Global Briefs: AstraZeneca, Gilead, Sanofi & More

A roundup of news from AstraZeneca, Gilead Sciences, Sanofi, PhRMA, SK bioscience and Emergent BioSolutions. Highlights below.  

* AstraZeneca, KYM Bio In $1.16-Bn Deal for Gastric Cancer ADC 
* Gilead Completes Acquisition of Tmunity Therapeutics 
* Sanofi Completes $35-M Equity Investment in Provention Bio
* Novartis CEO Named Chair of PhRMA 
* SK biosciences Investing $261 M in Center for Vaccine Research, Process Development
* Emergent BioSolutions To Sell Travel Health Business to Bavarian Nordic in $380-M Deal   

AstraZeneca, KYM Bio In $1.16-Bn Deal for Gastric Cancer ADC 
AstraZeneca and KYM Biosciences, a joint venture between Hong Kong-based biotech companies Keymed Biosciences and Lepu Biopharma, have entered into a global exclusive license agreement for an antibody drug conjugate (ADC) candidate of KYM Biosciences for treating gastric cancer in a deal worth up to $1.16 billion ($63 million upfront, $1.1 billion in milestone payments). 

The ADC candidate, CMG901, is in a Phase I clinical trial for treating Claudin 18.2-positive solid tumors, including gastric cancer. Under the agreement, AstraZeneca will be responsible for the research, development, manufacture, and commercialization of CMG901 globally. 

AstraZeneca will make an upfront payment of $63 million on transaction closing and additional development and sales-related milestone payments of up to $1.1 billion to KYM Biosciences as well as tiered royalties up to low double digits. The transaction is expected to close in the first half of 2023, subject to customary closing conditions and regulatory clearances.  

Source: AstraZeneca 

Gilead Completes Acquisition of Tmunity Therapeutics 
Kite, part of Gilead Sciences, has completed its acquisition of Tmunity Therapeutics, a Philadelphia, Pennsylvania-based clinical-stage bio/pharmaceutical company focused on CAR T-therapies and technologies. The acquisition was announced in December 2022.  

The acquisition of Tmunity complements Kite’s existing in-house cell-therapy research capabilities by adding additional pipeline assets, platform capabilities, and a strategic research and licensing agreement with the University of Pennsylvania. The acquisition provides Gilead with preclinical and clinical programs, including an “armored” CAR T technology platform, which potentially could be applied to a variety of CAR T’s to enhance anti-tumor activity as well as improve manufacturing processes. Tmunity’s prostate-specific membrane antigen (PSMA) and prostate stem cell antigen (PSCA) assets were not part of the acquisition and were spun out by Tmunity as part of the transaction. 

Source: Gilead Sciences 

Novartis CEO Named Chair of PhRMA 
The Pharmaceutical Research and Manufacturers of America (PhRMA), an industry trade association representing innovator-based drug companies in the US, has announced that Novartis CEO Vas Narasimhan, M.D., has assumed the role of Chair of the PhRMA Board of Directors. He succeeds Ramona Sequeira, President of Takeda’s Global Portfolio Division, as PhRMA’s Board Chair. 

Dr. Narasimhan has been CEO of Novartis since 2018. Since joining Novartis in 2005, Narasimhan has held a range of leadership roles, including Global Head of Drug Development and Chief Medical Officer and Global Head of Development for Novartis Vaccines. 

PhRMA also announced that Gilead Sciences’ Chairman and CEO, Daniel O’Day, is taking over as Board Chair-elect and that Albert Bourla, Chairman and CEO of Pfizer, will serve as Treasurer of the PhRMA Board. 

Source: PhRMA 

Sanofi Completes $35-M Equity Investment in Provention Bio 
Sanofi has completed a $35-million equity investment in Provention Bio, a Red Bank, New Jersey-based bio/pharmaceutical company focused on immune-mediated diseases. 

The companies are collaborating on Tzield (teplizumab-mzwv), which was approved in 2022 by the US Food and Drug Administration, to delay the onset of Stage 3 Type 1 diabetes in adults and pediatric patients eight years and older who currently have Stage 2 Type 1 diabetes. 

Under the agreement, Sanofi purchased 2,712,497 shares of Provention Bio’s common stock, par value $0.0001 per share, at a price of $12.90 per share, representing a total investment of $35 million. 

Source: Provention Bio 

SK bioscience Investing $261 M in Center for Vaccine Research, Process Development
SK bioscience, a Seongnam, South Korea-based bio/pharmaceutical and vaccine company, has announced a total investment of $261 million for a new vaccine research and process development center called the Songdo Global Research & Process Development Center in Songdo, South Korea.  

The center will occupy a 30,413.8-square-meter site. Once it is completed in the first half of 2025, the company’s headquarters and R&D center currently in Pangyo, South Korea, will move to the Songdo area. 

The center will use technologies covering the entire process from basic research to commercial manufacturing with a focus on new infectious diseases. SK bioscience plans to establish an Open Lab in the center as a joint research space for international organizations and bio/pharmaceutical companies to work with the company to develop new vaccines together.  

In addition, collaborations, such as manpower training for other countries that do not have enough research capacities but high demand for vaccine development, are planned in the Open Lab. The operation of the Open Lab will help develop the company’s globalization initiative, a project which transfers SK bioscience’s R&D and production capabilities to countries with high demand for vaccines but insufficient human and physical infrastructure. 

SK bioscience will also secure advanced BSL-3 (Biological Safety Level) research facilities to further strengthen its own vaccine pipeline. 

In addition, the company plans to operate a pilot plant at the center, which will be designed as a cGMP-level production facility. The plant will also be utilized for new tasks under the main growth strategies of SK bioscience, such as cell and gene therapies, mRNA, and viral vectors platforms research. The plant will be be used to produce samples for non-clinical, clinical, and commercial-scale, SK bioscience will also develop its pipeline through its vaccine-manufacturing facility in Andong, South Korea.   

Source: SK bioscience 

Emergent BioSolutions To Sell Travel Health Business to Bavarian Nordic in $380-M Deal   
Emergent BioSolutions, a Gaithersburg, Maryland-based specialty biopharmaceutical company and contract manufacturer, and Bavarian Nordic, a Hellerup (near Copenhagen), Denmark-based vaccine company, have entered into an agreement under which Emergent will sell its travel health business to Bavarian Nordic in a deal worth up to $380 million ($270 million upfront and $110 million in milestone payments).  

Under the agreement, Bavarian Nordic will acquire the rights to Vivotif, indicated for the active immunization to prevent typhoid fever, and Vaxchora, indicated for the active immunization to prevent cholera, as well as the development-stage vaccine candidate, Chikv VLP, for the chikungunya virus, which is spread through mosquitos.  

Bavarian Nordic will also acquire Emergent’s manufacturing site in Bern, Switzerland, and development facilities in San Diego, California. Approximately 280 current Emergent employees are expected to join Bavarian Nordic as part of the transaction. 

Upon closing, Bavarian Nordic will pay Emergent $270 million in upfront cash consideration. Additionally, Bavarian Nordic will pay Emergent up to $30 million in sales-based milestones associated with the commercial products and up to $80 million in development-based milestones associated with the Chikv VLP program. The transaction is expected to close in the second quarter of 2023, subject to regulatory clearance and customary closing conditions. 

Source: Emergent BioSolutions