RELIEF THERAPEUTICS Holding SA (“Relief”, “the Company”) announces that it has acquired from Genclis SA exclusive worldwide commercial and manufacturing sub-licensable rights for human applications on 2 products protected by Genclis patents. These products are: artificial colostrum and milk produced without hydrolysis. Both products have successfully completed pre-clinical validation. Artificial colostrum provides highly reactive immunoglobulins that closely mimic natural colostrum and will be clinically tested first for efficacy in hard-to-treat digestive infections. Non-hydrolyzed hypoallergenic bovine milk provides a novel therapeutic strategy for preventing milk allergies. Immediate application will focus on children at high risk of allergy, because it may contribute to reduce the allergic march on the premises that milk allergy is usually followed by allergies to various other foods and often culminates in persistent severe allergies to peanuts and other food.
Natural colostrum has many applications spanning from food to cosmetic and pharmaceutical industries. Likewise, given the global increase of food allergies, the market for allergy-preventing milk represents a substantial opportunity. With this purchase, Relief reinforces and diversifies its portfolio of medicinal product candidates (MPC), albeit initially with products requiring a simpler development path as dietary supplements. Relief will conduct the clinical studies necessary to confirm the utility of these products and then seek specialized commercial partners. Under the terms of the Licensing Agreement, Relief and Genclis will establish a close collaboration to reach these objectives.
Financial terms were not disclosed.
Relief is a clinical-stage company that currently has two MPCs at clinical development stages under the regulatory guidelines applicable to drugs candidates. Gael Hedou, CEO of Relief comments: “We have been highly impressed by the groundbreaking nature of Genclis’ discoveries that convey a disruptive approach towards a more natural control of severe intestinal infections and food allergies starting with milk. We look forward to expanding our collaboration with the aim of accelerating these clinical developments.”
Bernard Bihain, CEO of Genclis adds: “We are delighted to transfer these important pre-clinical assets to the Relief Team that has extensive experience in translational medicine. We have a long history of collaboration with the Relief scientists and look forward to working with them in order to rapidly provide patients with these novel solutions.”
RELIEF THERAPEUTICS Holding AG 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).
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 AG 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 AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Relief Therapeutics Holding AG 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.