This week, J&J JNJ said it will begin human clinical studies on its coronavirus vaccine in July, much ahead of the original schedule in September. AbbVie ABBV joined the race to develop a monoclonal antibody therapy for treating COVID-19 in collaboration with three parties. Lilly LLY announced initiation of a phase I study on its second potential COVID-19 antibody therapy. The FDA granted approvals to Merck’s MRK Recarbrio and Bristol-Myers’ BMY Opdivo for new patient populations.
Recap of the Week’s Most Important Stories:
J&J Speeds Up Human Study Initiation on Coronavirus Vaccine: J&J is accelerating the timeline for initiation of a phase I/II human clinical study on its vaccine candidate for COVID-19 to the second half of July rather than September as announced earlier. The phase I/II study will be conducted in 1045 healthy adults aged 18 to 55 years, plus adults aged 65 years and older and will be initiated in the United States and Belgium. J&J said that it is holding talks with the National Institutes of Allergy and Infectious Diseases to begin pivotal phase III studies on the candidate sooner than planned if data from the phase I/II study is positive.
AbbVie Enters Coronavirus Arena: AbbVie announced a collaboration with Harbour BioMed (HBM), Utrecht University (UU) and Erasmus Medical Center (EMC) to make a monoclonal antibody therapy to prevent and treat COVID-19. UU, EMC and HBM discovered 47D11 antibody, which targets the conserved domain of the spike protein of SARS-CoV-2, the virus that causes COVID-19. The focus of the collaboration will be to advance this antibody. While the three parties will take care of pre-clinical activities, AbbVie is preparing for clinical and later stage pre-clinical work and also has an option to exclusively license the antibody for clinical development and commercialization from them.
AbbVie also announced an oncology collaboration deal with Genmab to jointly develop and market three of the latter’s early-stage investigational bispecific antibody product candidate for an upfront payment of $750 million. The three candidates include epcoritamab, which is currently being evaluated in a phase I/II study for multiple hematological B cell malignancies. The companies also formed a discovery research deal to combine proprietary antibodies and technology from both companies to create upto four additional differentiated antibody therapeutics for cancer. In addition to the upfront payment, Genmab will be entitled to receive potential milestone payments of up to $3.15 billion
AbbVie’s phase III head-to-head study — SELECT CHOICE — comparing the efficacy of its new rheumatoid arthritis (RA) drug Rinvoq, with Bristol-Myers’s Orencia, met its primary and key secondary endpoints. Data from the study showed that Rinvoq met the primary endpoint of non-inferiority versus Orencia on change from baseline in Disease Activity Score 28 C-Reactive Protein (DAS28-CRP) at week 12 in patients with moderate-to-severe active RA who have had inadequate response to biologic DMARDs.
AbbVie also announced data from a phase IIa study on ABBV-3373, its novel antibody drug conjugate (ADC) to treat adult patients with moderate-to-severe rheumatoid arthritis. The novel ADC comprises an anti-tumor necrosis factor (TNF) and a proprietary Glucocorticoid Receptor Modulator. The data demonstrated clinical activity of TNF-ADC platform and supports its advancement for development in RA indication as well as initiating studies for other immunology indications.
Lilly’s Partner Begins Phase I Study on COVID-19 Antibody Candidate: Lilly announced that the first healthy volunteer (who has not been diagnosed with COVID-19) has been dosed in a phase I study on JS016, Lilly’s antibody candidate designed to fight COVID-19 under its collaboration with China-based, Junshi Biosciences. Lilly signed the deal with Junshi last month to co-develop therapeutic antibodies for the potential prevention and treatment of COVID-19. Junshi has dosed the patient in a phase I study in China, while Lilly will soon begin its phase I study in the United States.
Last week, Lilly initiated a phase I study on LY-CoV555, its lead antibody therapy candidate in collaboration with private biotech, AbCellera. Lilly signed the deal with AbCellera in March to create antibody therapies to treat and prevent COVID-19. The phase I study on LY-CoV555 will evaluate its safety and tolerability in patients hospitalized with COVID-19. Lilly will study JS016 both as a monotherapy as well as in combination with other antibody treatments including LY-CoV555, in COVID-19 patients
Lilly also announced that the first patient dose has been delivered in a cardiovascular outcome study on its dual GIP and GLP-1 receptor agonist (GIP/GLP-1 RA) candidate, tirzepatide. The head-to-head phase III study (SURPASS-CVOT) will evaluate non-inferiority and superiority of tirzepatide to Lilly’s blockbuster GLP-1 receptor agonist, Trulicity.
FDA Approves Merck’s Recarbrio for a New Indication: The FDA approved Merck’s new antibacterial injection Recarbrio for another indication — hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP). The application was based on data of the pivotal phase III RESTORE-IMI 2 study. Recarbrio is a fixed combination of relebactam with imipenem/cilastatin. Recarbrio was approved for the treatment of adults with complicated urinary tract infections and complicated intra-abdominal bacterial infections caused by certain susceptible gram-negative bacteria in July last year.
Meanwhile, Merck’s phase III advanced bladder cancer study (KEYNOTE-361) evaluating Keytruda plus chemotherapy failed to meet dual primary endpointsof overall survival (OS) or progression-free survival (PFS). The data showed that in the final analysis though there was an improvement in OS and PFS in the Keytruda arm, the results did not meet statistical significance.
FDA Approves Bristol-Myers’ Opdivo for Esophageal Cancer: The FDA granted approval to Bristol-Myers’ blockbuster cancer drug Opdivo for previously treated patients with advanced esophageal squamous cell carcinoma, regardless of PD-L1 expression. These patients are refractory or intolerant to at least one prior fluoropyrimidine- and platinum-based regimen. The approval was based on the phase III ATTRACTION-3 study.
Pfizer’s 4th Study on Abrocitinib Meets Goal: Pfizer’s PFE phase III study (JADE TEEN) evaluating two doses of its investigational JAK inhibitor, abrocitinib in adolescents patients(12 to <18 years of age) with moderate-to-severe atopic dermatitis (AD) met the co-primary endpoints. The data showed that a statistically significantly higher percentage of patients in the abrocitinib arm achieved each co-primary efficacy endpoint at Week 12 than placebo, for both doses. The safety profile in the study was consistent with other pivotal studies of abrocitinib reported to date. JADE TEEN is the fourth study in the JADE clinical development program on abrocitinib. Pfizer has successfully completed three other pivotal studies under the JADE program — JADE COMPARE, JADE MONO-1 and JADE MONO-2. The company plans to file a regulatory application seeking approval for abrocitinib as a treatment for AD later this year.
Novo Nordisk’s New Acquisition in Cardiovascular Disease Market: Novo Nordisk NVO announced a definitive agreement to acquire Waltham, MA based private biotech Corvidia Therapeutics for an upfront payment of $750 million to expand its presence in the cardiovascular disease market.
Corvidia Therapeutics’ lead candidate is IL-6 inhibitor, ziltivekimab, which is being developed in a phase IIb study to reduce the risk of atherosclerotic cardiovascular disease (ASCVD) in patients with chronic kidney disease (CKD and inflammation. Corvidia Therapeutics will be entitled to total regulatory and sales milestones payments of $2.1 billion if it achieves the desired targets.
The NYSE ARCA Pharmaceutical Index declined 3.57% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here is how the nine major stocks performed in the last five trading sessions.
Last week, all stocks declined with Pfizer declining the most (7.5%).
In the past six months, Lilly has risen the most (18.6%) while Merck declined the most (13.3%).
(See the last pharma stock roundup here: LLY Begins Coronavirus Antibody Phase I Study, FDA Approvals)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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