News Brief: Merck, Eisai, Sherlock, Bill & Melinda Gates Foundation and More

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It’s been a busy day so far for biopharma news and updates. Read on for more.

Merck and Eisai’s Keytruda-Lenvima Combo Hits Mark in Advanced Endometrial Cancer

Merck and Eisai announced that Merck’s checkpoint inhibitor Keytruda (pembrolizumab) in combination with Eisai’s Lenvima (lenvatinib) demonstrated significant improvement in several metrics compared to chemotherapy in advanced endometrial cancer after previous systemic therapy in their Phase III KEYNOTE-775/Study 309 trial. Lenvima is an orally available multiple receptor tyrosine kinase inhibitor. The trial hit its dual primary endpoints of overall survival (OS) and progression-free survival (PFS), and its secondary efficacy endpoint of objective response rate (ORR) in advanced endometrial cancer patients after at least one previous platinum-based regimen.

Abpro Launches COVID-19 Trial

Abpro initiated a global Phase II/III registrational trial evaluating ABP 300 for COVID-19. ABP 300 is a human neutralizing antibody derived from patients who recovered from COVID-19. The first trial site has been opened and the rest will open in 2021. The Phase I trial will include 42 people with results expected in the first quarter of 2021.

Bill & Melinda Gates Foundation Grants Sherlock Biosciences $5 Million

Sherlock Biosciences received a grant from the Bill & Melinda Gates Foundation for $5 million to advance INSPECTR, its instrument-free, synthetic biology-based molecular diagnostics foundation. INSPECTR stands for Internal Splint-Pairing Expression Cassette Translation Reaction. It uses synthetic biology to allow the creation of instrument-free diagnostic tests that can be used at home and at room temperature. It can be modified to work on a simple paper strip test or an electrochemical readout that can be read with a mobile phone. It can also be adapted for laboratory or point-of-care settings.

FSD Pharma Launches Phase II Trial in Hospitalized COVID-19 Patients

Toronto-based FSD Pharma dosed the first patient in its Phase IIa trial of FSD201 (ultramicronized palmitoylethanolamide) for hospitalized patients with COVID-19. It will be conducted on 352 patients to determine the efficacy and safety of FSD201 dosed at 600mg or 1200mg twice a day along with standard of care compared to standard of care alone in hospitalized COVID-19 patients.

Graphite Bio Gets Cleared to Launch Sickle Cell Disease Trial

Graphite Bio’s investigational new drug (IND) application for a Phase I/II trial of GPH101 in severe sickle cell disease (SCD) was given the go-ahead by the U.S. Food and Drug Administration (FDA). GPH101 is an investigational gene therapy that uses CRISPR and DNA’s natural homology-directed repair mechanisms to cut out the mutation in the sickle globin gene and paste in the correct natural DNA sequence. Graphite Bio licensed the product from Stanford University.

Novo Nordisk’s Semaglutide to Begin Phase III for Alzheimer’s

Novo Nordisk plans to launch a Phase III development program in Alzheimer’s disease with 14mg oral semaglutide, the company’s once-daily oral long-acting GLP-1 analogue. The pivotal Phase IIIa program will include about 3,700 people with early Alzheimer’s disease and is expected to launch in the first half of 2021. The drug, under the brand name Rybelsus, is approved as an adjunct to diet and exercise for adults with type 2 diabetes.

CytoDyn Completes Enrollment of Phase III Trial for Severe-to-Critical COVID-19

CytoDyn hit full enrollment in its Phase III trial for patients with severe-to-critical COVID-19. They are being treated with Vyrologix (leronlimab-PRO 140), a CCR5 antagonist that has potential for multiple therapeutic indications, including HIV and metastatic triple-negative breast cancer. It is a humanized IgG4 monoclonal antibody that blocks CCR5. The data on the 390 patients will be analyzed in about 28 days, with results expected shortly afterwards.

Sio Gene Therapies Presents 6-Month Follow-up Data on GM1 Gangliosidosis Trial

Sio Gene Therapies reported positive six-month follow-up data from the low-dose cohort of its dose escalation Phase I/II trial of AXO-AAV-GM1. The product is an AAV9-based gene therapy for GM1 gangliosidosis. Initial data from the trial in five patients demonstrated the gene therapy was generally well tolerated with a favorable safety profile and early indications of clinical disease stability. GM1 gangliosidosis is a life-limiting disease caused by GLB1 gene mutations that impair beta-galactosidase enzyme activity.

Valneva Launches COVID-19 Vaccine Trial

Valneva, based in Saint-Herblain, France, announced the initiation of a Phase I/II trial of its inactivated, adjuvanted COVID-19 vaccine, VLA2001. The trial will evaluate three dose levels in about 150 healthy adults and be conducted in the UK. It hopes to include more than 4,000 people in additional trials, with a possible regulatory approval by the fourth quarter of 2021.

Celyad Oncology Doses First Patient in Phase I Colorectal Cancer Trial

Belgium-based Celyad Oncology dosed the first patient in the expansion cohort of the Phase I alloSHRINK trial for CYAD-101 in refractory metastatic colorectal cancer (mCRC). CYAD-101 is an allogeneic T-cell receptor (TCR) inhibitor molecule (TIM)-based, non-gene edited CAR-T candidate.

Biohaven Publishes Migraine Study Data

Biohaven Pharmaceutical published data in The Lancet from its Phase III trial of Rimegepant for the prevention of migraine in adults. The data showed the drug was superior to placebo in decreasing monthly migraine days. The drug was approved by the FDA for acute treatment of migraine in adults in February 2020 and is marketed under the name Nurtec ODT. It is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in an orally disintegrating tablet.

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