Chinese COVID-19 vaccine maker eyes emergency use nod before studies wind up

Tianjin-based CanSino Biologics is reportedly in talks with several countries, apparently including Pakistan, some in Latin America and others, aimed at securing emergency approvals for its experimental COVID-19 vaccine despite large-scale late-stage testing that has yet to be completed.

China’s military has already signed off of the vaccine’s use.

According to SVP for international business Pierre Morgon, the vaccine did not show any serious safety signals while promoting an immune response in early-stage trials.

The race to regulatory approval in the most advanced countries is intense. Large-scale studies are underway or are about to start for leading contenders, including Pfizer/BioNTech, Moderna, AstraZeneca/University of Oxford and three from China: Sinovac, Wuhan Institute of Biological Products and Sinopharm/Beijing Institute of Biological Products.

Russia shocked the global medical community and regulators several weeks ago when President Vladimir Putin announced the approval of a COVID-19 vaccine, dubbed Sputnik V, that had only been tested in a small number of military personnel.

NIAID’s Dr. Anthony Fauci says the U.S. is unlikely to buy a Chinese or Russian vaccine over concerns with testing procedures.

https://seekingalpha.com/news/3609724-chinese-covidminus-19-vaccine-maker-seeking-emergency-use-nod-studies-wind-up

Enanta Pharma reports encouraging data on HBV and NASH candidates

Data from Enanta Pharmaceuticals’ (NASDAQ:ENTA) development programs for non-alcoholic steatohepatitis (NASH) and hepatitis B virus (HBV) will be virtually presented at the European Association for the Study of the Liver Annual Meeting.

Results from the Phase 1a clinical trial of EDP-514, a core inhibitor for HBV will be presented. Its NASH program will be discussed in an oral presentation detailing the Phase 2a ARGON-1 study of EDP-305 and two posters highlighting preclinical data on EDP-297, a follow-on FXR agonist.

The first-in-human Phase 1a study of EDP-514, demonstrated strong safety, tolerability and pharmacokinetic profile, which will help to further advance HBV program into two ongoing Phase 1b clinical studies.

The Phase 2a ARGON-1 study’s primary endpoint was achieved with a statistically significant alanine transaminase reduction of 28 U/L in the EDP-305 2.5mg arm versus 15 U/L in the placebo arm at week 12 (p=0.049).

Reduction in liver fat was also observed at the 2.5mg dose. Strong target engagement as shown by reductions in C4 and increases in FGF-19 and alkaline phosphatase was also seen.

Overall, EDP-305 was generally safe, with mild to moderate adverse events. However, there was a higher frequency of treatment discontinuation in 2.5mg dose compared to the 1mg or placebo.

Preclinical data for follow-on FXR Agonist EDP-297 targeting NASH demonstrated potent anti-fibrotic, anti-inflammatory and hepatoprotective effects.

Here are some of the other companies presenting at the Conference: Eiger BioPharmaceuticals (NASDAQ:EIGR), Adaptimmune (NASDAQ:ADAP), Arrowhead Pharmaceuticals (NASDAQ:ARWR), Intercept Pharmaceuticals (NASDAQ:ICPT), NGM Biopharmaceuticals and Viking Therapeutics.

https://seekingalpha.com/news/3609694-enanta-pharma-reports-encouraging-data-on-hbv-and-nash-candidates

Trevena up as Cantor joins bullish analysts on opioid promise

Trevena (NASDAQ:TRVN) finished after-hours trading up 6.4% after Cantor Fitzgerald initiated coverage at Overweight, pegged to promise in the company’s new painkiller.

It’s hard to get an approval for new opioids, analyst Brandon Folkes says, but Trevena’s new offering Olinvyk is “sufficiently differentiated” to make a mark.

“While Olinvyk does not have label claims over morphine safety we believe the data generated to date will be sufficient for hospitals, ambulatory surgical centers as well as other early targets to begin usage of Olinvyk on its elderly, obese and complex patients,” he writes.

He’s joining other analysts with a $5 price target, implying 218% upside.

https://seekingalpha.com/news/3609632-trevenaplus-6_4-cantor-joins-bullish-analysts-on-opioid-promise

Sanofi to launch tender offer for Principia buyout

Sanofi (NASDAQ:SNY) intends to commence a tender offer to acquire all of the outstanding common shares of Principia Biopharma for $100/share in cash, representing equity value of ~$3.68B.

The offer is scheduled to expire on September 25.

The company agreed to buy Principia Bio earlier in August.

https://seekingalpha.com/news/3609647-sanofi-to-launch-tender-offer-for-principia-buyout

Assembly Bio HBV core inhibitors show positive action in studies

Assembly Biosciences (NASDAQ:ASMB) announces clinical data on lead HBV core inhibitor vebicorvir (ABI-H0731) and second-generation core inhibitor ABI-H2158. The results were virtually presented at the European Association for the Study of the Liver (EASL) Annual Meeting.

Vebicorvir, combined with nucleos(t)ide reverse transcriptase inhibitor (NrtI) therapy in patients with HBeAg-negative chronic hepatitis B virus (HBV) infection showed a significant benefit. Specifically, 30% of patients in the mid-stage 211 study who were virologically suppressed at baseline had evidence of residual viral replication as determined by the company’s highly sensitive HBV DNA test despite long-term NrtI therapy (median duration four years). The addition of vebicorvir resulted in almost all patients reaching undetectable levels of HBV DNA. About 88% of study participants will achieve the stopping criteria and will be taken off therapy to be assessed for sustained virologic response (SVR). Vebicorvir continues to show a favorable safety profile.

It second-generation core inhibitor, ABI-H2158, showed 10x greater potency against covalently closed circular DNA (cccDNA), a certain DNA structure that arises from the propagation of HBV, than vebicorvir in preclinical testing. It also showed a favorable safety profile in a Phase 1b dose-ranging study.

https://seekingalpha.com/news/3609685-assembly-bio-hbv-core-inhibitors-show-positive-action-in-studies

FDA OKs Roche pan-tumor liquid biopsy test

The FDA approves Roche (OTCQX:RHHBY) unit Foundation Medicine’s FoundationOne Liquid CDx, a comprehensive pan-tumor liquid biopsy test for solid tumors. The genomic profiling test analyzes more than 300 cancer-related genes and multiple genomic signatures based on circulating cell-free DNA in a blood sample using massively parallel sequencing to detect the four main classes of genomic alterations.

It is also approved as a companion diagnostic for Clovis Oncology’s (NASDAQ:CLVS) PARP inhibitor Rubraca (rucaparib) for certain prostate cancer patients and three first-line tyrosine kinase inhibitors for non-small cell lung cancer.

https://seekingalpha.com/news/3609673-fda-oks-roche-pan-tumor-liquid-biopsy-test

Moderna in talks to supply 40M doses of COVID-19 vaccine to Japan August 28, 2020

Moderna (NASDAQ:MRNA) confirms that it is in discussions with Japan’s Ministry of Health, Labor and Welfare for the potential purchase of 40M or more doses of COVID-19 vaccine mRNA-1273.

Under the terms of the proposed agreement, it will supply the product and Takeda Pharmaceutical Co., Ltd. (NYSE:TAK) will distribute beginning in H1 2021, if the vaccine is approved.

https://seekingalpha.com/news/3609676-moderna-in-talks-to-supply-40m-doses-of-covidminus-19-vaccine-to-japan