- Precision BioSciences (NASDAQ:DTIL) announces positive interim results from its Phase 1/2a study of PBCAR0191, an off-the-shelf allogeneic CAR T cell therapy investigational candidate targeting CD19 for the treatment of patients with relapsed/refractory non-hodgkin lymphoma (R/R NHL) and R/R b-cell acute lymphoblastic leukemia (B-ALL).
- As of the November 16 cutoff, 27 patients including 16 patients with aggressive NHL and 11 patients with aggressive B-ALL were enrolled and evaluated. Response rates across both the cohorts were as follows:
- PBCAR0191 with enhanced lymphodepletion resulted in objective response rate (ORR) of 83% (5/6) in NHL and B-ALL.
- At day 28 or later, 75% (3/4) of NHL patients achieved a complete response (CR).
- Meanwhile, 33% of NHL patients (n=9) across DL2 and DL3 using standard lymphodepletion achieved a CR.
- 63% of NHL patients across DL1 achieved CR.
- The longest demonstrated response was > 11 months in a B-ALL patient at DL2.
- PBCAR0191 demonstrated a clear dose dependent increase in peak cell expansion.
- Compared to single standard lymphodepletion, enhanced lymphodepletion regimen with PBCAR0191 at DL3 resulted in approx. 95-fold increase in peak cell expansion, and approx. 45-fold increase in area under the curve.
- This was associated with a higher complete response rate in NHL (75%).
- PBCAR0191 had an acceptable safety profile with no cases of GvHD, no cases of Grade ≥ 3 CRS, and no cases of Grade ≥ 3 ICANS.
- Precision hosted a conference call and webcast today at 8:00 a.m. ET to discuss the updated interim clinical data and the learnings for PBCAR0191 from both the cohorts.
- https://seekingalpha.com/news/3641653-precision-bio-rises-6-on-positive-pbcar0191-data-in-blood-cancers
- Cortexyme (NASDAQ:CRTX) announces that, following an interim analysis by the independent Data Monitoring Committee (DMC), the Phase 2/3 clinical trial, GAIN, evaluating lead candidate atuzaginstat (COR388) in patients with mild-to-moderate Alzheimer's disease (AD) will continue unmodified to the one-year time point.
- The DMC's analysis was based on 300 participants who had reached six months of treatment.
- Topline data from the fully enrolled population of 643 subjects should be available in a year. The co-primary endpoints are the changes from baseline to week 48 in two AD scales called ADAS-Cog 11 and ADCS-ADL versus placebo. Secondary endpoints include additional efficacy measures.
- Atuzaginstat targets toxic protease enzymes, or gingipains, produced by a bacterium called Porphyromonas gingivalis (P. gingivalis), an oral pathogen that causes gum disease. The bacterium releases gingipains when it invades the brain. Results from nerve cell cultures showed that atuzaginstat and proprietary gingipain inhibitors protected neurons infected with the bacterium from synapse loss while reducing bacterial load in infected neurons, astrocytes and microglia and protecting against deficits in other pathways impacted by the pathogen.
- Management hosts a conference call this morning at 8:30 am ET to discuss the tollgate.
- https://seekingalpha.com/news/3641654-late-stage-study-of-cortexymes-alzheimers-med-atuzaginstat-passes-interim-tollgate
- Staying on script, sell-side analysts are on board with Moderna's (NASDAQ:MRNA) mRNA-1273, expected to receive an FDA emergency use nod this month followed by a thumbs up in Europe next month.
- Jefferies' Michael Yee says antibody levels remain high beyond three months and the trajectory continues to support likely protection against SARS-Cov-2 for about a year, in line with expectations. He sees supply constraints in H1 2021 but believes most Americans who want to be vaccinated should be able to do so by the summer. Investors continue to be concerned about supply issues after Pfizer's (NYSE:PFE) announcement yesterday that supply chain hurdles will constrain 2020 shipments of BNT162b2.
- Piper Sandler analysts expect positive opinions from the FDA panel meeting on the 17th and the meeting in Europe on January 12 by the advisory group CHMP.
- Investors clearly agree. Shares are up 704% this year.
- MRNA is up 1% premarket on light volume.
- Related tickers: (NASDAQ:BNTX) (-1%), (NYSE:JNJ) (+1%), (NASDAQ:AZN) (+1%)
- https://seekingalpha.com/news/3641671-sell-siders-bullish-on-moderna-covidminus-19-vaccine
- Chembio Diagnostics (NASDAQ:CEMI) is down 13% premarket on increased volume in response to its disclosure that the FDA will not prioritize its application for emergency use authorization (EUA) of its DPP SARS-CoV-2 IgM/IgG antibody blood test that is performed on its DPP Micro Reader.
- In a letter delivered to the company yesterday, the agency stated that, given the volume of EUA requests, it is prioritizing its review of the filings based on a range of factors such as the public health need for the product and its availability. In the case of the antibody combo test, it believes that authorization of the assay would have relatively limited impact on testing accessibility or capacity so it will not review the application at this time.
- Unsurprisingly, the company believes otherwise and plans to work with the agency to get its application into the review queue, adding that the response letter does not apply to its application for the DPP SARS-CoV-2 Antigen test system filed in October.
- https://seekingalpha.com/news/3641681-chembio-slumps-13-on-delay-of-u-s-nod-for-coronavirus-antibody-test
- Eli Lilly (NYSE:LLY) will team up with UnitedHealth Group (NYSE:UNH) on a pragmatic study of bamlanivimab (LY-CoV555) in a large diverse population of high-risk COVID-19-infected people.
- A pragmatic study is designed to assess the effectiveness of an intervention in real-life practice conditions.
- The large-scale study will draw on UNH's health benefits business and its Optum health services business to detect and treat high-risk symptomatic patients who test positive for COVID-19, including daily symptom tracking, in-home SARS-CoV-2 testing and in-home infusion services. Bamlanivimab will be administered via home infusions to allow for quarantining.
- Medicare Advantage members who meet FDA-authorized criteria for treatment will be invited to volunteer for the study through United in Research, UNH's virtual community and technology platform for citizen scientists.
- Those who volunteer and are in an area where they can receive treatment will be directed to download Optum's symptom-checking ProtectWell app and complete a daily questionnaire. Participants experiencing symptoms of COVID-19 will take an in-home SARS-CoV-2 test which they will self-administer and return. Those that are COVID-19 positive will receive outreach from an Optum Infusion Pharmacy nurse to schedule a home infusion treatment of bamlanivimab.
- The study will enroll up to 500,000 people, with at least 5,000 people expected to receive bamlanivimab therapy.
- The FDA signed off on emergency use of the antibody on November 9 for pediatric and adult patients with mild-to-moderate symptoms.
- https://seekingalpha.com/news/3641707-lilly-partners-unitedhealth-on-real-world-study-of-covidminus-19-med-in-diverse-high-risk
- November nonfarm payrolls: +245K vs. +500K consensus and +610K previous (revised from +638K).
- Unemployment rate: 6.7% vs. 6.8% consensus and 6.9% prior.
- The job report illustrates the continuing slowdown in the recovery as the number of COVID-19 cases increases across the country.
- In November, notable job gains occurred in transportation and warehousing, professional and business services, and health care. Employment declined in government and retail trade.
- 10.7M people are unemployed, 4.9M higher than in February.
- In November the number of long-term unemployed increased by 385K to 3.9M, accounting for 36.9% of the total unemployed.
- Labor force participation rate edged down to 61.5% from 61.7% in October; down from 63.2% in November 2019.
- Average hourly earnings for all employees on private nonfarm payrolls increased to $29.58 from $29.49; that's up from $28.34 a year ago.
- Unemployment rate by specific groups: adult women 6.1%, down from 6.5% in October; adult men 6.7%, unchanged M/M; White 5.9% vs. 6.0% in October; Black or African American 10.3% vs. 10.8%; Hispanic or Latino ethnicity 8.4% vs. 8.8%; Asian 6.7% vs. 7.6%.
- https://seekingalpha.com/news/3641692-november-jobs-gain-of-245k-slows-from-610k-in-october-and-misses-estimates-for-500k
