RepliCel Life Sciences Inc (TSXV:RP)
RepliCel is a regenerative medicine company developing autologous cell therapies that address diseases caused by a deficit of healthy cells required for normal healing and function.
Moderna (NASDAQ:MRNA) gains 3% after Canada doubled down on its order for the company’s COVID-19 vaccine candidate, which is currently undergoing the rolling review process there.
After exercising the option for another 20 million doses, the Canadian Government has increased its confirmed order commitment to 40 million doses of mRNA-1273.
Subject to regulatory approval, Moderna is on track to deliver the vaccine as soon as December from the company’s European production facility.
The company is seeking emergency use authorization in the United States and the European Union after initial data from a large late-stage trial indicated 94.1% efficacy with no serious safety concerns.
CEO Stephane Bancel says the company is committed to supplying 500M doses of the vaccine in 2021.
AbbVie (NYSE:ABBV) announces results from a long-term integrated analysis of two Phase 3 clinical studies (RESONATE-2 and iLLUMINATE) and additional pooled analysis evaluating the effect of IMBRUVICA (ibrutinib) based therapies for the first-line treatment of high-risk patients with chronic lymphocytic leukemia (CLL)/Small Lymphocytic Lymphoma (SLL).
In RESONATE-2, patients aged ≥65 years without del(17p) were randomized to single-agent IMBRUVICA or chlorambucil.
In iLLUMINATE, patients aged ≥65 years, or <65 years with coexisting conditions or del(17p)/TP53 mutation, were randomized to IMBRUVICA plus obinutuzumab or chlorambucil plus obinutuzumab.
The integrated analysis included 498 patients treated with first-line IMBRUVICA-based or chlorambucil-based therapy (n=249 each) with a median follow-up of 49.1 months.
At 42 months, PFS rates were higher across high-risk genomic subgroups in patients treated with IMBRUVICA (63 to 82%) compared to those receiving chlorambucil with or without obinutuzumab (6 to 34%), and consistent PFS benefit with IMBRUVICA was observed across all high-risk genomic subgroups.
When comparing IMBRUVICA-treated patients with specific high-risk genomic features vs. those without, results showed that PFS and ORR were comparable in the different subgroups, including patients with unmutated vs. mutated immunoglobin heavy chain variable (PFS Hazard Ratio [HR], 1.79, 95% Confidence Interval [CI] 0.99-3.24) or mutated vs. not mutated NOTCH1 (PFS HR, 1.05, 95% CI 0.65-1.69).
Results also showed improved outcomes for patients with del(17p)/TP53 mutated/BIRC3 mutated, the highest risk category (HR 1.05, 95% CI 0.54-2.04).
At a median duration of 35.7 to 43.8 months, no meaningful differences in the rates of treatment-emergent AEs of any grade were seen.
Additionally, a pooled analysis across four studies with up to 8 years of follow-up showed that IMBRUVICA-based therapies resulted in sustained, long-term efficacy with high 4-year PFS rates in high-risk CLL patients, defined as del(17p) or TP53 gene mutations.
At 48 months, the PFS rate was 79% among these high-risk patients treated with IMBRUVICA-based therapy, median duration was 46 months.
The data were presente at the virtual 2020 ASH Annual Meeting.
Progressive Care (OTCQB:RXMD) reports October consolidated net sales $3.3M, up 7% M/M.
October margins increased to 27%, thereby raising cash on hand by 53%.
Prescriptions filled during October grew 1% on a sequential monthly basis.
340B pharmacy dispensing fees grew 119% in October on a year-over-year basis.
The Company booked nearly $100K in revenues related to rapid results COVID-19 testing in October.
“October was another strong month characterized by expanding margins and strong execution,” commented Alan Jay Weisberg, CEO and Chairman of Progressive Care. “We have secured a market-leading position in COVID-19 testing in Dade County and we look forward to becoming a major provider of COVID-19 vaccines next year.”
Bayer (OTCPK:BAYZF), Atara Biotherapeutics (NASDAQ:ATRA) have entered into an exclusive worldwide license agreement, for mesothelin-directed CAR T-cell therapies for the treatment of solid tumors.
The agreement includes ATA3271, an allogeneic T-cell immunotherapy, and an autologous version, ATA2271, for high mesothelin-expressing tumors.
Atara will lead investigational new drug-enabling (IND) studies, process development for ATA3271 T-cell immunotherapy candidate, and will get upfront payment of $60M as well as is eligible for $610M in milestone payments.
Bayer will be responsible for submitting IND and subsequent clinical development and commercialization
Atara will provide translational and clinical manufacturing services to be reimbursed by Bayer.
For a limited period of time, Bayer has a non-exclusive right to negotiate license for additional Atara CAR T product candidates.
Atara shares are up 12% in premarket, and it will host a conference call today at 8:30 a.m ET.
Xencor (NASDAQ:XNCR) has entered into a research collaboration and license agreement with Janssen Biotech to focus on the discovery of XmAb bispecific antibodies against CD28, an immune co-stimulatory receptor on T cells, and an undisclosed prostate tumor target, for the potential treatment of patients with prostate cancer.
The company receives $50M upfront payment and is eligible to receive potential milestone payments and a royalty on net sales from commercialized medicines
Under the terms of the agreement, Xencor will apply its XmAb bispecific Fc technology to create and characterize XmAb CD28 bispecific antibody candidates against the tumor target specified by Janssen.
Preclinical activities and all clinical development, regulatory and commercial activities will be conducted by Janssen, which has exclusive worldwide rights to develop and commercialize the novel drug candidates.
