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.
‘The FDA plans to identify the specific deficiencies that are the basis for clinical hold and information on how to address those deficiencies,’ the Malvern, PA-based company said in a statement. ‘The Company expects to receive formal written communication with the additional information from the FDA and plans to work with the FDA in an effort to resolve its questions as promptly as possible.’
The news comes just a few weeks after Ocugen filed for emergency use authorization of the Bharat Biotech-partnered shot for just pediatric use based on an immuno-bridging study conducted in India.
Covaxin, a whole-virion, inactivated vaccine, was developed by Bharat Biotech along with the Indian Council of Medical Research. The World Health Organization granted it an emergency use listing earlier this month, stating that the jab is ‘extremely suitable for low- and middle-income countries due to easy storage requirements.’
In July, Bharat announced that the vaccine was 77.8% effective against Covid-19 of any severity, and 93.4% effective against severe disease in a Phase III trial with more than 25,000 participants in India. Fewer than 0.5% of patients experienced severe side effects, the Indian biotech said at the time.
Earlier this year, Ocugen announced plans to file for an EUA in the US in June. But when June rolled around, the company said it decided to pursue a biologics license application instead, upon recommendation by the FDA. At the end of October, Ocugen filed an IND to conduct a Phase III immuno-bridging study in ‘several hundred’ US adults who’ve never been vaccinated, or received two doses of an mRNA vaccine at least six months prior.
Just a week later, the company submitted an EUA for use in kids ages 2 to 18 based on another immuno-bridging study conducted in India. According to Ocugen, an immuno-bridging study showed that neutralizing antibody responses in the pediatric group were equivalent to those seen in adults.
‘Our research suggests that people are seeking more choices when selecting a vaccine, especially for their children,’ CEO Shankar Musunuri said. ‘Having a new type of vaccine available will enable people to discuss with their child’s physician the best approach for them to lower their child’s risk of contracting COVID-19.’
The clinical hold may not be a good sign for Ocugen’s pediatric EUA, though we’ll have to wait and see.
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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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.
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/ocugen-hits-another-snag-in-bringing-its-bharat-biotech-partnered-covid-19-vaccine-to-the-us/
