- Date of occurrence of the event: April 6, 2017
- Company name: OBI Pharma, Inc.
- Relationship to the Company (please enter ”head office” or ”affiliated company”): head office
- Reciprocal shareholding ratios: N/A
- Name of mass media: N/A
- Content reported: N/A
- Cause of occurrence: OBI-833, the cancer therapeutic vaccine, has met the primary safety indicators in Phase I clinical trial for US and Taiwan. According to the study results, OBI-833 demonstrates good safety without any major concerns.
- Countermeasures: None.
- Any other matters that need to be specified:
(1) New drug name or code: OBI-833
(2) Indication: It is a Globo H series polysaccharide vaccine for cancer treatment.
(3) Planned development stages: The planning of the subsequent clinical research and development of OBI-833 will be based on comprehensive consideration of the company’s cancer vaccine product portfolio and overall development strategy.
(4) Current development stage:
A. File application/approved/disapproved/Each of clinical trials (include interim analysis): Completed Phase I clinical trial safety assessment.
B. Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks & the associated measures the Company may occur: N/A.
C. After obtaining official approval or the results of statistically significant sense, the future strategy: N/A.
D. Accumulated investment expenditure incurred: NT$175,973,000
(5) Upcoming development plan:
A. Expected completion time: The planning of its indication, trial design, number of participants, and trial schedule will be based on comprehensive consideration of the OBI-822 global clinical trial development strategy.
B. Expected due responsibility: When executing the Phase I clinical trial, no license fee is required by OBI, the licensee, to the Academia Sinica, the original licensor.
(6) Market: According to the Yearbook of Pharmaceutical Industry 2016, the overall market size of anti-neoplastic drugs was US $78.9 billion in 2015, ranked first among the top ten drug categories. OBI-833, the cancer vaccine, is at the stage of clinical trial; satisfying unmet medical needs will be the main focus when considering the possible indications. The planning of the subsequent clinical research and development will be based on comprehensive consideration of the company’s product portfolio and overall development strategy.
(7) New drug development is a long journey associated with high cost. It is not a guaranteed success, which may increase the risk of investment. Investors shall make prudent judgments and investments.