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Samsung Biologics and Checkpoint Therapeutics Expand Manufacturing Partnership for Cosibelimab

Image_Samsung_Checkpoint_10302020.jpg
 

INCHEON, S. KOREA and NEW YORK CITY, US, 02 November 2020 – Samsung Biologics Co., Ltd. (“Samsung Biologics”) (KRX: 207940.KS) and Checkpoint Therapeutics, Inc. (“Checkpoint”) (NASDAQ: CKPT), today announced the expansion of a long-term manufacturing partnership for Checkpoint’s anti-PD-L1 antibody, cosibelimab. Building upon an existing contract manufacturing agreement entered into in 2017, Samsung Biologics will provide additional commercial-scale drug substance manufacturing for Checkpoint. Under the new agreement, Samsung Biologics will commence manufacturing in 2021 in Plant 1.

 

“We look forward to continuing our manufacturing partnership with Samsung Biologics for our lead product candidate, cosibelimab, currently in a pivotal clinical trial for metastatic cutaneous squamous cell carcinoma. Checkpoint is on track to report full topline results from the pivotal trial in mid-2021,” said James F. Oliviero, President and Chief utive Officer of Checkpoint. “This agreement provides Checkpoint access to a top-tier manufacturing site for the long-term commercial supply of cosibelimab after potential regulatory approvals worldwide.”

 

“We are extremely proud of this extended partnership with Checkpoint to support our client and make an impact by helping broader patient populations in need,” said Dr. Tae Han Kim, CEO of Samsung Biologics. “As a reliable contract development and manufacturing organization (“CDMO”) service provider, Samsung Biologics offers the highest quality manufacturing for Checkpoint to assist in its endeavor to bring innovative treatments for patients all around the globe.”

 

Samsung Biologics recently announced it will break ground on its fourth plant within this year to commence manufacturing activities in the latter half of 2022, deliver world-class client satisfaction, and fulfill the needs of the growing biopharmaceutical market.

 

About Cutaneous Squamous Cell Carcinoma

 

Cutaneous squamous cell carcinoma (“CSCC”) is the second most common human cancer in the United States, with an estimated annual incidence of 700,000 cases. While most cases are localized tumors amenable to curative resection, approximately 8% of patients will experience a local recurrence, 5% of patients will develop nodal metastases, and an estimated 2% of patients will die from their disease. Ten-year survival rates are less than 20% for patients with regional lymph-node involvement. For those patients who develop distant metastases, the median survival time is estimated to be less than two years. In addition to being a life-threatening disease, CSCC causes significant functional morbidities and cosmetic deformities based on tumors commonly arising in the head and neck region and invading blood vessels, nerves and vital organs such as the eye or ear.

 

About Cosibelimab

 

Cosibelimab (formerly referred to as CK-301) is a potential best-in-class, high affinity, fully-human monoclonal antibody of IgG1 subtype that directly binds to programmed death ligand-1 (PD-L1) and blocks the PD-L1 interaction with the programmed death receptor-1 (PD-1) and B7.1 receptors. Cosibelimab’s primary mechanism of action is based on the inhibition of the interaction between PD-L1 and its receptors PD-1 and B7.1, which removes the suppressive effects of PD-L1 on anti-tumor CD8+ T-cells to restore the cytotoxic T cell response. Cosibelimab is potentially differentiated from the currently marketed PD-1 and PD-L1 antibodies through sustained >99% target tumor occupancy to reactivate an antitumor immune response and the additional benefit of a functional Fc domain capable of inducing antibody-dependent cell-mediated cytotoxicity (“ADCC”) for potential enhanced efficacy in certain tumor types.

 

About Checkpoint Therapeutics

 

Checkpoint Therapeutics, Inc. (“Checkpoint”) is a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. Checkpoint is evaluating its lead antibody product candidate, cosibelimab, a potential best-in-class anti-PD-L1 antibody licensed from the Dana-Farber Cancer Institute, in an ongoing global, open-label, multicohort Phase 1 clinical trial in checkpoint therapy-naïve patients with selected recurrent or metastatic cancers, including ongoing cohorts in locally advanced and metastatic cutaneous squamous cell carcinoma intended to support one or more applications for marketing approval. In addition, Checkpoint is evaluating its lead small-molecule, targeted anti-cancer agent, CK-101, a third-generation epidermal growth factor receptor (“EGFR”) inhibitor, as a potential new treatment for patients with EGFR mutation-positive non-small cell lung cancer. Checkpoint is headquartered in New York City and was founded by Fortress Biotech, Inc. (NASDAQ: FBIO). For more information, visit www.checkpointtx.com. 

 

About Samsung Biologics Co., Ltd.

 

Samsung Biologics Co., Ltd (“Samsung Biologics”) (KRX: 207940.KS) is a fully integrated CDMO offering state-of-the-art contract development, manufacturing, and laboratory testing services. With proven regulatory approvals, the largest capacity, and the fastest throughput, Samsung Biologics is an award-winning partner of choice and is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide. For more information, visit www.samsungbiologics.com.  

 

Forward‐Looking Statements 

This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our plans to submit one or more Biologics License Applications (BLAs) and seek approvals for cosibelimab, statements regarding the potential differentiation of cosibelimab, including a potentially favorable safety profile as compared to the currently available anti-PD-1 therapies, statements relating to the half-life and functional Fc domain of cosibelimab translating into potential enhanced efficacy, statements relating to the timing of the completion of enrollment and full top-line results, statements relating to how long we believe our cash will fund our operations, any statements relating to our growth strategy and product development programs, and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks that regulatory authorities will not accept an application for approval of cosibelimab based on data from the ongoing Phase 1 study; risks relating to our growth strategy; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our Securities and Exchange Commission filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.


Image_Samsung_Checkpoint_10302020.jpg
 

INCHEON, S. KOREA and NEW YORK CITY, US, 02 November 2020 – Samsung Biologics Co., Ltd. (“Samsung Biologics”) (KRX: 207940.KS) and Checkpoint Therapeutics, Inc. (“Checkpoint”) (NASDAQ: CKPT), today announced the expansion of a long-term manufacturing partnership for Checkpoint’s anti-PD-L1 antibody, cosibelimab. Building upon an existing contract manufacturing agreement entered into in 2017, Samsung Biologics will provide additional commercial-scale drug substance manufacturing for Checkpoint. Under the new agreement, Samsung Biologics will commence manufacturing in 2021 in Plant 1.

 

“We look forward to continuing our manufacturing partnership with Samsung Biologics for our lead product candidate, cosibelimab, currently in a pivotal clinical trial for metastatic cutaneous squamous cell carcinoma. Checkpoint is on track to report full topline results from the pivotal trial in mid-2021,” said James F. Oliviero, President and Chief utive Officer of Checkpoint. “This agreement provides Checkpoint access to a top-tier manufacturing site for the long-term commercial supply of cosibelimab after potential regulatory approvals worldwide.”

 

“We are extremely proud of this extended partnership with Checkpoint to support our client and make an impact by helping broader patient populations in need,” said Dr. Tae Han Kim, CEO of Samsung Biologics. “As a reliable contract development and manufacturing organization (“CDMO”) service provider, Samsung Biologics offers the highest quality manufacturing for Checkpoint to assist in its endeavor to bring innovative treatments for patients all around the globe.”

 

Samsung Biologics recently announced it will break ground on its fourth plant within this year to commence manufacturing activities in the latter half of 2022, deliver world-class client satisfaction, and fulfill the needs of the growing biopharmaceutical market.

 

About Cutaneous Squamous Cell Carcinoma

 

Cutaneous squamous cell carcinoma (“CSCC”) is the second most common human cancer in the United States, with an estimated annual incidence of 700,000 cases. While most cases are localized tumors amenable to curative resection, approximately 8% of patients will experience a local recurrence, 5% of patients will develop nodal metastases, and an estimated 2% of patients will die from their disease. Ten-year survival rates are less than 20% for patients with regional lymph-node involvement. For those patients who develop distant metastases, the median survival time is estimated to be less than two years. In addition to being a life-threatening disease, CSCC causes significant functional morbidities and cosmetic deformities based on tumors commonly arising in the head and neck region and invading blood vessels, nerves and vital organs such as the eye or ear.

 

About Cosibelimab

 

Cosibelimab (formerly referred to as CK-301) is a potential best-in-class, high affinity, fully-human monoclonal antibody of IgG1 subtype that directly binds to programmed death ligand-1 (PD-L1) and blocks the PD-L1 interaction with the programmed death receptor-1 (PD-1) and B7.1 receptors. Cosibelimab’s primary mechanism of action is based on the inhibition of the interaction between PD-L1 and its receptors PD-1 and B7.1, which removes the suppressive effects of PD-L1 on anti-tumor CD8+ T-cells to restore the cytotoxic T cell response. Cosibelimab is potentially differentiated from the currently marketed PD-1 and PD-L1 antibodies through sustained >99% target tumor occupancy to reactivate an antitumor immune response and the additional benefit of a functional Fc domain capable of inducing antibody-dependent cell-mediated cytotoxicity (“ADCC”) for potential enhanced efficacy in certain tumor types.

 

About Checkpoint Therapeutics

 

Checkpoint Therapeutics, Inc. (“Checkpoint”) is a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. Checkpoint is evaluating its lead antibody product candidate, cosibelimab, a potential best-in-class anti-PD-L1 antibody licensed from the Dana-Farber Cancer Institute, in an ongoing global, open-label, multicohort Phase 1 clinical trial in checkpoint therapy-naïve patients with selected recurrent or metastatic cancers, including ongoing cohorts in locally advanced and metastatic cutaneous squamous cell carcinoma intended to support one or more applications for marketing approval. In addition, Checkpoint is evaluating its lead small-molecule, targeted anti-cancer agent, CK-101, a third-generation epidermal growth factor receptor (“EGFR”) inhibitor, as a potential new treatment for patients with EGFR mutation-positive non-small cell lung cancer. Checkpoint is headquartered in New York City and was founded by Fortress Biotech, Inc. (NASDAQ: FBIO). For more information, visit www.checkpointtx.com. 

 

About Samsung Biologics Co., Ltd.

 

Samsung Biologics Co., Ltd (“Samsung Biologics”) (KRX: 207940.KS) is a fully integrated CDMO offering state-of-the-art contract development, manufacturing, and laboratory testing services. With proven regulatory approvals, the largest capacity, and the fastest throughput, Samsung Biologics is an award-winning partner of choice and is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide. For more information, visit www.samsungbiologics.com.  

 

Forward‐Looking Statements 

This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. Such statements include, but are not limited to, any statements relating to our plans to submit one or more Biologics License Applications (BLAs) and seek approvals for cosibelimab, statements regarding the potential differentiation of cosibelimab, including a potentially favorable safety profile as compared to the currently available anti-PD-1 therapies, statements relating to the half-life and functional Fc domain of cosibelimab translating into potential enhanced efficacy, statements relating to the timing of the completion of enrollment and full top-line results, statements relating to how long we believe our cash will fund our operations, any statements relating to our growth strategy and product development programs, and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks that regulatory authorities will not accept an application for approval of cosibelimab based on data from the ongoing Phase 1 study; risks relating to our growth strategy; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; risks relating to the timing of starting and completing clinical trials; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our Securities and Exchange Commission filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

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Effective Date: [30Dec2019]

This Privacy Policy illustrates how Samsung Biologics ("we", “our”, “us”) use and protect information you provide through your use of this website (the "Website") or our customer inquiry and recruitment services (collectively the “Services”).

Please read this Privacy Policy carefully and feel free to contact us if you have any questions, using the contact information provided in the Contact Us section below.

Information we may collect from you
1.Customer Inquiry

When you fill out the “Contact Us Form” on our Website, we may collect the following types of information:

  • Customer Inquiry information include Category, Information we may collect from you.
    Category Information we may collect from you
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    Optional Any additional information you provide including but not limited to the job title
    Customer Inquiry information include Category, Information we may collect from you.
    Category Information we may collect from you
    Contact Us Mandatory Name, E-mail Address, Company Name, Occupation, Country, Areas of Interest, Inquiries/Comments
    Optional Any additional information you provide including but not limited to the job title

    Access log and website usage information collected through cookies. For more information about how we use cookies on our Website, please see our Cookie Policy.

2.Recruitment

When you submit your application via “TalentPool” on our Website, we may collect the following types of information:

  • Recruitment infomation include Category, Information we may collect from you.
    Category Information we may collect from you
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    Optional Any additional information you provide including but not limited to personal profiles on SNS
    Application Form
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    Education History (Name of School, Major, Enrollment Year/Month, Graduation Year/Month, Location), Employment History (Employment Period, Company, Job Title, Job Scope, Major Task), Language, Miscellaneous (Military Status, Reason for Exemption, Veteran Status)
    Optional Any additional information you provide including but not limited to research career, special qualifications and licenses, personal profiles on SNS.
    Recruitment infomation include Category, Information we may collect from you.
    Category Information we may collect from you
    Talent Pool Mandatory Name, E-mail Address, Country, Areas of Interest, Resume
    Optional Any additional information you provide including but not limited to personal profiles on SNS
    Application Form
    (in Korean)
    Mandatory Name, Date of Birth, Address, E-mail, Contact Number,
    Education History (Name of School, Major, Enrollment Year/Month, Graduation Year/Month, Location), Employment History (Employment Period, Company, Job Title, Job Scope, Major Task), Language, Miscellaneous (Military Status, Reason for Exemption, Veteran Status)
    Optional Any additional information you provide including but not limited to research career, special qualifications and licenses, personal profiles on SNS.

*No sensitive information will be collected.

How we use your information
1.Customer Inquiry

We may use the information we collect from you to conduct certain services or activities such as replying to inquiries, maintaining business records, and conducting market research.

2.Recruitment

In order to proceed with recruitment process and communicate status/result of job application(s).

Sharing information with third parties

We will not disclose your information to third parties for their marketing or business purposes without your consent. However, notwithstanding the above, we may disclose your information to the following entities for recruitment purposes:

  • Educational institutions in your application.
    Your information (name, date of birth, major, admission year, graduation year, etc.) may be disclosed to educational institutions named in your application.
  • Previous companies you worked for and reference check vendors.
    Your information (i.e. name) may be disclosed to your previous workplaces and reference check vendors.
  • Service providers.
    We may disclose your information to companies that provide Services on our behalf. These entities cannot use your information for purposes other than providing Services on our behalf.
  • Other parties when required by law or as necessary to protect our rights.
    There may be instances where we disclose your information to other parties:
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  • Other parties in connection with corporate transactions.
    We may disclose your information to a third party as part of a merger or transfer, or in the event of a bankruptcy.
  • Other parties with your consent or at your direction.
    In addition to the disclosures described in this Privacy Policy, we may disclose information about you to third parties when you consent to or request such disclosure.
Your Rights

To the extent permitted under applicable law(s), you may ask us to return, destroy, or correct any inaccuracies regarding your personal information. You may also ask us to restrict or limit our use of your personal information unless such restriction or limitation prevents us from complying with applicable law(s) or meeting a legal obligation.

However, your rights above may be limited in cases where your request would disclose personal information of a third party or where such a request would infringe the rights of a third party (including our rights) or if you ask us to delete information which we are required by law to preserve or have legitimate interests in retaining. Other relevant exemptions may exist under the GDPR and national laws. We will inform you of the relevant exemptions when responding to your request. To make such a request concerning your rights set forth herein, please refer to the Contact Us section below.

International Transfer of Information

We are a company based in Korea, and your use of our Website and Services will involve the transfer, storage, and processing of your personal information in Korea. Please note that the information protection laws and other applicable laws of countries outside the European Economic Area (“EEA”), to which your information may be transferred, might not be as comprehensive as those in your country. We will take appropriate measures, in compliance with applicable law, to ensure that your personal information remains protected. Such measures include the use of EU Standard Contractual Clauses to safeguard the transfer of information outside of the EEA or other methods. For more information, please contact us at privacy.bio@samsung.com.

Data Retention

We will retain your personal information for a reasonable period of time that enables us to communicate with you, to provide you with Services, to maintain business records for audit purposes, to meet recordkeeping requirements under applicable law(s), to defend or bring any legal claims and to deal with any queries or complaints you may have.

Keeping Your Information Secure

We have put in place reasonable measures to safeguard the information we collect in connection with the Services. However, please note that although reasonable steps will be taken to protect your information, no website, internet transmission, computer system or wireless connection is 100% secure from any and all potential threats.

Personal Information – Children under the age of 13

The Services are designed for general audience and are not intended or directed to children.

For US Residents Only

In connection with the Services, we will not knowingly solicit or collect personal information from children under the age of 13. In the event we do collect such personal information inadvertently or unknowingly and we later learn about it, we will promptly delete such information. If you believe that children under the age of 13 may have provided personal information to us, please contact us using the Contact Us section of this Privacy Policy.

If You are an individual resident in the EU

We process your personal information on the legal grounds that the processing is :

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If you do not provide certain information to us, we may, in some circumstances, be unable to comply with our obligations or provide you with the services that you request. We will inform you of the implications of not providing certain information.

As set forth in the “Your rights” section, you are entitled, in accordance with applicable law, to object to or request restriction of processing your personal information, and to request access to, correction of, or deletion of your personal information. When we use your information on the basis of your consent, you have the right to withdraw such a consent at any time. Any requests should be submitted in writing to the address listed below in the “Contact Us” section. You also have the right to file a complaint with data protection authorities.

Contact Us

If you have any questions about this Privacy Policy, please contact us using the details below.

- Contact : 032-455-9829

- Email : privacy.bio@samsung.com

Changes to this Privacy Policy

We may update this Privacy Policy from time to time. When we update the Privacy Policy, we will revise the “Effective Date” above and post the new Privacy Policy with a new date. We recommend that you review the Privacy Policy each time you visit our Website to stay informed of our most current practices and policies.

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