- The FDA designates Mesoblast Limited's (NASDAQ:MESO) Phase 3-stage Ryoncil (remestemcel-L) for Fast Track review for the treatment of acute respiratory distress syndrome (ARDS) due to COVID-19.
- Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.
- Remestemcel-L is an allogeneic mesenchymal stem cell product. It consists of culture-expanded mesenchymal stromal cells derived from the bone marrow of an unrelated donor. It is thought to have immunomodulatory properties to counteract the cytokine storms that are implicated in various inflammatory conditions by downregulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.
- https://seekingalpha.com/news/3640734-mesoblast-cell-therapy-fast-trackd-for-covidminus-19-related-acute-respiratory-distress
- The first patient has been enrolled in a Phase 2 clinical trial evaluating CytoDyn' (OTCQB:CYDY) leronlimab, for the treatment of non-alcoholic steatohepatitis (NASH) and/or Nonalcoholic Fatty Liver Disease (NAFLD).
- As previously reported, the Company’s preclinical study demonstrated strong positive data highlighting the potential of leronlimab in treating nonalcoholic fatty liver disease (NAFLD), a common precursor to NASH. Inhibition of CCR5 has been shown to be effective in reducing fibrosis in animal models of NASH liver fibrosis.
- Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.
- https://seekingalpha.com/news/3640733-cytodyn-launches-mid-stage-study-of-leronlimab-in-nonalcoholic-fatty-liver-disease
- Dosing is underway in a Phase 3 clinical trial, PRESECO, evaluating Appili Therapeutics' (OTCQX:APLIF) Avigen tablets (favipiravir) for the treatment of COVID-19 patients with mild-to-moderate symptoms. The goal is to alleviate the symptoms and prevent disease progression.
- Enrollment target is ~826 subjects. The primary endpoint is time to sustained recovery from day 0 to day 21 compared to placebo.
- Preliminary data should be available in H1 2021.
- Favipiravir is a broad-spectrum antiviral developed by FUJIFILM Toyama Chemical Co., Ltd. (OTCPK:FUJIF). It is approved in Japan for the treatment of influenza. Based on encouraging clinical data, Russia and India recently approved its emergency use for COVID-19. FUJIFILM recently announced positive results from a Phase 3 study in hospitalized COVID-19 patients.
- Appili is part of a consortium that includes Dr. Reddy's Laboratories (NYSE:RDY), Global Response Aid and FUJIFILM backing global development and distribution (ex. Japan, China and Russia) of Avigan tablets for the potential treatment and prevention of COVID-19.
- https://seekingalpha.com/news/3640768-appili-therapeutics-advances-late-stage-study-of-favipiravir-for-covidminus-19
- Kinnate Biopharma (KNTE) has raised the proposed deal size for its upcoming IPO.
- The company now plans to raise $213M by offering 11.5M shares at a price range of $18 to $19 vs. original offering of 10M shares at a range of $16 to $18.
- Kinnate is focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers. Its lead candidate, KIN002787, is a Rapidly Accelerated Fibrosarcoma (RAF) inhibitor for the treatment of patients with lung cancer, melanoma, and other solid tumors. The company expects to file an IND for KIN002787 in the 1H21.
- https://seekingalpha.com/news/3640795-kinnate-biopharma-increases-ipo-size-25-to-213m
- Aptevo Therapeutics (APVO +10.0%) announces that it has expanded its ADAPTIR bispecific platform technology to include a new multi-specific platform technology, ADAPTIR-FLEX™.
- Aptevo also announced that it has developed a new bispecific candidate, APVO442, that utilizes ADAPTIR-FLEX platform technology targeting PSMA and CD3 for the treatment of prostate cancer.
- Aptevo believes that ADAPTIR-FLEX CD3-based candidates have the potential to demonstrate reduced production of cytokines consistent with other ADAPTIR-based T-cell engagers like observations made for APVO436 in preclinical studies.
- "We are very excited about the launch of our second platform technology, ADAPTIR-FLEX, which expands our capability to design candidates with multiple new mechanisms of action, with potential best-in-class attributes. Recently, we had two patients in cohort 6 of our phase 1 APVO436 clinical trial achieve complete remission, which strengthened our resolve around the capabilities of our ADAPTIR platform technology. Our new bispecific candidate APVO442, built on ADAPTIR-FLEX, is a unique T-cell engager targeting PSMA and CD3 for the treatment of prostate cancer, and we are optimistic about the potential outcomes for patients impacted by these tumors." said Mr. Marvin White, President and CEO.
- https://seekingalpha.com/news/3640879-aptevoplus-7-expands-bispecific-platform-technology-and-introduces-new-bispecific-prostate
