Bo Ying, Abogen founder (Xi’an Jiaotong-Liverpool University)
With Moderna and BioNTech offering a model — in the US and Europe, respectively — for how mRNA biotechs can enjoy a meteoric rise to profit and fame with just one successful Covid-19 vaccine, a Chinese player is ready to put itself on the map.
Abogen, which set a record just three months ago with a $720 million Series C, has now raised another $300 million as it prepares to file its vaccine candidate for authorization. Partnered with Walvax and China’s military, ABO-028M first entered clinical testing in the summer of 2020 and is now in Phase III trials in Mexico, Indonesia and Nepal.
The company has kept itself largely secretive since being founded in January 2019 — its website is nearly entirely blank, save for an email address and a two-sentence description of the company. But one key differentiating factor appears to be greater stability of its mRNA vaccine at warm temperatures.
SoftBank Vision Fund and 5Y Capital co-led the new raise, which is being branded a Series C+, and other investors include Chimera Abu Dhabi, Fortune Ocean and Mirae Asset Financial Group.
As BioNTech’s jab, partnered with Fosun on development and distribution, remains in limbo in China, public health officials and regulatory authorities have been talking up the prospects of a rapid approval for a domestic shot.
In an effort to speed up the anticipated rollout, Abogen and Walvax said on Monday they will enlist contract manufacturer GenScript ProBio to produce the plasmids that will go into their commercial batches.
‘The pandemic is still raging,’ said Brian Min, CEO of GenScript ProBio. ‘Abogen Biosciences had launched the project since the very beginning of the outbreak of COVID-19.’
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.
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Stéphane Bancel, Moderna CEO
Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.
Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?
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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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Drugmakers looking to design a new registry or use an existing one to support a regulatory decision on a drug’s effectiveness or safety will need to consult with a new draft guidance released Monday by the FDA.
The agency’s reliance on registry data for regulatory decisions dates back more than two decades, at least, as in 1998 Bayer won approval for its anticoagulant Refludan (withdrawn from the market in 2013 for commercial reasons) based in part on a historical control group pulled from a registry.
Ken Song, Ablaze chairman and RayzeBio CEO
Thanks in part to interest from Big Pharma players like Bayer and Novartis over the last decade, there’s been no shortage in cash for new companies looking to slay tumor cells with targeted radioisotopes. Now a transpacific upstart has hooked $75 million to bring the increasingly popular drugs to China.
Ablaze Pharmaceuticals emerged from stealth on Monday with a Vivo Capital and AdvanTech Capital-led Series A round and a licensing pact with Versant-backed RayzeBio. The goal? Introduce targeted radiopharmaceutical therapies (TRTs) to the Chinese market.
Younger teens could be eligible for the Pfizer-BioNTech Covid-19 booster shots as early as next week, the Wall Street Journal reported Monday.
The companies will apply for regulatory approval for a booster shot in 16- and 17-year-olds this week, according to a source. The move comes as the Omicron variant has brought new cause for concern, and days after US President Joe Biden stood before the country and assured that it’s ‘not a cause for panic.’
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Sean Bohen, Olema Oncology CEO
Olema Oncology had been preparing to present the first clinical data from its lead program at a conference next week, but the biotech’s poster supposedly leaked online Monday. In response, Olema issued a statement saying the image was falsified, and published topline results in a press release Tuesday morning.
The leaked poster ostensibly came from a patient in the Phase I portion of the study, who posted on a discussion forum after saying they completed treatment and received a summary. Originally written on the advocacy website Inspire.com, the forum now leads to a 404 page, but some social media users managed to screenshot the post.
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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.
https://endpts.com/chinas-top-mrna-contender-is-ready-to-go-and-softbank-just-led-a-cash-infusion-pushing-it-over-the-1b-line/
