Genome & Company
7F GWANGGYO FLAX DESIAN, 50 Changnyong-daero 256beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, Republic of Korea ,16229
Consent to collection and use of personal information (Required)
Genome & Company (the ”Company”) regards the protection of personal information of our users very important, and complies with relevant laws, including the Personal Information Protection Act and the Act on Expansion of Dissemination and Promotion of Utilization of Information System. The Company hereby informs the purpose and method of using the personal information provided by our users through the Company’s website, and what measures are taken to protect the personal information. If the Company revises any of this Private Policy, it will be notified through the notices on the Company’s website (or individually notified).
The Company collects the following personal information to operate its Contact Service via the Company’s website (whereby the users can make general inquires, inquiry for business development, IR inquiry, media inquiry, etc.).
- Essential Information: name, e-mail address, phone number, organization, content of inquiry
- Collection method: The Company collects the personal information through the inquiries submitted via the Contact Bulletin Board on the Company’s website.
You have the right to refuse the ‘collection of essential information’ as well as the ‘collection of optional information’. If you refuse the collection of essential information, however, you may be restricted for using the Contact Service.
The following information may be automatically generated and collected in the process of using the website.
- IP Address, cookie, date and time of visit, records of service use
The Company uses the collected personal information for the following purposes.
- Personal verification, personal identification, delivery of inquiries and notification of results (answers and responses), etc. related to the use of Contact Service
In principle, the collected personal information is destroyed without any delay after achieving the purpose of collecting and using personal information. However, the Company may keep users’ information for a certain period of time as required by relevant laws.
- Retained information: personal information submitted with the inquiry, content of the inquiry, and ensuing responses
- Relevant Law: Act on the Consumer Protection in Electronic Commerce, etc.
- Retention Period: three years (records related to resolution of consumer complaints or disputes)
In principle, the information is destroyed without any delay after achieving the purpose of collecting and using personal information. The procedure and method of destruction are as follows.
The personal information submitted is transferred to a separate database (in case of paper, separate cabinet) after achieving the purpose and kept for a certain period of time according to the internal policy and other relevant laws, before it is destroyed. The personal information transferred to separate database shall not be used any other purposes other than for keeping in accordance with laws.
2) Destruction Method
Personal information saved in the form of electronic file shall be deleted by using technical method that cannot reproduce the records. Personal information printed in the paper shall be destroyed by shredding with a shredder or incinerating it.
In case users request the correction of any errors in personal information, we shall not use or provide the personal information until such correction is made. In addition, in case incorrect personal information is already provided to a third party, we will notify the third party the result of correction without delay.
The Company processes and destroys personal information at the request of users or their legal representatives in accordance with Section ‘3. Processing of Personal Information and Retention Period’ and Section ‘4. Destruction of Personal Information’, and such information shall not be opened or used for any other purposes.
The Company designates data protection officer and manager for managing personal information as follows to protect users’ personal information related to inquiries.
Data Protection Officer
Name: Seo Yeong-jin
Department: Business management
Data Protection Manager
Name: Seol Su-gi
Department: PR team
Position: Team Lead
You can submit to the personnel above any inquiries related to your personal information submitted to the Company while using our web service. The Company will quickly provide sufficient responses to your inquiries.
Please contact the below agencies if you need report or counseling for any infringement of personal data privacy.
- Personal Information Infringement Report Center (privacy.kisa.or.kr / 118 without area code)
- Personal Information Dispute Mediation Committee (kopico.go.kr / 1833-6972)
- Cyber Investigation Department, Supreme Prosecutor’s Office (www.spo.go.kr / 1301 without area code)
- Cyber Bureau of the National Police Agency (http://cyberbureau.police.go.kr / 182 without area code)
n Positive primary endpoint result of objective response rate (ORR) from the planned interim analysis of Phase II trial in advanced gastric/gastroesophageal junction adenocarcinoma (GC/GEJ).
n Top-line data of the final analysis from Phase II to be announced in the second half of next year.
[2023. 05. 19] Genome & Company (CEOs: Pae, Jisoo, Park, Hansoo), a global leading microbiome therapeutics developer, announced that this phase II trial (NCT05419362) will continue without modifications to move on to the second stage, based on the positive result of the interim analysis.
Using a single-strain bacteria in combination with avelumab (Bavencio®) from Merck KGaA, Darmstadt, Germany and Pfizer Inc. it is the first time to show positive antitumor activity per ORR in Phase II trial. The detailed results will be presented at a conference in the second half of 2023.
On the basis of these results and in accordance with the predetermined hypothesis of the interim analysis, Genome & Company highly expect that the evidence for treatment with GEN-001 plus avelumab as a 3rd line of therapy for GC/GEJ will be strongly established.
This is a Phase II study to evaluate the safety and efficacy of GEN-001 plus Avelumab as a ≥3rd line treatment for PD-L1 positive GC/GEJ patients regardless of prior immune-oncology (IO) treatment. Following enrollment of the 21st patient, a pre-planned interim analysis was conducted and results were reviewed by an independent data monitoring committee (IDMC).
As the observed ORR met the pre-determined criteria together with no safety concerns, the IDMC recommended to continue with the second stage without modifications and enroll additional 21 patients. The detailed results will be presented at an Oncology conference in the second half of 2023. The top-line data of the final analysis from Phase II are expected in the second half of next year.
Professor Jeeyun Lee, the principal investigator of clinical trials from the Hematology and Oncology Division at Samsung Medical Center, stated, “There is a strong unmet medical need to establish 3rd line of therapy for GC/GEJ patients compared with the establishing 1st and 2nd lines of therapy. Hence, the pre-planned interim result of this trial is quite interesting. We continue to enroll patients and look forward to seeing the final analysis of this trial soon.”
The CEO of Genome & Company, Pae, Jisoo, stated, "We attach great significance to presenting data-driven results for the first time through Phase II clinical trials on gastric cancer patients using the immuno-oncology microbiome therapeutic ‘GEN-001’ in combination with avelumab from Merck KGaA, Darmstadt, Germany and Pfizer Inc." and “we intend to obtain phase II clinical data for 'GEN-001' within next year and to discuss a licensing agreement with partners or global big pharmaceutical companies.”
It is also worth noting that GEN-001 is currently undergoing phase 2 clinical trial with combination therapy with MSD's pembrolizumab (Keytruda®) for patients with advanced biliary tract cancer. The first patient in will be initiated in the second half of this year. To expand treatment options for advanced biliary tract cancer with high unmet medical needs, Genome & Company recently requested approval from the Ministry of Food and Drug Safety (MFDS) in South Korea to amend the protocol.