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ErSo - Trials on Mice have eradicated Metastatic Breast Cancer Cells - we need HUMAN trials now ...

arpie
arpie Member Posts: 8,324

Beating breast cancer

Estrogen receptor–positive breast cancer is the most common type of breast cancer and, in its metastatic form, is currently incurable. In a new study, Boudreau et al. describe a compound, ErSO, that can activate the unfolded protein response, resulting in necrosis of human breast cancer cell lines in vitro. In vivo, this treatment induced complete regression of cell line and patient-derived orthotopic and metastatic breast cancer xenografts in mice. The authors showed that this treatment was well tolerated in mice, rats, and dogs and could provide a new avenue of intervention for this deadly disease.

Abstract

Metastatic estrogen receptor α (ERα)–positive breast cancer is presently incurable. Seeking to target these drug-resistant cancers, we report the discovery of a compound, called ErSO, that activates the anticipatory unfolded protein response (a-UPR) and induces rapid and selective necrosis of ERα-positive breast cancer cell lines in vitro. We then tested ErSO in vivo in several preclinical orthotopic and metastasis mouse models carrying different xenografts of human breast cancer lines or patient-derived breast tumors. In multiple orthotopic models, ErSO treatment given either orally or intraperitoneally for 14 to 21 days induced tumor regression without recurrence. In a cell line tail vein metastasis model, ErSO was also effective at inducing regression of most lung, bone, and liver metastases. ErSO treatment induced almost complete regression of brain metastases in mice carrying intracranial human breast cancer cell line xenografts. Tumors that did not undergo complete regression and regrew remained sensitive to retreatment with ErSO. ErSO was well tolerated in mice, rats, and dogs at doses above those needed for therapeutic responses and had little or no effect on normal ERα-expressing murine tissues. ErSO mediated its anticancer effects through activation of the a-UPR, suggesting that activation of a tumor protective pathway could induce tumor regression.

https://news.illinois.edu/view/6367/339688859?fbclid=IwAR0h1IknctZG6-YwnsbeAm-4Q_Yi9piOYfUPc7z1ymYl-NIeZXH5W16zjUE#image-2

One lady actually wrote to one of the reseachers and he said to contact Bayer directly, as they bought the "rights" and as yet, they haven't scheduled clinical trials.

I am sure that if controlling oestrogen was a major part of controlling Prostate or Testicular Cancer, they'd be RACING to get this to market ..... 

WE ALL NEED TO WRITE TO BAYER! Copy & Send this post to your Onc too!!   Here is a Bayer contact the researcher gave: rose.talarico@bayer.com

Hopefully, if LOTS OF PEOPLE from all around the world WRITE to Bayer - they may 'run with it'  .... but the facts are, if something like this isn't profitable enough to them - it might get shelved!  :( 

Comments

  • arpie
    arpie Member Posts: 8,324
    I have written to rose.talarico@bayer.com at Bayer, asking when clinical trials will begin on this drug .... ErSo

    and advise EVERYONE else to do so, too.


    Remember - that up to 30% of us 'may' go on to develop Mets .....

    IF IT WORKS - we need this drug to be on the market SOONER than later!
  • Afraser
    Afraser Member Posts: 4,475
    I’m all for research and new developments but by and large breast cancer has done pretty well in that regard compared to the paucity of support for research for some other cancers. There are processes to go through, not least the fact that what works for rodents and dogs may not work for or be tolerated as well by humans. Let’s encourage further development but checking it works well on humans, including those who try it first, is a big step. 
  • arpie
    arpie Member Posts: 8,324
    It starts with showing an interest - and if necessary, agitation, @Afraser

    Bayer have been interested enough to purchase the rights to all this university research on ErSo and it would be a shame if it sits on the shelf for years or decades - they have developed other drugs from the ground up, so they know the process...

  • Afraser
    Afraser Member Posts: 4,475
    Don’t disagree but the full
    press release clearly indicates that Bayer anticipates the new treatment to be distinctly profitable. 
  • arpie
    arpie Member Posts: 8,324
    From Bayer in Germany .... (copy below in English)
    https://www.media.bayer.de/baynews/baynews.nsf/id/2AE265D7D05978C4C12585E4002CFC31?open&ref=irrefndcd

    And I've just sent an email to THIS lady as well - an oncologist on their website who they say to contact:   anna.koch@bayer.com

    Bayer acquires an exclusive license from Systems Oncology for the innovative ERSO ™ treatment approach in breast cancer

    Exclusive global license agreement for preclinical drug candidate ERSO ™ for the treatment of metastatic estrogen receptor-positive breast cancer / Under the terms of the agreement, Bayer will be responsible for the worldwide development and commercialisation of ERSO

    Berlin, September 15, 2020 - Bayer has signed an exclusive global license agreement with Systems Oncology, LLC for ERSO ™, an orally administered drug in preclinical development for the treatment of metastatic estrogen receptor-positive (ER +) breast cancer. ERSO is a small molecule active ingredient that activates the so-called Unfolded Protein Response (UPR), a control mechanism in the cell, in ER + breast cancer cells. Its innovative mechanism of action offers significant potential for a novel treatment option in women with metastatic ER + breast cancer, an area in which new therapies are urgently needed.

    "Despite the general advances in breast cancer treatment, there are limited treatment options for patients with advanced disease, especially those in the metastatic stage," said Robert LaCaze, member of the Executive Committee of the Pharmaceuticals Division and head of the Oncology Strategic Business Unit at Bayer. “In line with our oncology strategy of focusing on areas of high unmet medical need and innovative approaches with the potential to significantly improve treatment, we are excited to partner with Systems Oncology to develop ERSO. ERSO offers a promising innovative approach to treating many women with ER-positive breast cancer, and is expanding our portfolio so that we can offer new therapies for patients,

    With over 2 million new cases worldwide in 2018, breast cancer is the most common tumor type in women and the second most common tumor type overall. The prognosis as well as the available treatment options strongly depend on the subtype and stage of the breast cancer. Around 70% of all women with breast cancer suffer from ER + disease, with the survival rate for metastatic ER + breast cancer being only 20%. Therefore, additional treatment options beyond established anti-hormonal treatment approaches are urgently needed.

    In preclinical studies, ERSO showed activity in ER + breast cancer cells as well as activity in ER mutations that are resistant to standard treatments. The mode of action of ERSO to activate the unfolded protein response (UPR) in ER + breast cancer cells offers a significant differentiation from current and potential future anti-hormonal agents. In addition, the therapeutic potential of this novel mode of action is also being investigated for other types of tumors.

    “Given ERSO's unique mechanism and potential to reshape cancer care, it was important for us to find a collaborative partner who would innovate. Bayer shares our vision for ERSO and has the clinical, scientific and business expertise to be successful, ”said Dr. Spyro Mousses, CEO and Co-Founder of Systems Oncology.

    "With the experienced Bayer team who will lead the development program, I assume that this novel approach has the potential to bring about a real paradigm shift for breast cancer treatment," said Dr. Joyce O'Shaughnessy of Baylor University Medical Center in Texas Oncology, US Oncology.

    "The collaboration with Systems Oncology combines their specialised know-how in identifying novel treatment approaches with our globally established profile of providing new treatment options for better patient outcomes," said Marianne De Backer, PhD, MBA, member of the Executive Committee of the Pharmaceuticals Division of Bayer and Head of Strategy and Business Development & Licensing. "It underlines our commitment to enter into partnerships for innovative treatment approaches at all levels."

    Under the terms of the agreement, Bayer will be responsible for developing and commercialising ERSO worldwide. Systems Oncology will receive a $ 25 million upfront payment and, upon reaching certain development and commercialisation milestones totalling $ 345 million, as well as royalties for future global net sales, will receive payments from Bayer.

    Bayer’s Pharmaceuticals Business Development & Licensing Team initiated the license agreement.

    About ERSO ™
    Systems Oncology scientists entered into a strategic research collaboration with two University of Illinois professors, Dr. David Shapiro and Dr. Paul Hergenrother, who conducted pioneering research into the biology and chemistry of the activation of UPR in breast cancer. The research resulted in proprietary novel small molecule drugs that can selectively and quantitatively kill cancer cells by hyperactivating the UPR. Inspired by a multi-scalar systems understanding of this mechanism, Systems Oncology licensed the university and invested in the advancement of preclinical studies and manufacturing development to eventually establish the ERSO program as a promising therapeutic compound with transformative potential. 

    A current poster describing ERSO,

    https://www.systemsoncology.com/wp-content/uploads/2020/02/Quantitative-Regression-of-Estrogen-Receptor-Alpha-Positive-Breast-Cancer.pdf

  • Julez1958
    Julez1958 Member Posts: 1,323
    Wow Arpie that will be a game changer if it comes off.
    Thx for letting us know .
  • Cath62
    Cath62 Member Posts: 1,531
    Thanks @arpie. I need to read this in depth but skimming it, it looks promising. I will have a better read over the weekend and write to the suggested contact. 

    Has anyone from BCNA or other organisations written to them or advocating from this work?
  • arpie
    arpie Member Posts: 8,324
    Incredibly exciting, @Cath62 - hopefully for many different cancers ...... Go to the Bayer site & search for ErSo & more documents come up too.

    I've written to 2 of them at Bayer & not heard back yet.  Maybe the Mods should pen something too?  ..... @BCNA
     
    anna.koch@bayer.com

    rose.talarico@bayer.com

    These are the pics that I am excited about from the brochure above!!





  • Blossom1961
    Blossom1961 Member Posts: 2,538
    @arpie, I have also penned a letter to them. Hubby says they are probably all caught up with COVID drugs but I reckon if enough of us nag them they might expand their visions.
  • arpie
    arpie Member Posts: 8,324
    AWESOME @Blossom1961 - the more who make contact, the better!   Even better again, if they do the trials in Aussie as well.

  • arpie
    arpie Member Posts: 8,324
    Just checked my emails & have received this reply:

    Dear Arpie,

    Thank you for contacting Bayer. 

    The compound is still in the early preclinical stages of development.  While we try to move our compounds through development as quickly as possible, we have to take prudent steps to ensure the compounds are safe and provide the benefits we are striving to achieve. Because of these necessary steps, the drug is not currently available for trial in humans, nor is it possible to state when or where these trials will commence. They will be registered in clinicaltrials.gov should ErSO proceed onto human trials.

    Should you have any further inquiries, please do not hesitate to contact us on 1800 008 757 (free call within Australia)/ 0800 229 376 (free call within New Zealand).

    Kind regards,
    Bayer ANZ Medical Information

    @Julez1958
    @wendy55
    @Blossom1961
    @Cath62



  • byo_boy
    byo_boy Member Posts: 39
    edited July 2024
    Just having a read through this post, and found this article from late last year:


    I think this the same approach, if not exactly the same as ErSo and looks to be heading towards clinical development / trials in 2025.

    Here's a reply to an admin from a Facebook group that follows the development of this treatment from the CEO of the company working on it:


    Could be good news!