DAEJEON, South Korea-Tuesday 2 October 2018 [ AETOS Wire ]
(BUSINESS WIRE)-- PharmAbcine, Inc, a clinical-stage biotech company developing novel antibody therapeutics for multiple cancer indications announces that the company received “Study May Proceed Letter “ from the US Food and Drug Administration (FDA) for the Investigational New Drug (“IND”) application of its flagship antibody, TTAC-0001. This enables the Company to begin opening US clinical trial sites for phase II clinical trial with bevacizumab (Avastin®) refractory recurrent GBM patients.
Recurrence of GBM is inevitable and recurrent GBM (rGBM) is one of the most aggressive and has the worst prognosis. The treatment options are limited with modest activity for rGBM. Therefore, there is no universally held standard of care available till now.
Patients with rGBM are suffering under cerebral edema and partially responded to bevacizumab. However, patients responded to bevacizumab ultimately become non-responder during the treatment and once patients become bevacizumab non-responder, unfortunately, there are no more therapeutic options.
Cerebral edema comes from excessive secretion of VEGF-A, B, C and D from brain tumors. While bevacizumab traps VEGF-A only, TTAC-0001 binds to VEGFR2 specifically and interferes the activation of VEGFR2 by VEGF-A, C and D.
TTAC-0001 has completed its phase IIa in recurrent GBM in Australia last year with clear safety profile (all DAE maintain within grade 2) and 25% disease control rate. rGBM patients in the study responded to TTAC-0001 for cerebral edema (>40%). No hypertension, hemorrhage, gastric/lung perforation or proteinuria have been observed.
Jin-San Yoo, CEO of PharmAbcine, Inc., commented: “As part of the study design, it was always planned that US trial sites would become part of our Bevacizumab refractory recurrent GBM Phase II clinical trial. We are pleased with today’s IND approval from the FDA as it will accelerate patient enrolment into the global bevacizumab recurrent GBM phase II trial. Moreover, the FDA’s decision is positive news for eligible American sufferers under this devastating condition who can now participate in the study.”
This research was supported by Korea Drug Development Fund (KDDF) funded by MSIT, MOTIE and MOHW (Grant No. KDDF201509-07, Republic of Korea)
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.
Selected pipeline:
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. 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. Both PMC-002 and PMC-002R are different scaffolds neutralizing same targets like 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, http://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.
Contacts
Media Contacts
For PharmAbcine:
Dr. Sung Woo Kim, +82-42-863-2017
sungwoo.kim@pharmabcine.com
Permalink : https://www.aetoswire.com/news/pharmabcine-announces-fda-accepts-ind-application-of-ttac-0001-for-the-treatment-of-recurrent-glioblastoma/en
(BUSINESS WIRE)-- PharmAbcine, Inc, a clinical-stage biotech company developing novel antibody therapeutics for multiple cancer indications announces that the company received “Study May Proceed Letter “ from the US Food and Drug Administration (FDA) for the Investigational New Drug (“IND”) application of its flagship antibody, TTAC-0001. This enables the Company to begin opening US clinical trial sites for phase II clinical trial with bevacizumab (Avastin®) refractory recurrent GBM patients.
Recurrence of GBM is inevitable and recurrent GBM (rGBM) is one of the most aggressive and has the worst prognosis. The treatment options are limited with modest activity for rGBM. Therefore, there is no universally held standard of care available till now.
Patients with rGBM are suffering under cerebral edema and partially responded to bevacizumab. However, patients responded to bevacizumab ultimately become non-responder during the treatment and once patients become bevacizumab non-responder, unfortunately, there are no more therapeutic options.
Cerebral edema comes from excessive secretion of VEGF-A, B, C and D from brain tumors. While bevacizumab traps VEGF-A only, TTAC-0001 binds to VEGFR2 specifically and interferes the activation of VEGFR2 by VEGF-A, C and D.
TTAC-0001 has completed its phase IIa in recurrent GBM in Australia last year with clear safety profile (all DAE maintain within grade 2) and 25% disease control rate. rGBM patients in the study responded to TTAC-0001 for cerebral edema (>40%). No hypertension, hemorrhage, gastric/lung perforation or proteinuria have been observed.
Jin-San Yoo, CEO of PharmAbcine, Inc., commented: “As part of the study design, it was always planned that US trial sites would become part of our Bevacizumab refractory recurrent GBM Phase II clinical trial. We are pleased with today’s IND approval from the FDA as it will accelerate patient enrolment into the global bevacizumab recurrent GBM phase II trial. Moreover, the FDA’s decision is positive news for eligible American sufferers under this devastating condition who can now participate in the study.”
This research was supported by Korea Drug Development Fund (KDDF) funded by MSIT, MOTIE and MOHW (Grant No. KDDF201509-07, Republic of Korea)
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.
Selected pipeline:
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. 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. Both PMC-002 and PMC-002R are different scaffolds neutralizing same targets like 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, http://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.
Contacts
Media Contacts
For PharmAbcine:
Dr. Sung Woo Kim, +82-42-863-2017
sungwoo.kim@pharmabcine.com
Permalink : https://www.aetoswire.com/news/pharmabcine-announces-fda-accepts-ind-application-of-ttac-0001-for-the-treatment-of-recurrent-glioblastoma/en
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