Humanigen rallies on positive lenzilumab data in COVID-19 patients

Humanigen (OTCQB:HGEN +37.3%) announces data on the first clinical use of lenzilumab, the proprietary Humaneered anti-human granulocyte macrophage-colony stimulating factor, in 12 COVID-19 patients.

Patients showed rapid clinical improvement with a median time to recovery of five days, median time to discharge of five days and 100% survival to the data cut-off date.

Rapid improvement in oxygenation, temperature, inflammatory cytokines and key hematological parameters consistent with improved clinical outcomes was also observed.

No treatment-emergent adverse events were attributable to lenzilumab and it was well-tolerated.

https://seekingalpha.com/news/3583023-humanigen-rallies-on-positive-lenzilumab-data-in-covidminus-19-patients

Momenta’s nipocalimab shows positive action in neuromuscular disorder

Momenta Pharmaceuticals (MNTA +0.9%) announces positive topline results from a proof-of-concept Phase 2 clinical trial, Vivacity-MG, evaluating nipocalimab (formerly M281) in patients with generalized myasthenia gravis (MG), a disorder characterized by weakness and rapid fatigue of skeletal muscles caused by disrupted communication between nerves and muscles.

All four treatment arms demonstrated efficacy as measured by the change from baseline in a scale of daily activities called MG-ADL at day 57, the primary endpoint. Specifically, 52% of treated patients experienced at least a two-point reduction in MG-ADL scores compared to 15% in the control arm (p=0.017).

On the safety front, nipocalimab was well-tolerated with no severe (grade 3) or worse treatment-related adverse events.

The trial should wind up next quarter. The company will announce 16-week data, along with duration of efficacy and analysis of secondary endpoints, in Q4.

The company plans to meet with regulators before year-end. A Phase 3 study will follow.

Nipocalimab is a fully human anti-neonatal Fc receptor (FcRn) aglycosylated immunoglobulin G (IgG1) monoclonal antibody engineered to reduce circulating IgG antibodies by blocking IgG recycling. MG is an antibody-mediated autoimmune disorder. Most (~80%) of MG sufferers have serum antibodies to acetylcholine receptors which leads to the disruption in communication between nerves and muscles.

https://seekingalpha.com/news/3582998-momentas-nipocalimab-shows-positive-action-in-neuromuscular-disorder

BeyondSpring’s lead drug successful in late-stage neutropenia study

BeyondSpring (NASDAQ:BYSI) announces positive results from a Phase 3 clinical trial, PROTECTIVE-2, evaluating lead candidate Plinabulin, combined with Amgen’s (NASDAQ:AMGN) Neulasta (pegfilgrastim) compared to Neulasta alone for the prevention of chemo-induced neutropenia (low levels of white blood cells called neutrophils).

Interim data showed that the combination significantly improved the rate of Grade 4 (life-threatening) neutropenia prevention compared to Neulasta alone (p<0.01), the primary endpoint.

A key secondary endpoint, the duration of severe neutropenia in cycle 1, was also met.

Plinabulin is a small molecule activator of a protein called GEF-H1.

Management will host a conference call this morning at 8:30 am ET to discuss the results.

https://seekingalpha.com/news/3582941-beyondsprings-lead-drug-successful-in-late-stage-neutropenia-study

Edesa Biotech rockets 160% on launch of COVID-19 study in Canada

Edesa Biotech (NASDAQ:EDSA) is up 160% premarket after receiving expedited approval from Health Canada to begin a Phase 2/3 clinical study of its investigational drug, EB05, as a potential treatment for moderate to severe COVID-19 patients.

The company is seeking government grants to accelerate the initiation and rollout of the study, beginning at up to 30 sites.

Edesa plans to enroll up to 355 patients in the first phase of the trial. Patients will be infused intravenously with EB05 or placebo. Should the drug treatment demonstrate promising results at the Phase 2 readout, the enrollment will continue as a pivotal Phase 3 study.

EB05 is a monoclonal antibody that has demonstrated the ability to suppress the release of proinflammatory cytokines that are often observed in severe COVID-19 patients.

https://seekingalpha.com/news/3582952-edesa-biotech-rockets-160-on-launch-of-covidminus-19-study-in-canada

Dosing underway in aTyr Pharma’s ATYR1923 study in COVID-19 patients

ATyr Pharma (NASDAQ:LIFE) has dosed the first patient in a Phase 2 study evaluating ATYR1923, in hospitalized COVID-19 patients with severe respiratory complications who do not require mechanical ventilation.

The study is expected to enroll 30 patients at up to 10 centers in U.S. and the company expects to have the majority of centers enrolling within the coming weeks.

The trial is designed to evaluate the preliminary safety and efficacy of ATYR1923 as compared to placebo through the assessment of key clinical outcome measures such as fever and hypoxia as well as inflammatory biomarkers.

ATYR1923 is an immunomodulator that has been shown to preclinically downregulate T-cell responses and improve inflammation and lung function.

https://seekingalpha.com/news/3582954-dosing-underway-in-atyr-pharmas-atyr1923-study-in-covidminus-19-patients

Bellicum Pharma on go with mid-stage study of BPX-603 for HER2+ solid tumors

The FDA has cleared Bellicum Pharmaceuticals’ (NASDAQ:BLCM) investigational new drug application (IND) for BPX-603.

BPX-603 is a GoCAR-T product candidate targeting solid tumors that express human epidermal growth factor receptor 2 (HER2).

The company plans to initiate Phase 1/2 trial later this year.

BPX-603 is the company’s first dual-switch GoCAR-T product, which incorporates both the company’s iMC activation and CaspaCIDe safety switch technologies.

https://seekingalpha.com/news/3582963-bellicum-pharma-on-go-mid-stage-study-of-bpxminus-603-for-her2-solid-tumors

Cue Biopharma’s lead drug shows encouraging action in cancer study

Thinly traded Cue Biopharma (NASDAQ:CUE) is up 3% premarket on light volume on the heels of updated data from a Phase 1 clinical trial evaluating lead candidate CUE-101 for the second-line treatment of patients with HPV-positive recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).

As of June 15, 13 patients have been enrolled, most receiving multiple cycles of therapy. Six remain on study for the ongoing data presentation.

Drug exposure in line with preclinical projections and is dose-proportional. Comparable exposures observed upon repeated administration.

Pharmacodynamic data showed selective expansion of targeted T cells in the peripheral blood of several participants in cohorts 2 and 3.

Preliminary radiographic evidence showed CUE-101 to be clinically active.

The company says it appears to have an “attractive” therapeutic window.

On the safety front, most treatment-related adverse events have been mild or moderate with no discontinuations. There was one severe adverse event (anemia and fatigue) that was possibly treatment-related. The patient had an underlying condition and remains on study. The anemia was resolved following a blood transfusion.

CUE-101, a member of the CUE-100 series, is a fusion protein designed to selectively activate tumor-specific T cells to fight HPV-driven cancers.

https://seekingalpha.com/news/3582965-cue-biopharmas-lead-drug-shows-encouraging-action-in-cancer-study