The Daily Biotech Pulse: Sanofi, GSK Begin Phase 1/2 Coronavirus Vaccine Study, Fulgent Strikes COVID-19 Testing Deal, New Data From Novavax

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Sept. 2)

  • Acutus Medical Inc AFIB
  • Akouos Inc AKUS
  • Avid Bioservices Inc CDMO (reacted to strong quarterly results)
  • BioLife Solutions Inc BLFS
  • Corcept Therapeutics Incorporated CORT
  • Edwards Lifesciences Corp EW
  • Evogene Ltd EVGN
  • Fortress Biotech FBIO
  • Generation Bio Co GBIO
  • Immunovant Inc IMVT (priced its 5.27-million-share common stock offering at $33 per share)
  • Inspire Medical Systems Inc INSP
  • Intuitive Surgical, Inc. ISRG
  • Silk Road Medical Inc SILK
  • Shockwave Medical Inc SWAV
  • Tandem Diabetes Care Inc TNDM
  • TG Therapeutics Inc common stock TGTX
  • Twist Bioscience Corp TWST (announced potent SARS-CoV-2 neutralizing data from COVID-19 therapeutic antibody program)
  • West Pharmaceutical Services Inc. WST
  • Zoetis Inc ZTS

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Sept. 2)

  • Acorda Therapeutics Inc ACOR
  • ADiTx Therapeutics Inc ADTX (priced a $9.6-million follow-on offering)
  • China SXT Pharmaceuticals Inc SXTC
  • Cyclacel Pharmaceuticals Inc CYCC
  • Entera Bio Ltd ENTX
  • Eyepoint Pharmaceuticals Inc EYPT
  • Gritstone Oncology Inc GRTS
  • Happiness Biotech Group Ltd HAPP
  • Histogen Inc HSTO
  • Interpace Biosciences Inc IDXG
  • Iterum Therapeutics PLC ITRM
  • NanoVibronix Inc NAOV
  • Neurobo Pharmaceuticals Inc NRBO
  • Nkarta Inc NKTX
  • Oncternal Therapeutics Inc ONCT
  • Psychemedics Corp. PMD
  • Rockwell Medical Inc RMTI
  • Sun BioPharma, Inc. SNBP
  • Sunesis Pharmaceuticals, Inc. SNSS

Stocks In Focus

Sutro To Present Positive Phase 1 Ovarian Cancer Data

In an abstract submitted to the International Gynecologic Cancer Society annual global meeting, Sutro Biopharma Inc STRO said STRO-002, its FRα-targeting antibody-drug conjugate being evaluated for ovarian cancer, produced a partial response in five of 29 evaluable patients (17%), with two confirmed on second scan.

STRO-002 has a promising emerging safety and efficacy profile and a preliminary clinical benefit/disease control rate of 48% in patients with relapsed/refractory ovarian cancer treated at more than or equal to 2.9 mg/kg.

No ocular toxicity signals have been observed, suggesting potential differentiation from other FRα-targeting investigational therapies, the company said.

Sutro said it has planned expansion cohorts in less heavily pre-treated patients for the fourth quarter of 2020.

Sutro said it will host a conference to discuss the updated data at 5:30 p.m. ET Sept. 9, and also make a presentation at the IGCS global meeting.

The stock advanced 10.96% to $12.50 in after-hours trading.

Fulgent Partners With New York On Large-Scale Student Testing 

Fulgent Genetics Inc FLGT said it is partnering with the New York City Health and Hospitals to provide COVID-19 testing to students across approximately 1,600 locations as they return to school in September and over the next several months.

Fulgent will provide its FDA EUA-approved at-home RT-PCR test, which it said provides the highest level of sensitivity and specificity, utilizing a self-collected nasal swab sample.

The company said it will provide results within 24-48 hours from the time when it receives and accepts a specimen for the test.

This is one of the first large-scale testing programs for COVID-19 to utilize an at-home test kit, Fulgent said. 

Separately, the company said that beginning Sept. 28, all patients tested for COVID-19 by Fulgent will also receive results for influenzas A and B.

The stock was trading 12.56% higher to $32.45 premarket Thursday.

See also: The Week Ahead In Biotech: Bristol-Myers Squibb FDA Decision, Adcom Review For Glaxo, Amarin Vascepa Hearing

Novavax Announces Publication Of More Detailed Positive Phase 1 Data For Coronavirus Vaccine

Novavax, Inc. NVAX announced publication in The New England Journal of Medicine more detailed Phase 1 data from its Phase 1/2 clinical trial of NVX CoV2373, showing the vaccine candidate demonstrated a reassuring safety and reactogenicity profile and induced robust antibody responses that are numerically superior to those seen in human convalescent sera.

"The rapid publication of Phase 1 results from our trial in a prestigious peer-reviewed journal reflects both the importance of the data and the urgent need for an effective vaccine to slow the COVID-19 pandemic," Gregory Glenn, Novavax's R&D president, said in a statement. 

The company released preliminary Phase 1 data in early August.

The stock was up 5.45% at $108.51 premarket. 

Sanofi, Glaxo Initiate Phase 1/2 Coronavirus Vaccine Trial

Sanofi SA SNY and GlaxoSmithKline plc GSK said they have started the Phase 1/2 clinical trial of their adjuvanted COVID-19 vaccine. The vaccine candidate uses the same recombinant protein-based technology as one of Sanofi's seasonal influenza vaccines alongside GSK's established pandemic adjuvant technology.

About 440 healthy adults from 11 sites in the U.S. are being enrolled in the trial, which is designed to evaluate safety, reactogenicity and immunogenicity.

The companies expect to release preliminary data from the study in early December, which is likely to help initiation of a Phase 3 trial in December. Contingent on the data, the companies said they plan to file a regulatory application in the first half of 2021.

ADMA Biologics Launches Assay To Detect SARS-CoV-2 Neutralizing Antibodies In Plasma

ADMA Biologics Inc ADMA announced the launch of COVID-19 ImmunoRank Neutralization MICRO-ELISA, a proprietary, fully validated ELISA assay for the detection of SARS-CoV-2 neutralizing antibodies in plasma.

ImmunoRank was developed in collaboration with Leinco Technologies, and is intended for use as an aid to identify individuals who produce an adaptive immune response to SARS-CoV-2, indicating recent or prior infection, and specifically for the detection of circulating SARS-CoV-2 neutralizing antibodies in human plasma of all immune globulin classes.

The stock was moving up 12.72% to $2.57 in premarket trading Thursday.

On The Radar

Earnings

  • Misonix Inc MSON (after the close)
  • Cooper Companies Inc COO (after the close)

Related Link: Attention Biotech Investors: Mark Your Calendar For September PDUFA Dates

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