NVAX's Covid Jab Shows 89.3% Efficacy In UK Trial, AZRX Awaits Data, FDA Lifts Hold On BLCM Trial

(RTTNews) - Today's Daily Dose brings you news about encouraging results of Novavax' Covid-19 vaccine candidate; FDA lifting the clinical hold on Bellicum's BPX-601 study; and near-term catalysts of Ayala Pharma and AzurRx.

Read on…

1. Will Ayala Pharma's Tenacity Pay Off?

Ayala Pharmaceuticals Inc. (AYLA) has dosed the first patient in its phase II clinical trial of AL101 for the treatment of patients with Notch-activated recurrent or metastatic (R/M) triple negative breast cancer.

The trial, dubbed TENACITY, is expected to initially enroll up to 26 patients with Notch-activated R/M TNBC whose disease has recurred or progressed after three or fewer lines of prior therapy. The preliminary data from the trial is expected to be reported by the end of 2021.

AYLA closed Thursday's trading at $12.94, down 4.85%.

2. AzurRx BioPharma to Report OPTION 2 extension study Data in Q1

AzurRx BioPharma Inc. (AZRX) has completed patient enrollment in the first cohort of its phase 2b OPTION 2 extension study evaluating immediate-release capsules of MS1819 for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis.

The Phase 2b OPTION 2 trial extension arm is currently dosing patients at clinical trial sites in the U.S. and Europe who have participated in the previous arms of the OPTION 2 trial. The company expects to report topline data by the end of first quarter 2021.

AZRX closed Thursday's trading at $1.50, down 8.54%.

3. FDA Lifts Clinical Hold on Bellicum's BPX-601 Trial

The FDA has lifted the clinical hold on Bellicum Pharmaceuticals Inc.'s (BLCM) phase I/II dose-escalation clinical trial evaluating BPX-601 and Rimiducid in patients with previously treated metastatic pancreatic or prostate cancer.

The phase I/II dose-escalation trial of BPX-601 was slapped with a clinical hold last month, following the death of a pancreatic cancer patient in the study. The patient death was classified as unrelated to BPX-601 by the company then.

Now, with the company satisfactorily addressing all clinical hold issues, the trial hold has been lifted, paving way for Bellicum to resume enrollment without modification to the current study protocol. The company plans to work with clinical investigators to resume patient enrollment.

Last October, Bellicum announced interim data from its BPX-601 Cohort 5C dose-escalation phase I/II clinical trial in patients with relapsed/refractory metastatic pancreatic cancer. BPX-601 followed by repeat Rimiducid dosing was tolerated and exhibited evidence of Rimiducid-mediated CAR-T cell activation in the first four patients treated, according to the company. However, clinically meaningful efficacy as measured by RECIST criteria was not observed.

BLCM closed Thursday's trading at $3.84, down 1.03%. In after-hours, the stock was up 65.89% at $6.37.

4. Novavax Covid-19 Jab Hits Key Goal

Shares of Novavax Inc. (NVAX) were up nearly 27% in extended trading Thursday, on news that its protein-based COVID-19 vaccine candidate, NVX-CoV2373, met the primary endpoint in a phase III trial conducted in the UK.

The study enrolled more than 15,000 participants between 18-84 years of age, including 27% over the age of 65. In the treatment group, two doses of NVX-CoV2373 were administered 21 days apart.

According to the first interim analysis, 56 cases of COVID-19 were observed in the placebo group compared to 6 cases that were reported in the NVX-CoV2373 group, resulting in an efficacy rate of 89.3%.

The UK variant strain was detected in over 50% of the symptomatic cases (32 UK variant, 24 non-variant, 6 unknown). The efficacy of the vaccine candidate by strain was calculated to be 95.6% against the original COVID-19 strain and 85.6% against the UK variant strain, the company added.

Novavax also announced encouraging results of its phase IIb study of NVX-CoV2373 vaccine conducted in South Africa.

This study enrolled over 4,400 patients beginning in August 2020, and approximately 1/3 of the patients enrolled were seropositive, demonstrating prior COVID-19 infection at baseline.

According to the trial results, 60% efficacy for the prevention of mild, moderate and severe COVID-19 disease was observed in the 94% of the study population that was HIV-negative. Twenty-nine cases were observed in the placebo group and 15 in the vaccine group. One severe case occurred in the placebo group and all other cases were mild or moderate.

The clinical trial also achieved its primary efficacy endpoint in the overall trial population, including HIV-positive and HIV-negative subjects - demonstrating an efficacy of 49.4%.

Another phase III trial evaluating NVX-CoV2373 with Matrix-M in subjects 18 years of age and older compared with placebo, dubbed PREVENT-19, is underway in the US and Mexico. The company expects to complete its targeted enrollment of 30,000 patients in the PREVENT-19 trial in first half of February.

NVAX closed Thursday's trading at $134.01, up 2.16%. In after-hours, the stock was up 26.93% at $170.10.

5. Stocks That Gained/Lost The Most

Lianluo Smart Limited (LLIT) closed Thursday's trading at $9.98, up 59.94%.

Armata Pharmaceuticals Inc. (ARMP) closed at $5.07, up 37.77%.

Cancer Genetics Inc. (CGIX) closed at $4.80, up 37.14%.

Accelerate Diagnostics, Inc. (AXDX) closed at $10.33, down 31.11%.

CEL-SCI Corporation (CVM) closed at $19.44, down 22.40%.