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CytoDyn and Samsung Biologics Formalize Manufacturing Partnership

CytoDyn and Samsung Biologics Formalize Manufacturing Partnership 

 

 

Samsung Biologics CEO shaking hands with CytoDyn's president and CEO

 

Dr. Tae Han Kim, CEO of Samsung Biologics and Dr. Nader Pourhassan, CEO of CytoDyn

 

INCHEON, S. Korea, 30 May 2019 - CytoDyn Inc., a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications and Samsung Biologics met at the Samsung Biologics Songdo headquarters for an official signing ceremony of the manufacturing agreement with Samsung Biologics that was previously announced on April 2, 2019.

 

The signing ceremony was attended by Nader Pourhassan, Ph.D., CytoDyn’s President and CEO, along with Nitya Ray, Ph.D., CytoDyn’s Chief Technology Officer, and hosted by top management of Samsung Biologics, including Dr. Tae Han Kim, Samsung Biologics CEO, along with John Rim, EVP, Head of Contract Manufacturing, James Park, SVP Head of Global Business Development and other members of the Samsung Biologics leadership team.

  

"We are excited to work with Samsung Biologics, one of the world's best CMO firms. Given the company has consistently demonstrated an extremely high level of quality assurance, capacity, and cost effectiveness, we expect that we will be able to market our new drug quickly following an expected approval," stated Nader Pourhassan, Ph.D, CytoDyn’s President, CEO and director. “It is important for our shareholders to realize that our partnership with Samsung is the first step in validating what we have accomplished and the future potential for leronlimab,” continued Dr. Pourhassan. “One of our major strategic challenges with leronlimab’s sales potential as a monotherapy (provided we obtain approval) was to ensure we have sufficient large scale biologics manufacturing capacity in place to meet the expected demand and our Samsung agreement now successfully satisfies this long-term strategic requirement,” concluded Dr. Pourhassan. 

 

“Samsung Biologics is very excited to be partnering with CytoDyn to bring this potential blockbuster drug to the market. It is clear that leronlimab and the CytoDyn team have an opportunity to bring significantly improved care to HIV patients around the world. Samsung Biologics is proud to support this effort by providing a stable supply of only the highest quality product,” said Dr. Tae Han Kim, CEO of Samsung Biologics.

 

 

Dr. Nader Pourhassan (Left), CEO of CytoDyn and Dr. Tae Han Kim, CEO of Samsung Biologics

 

Dr. Nader Pourhassan (Left), CEO of CytoDyn and Dr. Tae Han Kim, CEO of Samsung Biologics

 

The signing ceremony was capped by a tour of the Samsung Biologics campus including the Plant 2 VIP showroom and a window tour of Plant 3, Samsung Biologics’ latest state-of-the-art manufacturing facility optimized for high volume products such as leronlimab.

 

 

About Leronlimab (PRO 140)

 

The U.S. Food and Drug Administration (FDA) has granted a “Fast Track” designation to leronlimab as a combination therapy with HAART for HIV-infected patients and for metastatic triple-negative breast cancer.  Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that appears to play multiple roles with implications in HIV infection, tumor metastases and immune signaling.  Leronlimab has successfully completed nine Phase 1/2/3 clinical trials in over 700 people, including a successful pivotal Phase 3 trial in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients. 

 

In the setting of HIV/AIDS, leronlimab belongs to a new class of therapeutics called viral-entry inhibitors; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab can significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

 

In the setting of cancer, research has shown that CCR5 likely plays a central role in tumor invasion and metastasis and that increased CCR5 ex-pression is an indicator of disease status in several cancers. Moreover, research has shown that drugs that block CCR5 can block tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. CytoDyn is conducting   a Phase 2 human clinical trial in triple-negative breast cancer and was granted Fast Track designation in May 2019.  Additional research is being conducted with leronlimab in the setting of cancer and NASH with plans to conduct additional clinical studies when appropriate.  

 

The CCR5 receptor also appears to play a central role in modulating immune cell trafficking to sites of inflammation and may be crucial for the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to further support the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD and that blocking this receptor from recognizing certain immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted “orphan drug” designation to leronlimab for the prevention of graft-versus-host disease (GvHD).

 

 

About CytoDyn

 

CytoDyn is a biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a key role in the ability of HIV to enter and infect healthy T-cells.  The CCR5 receptor also appears to be implicated in tumor metastasis and in immune-mediated illnesses, such as graft-vs-host disease (GvHD) and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in 2019 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab (PRO 140) as a once-weekly monotherapy for HIV-infected patients and, plans to initiate a registration-directed study of leronlimab monotherapy indication, which if successful, could support a label extension. Clinical results to date from multiple trials have shown that leronlimab (PRO 140) can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, results from a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients, with some patients on leronlimab monotherapy remaining virally suppressed for more than four years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and has received clearance to initiate a clinical trial with leronlimab in metastatic triple-negative breast cancer.

 

 

Forward-Looking Statements 

 

This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict.  Words and ex-pressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as “believes,” “hopes,” “intends,” “estimates,” “expects,” “projects,” “plans,” “anticipates” and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. The Company’s forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Company’s cash position, (ii) the Company’s ability to raise additional capital to fund its operations, (iii) the Company’s ability to meet its debt obligations, if any, (iv) the Company’s ability to enter into partnership or licensing arrangements with third parties, (v) the Company’s ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Company’s ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Company’s clinical trials, (viii) the results of the Company’s clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company’s products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Company’s control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.


CytoDyn and Samsung Biologics Formalize Manufacturing Partnership 

 

 

Samsung Biologics CEO shaking hands with CytoDyn's president and CEO

 

Dr. Tae Han Kim, CEO of Samsung Biologics and Dr. Nader Pourhassan, CEO of CytoDyn

 

INCHEON, S. Korea, 30 May 2019 - CytoDyn Inc., a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications and Samsung Biologics met at the Samsung Biologics Songdo headquarters for an official signing ceremony of the manufacturing agreement with Samsung Biologics that was previously announced on April 2, 2019.

 

The signing ceremony was attended by Nader Pourhassan, Ph.D., CytoDyn’s President and CEO, along with Nitya Ray, Ph.D., CytoDyn’s Chief Technology Officer, and hosted by top management of Samsung Biologics, including Dr. Tae Han Kim, Samsung Biologics CEO, along with John Rim, EVP, Head of Contract Manufacturing, James Park, SVP Head of Global Business Development and other members of the Samsung Biologics leadership team.

  

"We are excited to work with Samsung Biologics, one of the world's best CMO firms. Given the company has consistently demonstrated an extremely high level of quality assurance, capacity, and cost effectiveness, we expect that we will be able to market our new drug quickly following an expected approval," stated Nader Pourhassan, Ph.D, CytoDyn’s President, CEO and director. “It is important for our shareholders to realize that our partnership with Samsung is the first step in validating what we have accomplished and the future potential for leronlimab,” continued Dr. Pourhassan. “One of our major strategic challenges with leronlimab’s sales potential as a monotherapy (provided we obtain approval) was to ensure we have sufficient large scale biologics manufacturing capacity in place to meet the expected demand and our Samsung agreement now successfully satisfies this long-term strategic requirement,” concluded Dr. Pourhassan. 

 

“Samsung Biologics is very excited to be partnering with CytoDyn to bring this potential blockbuster drug to the market. It is clear that leronlimab and the CytoDyn team have an opportunity to bring significantly improved care to HIV patients around the world. Samsung Biologics is proud to support this effort by providing a stable supply of only the highest quality product,” said Dr. Tae Han Kim, CEO of Samsung Biologics.

 

 

Dr. Nader Pourhassan (Left), CEO of CytoDyn and Dr. Tae Han Kim, CEO of Samsung Biologics

 

Dr. Nader Pourhassan (Left), CEO of CytoDyn and Dr. Tae Han Kim, CEO of Samsung Biologics

 

The signing ceremony was capped by a tour of the Samsung Biologics campus including the Plant 2 VIP showroom and a window tour of Plant 3, Samsung Biologics’ latest state-of-the-art manufacturing facility optimized for high volume products such as leronlimab.

 

 

About Leronlimab (PRO 140)

 

The U.S. Food and Drug Administration (FDA) has granted a “Fast Track” designation to leronlimab as a combination therapy with HAART for HIV-infected patients and for metastatic triple-negative breast cancer.  Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that appears to play multiple roles with implications in HIV infection, tumor metastases and immune signaling.  Leronlimab has successfully completed nine Phase 1/2/3 clinical trials in over 700 people, including a successful pivotal Phase 3 trial in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients. 

 

In the setting of HIV/AIDS, leronlimab belongs to a new class of therapeutics called viral-entry inhibitors; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab can significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

 

In the setting of cancer, research has shown that CCR5 likely plays a central role in tumor invasion and metastasis and that increased CCR5 ex-pression is an indicator of disease status in several cancers. Moreover, research has shown that drugs that block CCR5 can block tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. CytoDyn is conducting   a Phase 2 human clinical trial in triple-negative breast cancer and was granted Fast Track designation in May 2019.  Additional research is being conducted with leronlimab in the setting of cancer and NASH with plans to conduct additional clinical studies when appropriate.  

 

The CCR5 receptor also appears to play a central role in modulating immune cell trafficking to sites of inflammation and may be crucial for the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to further support the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD and that blocking this receptor from recognizing certain immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted “orphan drug” designation to leronlimab for the prevention of graft-versus-host disease (GvHD).

 

 

About CytoDyn

 

CytoDyn is a biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a key role in the ability of HIV to enter and infect healthy T-cells.  The CCR5 receptor also appears to be implicated in tumor metastasis and in immune-mediated illnesses, such as graft-vs-host disease (GvHD) and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in 2019 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab (PRO 140) as a once-weekly monotherapy for HIV-infected patients and, plans to initiate a registration-directed study of leronlimab monotherapy indication, which if successful, could support a label extension. Clinical results to date from multiple trials have shown that leronlimab (PRO 140) can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, results from a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients, with some patients on leronlimab monotherapy remaining virally suppressed for more than four years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and has received clearance to initiate a clinical trial with leronlimab in metastatic triple-negative breast cancer.

 

 

Forward-Looking Statements 

 

This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict.  Words and ex-pressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as “believes,” “hopes,” “intends,” “estimates,” “expects,” “projects,” “plans,” “anticipates” and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. The Company’s forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Company’s cash position, (ii) the Company’s ability to raise additional capital to fund its operations, (iii) the Company’s ability to meet its debt obligations, if any, (iv) the Company’s ability to enter into partnership or licensing arrangements with third parties, (v) the Company’s ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Company’s ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Company’s clinical trials, (viii) the results of the Company’s clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company’s products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Company’s control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.


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