Bristol Stock- BLUE/BMY’s CAR T Therapy Nod, KLDO’s COVID-19 Study News & More
The biotech sector continues to be in focus with updates on the development of antibodies and vaccines for coronavirus. Moreover, new drug approvals and other regulatory and pipeline updates kept the sector in the spotlight.
Recap of the Week’s Most Important Stories:
bluebird bio, Bristol Myers’ Gene Therapy Approved: bluebird bio BLUE and its partner Bristol Myers Squibb BMY announced that the FDA has approved their chimeric antigen receptor (CAR) T cell immunotherapy idecabtagene vicleucel under the brand name Abecma. The regulatory agency approved Abecma as the first B-cell maturation antigen (BCMA)-directed CAR T cell immunotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody. The immunotherapy is a personalized immune cell therapy approved as a one-time infusion with a recommended dose range of 300 to 460 x 106 CAR-positive T cells. The FDA nod was based on data from the pivotal phase II KarMMa study of 127 patients with relapsed or refractory multiple myeloma.
Separately, Bristol Myers also announced that the European Medicines Agency (EMA) has validated its type II variation application for Opdivo (nivolumab) for the adjuvant treatment of patients with surgically resected, high-risk muscle-invasive urothelial carcinoma.
bluebird bio currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Kaleido Reports Positive Results From COVID-19 Study: Kaleido Biosciences, Inc. KLDO reported positive results from a study on KB109 in patients with mild-to-moderate COVID-19. Results from a non-Investigational New Drug (IND) study of KB109 in these patients showed a reduction in overall COVID-19-related healthcare utilization comprising hospitalizations, emergency room visits and urgent care visits.
Importantly, the study also demonstrated a significant drop in the recovery time for patients aged 45 years or above or with one or more comorbidities, having received KB109 plus self-supportive care as compared to those who only received self-supportive care.
KB109 lowered healthcare utilization as measured by the total number of hospitalizations, emergency room visits and urgent care visits by approximately 62% among patients with one or more comorbidities and roughly 51% overall. For patients with one or more comorbidities, KB109 cut the median time to resolution of the 13 overall COVID-19 symptoms from 30 to 21 days.
Incyte’s Drug Approved in Europe: Incyte INCY announced that the European Commission (EC) has approved Pemazyre (pemigatinib) for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that progressed after at least one prior line of systemic therapy. An approval was in the cards as the European Medicines Agency’s Committee for Medicinal Products for Human Use gave a positive recommendation for the same in January 2021. The EC decision was based on data from the FIGHT-202 study evaluating the safety and efficacy of Pemazyre in adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status.
Vertex’s Kaftrio Gets Positive CHMP Opinion: Vertex Pharmaceuticals VRTX announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the label extension of Kaftrio.
The committee recommended the approval of Kaftrio in combination with ivacaftor 150 mg tablets, for the treatment of cystic fibrosis (CF) in all patients aged 12 years and above with at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
The positive opinion was based on the favorable results from a global phase III study (Study 445-104) evaluating the triple combination therapy in CF patients aged 12 years and above who are heterozygous for the F508del-CFTR mutation and a CFTR gating mutation (F/G) or a residual function mutation (F/RF).
Vir, Glaxo Submit EUA Application to FDA: Vir Biotechnology, Inc VIR and partner GlaxoSmithKline plc GSK announced that both have submitted an application to the FDA requesting an Emergency Use Authorization (EUA) for their investigational dual-action SARS-CoV-2 monoclonal antibody VIR-7831 (GSK4182136). The companies are seeking an EUA for the candidate to treat adults and adolescents (aged 12 years and older weighing at least 40 kg.
Meanwhile, Vir and Glaxo along with partner Eli Lilly also announced encouraging top-line data from the expanded phase II study BLAZE-4, which evaluated a cocktail of two antibodies low-risk adult patients with mild-to-moderate COVID-19.
The study evaluated 700 mg of Lilly’s bamlanivimab (LY-CoV555) co-administered with 500mg of Vir’s VIR-7831. Data from the same demonstrated that the cocktail therapy achieved 70% relative reduction in persistently high viral load after seven days of treatment compared to placebo. The therapy also demonstrated a statistically significant reduction of mean change in viral load at day 3, 5 and 7 from the baseline. Moreover, there were no COVID-related hospitalizations or deaths after 29 days of treatment.
Medical – Biomedical and Genetics Industry 5YR % Return
Medical – Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index lost 3.27% in the last five trading sessions. Among the biotech giants, Biogen gained 3.29% during the period. Over the past six months, shares of Alexion have surged 36.49%. (See the last biotech stock roundup here: Biotech Stock Roundup: REGN Cocktail Data Positive, INCY’s Jakafi Disappoints & More).
What’s Next in Biotech?
Stay tuned for more pipeline and regulatory updates.
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