Immunicum - a clever immunotherapy concept in Phase II

Immunicum AB (publ) Announces Appointment of Pawel Kalinski and Inge Marie Svane to Scientific Advisory Board

immunicum.se/investors/press-releases/press/?xml_id=2216241&xml_date=201809

One of the experts comments :

""Immunicum has developed a very unique and promising approach that stands out in the expanding field of immuno-oncology combination therapies and I am impressed with the clinical data the company has generated so far. Having had the experience of developing a range of immunotherapeutic strategies for a broad spectrum of cancer indications and advancing them through Phase I to III clinical trials, I am eager to support Immunicum's Scientific Advisory Board in actualizing the full, fundamental potential in the company's lead product candidate and pipeline," added Inge Marie Svane."

Interesting. I've never seen this before, where a company acknowledges ongoing talks a potential biopharma partner possibly being the reason for the halt. Would be great for you if that's the case and they ink a deal. Good luck!

The Phase I / II study outcome for median survival in renal cancer promises very well for the bigger Phase II study MERECA outcome which is to be presented in Q3 2019.


immunicum.se/wp-content/uploads/2018/04/20180411_Immunicum-Investor-Event-Presentation_Stockholm.pdf - see page 14 which shows that there were 3 out of 11 patients who did not achieve in the litterature comparative median survival in 15-16 months, while the other 8 did so very well, so that the median survival for the entire group lasted 48 months, which corresponds to a impressive median survival effect of approximately 2.7-2.8 years.


Random factors, however, may affect such a small study relatively much, but even if you correct for an assumed huge luck in the outcome and therefore remove all the 4 best outcomes in Immunicum Phase I / II study in renal cancer, the median survival for the 7 remaining patients will still be about 24 months, i.e. about 8-9 months longer than the comparative data in the litterature, which would still be a very good outcome, since if it had been achieved in a large Phase III study it would be sufficient for the market approval. A major cancer drug for many years, Avastin, with a much worse side-effect profile, is market-approved despite a median survival effect of only about 1-3 months in a variety of cancer indications.

Among other things, because the inter-individual variation of the immune system, the effect of ilixadencel is also varied between different patients within a treated group. Since Immunicum has also shown that many cancer patients have received a significant infiltration of tumor-specific T-cells in the cancerous tumors that verify the desired mechanism of action of ilixadencel, and this significantly reduces the risk that the very positive outcome of the Phase I / II study could depend entirely by chance.

An intuitive conclusion, without attempting to calculate this mathematically, should therefore be that the probability that the MERECA outcome, i.e. the major Phase II study in renal cancer, will be successful (eg at least 4 months median survival effect (my own subjective expectation value is currently around 8 months - 2 years median survival effect)) is at least over 50%, which is enough to imply a highly beneficial risk / reward to call the outcome to be presented in Q3 2019, especially since the ilixadencel's mechanism of action is applicable to virtually all cancer indications with solid tumors and the market value still is only a fraction of what such a success in MERECA would motivate, and Big Pharma would probably be very interested in licensing ilixadencel

Immunicum now has a market value of around USD 68 million.


However Do Your Own Due Diligence !

News Nov 16

Immunicum AB (publ) Announces Collaboration with Merck KGaA, Darmstadt, Germany, and Pfizer to Evaluate Ilixadencel in Combination with Avelumab in Multi-Indication Phase Ib/II Study

immunicum.se/investors/press-releases/press/?xml_id=2225959&xml_date=201811

If the renal cancer study MERECA Phase II results are positive as the Phase I/II-study could imply (MERECA results scheduled Q3 2019) this new collaboration indicates some possible future commercial partners for Immunicum/ilixadencel, since the mechanism of action of ilixadencel is the same in every solid tumor boosting T-cell response to by ilixadencel exposed tumorspecific antigens, even if the efficacy varies and also on an individual base due to the patients individual immune systems.
The probability of a future success in the ILIAD Phase Ib/II study in non-small cell lung cancer, gastric cancer and head and neck cancer with combination of ilixadencel with checkpoint inhibitors thus should also be elevated if MERECA is successfull.

Redeye made this comment www.redeye.se/company/immunicum/581709/immunicum-entering-clinical-collaboration-merck-kgaa-pfizer?utm_medium=RSS&utm_source=avanza

Immunicum now has around USD 48 million in cash and the market capital is just USD 76 million. The cash is supposed to last until late 2021.

With a very good chance of the MERECA Phase II renal cancer study being succesful (due to the median survival effect, about 2.7-2.8 years longer than standard treatment without ilixadencel, in the smaller Phase I/II-study in renal cancer) when the results will be announced in Q3 2019, Immunicum is very undervalued since the mechanism of action of its immune enhancer ilixadencel is the same in all types of solid tumors and that will also be investigated in the now starting ILIAD study in non small cell lung cancer, gastric cancer and head/neck cancer in Phase I/II.

Here is an article in Nature about the promising approach with neoantigens in cancer immunotherapy.

www.nature.com/articles/d41586-017-08706-3

But Immunicum's ilixadencel is an even smarter, more simple and less costly approach since it uses the own immune system to discover the tumorspecific neoantigens and present them to naive cytotoxic T-cells which then can kill cancercells with the same neoantigens.

A presentation of Immunicum and its ilixadencel held earlier this week by CEO.

www.aktiespararna.se/tv/immunicum-aktiedagen-lund-2019

Interview with CEO of Immunicum.

www.edisoninvestmentresearch.com/edison-tv/clip/executive-interview-immunicum?utm_campaign=1408722_Executive%20interview%20-%20Immunicum&utm_medium=email&utm_source=Edison%20Investment%20Research%20Limited&dm_i=2PWO,U6Z6,2H451Q,34FEV,1

New Immunicum presentation in pdf-file :
immunicum.se/wp-content/uploads/2019/02/IMMU-presentation-20190221-for-investors.pdf