Briefs

WHO, International Regulatory Authorities Promote COVID-19 Cooperation

The World Health Organization (WHO) and the International Coalition of Medicines Regulatory Authorities said in a statement late last week that they are committed to ensuring that “rigorous scientific standards” are upheld while seeking “safe, early and equitable COVID-19 treatments.”

The international bodies said they hope to align regulatory processes among members to speed the development and distribution of COVID-19 medicines.

Regulatory approval “should be based on an independent scientific assessment of the balance of benefits and risks,” they said in a joint statement.

FDA Seeks Public Comment on REMS Program

The FDA is seeking public comments on a proposed plan to release information on how drugmakers are doing in their implementation of Risk Evaluation and Mitigation Strategy (REMS) programs.

Under a REMS program, the agency requires manufacturers to implement specific postmarket safety measures and to send periodic assessments to the agency for review. Currently, the FDA’s reviews may only be publicly accessed through a Freedom of Information Act request.

The agency is considering changing its policy to make its internal reviews and manufacturer assessments public. The comments are due to the FDA by Jan. 4.

Sanofi Halts Trial Evaluating Hemophilia Drug

Sanofi has halted a global phase 3 trial evaluating its investigational hemophilia drug fitusiran after reports of adverse events.

Fitusiran is a once-monthly, subcutaneously administered drug designed to treat hemophilia A and B by blocking antithrombin, a protein that inhibits blood clotting and causes excessive bleeding.

Sanofi halted the study following a recommendation by the trial’s independent data monitoring committee. The company said it is investigating reports of nonfatal thrombotic events in trial participants.

Vifor Secures Kidney Drug Licensing Deal With Angion for $80 Million

Switzerland’s Vifor Pharma has forged an $80 million deal with Uniondale, N.Y.-based Angion for the international licensing rights to its investigational kidney drug ANG-3777.

Designed to activate the body’s natural organ-repair process, ANG-3777 is meant to improve kidney function following organ transplant as well as in kidney injury associated with complications from heart surgery.

Under the licensing deal, Vifor Pharma will gain worldwide rights except in China, Taiwan, Hong Kong and Macau.

Angion will receive up to $80 million and an additional $260 million in milestone payments for U.S. and EU regulatory approvals.

ImmunityBio, NantKwest Release Positive Phase 1 Data for COVID-19 Vaccine

ImmunityBio and NantKwest have reported that their COVID-19 vaccine candidate induced neutralizing antibodies and T-cell responses against both the SARS-CoV-2 spike protein and the nucleocapsid proteins that surround the core structure of the virus.

There were no serious adverse events in the low-dose arm of the phase 1 study, the companies said. But the vaccine’s safety is still being assessed in the high-dose cohort.

The early-stage trial at Hoag Hospital in Newport Beach, Calif., included just 20 volunteers.

Based on the promising early results, the companies plan to launch late-stage trials that will include volunteers previously infected with SARS-CoV-2.

EU Seeks Independent Experts for Drug Safety Committee

The European Commission is seeking independent scientific experts to join the European Medicines Agency’s (EMA) advisory committee on the safety of medicines.

The Pharmacovigilance Risk Assessment Committee (PRAC) plays a prominent advisory role to the EMA. It recently began a review of acute kidney injuries reported in some COVID-19 patients being treated with Gilead Sciences’ antiviral remdesivir.

PRAC members serve three-year terms and the incoming panel is scheduled to begin on July 2, 2021. Expressions of interest in joining the expert panel are due by Nov. 20.

Johnson & Johnson Restarts COVID-19 Vaccine Trials in Europe

Johnson & Johnson (J&J) announced that it has restarted all clinical trials in Europe evaluating its COVID-19 vaccine, Ad26.COV2.S, following a pause last month to investigate an adverse event.

The clinical trials resuming in Europe this week are phase 2 studies in Germany, the Netherlands and Spain, as well as a phase 1/2 study in Belgium, the company said. 

Ad26.COV2.S is derived from a common cold virus that is modified to carry a gene from the SARS-CoV-2 virus which causes COVID-19, prompting the immune system to develop resistance to the virus.

J&J, which is also conducting a global phase 3 trial in 60,000 participants, plans to launch a separate phase 3 trial evaluating a two-dose regimen across several countries in Europe.

Moderna Reports Positive Results from Cancer Vaccine Trial

Moderna has released promising early results from a small phase 1 trial of its experimental personalized cancer vaccine, mRNA-4157, in combination with Merck’s Keytruda (pembrolizumab).

The study enrolled 10 patients with human papillomavirus- (HPV) negative head and neck cancer and 17 colorectal cancer patients. The combination of mRNA-4157 and Keytruda was “well-tolerated at all dose levels” and induced tumor shrinkage in the head and neck cancer group, but no response in the colorectal cancer patients, the Cambridge, Mass., drugmaker said.

Moderna says it plans to expand enrollment for HPV-negative head and neck cancer patients.