The Federal Agency for Disruptive Innovation - SPRIND GmbH ("SPRIND") - aims to cre-ate new disruptive innovations from Germany. That means products, services and sys-tems that make all our lives noticeably and sustainably better. To achieve this, SPRIND brings together new thinkers from science and business, people with outstanding ideas, special expertise, and passion. Hence, SPRIND provides an entrepreneurial environment that turns ideas into reality.
The objective of BiconY Therapeutics GmbH, a SPRIND subsidiary, is the development of a bispecific antibody combination for the treatment of solid tumours. The combination con-sists of proprietary, bispecific CD3 anti-bodies (bsAbCD3) and bispecific CD28 co-stimulators (BiCos), which, when used together, significantly im-prove the specificity, sus-tainability, and efficiency of a T cell recruitment and thus the immune response against tumour cells. The aim of the research and development activities is to provide proof of concept for the effect of bispecific antibody therapy in the form of two phase I/IIa clinical trials.
For the IND application at Paul Ehrlich Institute (Germany) we have to show safety of our molecules in animal models. Following extensive discussions and thorough analyses, the PEI has granted approval for a comprehensive toxicological study of our lead candidate in mice. Therefore, we are looking for a service provider to support us regarding pharmaco-toxicological studies
The contracting entity may extend the contract twice.
All communication takes place in English via communication tool in the project area of the procurement portal DTVP.
According to Article 160, Section 3 of the German Act Against Restraint of Competition (GWB), application for review is not permissible insofar as1. the applicant has identified the claimed infringement of the procurement rules before submitting the application for review and has not submitted a complaint to the contracting authority within a period of 10 calendar days; the expiry of the period pursuant to Article 134, Section 2 remains unaffected,2. complaints of infringements of procurement rules that are evident in the tender notice are not submitted to the contracting authority at the latest by the expiry of the deadline for the application or by the deadline for the submission of bids, specified in the tender notice.3. complaints of infringements of procurement rules that first become evident in the tender documents are not submitted to the contracting authority at the latest by the expiry of the deadline for application or by the deadline for the submission of bids,4. more than 15 calendar days have expired since receipt of notification from the contracting authority that it is unwilling to redress the complaint.Sentence 1 does not apply in the case of an application to determine the invalidity of the contract in accordance with Article 135, Section 1 (2). Article 134, Section 1, Sentence 2 remains unaffected.
Bicony asks - within its discretion - the bidder to submit, complete or correct documents, within the framework laid down by law.
In accordance with §§ 123,124 GWB, § 22 LkSG
Experience with toxicological studies in mice (minmum 5 reference projects since 1 October 2022).
3 Audit results from pharma companies or/and regulatory agencies (the last three audits must be specified, whereby the last audit must not be older than 1 October 2022.)
Declaration that the following requirements are met:
GLP Certificate: issued by EMA (European Medicines Agency) or internationally recognized equivalent. If more than one facility is involved, a separate GLP certifi-cate needs to be available for each.
Compliance with the European Union Directive (2010/63/ EU) and the relevant implemented national law or if this EU Directive is not applicable to the bidder/bidding consortium the relevant comparable rules
Place of performanceThe place of performance must be in EU/EEA including Switzerland, UK, USA and/or Canada.