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The Daily Biotech Pulse: AstraZeneca's Cancer Drug Flunks COVID-19 Studies, Five Prime On a Roll, Morphosys, Xencor, Incyte Strike Cancer Deal

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The Daily Biotech Pulse: AstraZeneca's Cancer Drug Flunks COVID-19 Studies, Five Prime On a Roll, Morphosys, Xencor, Incyte Strike Cancer Deal

Here's a roundup of top developments in the biotech space over the last 24 hours:

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Nov. 11)

  • Beam Therapeutics Inc (NASDAQ: BEAM)
  • Biohaven Pharmaceutical Holding Co Ltd (NYSE: BHVN)
  • Celldex Therapeutics, Inc. (NASDAQ: CLDX)
  • Denali Therapeutics Inc (NASDAQ: DNLI)
  • Fate Therapeutics Inc (NASDAQ: FATE)
  • Five Prime Therapeutics Inc (NASDAQ: FPRX) (announced positive midstage stomach cancer study)
  • Halozyme Therapeutics, Inc. (NASDAQ: HALO)
  • Inspire Medical Systems Inc (NYSE: INSP)
  • Kura Oncology Inc (NASDAQ: KURA)
  • Kymera Therapeutics Inc (NASDAQ: KYMR)
  • MannKind Corporation (NASDAQ: MNKD)
  • Merit Medical Systems, Inc. (NASDAQ: MMSI)
  • Neuronetics Inc (NASDAQ: STIM)
  • OncoSec Medical Inc (NASDAQ: ONCS)
  • Pacific Biosciences of California Inc (NASDAQ: PACB)
  • Retrophin Inc (NASDAQ: RTRX)
  • Shockwave Medical Inc (NASDAQ: SWAV)
  • TRACON Pharmaceuticals Inc (NASDAQ: TCON)
  • Twist Bioscience Corp (NASDAQ: TWST)
  • Ultragenyx Pharmaceutical Inc (NASDAQ: RARE)
  • Veracyte Inc (NASDAQ: VCYT)
  • Vericel Corp (NASDAQ: VCEL)
  • Zai Lab Ltd – ADR (NASDAQ: ZLAB) (reacted to the positive tidings from Five Prime)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Nov. 11)

  • Eyegate Pharmaceuticals Inc (NASDAQ: EYEG)
  • Global Blood Therapeutics Inc (NASDAQ: GBT)
  • Polypid Ltd (NASDAQ: PYPD) (announced third-quarter results)
  • Qualigen Therapeutics Inc (NASDAQ: QLGN)

Stocks In Focus

Inhibrx Reports Positive Interim Phase 1 Bone Cancer Data

Inhibrx Inc (NASDAQ: INBX) announced updated interim results from the Phase 1 study of INBRX-109 in patients with chondrosarcoma, showing of the 12 evaluable patients, disease control was observed in 11 patients, with eight of the 12 patients seeing a decrease in tumor burden. As of October, two of the patients achieved partial responses, with reduction in tumor size of 60% and 32%.

"We believe the results in chondrosarcoma, a disease with a significant unmet need, are very promising," said CEO Mark Lappe.

The company said it plans to meet with the FDA in the near future to discuss the design of a registration-enabling study that's likely to commence in the second quarter of 2021.

The stock rallied 10.31% to $21.18 in after-hours trading.

Five Prime Reports Positive Preclinical Antibody Data

Five Prime presented at the Society for Immunotherapy of Cancer, SITC, conference preclinical data supporting evaluation of FPA157 as a novel immunomodulator with the potential to remove Treg-mediated immune suppression in solid tumors.

The data showed that the investigational immunotherapy FPA157 elicits anti-tumor activity in multiple preclinical models.

Separately, the company said it plans to offer 5 million shares of its common stock in an underwritten public offering.

The stock was up 15.78% at $20.84 premarket Thursday. 

Xencor, Morphosys, Incyte Form 3-Way Cancer Partnership

Xencor Inc (NASDAQ: XNCR), Morphosys Ag (NASDAQ: MOR) and Incyte Corporation (NASDAQ: INCY) announced a clinical collaboration to investigate the combination of tafasitamab, plamotamab and Bristol-Myers Squibb Co's (NYSE: BMY) Revlimid in patients with relapsed or refractory diffuse large B-cell lymphoma, or DLBCL, first-line DLBCL and relapsed or refractory follicular lymphoma.

Under the terms of the agreement, the companies initially plan to initiate a Phase 1/2 study evaluating the combo in patients with relapsed or refractory DLBCL. Additionally, the companies are planning to evaluate the combo in relapsed or refractory FL and first-line DLBCL in multiple Phase 1b studies.

MorphoSys and Incyte will provide tafasitamab for the studies, which will be sponsored and funded by Xencor and conducted in North America, Europe and Asia-Pacific.

In premarket trading Thursday, Morphosys shares were slipping 3.06% to $25.66, while Incyte was adding 1.47% to $83.98.

AstraZeneca's Cancer Drug Fails Midstage COVID-19 Studies

AstraZeneca plc (NASDAQ: AZN) said its ALAVI Phase 2 trials for Calquence in patients hospitalized with respiratory symptoms of COVID-19 did not meet the primary efficacy endpoint. The addition of Calquence to best supportive care did not increase the proportion of patients who remained alive and free of respiratory failure, the company said. 

The stock was edging down 1.02% to $57.43 in premarket trading.

Related Link: The Week Ahead In Biotech: Supernus, Sanofi Await FDA Decisions

Qiagen Launches Portable Digital COVID-19 Antigen Test In US

Qiagen NV (NYSE: QGEN) said it has started commercialization of a portable digital test in the U.S. that can be used by labs to detect SARS-CoV-2 antigens in people with active infections in 2-15 minutes. A point of care claim will be added and emergency use authorization amended later this year, the company said.

In premarket trading, the stock was 1.35% higher at $47.14. 

Earnings

PDL BioPharma Inc (NASDAQ: PDLI) reported revenue of $4.12 million for the two months ended Aug. 31, 2020 compared to $8.03 million for the three months ended Sept. 30, 2019. The company reversed from a loss of 16 cents per share to a profit of 4 cents per share.

The company said it plans to file a certificate of dissolution with the State of Delaware Jan. 4, 2021, with the stock expected to be delisted from the Nasdaq after Dec. 31.

The stock was up 3.98% premarket at $2.35. 

OpGen Inc's (NASDAQ: OPGN) third-quarter revenue climbed from $648,220 in 2019 to $1.057 million in 2020. The loss per share narrowed from $3.95 to 40 cents. Analysts had estimated a loss of 36 cents per share.

The stock was up 4.37% at $2.39 premarket. 

On The Radar

Clinical Readouts/Presentations

SITC Annual Meeting Presentations

Cue Biopharma Inc (NASDAQ: CUE) is due to make a poster presentation on Phase 1 study of CUE-101 in patients with recurrent/metastatic HPV16+ head and neck cancer.

Earnings

  • Myovant Sciences Ltd (NYSE: MYOV) (before the market open)
  • Sol Gel Technologies Ltd (NASDAQ: SLGL) (before the market open)
  • Galmed Pharmaceuticals Ltd (NASDAQ: GLMD) (before the market open)
  • DarioHealth Corp (NASDAQ: DRIO) (before the market open)
  • Axcella Health Inc (NASDAQ: AXLA) (before the market open)
  • ADC Therapeutics SA (NYSE: ADCT) (before the market open)
  • RedHill Biopharma Ltd (NASDAQ: RDHL) (before the market open)
  • ImmuCell Corporation (NASDAQ: ICCC) (after the close)
  • Aptinyx Inc (NASDAQ: APTX) (after the close)
  • Agile Therapeutics Inc (NASDAQ: AGRX) (after the close)
  • Achieve Life Sciences Inc (NASDAQ: ACHV) (after the close)
  • aTyr Pharma Inc (NASDAQ: LIFE) (after the close)
  • Alpine Immune Sciences Inc (NASDAQ: ALPN) (after the close)
  • Aytu Bioscience Inc (NASDAQ: AYTU) (after the close)
  • Dare Bioscience Inc (NASDAQ: DARE) (after the close)
  • Dyadic International, Inc. (NASDAQ: DYAI) (after the close)
  • Eton Pharmaceuticals Inc (NASDAQ: ETON) (after the close)
  • BioNano Genomics Inc (NASDAQ: BNGO) (after the close)
  • Helius Medical Technologies Inc (NASDAQ: HSDT) (after the close)
  • Thermogenesis Holdings Inc (NASDAQ: THMO) (after the close)
  • RA Medical Systems Inc (NYSE: RMED) (after the close)
  • Onconova Therapeutics Inc (NASDAQ: ONTX) (after the close)
  • Opiant Pharmaceuticals Inc (NASDAQ: OPNT) (after the close)
  • Inari Medical Inc (NASDAQ: NARI) (after the close)
  • Biocept Inc (NASDAQ: BIOC) (after the close)
  • Capricor Therapeutics Inc (NASDAQ: CAPR) (after the close)
  • OncoCyte Corp (NYSE: OCX) (after the close)
  • Viveve Medical Inc (NASDAQ: VIVE)
  • Sun Biopharma Inc (NASDAQ: SNBP)
  • Navidea Biopharmaceuticals Inc (NYSE: NAVB)
  • Processa Pharmaceuticals Inc (NASDAQ: PCSA)

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

 

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