Shares of Suzhou, China-based Kintor Pharmaceutical Ltd. (HKEX:9939) rose to HKD28.85 (US$3.68), up HKD14.87, or 106%, after the firm reported top-line data from the phase III multiregional clinical trial with proxalutamide in people with mild to moderate COVID-19 infection, regardless of vaccination status or risk factors. Among all randomized patients with at least one day of treatment (n=730), eight who received placebo were hospitalized (including one death) compared to four given proxalutamide (no deaths). All hospitalizations were COVID-19-related and proxalutamide, an androgen receptor antagonist, reduced the risk of hospitalization or death by 50% compared to the control group.

GSK, Vir work on higher sotrovimab dose as FDA rescinds COVID-19 EUA

Glaxosmithkline plc and Vir Biotechnology Inc.’s sotrovimab has become the latest COVID-19 antibody to be pulled from the market in the U.S., after the FDA revoked its emergency use authorization (EUA) because of the rise of the omicron BA.2 subvariant. Shares in San Francisco-based Vir (NASDAQ:VIR) were down nearly 11.5% to $22.42 in late trading after the April 5 announcement, continuing on their downward trajectory the following morning. But in a statement, Vir said that it is preparing a package of data to support its use at a higher dose to counter the BA.2 subvariant.

ACE2-independent blood cell infection linked to severe COVID

Investigators at Boston Children's Hospital have demonstrated that SARS-CoV-2 infection of blood monocytes and lung macrophages in the lung could kill the cells via pyroptosis, increasing inflammation and leading to severe COVID-19. The work was published online in Nature on April 6, 2022. The study also adds clinical insights into why some people develop severe inflammation when they are infected with SARS-CoV-2.

Biopharma financings in Q1 at lowest point since 2017

Biopharma financings for the first quarter of 2022 are at a five-year low, with 65.8% less money and 53% fewer transactions than a year ago. The industry raised $13.1 billion through 249 financings, compared with $38.3 billion from 529 transactions in 2021. Intense enthusiasm for biopharma products following the emergence of the SARS-CoV-2 virus appears to be waning as numerous vaccines and therapeutics to prevent and treat COVID-19 are now available. Experts believe the pandemic will soon move into the endemic phase.

Ontak making a comeback with new data from Citius

The rambling, quixotic course of the cancer therapy Ontak continues with new top-line data from Citius Pharmaceuticals Inc. The company’s phase III study of I/Ontak (E-7777), a reformulation of previously FDA-approved oncology treatment Ontak (denileukin diftitox), was consistent with the prior formulation. No new safety signals were identified in treating persistent or recurrent cutaneous T-cell lymphoma. The engineered IL-2-diphtheria toxin fusion protein was discontinued in the U.S. in 2014 due to production issues. In September, Cranford, N.J.,-based Citius acquired exclusive license rights to E-7777 from Dr. Reddy's Laboratories SA, a subsidiary of Hyderabad, India-based Dr. Reddy’s Laboratories Ltd. Based on the new data, Citius said it plans to file a BLA for the indication in the second half of 2022.

Allist furmonertinib meets primary endpoint in phase III trial to treat lung cancer

Shanghai Allist Pharmaceuticals Co. Ltd.’s third-generation EGFR tyrosine kinase inhibitor, furmonertinib, met its primary endpoint in a phase III trial, demonstrating longer progression-free survival (PFS) vs. first-generation EGFR TKI Iressa (gefitinib, Astrazeneca plc) as first-line therapy for locally advanced or metastatic EGFR mutation-positive non-small-cell lung cancer (NSCLC). After a median follow-up of 21 months, the primary endpoint of PFS was significantly longer with furmonertinib than gefitinib (median 20.8 vs. 11.1 months; p<0.0001). The PFS of patients in the furmonertinib group was prolonged by 9.7 months and the risk of disease progression or death was reduced by 56%, compared to the gefitinib group.

Resolution pads series A, adds allogeneic macrophage cell therapy program

Syncona Ltd. has added £10 million (US$13.1 million) to the £26.6 million it put into the series A round of Resolution Therapeutics Ltd., enabling the company to advance an allogeneic version of the macrophage cell therapy it is developing for the treatment of compensated liver disease. Since the first close of the round in December 2020, the company has been working on process development for the autologous product, and patients have continued to be recruited to a 50-patient phase II study being run by the academic founders of Resolution.

Australia to allow imports of overseas medicines to mitigate drug shortages

Medicine shortages have been of particular concern during the COVID-19 pandemic, and Australia’s Therapeutic Goods Administration (TGA) said it would seek to amend regulations to allow imports of overseas substitute drugs if the Australian drug has been discontinued and cancelled from the Australian Register of Therapeutic Goods (ARTG). Currently, the Australian drug must be registered to allow the import of a substitute from overseas. This change would allow a continued supply of substitutes without requiring registration or an annual charge waiver for a drug that has been discontinued.

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