South San Francisco (CA), USA and Basel, Switzerland, May 29, 2020 – Surrozen Inc., a biotechnology company pioneering a new class of targeted regenerative antibodies, and Lonza today announced that the companies have signed a collaboration agreement. Lonza will provide contract development and cGMP manufacturing services for Surrozen’s first two, and potentially additional, development candidates.
Surrozen will leverage Lonza’s process development and manufacturing capabilities and expertise in cell line development, early-stage formulation development and drug product manufacture. Process development and drug substance manufacturing will take place in Lonza’s cGMP facility for mammalian biopharmaceuticals in Slough, UK. The early-stage formulation and DP manufacture will be carried out in the Drug Product Services facility in Basel and Lonza’s recently acquired fill and finish facility in Stein, Switzerland.
The agreement includes Lonza’s Light Path™ cell line development program that will provide Surrozen with material to enter a phase I clinical study. This offering that includes gene to cGMP drug substance and drug product production services will help Surrozen to meet their clinical product supply needs as well as provide a CMC regulatory package for their IND filing. The scope of the package was tailored for the molecule to ensure the program met their requirements.
The two initial development candidates represent potent multivalent bi-specific antibodies that directly activate the Wnt signaling pathway, which regulates multiple biological processes and plays a key role in tissue homeostasis and injury repair. These candidates are both in the preclinical phase with potential INDs in 2021 and 2022. Surrozen’s targeted approach to tissue specific regenerative medicine aims to impact many areas, including neurodegenerative, lung, and inflammatory diseases.
“Lonza’s subject matter experts enjoyed working with the Surrozen’s technical team to identify specific molecule needs to design a tailored Light PathTM cell line development work package suitable to achieve their goals. This produced two critical outcomes; an end to end program beginning with their gene, ending with drug product and a CMC IND readiness package that will support Surrozen on their first IND filing. An enhanced, strong and collaborative working relationship between the parties drastically improves the chance of project success. ”
“We are excited to be working with Lonza, which has industry leading capabilities and expertise with complex biologics including antibodies and bi-specific molecules. Lonza’s extensive biologics development, manufacturing and CMC regulatory experience makes them an ideal partner for novel molecules like our SWAP and SWEETS bi-specific antibodies. Based on our molecules and some unique program needs, Lonza took a flexible and adaptable approach to designing a program that was tailored to meet our specific needs.”
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.
Since its founding in 2016, Surrozen has developed two proprietary platforms to selectively modulate the Wnt pathway for the potential treatment of injury and disease. Surrozen Wnt-mimetics, also referred to as SWAPs (Surrozen Wnt Signal Activating Proteins), are bi specific full-length human (IgG) antibodies that directly activate the canonical Wnt signaling pathway in target tissue. Surrozen Rspondin-mimetics, also referred to as SWEETS (Surrozen Wnt Signal Enhancer Engineered for Tissue Specificity), are uniquely engineered antibodies that stabilize Wnt receptors.
Surrozen is a biotechnology company pioneering a new class of targeted regenerative antibodies to repair a broad range of tissues and organs damaged by serious disease. Surrozen is designing tissuespecific antibodies that engage the body’s own biological repair mechanisms resulting in a broad pipeline of disease-specific therapies to help patients across multiple disease areas. For more information, please visit surrozen.com.
Dr. Kristin Koehler
Lonza Group Ltd
Tel +41 61 316 8782
Dr. Sanna Fowler
Head of External Communications
Lonza Group Ltd
Tel +41 61 316 8929
VP, Corporate Development and Strategy