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
Florian Winterstein Becomes New CEO of Jedox21.9.2018 15:46 | Pressemelding
The supervisory board of Jedox AG, a leading vendor of business intelligence and enterprise planning software, has appointed Florian Winterstein as Chief Executive Officer (CEO) effective October 2, 2018. This nomination will support Jedox’s international growth and a new development phase initiated by its latest fund raising in April 2018 with Iris Capital, eCAPITAL entrepreneurial Partners AG and Wecken & Cie. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180921005416/en/ Florian Winterstein (Photo: Business Wire) With 25 years of experience in strategy consulting and leadership in software and service organizations, Winterstein brings to the company a valuable combination of expertise in cloud solutions, business development, and value creation for customers and partners. As former Chief Strategy Officer of BravoSolution, he positioned the software-as-a-service company as trendsetting digitalization partner, extending it
Takeda Receives Positive CHMP Opinion Recommending ALUNBRIG® (brigatinib) for the Treatment of ALK+ Non-Small Cell Lung Cancer in Patients Previously Treated with Crizotinib21.9.2018 13:30 | Pressemelding
Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the full approval of ALUNBRIG® (brigatinib) as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. ALUNBRIG is a tyrosine kinase inhibitor (TKI) designed to target and inhibit the ALK mutation in NSCLC. Approximately three to five percent of NSCLC patients globally have the ALK mutation. If the CHMP opinion is affirmed, and the European Commission approves ALUNBRIG, it will become the only ALK inhibitor available in the European Union as a one tablet per day dose that can be taken with or without food. The randomized, global Phase 2 ALTA trial was designed to investigate the efficacy and safety of ALUNBRIG in patients with locally advanced or metastatic ALK+
Asda Selects HCL Technologies to Help Drive IT Transformation21.9.2018 12:16 | Pressemelding
HCL Technologies (HCL), a leading global technology company, today announced that it has been selected to help drive IT transformation at the UK’s third-largest grocery retailer, Asda. The three-year application services contract will see HCL transform Asda’s IT Application Services with a new DevOps delivery model to drive data and analytics and support back-office applications through the full lifecycle of development, testing and support. HCL will also build a central data management platform to enable Asda to improve its insight and analytics capabilities. Asda operates more than 600 stores across the UK, employing over 135,000 people. Asda wanted to adopt a more agile approach towards application development and testing. This would allow the company to respond faster to business requirements and reduce time to market, while driving better user experience and satisfaction. HCL was selected due to its extensive expertise in successfully delivering similar large scale IT transformati
Ipsen Receives Positive CHMP Opinion for Cabometyx® (Cabozantinib) for the Second-line Treatment of Patients with Hepatocellular Carcinoma (HCC)21.9.2018 05:30 | Pressemelding
Regulatory News: Ipsen (Euronext:IPN; ADR:IPSEY) announced today that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), provided a positive opinion for Cabometyx® (cabozantinib) as a monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have been previously treated with sorafenib. The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). Alexandre Lebeaut, MD, Executive Vice President, R&D and Chief Scientific Officer, Ipsen, said: “The global burden of liver cancer is increasing and despite the recent introduction of new agents, it remains the second leading cause of cancer mortality worldwide. Following today’s positive CHMP opinion and if approved by the European Commission, Cabometyx ® as monotherapy will give patients with HCC a much-needed new oral therapeutic option.” Dr Lorenza Rimassa,
Quanergy Selected as Exclusive LiDAR Partner for VRCO21.9.2018 05:00 | Pressemelding
Quanergy Systems, Inc., a global leader in the design and development of solid state LiDAR sensors and smart sensing solutions, and VRCO, designer and manufacturer of the luxury high-end e-VTOL (electric Vertical Take-Off and Landing) craft, the NeoXcraft XP2, today announced that VRCO will exclusively use Quanergy’s S3 solid state LiDAR sensors in the testing and market release versions of the aircraft. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180920006036/en/ VRCO NeoXcraft XP2 with Quanergy S3 LiDAR Sensor (Graphic: Business Wire) The NeoXcraft XP2, which VRCO and the University of Derby unveiled in late 2017 and intend to launch in 2020, is a two-passenger e-VTOL high-speed land, air, and water capable craft. The craft can scan and memorize take-off locations and store the data for use on the next approach to the same location. Quanergy’s innovative S3 solid state LiDAR sensor will be used for downward and forward
Overseas Roadshow for the IAPH Guangzhou 2019 World Ports Conference Was Held in London21.9.2018 03:08 | Pressemelding
Overseas roadshow for the IAPH Guangzhou 2019 World Ports Conference was successfully held in Armourer's Hall, London, UK on September 20th. Ms. Yuan Yue, Deputy Director General of Guangzhou Port Authority, met with over 100 senior representatives from British ports, ship-owners, commodity traders, shipping & service companies, shipping public policy research institutes, and other representatives from the port and shipping industry. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180920006031/en/ Speech made by Lord Jeffrey Evans, Chairman of Maritime London (Photo: Business Wire) In her keynote speech, Ms. Yuan Yue said, “Guangzhou is the gateway city of South China and is known as the “Millennium Business Capital” and a popular destination for business and investment. At present, Guangzhou has attracted investors from over 130 countries. Nearly 300 of the world's top 500 companies have businesses and investment in Guangzho