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List Of 'Operation Warp Speed' Finalists, SAVA To Reassess AD Study Results; KZR Jumps On MISSION

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Today's Daily Dose brings you news about the finalists in 'Operation Warp Speed' COVID-19 vaccine program; FDA approval of Fitbit Flow ventilator for emergency use; an update on Cassava's phase IIb study of PTI-125 in patients with Alzheimer's disease and promising initial data from Kezar Life's MISSION trial.

Read on…

1. White House Names 'Operation Warp Speed' Finalists

As part of 'Operation Warp Speed', the national program aiming for a COVID-19 vaccine by January 2021, the White House has finalized five companies namely, Moderna, Astrazeneca, Johnson & Johnson, Merck & Co., and Pfizer, reports The New York Times.

Moderna Inc.'s (MRNA) vaccine candidate mRNA-1273 against the novel coronavirus (SARS-CoV-2) is under a phase II study, with phase III study expected to be initiated in July.

AstraZeneca PLC's (AZN) COVID-19 vaccine candidate AZD1222, developed by Oxford University's Jenner Institute, is under a phase II/III trial at multiple sites in the UK.

Johnson & Johnson's (JNJ) COVID-19 vaccine candidate Ad26 SARS-CoV-2 is expected to enter human clinical trial this September.

Pfizer Inc. (PFE) is working in collaboration with the German biotech company BioNTech (BNTX) to develop a COVID-19 vaccine. There are four vaccine candidates under the BNT162 vaccine program, which are in phase I/II trial in Germany. If all goes well, Pfizer says it will have the potential to supply millions of vaccines by the end of 2020.

Merck (MRK) is working with IAVI, a nonprofit scientific research organization, to develop a vaccine against SARS-CoV-2. The vaccine candidate is in preclinical development, and clinical studies are planned to start later in 2020.

The selected finalists will get additional funding, according to the New York Times.

Shares of Inovio Pharmaceuticals Inc. (INO) and Novavax Inc. (NVAX) took a hit on Wednesday as the companies failed to make it to the list of finalists for the Operation Warp Speed initiative.

2. Fitbit Flow Ventilator Approved For Emergency Use

The FDA has approved Fitbit's (FIT) low-cost, easy-to-use emergency ventilator, Fitbit Flow, for emergency use during the COVID-19 public health emergency.

Fitbit Flow builds on standard resuscitator bags, like those used by paramedics, with sophisticated instruments, sensors, and alarms that work together to support automated compressions and patient monitoring, the Company noted.

Fitbit added that it is in talks with state and federal agencies to understand current domestic needs for emergency ventilators and also plans to work with U.S. and global aid organizations as well.

FIT closed Wednesday's trading at $6.26, down 0.32%.

3. Cassava To Reassess Alzheimer's Disease Trial Results

Cassava Sciences Inc. (SAVA) soared more than 60 percent on Wednesday, following an update provided by the Company, including a discussion regarding recently announced top-line results of a phase IIb study of PTI-125 in patients with Alzheimer's disease.

According to the results reported on May 15, the phase IIb study of PTI-125 in patients with Alzheimer's disease did not meet its primary endpoint. The pre-specified primary endpoint was a statistically significant effect of PTI-125 versus placebo on cerebrospinal fluid (CSF) levels of tau protein and other biomarker assessments from baseline to Day 28. However, PTI-125 significantly reduced a secondary endpoint, CSF levels of IL1-beta, a core biomarker of neuroinflammation, from baseline to Day 28.

In today's update regarding the phase IIb study of PTI-125 in patients with Alzheimer's disease, the Company revealed that "unexpectedly, placebo-treated patients showed significant swings (in both directions) in levels of certain CSF biomarkers of disease over 28 days and that placebo-treated patients showed no clear correlation between levels of certain biomarkers of disease".

Therefore, high variability in levels of biomarkers in the control group may drive a reassessment of study results, Cassava noted.

SAVA closed Wednesday's trading at $3.42, up 67.65%.

4. Kezar On Track To Accomplish MISSION

Shares of Kezar Life Sciences Inc. (KZR) jumped more than 80 percent in extended trading on Wednesday, following updated results from the phase 1b portion of phase Ib/II study evaluating KZR-616 in patients with systemic lupus erythematosus (SLE) with and without nephritis.

In the phase Ib/II study, dubbed MISSION, KZR-616 is administered as a subcutaneous injection weekly for 13 weeks (Phase 1b) or 24 weeks (Phase 2).

As of the May 4, 2020 data cutoff, the phase Ib portion of MISSION enrolled 39 SLE patients across five dose cohorts evaluating 45 mg and step-up dosing to 60 mg weekly for 13 weeks. Two SLE patients with biopsy-proven lupus nephritis were included in the phase Ib portion.

According to the updated results announced Wednesday, in the phase Ib portion of the MISSION study, overall, improvements were seen across seven measures of disease activity, and two of two patients with lupus nephritis experienced a greater than 50% reduction in proteinuria, a biomarker of disease severity.

We had alerted readers to KZR on February 7, 2020, when it was trading around $3.70.

Related reading

Stock To Watch: Kezar Life Sciences (KZR)

The stock closed Wednesday's trading at $4.47, down 8.21%. In after-hours, the stock was up 82.33% at $8.15.

5. Stocks That Moved On No News

IMARA Inc. (IMRA) closed Wednesday's trading at $44.90, up 22.98%.

CorMedix Inc. (CRMD) closed Wednesday's trading at $5.47, up 17.38%.

I-Mab (IMAB) closed Wednesday's trading at $25.80, up 16.85%.

Translate Bio Inc. (TBIO) closed Wednesday's trading at $16.15, down 18.64%.

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