
SARS-CoV-2 will probably continue to spread for weeks and maybe some months, but it should be good news if the relatively low South Korea fatality rate is a norm.
Re Crude fatality rate now ~5%!!!
But most likely there are several times more infected than currently over 9100 officially.
Due to the high official fatality rate the number infected could be for example 7 times higher - or more - in Italy, if you compare with South Korea fatality rate (0.7 %) where they have tested much more for SARS-CoV-2.
Many Swedes have got the covid-19 desease from travelling in Italy and come home infected. That is not possible if only some 9100 in Italy were infected.
Immunicum : Here is a statistical model simulation of the MERECA study median overall survival outcome. It is made by a "anonymous" person, but most likely skilled in mathematical/statistical modelling
It predicts a MOS of around 23-29 months for patients with ilixadencel + sunitinib versus 36-48 months for patients with sunitinib alone, with confidence intervals not overlapping. Se figure 7.
It is in line with my own estimation and it would imply a very successful MERECA (but I think it is already)
https://seeking-lambda.com/2020/02/11/beyond-kaplan-meier/
The raw data is from Immunicum's recent presentation.
https://immunicum.se/wp-content/uploads/2020/02/20200206_Immunicum-Company-Presentation.pdf?fbclid=IwAR1nerFYurSFXV6e8IYAhm7nNDy8QV8FTK4kPbcP2SHGH13EDDr6fg5U-DI
"Immunicum AB (publ) Presents Updated Data from Phase II MERECA Trial of Ilixadencel in Kidney Cancer at ASCO-SITC Clinical Immuno-Oncology Symposium
-- December 2019 data confirm the separation in survival curves in favor of the ilixadencel group that was projected by the Kaplan-Meier curves in the previous update from July 2019, while final median Overall Survival (OS) values were still not reached in either of the two study groups —
-- Survival as of December 2019 was 54% in the ilixadencel treatment group compared with 37% of patients in the control group treated with sunitinib monotherapy —
-- Confirmed Objective Response Rate (ORR) was 42% in the ilixadencel treatment group and 24% in the control group —
Immunicum AB (publ) announced today updated results from the randomized Phase II MERECA trial testing its off-the-shelf immune primer ilixadencel in combination with Sutent (sunitinib) first-line treatment regimen in newly diagnosed metastatic renal cell carcinoma (mRCC) patients. December 2019 data confirm the separation in survival curves in favor of the ilixadencel group that was projected by the Kaplan-Meier curves in the previous update from July 2019, while final median OS values were still not reached. Extended analysis of available data showed that compared to sunitinib monotherapy, combined treatment with ilixadencel demonstrated a nearly two-fold higher confirmed ORR. The results were presented in an oral podium presentation at the ASCO-SITC Clinical Immuno-Oncology Symposium on February 6th in Orlando, Florida.
The MERECA study evaluated intratumoral ilixadencel administration prior to kidney removal of the primary tumor-affected kidney followed by sunitinib treatment compared with kidney removal, without prior ilixadencel treatment, followed by sunitinib alone as first-line systemic therapy in patients with mRCC. Over a three-year period, 88 patients were randomly assigned in a two-to-one ratio to the ilixadencel combination treatment group or sunitinib control group.
Updated data as of December 2019 demonstrates a separation in Kaplan-Meier survival curves in favor of the ilixadencel treatment group, in line with the projected separation from July 2019. The proportion of patients alive was 54% (30 out of 56) of patients in the ilixadencel treatment group compared with 37% (11 out of 30) of patients in the control group. The median OS value cannot be calculated yet in either group as the data is not mature. Based on data on best overall response and the Duration of Response, Immunicum requested a post-study analysis by the contract research organization of confirmed ORR (a tumor response that is confirmed by a follow-up scan, per RECIST 1.1 criteria). The confirmed ORR for the ilixadencel treatment group was 42.2 % (19/45) versus 24.0% (6/25) for the sunitinib control group.
“The updated data emphasize that both tumor responses and the durability of patient response with ilixadencel treatment as part of a combination regimen were better compared to sunitinib alone. The addition of ilixadencel did not increase either the frequency or the severity of side effects. However, longer follow-up is required before we with certainty can comment on any differences in long-term survival,” stated Associate Professor Magnus Lindskog, clinical oncologist at Uppsala University Hospital, Sweden and principal investigator in the MERECA study who presented the results.
“The fact that ilixadencel, when combined with subsequent suntinib treatment, induces a nearly 2-fold increase in the confirmed Objective Response Rate and more complete responses when compared to sunitinib monotherapy, is of course highly encouraging. Additionally, the favorable early separation of the Kaplan-Meier curves that now has been confirmed and the long-term survival projections are clearly interesting,” commented Associate Professor Alex Karlsson-Parra, CSO and Interim CEO of Immunicum. “We continue our discussions with regulatory bodies to define the next step in the development of ilixadencel as a treatment for a range of solid tumors.”
The updated results including survival curves are available as part of the ASCO-SITC presentation and company presentation on Immunicum’s website."
immunicum.se/investors/press-releases/press/?xml_id=1981355
The stock should continue upwards tomorrow. Risk/reward is very attractive ! Ilixadencel has clear potential in nearly all solid tumors as a "primer" activating tumor-specific CD8+ T-cells that attack the tumors and metastases.
Immunicum's new abstract satisfies the stock market today.
https://finance.yahoo.com/quote/IMMU.ST?p=IMMU.ST&.tsrc=fin-srch
It is just one completely new item regarding the Phase II MERECA study in metastatic renal cell cancer (and shorters getting nervous) that is the cause of this : "Confirmed ORR was 42.2 % (19/45) versus 24.0% (6/25)"
Along with 4 other already communicated positive tumor response end points and very good OS data known since Sept 25 2019, there are increased expectations before new survival data from MERECA that will be reported on Feb 6, when Immunicum's abstract has been elected for oral presentation.
https://meetinglibrary.asco.org/record/183048/abstract
https://ml-eu.globenewswire.com/Resource/Download/52b7d633-236c-4598-ad61-02007401deb9
IMMU.ST Shorter's short squeeze takes off now it looks like.
https://tinyurl.com/y27eks8m
The stock should have gone to around SEK 15-25 in my judgement if the Sept 25 newsrelease had come Aug 29 instead of that unfortunate release Aug 29 which was not complete regarding tumor respons data (but did show HIGH CR rate).
The IMMU.ST stock bottomed out before the Sept 25 newsrelease at less than SEK 6 but as of now has passed SEK 9 on its way up up up since IMMU.ST is shorted as of Friday 6 at 3.88 % which is VERY high for a Swedish small cap stock.
The MERECA results were VERY good : https://immunicum.se/wp-content/uploads/2019/09/20190925_Immunicum-Webcast_Complete-Topline-Analysis.pdf
My own fundamentally based valuation is much higher than the SEK 15-25 interval.
Immmunicum : A shorter-induced short-squeeze hopefully may have started in the IMMU.ST stock after the very positive complementary MERECA study data for tumor respons and for individual survival data that were presented Sept 25 (after initially "uncomplete" data Aug 29 causing shorters to attack)
The stock price is still around half of the highest price in July before MERECA results. See the chart :
https://tinyurl.com/y27eks8m
Look carefully at pages 12-15 in the pdf-file in the link below for the survival data including page 15 for a Kaplan-Meier-based forecast which clearly indicate that the ilixadencel treated group more likely will have ha better MOS when the data become mature within a year or so.
https://immunicum.se/wp-content/uploads/2019/09/20190925_Immunicum-Webcast_Complete-Topline-Analysis.pdf
This is only in mRCC but ilixadencel has a clear potential in all injectable solid tumors when combined with checkpoint inhibitors since the mechanism of action is independant of cancer indikation in solid tumors. Ilixadencel is a primer activating a broad tumor specific CD8+ T-cell respons.
Immunicum has presented a pdf with the complete MERECA result analysis.
https://immunicum.se/wp-content/uploads/2019/09/20190925_Immunicum-Webcast_Complete-Topline-Analysis.pdf
Immunicum : They changed the link to
Immunicum CEO presented the MERECA results in a video today. There you can see explicit survival data for all 58 + 30 patients among other data.
I think this could pave the way for a deal with Big Pharma later on.
I have through these new data estimated/guessed a future median overall survival that could be around 30-37 months in the ilixadencel group and around 23 months in the control group.
Immunicum "takes revenge" with very good data from MERECA according to a newsrelease today :
Short sellers have contributed to a huge stock pullback the last few weeks, but now the doubts of ilixadencel's potential as an effective immune primer should be very much reduced.
"Immunicum AB (publ) Announces Complete Topline Data Analysis from Phase II MERECA Trial
Press Release
25 September 2019
Immunicum AB (publ) Announces Complete Topline Data Analysis from Phase II MERECA Trial
--Survival as of July 2019 was 57% (32 out of 56) of patients treated with ilixadencel compared with 43% (13 out of 30) of patients who did not receive ilixadencel; the median Overall Survival final value cannot yet be calculated in either group as the data is not mature enough--
--The Objective Response Rate (ORR), measured in all patients receiving sunitinib was 44% (20 out of 45 patients) in the ilixadencel combination group and 48% (12 out of 25 patients) in the sunitinib monotherapy group, while the number of Complete Responders was 11% (5 out of 45) and 4% (1 out of 25) in the respective groups--
--The median Duration of Response was 7.1 months for the ilixadencel combination group versus 2.9 months in the sunitinib monotherapy group over the 18 months study period—
--The overall safety data was similar in both treatment groups, meaning ilixadencel did not add toxicity, which supports ilixadencel’s favorable safety profile--"
https://immunicum.se/investors/press-releases/press/?xml_id=1920461
Immunicum's choice of an 18 month survival rate as a primary end point maybe was not so smart since the evaluable patients had a much bigger share of "only" intermediate risk patients this time, compared with the earlier Phase I/II in mRCC.
Probably around 60-70 % (I haven't received the exact number yet) in MERECA compared to just 45 % in Phase II.
So a 30 month survival rate primary endpoint might have been better IMO.
Time will tell if the MOS data will show a better outcome.
"Immunicum AB (publ) Announces Positive Phase II MERECA Topline Results Including Complete Tumor Responses in Metastatic Renal Cell Carcinoma Patients
Press Release
29 August 2019
Immunicum AB (publ) Announces Positive Phase II MERECA Topline Results Including Complete Tumor Responses in Metastatic Renal Cell Carcinoma Patients
--Ilixadencel in combination with Sutent® (sunitinib) achieved complete tumor responses in 5 out of 45 evaluable metastatic kidney cancer patients (11%) in contrast to 1 out of 25 in the sunitinib monotherapy control arm (4%)—"
Read more here :
https://immunicum.se/investors/press-releases/press/?xml_id=1908171
The market got sour due to unclear survival data after 18 months, which though can be partly explained by a smaller percentage of high risk patients compared to the earlier Phase I/II mRCC studie. We will have to wait for final MOS results several years I guess. The complete respons rate of 11 % is promising so the market has probably overreacted. The financial position is still strong with capital lasting to the end of 2021 and the ongoing ILIAD study will be important where ilixadencel is combined with checkpoint inhibitors i 3 big cancer indications.
Immunicum held a very informative company presentation in Stockholm today, mostly dealing with their unique immune primer ilixadencel.
I recommend watching it here.
https://redeye.solidtango.com/widgets/embed/nm4ornhg?as=0&auto_play=true&s_referrer=https%253A%252F%252Fwww.redeye.se%252Fcompany%252Fimmunicum&seek=
The Phase II RCC MERECA study results will be presented within 2 weeks. It could be a sensation in immuno oncology if the Phase I/II outcome will be repeated in MERECA which in the former case was for example an 18 month overall survival rate of 73 % compared to historical reference data of around 45 % for a group of patients with MSKCC high risk and MSKCC intermediate risk.
Of course I am a stockholder...
https://www.infoom.se/mysite/index.php?sida=81205&user=9801
Immunicum's new presentation http://immunicum.se/wp-content/uploads/2019/08/20190805-Immunicum-investor-presentation.pdf
Re nuere on Immunicum.
At least you can observe now that foreign investors as a group (outside Sweden) are big buyers of the Swedish biotech Immunicum, probably attracted by the still attractive risk/reward regarding the MERECA Phase II RCC study outcome, which will be presented the first week of September.
The MERECA outcome is important with huge implication, since it may increase the probability for the immune primer ilixadencel to have a clear potential to be effective in several if not all injectable solid tumors, IF it is combined with drugs that "pave the way" for ilixadencel's activated tumorspecific CD8+ T-cells, for example sunitinib, or checkpoint inhibitors that counteract the tumor's own immune suppression by different mechanisms. A synergy effect occurs.
It has already been shown to activate tumorspecific CD8+ T-cells in kidney cancer and liver cancer, regarding the majority of a total of 40 patients in 2 small previous studies and early interim results from MERECA itself.
My own analysis why MERECA according to my conclusion has a very good chance of being successful can be read here (also with links to an official Immunicum presentation etc) :
https://www.infoom.se/mysite/index.php?sida=81205&user=9801
I believe another Swedish company Immunicum will have better immuno-oncology-related success with possible Big Pharma(-s) as partner(-s) regarding Immunicum's unique immune primer ilixadencel (with its potential to activate tumorspecific CD8+ T-cells in all injectable solid tumors), maybe some reasonable time after the MERECA study results are presentated in the first week of September.
My MERECA outlook:
https://www.infoom.se/mysite/index.php?sida=81205&user=9801
Immunicum presentation from May:
http://immunicum.se/wp-content/uploads/2019/05/Immunicum-presentation.pdf
Immunicum presents today in New York within a few hours !
https://troutaccess.com/investor.php/con/9221/55i4/European+Biotech+Investor+Day+2019.html
My analysis of Immunicum's MERECA outlook automatically translated to English from the Swedish original seems readable even without editing.
https://www.infoom.se/mysite/index.php?sida=81205&user=9801
It explains why for examle I have a big share of Immunicum in my portfolio and look forward to the results of MERECA in the first week of september.
Immunicum has begun to rally before the MERECA Phase II RCC study results which will be presented in the first week of September this year.
But the stock is still very cheap with respect to its risk/reward.
https://tinyurl.com/y3zc6aeq
Immunicum will present at European Biotech Investor Day 2019
New York City, August 1, 2019.
https://troutaccess.com/index.php/con/9221/55i4/European+Biotech+Investor+Day+2019.html
But more important will be their presentation of the top-line MERECA Phase II metastatic RCC outcome early in September 2019. 58 patients received ilixadencel (intratumoral injected allogenic dendidric cells that produce cytokines + chemokines) + sunitinib, and 30 patients only sunitinib. A synergy effect is espected.
My belief after careful analysis is that MERECA has a very good chance of showing very good results for percentage survival after 18 months and also for ongoing median overall survival.
The small Phase I/II RCC study showed a MOS of impressive 4 years compared to 14-16 months in historical reference data from 3 studies.
Ilicadencel has potential in all injectable cancers with solid tumors, and especially if combined with sunitinib, checkpoint inhibitors and immune enhancers, since these can "pave the way" for ilixadencel's through tumor cells neoantigen primed and activated tumor specific CD8+ T-cells.
http://immunicum.se/wp-content/uploads/2019/05/Immunicum-
presentation.pdf
Yes I will stay long over MERECA results...
IMMU.ST MERECA results in Sept 2019 will be an extremely important trigger for Swedish based Immunicum.
A presentation :
http://immunicum.se/wp-content/uploads/2019/05/Immunicum-presentation.pdf
The stock has begun to move upwards this week.
https://finance.yahoo.com/quote/IMMU.ST/community?p=IMMU.ST
The potential is huge since ilixadencel is in principle cancer indication independant in injectable solid tumors since it "automatically" via intratumoral injection "only" primes the immune system including CD8+ T-cells to recognize neoantigenes of the tumor cells and will be able to kill them.
It is probably more of a question which cancer drugs it is combined with. You want a synergetic effect.
Sunitinib in MERECA Phase II study in renal cell cancer is an example of a most likely suitable drug since it also has mechanisms that inhibit the immune suppression generated by the tumor itself. But also checkpoint inhibitors such as anti PD-1 and anti PD-L1 are suitable since they are even more focused to inhibit the immune suppression on CD8+ T-cells, a suppression generated by the tumor.
In the bigger ILIAD study ilixadencel is combined with those types of checkpoint inhibitors. In fact Pfizer and KGaA MERCK have donated their checkpoint inhibitor to the Phase II part of ILIAD study, indicating an interest in and validation of ilixadencel. After a possibly successful MERECA a deal with Big Pharma would be logical.
The finished 11 patient Phase I/II study in renal cell cancer is very promising with an increased median survival to 48 months compared to 14-16 months in historical reference data (see page 12 in the link above to the presentation).
There are no serious adverse effects of ilixadencel, most likely because it just primes and directs CD8+ T-cells to the patient's tumor cells via recognized neoantigenes. Therefore it is suitable for combination therapies. The cost of production is very low since ilixadencel only consists of allogenic dendritic cells (prepared to release cytokines and chemokines) from blood donors.
The market capital is still below USD 100 million.
Of course I have a for me significant position in the Immunicum stock.
" I tend to be skeptical of MoAs that rely on an abscopal effect."
You do have a point, but as long as the metastases have several common neoantigens with the injectable primary tumor I find the method logical worth to study.
This study (not related to Immunicum) linked below showed that there in that case were several common neoantigens in the primary tumor and metastases, although even a lot more unique neoantigens, but those in common may be enough.
At least I know Immunicum have showed T-cell infiltration also in metastases.
https://oncologypro.esmo.org/Meeting-Resources/ESMO-2018-Congress/Discrepancy-of-tumor-neoantigen-burden-between-primary-lesions-and-matched-metastases-in-lung-cancer
The median overall survival data is at least very promising in the Phase I/II RCC study with ilixadencel in combination with TKI, although the study was small. One patient had complete remission of 4 brain metastases (and 3 other metastases) which is nearly never seen with just sunitinib. The bigger MERECA RCC study outcome in Q3 2019 will be interesting...
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5477104/
Immunicum AB (publ; IMMU.ST) announced today that the first patient has been treated in the Phase Ib/II ILIAD clinical trial. The trial will evaluate the safety and efficacy of Immunicum's lead product in development, ilixadencel, in combination with checkpoint inhibitors (CPIs) in three cancer indications: head and neck cancer, non-small cell lung cancer and gastric cancer. The initial Phase Ib portion of the trial will be conducted at clinical centers in the United States.
http://immunicum.se/investors/press-releases/press/?xml_id=2234280&xml_date=201902
IMMU.ST Presentation of Immunicum last Tuesday by CEO
Immunicum's big (150 participants) ILIAD Phase I/II study combining the immune enhancer (via "automatically" utilized personal tumor specific neoantigens and in the end of the mechanism of action neoantigens recognized by specific CD8+ T-cells) ilixadencel with check point inhibitor Keytruda in non-small-cell lung cancer, gastric cancer and head and neck cancer in the US arm of the study is now recruiting according an update Jan 18 2019 :
https://clinicaltrials.gov/ct2/show/NCT03735290?term=immunicum&rank=1
The study will later be expanded to Europe after Merck KGaA and Pfizer last autumn have agreed to supply the study with their checkpoint inhibitors without cost, indicating that they are well aware of the potential of ilixadencel. They will get data from the study.
Ilixadencel has a potential to become a key component in combination therapy against solid tumors according to Immunicum. It is due to the mechanism of action applicable to all injectable solid tumors and the promising Fas I/II renal cancer outcome
(see https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5477104/ )
...which in turn is promising för the bigger MERECA Phase II study also in renal cancer and its outcome will be presented in Q3 2019 and is a very big trigger for Immunicum, since a successfull MERECA would increase the probability for success also in the ILIAD study.
A review about ilixadencel and its mechanism of action
https://link.springer.com/article/10.1007/s11095-018-2438-x
Immunicum's home page http://immunicum.se
Immunicum : Here is another interview with CEO in Immunicum
https://www.biostock.se/2019/01/ceo-interview-immunicum-aims-to-take-immuno-oncology-to-new-heights/?fbclid=IwAR0-sUoQ0kacPCI5x0QI38b0fxpdyA0aErkr8VgI0_W61RA6vMdclfo4jFI
The unique immune enhancer ilixadencel has a clear potential to become a standard component in combination therapies in any cancer indication with injectable solid tumors.
Therefore the stock potential is enormous.
The mechanism of action of ilixadencel releases tumorspecific neoantigens and presents them for cytotoxic CD8+ T-cells which thus recognize tumor cells and can infiltrate the tumor (which they have proved in a Phase I/II-study).
Strong cash position USD 48 million.
Very promising Phase I/II renal cancer median survival data (2.7-2.8 years increased median survival).
Big trigger in Q3 when the Phase II study MERECA in renal cancer outcome will be official. If MERECA is successful the probabilty for success in other cancer indications also increases due to the versalite mechanism of action.
Market capital only USD 85 million due to a now completed (successful) diluting capital raize. (In Sweden there nearly always is a stock pullback when a capital raize is announced )
http://immunicum.se/
https://finance.yahoo.com/quote/IMMU.ST/?guccounter=1