Phase 1/2 Study of ESSA Lead Candidate Combo at Prostate Cancer Foundation Meet

 EPI-7386 in combination with enzalutamide was safe and well-tolerated at the doses tested with clinically relevant drug exposures and deep and durable prostate specific antigen ("PSA") reductions observed in five of six patients

ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, today announced the presentation of updated clinical data from the first two cohorts of the Phase 1/2 study of ESSA's lead candidate EPI-7386 in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer ("mCRPC"). Data will be presented in a poster format at the 2022 Prostate Cancer Foundation ("PCF") Scientific Retreat, taking place October 27-29, 2022 in Carlsbad, CA.

In the multicenter, open-label Phase 1/2 dose escalation study, seven mCRPC patients naïve to second generation antiandrogens were enrolled in the first two cohorts, with escalating doses of EPI-7386 and a fixed 120mg once a day (QD) dose of enzalutamide. The study permitted one prior line of chemotherapy. Pharmacokinetic results from these first two cohorts demonstrated that enzalutamide exposure was minimally impacted by EPI-7386 while exposures of EPI-7386 were reduced by coadministration with enzalutamide, but remained in the clinically relevant range as suggested by preclinical xenograft studies. The safety of the combination was favorable with a safety profile consistent with second-generation antiandrogens and no dose limiting toxicities observed. One of the patients in the first cohort discontinued after one cycle of dosing due to a strong CYP3A inducer concomitant medication which lowered exposures to both EPI-7386 and enzalutamide and was therefore not evaluable for efficacy. Anti-tumor activity in the remaining six patients enrolled demonstrated that four of six of these patients achieved a PSA90 by 12 weeks of dosing and five of six patients to date have achieved a PSA90.

https://finance.yahoo.com/news/updated-results-phase-1-2-110000290.html

TransCode: Positive Preclinical Results for Lead Candidate, TTX-MC138, in Pancreatic Adenocarcinoma

 TransCode Therapeutics, Inc. (Nasdaq: RNAZ), an RNA oncology company committed to more effectively treating cancer using RNA therapeutics, today reported Positive Preclinical Results with its Lead Candidate, TTX-MC138, in Pancreatic Adenocarcinoma.

TransCode Therapeutics evaluated the bioactivity of its lead therapeutic candidate, TTX-MC138, applied as monotherapy, in a murine model of pancreatic adenocarcinoma. In the study, mice bearing human pancreatic tumors implanted in their pancreas were treated once weekly for 10 weeks with TTX-MC138. The drug demonstrated a pharmacodynamic response by successfully inhibiting its target, microRNA-10b (miR-10b), as measured by qRT-PCR, a commonly used assay for measuring gene expression. Serum miR-10b, a possible surrogate biomarker of therapeutic efficacy, was down-regulated by TTX-MC138 in this study. Forty percent of animals treated with TTX-MC138 had complete responses, defined as complete regression of disease and long-term survival without recurrence. Additional studies to better define the optimal dose and therapeutic window in pancreatic cancer are ongoing.

https://finance.yahoo.com/news/transcode-therapeutics-reports-positive-preclinical-110000803.html

Were US Citizens Tracked Via Secret 'COVID Decree Violation' Scores?

 by Paul Joseph Watson via Summit News,

Tens of millions of US citizens were given a “COVID-19 decree violation” score as a result of a data harvesting program conducted during the first lockdown by voter analytics firm PredictWise.

“These Covid-19 decree violation scores were calculated by analyzing nearly two billion global positioning system (GPS) pings to get “real-time, ultra-granular locations patterns.” People who were “on the go more often than their neighbors” were given a high Covid-19 decree violation score while those who mostly or always stayed at home were given a low Covid-19 decree violation score,” writes Reclaim the Net’s Tom Parker.

The data collected was then used by PredictWise to help Democrats target over 350,000 “COVID concerned” Republicans with campaign ads relating to virus prevention measures.

“PredictWise understood that there were potential pockets of voters to target with Covid-19 messaging and turned high-dimensional data covering over 100 million Americans into measures of adherence to Covid-19 restrictions during deep lockdown,” the company states in its white paper.

This information was used to help identify 40,000 “persuasion targets” for Senate candidate Mark Kelly, who was subsequently elected.

As we highlighted throughout the COVID lockdowns, chilling components of the surveillance grid were weaponized against ordinary people.

At one point, a senior government minister in Australia refused to rule out citizens being forced to wear electronic ankle bracelets, even if they were fully vaccinated, to make sure they were complying with home quarantine orders.

Conservative MP Jeremy Hunt, who was recently promoted to become Chancellor of the Exchequer, called for the government to use GPS tracking technology to ensure Brits were complying with COVID quarantine measures.

“Daily contact with those asked to self-isolate – using GPS tracking to monitor compliance if necessary as happens in Taiwan and Poland,” said Hunt.

Police in the UK also used surveillance drones to monitor and threaten people who dared to go out into remote countryside to walk their dogs.

In Australia, tracking drones were deployed to catch people who didn’t wear masks outside and to keep track of cars that traveled further than 5km from home.

https://www.zerohedge.com/political/us-citizens-were-tracked-secret-covid-decree-violation-scores

Jaguar Health: Publication in Breast Cancer Research and Treatment of Investigator-Initiated Phase 2

 Results of the study provide the first proof-of-concept data for potential use of crofelemer - a novel, oral, plant-based, non-opioid antidiarrheal prescription medication - in breast cancer patients

Jaguar Health Inc. (NASDAQ:JAGX) and its wholly owned subsidiary Napo Pharmaceuticals today announced the publication in the peer reviewed journal Breast Cancer Research and Treatment of the results of the investigator-initiated HALT-D trial evaluating crofelemer for preventing chemotherapy-induced diarrhea (CID) in HER2-positive breast cancer patients being treated with trastuzumab, pertuzumab and a taxane. These therapies cause CID in up to 80% of breast cancer patients, reaching grade 3, which often requires hospitalization, in 8-12% of patients. No antidiarrheal medications are currently approved that specifically target the underlying mechanism of CID.

https://www.biospace.com/article/releases/jaguar-health-announces-publication-in-breast-cancer-research-and-treatment-of-investigator-initiated-phase-2-halt-d-study-of-crofelemer-for-prevention-of-chemotherapy-induced-diarrhea-cid-in-breast-cancer-patients/

AcelRx: Presentation of Investigator-Initiated Trial Results

 Brigham and Women's Hospital study found that SST-treated patients had significantly lower pain scores in the post-operative care unit (PACU) compared with patients in the two intravenous opioid control groups following major spine surgery

AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that the results of a 190-patient, investigator-initiated trial conducted at Brigham and Women's Hospital in Boston, MA, entitled, "The Impact of Sublingual Sufentanil on Postoperative Pain Control in Patients Undergoing Spine Surgery" (abstract # A4262), was presented at the ANESTHESIOLOGY® 2022 annual meeting, held October 21-25, 2022 in New Orleans, LA. The study found that patients who underwent major spine surgery had significantly lower reported postoperative pain scores when treated with sufentanil sublingual tablet (SST), 30 mcg (DSUVIA®) versus intravenous (IV) opioids.

The senior author of the study was Richard Urman M.D., Associate Professor and Founding Co-Director, Center for Perioperative Research, Department of Anesthesiology at Brigham and Women's Hospital. The study was an Institutional Review Board (IRB)-approved, prospective trial comparing an SST-treated cohort (n=30) with a two-arm (n=80 each) historical matched control. Study inclusion criteria consisted of patients 18 years or older undergoing spine surgery (up to 3 levels) and a planned inpatient stay.  Both the prospective arm and two retrospective control arms received standard general anesthetic, except the prospective SST arm received intraoperative sufentanil IV infusion and an initial dose of SST immediately following extubation.  SST was re-dosed as needed, no more than hourly, in the postoperative care unit (PACU) for numeric rating scale (NRS) pain scores of greater than 3 out of 10. Hydromorphone IV bolus was used for breakthrough pain not controlled by SST. Control Arm 1 received intraoperative remifentanil IV infusion and Control Arm 2 received intraoperative sufentanil IV infusion and both received hydromorphone IV bolus as the primary analgesic in the PACU as needed for NRS scores of greater than 3. A multi-variable linear regression adjustment and an inverse probability of treatment weighting was used to measure the effectiveness of SST in decreasing postoperative pain scores in the PACU as the primary outcome.

A total of 190 patients were analyzed and demographics were relatively similar among the groups. As a result of the linear regression model, adjusting for age, sex, BMI, ASA classification, surgical invasiveness, and medication history, the authors found that patients in the study group who received SST experienced statistically significantly lower pain scores in the PACU compared with the two IV opioid control groups (p<0.001). The SST group had a mean ± standard deviation NRS score of 3.2 ± 2.4, whereas the remifentanil/hydromorphone group averaged an NRS score of 5.7 ± 2.2 and the sufentanil/hydromorphone group averaged an NRS score of 5.0 ± 2.4.

The authors concluded that use of SST appears to be an effective alternative analgesic therapy in spine surgery patients who experience moderate to severe postoperative pain resulting in improved pain scores in the PACU, and, that further analysis of the data will examine the impact on postoperative opioid consumption and hospital length of stay.

https://www.biospace.com/article/releases/acelrx-pharmaceuticals-announces-presentation-of-investigator-initiated-trial-results-comparing-acelrx-s-sufentanil-sublingual-tablet-sst-versus-intravenous-opioids-for-postoperative-pain-at-the-anesthesiology-annual-meeting-2022/

Anixa Starts Phase 1b Trial of Breast Cancer Vaccine at Cleveland Clinic

  Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, today announced the initiation of a Phase 1b trial for its preventative breast cancer vaccine. The study is being conducted at Cleveland Clinic and will evaluate safety and monitor immune response. 

This novel study, funded by a grant from the U.S. Department of Defense, has begun recruitment of healthy, cancer-free participants at high risk for developing breast cancer who have decided to undergo voluntary bilateral mastectomy to lower their risk.  Typically, those women carry mutations in the BRCA1 or related genes and are therefore at risk of developing triple-negative breast cancer or have high familial risk for any form of breast cancer.  During the course of the study, participants will receive three vaccinations, each two weeks apart, and will be closely monitored for side effects and immune response. The study is estimated to be completed by the end of 2023.

A Phase 1a trial of this vaccine is currently ongoing. The Phase 1a study includes patients who have completed treatment for early-stage, triple-negative breast cancer within the past three years and are currently tumor-free but at high risk for recurrence.

https://www.biospace.com/article/releases/anixa-biosciences-announces-commencement-of-phase-1b-trial-of-its-breast-cancer-vaccine-at-cleveland-clinic/

Seres: FDA OKs Application for Microbiome Therapeutic SER-109 for Recurrent C. Difficile

 If approved, SER-109 expected to be the first-ever FDA-approved oral microbiome therapeutic –

– PDUFA target action date is April 26, 2023, with anticipated launch soon thereafter –

– FDA advised that they are not currently planning to hold an Advisory Committee Meeting to discuss the SER-109 application –

– Company to hold commercial investor event on December 8, 2022 

https://finance.yahoo.com/news/seres-therapeutics-announces-fda-acceptance-110000650.html