Covid-19 roundup: Manufacturing contract axed for Valneva’s vaccine; Penny stock halts early infection trial
French vaccine company Valneva and German CDMO IDT Biologika have decided to terminate their manufacturing collaboration for Valneva’s Covid-19 vaccine.
IDT Biologika was originally tasked with making Valneva’s VLA2001 vaccine, but the deal has been halted due to “the delivery of inactivated Covid-19 bulk vaccine to Valneva.” A statement from Valneva also lists a lack of orders and sufficient inventory as the other reasons.
With the manufacturing of the vaccine suspended, Valneva will pay €36.2 million ($35.8 million) to IDT in compensation along with €4.5 million ($4.4 million) for purchasing specialized equipment.
Valneva will continue to deliver doses of the vaccine to EU member states that had already ordered it and will keep inventory on hand in case of any uptick in demand. Valneva also said that it is reaching out to different nations across the world to ship its remaining eight to 10 million doses over the next year.
The company had initially signed a purchasing agreement with the EU last year to supply 60 million doses. In the summer, however, the EU changed its purchase to around 1.25 million doses.
Penny stock biotech’s Phase II/III trial for early Covid-19 infection fails to reach primary endpoint
Well into the penny stock zone, Adamis Pharmaceuticals has hit a major roadblock for its Covid-19 treatment.
The San Diego biotech announced Wednesday its Phase II/III clinical trial evaluating the risk of using Tempol in high-risk patients with an early Covid-19 infection had failed to hit the primary endpoint of “sustained clinical resolution” by day 14.
The Data Safety Monitoring Board (DSMB) also recommended that the trial be shut down due to a lack of efficacy. While Adamis emphasized that no safety concerns were raised, it will put a hold on the trial and figure out Tempol’s next move. According to ClinicalTrials.gov, 248 patients participated in the trial.
“We are obviously disappointed that the study did not meet its endpoints. Much of the preclinical work on Tempol for COVID-19 examined the effects of the drug on severe illness. This trial did not meet its primary endpoint, but we are exploring the possibility that vaccinations and the less virulent variants (Omicron) during the trial period may have obscured an effect of Tempol,” said Adamis CMO Ron Moss in a statement.
Investors will not be happy as the company’s stock price has already dropped even further into the penny stock nebula, where it has been since 2019. The price $ADMP has dropped 44% since Wednesday’s market opening to $.20, marking an 80% drop since September last year.