Gordon Stein, CFO of CleanTech Lithium, explains why CTL acquired the 23 Laguna Verde licenses. Watch the video here.
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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
The opportunity in metastatic breast cancer
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
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SFX-01 can be life-changing
Diagnosed age 40 ER+ Her2- early BC
Received surgery, chemotherapy and tamoxifen
After 5 years diagnosed with pleural nodules
Enrolled into STEM trial May 2017 – tamoxifen + SFX-01
Objective response to treatment, very well tolerated, able to continue her life caring for her 2 young children and husband with head and neck cancer
Entered the extended use programme and had Stable Disease for a total of 448 days, including tumour shrinkage of 63% from baseline
5 patients remained progression free after 1 year of treatment with SFX-01 + ET
..........................
STEM showed that SFX-01 shrinks tumoursand halts tumour growth
SFX-01 added to tamoxifen or fulvestrantcaused tumour shrinkage
SFX-01 added to endocrine therapy caused tumour stabilisation
........................
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
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
hTtps://twitter.com/robclarkelab?lang=en
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Understanding the role of STAT3 in therapy-resistance and metastatic progression of breast cancer (MRC CASE)
The University of Manchester Faculty of Biology, Medicine and Health
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.research.manchester.ac.uk/portal/en/researchers/robert-clarke
hTtp://www.breastcentre.manchester.ac.uk
Entry Requirements:
Applications are invited from UK/EU nationals only. Applicants must have obtained, or be about to obtain, at least an upper second class honours degree (or equivalent) in a relevant subject.