Clinical catch-up: Pfizer-BioNTech’s Comirnaty vaccine moves closer to full approval and more

The past week has seen promising developments in candidate therapies for cancer, congenital hyperinsulinism, chronic cough and COVID-19 vaccines. For that and more news, read on.

CHMP recommends full authorization of Comirnaty vaccine from Pfizer-BioNTech

The Committee for Medicinal Products for Human Use of the European Medicines Committee (CHMP) approved the conversion of the conditional marketing authorization for Pfizer and BioNTech‘s Comirnaty vaccine has standard or full marketing authorization for all of its authorized formulations and indications.

The recommendation is still subject to review by the European Commission before its observations can be declared final.

The CHMP opinion is based on current safety and efficacy data showing that the benefits of Comirnaty outweigh the risks. If the EC agrees with the CHMP, all intended uses will be authorized in the 27 EU member states, including the bivalent vaccines Comirnaty Original/Omicron BA.1 and Comirnaty Original/Omicron BA.4-5 as booster shots for children 12 years and older. at the top.

The CHMP also recommended Comirnaty as a booster dose of 10 µg given at least six months after the primary series for children aged five to 11 years. This is also subject to EC review.

Marengo advances TCR activator in human trials

Therapeutic Marengo is advance development of its lead TCR activator STAR0602 for solid tumors in human clinical trials after the US FDA approved its Investigational New Drug Application. The company plans to begin a Phase I/II clinical study in the fourth quarter of this year.

STAR0602 is a bi-functional fusion antibody demonstrating single agent capabilities in PD-1 refractory environments in preclinical studies. Marengo’s Selective T Cell Activation Repertoire (STAR) platform targets TCR-specific Vβ variants fused to different co-stimulatory moieties to develop potent T cell activators, fine-tuning the T cell response to generate anti-cancer T cells for tumors solid.

To carry out the trial, Marengo partnered with the National Cancer Institute’s Cancer Research Center and the new Immuno-Oncology Center through a cooperative research and development agreement ( CRADA). This is the first CRADA with a new CIO team, co-led by Dr. Jeffrey Schlom and Dr. James Gulley.

Zealand Pharma touts positive data for treatment of congenital hyperinsulinism

Zeeland Pharma share positive data from its Phase III clinical trial of dasiglucagon for congenital hyperinsulinism in neonates and infants.

In its presentation at the 60th Annual Meeting of the European Society of Pediatric Endocrinology in Rome, the company said that dasiglucagon significantly reduced the need for intravenous glucose to maintain blood sugar levels, reduced the duration of hypoglycemia and allowed discontinuation of IV glucose in most infants. It has also helped limit the need for pancreatectomy. Participants were children aged seven days to 12 months diagnosed with congenital hyperinsulinism.

At the end of the 21-day study, researchers found that the drug was well tolerated and effective in patients dependent on IV glucose. The company is now ready to submit a New Drug Application in 2023.

Trevi cronic cough contestant shows mid-term promise

Trevi Therapeutic show positive results from its phase II cough and nalbuphine (CANAL) trial of the investigational drug Haduvio (oral ER nalbuphine) for chronic cough.

Data from 38 participants showed the drug’s ability to meet the primary endpoint of the trial, demonstrating a 52.5% change from placebo users, as well as a 75.1% reduction in geometric mean percent change in cough frequency during the day.

There is currently no approved treatment for chronic cough. Trevi Therapeutics is now preparing to start its next clinical trial for the same patients in the first half of 2023.

Study examines accelerated FDA approval in non-oncology areas

A cohort study of FDA accelerated approval activity in non-oncology areas from 1992 to 2018 show that the regulatory body approved 48 drugs for 57 non-oncology indications, with a median time to regular approval of 53.1 months.

This number includes 23 HIV treatments. During the period, nine post-approval confirmatory studies failed to verify clinical efficacy, but one indication was withdrawn as it failed 136 months after receiving accelerated approval.

The objective of the study was to determine if the FDA program provided access to accelerated treatments in severe non-oncology cases. Congress authorized the program in 1992 to address the unmet medical needs of rapid drug development in the wake of the HIV/AIDS crisis. Data over 26 years was assessed from February to April 2022. A full drug study will need to be conducted at a later date. Details are published in JAMA Network.

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