Breaking Research News from sources other than Breastcancer.org
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Not exactly news, but a good overview of emerging drugs currently in trials:
https://www.targetedonc.com/view/emerging-therapie...
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Debbew thanks for posting the article. Very informative and makes you hopeful to see so many new medications being developed.
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ER Antagonist OP-1250 Demonstrates Continued Anti-Tumor Activity in Advanced ER+ HER2– Breast Cancer
"The results we presented today from our monotherapy dose expansion study provide further validation of our belief in OP-1250's potential to become the endocrine therapy of choice for [ER-positive] breast cancer. OP-1250 has a compelling profile for a CERAN/SERD as it is well-tolerated, achieves high drug exposure, and has demonstrated encouraging efficacy across both wild-type and ESR1 mutant tumors," Sean P. Bohen, MD, PhD, president and chief executive officer at Olema Oncology, said in the press release. "Our mission is to transform the breast cancer treatment landscape and to develop therapies that offer the potential to improve outcomes for women living with cancer. We believe in the potential of OP-1250, and we look forward to initiating our first pivotal Phase 3 trial mid-next year."
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Debbew: Thanks for posting. Due to a rare complication caused by radiation most bc treatments are off the table for me because of possible SEs. SERD/CERANs is one of the few med classes I could use so it is good to know about the ongoing research and development in this area.
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Oh Nicole I’m so sorry about the brain mets diagnosis. After you have taken time to process this information, please let us know when you have more information regarding treatment options. I’m hoping you can zap it with cyber knife or some type of SRS.
If you can stabilize the brain ( and liver) I’m wondering if you could try to get in to the erx-41 trial which is supposed to open up in the first quarter of 2023.
https://www.utsouthwestern.edu/newsroom/articles/year-2022/hard-to-treat-cancers.html
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[Phase I trial results show] Breast cancer vaccine safely generates anti-[HER2]tumor immunity
The vaccine used in this trial contained the DNA instructions for a part of the HER2 that is usually located within the cell. This intracellular portion is known to provoke stronger cytotoxic immune responses.
Sixty-six women who had metastatic cancer were enrolled in the study. All the women had completed a standard course of therapy and had either achieved complete remission or only had tumor remaining in their bone, which tends to grow slowly.
Although the study was not designed to see if the vaccine could slow or prevent progression of the cancer, the researchers noted that the participants have done much better than would be expected in patients with similar stages of breast cancer, about half of whom would be expected to die within 5 years of treatment.
"We've now followed these women for ten years and 80% of them are still alive," Disis noted.
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Dear debbew, wow, thanks, a very interesting trial indeed!
I wonder what portion of 66 women had breast cancer? To notice, they also have other interesting trials, one of them with alpha-TAE - to reverse HER2+ disease resistance to HER2 drugs, which looked very promising back in 2019. You can check them out here: https://www.uwcvi.org/clinical-trial-opportunities.
Saulius
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Saulius,
Just from the title, it looks like all the participants had metastatic breast cancer. Here's the abstract of the paper they published:
Safety and Outcomes of a Plasmid DNA Vaccine Encoding the ERBB2 [formerly called HER2] Intracellular Domain in Patients With Advanced-Stage ERBB2-Positive Breast Cancer
https://jamanetwork.com/journals/jamaoncology/arti...
Also, they added this to the article: [The phase II trial is recruiting patients; contact the research coordinator for more information: 206-543-3829.]
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Wow, without even looking at the link, I can tell you that that 206-543 phone number is for the University of Washington. I'm going to look at the stuff you've posted more in depth a little later. I'm just skimming this morning, as having some bad Letrozole muscle issues yesterday and today.
Debbew, thanks as always for posting these very interesting and informative links.
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Dear debbew, thanks, I know I sounded a bit stupid :)P asking about how many of 66 were MBC patients but what text states is "Sixty-six women who had metastatic cancer were enrolled in the study" and the trial recruited ovarian cancer patients too (https://clinicaltrials.gov/ct2/show/NCT00436254), so I got mixed up - means they did not recruit one ovarian cancer patient?:/ And one thing I don't understand why after having such success with stage IV NED in phase I they recruit only stage I-III HER2+ BCers in phase II, when their DFS, especially for stage I-II with today's anti-HER2 therapies, reaches >95%. Obviously the vaccine might be very effective but trial design is strange to me. Maybe there's some rationale behind it, I hope.
Again, I am very thankful that you reminded us of vaccine approach again. What was done to covid should/could be done to cancer too - harvesting our immune system (creating active immunity) to fight malignant cells is probably the only way to achieve an active controlling immunity for a long time or a cure. My wife got an anti-her2 dendritic cell vaccine in 2018-2020 (8 doses) and who knows - it might be the reason she is doing well today...
Saulius
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Lumpie, how are you? I haven't seen you in a while. I am worried.
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Longest follow-up of patients with early breast cancer shows radiotherapy does not improve survival after 30 years
https://medicalxpress.com/news/2022-11-longest-fol...
Also hoping to hear from Lumpie soon.
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Drug shows promise in overcoming endocrine therapy resistance in breast cancer
"Our mouse studies showed that OTX015 plus abemaciclib caused 50% greater tumor [harboring the Y537S mutations] reduction than fulvestrant plus abemaciclib," said Dr. Alluri.
According to Dr. Alluri, there are several BET inhibitors in early-stage clinical trials, including OTX015, which was shown to be safe in a phase 1 trial.
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Thanks for these as always, Debbew.
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Dear all, I stumbled up on an interesting article (https://www.science.org/content/blog-post/bacteria...). Well, I would not say it is completely new what they found there but question is what will they do further...
Saulius
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Fascinating study about the long term impact of radiotherapy - and personally applicable to me. I had radiation at age 38 following stage 1 cancer.
I guess some things I'm thinking about are the impact of improvements in radiation technology (and shielding organs from radiation), the impact of early recurrence on quality of life (as opposed to just longevity), and the impact of access to healthcare.
One thing that factored into my decision to go ahead with radiation was thinking about how incredibly stressful my diagnosis and treatment process was - even when my case overall was pretty best case scenario. Thinking about repeating it any sooner or more frequently than necessary was incredibly daunting. Also, I had been through periods of my life with patchy access to heath insurance and healthcare, and wasn't feeling super confident about the future. Now I'm slightly more confident about access to healthcare for me personally (based on the trajectory my career has taken) but possibly more pessimistic about access in general (in the USA.
I *think* - and I'd love to learn if I'm wrong - that by definition all the women in the study had access to ongoing screening and healthcare, and that this might have impacted the outcomes. I wonder if real life outcomes for a representative sample of women who might not have good insurance or access to good doctors would show a different outcome on average.
I also wonder that question when talking about mastectomy vs lumpectomy+radiation outcomes. I've sometimes thought that if I knew that I was unlikely to have access to good healthcare after my initial treatment, I should have opted for a mastectomy to minimize my reliance on access to screening, medical follow-up, etc.
Anyway, thank you again so much to the members who update this threat. It is incredibly valuable and meaningful.
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There is not a lot of press about this (perhaps a lesson learned) but for those who remember ErSO, SERA2 is System Oncology's next gen form of ErSO. They are looking for a partnering arrangement for this drug.
https://www.businesswire.com/news/home/20221206005...
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Thanks for posting this, Debbew. I do remember reading about ERSO. I was initially encouraged, but then read about how it would be 10 years at least, before it was ready for things like FDA approval and marketing. Then I read about what a flop the whole hype turned out to be. I'd like to be encouraged about this new one, but it too, even if it doesn't flop altogether like ERSO, will probably have to undergo years and years of human trials before any of us could ever actually take it and benefit. Obviously it's a good thing for the long run, but as I'm sure you understand, those of us with breast cancer are in serious need of more immediate help. Here's hopin'.
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For those with HER+, this looks interesting. I didn't quite get whether they think this would help with other types of breast cancer or not. As with all these studies, it's not a cure, but provides some hope, another option, and apparently without too many side effects. Years to go with more trials though, of course.
This is from a UW alumni newsletter that I get:
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TransCode Therapeutics Announces eIND Submission to US FDA for Planned First-in-Human Clinical Trial in Patients with Advanced Solid Tumors
"TTX-MC138 is designed to inhibit the pro-metastatic RNA, microRNA-10b, described as the master regulator of metastasis in a number of advanced solid tumors... In multiple preclinical murine [mouse] models of triple-negative breast cancer (TNBC), treatment with low-dose chemotherapy and TTX-MC138 eliminated pre-existing local metastases in 100% of treated animals representative of stage II/III metastatic cancer. In a more aggressive model representative of stage IV metastatic cancer, treatment with low-dose chemotherapy and TTX-MC138 resulted in elimination of distant metastases in 65% of animals treated."
This is just a submission to conduct a Phase 0 trial, to evaluate safety and mechanism of action using a low dose in up to 12 people, and not intended to show any therapeutic benefit. But in addition to moving this drug forward, the trial "could unlock the potential of a wide array of RNA-targeted therapeutics, since the TTX platform permits a modular drug design, centered around the same delivery vehicle but with different payloads."
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Happy new 2023 to everyone. Wow, dear debbew, that is extremely interesting. If it would be 65 % in humans also, we'd definitely take it! Saulius
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FDA Approved IND for CAR T Cell That Target Metastases-Causing Breast Cancer Tumor
The FDA approved an investigational new drug application (IND) that allows clinical trials to be done on MUC1*-CAR-1XX (huMNC2-CAR22; Minerva Biotechnologies) for patients with metastatic breast cancer. This is the first CAR T that targets muk 1 star ((MUC1*), huMNC2-CAR44).
MUC1* is a growth factor receptor that is responsible for driving the growth and metastasis of most solid tumor cancers. Investigators observed recently during their research that this transmembrane cleavage product may actually drive the growth of approximately 93% of breast cancers...
MUC1*-CAR-1XX has displayed early signs of safety and efficacy in this ongoing clinical trial. Patients have been shown to shift from progressive disease to stable disease and partial response. Further, CAR T cells are showing signs of expansion...
The CAR T cell is being studied as a treatment against multiple forms of metastatic breast cancers.
https://www.pharmacytimes.com/view/fda-approved-in...
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Dear debbew, uhh, good news - I got this trial in my bookmarks in 2020. It is interesting, if there are any phase 1 results somewhere?
Saulius
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When "we" are the studied.
I thought this was an interesting article. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9889398/
South Korean study of the frequency and topics of online communication based on Breast Cancer stage. They used data analysis of breastcancer.org forums. Some interesting lists of key words. They saw the same thing that I did as far as the population of users here, but their data is from 2021, so prior to the March 2022 glitchfest. Stage 4 community members really depend on what is done here, and earlier stage members tend to move on once treatment is done.
To me, it really elevates the importance of BCO having a healthy and functional experience. I'm still hopeful that promised upgrades can bring this resource back to being a reliable and usable place. It's going to take time to rebuild what we had. One of the statements in the article sticks out to me. "Depending on the stage of breast cancer, patterns change from informational to emotional." The purpose of BCO forums is indeed for support. Finding facts is much easier than finding and keeping a group of people going through a common and difficult experience.
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SarahMaude - Thanks for sharing such a good post. Their conclusions pretty well fit with my experience, and you are so right about how it will take some real time to get what we had again - even if they do actually fix things.
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[mouse study] Two-pronged immunotherapy eliminates [bone-only] metastatic breast cancer in mice
...The researchers investigated two models of human metastatic breast cancer in mice and found that the metastatic tumors were eliminated in mice that received a p38MAPK inhibitor and an immune therapy called an OX40 agonist, which binds and activates T cells. All these mice were still alive and tumor-free at least 80 days after treatment. Among mice receiving either of the two treatments alone, only about half of them were still alive 60 days after treatment.
Three different OX40 agonists are being investigated in phase 2 clinical trials for cancer, including breast cancer. And p38MAPK inhibitors have been investigated in a number of inflammatory disorders, including rheumatoid arthritis and chronic obstructive pulmonary disease.
"We are hopeful that our study will interest companies that make these drugs, so that we can work toward developing a clinical trial that could investigate this strategy in patients with metastatic breast cancer," Stewart said...
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Debbew - I saw this yesterday myself and almost posted it here. I've got some super bad pulled back muscles though, and am trying to reduce a lot of my activities overall. I'm still posting a bit (can't seem to stay away from this site for too long), but not quite as much as some days.
I was very encouraged when I read this ScienceDirect article, but as always it looks like it's light years away from anything that a lot of us might be able to benefit from. Also, we all know the risks and the side effects that can come with the immune therapy agents, but they never spoke to the possible side effects and risks of these T cell boosters, and the inhibitor.
I'd really like to see this turn into something seriously useful soon, but then I think of how promising ERso looked.
Here's hopin'!
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TransCode Therapeutics Announces IRB Approval for FDA Cleared First-In-Human [Phase 0] Clinical Trial
(If this sounds familiar, I posted about their applying for the approval a few months ago.)
…The planned [phase 0] clinical trial is to evaluate delivery of TransCode’s lead therapeutic candidate, TTX-MC138, to metastatic lesions in up to 12 cancer patients with advanced solid tumors. TTX-MC138 is designed to inhibit the pro-metastatic RNA, microRNA-10b, described as the master regulator of metastasis in a number of advanced solid tumors. TransCode believes that TTX-MC138 could become a treatment for many of these cancers…
The Company believes that TTX-MC138 has the potential to dramatically improve clinical outcomes in a range of cancers, including breast, pancreatic, ovarian and colon cancer, glioblastomas, and others. In a preclinical murine model of triple-negative breast cancer, treatment with low-dose chemotherapy and TTX-MC138 eliminated pre-existing local metastases in 100% of treated animals representative of stage II/III metastatic cancer. In a more aggressive murine model representative of stage IV metastatic cancer, treatment with low-dose chemotherapy and TTX-MC138 resulted in elimination of distant metastases in 65% of animals treated.
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Werewolf Therapeutics Publishes Preclinical Data on mWTX-330, an IL-12 INDUKINE™ Molecule, in Cancer Immunology Research
This article summarizes a paper recently published about preclinical research on mWTX-330 but the drug is already in a Phase 1 trial.
“IL-12 is a cytokine with broad stimulatory effects on various immune cell populations, having the ability to regulate antitumor immunity through numerous innate and adaptive immune pathways, but clinical administration has been limited due to serious toxicities when administered systemically,” said Cynthia Seidel-Dugan, Ph.D., Chief Scientific Officer of Werewolf and one of the article’s authors. “Our published preclinical data show that mWTX-330 generates potent anti-tumor immunity in mice by activating and restoring the metabolic health of tumor-infiltrating lymphocytes, with the potential to minimize the toxicity previously associated with systemic IL-12 administration.”
I can't summarize the summary without effectively copying the article, so use the link(s) to see the details.
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ASCO: Novartis pressures Lilly with Kisqali, targeting $3B opportunity in early breast cancer
[Article focus is on the pharma stocks involved, but the upshot is that new NATALEE study results show Kisqali (ribociclib, a CDK 4/6 inhibitor) as an additional adjuvent treatment for HR+/HER2- BC on top of hormone therapy can reduce the risk of recurrence by 25%. However, Verzenio (abemaciclib, another CDK 4/6 inhibitor) has already shown a 30% reduction in a similar study, monarchE) and has been approved for use in high risk cases. What is new with the NATALEE study is that Kisqali treatment also included a node-negative subgroup, which the monarchE study did not. The node-negative subgroup had an even higher reduction with Kisqali, 37%, though that wasn't statistically significant.]
https://www.fiercepharma.com/pharma/novartis-pressures-lilly-targeting-broader-use-adjuvant-kisqali-early-breast-cancer
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