OBI Pharma bags FDA Orphan Drug Designation for cancer drug, OBI-999
Category: #health  By Saipriya Iyer  Date: 2019-12-27
  • share
  • Twitter
  • Facebook
  • LinkedIn

OBI Pharma bags FDA Orphan Drug Designation for cancer drug, OBI-999

Taiwan-based biopharmaceutical firm, OBI Pharma, Inc. has reportedly been granted the Orphan Drug Designation by the U.S. FDA (Food and Drug Administration) for Pancreatic Cancer treatment OBI-999. Sources claim that the Phase 1/2 clinical trial of OBI-999 was commenced at the University of Texas M.D. Anderson Cancer Center in patients with locally advanced or metastatic solid tumors, including pancreatic, colorectal, gastric, and esophageal cancers.

The trial aimed at verifying the preliminary efficacy and safety of OBI-999 in patient who are already diagnosed with per protocol tumor types, including pancreatic and colorectal, cancers of high unmet clinical needs.

According to a statement, Tillman Pearce, CMO, OBI Pharma, said that their firm is thrilled about the potential value of OBI-999 that it would provide to patients with pancreatic cancer, given to the high potency observed using OBI-999 in pancreatic cancer xenograft models.

Pancreatic cancer usually originates in the endocrine or exocrine pancreatic cells and is likely to be caused by smoking, poor diet, and genetic factors. It is a deadly disease that reportedly affects around 69,839 people in the U.S. with a survival rate of only 8.5% at five years. Its treatment options are limited to surgical resection for patients with early stages of pancreatic cancer and may only have a five-year survival rate of up to 34.3%.

Meanwhile, as a potential treatment, OBI-999 is a first-in-class ADC (Antibody Drug Conjugate) with exclusive linker technology that offers consistent DAR (Drug-to-Antibody ratio) for cancer treatment that is based on Globo H.

The drug makes use of Globo H antibody to focus on cancer cells the possess higher Globo H expression. By letting out a small molecule chemotherapeutic drug through the specificity of the antibody, OBI-999 directly deploys cytotoxic therapy at the targeted cancer cells.

Source Credit: https://finance.yahoo.com/news/obi-pharma-granted-fda-orphan-100000544.html?guccounter=1



About Author

Saipriya Iyer

Email: [email protected]   

Saipriya Iyer

Saipriya Iyer develops content for Market Size Forecasters, Algosonline, and myriad other platforms. A computer engineer by profession, she ventured into the field of writing for the love of playing with words. Having had a previous experience of 3 years under her bel...

Read More

More News By Saipriya Iyer

New Medtronic Micra AV pacemaker receives approval from the U.S. FDA
New Medtronic Micra AV pacemaker receives approval from the U.S. FDA
By Saipriya Iyer

Medtronic plc, a renowned US-based medical device company, reportedly announced that its Micra AV pacemaker has received approval from the U.S. FDA. The Medtronic Micra AV is the world’s smallest pacemaker with A...

Health Canada grants two DIN to new Tetra Bio-pharma OTC products
Health Canada grants two DIN to new Tetra Bio-pharma OTC products
By Saipriya Iyer

Tetra Bio-pharma, a renowned Canadian biopharmaceutical company, reportedly announced that Health Canada, the regulatory health authority of Canada, has granted two new DIN (Drug Identification Numbers) for the first O...

Digital River & Magento team-up to create customized commerce solution
Digital River & Magento team-up to create customized commerce solution
By Saipriya Iyer

Digital River, a renowned global ecommerce facilitator for well-known and fast-growing brands, has reportedly signed a new strategic partnership deal with Magento, a leading provider of commerce innovations to retailer...