17 October 2018
RELIEF THERAPEUTICS Holding SA (“Relief”, “the Company”) announces today that it entered into a service agreement with Genclis SA. Under the terms of this agreement, Genclis will conduct all the experiments and process development activities to fulfil the requirements of the License and Co-development Agreement signed earlier with Health and Happiness (H&H) Hong Kong Limited. In particular, Genclis will annotate the cow genome to identify Transcription Infidelity events and will implement the lab-scale methods to remove the resulting peptides. The expected end-product is referred to as milk for prevention of allergy and/or hypoallergenic milk without hydrolysis.
RELIEF THERAPEUTICS Holding SA is a clinical-stage biotechnology company with a portfolio of drug candidates derived from natural human origins. Its two first candidates are Aviptadil for the treatment of sarcoidosis (to enter Phase III) and low dose interleukin-6 (Atexakin alfa) for the treatment of peripheral neuropathy (to enter Phase II). Aviptadil development in sarcoidosis addresses the orphan disease market, in which European regulators have indicated that a single pivotal Phase III trial would be sufficient to support approval. Atexakin alfa is the subject of an exclusive worldwide development and commercialization agreement with Merck KGaA, The current priority indication for Atexakin is to alleviate peripheral diabetic neuropathy, a market that is estimated to reach $4.1 billion in 2019 (source Datamonitor). In addition to these initial drug candidates, Relief has initiate a strategic collaboration with Genclis in April 2018 in order to co-develop and commercialize products arising from their disruptive technology.
Genclis is a privately-held biotechnology company incorporated in 2004 in Vandœuvre-lès-Nancy, France, that discovered a unique biological mechanism referred to as Transcription Infidelity (TI). TI produces RNA transcripts that differ from their originating DNA sequence. This mechanism explains the nonrandom occurrence of RNA to DNA divergences (RDD) that lead to translated proteins with sequences diverging from the canonical form. Genclis applies its artificial intelligence platform to extract, from large Genomic data sets, these low-intensity signals. Genclis has shown in both humans and animal models that specific RDD events shape selectively the repertoire of natural immunoglobulins and contribute to both allergy and other immunological disorders. Genclis has developed a diversified pipeline of disruptive diagnostic and therapeutic solutions that have and are completing pre-clinical evaluation. Genclis revenues grew >500 % to €2.2 million in fiscal year 2017 missing breakeven by less than 10 %. Genclis’ objectives for 2018 are to further expand commercial activities in both human and veterinary medicine as well as in the food industry to reach profitability, while relentlessly pursuing developments of several other novel disruptive pre-clinical assets.
Transcription Infidelity (TI) is a newly discovered ubiquitous epigenetic mechanism that increases RNA-DNA sequence divergences (RDD). TI was initially described and patented by Genclis1 and has since been confirmed by several independent academic teams2. TI can lead to base substitutions, insertions and deletions. The latter cause translational frameshifts that have important consequences in determining protein immunogenicity3. Genclis currently focuses on defining the effects of TI proteins translated from gapped RNA on normal and pathological humoral immunity.
This communication expressly or implicitly contains certain forward-looking statements concerning Relief Therapeutics Holding SA and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Relief Therapeutics Holding SA to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Relief Therapeutics Holding SA is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
1 Brulliard et al., 2007. PNAS, 104 (18): 7522–27 and “Transcription Infidelity, detection and uses thereof”, EP2046986, US8288091.
2 Ju et al., 2011. Nature Genetics 43 (8): 745–52; Li et al., 2011. Science, 333 (6038): 53–58; Peng et al., 2012. Nat Biotechnol 30: 253–60, Reid-Bayliss and Loeb, 2017. PNAS 114 (35): 9415.
3 Genclis patent: “Molecular origin of allergy“, EP16305297, WO2017158202A1.