Week of September 14

Oncology

• Takeda announced negative Phase 3 results for Ninlaro to treat newly diagnosed multiple myeloma. In combination with lenalidomide and dexamethasone, Ninlaro failed to meet the statistical significance of its primary endpoint of median progression-free survival (PFS) compared to lenalidomide, dexamethasone, and placebo. Link

• European Medicines Agency (EMA) validated Bristol Myers Squibb’s type II variation application for Opdivo plus Yervoy to treat patients with unresectable malignant pleural mesothelioma (MPM) as a first-line treatment. Validation of the application initiates the EMA’s centralized review process. Link

• Boehringer Ingelheim announced the advancement of their bi-specific and tetravalent therapeutic antibody, BI 905711, to Phase 1 clinical trials to treat patients with advanced gastrointestinal (GI) cancers. BI 905711 is designed to recognize the pro-apoptotic tumor necrosis factor (TNF)-related apoptosis-inducing ligand receptor 2 (TRAILR2) along with the tumor cell anchor cadherin 17 (CDH17) to initiate apoptosis in tumors mostly found in the GI tract. Link

CNS Disorders and Neurodegeneration

• Satsuma Pharmaceuticals announced negative Phase 3 results for STS101 to treat acute migraines. Compared to the placebo, STS101 failed to meet the statistical significance of its co-primary endpoints of freedom from pain and the most bothersome symptom. Link

• Sanofi Genzyme presented new data from across the company's neurology portfolio at MSVirtual2020. Some of the new data will feature tolebrutinib inhibition of microglia-driven neuroinflammation related to MS disease progression. Link

• Teva Pharmaceutical Industries published results in Neurology of their 52-week study evaluating AJOVY injections in patients with chronic migraine (CM) or episodic migraine (EM). The purpose of the study was to assess the safety and tolerability of AJOVY over the course of a year; however, this study did not include a placebo control group. Link

• Boehringer Ingelheim announced positive Phase 2 results for BI 425809 to treat patients with cognitive impairment associated with schizophrenia (CIAS). The Gly-T1 inhibitor met its primary endpoint of improving cognition after 12 weeks compared to the placebo. Currently, there is no approved treatments for CIAS. Link

Technologies

• Eli Lilly launched an innovation challenge called "Transforming Atopic Dermatitis Care: Enhancing Quality of Life and Patient Care for People Living with Inflammatory Skin Diseases." The company hopes individuals and teams will submit inspiring digital health solutions that can help people living with atopic dermatitis. Additional details about the challenge is available at link

• Sarepta Therapeutics completed a Type C ‘written response only’ meeting with the Office of Tissues and Advanced Therapies (OTAT), part of the Center for Biologics Evaluation and Research (CBER) at the FDA. This meeting is to help set up another clinical trial for SRP-9001 to treat patients with Duchenne Muscular Dystrophy. Link

• Corbus Pharmaceuticals announced negative Phase 3 results for lenabasum to treat diffuse cutaneous systemic sclerosis (SSc). Compared to placebo, lenabasum failed to meet the statistical significance of its primary endpoint median American College of Rheumatology Combined Response Index for Systemic Sclerosis (ACR CRISS). Link

Industry and Corporate Developments

• After last month’s agreement with AstraZeneca, Catalent invested $130M into its gene therapy site in Maryland. The additions, including 5 additional Phase 3 through commercial-scale manufacturing suites, will be used to produce bulk drug substances and viral vectors for the University of Oxford’s adenovirus-based Covid-19 vaccine. Link

• OncoImmune closed $65M Series B Financing from HM Capital and a blue-chip investor. Funding will be used to advance OncoImmune’s lead product, CD24Fc, a first-in-class biologic that regulates host inflammatory response to tissue injuries which has broad implications in oncology, autoimmune disease, metabolic syndrome, and graft-versus-host disease (GvHD). Link

• Gilead Sciences announced the acquisition of Immunomedics for $21B. The key driver for this deal was Immunomedics’ first-in-class Trop-2 directed antibody-drug conjugate (ADC) Trodelvy to treat patients with mTNBC. Link

• Pfizer and BioNTech concluded exploratory talks with the European Commission to supply 200 million doses of their investigational BNT162 mRNA-based vaccine candidate against SARS-CoV-2 with an option for further 100 million doses. Link

• Eli Lilly announced that Patrik Jonsson, senior vice president and president of Lilly Bio-Medicines, is being promoted to the new role as the senior vice president, president of Lilly USA, and Chief Customer Officer. Ilya Yuffa, currently the vice president of U.S. Diabetes, will succeed Jonsson’s senior vice president and president of Lilly Bio-Medicines position. Link

• Bayer and Recursion Pharmaceuticals announced a collaboration agreement to utilize Recursion’s purpose-built artificial intelligence-guided drug discovery platform and Bayer’s small molecule compound library to develop new treatments for fibrotic diseases. Link

• In the UK, the Medicines Health Regulatory Authority (MHRA) authorized AstraZeneca to resume their randomized, controlled Phase 3 for AstraZeneca’s and the University of Oxford’s coronavirus vaccine candidate. Link

• Takeda Pharmaceutical announced the expansion of its cell therapy manufacturing capabilities at its R&D headquarters in Boston, Massachusetts. The new 24,000 square-foot facilities will accelerate Takeda’s efforts to develop next-generation cell therapies, initially focused on oncology. Link