Genome & Company
Contact
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).
1. Items of Personal Information Collected and the Collection Method
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
2. Purpose of Collecting Personal Information
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
3. Processing of Personal Information and Retention Period
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)
4. Destruction of Personal Informatio
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.
1) Procedure
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.
5. Consignment of Personal Information Processing
The Company does not consign personal information to a third party. If consignment occurs in the future, it shall be notified through website and the contents of this Privacy Policy shall be updated.
6. Rights of Users and Their Legal Representatives
Users and their legal representative (for the users below the age of 14) may make an inquiry related to or request deletion or modification of their own personal information. In this case, please contact the Company’s Data Protection Manager (see Section 7 of this Privacy Policy) in writing, by phone, or by e-mail so that we can take measures without any delay after verifying your identification.
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.
7. Information on Data Protection Officer and Manager
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
Position: Vice-president
Telephone: 031-620-0150
Email: youngjin.seo@genomecom.co.kr
Data Protection Manager
Name: Seol Su-gi
Department: PR team
Position: Team Lead
Telephone: 070-4821-3840
Email: sugi@genomecom.co.kr
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)
8. Notification
We will notify users any additions, deletions, and modification on the current Privacy Policy in advance through ‘Notice’ on the Company’s website.
9. Other Websites
We inform you that any collection of personal information by other websites which may be hyperlinked on the Company’s website is not the subject of this Privacy Policy.
Press Release
Genome & Company receives FDA IND clearance for GEN-001
its first anti-cancer microbiome therapeutic
-- Asia’s first company to sponsor clinical trial of combination therapy of anti-cancer microbiome and anti-PD1/anti-PD-L1 drug
-- Enables to initiate Phase 1/1b clinical trial on combinational therapy of Merck KGaA, Darmstadt, Germany/Pfizer’s avelumab (BAVENCIO®) with Genome & Company’s GEN-001 microbiome therapeutic
Genome & Company (KONEX: 314130), a biotechnology company developing innovative therapeutics in immune-oncology, announced today that the United States (US) Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for GEN-001 for combination treatment with avelumab (BAVENCIO®) in patients with solid cancers. Avelumab is an anti-PD-L1 antibody co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer Inc.
With this clearance, Genome & Company will be the first Asian company to initiate a first-in-human trial of anti-cancer microbiome and anti-PD1/anti-PD-L1 combination treatment as a sole sponsor. The phase 1/1b clinical trial will be initiated at the US clinical sites and the first patient is expected to be enrolled within this year.
“IND clearance from FDA for our first anti-cancer microbiome therapeutic GEN-001 is a very significant milestone as it will transition Genome & Company into a clinical-stage biotechnology company. We hope to add meaningful value and advancement in the microbiome and immuno-oncology industry with our combinational approach to cancer patients who have progressed on prior anti-PD1/anti-PD-L1 therapy,” said Dr. Hansoo Park, Chief Technical Officer of Genome & Company.
Dr. Jisoo Pae, CEO of Genome & Company further quoted, “This IND approval is a meaningful corporate milestone and a critical step forward to achieving new arrangements in strategic partnering. We are indeed looking forward to further investigate how our clinical data will be translated into our cancer patients. I thank all the members and partners of Genome & Company for dedicating themselves to accomplishing this milestone.”
In January this year, Genome & Company had entered into a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany and Pfizer Inc. to evaluate the safety, tolerability, biological and clinical activities of GEN-001 therapy in combination with avelumab in multiple cancer indications. The combination trial is designed to be a first-in-human study including dose escalation and expansion cohorts to evaluate the safety and preliminary efficacy.
BAVENCIO® is a trademark of Merck KGaA, Darmstadt, Germany.
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About GEN-001
GEN-001 is an oral microbiome therapeutic candidate developed to have immune modulating activities, resulting in potential partnership with immune checkpoint inhibitors. GEN-001 consists a single strain bacteria isolated from gut of healthy human volunteers that has been shown to activate dendritic cells, macrophages and T cell response. In preclinical studies, GEN-001 has shown optimal safety margin and synergistic effects in combination with immune checkpoint inhibitors by enhancing the effect of suppressing the growth of both immune checkpoint inhibitor sensitive and resistant tumor models.
About Genome & Company
Genome & Company is a clinical stage biotechnology company based in Republic of Korea that focuses on discovering and developing the next waves of innovative therapeutics in immuno-oncology through diverse modalities of microbiome, novel target immune checkpoint inhibitors and fusion proteins to fulfill the unmet needs of cancer patients.
Avelumab Approved Indications
Avelumab (BAVENCIO®) in combination with axitinib is indicated in the US, EU, Japan and other countries for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
The US Food and Drug Administration (FDA) also granted accelerated approval for avelumab (BAVENCIO®) for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.
Avelumab is currently approved for patients with mMCC in 50 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment.
Avelumab Important Safety Information from the US FDA-Approved Label
The warnings and precautions for avelumab (BAVENCIO®) include immune-mediated adverse reactions (such as pneumonitis and hepatitis [including fatal cases], colitis, endocrinopathies, nephritis and renal dysfunction and other adverse reactions [which can be severe and have included fatal cases]), infusion-related reactions, hepatotoxicity, major adverse cardiovascular events (MACE) [which can be severe and have included fatal cases], and embryo-fetal toxicity.
Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO® monotherapy include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite/hypophagia, urinary tract infection and rash. Common adverse reactions (reported in at least 20% of patients) in patients receiving BAVENCIO® in combination with axitinib include diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain and headache. Grade 3-4 clinical chemistry and hematology laboratory value abnormalities reported in at least 10% of patients treated with BAVENCIO® monotherapy include hyponatremia, lymphopenia, GGT increased; in patients receiving BAVENCIO® in combination with axitinib, grade 3-4 clinical chemistry and hematology laboratory value abnormalities included blood triglyceride increased and lipase increased.
For full Prescribing Information and Medication Guide for BAVENCIO®, please see www.BAVENCIO.com.