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Post by loparn on Jun 17, 2019 17:31:12 GMT
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Post by loparn on Jun 27, 2019 16:17:32 GMT
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Post by loparn on Jul 3, 2019 10:48:57 GMT
Repetition : IMMU.ST MERECA results in Sept 2019 will be an extremely important trigger for Swedish based Immunicum. A presentation : immunicum.se/wp-content/uploads/2019/05/Immunicum-presentation.pdf The stock has begun to move upwards this week. 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study in renal cell cancer is very promising with an increased median survival to 48 months compared to 14-16 months in historical reference data (see page 12 in the link above to the presentation).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.
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Post by loparn on Jul 15, 2019 9:39:03 GMT
Immunicum will present at European Biotech Investor Day 2019 New York City, August 1, 2019. 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 dendritic 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. immunicum.se/wp-content/uploads/2019/05/Immunicum- presentation.pdf Yes I will stay long over MERECA results...
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Post by loparn on Jul 25, 2019 10:30:41 GMT
Immunicum has begun to rally before the MERECA 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. tinyurl.com/y3zc6aeqMy analysis of Immunicum's MERECA outlook automatically translated to English from the Swedish original seems readable even without editing. 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.
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Post by loparn on Aug 9, 2019 8:44:15 GMT
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Post by loparn on Aug 21, 2019 17:35:37 GMT
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Post by loparn on Aug 29, 2019 9:17:51 GMT
"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 : immunicum.se/investors/press-releases/press/?xml_id=1908171The market got sour due to unclear survival data after 18 months, which though can be partly explained by less degree 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.
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Post by loparn on Sept 4, 2019 11:07:06 GMT
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Post by loparn on Sept 25, 2019 10:39:39 GMT
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--" immunicum.se/investors/press-releases/press/?xml_id=1920461
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Post by loparn on Sept 25, 2019 15:22:48 GMT
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. youtu.be/yvOZUxT-85A?t=671
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Post by loparn on Sept 26, 2019 9:47:13 GMT
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Post by loparn on Oct 4, 2019 8:11:43 GMT
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 : tinyurl.com/y27eks8mLook 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. immunicum.se/wp-content/uploads/2019/09/20190925_Immunicum-Webcast_Complete-Topline-Analysis.pdfThis 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.
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Post by loparn on Oct 21, 2019 10:28:13 GMT
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Post by loparn on Dec 20, 2019 8:56:45 GMT
"Immunicum AB (publ; IMMU.ST) announced today that the abstract covering data from the Phase II MERECA trial has been accepted for an oral presentation at the ASCO-SITC Clinical Immuno-Oncology Symposium, which will be held February 6-8, 2020 in Orlando, Florida. The MERECA trial investigated the therapeutic benefit of combining Immunicum’s lead product, ilixadencel, and Sutent® (sunitinib) as a first-line treatment in patients with metastatic kidney cancer. Immunicum announced top-line results from the study in the third quarter of 2019 and will present more detailed results at the symposium, including the first half-yearly follow-up of patient survival in the study." immunicum.se/investors/press-releases/press/?xml_id=1963271
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Post by loparn on Feb 4, 2020 10:24:20 GMT
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Post by loparn on Feb 6, 2020 19:53:06 GMT
Newsrelease today : "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=1981355The stock should continue upwards tomorrow. Risk/reward is very attractive ! Ilixadencel has clear potential in nearly all solid tumors.
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Post by loparn on Feb 7, 2020 14:03:45 GMT
Edison increases the valuation of Immunicum. "Immunicum’s updated results from the Phase II MERECA trial with ilixadencel delivered a positive surprise. The company was selected for an oral presentation at the ASCO-SITC Clinical Immuno-Oncology Symposium yesterday. The maturing data (24-month follow up) confirmed the separation of the Kaplan-Meier curves, which was projected in September 2019 at the time of the release of the final MERECA results (18-month follow up). In addition, Immunicum found that a stricter definition of tumour response, the confirmed objective response rate (ORR; vs best ORR), showed a clear difference between the active and control arms. We view these new data as positive, even though the statistical analysis is not available due to the relatively small number of patients. Our valuation has increased to SEK2.4bn or SEK25.8 per share (from SEK21.6 per share)." www.edisongroup.com/publication/updated-phase-ii-mereca-data-positive/26121
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Post by loparn on Feb 12, 2020 21:11:47 GMT
Here is a anonymous person's model simulation of the MERECA study median overall survival outcome. 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 successful MERECA (but I think it is already) seeking-lambda.com/2020/02/11/beyond-kaplan-meier/
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Post by loparn on May 9, 2020 8:02:49 GMT
" Immunicum AB (publ) Receives Regenerative Medicine Advanced Therapy Designation from FDA for Ilixadencel in Kidney CancerPress Release 6 May 2020 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. “We are very excited to have received the RMAT designation for ilixadencel in kidney cancer as it recognizes both the potential of our novel therapeutic approach as well as the clear need for viable therapies to address this difficult-to treat disease. As a designation similar to the FDA’s Breakthrough Therapy Designation, we will now also have the opportunity to receive direct guidance from the FDA which will inform key development decisions and ultimately bring us closer to delivering ilixadencel to patients in need,” commented Alex Karlsson-Parra, CEO of Immunicum. Established in 2017 under the 21st Century Cures Act in the United States, RMAT designation is an expedited program designed to facilitate the development and review of regenerative medicine therapies intended to address an unmet medical need in patients with serious conditions. An investigational regenerative medicine therapy (e.g. cell or gene therapy) is eligible for RMAT designation if it is intended to treat, modify, reverse or cure a serious condition and preliminary clinical evidence indicates that the drug or therapy has the potential to address unmet medical needs for such a disease or condition. As a cell therapy medicinal product, ilixadencel falls within the definition of a regenerative medicine therapy. The latest results of the Phase II MERECA trial were presented in February at the ASCO-SITC Clinical Immuno-Oncology Symposium 2020 in Orlando, Florida. As of December 2019, the patient follow up data indicates a separation in Kaplan-Meier survival curves in favor of the ilixadencel treatment group in line with the projected separation based on the data from July 2019. The median OS value could not be calculated yet in either group as the data is not mature. The confirmed ORR for the ilixadencel treatment group was 42.2% (19/45) versus 24.0% (6/25) for the sunitinib control group. Refer to the following link for more information on Regenerative Medicine Advanced Therapy Designation: globenewswire.com About MERECA MERECA is an exploratory, international, randomized, controlled and open-label Phase II clinical trial in which a total of 88 newly diagnosed, intermediate and poor-prognosis metastatic renal cancer patients were enrolled. Based on a 2-to-1 randomization, patients received either two intratumoral doses of ilixadencel before nephrectomy (surgical removal of the tumor-affected kidney) and subsequent treatment with sunitinib or sunitinib therapy alone post-nephrectomy. The primary objectives of the study are to evaluate median OS and 18-month survival rates. Secondary objectives include evaluation of safety and tolerability, tumor response and immunological profiling including T cell infiltration. About renal cell cancer / carcinoma There are approximately 273,000 new cases of Renal Cell Cancer diagnosed worldwide each year, representing approximately two percent of all cancers. The therapeutic effect of existing treatments, called targeted therapies, is often of short duration, with limited survival gain. With no alternatives to these therapies, there exists a relatively large unsatisfied medical need for new treatments that are effective, more cost-efficient and have less unwanted side effects. About ilixadencel Ilixadencel is an off-the-shelf cell-based cancer immunotherapy developed for the treatment of solid tumors. Its active ingredient is activated allogeneic dendritic cells, derived from healthy blood donors. Injection of these cells in the patient’s tumor generates an inflammatory response which in turns leads to tumor-specific activation of the patient’s cytotoxic T cells. To-date ilixadencel has been tested in a range of clinical trials in various solid tumor indications including metastatic Renal Cell Carcinoma (mRCC), hepatocellular carcinoma (HCC) and gastrointestinal stromal tumors (GIST) and in combination with several standard-of-care cancer therapies such as the tyrosine kinase inhibitors Sutent® (sunitinib) and Stivarga® (regorafenib), and the checkpoint inhibitor Keytruda® (pembrolizumab). Ilixadencel has consistently maintained a positive safety and tolerability profile and demonstrated initial signs of efficacy as seen in the randomized Phase II MERECA trial. Ilixadencel is currently moving towards late-stage clinical development. " Immunicum is extremely undervalued according to my analysis, market capital is less than USD 100 M. ilixadencel has a clear potential in at least 8 cancer forms. immunicum.se/investors/press-releases/press/?xml_id=2028129
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