Member Info for Moneymunch

More news this week I reckon, news of the appointment of the new CEO coming soon along with potential Transformational funding news for SFX-01 patient trials for Covid-19. Gla :-)

" And our recent clinical trial was life changing for some patients "

January 2020

Next Steps

Start the path to registration with an adaptive Phase IIb/III study – trial design to be developed in H1 2020

All preclinical breast data due to published in high impact journal early in 2020

Supplementary preclinical work to cement the right opportunity will commence early 2020

New “commercial ready” solid tablet formulation completed in H2 2020

Early partnering or sourcing of non-dilutive capital to fund the IIb part of the study in H2 2020

CTA/IND by end of 2020

Targeting first patient first dose H1 2021

hTtp://evgen.com/wp-content/uploads/2020/01/EVG-Investor-Presentation-13Jan20-FINAL-.pdf

Evgen Pharma PLC Paper on SFX-01 in ER positive breast cancer
08/06/2020 7:00am
RNS Non-Regulatory

TIDMEVG

Evgen Pharma PLC

08 June 2020

Evgen Pharma plc

("Evgen" or the "Company")

Paper published on SFX-01 in ER positive breast cancer

Evgen Pharma plc (AIM: EVG), a clinical stage drug development company focused on the treatment of cancer and neurological conditions, announces the publication of a scientific paper entitled " Targeting STAT3 signaling using stabilised sulforaphane (SFX-01) inhibits endocrine resistant stem-like cells in ER-positive breast cancer". SFX-01 is the Company's synthetic formulation of stabilised sulforaphane (SFN).

The paper, in the prestigious journal Oncogene, is co-authored by Bruno Simoes, Research Fellow at the Division of Molecular & Clinical Cancer Sciences, The University of Manchester and Sacha Howell, Honorary Consultant in Medical Oncology at the Christie Hospital. The paper describes a body of work carried out in a collaboration between Evgen and the University of Manchester, over a number of years, on the potential use SFX-01 to combat endocrine resistance in ER-positive breast cancer.

The paper reports that SFX--01, used in combination with endocrine therapies, prevents breast cancer stem-like cell (CSC) enrichment in patient samples and patient-derived xenograft tumours. Thus SFX-01 reduces the formation of stem-like cells (thought to be the clones that survive once tumours are treated with therapies such as endocrine therapies, and which cause metastases). SFX-01 also blocks STAT-3, itself implicated in resistance to endocrine therapies. SFX-01 therefore has the potential to overcome such resistance and improve clinical outcomes.

The paper can be viewed at: https://rdcu.be/b4uXz and on the Evgen website.

Barry Clare, Executive Chairman of Evgen, commented:

"This paper clearly elucidates the potential of SFX-01 in the treatment of ER+ metastatic breast cancer and its potential as a STAT3 inhibitor. We look forward to building on this work, and on the data from our successful phase II trial in metastatic breast cancer, in the next trial."

Another strong indication of SFX-01's potential for a Covid-19 treatment. Gla ;-)

Broccoli florets have anti-inflammatory and antioxidant effects, due to inhibiting nitric oxide, which has been shown to play a role in inflammation. Sulforaphane also helps to fight inflammation, and the vitamin K in broccoli also helps reduce inflammatory markers in the blood.

https://www.cookist.com/14-amazing-health-benefits-of-eating-broccoli/

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COVID-19 Update: Vitamin K in Cheese Can Fight the Coronavirus; COVID-19 Patients Found to be Suffering From Vitamin Deficiency

5 June 2020 Tech Times

As efforts to find a COVID-19 vaccine continue around the world, scientists continue to uncover new facts about the virus and what could prevent further infections.

A new study has claimed that vitamin K found in some cheeses can fight the coronavirus. According to The Guardian's latest report, patients who have been admitted to intensive care with COVID-19 or those who died from the virus were discovered to have been suffering from vitamin K deficiency. The nutrient is often found in eggs, broccoli, spinach, and hard blue cheeses.

According to their study, the degradation of elastic fibers in the lungs is caused by blood clotting created by COVID-19. The study claimed that vitamin K could protect the lungs against the viral disease since it helps the production of proteins that regulate clotting when ingested through food and absorbed in the gastrointestinal tract.

Although the findings may provide promising results, Dr. Rob Janssen, a scientist working on the project, suggested that people can have a healthy intake of vitamin K except those who are on blood-thinning medications such as warfarin.

"We are in a terrible, horrible situation in the world. We do have an intervention which does not have any side effects, even less than a placebo. There is one major exception: people on anti-clotting medication. It is completely safe in other people," Janssen explained.

He added that even those who are not suffering from severe illnesses caused by the novel coronavirus should take vitamin K supplements since it can help strengthen their bones, blood vessels, and lungs. Janssen said that there are other vitamins similar to vitamin K; vitamin K1 and vitamin K2. K1 is found in broccoli, spinach, green vegetables, blueberries, and all types of vegetables and fruits.

The 100k trade is listed as

Ordinary
Non protected portfolio
Single protected transaction

Which suggests one institution to another. Gla :-)

Ps The previous Rns 4/12/19 confirming Notice of a Results was followed the next day by the Rns confirming news of the MoU with Dundee University , and the Evgen Investor Presentation was released the same day as the Half Yearly Results 17/12/19 and so I reckon there's a very good chance of an update on proceedings this coming week...fingers firmly crossed for a stellar Rns. :-)

Notice of Results

Evgen Pharma plc (AIM: EVG), the clinical stage drug development company focused on the treatment of cancer and neurological conditions, will announce its final results for the year ended 31 March 2020 on Monday, 15 June 2020.

" And our recent clinical trial was life changing for some patients "

A pretty amazing result for any drug trial, which presumably ensures its continued development and subsequent funding which potentially could add significant value, news of which could arrive at anytime.

As far as funding news for the potential Covid-19 trial for SFX-01, i'm sure most were hoping for news by now, although its perceived delay could be connected to the appointment of a new CEO, whereby they want the new leader in place before news on funding is released which would make perfect sense, rather than the other way around, and so hopefully not too much longer before all is made clear. Gla ;-)

News on progress and potential JV partnership/funding on SFX-01 for Breast Cancer highly likely, with study results published 30/5/20 in ‘Oncogene’ publication, linked to the scientific journal Nature.

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

2/6/20

Drug developed to fight breast cancer uses compound found in broccoli

htTps://www.macaubusiness.com/portugal-drug-developed-to-fight-breast-cancer-uses-compound-found-in-broccoli/

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Article

30 May 2020 Open Access

Targeting STAT3 signaling using stabilised sulforaphane (SFX-01) inhibits endocrine resistant stem-like cells in ER-positive breast cancerBruno M. Simões, Angélica Santiago-Gómez[…]Robert B. Clarke

hTtps://www.nature.com/onc/

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

Evgen Investor Presentation - January 2020 which outlines next steps for development.

SFX-01 prevents tumour metastases by targeting STAT3

SFX-01 can be life-changing

STEM showed that SFX-01 shrinks tumoursand halts tumour growth

.........

What is the opportunity ?

ER+ breast cancer is the most prevalent breast cancer sub-type (70%)

Metastatic breast cancer is incurable with 5-year survival rates of 22%

Patients become resistant to all drugs

SFX-01 is being developed to prevent and/or reverse resistance

Our data on SFX-01 shows prevention of metastases by the STAT3 pathway

And our recent clinical trial was life changing for some patients

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

Market opportunityin ER+ metastatic breast cancer

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

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

Next Steps

Start the path to registration with an adaptive Phase IIb/III study – trial design to be developed in H1 2020

All preclinical breast data due to published in high impact journal early in 2020

Supplementary preclinical work to cement the right opportunity will commence early 2020

New “commercial ready” solid tablet formulation completed in H2 2020

Early partnering or sourcing of non-dilutive capital to fund the IIb part of the study in H2 2020

CTA/IND by end of 2020

Targeting first patient first dose H1 2021

http://evgen.com/wp-content/uploads/2020/01/EVG-Investor-Presentation-13Jan20-FINAL-.pdf

Another 250k buy!!! All bodes well ;-)

Fingers crossed funding news is leaking. Gla :-)

A 250k buy just in....Gla :-)

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MNA International

2nd June 2020

Portugal: Drug developed to fight breast cancer uses compound found in broccoli

A new drug based on a natural compound found in broccoli, brussels sprouts and other vegetables may be effective in reversing or even preventing resistance to breast cancer hormone therapy, according to a scientific report. 

Portuguese scientist Bruno Simões and other scientists at the University of Manchester, UK, have discovered that the drug SFX-01 may reverse or even prevent resistance to treatment by blocking a major cancer signalling route called STAT3. 

The drug was developed with a British company that stabilised the sulforaphane compound, which US researchers had already shown to affect cancer treatment, and which Bruno Simões and his colleagues tested on mice to ensure that the stabilised molecule had the same impact. 

A clinical test was then carried out on more than 40 patients, which concluded that 25% saw their cancer stop progressing during the six months they received treatment. 

“Many of these cancers eventually develop resistance to treatment. What we have shown is that this compound can eliminate cells that are resistant to treatment,” he told Lusa.

The result of the study was published on Saturday in the ‘Oncogene’ publication, linked to the scientific journal Nature, and represents, according to Simoes, an example of translational research, which started from a basic investigation of the biological mechanism and had a real application, being now in clinical trials. 

This drug will continue to be developed with more clinical tests to test efficacy, but Bruno Simões, who graduated from the Faculty of Sciences in Lisbon and completed his PhD in Bilbao, Spain, intends to focus on research into prevention mechanisms. 

“When breast cancer reaches an advanced stage, no matter how many drugs we try to use, we can only slow down the progression a little, but it is difficult to control it. We are interested in studying cases of high-risk women to identify drugs that can prevent cancer from occurring,” he said. 

htTps://www.macaubusiness.com/portugal-drug-developed-to-fight-breast-cancer-uses-compound-found-in-broccoli/

..........

Article 
30 May 2020 | Open Access

Targeting STAT3 signaling using stabilised sulforaphane (SFX-01) inhibits endocrine resistant stem-like cells in ER-positive breast cancerBruno M. Simões, Angélica Santiago-Gómez[…]Robert B. Clarke

hTtps://www.nature.com/onc/

Perfectly poised and primed for take off....Gla EVG Holders ....Transformational news is on coming this way!!!....;-)

If You Only Eat One Vegetable for the Rest of Your Life It Should Be This

May 28, 2020

Your mom always told you to eat your broccoli. Turns out she was right. Now there is research that shows that this always-healthy food contains an even more powerful compound than your everyday lineup of vitamin-packed veggies, one that could possibly help fight off the virus that we are all trying to avoid: COVID-19. It also protects against cancer and other ailments, according to emerging research.

There is a building body of research to show that the controversial green veggie (George Bush 1 was no fan) is found to deliver a super compound called Sulforaphane Glucosinolate, which is known as a disease-fighting agent that boosts immunity even as it helps take the stress off your other organs.

https://thebeet.com/if-you-only-eat-one-vegetable-for-the-rest-of-your-life-make-it-broccoli/?utm_source=tsmclip&utm_medium=referral

Should be interesting to see who the new CEO will be. Gla ;-)

MANAGEMENT

It is a reflection of the very significant potential of Evgen Pharma’s technology that the company has been able to attract a high calibre commercial, scientific and advisory team.

SALLY ROSS, CLINICAL DEVELOPMENT OFFICER

Sally has over 18 years of experience working across pre-clinical and clinical settings in academia, pharma and CROs.  Sally held many different roles at AstraZeneca, starting off as a translational Scientist working on Iressa and then moved into more clinical roles as a Global Project/Programme Manager in the Oncology and Infection Therapeutic Areas, and subsequently as a Principal Medical Scientist in both early and late clinical development. Upon leaving AstraZeneca Sally worked for a large mid-sized contract research organisation as Director of Project Management.

CONSULTANTSDR THOMAS MORRIS – MEDICAL ADVISOR

Tom is a physician who has worked in pharmaceutical medicine and drug development for over 20 years with much of this time specialising in oncology. After several years working in clinical medicine, he joined firstly Medeval Ltd (University of Manchester) and then AstraZeneca, where he has held a number of global R&D roles. Most recently these included Senior Medical Director and Executive Director Clinical Programs. He has overseen several global drug development programs, interacting with leading external medical and scientific experts, academic groups and regulatory agencies.

 0

Another strong Astazeneca connection. Gla ;-)

DR ALAN BARGE, NON-EXECUTIVE DIRECTOR

Alan is the former chief medical officer of Singapore-based ASLAN Pharmaceuticals PTE. Up until 2011, he was vice-president and head of oncology & infection at AstraZeneca, a role in which he was responsible for the overall strategy in oncology and infection from drug discovery to pr1oof-of-concept. He was also chairman of AstraZeneca’s Therapy Area Portfolio Team and accountable for the design and delivery of all projects, including budgetary oversight. Prior to his career at AstraZeneca, Alan was European and global medical director for Amgen Inc.

https://evgen.com/about/management/

Watch this space Daddio, EVG is still under the Radar, as we await potential Transformational funding news for SFX-01 to enter Covid-19 patient trials, speculation of which was considered rubbish by your good self, until the Rns confirmed they were in discussions ....news could drop at anytime....Gla Holders!!! :-)

Long standing collaboration between AstraZeneca and University of Manchester as well as a long standing collobaration with Evgen, the blockbuster cancer drugs Tamoxifen and Fulvestrant are both maketed by AstraZeneca and the recent phase 11 trials for SFX-01 confirm that both drugs in combination improves clinical outcomes, which would suggest that AstraZeneca could be a ptential partner for SFX-01's develoment.

AstraZeneca also have two drugs in patient trials for Covid-19, via the the Govt's Accord platform, and so more tgan conceivable that they could be the potential funding source for SFX-01's proposed Covid-19 patient trials, given the fact that through the University of Manchester's collaboration, they must be very much aware of the attributes and potential of SFX-01....Gla Holders....Fingers crossed for stellar news soon. ;-)

7/5/20

Two AstraZeneca molecules to be explored as Covid-19 treatments under government’s ACCORD platform

Published:07 May 2020

The AstraZeneca molecules being explored in this first wave are a Bruton’s tyrosine kinase (BTK) inhibitor previously approved for a different indication, and a phase II drug candidate targeting interleukin 33 (IL-33).

Evidence shows how a hyper-activated immune response in Covid-19 patients can result in pneumonia, respiratory failure and death.

hTtps://www.cambridgeindependent.co.uk/business/two-astrazeneca-molecules-to-be-explored-as-covid-19-treatments-under-government-s-accord-platform-9108658/

"SFX-01 reduced MFE of both ER+ primary and metastatic patient samples. Both tamoxifen and fulvestrant increased MFE and ALDH activity of PDX tumors, which was reversed by combination with SFX-01."

University of Manchester

“Through extensive close collaborative clinical and laboratory work with colleagues at locally based AstraZeneca, Manchester researchers have successfully improved treatments over the years. Today, more women presenting with early breast cancer are cured, remission in advanced disease lasts longer and survival is prolonged."

hTtps://www.manchester.ac.uk/research/beacons/breakthroughs/breast-cancer-treatment/

6/2/20

University of Manchester collaboration discovery

Gene signature identified which may determine response to SFX-01 in ER+ breast cancer treatment

Evgen closer to predicting which patients are most likely to benefit from breast cancer drug

Steve Franklin, CEO of Evgen Pharma, said: "This latest data from an eight-year collaboration with Manchester University, and the forthcoming publication, are very positive developments for both the design of future clinical trials and for supporting business development activity with potential partners. The University of Manchester have been tremendous collaborators and we would like to thank them for their continued commitment and enthusiasm.

4th February 2020

Stephen Robinson

Retweeted

Rob Clarke

@RobClarkeLab

·

4 Feb

Today we added the fifth submission from my lab to BioRxiv. The summation of more than 5 years research that culminated in a successful clinical trial

@ismenasg

@DrRachelEyre

@DrDAlferez

@asimslab

funded by

@BreastCancerNow

@ManchesterBRC

@TheChristie

Targeting STAT3 signalling using stabilised sulforaphane (SFX-01) inhibits endocrine resistant stem-like cells in ER-positive breast cancer

ABSTRACT

PURPOSE Estrogen receptor (ER) positive breast cancer is frequently sensitive to endocrine therapy. Multiple mechanisms of endocrine therapy resistance have been identified, including cancer stem-like cell (CSC) activity. Sulforaphane (SFN) has previously been shown to target CSCs but its mechanism of action is unclear. Here we investigate SFX-01, a stabilised formulation of SFN, for its effects on breast CSC activity in ER+ preclinical models and to study its mechanism.

EXPERIMENTAL DESIGN CSC activity was measured by mammosphere formation efficiency (MFE), aldehyde dehydrogenase (ALDH) activity, and tumor formation using patient samples and patient-derived xenograft (PDX) tumors treated with SFX-01 alone or in combination with tamoxifen or fulvestrant. Gene expression and SFN target proteins in treated samples were assessed.

RESULTS SFX-01 reduced MFE of both ER+ primary and metastatic patient samples. Both tamoxifen and fulvestrant increased MFE and ALDH activity of PDX tumors, which was reversed by combination with SFX-01. SFX-01 significantly reduced tumor initiating cell frequency in secondary transplants at limiting dilution and reduced the formation of spontaneous lung micrometastases by PDX tumors in mice. Mechanistically, we establish that both tamoxifen and fulvestrant induce STAT3 phosphorylation. SFX-01 suppressed phospho-STAT3 and SFN directly bound STAT3 in patient and PDX samples. Analysis of ALDH+ cells from endocrine-resistant patient samples revealed activation of STAT3 target genes MUC1 and OSMR, which were inhibited by SFX-01 in patient samples. Increased expression of these genes after 3 months’ endocrine treatment of ER+ patients (n=68) predicted poor prognosis.

CONCLUSIONS Our data establish the importance of STAT3 signaling in CSC-mediated resistance to endocrine therapy and the potential of SFX-01 for improving clinical outcomes in ER+ breast cancer.

hTtps://www.biorxiv.org/content/10.1101/2020.02.03.932194v1

Sulforaphane: Its “Coming of Age” as a Clinically Relevant Nutraceutical in the Prevention and Treatment of Chronic Disease

Published 14 Oct 2019

https://www.hindawi.com/journals/omcl/2019/2716870/