The biotech sector continues to be in the spotlight as the need for coronavirus treatments become imminent as the contagion impacts countries worldwide. The biotech companies continue to evaluate both treatments for the infected and prevention of the contagion. Apart from these, other regulatory and pipeline updates were in focus this week.

Recap of the Week’s Most Important Stories:

Gilead Starts Testing Inhaled Version of Remdesivir:  Gilead Sciences, Inc. GILD announced that it has initiated an early-stage study to evaluate its experimental coronavirus treatment, remdesivir, for use in inhaled formulation outside of hospitals. The drug is currently administered to hospitalized patients intravenously. A phase I study has been initiated to evaluate the safety, tolerability and pharmacokinetics of an investigational, inhaled solution of remdesivir in healthy volunteers. This randomized, placebo-controlled study will enroll approximately 60 healthy individuals aged 18-45 years in the United States to form the basis for further clinical study of the inhaled drug, particularly in patients whose disease has not progressed to require hospitalization. Delivering remdesivir directly to the primary site of infection with a nebulized, inhaled solution may enable more targeted and accessible administration in non-hospitalized patients, as the upper respiratory tract is the most prevalent site of SARS-CoV-2 infection early in the disease. Moreover, additional clinical studies evaluating remdesivir in combination with anti-inflammatory medicines in vulnerable patient populations and outpatient settings are ongoing or planned to be initiated shortly.

Moreover, Gilead announced additional data on remdesivir. A comparative analysis of the phase III SIMPLE-Severe study and a real-world retrospective cohort of patients with severe COVID-19 showed that remdesivir was associated with an improvement in clinical recovery and a 62% reduction in the risk of mortality compared with standard of care.

This comparative pre-planned analysis included 312 patients treated in the phase III SIMPLE-Severe study and a separate real-world retrospective cohort of 818 patients with similar baseline characteristics and disease severity, who received standard-of-care treatment in the same time period as the SIMPLE-Severe study.

The mortality rate for patients treated with remdesivir in the analysis was 7.6% at day 14 compared with 12.5% among patients not taking the drug. However, this analysis will require confirmation in prospective clinical trials, per the company.

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

Moderna Announces Positive Data on Vaccine Study: Moderna MRNA announced positive updated interim data from a phase I study evaluating its mRNA-based coronavirus vaccine candidate, mRNA-1273. The data demonstrated that participants vaccinated twice with mRNA-1273 induced rapid and strong immune responses against SARS-CoV-2 in all patients through day 57, across all three dose cohorts. The data also showed that mRNA-1273 induced binding antibodies to the full-length SARS-CoV-2 Spike protein (S) in all participants after the first vaccination, with all participants seroconverting by day 15. Neutralizing antibody titers were observed in 100% of evaluated participants; at the 100-µg dose level selected for phase III. The geometric mean titers were above those seen in convalescent sera.

Moderna has completed enrollment in a phase II study on mRNA-1273, which is being conducted under its own investigational new drug application last month. The study is evaluating 50 µg and 100 µg doses of mRNA-1273.

Equillium Skyrockets on Positive Results of Coronavirus Drug: Shares of clinical-stage biotechnology company, Equillium, Inc. EQ, surged after it announced top-line results of patients treated with itolizumab in a clinical study conducted in India by partner Biocon.

Data from the study showed that itolizumab significantly reduced mortality in patients hospitalized with COVID-19. Biocon conducted a randomized, controlled, open-label study at four hospitals in India, enrolling a total of 30 hospitalized COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS).

The regulatory agency in India, The Drugs Controller General of India (DCGI), has granted restricted emergency use of itolizumab for the treatment of cytokine release syndrome (CRS) in COVID-19 patients with moderate to severe ARDS. Consequently, Equillium is planning to conduct a global, randomized, controlled clinical study of itolizumab in COVID-19 patients, for which it will file an investigational new drug application (IND) in the United States.

Rigel Surges on Coronavirus Study Initiation: Shares of Rigel Pharmaceuticals, Inc. RIGL soared after it initiated an investigator-sponsored study being conducted by Imperial College London to evaluate the efficacy of fostamatinib, its oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of COVID-19 pneumonia. We note that fostamatinib is already marketed in the United States as Tavalisse as a treatment for adult chronic immune thrombocytopenia (ITP). Encouraging data from pre-clinical models of fostamatinib makes the company believe that there is potential for SYK inhibition to help treat the severity of the disease for these patients and prevent ARDS.

Biogen’s Update on AD Treatments: Biogen BIIB announced that a new phase III study has been initiated to evaluate BAN2401 anti-amyloid beta monoclonal antibody to treat preclinical (asymptomatic) Alzheimer’s disease. The candidate is being developed in collaboration with Eisai, its Japan-based partner. The phase III study, AHEAD 3-45, to be conducted as a public-private partnership between The Alzheimer’s Clinical Trials Consortium (ACTC) and Eisai, has been initiated in the United States. Around 1400 participants will be enrolled in the AHEAD 3-45 study. The study will be conducted in the United States, Japan, Canada, Australia, Singapore and Europe. Currently, BAN2401 is being studied in a pivotal phase III study in symptomatic early AD (Clarity AD), following the outcome of the phase II study (Study 201).

Separately, Biogen submitted a biologics license application (BLA) to the FDA seeking approval of aducanumab, its much talked about investigational treatment for Alzheimer’s disease. The completed BLA filing includes data from the ENGAGE and EMERGE phase III studies as well as the phase Ib PRIME study in patients with early-stage Alzheimer’s disease. Shares were up on the news as the BLA filing removed significant uncertainty regarding the regulatory filing timeline of aducanumab.

Amgen Increases Investments in BeiGene: Amgen AMGN announced that it made an additional investment of approximately $421 million in its China-based collaborator for oncology products, BeiGene BGNE. Amgen made the investment through purchase of BeiGene’s registered direct offering of ordinary shares to certain existing investors, announced by the company earlier this week. BeiGene plans to raise approximately $2.08 billion in gross proceeds through this offer. The additional investment made by Amgen will, however, maintain its current pro-rata ownership of BeiGene at approximately 20.3%. Amgen and BeiGene had signed a collaboration agreement in October 2019 and announced its closing in January this year. Amgen is looking to expand its oncology presence in China, given the significant market potential.

Performance    

The Nasdaq Biotechnology index gained 1.25% in the last five trading sessions. Among the biotech giants, Alexion gained 2.90% during this period. Over the past six months, shares of Regeneron have gained 61.93%. (See the last biotech stock roundup here: Biotech Stock Roundup: REGN Initiates Coronavirus Study, NVAX Surges & More)

What’s Next in Biotech?

Stay tuned for more pipeline updates, with a focus on treatments for the novel coronavirus.

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