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Genticel S.A.. (11/30/16). "Press Release: Genticel Successfully Completes Determining Milestone in Partnership with Serum Institute Regarding Use of GTL003 in Multivalent Vaccines". Paris & Toulouse.

Organisations Organisation Genticel S.A. (Euronext Paris + Brussels: GTCL)
  Today Genkyotex S.A. (Euronext Paris + Brussels: GKTX)
  Group Genkyotex (Group)
  Organisation 2 Serum Institute of India Ldt. (SII)
  Group Poonawalla (Group)
Products Product GTL003 (Genticel)
  Product 2 vaccine
Persons Person Timmerman, Benedikt (Genticel 201304 CEO + Founder)
  Person 2 Orešanský, Dušan (NewCap 201404)
     


The Company has also been granted US patent protecting Vaxiclase and GTL003


Genticel (Euronext Paris & Brussels: FR00011790542 – GTCL), a clinical-stage biotechnology company and developer of innovative immunotherapies, today announced that a determining milestone in its partnership with Serum Institute of India Pvt. Ltd. (Serum Institute) has been successfully completed.

As per the agreement signed in February 2015 with Genticel, Serum Institute has been evaluating the benefits of using GTL003 in new and improved multivalent vaccines and has obtained excellent preclinical results. In preclinical in vivo experimentation, Genticel’s proprietary reengineered adenylate cyclase, GTL003, fulfilled the predetermined objectives.

This was the last preclinical milestone of the agreement, corresponding to a $1.2 million milestone payment. Serum Institute can now proceed to finalize the formal preclinical testing prior to clinical development and subsequent commercialization in emerging markets only.

The agreement could generate for Genticel up to $57 million in milestone payments and then single digit-royalties on further sales.

In parallel, Genticel has just been granted a new United States patent, No 9,499,809, entitled “CyaA-based chimeric proteins comprising a heterologous polypeptide and their uses in the induction of immune responses.” One of the claims in this patent protects Vaxiclase when used as a product per se (GTL003), which is the case in Genticel’s partnership with Serum Institute.

Benedikt Timmerman, PhD, Chief Executive Officer of Genticel, commented: “These are all very good news regarding our agreement with Serum Institute and the protection of resulting product candidates in a key market such as the USA, to which Genticel has retained all commercial rights.” He continued: “Our partnership with Serum Institute is progressing as planned and Genticel can now confidently move its business development activities forward, with a particular focus on the Company’s access to innovative drug candidates.”


About Genticel

Genticel’s versatile platform, Vaxiclase, is well suited for the development of various immunotherapies.. A partnership on the use of Vaxiclase as an antigen per se (GTL003) has been established with Serum Institute of India Ltd (SILL), the largest producer of vaccine dose worldwide. This agreement covers territories outside of the USA and Europe, and could generate up to $57 million in revenues for Genticel, before royalties on sales, It will enable SIIL to develop acellular multivalent combination vaccines against a variety of infectious diseases, including whooping cough.
More information at www.genticel.com

Forward Looking Statement

This press release contains forward-looking statements that are not promises or guarantees and involve substantial risks and uncertainties. The Company’s product candidates have not been approved for sale in any jurisdiction. Among the factors that could cause actual results to differ materially from those described or projected herein are uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, the risk that historical preclinical results may not be predictive of future clinical trial results, and the risk that historical clinical trial results may not be predictive of future trial results. A further list and description of these risks, uncertainties and other risks can be found in the Company’s regulatory filings with the French “Autorité des Marchés Financiers”, including in the Company’s Annual Report for the year ended December 31, 2015 and future filings and reports by the Company which are available on the Company’s website.. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Genticel undertakes no obligation to update or revise the information contained in this Press Release, whether as a result of new information, future events or circumstances or otherwise.


EU INVESTORS
NewCap
Dušan Orešanský
+33 1 44 71 94 92
dusan@newcap.fr

US INVESTORS
Life Sci Advisors
Brian Ritchie
+1 212 915 2578
britchie@lifesciadvisors.com

MEDIA
ALIZE RP
Caroline Carmagnol et Florence Portejoie
+33 6 64 18 99 59 / +33 6 47 38 90 04
genticel@alizerp.com



   
Record changed: 2019-06-09

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