Aviceda submits Investigational New Drug application for AVD-104 for geographic atrophy

News Research and clinical trials

Aviceda Therapeutics submitted Investigational New Drug (IND) and Fast Track Designation applications to the FDA to support the use of its lead intravitreal ocular asset, AVD-104 – a novel glycan-coated nanoparticle – for the treatment of GA secondary to AMD. Aviceda is a private biotech company focused on the development of next generation immuno-modulators by harnessing the power of glycobiology to modulate the innate immune system and alleviate chronic non-resolving inflammation.


“With only one currently approved therapy for the treatment of GA, there is still a significant unmet medical need for patients with this condition. This IND application brings us a step closer to offering a new and differentiated treatment option for disease modification of the key underlying pathobiology of AMD via the modulation of immune and complement dysfunction,” Mohamed Genead, MD, Co-Founder, CEO & President of Aviceda, said in a press release.


Aviceda had previously announced the successful completion of IND-enabling Good Laboratory Practice (GLP) toxicity studies that demonstrated positive safety outcomes for multiple well-tolerated doses of AVD-104, including dose-range finding studies in non-human primates and rabbits, to support continued development and the initiation of the Phase 2 in the human clinical trials.


“As a retina specialist and ocular immunologist, I am excited about advancing AVD-104 into the clinical phase as we believe that this novel ocular nanoparticle-based therapy will be key in the treatment of this devastating blinding eye disease with enhanced efficacy, safety, and prolonged durability. We anticipate beginning our Phase 2 trial as soon as possible after FDA review,” David Callanan, MD, Aviceda’s Chief Medical Officer said. “This key milestone advances our technology to the clinical phase, and further validates the Company’s platform, which includes assets to be directed at neuro-inflammation/degeneration, oncology, fibrosis, and other rare immune pathologies.”

Source: https://eyewire.news/news/aviceda-submits-investigational-new-drug-application-for-avd-104-for-the-treatment-of-ga-associated-with-amd?c4src=article:infinite-scroll

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Legal basis of processing

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Retention time

Personal Data shall be processed and stored for as long as required by the purpose they have been collected for.

Therefore:

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The Owner may be allowed to retain Personal Data for a longer period whenever the User has given consent to such processing, as long as such consent is not withdrawn. Furthermore, the Owner may be obliged to retain Personal Data for a longer period whenever required to do so for the performance of a legal obligation or upon order of an authority.

Once the retention period expires, Personal Data shall be deleted. Therefore, the right to access, the right to erasure, the right to rectification and the right to data portability cannot be enforced after expiration of the retention period.

The purposes of processing

The Data concerning the User is collected to allow the Owner to provide its Services, as well as for the following purposes: Analytics, Contacting the User and Displaying content from external platforms.

Users can find further detailed information about such purposes of processing and about the specific Personal Data used for each purpose in the respective sections of this document.

Analytics

The services contained in this section enable the Owner to monitor and analyze web traffic and can be used to keep track of User behavior.

Google Analytics (Google Ireland Limited)

Google Analytics is a web analysis service provided by Google Ireland Limited (“Google”). Google utilizes the Data collected to track and examine the use of this Application, to prepare reports on its activities and share them with other Google services.
Google may use the Data collected to contextualize and personalize the ads of its own advertising network.

Personal Data collected: Cookies; Usage Data.

Place of processing: Ireland – Privacy Policy – Opt Out. Privacy Shield participant.

Contacting the user

Contact form (this Application)

By filling in the contact form with their Data, the User authorizes this Application to use these details to reply to requests for information, quotes or any other kind of request as indicated by the form’s header.

Personal Data collected: email address; first name; last name.

Mailing list or newsletter (this Application)

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Personal Data collected: email address.

Displaying content from external platforms

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This type of service might still collect web traffic data for the pages where the service is installed, even when Users do not use it.

YouTube video widget (Google Ireland Limited)

YouTube is a video content visualization service provided by Google Ireland Limited that allows this Application to incorporate content of this kind on its pages.

Personal Data collected: Cookies; Usage Data.

Place of processing: Ireland – Privacy Policy. Privacy Shield participant.

The rights of Users

Users may exercise certain rights regarding their Data processed by the Owner.

In particular, Users have the right to do the following:

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  • Restrict the processing of their Data. Users have the right, under certain circumstances, to restrict the processing of their Data. In this case, the Owner will not process their Data for any purpose other than storing it.
  • Have their Personal Data deleted or otherwise removed. Users have the right, under certain circumstances, to obtain the erasure of their Data from the Owner.
  • Receive their Data and have it transferred to another controller. Users have the right to receive their Data in a structured, commonly used and machine readable format and, if technically feasible, to have it transmitted to another controller without any hindrance. This provision is applicable provided that the Data is processed by automated means and that the processing is based on the User’s consent, on a contract which the User is part of or on pre-contractual obligations thereof.
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Details about the right to object to processing

Where Personal Data is processed for a public interest, in the exercise of an official authority vested in the Owner or for the purposes of the legitimate interests pursued by the Owner, Users may object to such processing by providing a ground related to their particular situation to justify the objection.

Users must know that, however, should their Personal Data be processed for direct marketing purposes, they can object to that processing at any time without providing any justification. To learn, whether the Owner is processing Personal Data for direct marketing purposes, Users may refer to the relevant sections of this document.

How to exercise these rights

Any requests to exercise User rights can be directed to the Owner through the contact details provided in this document. These requests can be exercised free of charge and will be addressed by the Owner as early as possible and always within one month.

Additional information about Data collection and processing

Legal action

The User’s Personal Data may be used for legal purposes by the Owner in Court or in the stages leading to possible legal action arising from improper use of this Application or the related Services.
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Additional information about User’s Personal Data

In addition to the information contained in this privacy policy, this Application may provide the User with additional and contextual information concerning particular Services or the collection and processing of Personal Data upon request.

System logs and maintenance

For operation and maintenance purposes, this Application and any third-party services may collect files that record interaction with this Application (System logs) use other Personal Data (such as the IP Address) for this purpose.

Information not contained in this policy

More details concerning the collection or processing of Personal Data may be requested from the Owner at any time. Please see the contact information at the beginning of this document.

How “Do Not Track” requests are handled

This Application does not support “Do Not Track” requests.
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Changes to this privacy policy

The Owner reserves the right to make changes to this privacy policy at any time by giving notice to its Users on this page and possibly within this Application and/or – as far as technically and legally feasible – sending a notice to Users via any contact information available to the Owner. It is strongly recommended to check this page often, referring to the date of the last modification listed at the bottom.

Should the changes affect processing activities performed on the basis of the User’s consent, the Owner shall collect new consent from the User, where required.

Definitions and legal references

Personal Data (or Data)

Any information that directly, indirectly, or in connection with other information — including a personal identification number — allows for the identification or identifiability of a natural person.

Usage Data

Information collected automatically through this Application (or third-party services employed in this Application), which can include: the IP addresses or domain names of the computers utilized by the Users who use this Application, the URI addresses (Uniform Resource Identifier), the time of the request, the method utilized to submit the request to the server, the size of the file received in response, the numerical code indicating the status of the server’s answer (successful outcome, error, etc.), the country of origin, the features of the browser and the operating system utilized by the User, the various time details per visit (e.g., the time spent on each page within the Application) and the details about the path followed within the Application with special reference to the sequence of pages visited, and other parameters about the device operating system and/or the User’s IT environment.

User

The individual using this Application who, unless otherwise specified, coincides with the Data Subject.

Data Subject

The natural person to whom the Personal Data refers.

Data Processor (or Data Supervisor)

The natural or legal person, public authority, agency or other body which processes Personal Data on behalf of the Controller, as described in this privacy policy.

Data Controller (or Owner)

The natural or legal person, public authority, agency or other body which, alone or jointly with others, determines the purposes and means of the processing of Personal Data, including the security measures concerning the operation and use of this Application. The Data Controller, unless otherwise specified, is the Owner of this Application.

This Application

The means by which the Personal Data of the User is collected and processed.

Service

The service provided by this Application as described in the relative terms (if available) and on this site/application.

European Union (or EU)

Unless otherwise specified, all references made within this document to the European Union include all current member states to the European Union and the European Economic Area.

Cookies

Small sets of data stored in the User’s device.

Legal information

This privacy statement has been prepared based on provisions of multiple legislations, including Art. 13/14 of Regulation (EU) 2016/679 (General Data Protection Regulation).

This privacy policy relates solely to this Application, if not stated otherwise within this document.