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Tuesday, July 14, 2020

Eisai, Biogen launch Phase 3 BAN2401 program in asymptomatic Alzheimer’s

Eisai (OTCPK:ESALF), in collaboration with Alzheimer’s Clinical Trials Consortium and Biogen (NASDAQ:BIIB), has initiated a new global Phase 3 clinical study (AHEAD 3-45) with BAN2401, an anti-amyloid beta (Aβ) protofibril antibody.
The study will evaluate the therapeutic effect of BAN2401 on the progression of Alzheimer’s disease in individuals in preclinical (asymptomatic) stages of the disease.
The AHEAD 3-45 program consists of two trials, A3 and A45, which aim to evaluate the potential of BAN2401 to reduce accumulation of harmful amyloid beta aggregates in the brain and prevent cognitive decline.
A total of 1400 participants will be enrolled in the study.

Celyad up on advancement of CAR-T candidate CYAD-211

The FDA has signed off on Celyad Oncology SA’s (NASDAQ:CYAD) IND for a Phase 1 clinical trial evaluating lead off-the-shelf short hairpin RNA-based allogeneic CAR-T candidate CYAD-211.
The study, in relapsed/refractory multiple myeloma patients, should launch by year-end.

Karyopharm sees Q2 Xpovio sales of $18.5M

Karyopharm Therapeutics (NASDAQ:KPTI) expects preliminary Q2 net product sales for XPOVIO (selinexor) to be ~$18.5M, (+15% Y/Y), topping Bloomberg’s average estimate of $17.5M (range $17M to $19M).
Prescription refill rates, as well as the average number of prescriptions per patient, continued to grow during the quarter.
Additionally, recently, the FDA has granted accelerated approval of XPOVIO for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma.
The company expects to report Q2 results in early August.

Rigel launches fostamatinib trial in patients with COVID-19 pneumonia

July 14, 2020

Rigel Pharmaceuticals (NASDAQ:RIGL) jumps 18% after initiating an investigator-sponsored trial (IST) being conducted by Imperial College London to evaluate the efficacy of fostamatinib, its oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of COVID-19 pneumonia.
SYK is a key mediator of immunoreceptor signaling in a host of inflammatory cells. By inhibiting SYK, fostamatinib may specifically inhibit the infiltration and activation of monocytes and neutrophils in the lungs that are prominent in COVID-19.
The IST will be a two-stage trial with patients randomized (1:1:1) to fostamatinib, ruxolitinib, or standard of care. The primary objective will be to determine the efficacy of fostamatinib and ruxolitinib compared to standard of care to reduce the proportion of hospitalized patients progressing from mild or moderate to severe COVID-19 pneumonia.
Rigel will provide support for this trial along with Novartis.
On another note, researchers in Massachusetts recently screened 3,713 FDA-approved compounds that reduce the abundance of a protein called mucin-1 (MUC1), a biomarker to predict the development of acute lung injury and acute respiratory distress syndrome. Fostamatinib was the only one that qualified, demonstrating preferential depletion of MUC1 from epithelial cells without affecting cell viability.
The company markets fostamatinib in the U.S. under the band name Tavalisse for chronic immune thrombocytopenia.

AstraZeneca teams up with Iqvia to speed advancement of COVID-19 vaccine

AstraZeneca (NYSE:AZN) will collaborate with contract research services and advanced analytics provider IQVIA (NYSE:IQV) under the U.S. government’s Operation Warp Speed to accelerate the delivery of U.S. clinical trials evaluating COVID-19 vaccine candidate AZD1222.
Enrollment will launch this summer in an expansive subject study leveraging IQV’s Virtual Trial solutions including Study Hub.
Financial terms are not disclosed.

Early-stage study underway on COVID-19 vaccine with Dynavax adjuvant

Dynavax Technologies (NASDAQ:DVAX) jumps 10% premarket on modest volume in reaction to its announcement that dosing is underway in a Phase 1 clinical trial evaluating Medicago’s plant-derived COVID-19 vaccine candidate that includes its CpG 1018 adjuvant (also used in HEPLISAV-B).
As previously reported, the companies plan to explore a broader collaboration aimed at other opportunities.

Flexion Therapeutics sees Q2 Zilretta sales of $15.4M

Flexion Therapeutics (NASDAQ:FLXN) announces preliminary Q2 ZILRETTA net sales of $15.4M, vs. Q2 total sales consensus of $9.97M.
Demand for ZILRETTA increased month-over-month throughout Q2 with purchases by healthcare providers reaching 4,863 units, 13,547 units and 18,287 units in April, May and June, respectively, with total demand in line with Q1.
In addition, the Company also plans to recommence ZILRETTA manufacturing in Q4.
Flexion expects to report its complete Q2 results in August.