Therapeutic areas in focus
MERGERS & ACQUISITIONS
Gilead and MacroGenics partner for bispecific antibody development
Gilead Sciences, a biopharmaceutical company committed to advancing innovative medicines to prevent and treat life-threatening diseases, has announced a collaboration with Macrogenics, a biopharmaceutical company focused on developing and commercialising innovative monoclonal antibody-based therapeutics for the treatment of cancer.
Within the partnership, Gilead will pay MacroGenics an upfront payment of $60m, with MacroGenics being eligible to receive up to $1.7bn in target nomination, option fees, and development, regulatory and commercial milestones.
The collaboration is an exclusive option and collaboration agreement to develop MGD024 ‒ an investigational, bispecific antibody that binds CD123 and CD3 using MacroGenics’ DART
platform, and two additional bispecific research programmes.
This will also give Gilead the option for licensing MGD024 as a possible treatment for specific blood cancers, including myelodysplastic syndromes (MDS) and acute myeloid leukaemia (AML).
MGD024 is a next-generation, bispecific that incorporates a CD3 component that is designed to minimise cytokine-release syndrome (CRS), a potentially life-threatening toxicity, while increasing the magnitude of antitumour activity with a longer half-life to permit intermittent dosing.
Scott Koenig, MD, PhD, President and CEO, MacroGenics said, “Rapid advances over the last decade have made CD123 a very promising target in oncology research. Advancing our bispecific DART molecule, MGD024, through a strategic collaboration with the team at Gilead will accelerate our ability to drive further development of MGD024 to the potential benefit of people living with blood cancers.”
“MacroGenics’ bispecific expertise naturally complements Gilead’s portfolio strengths in immuno-oncology and our growing haematology franchise. We believe MGD024, with its potential to reduce CRS and permit intermittent dosing through a longer half-life, could translate to more patient-friendly dosing and enhanced clinical outcomes for people living with AML and MDS. This partnership is the latest in our efforts to develop and advance transformative new cancer therapies as we deepen our portfolio across oncology indications,” added Bill Grossman, MD, PhD, Senior Vice President, Oncology Clinical Development, Gilead Sciences.
AI device to treat chronic pain approved by FDA
The FDA has approved the use of the Nevro Corporation’s advanced spinal cord stimulator (SCS), which uses AI to individualise treatment for the specific patient to treat their individual chronic pain.
Nevro’s Senza HFX iQ device is said to “learn from patients” as they continue to use the device, allowing it to create customised algorithms to treat the patient’s pain, specifically chronic back pain, leg pain and pain from diabetic neuropathy.
The algorithm is designed to gradually adjust pain management, after accounting for patient input and medical data, including factors such as pain scores, activity levels and pain medication use. The patient will also be able to adjust the pain management programmes through a smartphone app linked to the device. The surgically implanted SCSs are often considered the last resource in chronic pain management, for patients who do not respond to other pain management strategies. They emit low levels of electricity to reduce the intensity of the patient’s pain signals.
Keith Grossman, Chair and CEO of Nevro, said in a news release: “HFX iQ is designed to improve the consistency of pain relief and is the only SCS system that truly personalises care. […] Pain is variable from patient to patient and over time. Using the Big Data from our HFX Cloud patient database, our unique HFX Algorithm was developed to identify those programmes where patients have been more likely to get relief in the real world. HFX iQ takes direct input from each patient on their pain and quality of life measures to get smarter over time and recommend programme changes.”
EC approves CAR T cell therapy for B cell lymphoma
Kite, a global biopharmaceutical company based in California, has announced that the European Commission (EC) has approved its cell therapy Yescarta ®for B cell lymphoma patients.
The approval is based on results from a phase 3 ZUMA-7 trial, the largest and longest Chimeric Antigen Receptor (CAR) T cell therapy versus standard of care (SOC) study in this patient population.
Yescarta is now the first CAR T cell therapy approved for patients in Europe who don’t respond to first-line treatment.
Typically, 60% of newly diagnosed large B cell lymphoma (LBCL) patients, including those with diffuse large B cell lymphoma (DLBCL), will respond favourably to initial treatment, however the remainder will either have no reaction, or relapse. Yescarta will be used to treat patients with DLBCL and high-grade B cell lymphoma (HGBCL), who relapse within 12 months or who don’t react to chemo-immunotherapy.
Christi Shaw, CEO, Kite stated: “We are very proud to announce Kite’s fifth approved indication in Europe in our continued commitment to the research and delivery of cell therapies with curative potential to patients who might benefit around the world. Today’s approval marks an important step by providing patients in Europe this option of CAR T cell therapy earlier in their treatment journey.”
Professor John Gribben, Professor of Medical Oncology at the Cancer Research
UK Barts Centre, London, added, “This approval marks a major shift in the treatment of LBCL when initial treatment has failed. In ZUMA-7, treatment with axicabtagene ciloleucel resulted in an overall better outcome for patients than standard of care, especially in terms of event-free survival, marking a new era for treatment earlier in the disease pathway for more patients. The ZUMA-7 data has also broadened our understanding of this CAR T cell therapy, allowing us to better manage or prevent side effects, which is important as it moves earlier in the treatment pathway and for older patients and those with medical conditions for whom the standard of care might have been difficult.”