“We have more than 5 ex­cit­ing Biosim­i­lar mol­e­cules in our pipe­line”

De­bayan Ghosh, Pres­i­dent and Founder, Epy­gen Biotech

BioSpectrum (India) - - BIO CONTENT - De­bayan Ghosh, Pres­i­dent and Founder, Epy­gen Biotech Dr Man­beena Chawla man­[email protected]­tiv.com

Anew clot buster, PEGy­lated Strep­tok­i­nase – a Novel Bi­o­log­i­cal En­tity (NBE) de­vel­oped by Dr Girish Sahni, Di­rec­tor Gen­eral, Coun­cil of Sci­en­tific and In­dus­trial Re­search (CSIR) and Sec­re­tary, De­part­ment of Sci­en­tific and In­dus­trial Re­search (DSIR) and his team of in­ven­tors at CSIRIn­sti­tute of Mi­cro­bial Tech­nol­ogy (CSIR-IMTECH), Chandi­garh is all set to rev­o­lu­tion­ize the treat­ment of is­chemic strokes around the globe. Is­chemic stroke is a con­di­tion caused by a dys­func­tion in the sup­ply of blood to the brain due to em­boli, throm­bus or ath­er­o­scle­ro­sis oc­cur­ring in cere­bral ar­ter­ies. Is­chemic Stroke is the lead­ing cause of death and dis­abil­ity in the pa­tients. An es­ti­mated 12 lakh In­di­ans suf­fer from it ev­ery year.

Epy­gen Biotech has re­cently an­nounced a part­ner­ship with CSIR-IMTECH mak­ing it the first com­pany in In­dia with ex­clu­sive li­cense of this NBE throm­bolytic pro­tein for is­chemic strokes. CSIR has trans­ferred the tech­nol­ogy to Epy­gen Biotech that would carry out pre-clin­i­cal stud­ies and sub­se­quently clin­i­cal tri­als. De­bayan Ghosh, Pres­i­dent and Founder, Epy­gen Biotech spoke to BioSpec­trum with re­gard to this re­cent de­vel­op­ment. Edited ex­cerpts;

How do you plan to take this part­ner­ship with CSIR- IMTECH fur­ther in or­der to strengthen in­dus­try-academia as­so­ci­a­tion?

In my opin­ion, the academia needs to work closely with the in­dus­try for pri­mar­ily two rea­sons. First, to pro­duce can­di­dates who will add value to in­dus­try with knowl­edge and train­ing, and sec­ond to in­no­vate and im­prove tech­nolo­gies suit­able for the in­dus­try. Epy­gen does not look at the Coun­cil of Sci­en­tific and In­dus­trial Re­search (CSIR) as just an academia, but rather as a use­ful or­ga­ni­za­tion that it part­ners for crit­i­cal in­dus­trial tech­nol­ogy re­search. We see them to have end­less po­ten­tial to un­der­take high qual­ity re­search on fun­da­men­tal and ap­plied biotech­nol­ogy, es­pe­cially in ar­eas of fer­men­ta­tion, pro­tein engi­neer­ing, pro­teomics, ge­nomics and re­com­bi­nant work.

Cur­rently, we have li­censed mul­ti­ple tech­nolo­gies from this or­ga­ni­za­tion, in­clud­ing Novel Bi­o­log­i­cal En­tity (NBE) with tremen­dous po­ten­tial for stroke and car­dio­vas­cu­lar ar­eas, be­ing the sec­ond lead­ing cause of death in the world, af­fect­ing nearly 15 mil­lion peo­ple ev­ery year. We shall closely work with CSIR to es­tab­lish and sub­stan­ti­ate the unique­ness of this tech­nol­ogy, not only in In­dian perspective, also in global con­text. We strongly be­lieve that CSIR-IMTECH has var­i­ous other tech­nolo­gies which Epy­gen would like to en­cour­age in the near fu­ture.

Epy­gen def­i­nitely has a pref­er­ence to work with CSIR-IMTECH over pri­vate re­search com­pa­nies, since we are aware that agen­cies like CSIR at­tracts a pool of smart sci­en­tists, ca­pa­ble of de­liv­er­ing stu­pen­dous re­sults in this field. They def­i­nitely need en­cour­age­ment from in­dus­try to uti­lize their po­ten­tial, and we, for one, strongly be­lieve that In­dia needs to nur­ture this cru­cial part­ner­ship be­tween the in­dus­try and re­search agen­cies.

What ad­van­tage will this new drug of­fer for the treat­ment of Is­chemic strokes as com­pared to

the ex­ist­ing ones in the mar­ket?

Ac­cord­ing to the Amer­i­can Stroke As­so­ci­a­tion (ASA), brain strokes are the sec­ond lead­ing cause of death in the world with a stag­ger­ing 15 mil­lion peo­ple ef­fected caus­ing 11 mil­lion peo­ple ei­ther die or be­come per­ma­nently dis­abled. The preva­lence of stroke is much higher in In­dia than the west and about 87 per cent of all the strokes are is­chemic strokes.

To put it sim­ply, an Is­chemic stroke is the for­ma­tion of a clot in blood ves­sels in the brain where the sub­parts of the brain tis­sue fails to re­ceive nec­es­sary in­gre­di­ents to con­tinue to live healthily and dies off. Cere­bral Is­chemia caused cy­to­toxic in­tra­cel­lu­lar cal­cium over­load and mi­to­chon­drial dys­func­tion trig­gers the ex­e­cu­tion of pro­grammed cell death in neu­rons. The blood–brain bar­rier

(BBB) is a highly se­lec­tive semiper­me­able sys­tem that sep­a­rates the cir­cu­lat­ing blood from the brain and ex­tra­cel­lu­lar fluid in the cen­tral ner­vous sys­tem (CNS) al­low­ing only the pas­sage of wa­ter, gases, amino acids, glu­cose and hor­mones that are cru­cial to neu­ral func­tion. How­ever, it re­stricts pas­sage of solutes in the blood (e.g., bac­te­ria) and large or hy­drophilic mol­e­cules. Dur­ing stroke, one crit­i­cal event that oc­curs is the disruption of this blood-brain bar­rier caused by fac­tors like MMP.

There are pri­mar­ily two lines of treat­ments cur­rently used for stroke. One is a med­i­cal de­vice which tracks the po­si­tion of the clot by imag­ing and re­trieves it by me­chan­i­cal meth­ods. Need­less to men­tion, such ad­vanced equip­ment are rarely avail­able in most parts of the de­vel­op­ing world.

The other one is a throm­bolytic treat­ment cur­rently used for stroke based on Tis­sue Plas­mino­gen Ac­ti­va­tor (tPA), namely Al­teplase and Tenecteplase. Once in­jected into the pa­tient, these pro­teins sol­u­bi­lizes the clot and re­in­state blood flow sav­ing the brain tis­sue from star­va­tion. How­ever tPA’s pleiotropic ac­tions in the brain in­clud­ing ac­ti­va­tion of MMPs and other molec­u­lar path­ways in­creas­ing tPA neu­ro­tox­i­c­ity, has a po­ten­tial to fur­ther da­m­age the BBB, and worsen edema and cere­bral hem­or­rhage.

On the other hand, the Novel Bi­o­log­i­cal En­tity (NBE) that is be­ing de­vel­oped for Is­chemic Stroke would ef­fi­ciently sol­u­bi­lize the clot in the brain with­out trig­ger­ing any ad­verse ef­fect on BBB hence with­out Neu­ro­tox­i­c­ity.

What chal­lenges do you fore­see in car­ry­ing out pre-clin­i­cal and clin­i­cal stud­ies using this new tech­nol­ogy?

The pre-clin­i­cal and clin­i­cal tri­als for this tech­nol­ogy would be con­ducted on an in­ter­na­tional plat­form, which at­tracts ex­tremely high reg­u­la­tory com­pli­ance. In ad­di­tion, un­like many other mol­e­cules which can be tested on species like rats, mice and rab­bits, this model re­quires test­ing on a species of cynomol­gus pri­mate, com­monly known as a crab eat­ing Ma­caque!

How would this de­vel­op­ment con­trib­ute to the com­pany’s growth in the com­ing years? What other plans are in store for the fu­ture?

This de­vel­op­ment is phe­nom­e­nal for the com­pany’s fu­ture be­cause we had al­ready been work­ing in the car­dio­vas­cu­lar area for the past few years, de­vel­op­ing the ad­vanced biosim­i­lar ver­sion of rSK based throm­bolytic pro­tein for My­ocar­dial In­farc­tion. This novel bi­o­log­i­cal en­tity would cer­tainly add cre­den­tials in Epy­gen’s ad­vance­ment in the field of Bi­o­log­ics, for treat­ment of crit­i­cal ail­ments. We have taken a two tong ap­proach to our Bi­o­log­ics busi­ness. The first one is Li­cens­ing in proven Biosim­i­lar tech­nolo­gies and uti­liz­ing our ‘state of the art’ Bi­o­log­ics fa­cil­ity in In­dia to pro­duce, com­plete reg­u­la­tory path­way, scaleup and com­mer­cial­ize those mol­e­cules. We have more than 5 ex­cit­ing Biosim­i­lar mol­e­cules in this pipe­line. The sec­ond model is where we Li­cense in novel bi­o­log­i­cal tech­nolo­gies and take them from an early stage through late stages uti­liz­ing our deep un­der­stand­ing of the con­cept, pro­tein ex­pres­sion, pu­rifi­ca­tion and reg­u­la­tory path­ways, un­leash­ing bil­lions of dol­lars of po­ten­tial in each mol­e­cule. It is un­der­stood that de­vel­op­ing a Bi­o­logic needs deep minds and even deeper pock­ets, but we are pre­pared to deal with that as­pect ow­ing to the tremen­dous po­ten­tial of these tech­nolo­gies, both fi­nan­cially and in hu­man wel­fare.

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