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30 BioPharm International ® Emerging Therapies eBook September 2024 www.biopharminternational.com Treatments for cancer and other diseases of concern New developments in oncology made headlines in sum- mer 2024. FDA granted a Breakthrough Therapy desig- nation to GSK for an antibody-drug conjugate (ADC) that targets a protein, B7-H3, considered to be a valuable tar- get for cancer therapy (4). The investigational ADC has been under evaluation for treatment of patients with extensive-stage small-cell lung cancer. Bristol Myers Squibb received validation of a Type II variation application from the European Medicines Agency for an expansion of the indication for Breyanzi to include adults with relapsed or refractory follicular lymphoma. And the human epidermal growth factor receptor 2 (HER2)-directed ADC Enhertu, developed jointly by AstraZeneca and Daiichi Sankyo, got con- ditional approval from the National Medical Products Administration of China for treatment of adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinomas (5–6). As the summer went along, a new wave of an mpox outbreak in Africa caused the World Health Organiza- tion to declare the spread of the virus a public health emergency of international concern (7). But with the par- asite for another disease, malaria, accounting for more than 200,000 stillbirths and 50,000 maternal deaths in Africa annually, the National Institutes of Health said on Aug. 14, 2024 that two trials had shown an experimental malaria vaccine to be safe in healthy adults, particularly in healthy women of childbearing potential (8). AAVs' impact on manufacturing and acquisitions News on adeno-associated viruses (AAVs) provided a common thread for some business- and industry-fo- cused developments. Rentschler Biopharma announced in September the launch of an expanded service offering at its advanced therapies site in Stevenage, United King- dom, including a new lentiviral vector manufacturing toolbox for advanced therapy medicinal products, to complement Rentschler's AAV viral vector services (9). In August, Andelyn Biosciences announced a license agreement with the Broad Institute of MIT and Harvard to add MyoAAV plasmids to expand Andelyn's AAV Cu- rator Platform (10). The plasmids are designed to pro- duce AAVs ten times more efficient in reaching muscle tissue and targeting the liver than wild-type vectors. Roche Group member Genentech entered into a li- cense agreement with Sangamo Therapeutics for de- veloping genomic medicines to treat neurodegenerative diseases, including exclusive licensing of Sangamo's proprietary zinc finger repressors directed to the tau gene and its neurotropic AAV capsid, STAC-BBB (11). Finally, Merck, known as MSD outside of the United States and Canada, agreed to acquire, through a subsid- iary, Curon Biopharmaceutical's CN201, a novel, inves- tigational clinical-stage bispecific antibody for treating B-cell associated diseases (12). References 1. FDA. FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants. Press Release. Aug. 22, 2024. 2. Spivey, C. A Discussion on the Outsourcing of mRNA Pro- duction (BIO 2024). PharmTech.com, Aug. 22, 2024. 3. MediWound. MediWound Announces US Food and Drug Administration Approval of NexoBrid for the Treatment of Pediatric Patients with Severe Thermal Burns. Press Release. Aug. 15, 2024. 4. GSK. GSK Receives US FDA Breakthrough Therapy Desig- nation for Its B7-H3-Targeted Antibody-Drug Conjugate in Relapsed or Refractory Extensive-Stage Small-Cell Lung Cancer. Press Release. Aug. 20, 2024. 5. Bristol Myers Squibb. European Medicines Agency Val- idates Bristol Myers Squibb's Application for CAR T Cell Therapy Breyanzi for Relapsed or Refractory Follicular Lymphoma. Press Release. Aug. 19, 2024. 6. AstraZeneca. Enhertu Approved in China for Patients with Previously Treated HER2-Positive Advanced or Met- astatic Gastric Cancer. Press Release. Aug. 13, 2024. 7. Hennessy Jr., M. Responding to Mpox. PharmTech.com, Sept. 3, 2024. 8. National Institutes of Health. Candidate Malaria Vaccine Provides Lasting Protection in NIH-Sponsored Trials. Press Release. Aug. 14, 2024. 9. Rentschler Biopharma. Rentschler Biopharma Introduces New Lentiviral Vector Manufacturing Toolbox for Ad- vanced Therapies. Press Release. Sept. 3, 2024. 10. Andelyn Biosciences. Andelyn Biosciences Expands AAV Curator Platform Offering to Include MyoAAV Plasmids through a License Agreement from the Broad Institute of MIT and Harvard. Press Release. Aug. 6, 2024. 11. Sangamo Therapeutics. Sangamo Therapeutics An- nounces Global Epigenetic Regulation and Capsid Deliv- ery License Agreement with Genentech to Develop Novel Genomic Medicines for Neurodegenerative Diseases. Press Release. Aug. 6, 2024. 12. Merck. Merck to Acquire Investigational B-Cell Depletion Therapy, CN201, from Curon Biopharmaceutical. Press Re- lease. Aug. 9, 2024. ■ BioVectra ........................................................................................ 29 Datwyler ......................................................................................... 19 Entegris........................................................................................... 21 Eppendorf ........................................................................................ 5 Eurofins Lancaster Laboratories ................................................. 23 G-CON Manufacturing .................................................................. 27 Intertek ............................................................................................. 2 LabVantage Solutions, Inc. ........................................................... 13 Sartorius Stedim North America, Inc .....................................17, 31 Sino Biological ................................................................................ 25 Tosoh Bioscience ................................................... 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