PDS Biotech teams up with Farmacore on COVID-19 vaccine

PDS Biotechnology (NASDAQ:PDSB) inks an agreement with Farmacore Biotechnology to co-develop a COVID-19 vaccine.

The candidate, dubbed Versamune-CoV-2FC, combines PDS’s Versamune platform with Farmacore’s recombinant SARS-CoV-2 protein.

Under the terms of the deal, Farmacore retains commercialization rights in Latin America while revenue there will be shared. PDS retains the right of first refusal for commercialization rights ex-Latin America. Specific financial terms are not disclosed.

PDS is in talks with governmental and non-governmental agencies about additional funding for the vaccine.

A Phase 1 study in Brazil is next up.

https://seekingalpha.com/news/3583779-pds-biotech-teams-up-farmacore-on-covidminus-19-vaccine

Dosing underway in Akero’s expanded cohort of Balanced trial in NASH

Akero Therapeutics (AKRO +1.6%) doses first subject in Cohort C, the expansion of its Phase 2a BALANCED trial, which will enroll 30 subjects who have non-alcoholic steatohepatitis (NASH) with compensated cirrhosis (F4), Child-Pugh Class A.

The primary objective of Cohort C is to assess safety and tolerability of treatment with AKR-001 in NASH patients at greatest risk of progressing to end-stage liver disease.

AKR-001 is an engineered human Fc-FGF21 fusion protein designed to induce the benefits of the endogenous hormone FGF21 which can potentially reduce liver fat, mitigate inflammation and reverse fibrosis. It is administered once per week via subcutaneous injection.

The company on Jan. 31, expanded the Phase 2a trial in NASH to include cohort of cirrhotic patients.

https://seekingalpha.com/news/3583799-dosing-underway-in-akeros-expanded-cohort-of-balanced-trial-in-nash

BioMarin gene therapy shows durable long-term effect in hemophilia A study

Updated data from an open-label Phase 1/2 clinical trial evaluating BioMarin Pharmaceutical’s (BMRN +1.9%) gene therapy valoctocogene roxaparvovec in patients with severe hemophilia A showed a sustained benefit from a single administration. The results were presented at the World Federation of Hemophilia Virtual Summit.

At data cutoff on April 8, six participants who were previously on Factor VIII (FVIII) prophylaxis in the 6e13 vg/kg cohort experienced sustained reductions in bleeding episodes that required FVIII infusions. In the year prior to receiving the gene therapy, the mean annualized bleed rate (ABR) was 16.3 while the median was 16.5. During the four years post treatment, cumulative mean ABR dropped 95% to 0.8. In year 4, mean ABR was 1.3 while the median was zero. FVIII usage dropped 96% to 5.4 infusions per year cumulatively over four years compared to 135.6 infusions/year at baseline. Six of seven subjects were bleed-free in year 4 and all remain off FVIII prophylaxis therapy.

At the end of year 4, mean FVIII activity levels were 24.2 IU/dL or 35.4 IU/dL, depending on the test used. Median FVIII levels were 16.4 IU/dL or 23.4 IU/dL (normal range is 50 – 150 IU/dL. Hemophilia A is defined as levels below 50).

Six patients in the 4e13 vg/kg cohort experienced similar benefits. In the year prior to treatment, mean and median ABR were 12.2 and 8.0, respectively. After treatment, cumulative mean ABR dropped 93% to 0.9 during the three-year follow-up period. During year 3, mean ABR was 0.5 and median was zero. Four of six participants were bleed-free and five of six experienced no spontaneous bleeds. Mean Factor VIII usage dropped 96% to 5.7 infusion per year over three years from a baseline of 142.8 infusions per year.

At the end of year 3, mean FVIII levels were 9.9 IU/dL or 14.9 IU/dL depending on the test used. Median FVIII levels were 7.9 IU/dL or 12.3 IU/dL.

The company will host a webinar today at 5:00 pm ET to discuss the data.

https://seekingalpha.com/news/3583790-biomarin-gene-therapy-shows-durable-long-term-effect-in-hemophilia-study

Adial Pharma on go with late-stage study of lead drug in alcohol use disorder

After the long COVID-19 lockdown, Adial Pharmaceuticals (ADIL +0.7%) has launched its Latvia-based Phase 3 clinical trial, ONWARD, evaluating lead candidate AD04 (ondansetron) in people with alcohol use disorder (AUD).

Two Latvian sites would be active immediately while a third will be added shortly.

Ondansetron is a selective serotonin-3 antagonist. It was originally marketed by GlaxoSmithKline for the treatment of chemotherapy-induced nausea and vomiting.

Previously: Adial Pharma verifies companion diagnostic for substance abuse med AD04 (April 16)

https://seekingalpha.com/news/3583814-adial-pharma-on-go-late-stage-study-of-lead-drug-in-alcohol-use-disorder

One Medical and MedStar Health team up to offer coordinated care

1Life Healthcare’s One Medical (ONEM -2.5%) has selected MedStar Health as its new preferred health system partner in Maryland and the Washington, D.C.

Through One Medical’s primary care platform, members can access MedStar Health’s network of specialists, ambulatory facilities and hospitals in the region.

Both organizations intend to expand their presence across the region to provide coordinated care across primary and specialty care settings.

https://seekingalpha.com/news/3583919-one-medical-and-medstar-health-team-up-to-offer-coordinated-care

FDA yanks emergency use authorization of Chembio COVID-19 blood test

Citing concerns with accuracy, the FDA has revoked the emergency use authorization of Chembio’s (NASDAQ:CEMI) DPP COVID-19 IgM/IgG System, its SARS-CoV-2 antibody test.

Data submitted by the company and results from an independent evaluation of the test showed a higher-than-expected rate of false results that was higher than the device’s labeling.

The FDA OK’d the emergency use of the test on April 15.

https://seekingalpha.com/news/3583676-fda-yanks-emergency-use-authorization-of-chembio-covidminus-19-blood-test

Ipsen’s Onivyde Fast Track’d for combo treatment for pancreatic cancer

The FDA has granted Fast Track designation for Ipsen’s (OTCPK:IPSEY) investigational use of liposomal irinotecan (ONIVYDE) in combination with 5-fluorouracil/leucovorin (5-FU/LV) and oxaliplatin (OX), together known as NALIRIFOX, for patients with previously untreated, locally advanced and metastatic pancreatic ductal adenocarcinoma (PDAC).

Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.

The final analysis from the Phase 1/2 study will be presented at the virtual ESMO World Congress on Gastrointestinal Cancer on July 1.

Ipsen has exclusive commercialization rights for the current and future indications for ONIVYDE in U.S. Servier, an international pharma company, and is responsible for the commercialization outside the U.S. and Taiwan.

https://seekingalpha.com/news/3583673-ipsens-onivyde-fast-trackd-for-combination-treatment-for-pancreatic-cancer