PharmAbcine Announces FDA Orphan Drug Designation Granted to TTAC-0001 for Glioblastoma Multiforme
PharmAbcine Inc., a clinical-stage biotech company developing novel antibody therapeutics for multiple cancer indications, announced today that U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its leading clinical compound TTAC-0001 for “treatment of Glioblastoma Multiforme.”
“We are very pleased with this Orphan Drug Designation from FDA for TTAC-0001 for GBM treatment since we have been preparing for clinical studies of TTAC-0001 plus KEYTRUDA® (pembrolizumab) combo therapy for recurrent GBM in addition to TTAC-0001 mono therapy for recurrent GBM progressed after bevacizumab treatment. It will accelerate the progress of TTAC-0001 to provide clinical benefit in the treatment of GBM,” said Dr. Jin-San Yoo, president and chief executive officer of PharmAbcine, Inc.
The FDA Office of Orphan Products Development grants Orphan Drug Designation to investigational drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. Orphan drug status is intended to facilitate drug development for rare diseases and may provide several benefits to drug developers, including seven years of market exclusivity upon regulatory product approval, exemptions from certain FDA application fees, and tax credits for qualified clinical trials costs.
About TTAC-0001 (=Tanibirumab)
PharmAbcine’s lead candidate TTAC-0001, an investigational therapy, is a highly selective and potent anti-VEGFR2 (KDR/flk-1) mAb in clinical development for rGBM indications. VEGFR2 is over-expressed in most malignant tumors, such as gastric, liver, non-small cell lung cancer (NSCLC), ovarian, brain, colorectal, and breast cancers and this signaling pathway is a key regulator for tumor angiogenesis.
Increased understanding of the role of VEGF/VEGFR2 in the tumor vessel formation, immune suppressive modulation of tumor microenvironment (TME) and the function of the antagonist molecule to disorganized tumor vessel normalization, immune supportive modulation, and ultimately tumor vessel disruption, supports the rationale for evaluating TTAC-0001 in GBM, rGBM and Avastin® (bevacizumab) refractory GBM.
About PharmAbcine Inc.
PharmAbcine is a leading clinical stage biologics company that develops fully human therapeutic antibody (mAb) and next generation multispecific antibody therapeutics based on in-house developed novel platform, DIG-Body, PIG-Body and TIG-Body using innovative discovery technology and excellent human resources for the treatment of human diseases, such as cancer and inflammatory diseases.
PharmAbcine’s fully human antibody libraries and innovative selection system are our priceless proprietary assets. PharmAbcine provides antibody generation services by using antibody library and selection systems. PharmAbcine also provides co-development opportunities with novel antibodies.
Under the collaboration with SAMSUNG MEDICAL CENTER, PharmAbcine has >300 patients derived cancer stem cell libraries and its animal model system for evaluating internal pipeline development.
TTAC-0001(=Tanibirumab): anti-KDR neutralizing fully human IgG with unique cross species cross reactivity has completed its Phase IIa recurrent GBM trial in Australia in August 2017 and its final report will be available early in 2018. Promising molecule to combine with immune checkpoint blockade is open for out-licensing, co-development and combination clinical trials.
PMC-001(=DIG-KT): next generation bispecific antibody neutralizing both VEGF-KDR and Angiopoietin-TIE2 pathways is superior to bevacizumab and Tanibirumab in preliminary studies. It also overcomes the Avastin resistant brain tumor growth. PMC-002, PMC-003, PMC-004 are derivative molecules from PMC-001.
PMC-201: next generation bispecific antibody neutralizing both VEGF-KDR and Notch-DLL4 pathways overcomes anti-cancer drug resistant tumor growth.
PMC-005B: Anti-EGFRviii truly specific fully human IgG with internalization property is perfect for ADC, CAR-T and CAR-NK purpose and is open for codevelopment or out-licensing.
PMC-309a-z: anti-VISTA fully human antibodies collection as either agonistic or antagonistic. Antagonistic antibody performed synergy effects in combination with other immuno-oncology drug.
"3G-System" platform provides high performing production cell lines and we do have both
PMC-901: bevacizumab biosimilar cell line with 3g/L productivity.
PMC-902: aflibercept biosimilar cell line with >3g/L productivity.
Additional information about PharmAbcine is available through its website, https://www.pharmabcine.com
About GBM, recurrent GBM and Avastin refractory recurrent GBM
Glioblastoma multiforme (GBM) is the most common malignant brain tumor in adults, with a median survival of less than 15 months from diagnosis and recurs frequently within a year following the initial treatment. Chemotherapy, radiation and surgery are the primary initial treatments; chemotherapy and surgery may be possible for recurrent disease, with limitations in using radiation dependent on the site of recurrence. Avastin is approved as an active treatment option (single agent) for patients with rGBM who have failed previous TMZ and radiation therapy. During Avastin treatment, some of patients become Avastin refractory recurrent GBM.
Dr. Sung Woo Kim, 82-42-863-2017
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
ABB Showcases World-Leading e-Vehicle Fast Chargers and Launches AI Readiness Index at Hannover22.4.2018 10:00 | Pressemelding
ABB spotlighted its world-leading Terra HP family of fast chargers for electric vehicles at Hannover Messe, the biggest global industrial trade fair. By operating at powers of up to 350 kilowatts and adding as much as 300 kilometers of range to an electric vehicle in just 12 minutes, the Terra HP family of chargers have made electric cars more appealing for consumers by enabling them to refresh the batteries in about the same time required for filling up a petrol-powered car. Terra HP chargers are being installed around the world, and they have been selected for use by Electrify America, the biggest electric vehicle infrastructure project to date in the United States. ABB, whose broad array of digitally driven technologies for electric-power management are used by utilities and businesses worldwide, is also a global leader in industrial automation and robots enabled by artificial intelligence (AI). Demonstrating its commitment to helping the international community address the opportun
PSE: APM Forum 2018 Focus on Digitalisation for the Process Industries20.4.2018 15:13 | Pressemelding
At the 2018 Advanced Process Modelling (APM) Forum this week, process industry organisations presented on digital design and operations applications ranging from accelerating development of the next generation of pharmaceuticals to realising millions of dollars per year in increased profit for large process plants. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180420005517/en/ Ben Weinstein, head of R&D Product and Process Systems Modeling at Procter & Gamble, delivers the keynote speech on how digital design techniques are used systematically to accelerate innovation in P&G. (Photo: Business Wire) Introducing the conference, Prof. Costas Pantelides, MD of conference host Process Systems Enterprise (PSE), described the current wave of digitalisation as the culmination of many years of advanced modelling and IT development. “This is a time of extraordinary opportunities for the process industries” he said. Keynote speaker Ma
Aperta Provides Electronic Funds Transfer (EFT) in Cayman Islands20.4.2018 14:01 | Pressemelding
Once again, the Aperta Active Clearing System (ACS) has delivered the mechanism for a country to implement a world-class electronic payment processing environment to maximize a national payments system’s efficiency, effectiveness, security and control. Aperta partnered with the Cayman Islands ACH Operator (Prism Services (Cayman) Ltd.) and local commercial banks to deliver a new Electronic Funds Transfer system. The old process of banks swapping files in a wide-variety of standards and settling bilaterally has been replaced with a common system and standards, employing international-standard secure file transfer protocol, allowing participants to monitor real time net settlement and collateral positions via a secure portal. The Cayman Islands Automated Clearinghouse (CIACH) links all six of the country’s banks and provides the central clearing and settlement mechanism for banks to exchange direct debit and direct credit transactions seamlessly across the country. It is functionally NAC
FII Tech Growth Invests in SECO20.4.2018 13:39 | Pressemelding
FII Tech Growth, a fund managed by Fondo Italiano d’Investimento SGR, announces today its second investment in SECO SpA, one of the European leaders in the embedded electronics market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180420005413/en/ (Photo: SECO) SECO, headquartered in Arezzo, Tuscany, with subsidiaries in the U.S.A., Germany and Taiwan, was founded in 1979 by entrepreneurs Daniele Conti and Luciano Secciani. The company designs and manufactures micro-computers and integrated systems for industrial applications. With more than 250 employees, SECO supports customers with a worldwide presence such as Cimbali, Esaote, Technogym and Vimar, and generated revenue in excess of Euro 50 million in 2017. The ability to offer innovative solutions by using cutting-edge technologies has allowed SECO to grow steadily over time. The company developed a network of collaborations with universities and research centres La Sapi
Schlumberger Announces First-Quarter 2018 Results20.4.2018 11:05 | Pressemelding
Schlumberger Limited (NYSE:SLB) today reported results for the first quarter of 2018. (Stated in millions, except per share amounts) Three Months Ended Change Mar. 31, 2018 Dec. 31, 2017 Mar. 31, 2017 Sequential Year-on-year Revenue $7,829 $8,179 $6,894 -4% 14% Pretax operating income $974 $1,155 $757 -16% 29% Pretax operating margin 12.4% 14.1% 11.0% -169 bps 145 bps Net income (loss) - GAAP basis $525 $(2,255) $279 n/m 88% Net income, excluding charges & credits* $525 $668 $347 -21% 51% Diluted EPS (loss per share) - GAAP basis $0.38 $(1.63) $0.20 n/m 90% Diluted EPS, excluding charges & credits* $0.38 $0.48 $0.25 -21% 52% *These are non-GAAP financial measures. See section below entitled "Charges & Credits" for details. n/m = not meaningful Schlumberger Chairman and CEO Paal Kibsgaard commented, “As forecast, our results in the first quarter of 2018 largely reflected transitory factors, with seasonal reductions in activity in the Northern Hemisphere and planned project startup costs
Biogen and Ionis Expand Strategic Collaboration to Develop Drug Candidates for a Broad Range of Neurological Diseases20.4.2018 10:30 | Pressemelding
Biogen (Nasdaq: BIIB) and Ionis Pharmaceuticals (Nasdaq: IONS) announced today they have expanded their strategic collaboration through a new ten-year collaboration agreement to develop novel antisense drug candidates for a broad range of neurological diseases. This collaboration capitalizes on Biogen’s expertise in neuroscience research and drug development and Ionis’ leadership in RNA targeted therapies with the goal of developing a broad pipeline of investigational therapies. It builds upon a productive collaboration that produced SPINRAZA, the first and only approved treatment for patients with spinal muscular atrophy. Today, April 20, 2018, Biogen and Ionis will host company conference calls and webcasts to discuss the new collaboration. Full webcast details can be found below. Under the terms of the collaboration, Biogen will pay Ionis $1 billion in cash, which will include $625 million to purchase 11,501,153 shares of Ionis common stock at a price of $54.34 per share, at an appr