Week of July 13
This weekly post looks to identify important advancements in the areas of oncology, CNS disorders and neurodegeneration, technologies, and industry and corporate developments. More in-depth reading and analysis can be found in the attached links.
Oncology
Before the ODAC approval vote on July 14, the FDA highlighted safety concerns over GSK’s belantamab mafodotin in multiple myeloma. In a Phase 2 trial, 71% of patients had keratopathy that ranges from dry eyes to severe vision loss. While the FDA has not seen this side effect in other myeloma drugs, analysts predicted belantamab mafodotin will be approved. Link
Roche announced negative results from their Phase 3 IMagyn050 study in front-line treatment of newly diagnosed advanced stage ovarian cancer. The addition of Tecentriq to Avastin, paclitaxel and carboplatin did not meet its primary endpoint of progression-free survival (PFS). Both in combination or alone, Tecentriq has multiple planned and ongoing Phase 3 trials in various cancers. Link
ADC Therapeutics announced that the FDA has lifted its clinical hold on camidanlumab tesirine’s Phase 2 trial in patients with relapsed or refractory Hodgkin Lymphoma (HL). Patient enrollment was halted after two patients were diagnosed with Guillain-Barré syndrome. Link
Predicine, Chris O’Brien Lighthouse, and the Monash School of Clinical Science partnered together in developing a blood test determining mCRPC patients’ responsiveness to conventional therapy. Link
CNS Disorders & Neurodegeneration
Biogen submitted a Biologics License Application (BLA) to the FDA for aducanumab for the treatment of Alzheimer’s disease. If approved, aducanumab would be the first approved therapy to connect amyloid beta removal to improved clinical outcomes. Link
Kymera Therapeutics and Sanofi entered into a strategic partnership to advance novel protein degrader therapies. This multi-program partnership will first focus on commercializing a first-in-class protein degrader targeting IRAK4 in patients with immune-inflammatory diseases. Link
PTC Therapeutics announced the start of their Phase 1 trial evaluating PTC857 safety in healthy volunteers. This novel small molecule inhibits a key enzyme involved in neuroinflammation and oxidative stress. PTC857’s first indication will be GBA Parkinson's disease. Link
Technologies
FDA placed a clinical hold on Cellectis’s allogeneic CAR T-cell therapy UCARTCS1A. The hold was placed on a Phase 1 trial treating patients with multiple myeloma after one patient experienced a treatment related fatal cardiac arrest. Link
Roche announced they are pushing their hemophilia A gene therapy’s phase 3 study to 2021. While the gene therapy showed improvements in factor VIII expression and bleeding out as far as 3.3 years, competitors will have already started their phase 3 trials or have FDA approval. Link
Industry and Corporate Developments
In a deal worth $986 million, Kiadis Pharma signed an exclusive licensing deal with Sanofi for Kiadis Pharma’s innovative natural killer (NK) therapy. Sanofi plans to combine this NK cell therapy to its recently approved therapy, Sarclisa, to optimize treatment efficacy in multiple myeloma patients. Link
Pfizer announced it will pledge $100 million to the Antimicrobial Resistance (AMR) Action Fund to address the global rise in antibiotic-resistant infections. The fund hopes to rejuvenate and accelerate antibiotic development by bringing 2-4 new antibiotics to market by 2030. Link
A study conducted by the Center for Integration of Science and Industry at Bentley University suggests that $6.5 billion in NIH funding laid crucial groundwork for getting Gilead’s remdesivir approved. This study continues the debate over remdesivir’s $2,340 price tag especially with generic versions being priced at around $350-700. Link
Despite the ongoing pandemic, GoodRx reports that brand and generic drug prices have continued to increase by an average of 6.8% since January of this year. Link