ARPO Soars, GNFT's NASH Study Fails, Moderna's COVID-19 Vaccine On Fast Track

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Today's Daily Dose brings you news about Aerpio Pharma's amended licensing deal with Gossamer Bio; Gamida's encouraging results from phase III study of Omidubicel malignancies; Genfit's disappointing NASH trial results; Fast Track designation for Moderna's mRNA vaccine against the novel coronavirus and NanoViricides' progress in the COVID-19 drug development program.

Read on…

Aerpio Pharmaceuticals (ARPO) has received an immediate payment of $15 million, following a restructuring of its licensing deal with Gossamer Bio Inc., for its HIF-1 alpha stabilizer, GB004.

Gossamer licensed GB004, formerly known as AKB-4924, in development for irritable bowel disease, from Aerpio Pharma in 2018.

Under the amended licensing deal, apart from the upfront payment, Aerpio is also entitled to receive a total of $90 million in milestone payments related to regulatory approvals and commercial sales. In addition, Aerpio is also eligible to receive tiered royalties on sales of licensed products at percentages ranging from the low to mid-single digits.

Gossamer Bio recently completed a phase Ib study of GB004 in patients with ulcerative colitis and is planning a phase II study.

ARPO closed Tuesday's trading at $0.62, up 2.08%. In after-hours, the stock gained 44.45% and was at $0.90.

Gamida Cell Ltd.'s (GMDA) phase III study of Omidubicel, an investigational advanced cell therapy for blood cancer patients in need of bone marrow transplant, has yielded positive results.

In the phase III study, Omidubicel was evaluated against standard umbilical cord blood transplant in patients with high-risk hematologic malignancies, and the time to neutrophil engraftment, which was the primary endpoint, was analyzed.

Neutrophil engraftment is a measure of how quickly the stem cells a patient receives in a transplant are established and begin to make healthy new cells, and rapid neutrophil engraftment has been associated with fewer infections and shorter hospitalizations.

According to the study results, the median time to neutrophil engraftment was 12 days for patients randomized to Omidubicel compared to 22 days for the comparator group.

In the study, 96 percent of patients who received Omidubicel achieved successful neutrophil engraftment compared to 88 percent of patients in the comparator group.

Gamida expects to begin the submission of its biologics license application for Omidubicel to the FDA on a rolling basis in the fourth quarter of this year.

A phase I/II study of Omidubicel in patients with severe aplastic anemia, a rare, life-threatening bone marrow failure disease, is underway, with additional data from the study expected in the second half of 2020.

GMDA closed Tuesday's trading at $6.20, up 36.56%.

Genfit SA (GNFT) slumped more than 67 percent on Tuesday, following disappointing results from its NASH trial.

The trial, dubbed RESOLVE-IT, is a phase III study evaluating once-daily, 120mg of Elafibranor in adults with non-alcoholic steatohepatitis (NASH).

The trial did not meet the predefined primary endpoint of NASH resolution without worsening of fibrosis. The response rate was 19.2% for patients who received Elafibranor 120mg compared to 14.7% for patients in the placebo arm. On the fibrosis key secondary endpoint, 24.5% of patients who received Elafibranor 120mg achieved fibrosis improvement of at least one stage compared to 22.4% in the placebo arm. The other key secondary endpoint related to metabolic parameters did not achieve statistical significance, noted the Company.

Genfit is planning to engage with regulatory authorities to determine next steps regarding the extension phase evaluating the effect of Elafibranor on clinical outcomes.

GNFT closed Tuesday's trading at $7.10, down 67.28%.

Moderna Inc.'s (MRNA) mRNA-1273, an investigational mRNA vaccine against the novel coronavirus, has been granted Fast Track designation by the FDA.

Programs with Fast Track designation may benefit from early and frequent communication with the FDA, in addition to a rolling submission of the marketing application.

The Company is awaiting full set of clinical data from its phase I study of mRNA-1273 vaccine, with phase II study expected to begin shortly. The pivotal phase III study of the mRNA-1273 vaccine is expected to begin early this summer.

Last month, the Company was awarded a grant of up to $483 million by the U.S. Government Agency BARDA to accelerate the development of the mRNA-1273 vaccine.

MRNA touched an all-time high of $68.48 in intraday trading on Tuesday, before closing the day's trading at $62.35, down 6.80%.

Shares of NanoViricides Inc. (NNVC) jumped more than 28 percent on Monday on news that the Company has developed drug candidates that have demonstrated very high anti-viral effectiveness in cell culture studies against multiple coronaviruses.

According to the Company, two of the tested nanoviricides drug candidates were highly effective in cell culture assays against multiple coronaviruses like hCoV-NL63 and hCoV-229E that infect humans - and they were more effective than Favipravir.

Favirpravir is a broad-spectrum nucleoside-like analog drug that is in clinical testing against SARS-CoV-2, originally developed by Fujifilm.

Human coronavirus NL63 uses the same ACE2 receptor as the SARS-CoV-2 that causes CoVID-19, and it is known to be very similar to SARS-CoV-2 in terms of clinical pathology and receptor usage, except that it is much milder, noted the Company.

NNVC closed Tuesday's trading at $9.12, up 28.27%.

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