1.Date of occurrence of the event:2024/01/31
2.New drug name or code:
The active cancer immunotherapy Adagloxad Simolenin (OBI-822)/OBI-821
3.Indication:
Adagloxad Simolenin (OBI-822) is a therapeutic cancer vaccine classified as
an active cancer immunotherapy. Globo H-KLH conjugate triggers immune
response against hard-to-treat cancers once injected into the human system.
OBI-821 is an adjuvant that is mixed with OBI-822 to strengthen the immune
response.
Clinical trial information:
United States:
https://www.clinicaltrials.gov/ct2/show/NCT03562637
Taiwan:
https://www1.cde.org.tw/ct_taiwan/search_case2.php?caseno_ind%5B2%5D=2681
4.Planned development stages:
Phase III clinical trial, and BLA (Biologics License Applications)
5.Current development stage:
(1)Application submission/approval/disapproval/each of clinical trials
(include interim analysis):1st interim analysis of Adagloxad Simolenin
(OBI-822)/OBI-821 TNBC (triple-negative breast cancer) Phase III clinical
trial
A. Clinical Study Design:
a. Protocol Title: The GLORIA Study: A Phase III, Randomized,
Open-Label Study of the Anti-Globo H Vaccine Adagloxad Simolenin
(OBI-822)/OBI-821 in the Adjuvant Treatment of Patients With Early
Stage, High Risk, Globo H-Positive Triple Negative Breast Cancer
b. Study Purpose: To assess the efficacy and safety of Adagloxad
Simolenin (OBI-822)/OBI-821
c. Phase of Clinical Study: Phase III clinical trial
d. Investigational product: The active cancer immunotherapy Adagloxad
Simolenin (OBI-822)/OBI-821
e. Indication: Early stage, high risk, Globo H-Positive Triple
Negative Breast Cancer
f. Endpoints:
Primary endpoints:
To determine the effect of Adagloxad Simolenin (OBI-822)/OBI-821
treatment on improving invasive disease free survival (IDFS) in the
study population.
Secondary endpoints:
To determine the impact of Adagloxad Simolenin (OBI-822)/OBI-821
treatment in the study population, on:
-Overall survival (OS)
-Quality of Life (QoL)
-Breast cancer-free interval (BCFI)
-Distant disease-free survival (DDFS)
-To determine safety and tolerability of Adagloxad Simolenin
(OBI-822)/OBI-821 in the study population.
g. Number of subjects enrolled: 668 (target)
B. Primary and secondary endpoints and the statistical results:
a. The company’s Phase III clinical trial targeting patients with
early stage, high risk, Globo H-Positive Triple Negative Breast
Cancer is still in progress. This time, DSMB (Data and Safety
Monitoring Board) recommendation is announced after their review of
the first interim analysis data. The DSMB will not reveal data to
OBI until the clinical trial completion. OBI remains blinded and
will only announce DSMB’s recommendation.
b. Based on the GLORIA study protocol, the first interim analysis is
conducted at 40% of information fraction (estimated to be when 75
of the total 187 primary endpoint events occurred) to assess
futility.
The DSMB reviewed the interim analysis data, evaluated the
patient’s risk-benefit, and provided a positive recommendation.
After their recommendation, the company will continue the clinical
trial according to the proposed timeline.
C. The results of a single clinical trial (including the p value or
whether there are statistical significance in primary, secondary
endpoints) shall not be sufficient to reflect the success or failure
of the new drug in the future development. The investors shall be
careful in judgement and investment.
(2)If not approved by competent authority, or should the interim analysis
or the clinical trial not reach statistical significance, the risks and
the associated measures the Company may occur: Not applicable.
(3)After obtaining official approval or the results of interim analysis or
the clinical trial reaching statistical significance, the future
strategy will be: Please refer to the 6. for clarification.
(4)Accumulated investment expenditure incurred: For negotiation on
potential licensing deals in the future, and for the best interest of
shareholders, this information is kept confidential temporarily.
6.Upcoming development plan:
Adagloxad Simolenin (OBI-822)/OBI-821 TNBC phase III clinical trial
(1)Estimated date of completion: The clinical trial enrollment is expected
to be completed by the end of 2025, but the progress will be adjusted
based on the actual recruitment. This is a Phase III clinical trial
targeting patients with early stage, high risk, Globo H-Positive Triple
Negative Breast Cancer. The primary efficacy endpoints is invasive
disease free survival (IDFS), defined as the time from the date of
randomization to the date of first invasive disease recurrence (local,
regional, or distant), the date of second primary invasive cancer
(breast or not), or death from any cause, whichever occurs first.
Assuming a treatment effect with a hazard ration (HR) of 0.66 in the
final analysis, a total of 187 primary endpoint events will be required
to detect a treatment difference with 80% power, based on a two-sided
log-rank test with an overall type I error rate of 5%. Once it reaches
the 187 primary events, it will trigger the condition to unblind the
study. An interim analysis will be conducted at 40% and 60 % of
information fraction (estimated to be when approximately 75 and 113
primary endpoint events occur) to assess futility. The company will
remain blinded to study results until the final analysis. Interim
analyses will be conducted by the contract research organization (CRO)
assigned to the study, with the DSMB providing recommendations on the
conclusion of the futility assessments.
(2)Estimated responsibilities: Clinical trial related R&D expenses
7.Market situation: According to a public research report from IQVIA, the
global oncology drug market size was valued at USD $196 billion in 2022,
and is expected to reach over US$ 375 billion by 2027, growing at a
compound annual growth rate (CAGR) of 14%. While Adagloxad Simolenin
(OBI-822)/OBI-821 is intended to target unmet medical needs where a
meaningful clinical benefit to the patients is identified, advancement in
further studies will be determined eventually as part of the development
strategy for the entire OBI pipelines.
8.Any other matters that need to be specified(the information
disclosure also meets the requirements of Article 7, subparagraph 8
of the Securities and Exchange Act Enforcement Rules, which brings
forth a significant impact on shareholders rights or the price of
the securities on public companies.): None.
9.New drug development requires long process, vast investments and with
no guarantee in success which may pose investment risks. The investors
are advised to exercise caution and conduct thorough evaluation.