The Daily Biotech Pulse: Roche's COVID Combo Therapy Reduces Need For Ventilation, ESMO Presentations

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 Sept. 17)

• Beigene Ltd BGNE
• Bicycle Therapeutics PLC BCYC(reacted to ESMO presentation)
• Cardiff Oncology Inc CRDF
• Dr.Reddy's Laboratories Ltd RDY(announced a patent litigation settlement with Bristol-Myers Squibb Co BMY with respect to multiple myeloma drug Revlimid)
• Forte Biosciences Inc FBRX
• Fortress Biotech FBIO
• Mirati Therapeutics Inc MRTX (announced a clinical collaboration with Boehringer Ingelheim to evaluate the combination of BI 1701963 and MRTX849 in patients with solid tumors that harbor the KRAS G12C mutation)
• Novocure Ltd NVCR
• Novo Nordisk A/S NVO
• Outset Medical Inc OM (IPOed Wednesday)
• Paratek Pharmaceuticals Inc PRTK
• TRACON Pharmaceuticals Inc TCON
• Trillium Therapeutics Inc. TRIL
• Turning Point Therapeutics Inc TPTX
• Vericel Corp VCEL
• Xencor Inc XNCR

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Sept. 17)

• Renalytix AI PLC RNLX
•  

Stocks In Focus

Kezar Reports Positive Phase 1 Data For Inflammatory Disorder Drug

Kezar Life Sciences Inc KZR announced data from the Phase 1b portion of the MISSION study demonstrating safety, tolerability and early efficacy signals of KZR-616 in patients with systemic lupus erythematosus and lupus nephritis at the Pan-American Congress of Rheumatology.

"These encouraging early positive data suggest that the novel mechanism of KZR-616 has the potential to address the underlying drivers of inflammation, resulting in improvements across organ systems in this disease," the company said.

The stock was up 9.50% to $5.65 in after-hours trading.

Immutep Reports Positive Results For Cancer Drug In Multiple Studies

Immutep ADS Representing 10 Ord Shs IMMP announced at the ESMO Congress promising new interim data from its ongoing Phase 2 TACTI-002 study that is evaluating its lead product candidate eftilagimod alpha with Merck & Co., Inc.'s MRK Keytruda in second-line head and neck squamous cell carcinoma, or HNSCC, or in first- and second-line settings in non-small cell lung cancer patients, or NSCLC.

Three complete responses were reported as of the cut-off date of Aug. 21, and five responses were observed in patients with negative PD-L1 expression, where Keytruda monotherapy does not work well, Immutep said.

Median progression-free survival, or PFS, was 4.3 months in HNSCC patients and 47% were progression free at six months, the company added. In first-line NSCLC patients, median PFS was 11.8 months, and patients with responses have durable ones.

Separately, the company announced interim data from the INSIGHT-004 Phase 1 clinical trial, which is evaluating eftilagimod alpha with Bavenico, which is jointly promoted by German pharma company Merck KGaA and Pfizer Inc. PFE in solid tumors, primarily gastrointestinal. About 41.7% of patients showed partial response to the combo therapy, up from the 33% reported previously, with the combo continuing to be safe and well tolerated.

In after-hours trading, Immutep shares gained 11.87% to $1.79.

Roche's Drug Combo Reduces Need For Ventilation in Hospitalized COVID Patients

Roche Holdings AG Basel ADR Common Stock RHHBY said the phase 3 EMPACTA study that evaluated Actemra/RoActemra in hospitalized COVID-19. Patients with COVID-19-associated pneumonia who received Actemra/RoActemra plus standard of care were 44% less likely to progress to mechanical ventilation or death compared to patients who received placebo plus standard of care, Roche said.

However, there was no statistical difference in mortality between patients who received Actemra/RoActemra or placebo, it added.

Separately, Roche said it has launched its Elecsys anti-SARS-CoV-2 S antibody test for markets accepting the CE Mark. The company said it has filed for emergency use authorization with the FDA.

Morphosys Given Nod to Start Early-stage Solid Tumor Study

Morphosys Ag MOR and I-Mab ADR IMAB announced the FDA has cleared the investigational new drug application for MorphoSys' investigational human anti-C5aR1 antibody MOR210/TJ210 for the treatment of relapsed or refractory advanced solid tumors. This allows the start of the Phase 1 study, which is expected to commence shortly.

MoerphoSys and I-Mab are jointly developing MOR210/TJ210 under a 2018 agreement.

Sonoma's Disinfectant and Hand Sanitizer Gets Canadian Nod

Sonoma Pharmaceuticals Inc SNOA said its partner MicroSafe Group received approval by Health Canada for their patented and trademarked Nanocyn disinfectant & sanitizer, which is manufactured by Sonoma using its patented Microcyn Technology, to be sold into Canada through an interim measure for disinfectants and hand sanitizers.

Sonoma shares rallied 18.10% to $8.94 in after-hours trading.

Achieve Life Sciences's Smoking Cessation Drug Stacks Up Well Against Pfizer's

Achieve Life Sciences Inc ACHV presented at the Society for Research on Nicotine and Tobacco European Annual Meeting results comparing its smoking cessation drug candidate cytisinicline versus Pfizer's Chantix in 5-HT3 receptor binding assay study, showing the incidence of nausea and vomiting associated with cytisinicline appears to be consistently lower than that seen with Chantix.

In premarket trading Friday, the stock was climbing 9.02% to $11.96.

Offerings

Checkpoint Therapeutics Inc CKPT said it has entered into an underwriting agreement with H.C. Wainwright & Co., under which the underwriter has agreed to purchase on a firm commitment basis 7.143 million shares at $2.80 per share.

The closing of the offering is expected to occur on or about Sept. 22, subject to satisfaction of customary closing conditions.

The stock slumped 14.53% to $3 in after-hours trading.

Adamis Pharmaceuticals Corp ADMP said it intends to offer shares of its common stock in an underwritten public offering.

On The Radar

Clinical Readouts

Other ESMO 2020 Conference Presentations

Alkermes Plc ALKS: Safety and anti-tumor efficacy data from the phase 1/2 ARTISTRY-1 study, evaluating ALKS 4230 as monotherapy and in combination with Keytruda in patients with refractory solid tumors

Ayala Pharmaceuticals Inc AYLA: interim results from the Phase 2 ACCURACY clinical trial of AL101 for the treatment of recurrent/metastatic (adenoid cystic carcinoma harbouring Notch activating mutations

Agenus Inc AGEN: data from two Phase 2 trials of balstilimab alone and in combination with zalifrelimab in cervical cancer

Autolus Therapeutics PLC AUTL: Phase 1/2 data for AUTO3, its CAR T cell therapy being investigated in relapsed/ refractory diffuse large B cell lymphoma

IPOs

Athira Pharma, Inc., a late clinical-stage biopharma focused on developing small molecules to restore neuronal health and stop neurodegeneration, priced its initial public offering of 12 million shares at $17.00 per share, at the upper end of the estimated price range of $15-$17, for raising gross proceeds of $204 million. All of the shares are being offered by Athira. The company's shares will begin trading on the Nasdaq under the ticker symbol ATHA.