Allovir's COVID-19 therapy saw anti-viral activity in pre-clinical data

 

• The late clinical-stage cell therapy company, AlloVir, Inc. (NASDAQ:ALVR) announced pre-clinical results for ALVR109, an Off-the-Shelf SARS-CoV-2 Specific T Cell Therapy.
• The data presented at the 62nd American Society of Hematology ASH Annual Meeting over the weekend indicated selective antiviral activity of the experimental therapy against SARS-CoV-2, the virus causing COVID-19.
• A proof-of-concept clinical trial is in progress at the Houston Methodist Hospital to assess the safety and efficacy of ALVR109 in preventing severe disease in hospitalized COVID-19 patients with high-risk features.
• The company’s proprietary technology platforms leverage off-the-shelf, allogeneic, multi-virus specific T cells targeting devastating viruses in patients with T cell deficiencies who are at risk from the life-threatening consequences of viral diseases.
• “It’s increasingly clear that T cell dysregulation is a critical factor in the development of severe COVID-19 and that the presence of healthy SARS-CoV-2-specific CD4+ and CD8+ T cells is important in helping patients fight off the virus,” said Ann Leen, Ph.D., Chief Scientific Officer at AlloVir.
• https://seekingalpha.com/news/3642095-allovirs-covidminus-19-therapy-saw-anti-viral-activity-in-pre-clinical-data

Kura Oncology Up on First In-Human Data for AML Candidate

 

• Kura Oncology, Inc. (NASDAQ:KURA) is up ~16% in pre-market trading after announcing encouraging preliminary clinical data for KO-539 in a Phase 1/2A clinical trial for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML).

• The data presented during the 62^nd American Society of Hematology (NYSE:ASH) Annual Meeting and Exposition were the first-in-human data generated by KO-539, a novel, once-daily, oral menin inhibitor for the treatment of genetically defined AML patients with a high unmet need.

• The enrollment is ongoing in the dose escalation of Phase 1/2A clinical trial to determine the safety, tolerability and recommended Phase 2 dose of KO-539, and an expansion phase in specific genetic subgroups is expected in the first quarter of 2021. 

• On the safety front, there have been no drug discontinuations due to treatment-related adverse events, and the continuous daily dosing of KO-539 has been well tolerated with a manageable safety profile to date.

• “The preliminary clinical data for KO-539 suggest it has the potential to be effective for multiple genetically defined AML subgroups of high unmet need” said Eunice Wang, M.D., Chief of the Leukemia Service at Roswell Park Comprehensive Cancer Center and principal investigator of the trial.

• KO-539 has already won the Orphan Drug Designation from the FDA.

• https://seekingalpha.com/news/3642092-kura-oncology-jumps-16-after-announcing-first-in-human-data-for-aml-candidate

Gilead Sciences sees cool reaction to ASH presentation

 

• Wells Fargo keeps an Equal Weight rating on Gilead Sciences (NASDAQ:GILD) following magrolimab update in AML at the ASH conference over the weekend.
• The firm says that while azacytadine combo data are compelling, it views the CD47 category as highly competitive and would take a wait-and-see approach to relative positioning.
• Magrolimab breakdown: "GILD reported data for 64 treatment-naïve elderly AML patients unfit for intensive chemotherapy, treated with magrolimab (1–30 mg/kg IV weekly to mitigate on-target anemia followed by 30 mg/kg Q2W dosing in cycle 3 and beyond) plus AZA 75 mg/m2 on days 1–7 every 28 days. The trial enriched for patients with a p53 mutation (73%) and 70% of subjects had poor risk cytogenetics. The most common treatment-related adverse event was anemia which was generally transient and grade 3 or less, 4.7% of patients each discontinued due to a drug-related adverse event or required dose reduction. Thirty-day and 60-day all-cause mortality rates were 4.7% and 7.8% respectively."
• Previously: Gilead's magrolimab shows clinical responses in untreated acute myeloid leukemia patients
• https://seekingalpha.com/news/3642084-gilead-sciences-sees-cool-reaction-to-ash-presentation

Teladoc Health falls after Stephens calls it "show me" story

 

• Stephens drops its rating on Teladoc Health (NYSE:TDOC) to Equal Weight after having it slotted at Overweight on concerns over competition and valuation.
• "While we are not forecasting a deceleration in fundamentals for the telehealth industry, we see the TDOC story as now more of a show me story, particularly towards their long-term synergy targets," warns the firm.
• https://seekingalpha.com/news/3642061-teladoc-health-falls-2-after-stephens-calls-show-me-story

Aptose Biosciences falls after ASH presentation disappointment

 

• Oppenheimer updates on the investor event held by Aptose Biosciences (NASDAQ:APTO) at the ASH conference yesterday.
• Analyst Matthew Biegler: "Several CLL/NHL patients in CG-806's Phase 1 trial have shown tumor size reductions, although no objective responses were observed. Since EHA, dosing has escalated to 750 mg BID, but two of the three patients stopped treatment early due to AEs that we believe were likely unrelated to CG-806. Thus, the clinical body of evidence was smaller than we had hoped, and we have updated our model to reflect slightly prolonged development timelines and revised estimates. Early results from one FLT3+ patient showed clear evidence of peripheral blast reduction, which could bode well for CG-806’s development in AML."
• Oppenheimer keeps an Outperform rating on Aptose and the price target is cut to $8.00.
• See the Aptose presentation details.
• https://seekingalpha.com/news/3642069-aptose-biosciences-falls-27-after-ash-presentation-disappointment

Fate Therapeutics up after ASH presentation attracts attention

 

• Fate Therapeutics (NASDAQ:FATE) trades higher after a presentation over the weekend at the ASH conference on FT516 data.
• "Given the heavily pretreated nature of these patients, we believe FT516 played a dominant role in the combination’s activity, further de-risking iNK cells as a therapeutic modality. In our view, these data showcase the therapeutic potential of Fate's PSC-NK pipeline, and will likely attract additional investor interest," updates Oppenheimer analyst Matthew Biegler.
• The firm keeps an Outperform rating on Fate and boosts its price target to $70 from $60.
• https://seekingalpha.com/news/3642071-fate-therapeutics-jumps-9-after-ash-presentation-attracts-attention

India's Serum Institute seeks emergency use nod for AstraZeneca's COVID-19 vaccine

 

Serum Institute of India, the world's largest vaccine producer by volume, has sought emergency use authorization in the country for AstraZeneca Plc's COVID-19 vaccine on Sunday, according to several reports in Indian media, citing PTI.

The company applied to the Drugs Controller General of India, citing unmet medical needs due to the pandemic and in the interest of the public at large, the agency report said, citing official sources.

Serum was not immediately available to Reuters request for comment.

The move comes close on the heels of Pfizer Inc applying for a similar authorization of its coronavirus vaccine in India on Saturday..

"We remain committed to engaging with the Government of India and explore opportunities to make this vaccine available for use in the country," a Pfizer spokeswoman told Reuters.

Serum's application stated that data from four clinical studies, two in the UK and one each in Brazil and India, showed that the vaccine, Covishield, was highly effective against severe COVID-19 infections, the report said.

AstraZeneca's vaccine is logistically feasible for distribution in India since it could be stored at two to eight degrees Celsius.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/India-s-Serum-Institute-seeks-emergency-use-nod-for-AstraZeneca-s-COVID-19-vaccine-local-media-31950312/