Moderna pushes for diverse Phase III as COVID-19 vaccine program nears enrollment target
Plus €252 million for CureVac, J&J’s challenge data and GSK-Sanofi vaccine enters clinic
Moderna is working to engage racial and ethnic minority communities in the Phase III trial of its mRNA COVID-19 vaccine, which is expected to complete enrollment this month.
Meanwhile, other vaccine developers provided updates on their programs this week. CureVac N.V. (NASDAQ:CVAC) is receiving a grant worth over €250 from the German government to develop its vaccine; Johnson & Johnson (NYSE:JNJ) reported a single dose of its vaccine protected hamsters; and partners Sanofi (Euronext:SAN; NASDAQ:SNY) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) started clinical testing of their candidate.
Moderna Inc. (NASDAQ:MRNA) said its clinical trial sites are working within their local communities to reach a diverse population of volunteers, and the company itself has been working with community engagement networks to reach underrepresented communities.
“As enrollment in the trial has been building towards its target of approximately 30,000 participants, Moderna has been encouraging sites to further emphasize outreach to diverse populations, even if those efforts impact the speed of enrollment,” the spokesperson said.
The lack of diversity in clinical trials remains a glaring problem across the biopharma industry, and Black patients are particularly underrepresented. On average, Black subjects represent about 9% of participants in clinical trials for drugs that were approved last year by FDA’s Center for Drug Evaluation and Research (CDER), despite being over 13% of the overall U.S. population. (see “Real-world Data’s Power to Increase Racial Diversity in Clinical Research”).
Moderna said that as of Friday afternoon, 21,411 patients have been enrolled, 33% of which are from ethnic minority communities.
In an open letter published Thursday, past and present members of BIO’s leadership called for drug developers to conduct COVID-19 clinical trials with ethical participation of diverse populations of subjects (see “BIO Leaders Urge Industry to Hew to Norms”).
Germany bumps up CureVac funding
CureVac said it will receive €252 million ($298.4 million) from the German Federal Ministry of Education and Research to develop and manufacture its COVID-19 vaccine. Payments for the grant are milestone-based; CureVac expects to receive €103 million this year, and up to €149 million in 2021.
The company’s mRNA-based vaccine is in Phase I testing in Germany and Belgium, with data expected in 4Q20. If the results are positive, a Phase IIb/III trial could start that quarter.
The German government made a €300 million investment in the biotech in June, and last month, CureVac raised $213.3 million in a NASDAQ IPO. KfW, a Germany government-backed fund, holds about a 16.9% stake (see “Big Post-IPO Gain for CureVac”).
J&J vaccine protects hamsters
J&J reported in a Nature Medicine paper Thursday that traces of SARS-CoV-2 were undetectable in an animal challenge model of severe COVID-19 two weeks after vaccination.
Ten hamsters were challenged intranasally with a high viral load of SARS-CoV-2, intended to mimic a severe disease scenario, four weeks after being given a single dose of adenovirus vector vaccine Ad26.COV2.S.
Four days after infection, SARS-CoV-2 RNA levels in the lung tissue was six logs lower in vaccinated hamsters than in control animals. No viral copies were detectable after 14 days in the vaccinated hamsters, which were also protected against death.
J&J is testing the vaccine in a Phase I/IIa trial.
Sanofi, GSK kick off vaccine trial
Sanofi and GSK started a Phase I/II trial for their COVID-19 vaccine on Thursday. The partners plan to enroll 440 healthy adults in the U.S.
Data are expected in early December, and a Phase III trial is slated to start shortly after that month. The partners plan to seek approval of the vaccine in 1H21.
The vaccine uses an antigen from Sanofi, based on the recombinant protein technology used in the company’s flu vaccine, along with an adjuvant from GSK