On October 2, 2018 PharmAbcine, Inc, a clinical-stage biotech company developing novel antibody therapeutics for multiple cancer indications reported 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 (Press release, PharmAbcine, OCT 2, 2018, View Source [SID1234529710]). This enables the Company to begin opening US clinical trial sites for phase II clinical trial with bevacizumab (Avastin) refractory recurrent GBM patients.
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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)