The emergence of the Omicron variant over the holiday has reignited the focus on vaccine equity, and in its efforts to bring more shots to Africa, one South African biotech is reportedly close to reproducing Moderna’s mRNA shot.
Afrigen Biologics and Vaccines is speeding toward its pivotal trials, the Washington Post reported Sunday, though it’s doing so without Moderna’s recipe. The biotech reportedly has finished sequencing the Moderna vaccine and plans to soon compare its own recreation to Moderna’s jab.
A key differentiator, however, is Afrigen is attempting to make a vaccine that will not require freezing in storage — hopefully lowering costs and enabling better access for African countries.
Though Moderna has said it will not seek damages during the course of the pandemic, the biotech has thus far refused to share its intellectual property. Moderna has also pledged up to $500 million to build an mRNA manufacturing site in Africa to eventually make up to 500 million vaccine doses each year.
As a result, Afrigen’s development process is largely made up of publicly available information and help from outside advisors. If Moderna shares its formula, Afrigen could have the continent’s first mRNA shot within a year, managing director Petro Terblanche told the Post. Without it, the process could take up to three years.
Earlier this year, Afrigen joined an mRNA tech transfer hub established with both the WHO and COVAX to try to boost vaccination rates in Africa. With wealthy nations having bought up most of the early supply, vaccination of the continent’s 1.2 billion people remains at just 6%, per the Post, compared to 60% in the US, 70% in France and 77% in China.
Meanwhile, the WHO is stepping up pressure on rich countries in a new statement out Monday morning. The organization called out vaccine donation efforts to Africa, saying that in order for the continent to reach 70% immunization, ‘the quality of donations needs to improve.’
‘The majority of the donations to-date have been ad hoc, provided with little notice and short shelf lives,’ the statement read in part. ‘This has made it extremely challenging for countries to plan vaccination campaigns and increase absorptive capacity. To achieve higher coverage rates across the continent, and for donations to be a sustainable source of supply that can complement supply from AVAT and COVAX purchase agreements, this trend must change.’
WHO seeks to establish permanent pandemic prevention task force
As the Omicron variant continues its spread, the WHO is putting together a new task force to strengthen pandemic preparedness and response.
During the second special session of the World Health Assembly on Sunday, the organization said it is planning on establishing a new negotiating body to better coordinate responses to future pandemics. The first meeting of the panel will take place no later than next March 1, and each of the six WHO regions will get a seat at the table in either a co-chair or vice chair post.
Should everything go well at the first meeting, the WHO said a second meeting will take place on or before Aug. 1, after which a proposal will be submitted to enshrine the body in the WHO’s constitution.
In addition to highlighting continued inequities and spurring WHO action, the Omicron variant is also creating logistical nightmares for travelers and governments, as the WTO postponed a meeting in Geneva over virus concerns, the body said in a statement. The in-person meeting had been scheduled to run Tuesday through Friday in Geneva.
Among the topics expected to have been discussed were waivers for Covid-19 treatments, vaccines and therapeutics, which has proved a thorny issue throughout the pandemic. The Biden administration has supported temporarily waiving patents since May, while the EU said last week it will consider a ‘targeted’ waiver after lengthy opposition.
The waiver was first proposed by South Africa and India in October 2020.
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While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.
Tillman Gerngross (Adagio)
Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.
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Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.
Ursula von der Leyen, President of the European Commission
As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine ‘within 100 days’ if necessary while a third spelled out its 3-prong strategy hours later.
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Shankar Musunuri, Ocugen CEO
Back in July, Ocugen and Bharat Biotech unveiled some Phase III data suggesting their Covid-19 vaccine, Covaxin, was 77.8% effective at preventing overall disease in India. They’re now looking to launch an immuno-bridging study to see if those numbers hold up in the US — but on Friday, the FDA said not so fast.
Regulators have placed a clinical hold on the partners’ IND, Ocugen shared on Friday. Ocugen’s stock $OCGN sank 9% on the news Friday, but was up almost 7% in pre-market trading on Monday.
Jonathan Montagu (L) and Gerry Harriman, HotSpot co-founders
HotSpot Therapeutics, the allostery-focused biotech that works on what it calls ‘natural hotspots’ — hence the name — is getting a bit hotter in its valuation from investors. And to that end they’ve raised $100 million.
The four-year-old AI computational biotech started by two former Nimbus execs announced this morning that it closed its Series C round right at the line of a 9-figure investment, courtesy of some big investors.
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Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.
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At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.
In a phrase: broader and deeper.
It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.
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The FDA has slapped a clinical hold on the early-stage program for one of Kura Oncology’s cancer drugs following a patient’s death in a clinical trial.
The biotech $KURA reported early Wednesday that the Phase Ib study of KO-539 for acute myeloid leukemia would be halted, suspending enrollment, while researchers and the FDA probed the death. Patients already on the drug can continue taking it.
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https://endpts.com/covid-19-roundup-as-omicron-spreads-african-biotech-reportedly-close-to-reproducing-modernas-vaccine-while-who-creates-pandemic-prevention-body/
