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.
Apparently aimed a managing supply expectations as COVID-19 vaccine frontrunners move closer to key data readouts and potential emergency use authorizations, Moderna (MRNA -1.2%) discloses that it expects to produce ~20M doses of mRNA-1273 this year. Projections for next year, previously announced, are 500M – 1,000M doses.
Agenus (NASDAQ:AGEN) presents preliminary results from two clinical trials evaluating PD-1 inhibitor balstilimab in patients with recurrent/metastatic cervical cancer. The results were presented virtually at ESMO.
160-patient monotherapy trial showed overall response rates (ORRs) of 14% in all treated patients, 19% in PD-L1-positive patients and 10% in PD-L1-negative patients.
155-patient study of balstilimab + zalifrelimab (CTLA-4 inhibitor) showed an ORR of 22% in all patients, 27% in PD-L1-positive patients and 11% in PD-L1-negative patients.
Median duration of response (DOR) was 15.4 months in the monotherapy trial and had not been reached in the combo study.
Shares up 9% premarket.
Roche (OTCQX:RHHBY) announces the launch of a new test to quantitatively measure the level of coronavirus antibodies.
The Elecsys Anti-SARS-CoV-2 S antibody test would specifically target antibodies against the SARS-CoV-2 spike protein responsible for binding to the host cell receptor, which is required for the virus to enter the host cell.
The majority of current candidate vaccines aim to induce an antibody response against the spike protein.
“The new quantitative Elecsys antibody test can play a pivotal role in vaccine clinical trials as well as helping clinicians assess patients immune response,” said Thomas Schinecker, CEO.
It is the 12th test in Roche’s coronavirus portfolio and the company has filed for emergency use authorization from the FDA.
Shares have increased around 14% YTD. While Quant Rating is Neutral, Wall Street Analysts are Very Bullish with price target of $50.07.
Following up on their earlier announcement, Sanofi (NASDAQ:SNY) and collaboration partner GlaxoSmithKline (NYSE:GSK) have inked an agreement with the European Commission to supply up to 300M doses of their COVID-19 vaccine after approval.
The EU will provide upfront funding to support the scale-up of manufacturing capacity in Europe. The antigen and final vaccine doses will be made at sites in Belgium, Italy, Germany and France.
A Phase 3 clinical trial should launch by year-end. If all goes according to plan, a regulatory application will be submitted in H1 2021.
The companies, which have also inked supply deals in the U.S. and UK, aim to produce up to 1B doses per year.
Both stocks are up 1% premarket on light volume.
Generex Biotechnology (OTCQB:GNBT) and Bintai Kinden of Malaysia have agreed to collaborate for the development of the Ii-Key-CoV-2 vaccine for Malaysia.
Bintai will pay Generex an up-front licensing fee of $2.5M within two weeks, as well as $17.5M in milestone payment and Generex will earn royalties on sales of the vaccine equal to $3 per dose on government sales and $4.50 per dose in the private sector.
Bintai will have the right of first refusal for the Ii-Key-SARS-CoV-2 vaccine in Australia, New Zealand, and the global HALAL markets, particularly in Southeast Asia.
