Week of September 7

Oncology

• Bristol Myers Squibb announced they will present research spanning 15 different cancers at the upcoming European Society for Medical Oncology (ESMO) Virtual Congress 2020. Bristol Myers Squibb will present early-stage data exploring various novel tumor targets and novel treatment combinations in oncology including non-Hodgkin lymphoma, extensive-stage small cell lung cancer, diffuse large B-cell lymphoma, and glioblastoma. Link

• AstraZeneca announced they will present clinical updates at the ESMO Virtual Congress 2020. Results include Phase 3 results demonstrating the long-term benefit of Lynparza in biomarker-selected patients with metastatic castration-resistant prostate cancer (mCRPC) and exploratory data reinforcing the unprecedented patient benefit of Tagrisso as an adjuvant treatment for epidermal growth factor receptor-mutated (EGFRm) NSCLC. Link

• FDA approved Roche’s Gavreto for the treatment of patients with metastatic rearranged during transfection (RET) fusion-positive NSCLC under the FDA’s Accelerated Approval program. Link

• Sanofi and Regeneron Pharmaceuticals announced they will present clinical updates for their PD-1 inhibitor, Libtayo, at the ESMO Virtual Congress 2020. Both companies will present late-breaking results on the investigational use of Libtayo as a first-line monotherapy treatment for advanced NSCLC and locally advanced basal cell carcinoma (BCC). Link

• Boehringer Ingelheim announced positive results from their real-world retrospective, observational study for afatinib followed by osimertinib to treat Del19/L858R EGFR mutation-positive NSCLC patients with acquired T790M mutations. The sequential treatment demonstrated a median overall survival (OS) of 37.6 months median Time to Treatment Failure (TTF) of 27.7 months. Link

CNS Disorders and Neurodegeneration

• Teva Neuroscience, an affiliate of Teva Pharmaceutical Industries, announced they will present clinical data on the completed RIM-TD 3-year open-label extension of AUSTEDO at the International Parkinson and Movement Disorder Society annual congress (MDS Virtual Congress 2020) and during the Psych Congress 2020 Virtual Experience. AUSTEDO is being assessed to reduce involuntary movements in patients severely impacted by tardive dyskinesia (TD). Link

• Roche announced they will present clinical data at MSVirtual2020. Results include two-year open-label Phase 3b results demonstrating OCREVUS treatment leads to a high rate of no evidence of disease activity (NEDA) in patients with relapsing-remitting MS (RRMS) and Phase 3 results demonstrating ENSPRYNG lowered relapse severity in patients with neuromyelitis optica spectrum disorder (NMOSD). Link

• Janssen Pharmaceutical Companies of Johnson & Johnson announced they will present clinical data at MSVirtual2020. Results include a new patient-reported outcome instrument, the Fatigue Symptoms, and Impacts Questionnaire – Relapsing MS (FSIQRMS). Link

Technologies

• Researchers at the University of Pittsburgh have created a CRISPR-based system that can be used to combat the body’s immune response against AAV gene therapy. One of the co-senior authors, Samira Kiani, co-founded SafeGen Therapeutics with the goal of bringing AAV gene therapy to the clinic to enable safer gene therapy. Link

• Novartis has renamed AveXis to Novartis Gene Therapies, dually distancing itself from a data scandal around Zolgensma while highlighting Novartis’ prioritization of gene therapies. Link

• FDA gave 510k clearance for Roche’s BKV Test on the cobas 6800/8800 Systems which has previously received an FDA Breakthrough Device designation. The BKV Test assesses the risk of organ transplant complications caused by the BK virus and identifies effective treatment options. Link

• FDA gave Emergency Use Authorization (EUA) for Roche’s SARS-CoV-2 and Influenza A/B Test on the cobas 6800/8800 Systems. This test can simultaneously detect and differentiate between SARS-CoV-2, Influenza A, and Influenza B in patients with respiratory viral infection. Link 

• Sanofi and GSK announced the start of their adjuvanted COVID-19 vaccine Phase 1/2 clinical trial. A total of 440 healthy adults are being enrolled to evaluate the safety, reactogenicity, and immunogenicity of the recombinant protein-based vaccine. Link

Industry and Corporate Developments

• Taysha Gene Therapies, biotech looking to eradicate monogenic CNS disease, recently announced the appointment of its executive leadership team. Two members of the Board of Directors, the CFO, and CPO came from AveXis, now called Novartis Gene Therapies. Link

• Orca Bio and Lyell Immunotherapy announced a research partnership to jointly identify next-generation T cell therapies in solid tumors. Link

• AbbVie and I-Mab announced a global agreement to jointly develop and commercialize lemzoparlima. AbbVie will focus on the development and global commercialization of lemzoparlima and I-Mab will receive $180M in upfront payments. Link

• Mylan and Biocon Biologics announced the launch of an insulin glargine injection, Semglee, to treat adult and pediatric patients with type 1 diabetes and adults with type 2 diabetes. Both companies plan to price Semglee far below its competitors, including Sanofi’s Lantus. Link

• Rep. Carolyn Maloney subpoenaed AbbVie for information on Humira and Imbruvica, after previous attempts at gathering information on their pricing failed. Link

• Nestlé announced the acquisition of Aimmune Therapeutics for $473M. The key driver for this deal was Aimmune’s Palforzia, the only FDA-approved treatment to help reduce the frequency and severity of allergic reaction to peanuts. Link

• Nine CEOs consisting of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi announced a historic pledge to not seek premature FDA approval for a COVID-19 vaccine until safety and efficacy has been proven in Phase 3 clinical study. Link