First-in-human, dose escalation, phase I study of an antibody-based immunotherapy in patients with solid tumor (Kopie)

Conduct of a multicenter, first-in-human, dose escalation, phase I study of an antibody-based immunotherapy in patients with solid tumor (basket trial). Scope of Services 1. CRO service with following listed items for the clinical trial 2. Regular update meetings

CPV: 85145000 Services provided by medical laboratories, 85148000 Medical analysis services
Place of execution:
First-in-human, dose escalation, phase I study of an antibody-based immunotherapy in patients with solid tumor (Kopie)
Awarding body:
BiconY Therapeutics GmbH
Award number:
BIC-24-20

1. Buyer

1.1 Buyer

Official name : BiconY Therapeutics GmbH
Legal type of the buyer : Organisation awarding a contract subsidised by a contracting authority
Activity of the contracting authority : Health

2. Procedure

2.1 Procedure

Title : First-in-human, dose escalation, phase I study of an antibody-based immunotherapy in patients with solid tumor (Kopie)
Description : Conduct of a multicenter, first-in-human, dose escalation, phase I study of an antibody-based immunotherapy in patients with solid tumor (basket trial).
Procedure identifier : 7d4d4fa1-74bc-412c-925c-279c672fac40
Internal identifier : BIC-24-20
Type of procedure : Negotiated with prior publication of a call for competition / competitive with negotiation
The procedure is accelerated : no
Justification for the accelerated procedure :
Main features of the procedure :

2.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 85145000 Services provided by medical laboratories
Additional classification ( cpv ): 85148000 Medical analysis services

2.1.2 Place of performance

Country subdivision (NUTS) : Leipzig, Kreisfreie Stadt ( DED51 )
Country : Germany

2.1.4 General information

Additional information : Bekanntmachungs-ID: CXP4YWL5D3K
Legal basis :
Directive 2014/24/EU
vgv -

2.1.6 Grounds for exclusion

Purely national exclusion grounds :
Analogous situation like bankruptcy under national law :
Corruption :
Participation in a criminal organisation :
Agreements with other economic operators aimed at distorting competition :
Breaching of obligations in the fields of environmental law :
Money laundering or terrorist financing :
Fraud :
Child labour and other forms of trafficking in human beings :
Insolvency :
Breaching of obligations in the fields of labour law :
Assets being administered by liquidator :
Guilty of misrepresentation, withheld information, unable to provide required documents and obtained confidential information of this procedure :
Conflict of interest due to its participation in the procurement procedure :
Direct or indirect involvement in the preparation of this procurement procedure :
Guilty of grave professional misconduct :
Early termination, damages or other comparable sanctions :
Breaching of obligations in the fields of social law :
Payment of social security contributions :
Business activities are suspended :
Payment of taxes :
Terrorist offences or offences linked to terrorist activities :

5. Lot

5.1 Lot technical ID : LOT-0001

Title : First-in-human, dose escalation, phase I study of an antibody-based immunotherapy in patients with solid tumor (Kopie)
Description : Scope of Services 1. CRO service with following listed items for the clinical trial 2. Regular update meetings
Internal identifier : BIC-24-20

5.1.1 Purpose

Main nature of the contract : Services
Main classification ( cpv ): 85145000 Services provided by medical laboratories
Additional classification ( cpv ): 85148000 Medical analysis services

5.1.2 Place of performance

Country subdivision (NUTS) : Leipzig, Kreisfreie Stadt ( DED51 )
Country : Germany
Additional information :

5.1.3 Estimated duration

Duration : 4 Year

5.1.6 General information

Procurement Project not financed with EU Funds.
The procurement is covered by the Government Procurement Agreement (GPA) : yes

5.1.7 Strategic procurement

Aim of strategic procurement : No strategic procurement

5.1.9 Selection criteria

Criterion :
Type : Other
Name : The applying CRO must be based within the EU
Description : The applying CRO must be based within the EU
Criterion :
Type : Technical and professional ability
Name : Experience with conduct of phase I, first-human trials
Description : The applying CRO is requested to provide proven record, e.g. publications, references of industrial partners
Criterion :
Type : Other
Name : Close contact with clinical sites in the EU with special focus on Germany, which are suitable for conduct of early clinical trials
Criterion :
Type : Technical and professional ability
Name : Recent audit results from big pharma companies or/and regulatory agencies
Description : at least 1 within the last 2 years

5.1.11 Procurement documents

Languages in which the procurement documents are officially available : English
Deadline for requesting additional information : 05/12/2024 00:00 +01:00
Ad hoc communication channel :

5.1.12 Terms of procurement

Terms of submission :
Electronic submission : Required
Languages in which tenders or requests to participate may be submitted : English
Electronic catalogue : Not allowed
Variants : Allowed
Tenderers may submit more than one tender : Allowed
Deadline for receipt of requests to participate : 16/12/2024 12:00 +01:00
Information that can be supplemented after the submission deadline :
At the discretion of the buyer, some missing tenderer-related documents may be submitted later.
Additional information : Some missing bidder documents may, at the discretion of the awarding authority, be submitted after the deadline.
Terms of contract :
The execution of the contract must be performed within the framework of sheltered employment programmes : No
Conditions relating to the performance of the contract : 1. The applying CRO must be based within the EU 2. Experience with conduct of phase I/first-human trials The applying CRO is requested to provide proven record, e.g. publications, references of industrial partners 3. Close contact with clinical sites in the EU with special focus on Germany, which are suitable for conduct of early clinical trials 4. Recent audit results from big pharma companies or/and regulatory agencies, at least 1 within the last 2 years BiconY reserves the right to verify information in case of doubt.
Electronic invoicing : Not allowed
Electronic ordering will be used : no
Electronic payment will be used : no

5.1.15 Techniques

Framework agreement :
No framework agreement
Information about the dynamic purchasing system :
No dynamic purchase system
Electronic auction : no

5.1.16 Further information, mediation and review

Review organisation : Vergabekammern des Bundes
Organisation providing additional information about the procurement procedure : BiconY Therapeutics GmbH
Organisation providing more information on the review procedures : Vergabekammern des Bundes
Procurement service provider : Mazars Rechtsanwaltsgesellschaft mbH
TED eSender : Datenservice Öffentlicher Einkauf (in Verantwortung des Beschaffungsamts des BMI)

8. Organisations

8.1 ORG-0001

Official name : BiconY Therapeutics GmbH
Registration number : Amtsgericht Leipzig HRB 41594
Town : Leipzig
Postcode : 04103
Country subdivision (NUTS) : Leipzig, Kreisfreie Stadt ( DED51 )
Country : Germany
Telephone : +49 30 208 88 1514
Roles of this organisation :
Buyer
Organisation providing additional information about the procurement procedure

8.1 ORG-0002

Official name : Mazars Rechtsanwaltsgesellschaft mbH
Registration number : Amtsgericht Charlottenburg (Berlin) HRB 143974 B
Town : Berlin
Postcode : 10557
Country subdivision (NUTS) : Berlin ( DE300 )
Country : Germany
Telephone : +4930208881514
Roles of this organisation :
Procurement service provider

8.1 ORG-0003

Official name : Vergabekammern des Bundes
Registration number : Telefon: +49 228 9499 0
Town : Bonn
Postcode : 53113
Country subdivision (NUTS) : Bonn, Kreisfreie Stadt ( DEA22 )
Country : Germany
Telephone : +49 228 9499 0
Roles of this organisation :
Review organisation
Organisation providing more information on the review procedures

8.1 ORG-0004

Official name : Datenservice Öffentlicher Einkauf (in Verantwortung des Beschaffungsamts des BMI)
Registration number : 0204:994-DOEVD-83
Town : Bonn
Postcode : 53119
Country subdivision (NUTS) : Bonn, Kreisfreie Stadt ( DEA22 )
Country : Germany
Telephone : +49228996100
Roles of this organisation :
TED eSender

11. Notice information

11.1 Notice information

Notice identifier/version : a177528a-3b9d-4033-9323-81375dd6829c - 01
Form type : Competition
Notice type : Contract or concession notice – standard regime
Notice dispatch date : 15/11/2024 17:30 +01:00
Languages in which this notice is officially available : English

11.2 Publication information

Notice publication number : 00703616-2024
OJ S issue number : 225/2024
Publication date : 19/11/2024