Quite a few regular pipeline and regulatory updates grabbed focus in the biotech sector this week. Importantly, updates on COVID-19 vaccines continue to be in the spotlight amid a resurgence in cases due to the emergence of a new variant called Deltacron.
Bristol Myers’ Gets Drug Approval: Bristol Myers Squibb BMY announced that the FDA approved a new, first-in-class, fixed-dose combination of PD-1 inhibitor Opdivo (nivolumab) and relatlimab (novel LAG-3-blocking antibody) administered as a single intravenous infusion for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma (a kind of skin cancer).
The drug is approved under the brand name Opdualag.The approval is based on positive results from the phase II/III RELATIVITY-047 study, which compared Opdualag (n=355) to Opdivo alone (n=359). Opdualag more than doubled median progression-free survival compared to Opdivo monotherapy. The FDA-approved dosing for adult patients and pediatric patients 12 years of age or older who weigh at least 40 kg is 480 mg nivolumab and 160 mg relatlimab administered intravenously every four weeks. The approval strengthens BMY’s growing and differentiated oncology portfolio, which also has Yervoy approved for melanoma.
Moderna’s Vaccine Update:Moderna MRNA announced that it submitted an amendment to the emergency use authorization (EUA) to the FDA for allowing the fourth dose of its COVID 19 vaccine in adults aged 18 years and above. The population includes adults who have already received an initial booster dose of any authorized COVID vaccine in the United States. Moderna’s filing with the FDA is based on data generated in the United States and Israel following the emergence of the Deltacron variant of the coronavirus. The recent surge in cases in some countries has fueled the demand for vaccines again.
The FDA had approved the biologics license application (BLA) for Moderna’s COVID 19 vaccine to prevent COVID-19 in individuals 18 years of age and older on Jan 31, 2022.A booster dose of the vaccine at the 50 µg dose level is authorized for emergency use in the United States under EUA for adults 18 years and older. A third dose of the vaccine at the 100 µg dose level is authorized for emergency use in immunocompromised individuals 18 years of age or older in the United States who have undergone solid organ transplantation or are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
Vallon Down On Study Update:Vallon Pharmaceuticals, Inc. VLON plunged significantly after the company announced that its pivotal SEAL study evaluating ADAIR failed to achieve its main goal. Vallon’s lead investigational product candidate, ADAIR, is a novel abuse-deterrent formulation of amphetamine immediate release being developed for the treatment of ADHD and narcolepsy.The SEAL study (Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Immediate Release Formulation) is an intranasal human abuse liability study assessing the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability of snorting professional laboratory-manipulated ADAIR 30 mg when compared to crushed d-amphetamine sulfate and placebo in recreational drug users.
The study did not meet its primary endpoint. ADAIR scored similarly to what was observed in an earlier proof-of-concept study. However, reference dextroamphetamine did not score as high as expected and as seen in the previous study, thus driving the lack of statistical significance. On a positive note, all pharmacodynamic secondary endpoints met with statistical significance.
Pipeline Progress by Vertex: Vertex Pharmaceuticals VRTX announced that it will advance experimental therapy VX-147 into development for people living with proteinuric kidney disease mediated by two mutations in the APOL1 gene (AMKD).Vertex will evaluate the safety and efficacy of VX-147 in a single study to evaluate the impact of VX-147, on top of standard of care, on kidney function and proteinuria in people with AMKD.This randomized, double-blind, placebo-controlled phase II/III adaptive study will first evaluate two doses of VX-147 for 12 weeks to select a dose for phase III and subsequently evaluate the efficacy and safety of the single selected dose in the phase III portion of the study.
The primary endpoint of this study is the reduction in the rate of decline of kidney function as measured by estimated glomerular filtration rate (eGFR) slope versus placebo at approximately two years. Vertex targets a pre-planned interim analysis at week 48 evaluating eGFR slope in VX-147 versus placebo, supported by a percent change from baseline in proteinuria.Vertex will seek accelerated approval of VX-147 in the United States for patients with AMKD assuming positive results from the interim analysis.
Vertex currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index has gained 8.39% in the past five trading sessions. Among the biotech giants, Moderna has gained 26% during the period. Over the past six months, shares of Moderna have lost 57.63%. (See the last biotech stock roundup here: Biotech Stock Roundup: NKTR Plunges on Study Failure, MRNA Offers Updates & More)
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Stay tuned for more pipeline and regulatory updates.
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