Member Info for Moneymunch

Finnacap 21/1/21

Newsflow: Highly positive data for SFX-01 in pre-clinical models of glioma and glioblastoma have been generated through a collaboration with a prominent European university.

Fuller details are pending the publication in a peer-reviewed journal.

However, Evgen is particularly excited with the findings and with limited additional preclinical work, has indicated that SFX-01 could be ready to enter the clinic (Phase Ib/IIa) by the year-end.

Glioma is the most common type of brain tumour, developing in glial cells (supporting cells) in the brain or spinal cord. Different types of glioma are named after the types of glial cell and include Glioblastoma, which is an aggressive type of astrocytoma (forms in astrocyte cells).

Glioblastoma accounts for c.45% of cases with a median survival of 14 months and 5-year survival of c.5%. It is an orphan disease affecting 5 per 100,000 people.

We would expect SFX-01 to receive Orphan Drug Designation, Fast Track and potentially breakthrough status (in the US) as the treatment options are currently limited to surgery, radiotherapy and treatment with temozolomide.

Preclinical findings. Tumour shrinkage and significantly extended survival times were seen in standard pre-clinical models and then dosed with SFX-01, including more disease-relevant orthotopic models where glioma cells are implanted in brain tissue.

SFX-01 was also found also to substantially increase the therapeutic effect of radiotherapy in these models.

Implications: The data are sufficiently encouraging to warrant disclosure. Evgen retains all commercial rights to SFX-01 and will consider all options for further development.

It is quite conceivable that once limited additional preclinical work is completed a high-value preclinical deal could be struck, given the paucity of current treatment options and products in development for this indication.

https://youtu.be/xwflrBd83kg

today's Proactive Investor Interview with Evgen's CEO.

htttPs://youtu.be/xwflrBd83kg

just listened to Huw's latest interview again, and when talking about the glioblastoma, very exciting early data, he says that they are just working out now how to plan and od more experiments and are " starting out on another couple of collaborations "......Gl ;-)

hTtPs://youtu.be/xwflrBd83kg

Lol...ramp or deramp...ha ha ha :-)

Evgen Pharma updates on the ‘STAR’ trial for Covid-19, Glioma research and key breast cancer drug

•25 Jan 2021

https://www.youtube.com/watch?v=xwflrBd83kg&feature=youtu.be

Falling knife....ha ha ha ha....anyone would think you were trying to deramp current potential and prospects to drive the sp down......ho ho ho.........more like a nose bleed as the sp heads UPwards.....Gla Holders......On and UP!!! ;-)

ps those waiting for a lower entry price will have to pay a premium soon enough....plenty more newsflow could drop at anytime to add significant value.....Evgen's sp and market cap is woefully undervalued given the multiple prospects and potential at hand.....a rare opportunity for undoubted transformational UPside, as good new is delivered. ;-)

16th July 2020

Current and planned work programme

All preclinical breast data published in high impact journal in June 2020

Extensive review of clinical pathway to approval close to completion

Supplementary preclinical work required to confirm CDK4/6i “resistance-breaking” hypothesis

New “commercial ready” solid tablet formulation to be completed in H3 2020

Non-dilutive capital e.g. partnering to fund the next trial(s)

Targeting CTA/IND in H1 2021 with first patient first dose in Q2/Q3 2021

http://evgen.com/wp-content/uploads/2020/07/EVG-AGM-presentation-2020-16Jul20.pdf

...............................

Market opportunity in ER+ metastatic breast cancer

Incidence of ER+ metastatic breast cancer is approximately 130,0001 in US and Europe

CDK4/6 inhibitors are now first line treatment, in combination with hormone therapy

Pfizer (Ibrance®/palbociclib), Novartis (Kisqali®/ribociclib) and Eli Lilly (Versenio®/abemaciclib ) are the key players with billion plus sales - sales forecast to reach c.$9bn by 2021/2

All patients become resistant to CDK4/6 inhibitors

Treatment options post CDK4/6 inhibitors are generally poorly tolerated – treatments which improve quality of life are needed in this terminal population

Potential of SFX-01 to be treatment of choice post CDK4/6 inhibitor failure, extending progression free survival with favourable side-effect profile.

http://evgen.com/wp-content/uploads/2020/07/EVG-Investor-Presentation-06Jul20-FINAL.pdf

News on SFX-01's planned phase 2b trial for breast cancer, including, " understanding the mechanisms of STAT3 signalling and establish predictive biomarkers that will have translational value in precision medicine clinical trials" could drop at anytime. The phase 2 results were outstanding and life changing for some patients and so undoudted transformational potential for all concerned. Gla ;-)

Rob Clarke
@RobClarkeLab
·
Jun 24
We’re looking for a talented student to carry out a PhD starting this September: Understanding the role of STAT3 in therapy-resistance and metastatic progression of breast cancer (MRC CASE) at The University of Manchester on htTp://FindAPhD.com

About the Project

Resistance to endocrine and other therapies during metastatic progression is the major cause of mortality in breast cancer. We have previously reported that endocrine resistance can be driven by ALDH+ breast cancer stem cells (CSCs) and more recently that STAT3 is activated in these cells (Simoes et al., 2015 and 2020). We and others have reported that breast cancers resistant to the recently FDA-approved CDK4/6 inhibitors such as Palbociclib have increased numbers of CSCs and activation of STAT3 signalling, and that inflammatory and obesity-related breast cancer are driven by IL6 and leptin activating STAT3 transcriptional activity.

Our hypothesis is that targeting STAT3 would benefit breast cancer patients where CSCs are driven by the STAT3 signalling pathway, and in particular would combat therapy resistance and metastatic progression. In the Clarke lab, we have established in vitro and in vivo models of breast cancer patient-derived organoids and xenografts that metastasise to relevant organs such as lung and bone (Byrne et al., 2017, Eyre et al., 2019). The student will use these models to perform CSC assays, gene and protein expression analyses to characterise the signalling pathways targeted by SFX-01 and discover biomarkers that predict response.

The potential outcome is the definition of which breast cancers have STAT3 dependency and are sensitive to STAT3-targeted therapies. We aim to understand the mechanisms of STAT3 signalling and establish predictive biomarkers that will have translational value in precision medicine clinical trials, which the appointed student would help design during a placement in the iCASE partner company Evgen Pharma PLC, who aim to develop SFX-01 for improved breast cancer therapy.

htTps://www.findaphd.com/phds/project/understanding-the-role-of-stat3-in-therapy-resistance-and-metastatic-progression-of-breast-cancer-mrc-case/?p122397

..........................

Rob Clarke Retweeted
Mcr Breast Centre
@MCRBreastCentre
·
Jan 19

Thank you to Dr Roger Gomis for presenting an excellent seminar on “Mechanisms of breast cancer tissue-specific and time dependent metastasis” for the first talk in our external seminar series this year.
@RogerGom1
@IRBBarcelona
@BreastCancerNow
@MCRCnews
@CRUK_MI
@UO

16th December 2020

CEO interview.

"We're happy with our cash burn and we're happy with our funding well into the tail end of next year"

https://youtu.be/Pg2x00c9umM

Yes of course they will need to raise more cash before the end of the year, but no reason to raise any just yet imho unless for a very special material event, and no reason to raise any cash at all if an early commercial JV is secured. Gl :-)

They have enough cash until end of this year according to the CEO last month , and so unless they've changed their business plan, I'm not expecting one near term...Gla :-)

Our strategy is to move to a business model where we facilitate multiple clinical trials on SFX-01 in risk-sharing arrangements, with the objective of attracting non-dilutive funding from grants and/or charities to wholly or substantially fund future clinical activity. This strategy has three key components:

(1) Our first priority is to ensure the continued development of the breast cancer programme. We will complete the trial design and cost a clinical trial protocol and then seek non-dilutive funding for Evgen and/or an affiliated clinical institution to sponsor the trial.

(2) In parallel we aim to leverage the extensive pre-clinical and clinical data that shows the potential for SFX-01, as a sulforaphane delivery platform, to be used in diseases that are beyond our capacity to pursue.

(3) In addition, we will pursue opportunities to apply our intellectual property on stabilised sulforaphane to non-pharmaceutical opportunities which offer a more rapid route to market.

We will therefore support a number of proposed Investigator-Initiated Trials - these are trials led by a clinician from a well-renowned institution, with that institution being the sponsor for the trial. Evgen will provide support as required (in the confines of an investigator sponsored study), sharing our knowledge, experience and the methods and laboratories used for pharmacodynamic and pharmacokinetic endpoints. All such trials are subject to grant funding being procured and Evgen will supply clinical centres with SFX-01 and, where appropriate, a placebo.

Evgen will have the right to access the clinical data on fair commercial terms to advance its clinical and commercial development. Since the principal funding for these trials will be obtained by the investigator/ institution they have limited impact on our cash reserves.

There seems to have been a chorus of "placing coming " from all and sundry which no doubt has supressed the sp , deterred investors and even encouraged sellers imho, having said that, I'm expecting / hoping for a big bounce this coming week, the chart certainly looks primed towards the UPside...Gla holders and keep the newsflow coming Huw....On and UP!!! :-)

Nothing wrong with a fund raise for the right reasons, but unless Evgen have completely changed their business model without telling us, then i really don't see the need for a fund raise at this stage of proceedings, Huw stated last month they had enough cash until end of year, and so why would they need extra funds now and what for??? 

https://youtu.be/nY4isQVSgDg

Lol....anyone would think the small town short spread betters were in town....ha ha ha ha.....:-))))))

A very balanced view at that, well done, and if Evgen raises cash then it will be for a very good reason , as it is totally the opposite to their business model. Gl :-)

A little reminder of the business model, also that the CEO stated last month that they had enough cash until end of year. Gla ;-)

Our strategy is to move to a business model where we facilitate multiple clinical trials on SFX-01 in risk-sharing arrangements, with the objective of attracting non-dilutive funding from grants and/or charities to wholly or substantially fund future clinical activity. This strategy has three key components:

(1) Our first priority is to ensure the continued development of the breast cancer programme. We will complete the trial design and cost a clinical trial protocol and then seek non-dilutive funding for Evgen and/or an affiliated clinical institution to sponsor the trial.

(2) In parallel we aim to leverage the extensive pre-clinical and clinical data that shows the potential for SFX-01, as a sulforaphane delivery platform, to be used in diseases that are beyond our capacity to pursue.

(3) In addition, we will pursue opportunities to apply our intellectual property on stabilised sulforaphane to non-pharmaceutical opportunities which offer a more rapid route to market.

We will therefore support a number of proposed Investigator-Initiated Trials - these are trials led by a clinician from a well-renowned institution, with that institution being the sponsor for the trial. Evgen will provide support as required (in the confines of an investigator sponsored study), sharing our knowledge, experience and the methods and laboratories used for pharmacodynamic and pharmacokinetic endpoints. All such trials are subject to grant funding being procured and Evgen will supply clinical centres with SFX-01 and, where appropriate, a placebo.

Evgen will have the right to access the clinical data on fair commercial terms to advance its clinical and commercial development. Since the principal funding for these trials will be obtained by the investigator/ institution they have limited impact on our cash reserves.

All preclinical breast data published in high impact journal in June 2020

Extensive review of clinical pathway to approval close to completion

Supplementary preclinical work required to confirm CDK4/6i “resistance-breaking” hypothesis

New “commercial ready” solid tablet formulation to be completed in H3 2020

Non-dilutive capital e.g. partnering to fund the next trial(s)

Targeting CTA/IND in H1 2021 with first patient first dose in Q2/Q3 2021

hTtp://evgen.com/wp-content/uploads/2020/07/EVG-AGM-presentation-2020-16Jul20.pdf

I'd be surprised if he could, but I can. Gl :-)

Evgen will supply clinical centres with SFX-01 and a placebo as its contribution to the trial. No additional financing is required as the costs of providing SFX-01 for the trial are not material.

The clinical study is being supported by a grant from LifeArc, as part of its activities to address the need for new therapies for COVID-19. LifeArc has made GBP10m available to repurpose existing medicines or those in the late stage of development, as this approach offers one of the fastest routes to develop new treatments that could tackle the virus and its impact. LifeArc received more than 130 in-scope applications from around the globe for this scheme and an independent panel of experts assessed shortlisted applications selected on a number of criteria including scientific rationale of approach.