REGN provides updates from COVID-19, MYOV partners with PFE and more

Many regulatory and pipeline updates caught the eye in the biotech industry last week. Collaborations were once again the center of attention in the sector. Meanwhile, updates to the COVID-19 vaccine were gaining more importance in the sector with each passing day, as the pandemic registered an increase again.

Recap of the week’s most important stories:

Regeneron announces positive data on cocktails: Regeneron Pharmaceuticals, Inc. REGN announced encouraging initial data from an ongoing phase I / II / III study of its antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen. Casirivimab and imdevimab are a cocktail of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and have been specifically designed to block the infectivity of SARS-CoV-2, the virus that causes COVID-19. The analysis was designed prospectively to focus on patients who have not yet developed their own immune response to SARS-CoV-2 (ie, had no antibodies at the start of the study: seronegative). The initial analysis was conducted to determine whether there was sufficient efficacy in these patients to ensure continuation of the study (ie, futility analysis). The results were approved in the futility analysis, since seronegative patients treated with the antibody cocktail had a lower risk of death or mechanical ventilation.

Regeneron currently carries a Zacks Rank # 3 (Hold). You can see the full list of today’s Zacks # 1 Rank (Strong Buy) stocks here.

Bristol Myers provides regulatory and pipeline updates: Bristol Myers BMY announced that the phase III study, CheckMate -548, assesses the addition of the immuno-oncological drug Opdivo (nivolumab) to the current standard of treatment (temozolomide and radiotherapy) versus placebo plus the standard of care in patients with newly glioblastoma multiforme diagnosed (GBM) failed. After a routine review of the study by an independent data monitoring committee (DMC), the company was informed that, based on the number of events to date, the study will not reach its primary goal of overall survival in patients without use of basal corticosteroid or the general random population. The DMC indicated that there were no safety problems observed in patients treated with Opdivo that justified the interruption of the study.

The company also announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) for Zeposia (ozanimod) for the treatment of adults with moderate to severely active ulcerative colitis (UC).

Separately, the company also announced that it had decided to withdraw from the American market the indication of small cell lung cancer (SCLC) for Opdivo, in consultation with the FDA. The drug obtained accelerated approval from the FDA in 2018 for the treatment of patients with CPPC whose disease progressed after platinum-based chemotherapy and at least one other line of therapy. Accelerated approval was based on the effect of Opdivo on the substitute outcomes of the CheckMate -032 phase I / II trial in patients with advanced or metastatic solid tumors, which showed encouraging response rates and duration of response with Opdivo on the SCLC. However, subsequent confirmatory studies in different treatment settings, CheckMate -451 and CheckMate -331, did not meet their primary endpoints for overall survival.

Myovant wins in Pfizer collaboration: Actions of Myovant Sciences MYOV came about after announcing a collaboration with Pfizer PFE for the development and commercialization of relugolix – an antagonist of the oral gonadotropin releasing hormone (GnRH) receptor once a day – in oncology and women’s health in the United States and Canada.

According to the terms of the agreement, both companies will jointly develop and market Orgovyx (relugolix) in advanced prostate cancer and, if approved, a combined relugolix tablet (relugolix 40 mg, estradiol 1.0 mg and norethindrone acetate 0.5 mg) on women’s health in the United States and Canada. Myovant will remain responsible for regulatory interactions and drug delivery and will continue to lead the clinical development of the combined relugolix tablet. Myovant will receive up to $ 4.2 billion, including an initial payment of $ 650 million, $ 200 million in potential regulatory milestones for FDA approval of the relugolix combination tablet in women’s health and tiered sales milestones up to $ 2.5 billion in net sales when reaching certain limits for prostate cancer and also for combined female health indications. Myovant will also receive $ 50 million and will be entitled to receive double-digit royalties on sales, if Pfizer exercises the option of marketing relugolix in oncology outside the United States and Canada, except for some Asian countries.

Novavax Initiates Phase III COVID-19 Vaccine Study: Novavax, Inc. NVAX started PREVENT-19, a phase III study in the United States and Mexico, to assess the efficacy, safety and immunogenicity of NVX-CoV2373, its candidate vaccine COVID-19. The study will assess the efficacy, safety and immunogenicity of NVX-CoV2373 in up to 30,000 people aged 18 and over compared to placebo. The primary objective of the study is the prevention of symptomatic COVID-19 confirmed by PCR. The key secondary endpoint is the prevention of moderate or severe symptomatic COVID-19 confirmed by PCR. Both outcomes will be assessed at least seven days after the second study vaccination in volunteers who have not been previously infected with SARS-CoV-2.

Aprea crashes on study failure: Aprea Therapeutics, Inc APRE fell 78% after the final stage study that assessed the safety and efficacy of the lead candidate, eprenetapopt, combined with azacytidine (AZA) versus AZA alone in TP53 mutant myelodysplastic syndromes (MDS) failed to achieve the primary endpoint. The phase III study involved 154 patients with MDS, randomized 1: 1 to the eprenetapopt arm with AZA or just the AZA arm. The study did not achieve the predefined primary outcome of complete remission rate (CR). The analysis of the primary endpoint in this data cut showed a higher CR rate in the experimental arm that received eprenetapopt with AZA compared to the control arm that received AZA alone, but did not reach statistical significance. In the population intending to treat 154 patients, the rate of CR in the arm with eprenetapopt with AZA was 33.3% compared to 22.4% in the arm with AZA alone.

Arcturus tanks in the study update: Actions of Arcturus Therapeutics Holdings Inc. ARCT came to a halt after the release of new data on its candidate vaccine, ARCT-021, for COVID-19. Although the results of phase I / II indicate that ARCT-021 leads to a potent immune response to SARS-CoV-2, the level of antibodies generated was not impressive.

Meanwhile, the company has also received approval from the Singapore Health Sciences Authority to proceed with a phase II clinical study of its candidate vaccine, ARCT-021.

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Medical – Biomedical and Genetic Industry 5 years return

The Nasdaq Biotechnology Index lost 2.16% in the last four trading sessions. Among the biotech giants, Amgen gained 2.66% during that period. In the past six months, Alexion’s shares have risen 39.68%. (See the latest summary of biotechnology actions here: Biotechnology stock summary: PFE / BNTX vaccine authorized in Europe, AMGN updates and more)

What’s next in biotechnology?

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What’s next in biotechnology?

The hottest technological megatrend of all

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