Today’s Daily Dose brings you news about encouraging data related to AC Immune’s vaccine candidate ACI-35.030 for the treatment of Alzheimer’s disease; ESSA Pharma’s prostate cancer trial results; GenMark’s near-term catalyst; Infinity’s urothelial cancer trial data; and Monopar’s imaging agent to Improve surgical outcomes in bladder cancer.
1. AC Immune Is Taking A Shot At Treating Alzheimer’s
AC Immune SA’s (ACIU) ongoing Phase 1b/2a clinical trial evaluating its first-in-class anti-phospho-Tau (pTau) vaccine candidate ACI-35.030 for the treatment of Alzheimer’s disease has yielded positive interim results.
One of the key pathological features of Alzheimer’s is the accumulation of phosphorylated tau (pTau).
According to the interim results from the first two dosing groups, ACI-35.030 vaccination generated a potent antigen-specific antibody response against pTau in 100% of older patients with early Alzheimer’s. ACI-35.030 was safe and well tolerated with no clinically relevant safety concerns observed to date.
Now that the first two doses of the ACI-35.030 vaccine have generated encouraging results, the third and highest dose is all set to be tested.
AC Immune is developing the ACI-35.030 vaccine in collaboration with Janssen Pharmaceuticals, Inc. under a 2014 licensing agreement signed between the two companies.
ACIU closed Thursday’s trading at $8.43, up 15.32%.
2. ESSA Pharma Soars On Positive Preliminary Prostate Cancer Trial Results
Shares of ESSA Pharma Inc. (EPIX) jumped to a new high on Thursday, following encouraging preclinical and preliminary clinical data from a Phase 1 study evaluating EPI-7386 in patients with metastatic castration-resistant prostate cancer who have become resistant to standard of care treatments.
In preclinical trials, EPI-7386 was well-absorbed, demonstrated high exposure levels and was confirmed to have a long half life of at least 24 hours.
According to the company, in the initial cohort of patients receiving the 200 mg once-daily dose EPI-7386 in the phase I trial, the drug candidate was well-tolerated with no serious adverse events observed.
Even with the 200 mg dose, one out of three patients who completed 12 weeks of EPI-7386 therapy experienced a prostate specific antigen (“PSA”) decline of more than 50 percent after three cycles of EPI-7386 therapy (12 weeks) with ongoing continued PSA declines continuing through six cycles of therapy, despite previously having failed enzalutamide and abiraterone acetate.
The company recently completed the 28-Day safety evaluation period for the 400mg dose cohort and is currently dosing patients in the 600 mg cohort.
The company will be providing more clinical data on the progress of the phase I study of EPI-7386 in metastatic castration-resistant prostate cancer in the second half of 2021.
EPIX closed Thursday’s trading at $28.65, up 47.91%.
3. GenMark Hits New High
Shares of GenMark Diagnostics Inc. (GNMK) closed at a 5-year high of $22.45, up more than 33%, as the company gears up to release its fourth quarter and full year earnings results after market close on Thursday, February 25, 2021.
The company markets ePlex, a multiplex, sample-to-answer platform that is designed to optimize laboratory efficiency and address a broad range of infectious disease testing needs, including respiratory, bloodstream, and gastrointestinal infections, in the United States, Europe, and certain other geographic regions.
The company expects total revenue to be approximately $50 million for the fourth quarter of 2020 and $171 million for the full year 2020, well above analysts’ estimates.
Analysts polled by Thomson Reuters expect the company to report revenue of $46.56 million in the fourth quarter and $168.1 million for full year 2020. The total revenue was $27.2 million in fourth quarter of 2019 and $88 million in full year 2019.
GNMK closed at $22.45, up 33.16%.
4. Infinity’s Eganelisib Addition To Opdivo Demonstrates Encouraging Data In Urothelial Cancer
Infinity Pharmaceuticals Inc. ‘s (INFI) Phase 2 study evaluating the efficacy and safety of its investigational drug Eganelisib in combination with Bristol Myers Squibb’s Opdivo in platinum-refractory, I/O naïve patients with advanced urothelial cancer has demonstrated encouraging data.
The combination of Eganelisib with Opdivo resulted in an increase in overall response rate of 35% and disease control rate of 55% in advanced urothelial cancer patients. The overall response rate was 25% and disease control rate was 31% with Opdivo monotherapy, the approved second line standard of care. There was also a 46% lower probability of progression on combination arm versus control arm in PD-L1 negative patient population representing the majority of metastatic urothelial cancer patients.
Program death ligand-1 (PD-L1) is a cell membrane protein that is expressed in several types of tumor cells, including urothelial cancer.
Based on the strength of the data and the magnitude of the unmet need in the PD-L1 low population, the company is planning a registration-enabling study with Eganelisib in advanced urothelial cancer.
INFI closed Thursday’s trading at $4.47, up 13.16%.
5. Monopar Catches Eyes
The potential utility of Monopar Therapeutics Inc.’s (MNPR) MNPR-101 as an imaging agent to Improve surgical outcomes in bladder cancer has been published in a peer-reviewed study in the European Journal of Cancer.
MNPR-101, a multimodal imaging probe was developed and tested in vivo in human bladder cancer models. According to the Journal, high expression of uPAR in bladder cancer is localized at the tumor periphery, suggesting that using a fluorescent-conjugated MNPR-101 probe might allow surgeons to better visualize the borders of the tumor, potentially resulting in more complete tumor resection and thereby minimizing relapse. Similar approaches have been utilized successfully in the resection of other tumor types, such as breast cancer.
“If confirmed in a clinical setting, an imaging probe based on MNPR-101 could result in a paradigm shift, altering how urologists survey and treat bladder cancer,” said Cornelis Sier, PhD, member of the Image-Guided Surgery group at Leiden University Medical Center (LUMC), and the principal investigator on the study.
MNPR closed Thursday’s trading at $10.60, up 26.19%.
6. Stocks That Gained/Lost The Most In A Day
Ayala Pharmaceuticals Inc. (AYLA) closed Thursday’s (Feb.11, 2021) trading at $19.95, up 53.46%.
ADiTx Therapeutics Inc. (ADTX) closed at $5.26, up 28.29%.
DermTech Inc. (DMTK) closed at $66.75, up 25.82%.
Anchiano Therapeutics Ltd. (ANCN) closed at $4.81, down 39.57%.
Zynerba Pharmaceuticals Inc. (ZYNE) closed at $6.11, down 30.25%.
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