OBI Pharma Updates on Clinical Trial Activities During COVID-19 Pandemic

OBI Pharma Granted U.S. FDA Orphan Drug Designation for the Treatment of Gastric Cancer for Its Antibody-Drug Conjugate (ADC) Targeted Cancer Therapy, OBI-999
January 21, 2020
OBI Pharma Announces Poster Presentations at 2020 ASCO Virtual Annual Meeting for Adagloxad Simolenin, OBI-999 and OBI-3424
May 20, 2020

TAIPEI, TAIWAN. APRIL 8, 2020– OBI Pharma has been closely monitoring the impact of the COVID-19 pandemic worldwide. We realize the intense challenges that patients and our clinical research investigators and institutions are under due to the COVID-19 crisis. Therefore, in order to allow our collaborating clinical research centers to prioritize response to the pandemic, we will place a three-month pause to the Adagloxad Simolenin Phase 3 GLORIA Triple-Negative Breast Cancer (TNBC) study, enrollment to ongoing Phase 1/2 clinical trials and activations of new research sites.

We are working with our clinical research sites to optimize management of patients who are currently enrolled, including implementation of remote monitoring where possible. Based on feedback from our lead investigators, we are also proposing an amendment to our Adagloxad Simolenin Phase 3 GLORIA TNBC study that would substantially streamline study visits.

Other OBI products under Phase 1/2 clinical studies (OBI-888, OBI-999 and OBI-3424) have also been affected by the global restrictions at clinical sites due to the COVID-19 pandemic. These studies will be monitored for re-engagement on an ongoing basis.

“We will continue to work with our sites and collaborating clinical research organizations to minimize impact on recruitment timelines, since all of OBI Pharma’s programs are directed towards improving care for patients with cancer”, noted Tillman Pearce, MD, the Chief Medical Officer of OBI Pharma.

“OBI Pharma realizes that “we are all in this together,” and that the actions we are taking now will be to the benefit of the patients, investigators, institutions, and collaborating organizations that have chosen to work with us for the benefit of patients with cancer,” added Dr. Pearce.

About OBI Pharma, Inc.

OBI Pharma has a diverse portfolio of innovative cancer therapies at various stages of development. OBI is focused on the development of therapeutic vaccines, monoclonal antibodies, antibody drug conjugates targeting Globo series, Globo H (Adagloxad Simolenin, OBI-833 vaccines, OBI-888 mAb, OBI-999 ADC) and SSEA-4 (OBI-866 vaccine, OBI-898 mAb, OBI-998 ADC) and a prodrug targeting the tumor-specific enzyme AKR1C3 (OBI-3424).

For more information, please visit www.obipharma.com

Forward-Looking Statements

Statements included in this press release that are not a description of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about future clinical trials, results and the timing of such trials and results. Such risk factors are identified and discussed from time to time in OBI Pharma’s reports and presentations, including OBI Pharma’s filings with the Taiwan Securities and Futures Bureau.

COMPANY CONTACT:
Kevin Poulos
Chief Commercial Officer
OBI Pharma USA, Inc.
Ph: 619-537-7698 Ext 102
kpoulos@obipharmausa.com