Feliza Mirasol is the science editor for 

Feliza Mirasol

Gilead Sciences and Arcus Biosciences, a US-based clinical-stage biopharmaceutical company, announced on May 15, 2023 that they are expanding a previously announced research collaboration to now include development of therapies for treating inflammatory diseases. Their initial collaboration agreement, worth potentially more than $1.6 billion, focused on oncology (1).

Under the expanded collaboration, Arcus will receive an upfront payment of $35 million. Arcus will initiate research programs against up to four targets that are jointly selected by both parties and that are applicable to inflammatory diseases. Gilead would have the option to license each program at two separate, prespecified time points. If Gilead exercises its option for the first two target programs at the earlier time point, then Arcus would be eligible to receive up to $420 million in option and milestone payments as well as tiered royalties for each optioned program. For any other option exercised by Gilead for the four target programs, the two parties would have rights to co-develop the candidates. In addition, both parties would share global development costs and co-commercialize and share profits in the United States for optioned programs.

“We are pleased to build upon Gilead’s efforts in inflammation with the expansion of our strategic collaboration with Arcus,” said Flavius Martin, executive vice-president, Research, Gilead Sciences, in a company press release. “Arcus is an excellent partner with clear strengths in discovery and development, and we believe this partnership will significantly accelerate our progress in developing transformative new therapies for inflammatory diseases.”

“Since its founding, Arcus has been creating and developing therapeutic interventions that can modulate the immune system to treat cancer. Through this expansion of our partnership with Gilead, we can combine our research expertise in immunology and small-molecule drug discovery with Gilead’s strong clinical experience in inflammation,” said Terry Rosen, CEO, Arcus, in the release. “The research collaboration facilitates much earlier alignment between Gilead and Arcus on our discovery and development activities, while enabling Arcus to expand into inflammation in a capital-efficient manner.”

1. Gilead Sciences, Gilead Sciences and Arcus Biosciences Establish 10-year Partnership to Co-develop and Co-commercialize Next-generation Cancer Immunotherapies. Press Release, May 27, 2020.

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Gilead Sciences and Arcus Biosciences have expanded their research collaboration to include inflammatory diseases in addition to oncology. 

Gilead Sciences and Arcus Biosciences Expand Research Partnership

On May 15, 2023, the Canadian Advanced Therapies Training Institute (CATTI) announced that it has launched a cell and gene therapy (CGT) training center of excellence at the University of Guelph in Guelph, Ontario, Canada through a partnership with the university, CCRM, a Canada-based public–private partnership, and OmniaBio, a subsidiary of CCRM and a contract development and manufacturing organization specializing in the production of gene-modified cells and viral vectors. According to the institute’s press release, the new center is CATTI’s first in-person training site at the university.

The CGT training program is slated to begin in the summer of 2023 and will cater to recent post-secondary graduates, industry professionals, and companies looking to grow their cleanroom manufacturing staff. The site will begin to address the industry’s critical training needs, and, according to CATTI in the press release, the program represents the first stage of a larger, multi-site training strategy for the institute.

In its first year, the program will focus on human pluripotent stem cell banking, aseptic techniques, good manufacturing practices (GMPs) optimized for CGT manufacturing, and lab skills, including pipetting, vessel handling, microscope operation, and other skills. The curriculum is expected to include a combination of online courses and hands-on courses in a specialized training lab. The lab is designed to focus on providing GMP industry standard skill sets, according to the press release.

“The biosafety level 2 lab space at the University of Guelph will expand CATTI’s offering in central Canada and provide hands-on-learning in a one-of-a-kind, state-of-the-art space for workers across Canada and internationally,” said Vanessa Laflamme, CEO, CATTI, in the release. “We expect to train [more than] 600 people in the next two years, including [more than] 300 employees for OmniaBio, one of CATTI’s strategic customers.”

“OmniaBio has a significant need for trained talent due to the growth trajectory and technical capability of its operation,” said Mitchel Sivilotti, CEO, OmniaBio, in the release. “This collaboration with CATTI and the University of Guelph is a win for everyone involved. We will support the effort by providing funding, strategic guidance, and content development input to facilitate a hands-on, highly-focused, GMP training experience utilizing the most current equipment and technologies used in CGT manufacturing today.”

OmniaBio, which was itself recently launched by CCRM in March 2022 (1), is also in the process of constructing new facilities. In the first phase of construction, OmniaBio is building an 89,000-ft2 (7,432-m2) facility, which will be equipped with 15 clean rooms and employ 500 staff members. This first facility is expected to be completed in 2024. A second building is also planned. Upon completion, OmniaBio and CCRM will have more than 50 cleanrooms and more than 1000 employees.

1. CCRM, Funding from Ontario Government Launches OmniaBio Inc. Press Release, March 31, 2022.

Canadian Advanced Therapies Training Institute

CATTI has launched an in-person training site at the University of Guelph in Ontario, Canada, for training personnel in cell and gene therapy manufacturing.

CATTI Starts Up CGT Training Center at University of Guelph

On May 15, 2023, BiOneCure Therapeutics, a US-based clinical-stage biopharmaceutical company focused on developing antibody-drug conjugates (ADCs), announced that it has entered into a strategic collaboration with China- based Nanjing Leads Biolabs, a clinical-stage biopharmaceutical company focused on second-generation immuno-oncology therapeutics, to develop a range of innovative ADCs for treating solid tumors.

The companies intend to leverage their complementary technologies in the collaboration, which they expect will strengthen their R&D and product development capabilities. BiOneCure’s technology includes several proprietary ADC payload-linker platforms. Its first product, BIO-106, is an anti-Trop-2 ADC that is currently in a Phase I clinical study. Leads Biolabs’ portfolio holds more than 20 novel mono- or bispecific antibody drug projects to fulfill unmet medical needs, according to a company press release.

"We are excited to collaborate with Leads Biolabs to develop ADC drugs," said Haifeng Bao, CEO of BiOneCure, in the press release. "Through this collaboration, we aim to accelerate innovation and development in the ADC field and provide better treatment options for patients."

"We believe that BiOneCure has leading ADC technology platforms, and [its] ADC molecule is in the clinical stage," said Xiaoqiang Kang, founder and chairman of Leads Biolabs, in the release. "Leads Biolabs is a clinical-stage antibody new drug company, with multiple antibody technology platforms. We are convinced that this collaboration will greatly expand the innovative R&D capabilities of both parties."

Under the collaboration, BiOneCure Therapeutics and Nanjing Leads Biolabs intend to develop a range of innovative antibody-drug conjugates for treating solid tumors.

BiOneCure Therapeutics and Nanjing Leads Biolabs Partner to Develop ADCs for Solid Tumors

Synthego, a US-based provider of genome engineering solutions, has opened its new good manufacturing practice (GMP) synthesis facility. According to a May 11, 2023 company press release, the 18,000-ft

 facility will support the growing demand for the development of high-quality, clustered regularly interspaced short palindromic repeats (CRISPR)-enabled 

 therapeutics. Services at the new facility will also include investigational new drug-, new drug application-, and biologics license application-enabling clinical studies.

The new facility features multiple multiplexed manufacturing lines, fully automated controls, and an integrated manufacturing execution system. The company will have the capability to produce a range of oligonucleotides, including synthetic single guide RNAs. The facility also includes dedicated process development, analytical testing, and quality control areas, which will ensure that all aspects of the manufacturing process are closely controlled. The facility meets the requirements of both domestic and international regulatory authorities including FDA, the European Medicines Agency, the Medicines and Healthcare products Regulatory Agency, and Health Canada, according to the press release.

“This facility will be essential in supporting the burgeoning field of clinical phase, first-in-human, CRISPR-enabled medicines both for more common genetic diseases but also for rare diseases affecting children for whom other treatments do not exist,” said Adrian Thrasher, a clinician and professor of Pediatric Immunology at University College London Great Ormond Street Institute of Child Health, in the press release. Thrasher’s laboratory is developing new CRISPR-enabled medicines for children with rare genetic diseases.

“As we move into this new generation of cell and gene therapies, it will be crucial that there are strong, reliable manufacturing capabilities that exist for the necessary components of the CRISPR technology—such as the guide RNA—in order to accelerate the path to clinic and treat patients," Thrasher said in the release.

“Synthego pioneered the mass production of guide RNAs for discovery research that has enabled many of the CRISPR-based cell and gene therapy trials happening today. Having been a key leader in providing the technology for researchers and clinicians, it follows that they are now expanding their capacity to support this research as it translates into the clinic,” said Don Kohn, distinguished professor and clinician of Pediatric Hematology and Oncology at University of California, Los Angeles. Kohn’s laboratory pioneered genetic therapies for immunocompromised children.

Synthego has opened its new GMP-compliant RNA manufacturing facility in Redwood City, Calif., for CRISPR-enabled genomics therapeutics.

Synthego Launches New RNA Manufacturing Facility

Amgen and TScan Therapeutics, a US-based clinical-stage biopharmaceutical company specializing in T cell receptor-engineered T-cell therapies, announced on May 9, 2023 that they have entered into a multi-year collaboration under which they will use TScan's proprietary target discovery platform, TargetScan, to identify antigens recognized by T cells in patients with Crohn's disease. Under the agreement, TScan will receive a $30 million upfront payment. The company is also eligible to earn more than $500 million upon achievement of preclinical, clinical, regulatory, and commercial milestones as well as tiered single-digit royalty payments.

For its part, Amgen will evaluate a variety of modalities as it seeks to create therapeutics based on targets discovered by TScan. Amgen will retain all global development and commercial rights. It also has an option, under certain terms, to expand the collaboration to ulcerative colitis. Each party will handle its own research expenses.

"Anti-inflammatory drugs have traditionally been the standard of care for patients suffering from inflammatory bowel disease, but often lack efficacy and durability," said Raymond Deshaies, senior vice-president of Global Research at Amgen, in a company press release. "TScan's platform provides [an] approach to identify non-conventional drug targets to enable the development of potential first-in-class therapeutics to address unmet medical needs."

"We're excited to apply our target discovery platform to the autoimmunity space," said Gavin MacBeath, acting CEO and chief scientific and operating officer at TScan, in the release. "Our TargetScan platform, which we have now extended to identify MHC [major histocompatibility complex] class II targets of CD4+ T cells, is well-suited for the discovery of antigens targeted by the immune system in inflammatory bowel disease. We look forward to developing the value of our platform both in this partnership with Amgen and in other autoimmune diseases."

In a deal potentially worth more than $530 million, Amgen will use TScan Therapeutics’ target discovery platform to home in on novel targets for Crohn’s disease treatment.

Amgen and Tscan Therapeutics Team Up to Identify Novel Targets in Crohn's Disease

On May 09, 2023, Sandoz, a Novartis division, and Just – Evotec Biologics, a US-based wholly owned subsidiary of Evotec SE that specializes in using artificial intelligence (AI)/machine learning (ML) technologies for biotherapeutic development, announced a multi-year partnership. Under the agreement, the companies will develop and manufacture multiple biosimilar medicines.

Sandoz will have access to Just – Evotec Biologics’ AI/ML-driven drug substance development platform and manufacturing technology, which Sandoz will use to expand its current biosimilars pipeline from 15+ to 24 assets. Sandoz also intends to continue development of its early-stage biosimilars pipeline through the partnership.

“This strategic partnership is founded on a strong shared sense of purpose and commitment to use disruptive technology with lower operational costs to deliver high-quality biosimilars at scale to patients around the world,” said Sandoz CEO Richard Saynor in a company press release.

“It provides us with additional capabilities to support the strategic expansion of our pipeline with new assets and to begin immediately transitioning our early biosimilar pipeline—ensuring continuity in development and manufacturing while Sandoz finalizes its planned separation from Novartis. Development of the biosimilars will ramp-up over the coming 12–18 months,” Saynor also said in the release.

The new partnership between Sandoz, a Novartis division, and Just – Evotec Biologics will aim to develop and manufacture multiple biosimilars.