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>>> Humanigen and Lonza Announce Collaboration to Expand Manufacturing of Humanigen's COVID-19 Therapeutic Candidate Lenzilumab


ACCESSWIRE

September 15, 2020


https://finance.yahoo.com/news/humanigen-lonza-announce-collaboration-expand-050000259.html


Collaboration to expand lenzilumab manufacturing capacity in advance of potential Emergency Use Authorization in 2020

Commercial manufacturing to begin in 2021 at Lonza's manufacturing facility at Hayward

The collaboration is projected to take lenzilumab through product launch and commercial supply


Quote from Jean-Christophe Hyvert, Chief Commercial Officer, Lonza:
"In an effort to change the course of this pandemic, advancing lead COVID-19 therapeutics requires matched supply chain efforts and expertise to meet the continued and urgent patient needs. COVID-19 has highlighted the need for heightened industry collaboration and coordination and we are excited to work closely with Humanigen as we work to combat this global health crisis."

Quote from Cameron Durrant, MD, MBA, Chief Executive Officer, Humanigen:
"We are ramping up our manufacturing efforts for lenzilumab, our lead drug candidate, and this collaboration with Lonza, a global manufacturing leader with expertise in technology transfer and an established track record of working with regulatory bodies for approved and commercialized products, comes at a crucial time to meet production demand for COVID-19 therapeutics this winter."


BURLINGAME, CA AND BASEL, SWITZERLAND / ACCESSWIRE / September 15, 2020 / Humanigen, a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm,' and Lonza today announced a strategic collaboration to expand the manufacturing capacity for lenzilumab, currently in Phase 3 clinical trials for COVID-19, in advance of potential Emergency Use Authorization in 2020 and subsequent commercialization.

The collaboration enables Humanigen to leverage Lonza's monoclonal antibody manufacturing and regulatory expertise. Lenzilumab represents Humanigen's proprietary Humaneered® anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody with the potential to prevent and treat cytokine storm, which is believed to trigger the acute respiratory distress syndrome in severe cases of COVID-19.

This collaboration provides Humanigen with additional capacity for cGMP production of lenzilumab with operations intended to start in 2021. Production of lenzilumab will begin at Lonza's 2,000L manufacturing facilities at Hayward (CA), USA. Technology transfer is expected to begin in Q3 2020.

More details on Humanigen's programs in COVID-19 can be found at www.humanigen.com/covid-19, and details of the US Phase 3 potential registration study can be found at clinicaltrials.gov using ClinicalTrials.gov Identifier NCT04351152.

About Lonza

At Lonza, we combine technological innovation with world class manufacturing and process excellence. Together, these enable our customers to deliver their discoveries in the healthcare, preservation, and protection sectors.

We are a preferred global partner to the pharmaceutical, biotech and specialty ingredients markets. We work to prevent illness and promote a healthier world by enabling our customers to deliver innovative medicines that help treat or even cure a wide range of diseases. We also offer a broad range of microbial control solutions, which help to create and maintain a healthy environment.

Founded in 1897 in the Swiss Alps, Lonza today operates in 120 sites and offices in more than 35 countries. With approximately 15,500 full-time employees, we are built from high-performing teams and of individual employees who make a meaningful difference to our own business, as well as the communities in which we operate. The company generated sales of CHF 5.9 billion in 2019 with a CORE EBITDA of CHF 1.6 billion. Find out more at www.lonza.com and follow us on Twitter @LonzaGroup or Facebook @LonzaGroupAG.

About Humanigen

Humanigen, Inc. is developing its portfolio of clinical and pre-clinical therapies for the treatment of cancers and infectious diseases via its novel, cutting-edge GM-CSF neutralization and gene-knockout platforms. We believe that our GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection. The company's immediate focus is to prevent or minimize the cytokine release syndrome that precedes severe lung dysfunction and ARDS in serious cases of SARS-CoV-2 infection.

The company is also focused on creating next-generation combinatory gene-edited CAR-T therapies using strategies to improve efficacy while employing GM-CSF gene knockout technologies to control toxicity. In addition, the company is developing its own portfolio of proprietary first-in-class EphA3-CAR-T for various solid cancers and EMR1-CAR-T for various eosinophilic disorders. The company is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, bispecific or natural killer (NK) T cell engaging immunotherapy treatments to break the efficacy/toxicity linkage, including to prevent and/or treat graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). Additionally, Humanigen and Kite, a Gilead Company, are evaluating lenzilumab in combination with Yescarta® (axicabtagene ciloleucel) in patients with relapsed or refractory large B-cell lymphoma in a clinical collaboration. For more information, visit www.humanigen.com.

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