FPRX Takes Flight On FIGHT Data, AGTC To Report XLRP Trial Results, PDSB To Advance COVID-19 Vaccine

biotech nov11

Today's Daily Dose brings you news about Five Prime's encouraging results from its FIGHT trial of gastric or gastroesophageal junction cancer, PDS Biotech and Farmacore advancing their COVID-19 vaccine candidate into human clinical trials, and impressive third-quarter results of 1Life Healthcare.

Read on…

1. Applied Genetic To Report New Data on XLRP Trial

Applied Genetic Technologies Corp. (AGTC) is all set to release certain data from its phase I/II trial of its Adeno-associated virus-based gene therapy product candidate AGTC-501 for the treatment of X-linked retinitis pigmentosa on November 11.

The ongoing trial involves 6 dose groups and 28 patients.

The results that are to be announced Wednesday are the 12-month data for Groups 1 through 4 evaluating durability of effect and continued safety and interim data of Groups 5 and 6 evaluating safety and efficacy at higher doses of AGTC-501.

X-linked retinitis pigmentosa, or XLRP, which is associated with degeneration of rods and cones, leads to early night blindness and progressive constriction of visual fields. This rare disease affects an estimated 20,000 patients in the U.S. and the EU.

AGTC closed Tuesday's trading at $5.65, up 4.44%. In after-hours, the stock was up 1.95% at $5.76.

2. Five Prime Soars Through The Roof On FIGHT Data

Shares of Five Prime Therapeutics Inc. (FPRX) were up an impressive 350% in extended trading Tuesday, following positive topline results from a phase II trial of its drug candidate Bemarituzumab in patients with fibroblast growth factor receptor 2b-positive (FGFR2b+), HER2-negative front-line advanced gastric or gastroesophageal junction (GEJ) cancer, dubbed FIGHT.

Bemarituzumab is a first-in-class targeted antibody that blocks fibroblast growth factors (FGFs) from binding and activating FGFR2b. Blocking FGFR2b activation is believed to slow cancer progression.

The FIGHT trial enrolled 155 patients in 15 countries across Asia, the European Union, and the United States, and all three efficacy endpoints - progression-free survival, overall survival, and overall response rate - met pre-specified statistical significance.

FGFR2b is overexpressed in numerous other cancers, including squamous non-small-cell lung cancer (NSCLC), triple negative breast cancer (TNBC), ovarian cancer, pancreatic cancer and intrahepatic cholangiocarcinoma. The FIGHT trial data points to additional potential areas for development of Bemarituzumab beyond gastric and gastroesophageal junction cancer, the company noted.

FPRX closed Tuesday's trading at $5.34, down 2.73%. In after-hours, the stock soared 350% to $24.03.

3. PDS Biotech, Farmacore to Move COVID-19 Vaccine Candidate into Human Trials

PDS Biotechnology Corp. (PDSB) and Brazil-based Farmacore Biotechnology are advancing PDS0203, a Versamune-based vaccine aimed at preventing COVID-19 infection into human clinical trials.

PDS Biotechnology's proprietary Versamune T-cell activating technology platform is designed to effectively deliver disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies.

Given the fact that PDS0203 has shown promising results in preclinical studies, PDS Biotech and Farmacore have jointly prioritized advancement of PDS0203 to human clinical trials.

The companies had a successful pre-investigational new drug meeting with the Brazilian Health Regulatory Agency on November 6, and a phase 1/2 human clinical trial protocol has been agreed upon.

The phase I/II trial of PDS0203 for the prevention of COVID-19 is expected to begin during the first half of 2021.

PDSB closed Tuesday's trading at $2.11, up 3.43%. In after-hours, the stock gained another 1.42% to $2.14.

4. 1Life Healthcare Q3 Results Trump Estimates, Issues Upbeat Outlook

Shares of 1Life Healthcare, Inc. (ONEM) were up over 9% in extended trading Tuesday, following better-than-expected third quarter results and rosy outlook.

1Life Healthcare is a membership-based health care platform offering digital health.

For the third quarter ended September 30, 2020, net loss attributable to the company was $16.41 million or $0.13 per share on net revenue of $101.7 million. Wall Street analysts were expecting a loss of $0.19 per share and revenue of $86.18 million.

This compares with a net loss attributable to the company of $15.27 million or $0.82 per share and net revenue of $69.6 million in the third quarter of 2019.

Looking ahead, the company expects net revenue to be in the range of $104 million to $109 million in the fourth quarter of 2020, and in the range of $362 million to $367 million for the full year of 2020. Analysts polled by Thomson Reuters are expecting net revenue of $90.9 million in the fourth quarter and $333.88 million for full year.

ONEM closed Tuesday's trading at $32.92, up 1.73%. In after-hours, the stock was up 9.36% at $36.00.

5. Stocks That Hit New Highs/Lows

Community Health Systems Inc. (CYH) closed Tuesday's trading at a new high of $9.78, down 0.10%.

Stoke Therapeutics Inc. (STOK) closed at a new high of $46.57, up 9.52%.

ShockWave Medical Inc. (SWAV) closed at a new high of $86.68, up 5.71.

SOC Telemed Inc (TLMD) closed at a new low of $8.22, down 6.48%.

Qualigen Therapeutics Inc. (QLGN) closed at a new low of $3.38, down 5.59%.

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