announced new preclinical data from ARX517 and ARX305 studies at the 2023 American Association for Cancer Research (AACR) Annual Meeting.
The stability of ARX517 was demonstrated in a non-human primate (monkey) study.
Pharmacokinetic measurements confirm the high stability of ARX517 in circulation with an extended half-life of 11 or 15 days.
The main metabolite of ARX517 cytotoxic linker payload, pAF-AS269, was barely measurable (0.2 ng/mL) in the serum in a repeat dosing study.
At the highest non-severely toxic dose (HNSTD), ARX517 serum exposure was greater than ARX517 exposure at a pharmacologically active dose in mice, showing a clear therapeutic index.
In an enzalutamide-sensitive mouse model of prostate cancer, ARX517 demonstrated anti-tumor activity. Further, the combination of 3 mg/kg ARX517 plus 10 mg/kg enzalutamide delivered an 86% reduction in tumor size.
In an enzalutamide-resistant prostate cancer model, three weekly doses of 3 mg/kg of ARX517 significantly inhibited tumor growth by 79% in a dose-dependent manner.
Ambrx is investigating ARX517 in the APEX-01 Phase 1 study in adult subjects and enrolling patients with advanced prostate cancer whose tumors have progressed following at least two FDA-approved treatments.
In a renal cell carcinoma (RCC, 786-OS3) xenograph model, ARX305 dose-dependently inhibited tumor growth and outperformed sunitinib.
In another RCC (Caki-1) xenograph model, weekly administration of ARX305 resulted in significant, dose-dependent, anti-tumor activity.
Pharmacokinetic studies of ARX305 in mice confirm the high ADC stability in circulation with a long terminal half-life of 16.5 days.
announced that the safety of SON-1010 dosing has been formally reviewed in both the current Phase 1 clinical trials, and the company is now enrolling the final dose cohort in the cancer trial.
Of the 15 patients from the first five cohorts of SB101 evaluable for follow-up at this latest cutoff, 9 had stable disease at the first follow-up scan, 4 of which were already progressing at study entry.
At four months of follow-up, 5 of 14 patients remained stable at the second scan, suggesting the clinical benefit of SON-1010 in 36% of patients.
The first patient dosed with an aggressive endometrial sarcoma had target tumor shrinkage with complete resolution of ascites at one point and has been clinically stable for nearly a year.
SON-1010 has been safe and tolerable at all doses tested to date, with adverse events generally mild/moderate in intensity and transient.
Chardan Capital maintains a Buy rating on the stock with a price target of $17, down from $22.
An estimated 77% of Americans are engaging in addictive behaviors to cope with mental health issues — often in spite of efforts to find effective clinical therapies.
The GeneSight Mental Health Monitor study, conducted by Myriad Genetics in Salt Lake City, Utah, counted several potentially high-risk behaviors among those used to cope with anxiety and depression, including alcohol use, drug use, gambling, food consumption, binge-watching media, oversleeping, excessive exercise and partying.
Notably, even those who have actively sought mental health care are turning to the aforementioned habits to cope as a result of medication failure or other ineffective treatments.
And nearly all those surveyed — 94% — agree that these addictions could also be covering up underlying mental health issues.
“Many of my patients have struggled with depression and/or anxiety but failed to find a treatment that made them feel better. So, they resorted to alcohol, drugs or destructive behaviors to soothe themselves, as these offered short-term relief,” Dawn Johnson, a psychiatric mental health nurse practitioner at the Indiana Center for Recovery in South Bend, said in a news release.
“However, this behavior resulted in worsening mental health and destruction of their lives.”
Fifty-eight percent of participants diagnosed with depression and/or anxiety shared that proper mental health treatment helped alleviate any concerns about addiction.Myriad Genetics, Inc.
Two-thirds of survey participants with anxiety or depression have gone through a trial-and-error process of finding a medication that works for them. Unfortunately, 45% of the patients for whom meds didn’t work admitted to falling back on the aforementioned unhealthy behaviors to manage their illness.
For example, 77% of respondents diagnosed with depression or anxiety agreed that drinking alcohol solo is an addictive and unhealthy coping behavior, despite the fact that 41% of them keep up the unhealthy habit, while just a quarter of those who heavily drink alone acknowledged that they might have a problem.
Other respondents diagnosed with depression and anxiety confessed to sleeping too much or too little (70%), withdrawing from social activities (64%), binge-watching TV or movies (49%) and skipping work, school or household responsibilities (48%) to cope with psychological stress.
Many view behaviors such as alcohol use, marijuana use, drug use, gambling, food consumption, sleeping, exercise, digital behavior, binge-watching TV or movies, clubbing or partying as addictive or unhealthy, but still confess to using them.Myriad Genetics, Inc.
More than half of depression or anxiety patients, 58%, who were told they have a problem believe that proper mental health treatment helped alleviate any concerns about addiction.
At the Indiana Center for Recovery, Johnson uses genetic testing to determine how her patients might react to various medications prescribed for mental health conditions, such as not being able to metabolize the drugs properly, not experiencing any symptom relief or experiencing unwanted side effects.
“The GeneSight report reassures them that we’re not just throwing medications at them, we’re actually customizing their plan based on their genetic makeup,” she explained.
A nationwide survey discovered that 77% of Americans admit to using at least one addicting behavior and/or unhealthy coping mechanism to deal with mental health issues.Myriad Genetics, Inc. “Mental health and addiction often go hand-in-hand,” said Morgan Freas, a senior medical science liaison with Myriad Genetics. “Yet the stigma associated with admitting mental health challenges is often greater than escaping into substance or behavioral abuse.”
