ImmunityBio has licensed technology underpinning a COVID-19 vaccine that could be administered orally rather than by injection from UK biotech iosBio.
Approvals for injectable vaccines for COVID-19 are starting to build, but non-injectables like oral and intranasal vaccines could be required if the pandemic is to be fought across all areas of the globe, according to Wayne Channon, the UK firm’s chairman.
“Non-injectables remove the need for health professional-led immunisation programmes, making widespread vaccine roll-outs quicker and easier and more affordable,” Channon told pharmaphorum.
“They also offer the potential for self-administration at home rather than in a health setting, making compliance with booster dosage potentially higher.”
ImmunityBio’s hAd5 candidate – using iosBio’s technology – has already shown encouraging preclinical results in non-human primates using an initial injection followed by two oral booster doses.
An injectable/oral ‘prime and boost’ regimen is in a phase 1b study due to conclude in November, according to the clinicaltrials.gov database, and ImmunityBio has said it is also recruiting patients for a phase 2/3 trial.
In time, it may be possible to deliver the entire immunisation course by the oral route, according to iosBio, while ImmunityBio has suggested the oral candidate could be used to provide a boost to other injectable vaccinations.
One of the primary advantages of this approach is that the oral vaccine capsules are stable at room temperature, which means they do not require cold chain storage. They are also cheaper to produce and store and can be distributed across the globe easily – all without the need for specialised equipment or personnel – according to iosBio.
“This is particularly important in developing countries, where access to cold-chain is limited,” said Channon.
There are other theoretical advantages as well. For instance, oral vaccines could allow repeat dosing without a treatment-limiting anti-vector response – where the body generates an immune response against the harmless, non-replicating viruses used to deliver the COVID-19 antigens.
“This can render the repeat administration of that vaccine as a booster, or a vaccine against a different infectious disease using the same viral vector, ineffective,” according to Channon.
The lack of anti-vector immunity in the gastrointestinal (GI) tract means repeat dosing with vaccines based on iosBio’s tech is possible, he suggested, because of the natural level of tolerance in the gut that avoids generating an immune response to food, for instance.
“This allows the same vector to be repeatedly orally administered and re-used for multiple vaccine programmes.”
ImmunityBio – led by billionaire surgeon and Nantworks and NantKwest founder Patrick Soon-Shiong – isn’t the only company looking at non-injectable COVID-19 vaccines.
Vaxart said in November it had completed enrolment in a phase 1 trial of its oral COVID-19 vaccine VXA-CoV2-1, having reported viral load reduction and antibody responses in a COVID-19 hamster challenge model. Symvivo also has an oral candidate in a phase 1 study which started last November.
Altimmune meanwhile is taking a different tack with its single-dose intranasal candidate AdCOVID, which had been due to generate initial clinical study results in the next few weeks but was placed on a clinical hold by the FDA last month after a request for more manufacturing data.
Soon-Shiong said that oral vaccines could have another key advantage as they stimulate mucosal, systemic and T-cell immune responses.
“As we see multiple mutations in the SARS-CoV-2 spike protein, there is an urgent need for a vaccine that not only offers immediate protection but also activates T-cells to clear the virus,” he said.
ImmunityBio’s vaccine design drives both antibody and T-cells to the spike (S) protein and nucleocapsid (N) protein.
That means it could “potentially serve as a universal boost to current vaccines that focus only on the monovalent S protein, as well as address future mutations of the S protein,” according to Soon-Shiong.
ImmunityBio and NantKwest announced last month they will merge into a single company focusing on immunotherapies and cell therapies for cancer and infectious diseases.
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Zosano Pharma has been hit by an FDA rejection of its marketing application for migraine drug Qtrypta, asking for new bioequivalence data.
Qtrypta takes the form of a transdermal patch loaded with zolmitriptan, a well-established medicine for acute migraine that has been available for years in various formulations including tablets and nasal sprays.
Zosano’s product uses microneedles to help the drug get absorbed into the blood, but the Complete Response Letter (CRL) from the FDA says it is concerned about inconsistencies in how much zolmitriptan was being delivered with Qtrypta.
Specifically, the FDA pointed to differences in zolmitriptan exposures between subjects receiving different lots of Qtrypta in the company’s trials, including some unexpectedly high results in five individuals.
It also mentions “inadequate pharmacokinetic bridging between the lots that made interpretation of some safety data unclear.”
The CRL comes just a couple of weeks after Zosano received a discipline review letter (DRL) from the FDA, a preliminary sharing of the agency’s stance, after which the company had already said it did not expect approval by the action date of 20 October.
Shares in the Nasdaq-listed biopharma lost around 25% of their value after the announcement, as investors tried to gauge how long the programme might now be delayed, and the implications for its delivery platform, which is the first microneedle patch to be Included in a new drug application to the FDA.
Qtrypta is Zosano’s lead product candidate, but the company is also working on a follow-up in phase 2/3 for cluster headache.
The FDA wants a new bioequivalence study between three of the Qtrypta lots tested during development, as well as product quality validation data, originally due to be filed after approval, as part of the new drug application (NDA).
The agency also says that inspection of Zosano’s contact manufacturing facilities for the product – while currently on hold because of the pandemic – will also have to be completed before Qtrypta can be approved.
That suggests the delay could be some time, but Zosano is keeping tight-lipped until it has a chance to meet with the FDA to discuss a way forward for the programme.
“We are working diligently to address the deficiencies identified by the FDA and look forward to the possibility of resubmitting our NDA,” said the company’s CEO Steven Lo.
“There are thousands of people suffering from migraine attacks that are not adequately addressed with available drugs, and we continue to believe that Qtrypta, if approved, could offer a much-needed new therapy for these patients,” he added.
The company has previously reported data showing that Qtrypta can deliver fast relief from a migraine with fewer than 2% of patients experiencing side effects common with triptan drugs, like dizziness and pins and needles.
Zosano recently signed a five-year deal worth $250 million deal with Eversana to commercialise and distribute Qtrypta if gets past the FDA.
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The gradual shift of healthcare industry towards the development of biologics is a well-known fact. Owing to this shift, there are over 1,000 cell and gene therapies which are being developed for the treatment of various disorders, majority of them being oncological disorders, cardiovascular disorders and neurological disorders. Additionally, over the last decade, multiple immunotherapies have been developed, and have led to a decrease in lung cancer and melanoma-related mortality. However despite their many benefits, biologics present a number of challenges, such as drug delivery-related complexities, systemic toxicity and compromised efficacy owing to the inaccurate delivery to the target site. To address such challenges, a number of innovator companies in the biopharmaceutical sector are actively engaged in identifying targeted drug delivery strategies for biologics.
Several industry and non-industry stakeholders have already developed targeted drug delivery devices that allow to deliver high and sustained concentrations of biologics (including gene therapies, cell / stem cell therapies, immunotherapies and therapeutic proteins) to its desired targeted area, hence increasing efficacy and reducing systemic toxicity. Examples of devices designed for the targeted delivery of biologics include Advance® CS, ExtroducerTM microcatheter, HelixTM biotherapeutic delivery system, ImmunoPulse® IL-12, SmartFlow® neuro ventricular cannula and MailPan®. This intersectional research looking at both devices and biological therapies is likely to determine the future success of biological therapeutics and can improvise the ways to treat chronic diseases.
Stakeholders Involved in the Development of Such Devices
This domain is featured by the presence of 33 players (industry / non-industry) that are presently engaged in development of targeted drug delivery devices for biologics. Around 30 devices are approved / under development for targeted delivery of biologics. Majority of these devices are intended for delivery of anti-cancer medication, including a number of gene therapies and cell-based interventions.
To know more about the stakeholders and different type of targeted drug delivery devices for biologics, check out our report here.
The Rising Research Activity in the Field of Stem Cell and Gene Therapies and Likely Opportunities for Targeted Drug Delivery Device Developers
Till date, around 380 clinical studies have been completed / are ongoing for evaluation of various gene therapies (194) and stem cell therapies (183), which are likely to be developed for intra-organ / targeted delivery. In terms of the number of patients, over 21,300 patients have been enrolled in trials focused on this domain.
Over 80 stem cell and 120 gene therapy developers, are likely to enter into strategic partnerships with targeted drug delivery device developers over the coming years. Majority (21) of these stem cell therapy developers are headquartered in the Asia-Pacific region. However, on the other hand, majority (64) of the gene therapy developers that are likely to partner with targeted device developers are headquartered in North America.
To know further about the insights of this analysis, check out the report here.
Likely Growth of Targeted Drug Delivery Devices for Biologics Market
The market for drug device combination products in the organ-based / targeted drug delivery devices for biologics market is expected to be worth around USD 5 billion in 2030. Analysis of the opportunity in terms of therapeutic area revealed that 70% of the current sales-based revenues reported within the market, is driven by applications related to various cardiovascular disorders (including heart failure and myocardial ischemia). This is followed by neurological disorders (19%).
Moreover, in 2022, the market is likely to be driven by catheter based devices, followed by encapsulation based delivery devices. This trend is likely to persist in the future as well. The North American market currently holds the dominant share (95%) in the overall market (in terms of revenues generated from product sales); it is further anticipated to grow at an annualized growth rate of 77% till 2030. The figure given below presents the distribution of market for drug-device combination products across type of device, target organ, therapeutic area and key geographical regions.
To know further about the market forecast analysis, highlighting the likely growth of the targeted drug delivery devices market for biologics, for the time period 2020-2030, .
Check out the report here.
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