ValiRx con­tin­ues its strong progress

Web­site: www.valirx.com

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With can­cer world­wide be­ing the sec­ond lead­ing cause of death af­ter heart dis­ease,

ValiRx (VAL: AIM) aims to ap­ply its tech­nolo­gies to mod­ern medicine’s bet­ter un­der­stand­ing of can­cer and to de­liver im­proved and more tar­geted treat­ments for the dis­ease.

The com­pany aims to make a sig­nif­i­cant con­tri­bu­tion in ‘pre­ci­sion’ medicine and sci­ence, through the early de­tec­tion of can­cer and its per­son­alised ther­a­peu­tic in­ter­ven­tion. By so do­ing, ValiRx is striv­ing to de­velop ther­a­peu­tics that can sub­stan­tially im­prove hu­man health and well-be­ing.

Cur­rently, the com­pany has four ther­a­peu­tic drugs in de­vel­op­ment, two of which are in clin­i­cal tri­als. Both its clin­i­cal stage ther­a­peu­tics and pre-clin­i­cal as­sets have demon­strated clear po­ten­tial for ad­dress­ing sig­nif­i­cant un­met med­i­cal need. The com­pany has world­wide ex­clu­sive de­vel­op­men­tal and com­mer­cial rights and its com­pounds have world­wide patent pro­tec­tion.

Fur­ther­more, the tech­nolo­gies and sci­ence ly­ing be­hind the de­vel­op­ment pro­grammes and ther­a­peu­tics, orig­i­nate or de­rive from Word class in­sti­tu­tions, such as Can­cer Re­search UK and Im­pe­rial Col­lege.

While es­tab­lished can­cer treat­ments, such as surgery, ra­di­a­tion and chemo­ther­apy, are still im­prov­ing, re­cent ex­cit­ing ad­vances in the can­cer arena to­day, lie in the de­vel­op­ment of novel and tar­geted ther­a­pies, oth­er­wise known as ‘Pre­ci­sion Medicine’. This tar­geted, per­son­alised medicine in­cludes early stage di­ag­no­sis of every spe­cific can­cer, tai­lor-made ther­a­peu­tic in­ter­ven­tion and the care­ful mon­i­tor­ing of progress.

With the de­vel­op­ment of tar­get-based agents, primed to at­tack only iden­ti­fied can­cer cells, higher re­sponse rates for treat­ments, as well as less toxic and more ef­fec­tive out­comes, are now pos­si­ble. New drugs in this group—such as those in ValiRx’s pipe­line— prom­ise to greatly im­prove out­comes for can­cer pa­tients.

RE­CENT CLIN­I­CAL TRIAL PROGRESS AND LAT­EST DE­VEL­OP­MENTS VAL401

ValiRx’s com­pound clos­est to Mar­ket Ap­proved Ap­pli­ca­tion (MAA) is VAL401, which is a re­for­mu­lated drug, Ris­peri­done, with an es­tab­lished safety record de­rived from clin­i­cal stud­ies and years of use in other med­i­cal ar­eas. ValiRx’s sub­sidiary, Val­iSeek, has com­pleted its Phase II trial of VAL401 as an oral treat­ment of late stage non-small cell lung ade­no­car­ci­noma in a clin­i­cal study in Tbil­isi, Ge­or­gia.

Pos­i­tive VAL401 clin­i­cal data from the com­pleted trial in De­cem­ber 2017 showed that the VAL401 treat­ment had a sta­tis­ti­cally sig­nif­i­cant im­prove­ment in over­all sur­vival for pa­tients with non-small cell lung can­cer com­pared to those re­ceiv­ing no treat­ment. The trial also demon­strated that the VAL401 treat­ment had a mea­sure­able im­prove­ment

IN­TRO­DUC­ING… VALIRX A clin­i­cal stage biotech­nol­ogy com­pany spe­cial­is­ing in de­vel­op­ing tar­geted novel treat­ments for can­cer and as­so­ci­ated biomark­ers.

on pa­tient qual­ity of life and did not trig­ger any un­wanted im­mune re­sponses.

The com­pany is cur­rently in the process of fil­ing the for­mal trial re­port to reg­u­la­tors and it is cur­rently in ad­vanced ne­go­ti­a­tions with a num­ber of po­ten­tial part­ners. Sig­nif­i­cant in­ter­est has been re­ceived from or­gan­i­sa­tions in the UK, Europe, US and Asia in­clud­ing po­ten­tial joint ven­ture, li­cens­ing-out and co-de­vel­op­ment struc­tures vis-à-vis the com­pound’s pro­gres­sion into a Phase III clin­i­cal study.

The VAL401 tech­nol­ogy has re­ceived re­cent patent grants in the US and New Zealand. With its world­wide patent pro­tec­tion, al­lied to the trial’s very en­cour­ag­ing re­sults, re­gard­ing both ef­fi­cacy and its pal­lia­tive ef­fect on pa­tients, VAL401 is on the cusp of a piv­otal trial and the value in­flec­tion that would rep­re­sent.

VAL201

ValiRx’s other clin­i­cal-stage com­pound, VAL201, has the po­ten­tial to treat hor­monein­duced on­co­log­i­cal con­di­tions and ab­nor­mal growth in cells, in­clud­ing prostate, breast and ovar­ian can­cers, as well as En­domet­ro­sis.

The com­pound is be­ing tri­alled in pa­tients with hor­mone-re­frac­tory prostate can­cer at Univer­sity Col­lege Lon­don Hospi­tal and has in prac­tise com­pleted its Phase I study. VAL201 is a com­pound with a unique mech­a­nism of ac­tion, which was first dis­cov­ered by aca­demics, partly with sup­port from Can­cer Re­search UK.

VAL201 has per­formed ex­tremely well in its clin­i­cal tri­als and has con­firmed to date, that be­yond it be­ing well tol­er­ated and safe, it is ef­fi­ca­cious and works. The com­pound had a ma­jor trial re­view of its pro­to­col at the end of 2017, which the reg­u­la­tory au­thor­i­ties sub­se­quently ap­proved.

This mod­i­fi­ca­tion to the trial pro­to­col al­lows the Com­pany to es­ca­late or ac­cel­er­ate the dos­ing reg­i­men of the study, from 4mg to 16mg in a cou­ple of steps; ef­fec­tively see­ing a sub­stan­tial in­crease in the dose of VAL201 be­ing ad­min­is­tered to pa­tients, which al­lows treat­ment to more speed­ily reach its full ther­a­peu­tic po­ten­tial and po­ten­tial anti-can­cer im­pact on pa­tients.

The com­pany is ac­tively re­cruit­ing pa­tients for the trial and is hope­ful that data will be­gin to emerge by the yearend, although with the caveat that such an out­come does de­pend on the right sub­jects be­com­ing avail­able and with the ap­pro­pri­ate com­mit­ment level and pro­gres­sion of the dis­ease.

A ma­jor chal­lenge ex­pe­ri­enced in any can­cer treat­ment is the abil­ity of can­cer cells to seek new lo­ca­tions and to spread to other sites in the body. This is called metas­ta­sis. The abil­ity of can­cer cells to metas­ta­size is, as a rule, very bad news for can­cer suf­fer­ers, as it of­fers the can­cer cells po­ten­tial new places in the body for growth.

With this is­sue in mind, sci­en­tists at ValiRx have been very ex­cited by what they have seen in a sub­set of the pre-clin­i­cal data ob­tained with VAL201, as it shows that the com­pound, when ad­min­is­tered in can­cer mod­els, de­creased metastatic growth by up to 50%. Since all can­cers have the po­ten­tial for metastatic growth, ValiRx be­lieves that this treat­ment could po­ten­tially be used in sev­eral on­co­log­i­cal in­di­ca­tions, to­gether with a spe­cific can­cer tar­get­ing treat­ment.

VAL301

By good for­tune, pre­clin­i­cal stud­ies of VAL201 in a slightly dif­fer­ent use, also sug­gested that the com­pound would work against a ma­jor gy­nae­co­log­i­cal in­di­ca­tion, namely En­dometrio­sis. This is a med­i­cal con­di­tion in which cells from the lin­ing of the uterus ap­pear and flour­ish out­side the uter­ine cav­ity. En­dometrio­sis is ex­ces­sively de­bil­i­tat­ing and it rep­re­sents

one of the ma­jor causes of fe­male in­fer­til­ity.

In pre­clin­i­cal stud­ies, VAL201’s re­for­mu­la­tion, which has been named VAL301, has been shown to re­duce the en­dome­trial le­sions by up to 50%. The con­di­tion is not ad­e­quately served with cur­rent med­i­ca­tions, as those med­i­ca­tions are fre­quently poorly tol­er­ated. How­ever, due to VAL201’s safety pro­file and lack of any no­tice­able side ef­fects, the com­pound is well placed as a po­ten­tial treat­ment.

The com­pound has re­cently re­ceived a US patent grant for its use in En­dometrio­sis and is cur­rently in the fi­nal pre­clin­i­cal stage with an am­bi­tion to move into the clinic within the next twelve months de­pen­dant on fund­ing and reg­u­la­tory clear­ance.

VAL101

The mol­e­cule VAL101 is based on a tech­nol­ogy, which is called Gene­ice (‘Gene In­ac­ti­va­tion by Chro­matin En­gi­neer­ing’) and is li­censed from Im­pe­rial Col­lege. All cells in our bod­ies con­tain the same genome and tis­sue dif­fer­en­ti­a­tion re­quires well main­tained, tuned spe­cific gene ac­tiv­ity reg­u­la­tion.

If this reg­u­la­tion sys­tem goes wrong or genes have un­wanted mu­ta­tions and are ‘re­bel­lious’, prob­lems such as can­cer­ous growth or neu­ro­log­i­cal in­di­ca­tions and prob­lems will oc­cur.

The Gene­ice tech­nol­ogy al­lows the de­sign of mol­e­cules which find and bind th­ese ‘re­bel­lious genes’, thereby po­ten­tially re­vers­ing the prob­lem. VAL101 is a mol­e­cule based on this tech­nol­ogy and it is cur­rently in pre­clin­i­cal tri­als.

The com­pound has been op­ti­mised af­ter con­sid­er­able re­for­mu­la­tion and back­ground work, funded by two pres­ti­gious Eurostars grants. ValiRx is now in dis­cus­sions with Euro­pean, US and Chi­nese or­gan­i­sa­tions over ways to take the com­pound for­ward and more de­tails on th­ese dis­cus­sions will emerge in the near fu­ture.

BUSI­NESS MODEL

The Com­pany’s busi­ness model fo­cuses on in-li­cens­ing early stage drugs and tech­nolo­gies from Worldlead­ing aca­demic in­sti­tu­tions, such as Can­cer Re­search UK and Im­pe­rial Col­lege and ma­tur­ing them to the point where they can be out­li­censed to phar­ma­ceu­ti­cal part­ners or co-de­vel­oped and taken to mar­ket. The model for biotech­nol­ogy com­pa­nies, like ValiRx, is to act as a spe­cialised and ex­pe­ri­enced bridge be­tween World-class aca­demic sci­ence and big pharma.

Cur­rently phar­ma­ceu­ti­cal com­pa­nies are fac­ing an in­creas­ing need for novel, more pre­cise and ef­fec­tive ther­a­pies across a num­ber of in­di­ca­tions and ac­cord­ingly, ValiRx strives to be in con­tin­u­ous dis­cus­sions with th­ese ma­jor play­ers in the on­col­ogy field.

THE NEXT STAGE AND INTO THE FU­TURE

Given the cur­rent in­dus­try cli­mate, ValiRx be­lieves that in view of the progress of th­ese tri­als, the com­pany’s ther­a­peu­tic ap­proaches are in­creas­ingly at­trac­tive to pharma part­ners, as a li­cens­ing op­por­tu­nity or a co-de­vel­op­ment part­ner. The in­ter­est ValiRx has seen from po­ten­tial part­ners to date has been very en­cour­ag­ing. Based on ValiRx’s his­tory of out-li­cens­ing sep­a­rate tech­nolo­gies, the com­pany re­mains op­ti­mistic of a suc­cess­ful out­come to its talks and the crys­talli­sa­tion of sub­stan­tial value for its as­sets.

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